Title 22 DCMR — HEALTH

22-A MENTAL HEALTH

22-A DCMR § 100 PURPOSE AND APPLICATION

100.1 The purpose of these rules is to protect and enhance the rights and protections of consumers by establishing:

(a) The specific procedures for obtaining informed consent to treatment from consumers, including treatment with medication;

(b) The specific procedures for obtaining informed consent to treatment when a consumer lacks capacity to make a treatment decision; and

(c) The specific procedures for obtaining a valid declaration of advance instructions regarding psychiatric care and treatment from a consumer.

100.2 The rules in this Chapter are applicable to each MH provider and the DMH.

100.3 For purposes of this Chapter, a MH provider includes all privately and publicly operated providers of mental health services and supports, including the public core services agency and St. Elizabeths Hospital. References to DMH refer to DMH when it is acting in its capacity as the mental health authority for the District.

100.4 For purposes of this Chapter, each consumer 18 years of age or older who is receiving mental health services and supports is presumed to have the legal capacity to make treatment decisions unless:

(a) A court has declared the consumer incompetent to make treatment or health care decisions and has appointed a guardian to make such decisions;

(b) It has been determined that the consumer lacks the capacity to make a health care decision under § 5 of the Health-Care Decisions Act (HCDA), effective March 16, 1989 (D.C. Law 7-189; D.C. Official Code § 21-2204); or

100.5 A person who is under 18 years old and seeks or receives mental health services or mental health supports may lawfully consent to treatment or make treatment decisions consistent with Section 214 of the Mental Health Services Delivery Reform Act of 2001 (Act), effective date December 18, 2001 (D.C. Law 14-56; D.C. Official Code §§ 7-1231.01 et seq.).

100.6 Each consumer has the rights and protections set forth in the Mental Health Service Delivery Reform Act of 2001. In addition each consumer has the following rights and protections related to informed consent for treatment. The right to:

(a) Be treated with consideration and respect for dignity, autonomy, and privacy;

(b) Service in a humane setting that is the least restrictive feasible as defined in the consumer's service plan;

(c) Be informed of the consumer's own condition, of proposed or current services, treatment or therapies, and of the alternatives;

(d) Consent to or refuse any service, treatment, or therapy upon full explanation of the expected consequences of such consent or refusal, except as provided in § 100.4 of this chapter;

(e) Active and informed participation in the establishment, periodic review and reassessment of the consumer's service plan;

(f) Freedom from unnecessary or excessive medication;

(g) Freedom from unnecessary restraint or seclusion;

(h) Be informed of and refuse any unusual or hazardous treatment procedures, and to refuse to participate in research projects of experimental programs; and

(i) Be advised of and refuse observation by techniques such as one-way vision mirrors, tape recorders, televisions, movies or photographs.

100.7 Each MH provider shall adhere to the requirements regarding posting and distributing the Consumer Rights Statement set forth in 22A DCMR, Chapter 3.

History

SOURCE: New by emergency and proposed rulemaking at 49 DCR 3058(July 19, 2002)[EXPIRED]; as amended by emergency and proposed rulemaking at 49 DCR 8768(September 20, 2002)[EXPIRED]; Final Rulemaking published at 49 DCR 11245 (December 13, 2002).

22-A DCMR § 101 INFORMED CONSENT TO TREATMENT

101.1 For purposes of this Chapter, the term "informed consent" means that a consumer grants, refuses or withdraws consent to treatment after the MH provider presents the consumer with information about the proposed mental health services, mental health supports, or treatment, in language and a manner that the consumer can understand. As part of informed consent, the consumer must be capable of making and communicating a decision about the proposed mental health service, mental health support, or treatment. The information provided to the consumer shall include an explanation of:

(a) The consumer's mental illness or mental health related problem, including diagnosis;

(b) The purpose of the proposed mental health service, mental health support, or treatment;

(d) The known and potential common side effects or risks of the proposed mental health service, mental health support, or treatment;

(e) The potential benefits of the proposed mental health services, mental health supports, or treatment; and

(f) Any feasible alternatives to the proposed mental health services, mental health supports, or treatment.

101.2 Each MH provider shall obtain informed consent to treatment from each consumer receiving mental health services or mental health supports from the MH provider prior to implementing the consumer's service plan. Informed consent to treatment shall be written. If the consumer is unwilling or unable to sign a consent to treatment form, then the MH provider shall document the reason in the consumer's clinical records.

101.3 Each consumer shall also be given an opportunity to ask questions about the proposed mental health services, mental health supports, or treatment, and shall be given an opportunity to give informed consent to each component of the individual recovery plan or service plan. The written consent to treatment form shall identify each mental health support, mental health service, or treatment, including the name and dosage of the medication prescribed, if any, for which the consumer has given his or her informed consent. The written consent to treatment form is not the same as the form signed by a consumer consenting generally to receive services from or enrolling with a MH provider.

101.4 Each MH provider's discussion with a consumer about the information described in § 101.1 shall be documented in the consumer's clinical record. The consumer shall acknowledge, in writing, that the MH provider has provided the consumer with the information necessary for the consumer to give informed consent to the proposed mental health services, mental health supports and course of treatment. If the consumer is unable or unwilling to make this acknowledgement in writing, then the MH provider shall document the reason in the consumer's clinical record.

101.5 Each MH provider shall document in the consumer's clinical record whether the consumer has consented to the mental health services, mental health supports or course of treatment recommended by the provider. Each MH provider shall document in the consumer's clinical record whether the consumer has declined to consent to the proposed treatment, mental health service or mental health support.

101.6 If a consumer who has given informed consent to a mental health service, mental health support, or treatment decides he or she no longer consents to the treatment, then the MH provider must document the decision in the consumer's clinical record. A MH provider may not continue providing a specific mental health service, mental health support, or treatment to a consumer who withdraws his or her consent to that particular form of treatment.

101.7 No MH provider shall administer electroconvulsive treatment to a consumer without the written informed consent of the consumer or a court order issued in compliance with D.C. Official Code § 21-2047(c)(2) and § 21-2211(b).

101.8 No MH provider shall condition the receipt of any individual mental health service, mental health support or treatment upon the consumer's agreement to accept another mental health service, mental health support or treatment.

History

SOURCE: New by emergency and proposed rulemaking at 49 DCR 3058(July 19, 2002)[EXPIRED]; as amended by emergency and proposed rulemaking at 49 DCR 8768(September 20, 2002)[EXPIRED]; Final Rulemaking published at 49 DCR 11245 (December 13, 2002).

22-A DCMR § 102 INFORMED CONSENT FROM SUBSTITUTE DECISION-MAKER

102.1 If, while or after presenting the information required by § 101.1 to a consumer, the consumer's treating psychiatrist or psychologist believe that the consumer is incapable of making or communicating a decision regarding the provision of a mental health service, mental health support or treatment, the psychiatrist or psychologist may seek certification of the consumer's incapacitation in accordance with D.C. Official Code § 21-2204.

(a) Certification of incapacity to make a treatment decision requires a determination by two physicians, one of whom shall be the consumer's treating psychiatrist, that the consumer lacks the capacity to understand the decision to be made, or to make or communicate a decision about the proposed treatment.

(b) A consumer shall not be deemed incapacitated if the consumer is capable of understanding the decision to be made, making the decision, and communicating the decision, but refuses to consent to a proposed treatment or makes a decision different than the MH provider would prefer.

102.2 If a consumer has been certified as incapacitated in accordance with D.C. Official Code § 21-2204, the MH provider shall seek informed consent to the proposed mental health service, mental health support or course of treatment as follows:

(a) From the consumer's designated attorney-in-fact, if the consumer has executed a valid durable power of attorney for health care; or

(b) From a substitute health care decision-maker in accordance with D.C. Official Code § 21-2210.

102.3 If a consumer has been certified as incapacitated in accordance with D.C. Official Code § 21-2204 and the MH provider is not able to obtain informed consent from either a designated attorney-in-fact or a substitute health care decision-maker, the MH provider shall petition the court for appointment of a guardian and seek informed consent from the guardian appointed by the court pursuant to D.C. Official Code § 21-2041, except as provided in § 103 and § 104 of this chapter.

102.4 A MH provider shall seek appointment of a guardian for a consumer in accordance with subchapter V of Chapter 20 of Title 21 of the District of Columbia Official Code, if:

(a) A consumer remains incapacitated for purposes of making a particular health care decision for more than thirty (30) days following certification of incapacitation as described in § 102.1 of this chapter; and

(b) The consumer does not have an attorney-in-fact designated in a durable power of attorney document available to make a decision about the delivery of mental health services, mental health supports or treatment to the consumer.

102.5 A substitute decision-maker shall act in accordance with the consumer's treatment preferences as expressed in an advance directive or a declaration of advance instructions. A substitute decision-maker's decision regarding mental health treatment which is based on the consumer's expressed treatment preferences shall be followed by DMH or the MH provider, except for good cause as documented in the consumer's clinical records, and shall never be overridden for the convenience of DMH or the MH provider.

102.6 In the absence of an advance directive or declaration of advance instructions, a substitute decision-maker shall grant, refuse or withdraw consent to mental health treatment based on the known wishes of the consumer or, if the wishes of the consumer are unknown and cannot be ascertained, on a good faith belief as to the best interests of the consumer. D.C. Official Code § 21-2210(b). A substitute decision-maker may consent to the administration of medication for the consumer only in accordance with the consumer's treatment preferences as expressed in a durable power of attorney document or in a declaration of advance instructions for mental health treatment.

102.7 A MH provider shall document whether the substitute decision-maker grants, refuses or withdraws consent to mental health treatment on behalf of a consumer in the consumer's clinical record. At least one (1) witness shall be present whenever a substitute decision-maker grants, refuses or withdraws consent to treatment on behalf of a consumer.

History

SOURCE: New by emergency and proposed rulemaking at 49 DCR 3058(July 19, 2002)[EXPIRED]; as amended by emergency and proposed rulemaking at 49 DCR 8768(September 20, 2002)[EXPIRED]; Final Rulemaking published at 49 DCR 11245 (December 13, 2002).

22-A DCMR § 103 INFORMED CONSENT NOT REQUIRED IN EMERGENCY

103.1 An emergency means a situation in which a consumer is experiencing a mental health crisis and in which the immediate provision of mental health treatment is necessary to prevent serious injury to the consumer or others.

103.2 If an emergency exists, the MH provider shall obtain a written opinion from either the consumer's attending physician or treating physician stating that delay in obtaining informed consent to the mental health service, mental health support or treatment is likely to result in serious injury to the consumer (Emergency Opinion). If the MH provider has information that the consumer would not consent to emergency treatment based on the consumer's religious beliefs, the MH provider must obtain a court order prior to administering treatment that would terminate the emergency.

103.3 After receipt of the Emergency Opinion, the MH provider shall provide mental health services, mental health supports or treatment to the extent necessary to terminate the emergency.

History

SOURCE: New by emergency and proposed rulemaking at 49 DCR 3058(July 19, 2002)[EXPIRED]; as amended by emergency and proposed rulemaking at 49 DCR 8768(September 20, 2002)[EXPIRED]; Final Rulemaking published at 49 DCR 11245 (December 13, 2002).

22-A DCMR § 104 ADMINISTRATION OF MEDICATION

104.1 Each MH provider shall obtain informed consent from each consumer prior to administering medication for the purposes of mental health treatment, except as described in § 104.4 through § 104.17 of this chapter.

104.2 Prior to administering any medication for purposes of mental health treatment, a MH provider shall present the consumer with information about the proposed medication, including, but not limited to:

(a) The name and dose of the medication being prescribed;

(b) The purpose of administering the medication;

(d) Potential risks and benefits of taking the medication;

(e) Information about feasible alternative treatments; and

(f) An opportunity to ask questions about the proposed medication and to discuss the decision with family or others.

104.3 Each MH provider shall obtain the consumer's written informed consent to administration of medication, prior to prescribing and administering such medication. Such informed consent shall be documented in the consumer's clinical record. If the consumer consents to treatment with medication but is not willing or able to give consent in writing, the MH provider shall document this in the consumer's clinical records prior to beginning treatment with medication and document the reason the consumer has not given written consent.

104.4 If, after presenting the information described in § 104.2, the MH provider and the consumer's attending or treating physician believe that the consumer is incapable of making a decision about treatment with medication, the MH provider and consumer's attending or treating physician shall seek certification of incapacitation in accordance with § 102.1. If a consumer has been certified as incapacitated for purposes of making a health care decision, the MH provider shall seek informed consent to the proposed treatment in accordance with § 11 of the HCDA (D.C. Official Code § 21-2210).

104.5 Any consent to the administration of medication by a consumer's attorney-in-fact or substitute health care decision-maker must be consistent with the consumer's treatment preferences, as expressed in a validly executed durable power of attorney for health care or declaration of advance instructions for mental health treatment.

104.6 A MH provider may administer medication for mental health treatment to an incapacitated consumer without the consumer's written informed consent, pursuant to the MH provider's policy that shall be approved by DMH and shall be consistent with these rules and other relevant Federal and local laws and regulations, in:

(a) An emergency, as defined in § 103.1; or

(b) The absence of an attorney-in-fact or substitute health care decision-maker available and willing to make a decision about the administration of medication, after affording the consumer the right to procedures guaranteed by § 208 of the Mental Health Consumers' Rights Protection Act of 2001 (Title II), effective December 18, 2001 (D.C. Law 14-56; D.C. Official Code § 7-1231.08).

104.7 A consumer's refusal to consent to the administration of medication on the basis of a valid religious objection shall not be overridden, in either an emergency or non-emergency, without a valid court order.

104.8 The Director or his/her designee shall designate a neutral person within DMH or the MH provider to serve as the internal reviewer of the necessity for involuntary administration of medication (Medication Review Officer).

104.9 A MH provider seeking approval of involuntary administration of medication to an incapacitated consumer shall:

(a) Provide the consumer with written and oral information about available advocacy services;

(b) Notify the Director or the Chief Clinical Officer of a consumer's request for a meeting with the designated Medication Review Officer;

(d) Notify the consumer of his or her right to be present and have a personal representative present during the meeting with the Medication Review Officer.

104.10 The Medication Review Officer shall schedule a meeting with the MH provider, the consumer and the consumer's representative, and the psychiatrist seeking to administer the medication. The consumer, the MH provider and the psychiatrist shall have the opportunity to present information about the proposed treatment with medication, the necessity for administering the medication, the consumer's capacity to make a decision about the proposed medication, and the consumer's reasons for not consenting to medication. In addition, the Medication Review Officer shall review the consumer's advance directive or declaration of advance instructions, if one exists.

104.11 The Medication Review Officer shall document the outcome of the review of the need for involuntary administration of medication in a written report to be included in the consumer's clinical record. In addition, a copy of the report shall be submitted to the Director or the Chief Clinical Officer, the consumer, the MH provider and the consumer's treating psychiatrist within three (3) business days after the meeting. The Medication Review Officer's report shall state whether the medication may be administered over the consumer's objection. If the Medication Review Officer's report authorizes the administration of medication, it shall be valid for a maximum of thirty (30) days from the date of issuance. The written report shall include the following:

(a) A list of the facts and circumstances considered during the review;

(b) Findings of Fact;

(d) Recommendations.

104.12 If the Medication Review Officer concurs in the conclusion that the consumer lacks the capacity to make a decision regarding treatment with medication and determines that the consumer should be treated with medication without informed consent, then the Medication Review Officer shall notify the consumer and the consumer's representative, if one is involved, that the consumer may seek a review of the decision with the DMH Medication Review Panel.

104.13 The consumer shall have the right to appeal the Medication Review Officer's decision to the DMH Medication Review Panel. Within one (1) day of the date of the Medication Review Officer's decision, the consumer or the consumer's personal representative must inform the Medication Review Officer or the Chief Clinical Officer if the consumer would like to appeal the Medical Review Officer's decision. If the consumer would like his or her representative to participate in the Medication Review Panel process, then the consumer or the representative must inform the Medication Review Officer or the Chief Clinical Officer whether there are any times in the next 72 hours when the representative would not be available.

104.14 The Director shall appoint a Medication Review Panel to review decisions of the Medication Review Officer, if the consumer has requested an appeal. The members of the Medication Review Panel shall:

(a) Not be affiliated with the consumer, the MH provider or psychiatrist seeking to administer the medication; and

(b) Include a board-certified psychiatrist, a licensed mental health practitioner and a consumer or if unavailable, a consumer advocate.

104.15 The DMH Medication Review Panel shall convene within seventy-two (72) hours of receipt of the appeal and shall review the Medication Review Officer's decision. Notice of the time for the DMH Medication Review Panel meeting shall be provided to the consumer and the consumer's representative, if one has been involved. The Medication Review Panel shall convene at the MH provider facility where the consumer receives services.

104.16 The Medication Review Officer's decision shall be stayed pending review by the DMH Medication Review Panel.

104.17 The DMH Medication Review Panel shall issue a decision upholding or overturning the Medication Review Officer's decision within one (1) day of its meeting.

History

SOURCE: New by emergency and proposed rulemaking at 49 DCR 3058(July 19, 2002)[EXPIRED]; as amended by emergency and proposed rulemaking at 49 DCR 8768(September 20, 2002)[EXPIRED]; Final Rulemaking published at 49 DCR 11245 (December 13, 2002).

22-A DCMR § 105 ADVANCE DIRECTIVES AND INSTRUCTIONS

105.1 Each consumer has the right to make health care decisions for himself or herself, including the right to accept or refuse life-sustaining medical treatment if such treatment becomes necessary, unless certified as incapacitated pursuant to D.C. Code § 21-2204. In addition, each mental health consumer has the right to execute advance directives to be used if a determination is made that the consumer lacks the capacity to make a health care decision.

105.2 An advance directive is a written document signed by a consumer that indicates the consumer's preferences regarding medical treatment decisions, including mental health treatment, and may be in the form of:

(a) A validly executed and current living will prepared in accordance with the requirements of § 3 of the Natural Death Act of 1981, effective February 25, 1982 (D.C. Law 4-69; D.C. Official Code § 7-622);

(b) A validly executed and current durable power of attorney for health care prepared in accordance with the requirements of § 6 of the HCDA (D.C. Official Code § 21-2205), which may include an advance directive for health or mental health treatment; or

(c) A validly executed declaration of advance instructions for mental health treatment prepared in accordance with the requirements of § 105.7 of this chapter.

105.3 The existence of a living will, durable power of attorney for health care, advance directive or declaration of advance instructions for mental health treatment shall not affect a consumer's right to make decisions about the receipt of particular mental health services or mental health supports when the consumer is capable of making such decisions.

105.4 Each MH provider shall establish a system to verify whether each consumer receiving mental health services from the MH provider has prepared a living will, a durable power of attorney for health care or a declaration of advance instructions (Advance Directive Verification System). The Advance Directive Verification System shall include the following elements:

(a) An explanation of advance directives and advance instructions in language the consumer can understand;

(b) An opportunity for the consumer to give the MH provider a copy of the consumer's current living will, durable power of attorney for health care or declaration of advance instructions; and

(c) An opportunity for the consumer to execute a living will, durable power of attorney for health care or declaration of advance instructions.

105.5 Each MH provider shall ensure that the living will, durable power of attorney for health care or declaration of advance instructions executed by each consumer receiving mental health services from the MH provider becomes part of the consumer's clinical record.

105.6 Each MH provider shall establish a system to ensure that the clinical record for each consumer receiving mental health services from the MH provider is updated to reflect any changes to the consumer's living will, durable power of attorney for health care, or declaration of advance instructions.

105.7 A valid declaration of advance instructions shall:

(a) Be written;

(b) Include the signature of at least one adult witness who is not related to the consumer by blood or marriage, who is not employed by DMH or the MH provider, and who is not the consumer's attending physician;

(c) Include acknowledgment that the witness believes the consumer is able to express the preferences set forth in the declaration of advance instructions; and

(d) Be signed and dated by the consumer.

105.8 A consumer may be capable of executing a durable power of attorney for health care even though a determination has been made, pursuant to the HCDA, that the consumer lacks the capacity to make a treatment decision. In the absence of a durable power of attorney for health care, the MH provider will rely on a substitute decision maker as identified in § 11 of the HCDA (D.C. Official Code § 21-2210).

History

SOURCE: New by emergency and proposed rulemaking at 49 DCR 3058(July 19, 2002)[EXPIRED]; as amended by emergency and proposed rulemaking at 49 DCR 8768(September 20, 2002)[EXPIRED]; Final Rulemaking published at 49 DCR 11245 (December 13, 2002).

22-A DCMR § 199 DEFINITIONS

199.1 The following terms have the meaning ascribed in this section:

"Advanced directives" - a written statement or document signed by a consumer indicating what decision the consumer would make regarding health care or mental health care, which may be relied on by a substitute decision-maker in the event that the consumer is deemed incapacitated under the Health-Care Decisions Act. This statement or document may be incorporated into another document, such as a durable power of attorney designation, but could be freestanding.

"Attending physician" - the physician, who may be a psychiatrist, on duty or on call at the MH provider who becomes involved in the care of a consumer.

"Attorney-in-fact" - a person who has been appointed by a consumer to make health care decisions on the consumer's behalf, in the consumer's durable power of attorney for health care, in accordance with D.C. Official Code § 21-2205(a).

"Capacity" - the ability to understand and appreciate the nature and consequences of the proposed mental health treatment, including the benefits and risks of, and alternatives to, the proposed mental health treatment and to make and communicate a decision regarding the proposed mental health treatment.

"Chief Clinical Officer" - the person appointed by the Director to be the Chief Clinical Officer of the Department, pursuant to § 107 of the Act (D.C. Official Code § 7-1131.07).

"Consumer" - a person 18 years of age or older eligible to receive mental health services and mental health supports as defined in § 102 of the Act (D.C. Official Code § 7-1131.02(18) and (19)).

"Consumer Rights Statement" - a document prepared and distributed by DMH to all MH providers which describes all the consumer rights and protections available under federal and District laws and regulations.

"Court" - means the Superior Court of the District of Columbia

"Declaration of advance instructions" - a written statement of a consumer's mental health treatment preferences, including the consumer's informed choice to accept or forego particular mental health services and mental health supports.

"Director" - the Director of DMH.

"DMH" - the Department of Mental Health

"DMH Medication Review Panel" - a panel of three persons appointed by the Director to review appeals from decisions by the Medication Review Officer.

"Durable power of attorney for health care" - a document prepared by a consumer in accordance with the requirements of the HCDA which designates an attorney-in-fact to make various health care decisions on the consumer's behalf when the consumer is unable to make such decisions. A durable power of attorney for health care may include instructions for the attorney-in-fact about health care decisions, including mental health treatment preferences.

"Emergency" - a situation in which a consumer is experiencing a mental health crisis and in which the immediate provision of mental health treatment is, in the written opinion of the attending physician, necessary to prevent serious injury to the consumer or others.

"Grievance" - a description by any individual of his or her dissatisfaction with either DMH or a MH provider, including the denial or abuse of any consumer right or protection provided by applicable federal and District laws and regulations.

"Living will" - a document prepared by a consumer in accordance with the requirements of the Natural Death Act of 1981, which sets forth the consumers wishes regarding application or withdrawal of life sustaining procedures.

"Medication Review Officer" - a neutral person within DMH or a MH provider, appointed by the Director or her/his designee to review the necessity for involuntary administration of medication.

"Mental Illness" - a substantial disorder of thought, mood, perception, orientation, or memory that grossly impairs judgment, behavior, capacity to recognize reality, or ability to meet the ordinary demands of life.

"Mental health services" - the services funded or regulated by DMH for the purpose of addressing mental illness or mental health problems.

"Mental health supports" - the supports funded or regulated by DMH for the purpose of addressing mental illness or mental health problems.

"MH provider" - any individual or entity, public or private, which is licensed or certified by the District to provide mental health services and mental health supports, or that has entered into an agreement with DMH to provide mental health services and supports.

"Policy" - a written statement developed by an MH provider that gives specific direction regarding how the MH provider shall operate administratively and programmatically.

"Procedure" - a written set of instructions describing the step-by-step actions to be taken by MH provider staff in implementing a policy of the MH provider.

"Service plan" - the individual recovery plan (IRP) for adults, the individual service plan (ISP) for children and youth, or the treatment plan for a consumer. The service plan identifies the mental health supports and mental health services that will be provided to a consumer.

"St. Elizabeths Hospital" - the inpatient psychiatric hospital operated by DMH.

"Substitute health care decision-maker" - means an individual authorized to make an incapacitated consumer's health care treatment pursuant to D.C. Official Code § 21-2210(a).

"Treating physician" - the physician, who may be a psychiatrist, responsible for regularly treating a particular consumer. In some instances the treating physician may also be the attending physician.

History

SOURCE: New by emergency and proposed rulemaking at 49 DCR 3058(July 19, 2002)[EXPIRED]; as amended by emergency and proposed rulemaking at 49 DCR 8768(September 20, 2002)[EXPIRED]; Final Rulemaking published at 49 DCR 11245 (December 13, 2002).

22-A3 CONSUMER GRIEVANCE PROCEDURES

22-A DCMR § 300 PURPOSE AND APPLICATION

300.1 The purpose of these rules is to protect and enhance the rights and protections of consumers by establishing the specific procedure for response to and impartial resolution of grievances.

300.2 The rules in this Chapter are applicable to each mental health provider (MH provider) and the Department of Mental Health (DMH). References to DMH may refer to DMH when it is acting in its capacity as the Mental Health Authority for the District of Columbia.

History

SOURCE: Final Rulemaking published at 50 DCR 8480 (October 10, 2003).

22-A DCMR § 301 CONSUMER RIGHTS AND PROTECTIONS PROCEDURE

301.1 Each MH provider shall establish and adhere to a Consumer Rights Policy. The MH provider's Consumer Rights Policy must be approved by the MH provider's governing authority and DMH, and contain, at a minimum, the following:

(a) A Consumer Rights Statement published by DMH;

(b) A copy of the MH provider's Grievance Procedure established in accordance with § 306;

(d) The following statement: "You may also have the option to initiate a grievance with any or all of several outside entities, including but not limited to the Office of Administrative Review and Appeals at the Department of Human Services, the U.S. Department of Health and Human Services, and the District of Columbia's program for the protection and advocacy for persons with mental illness. For further information, contact the Department of Mental Health's Access Hotline or its web site."

301.2 Within one hundred eighty (180) days of the effective date of these rules, each MH provider shall submit to DMH its written Consumer Rights Policy, including the MH Provider Grievance Procedure, for approval. DMH must approve the Consumer Rights Policy of each MH provider in order for the MH provider to be certified and licensed by DMH.

(a) A MH provider shall submit subsequent substantive changes to its Consumer Rights Policy or MH Provider Grievance Procedure to DMH for approval before implementation of the changes by the MH provider.

(b) A MH provider may continue to utilize existing consumer grievance policies approved by DMH in the certification process for MH providers, until the MH provider adopts a new procedure consistent with §§ 304 through 306 and approved by DMH as required by this section 301.2.

301.3 Each MH provider shall disseminate its Consumer Rights Policy in ways designed to foster consumer understanding, including, at a minimum:

(a) A MH provider shall provide a copy of its Consumer Rights Policy to each consumer at his or her initial appointment with the provider or at the next appointment. At the same time the MH provider shall also offer a verbal explanation of the Policy to the consumer and provide such explanation upon request.

(b) The consumer, and his or her legal guardian if present, shall sign a DMH-approved form acknowledging receipt of the Policy and any verbal explanation. The receipt form shall be placed in the consumer's clinical record.

(c) If the consumer elects not to sign the receipt form, the reasons given for not signing shall be recorded on the form.

(d) In the event of a crisis or other emergency at the initial or next appointment that prevents a written and verbal explanation of the Consumer Rights Policy, the consumer shall be verbally advised of, at a minimum, the consumer's immediately pertinent rights and protections, such as the right to consent to or to refuse the offered treatment and the consequences of that consent or refusal. In such cases, distribution and explanation of the Consumer Rights Policy shall be accomplished at the consumer's next appointment and the reason for the delay shall be documented on the receipt form.

(e) Each MH provider shall post a copy of the Consumer Rights Policy in strategic and conspicuous locations in each building operated by the provider, and shall make additional copies of the Consumer Rights Policy available to consumers, parents, guardians, family, designated personal representatives and staff upon request.

(f) Each MH provider shall ensure that every current staff member, including administrative, clerical, and support staff, is knowledgeable about its Consumer Rights Policy when its grievance procedure goes into effect. Each MH provider shall also establish a means of ensuring that all new staff members who are hired in the future are knowledgeable about its Consumer Rights Policy.

History

SOURCE: Final Rulemaking published at 50 DCR 8480 (October 10, 2003).

22-A DCMR § 302 INDEPENDENT PEER ADVOCACY PROGRAMS

302.1 DMH shall facilitate and provide funding to establish one or more peer advocacy programs independent of all MH providers to assist consumers throughout the grievance process, including filing a grievance, accompanying consumers to meetings, helping consumers gather relevant information, and presenting the information in any subsequent proceedings. A peer advocacy program may provide services to consumers in addition to assistance with grievances.

302.2 The responsibilities of a peer advocacy program established under § 302.1 shall include:

(a) Recruit and collaborate with DMH to train independent peer advocates;

(b) Ensure that independent peer advocates abide by all federal and local requirements for the confidentiality of consumer information;

(d) Provide an intake function that permits consumers to submit requests for assistance twenty-four (24) hours per day, seven (7) days per week; and

(e) Ensure that an independent peer advocate is available for individual consultation no later than twenty-four (24) hours after a consumer has submitted a request for assistance pursuant to § 302.2 (d) above.

302.3 An independent peer advocate shall not assist a consumer with a grievance against a MH provider from which the peer advocate is currently receiving mental health services or supports, unless the consumer consents in writing to such assistance.

302.4 The existence of an independent peer advocacy program is not intended to replace or discourage the use of any consumer advocacy programs a MH provider may offer.

History

SOURCE: Final Rulemaking published at 50 DCR 8480 (October 10, 2003).

22-A DCMR § 303 CORE SERVICES AGENCY TRANSITIONAL PEER ADVOCACY PROGRAM

303.1 Within thirty (30) days from the effective date of these rules and until such time as DMH notifies MH Providers that an Independent Peer Advocacy Program has been established in accordance with § 302, each Core Services Agency (CSA) shall maintain an internal peer advocacy program.

303.2 Each CSA shall appoint one or more peer advocates who shall be available to provide information and advice to consumers and to act as representatives of consumers who have filed or contemplate filing a grievance.

303.3 Each CSA shall make consumers aware of the availability of peer advocates and shall ensure that consumers have reasonable access to peer advocacy services.

303.4 Each CSA peer advocate shall complete a training course provided by DMH.

303.5 A CSA may elect to establish a permanent peer advocacy program at any time.

History

SOURCE: Final Rulemaking published at 50 DCR 8480 (October 10, 2003).

22-A DCMR § 304 GRIEVANCE PROCEDURE - GENERAL PROVISIONS

304.1 A grievance is the expression by any individual of his or her dissatisfaction with either DMH or a MH provider, including the denial or abuse of any consumer right or protection provided by applicable federal and District laws and regulations. A grievance will not be entertained if it complains of a specific action that occurred more than six (6) months prior to the filing of the grievance, absent extenuating circumstances.

304.2 DMH shall establish a grievance procedure (Grievance Procedure) that complies with applicable federal and District laws and regulations and that is available to all consumers and other interested parties. As part of the Grievance Procedure, each MH provider shall establish and adhere to an internal grievance procedure for its consumers (MH Provider Grievance Procedure) that has been approved by DMH according to § 301.2.

304.3 Consumers are not required to utilize the Grievance Procedure. Consumers may pursue other legal, administrative, or informal relief in lieu of or concurrently with filing a grievance.

304.4 Any consumer who believes he or she has been denied a service for which the consumer is eligible under Medicaid may file a grievance with the Office of Fair Hearings at the Department of Human Services, pursuant to D.C. and federal law. A Medicaid consumer who has a grievance regarding the receipt, termination, amount, kind, or conditions of Medicaid services is not required to go through DMH or MH Provider Grievance Procedures before filing a grievance with the Office of Administrative Review and Appeals, which is part of the Department of Human Services.

304.5 A MH provider's continuing obligations to safeguard the welfare of consumers, including the filing of Unusual Incident reports and other reports of allegations of abuse or neglect, are not affected by the Grievance Procedure.

304.6 Mental health services and mental health supports shall continue without limitation, reduction, or termination pending resolution of grievances regarding such mental health services and mental health supports.

304.7 Neither DMH nor a MH provider shall retaliate against the consumer or his or her representative in any way because the consumer filed a grievance. An allegation of retaliation shall be treated and filed as a new grievance against the MH provider or DMH.

304.8 DMH may institute proceedings to revoke or suspend a MH Provider's certification and/or licensure or to impose other sanctions if:

(a) DMH substantiates an allegation that the MH provider retaliated against a consumer, or his or her representative, for filing a grievance;

(b) The MH provider fails to obtain approval of either its MH Provider Grievance Procedure or changes to its MH Provider Grievance Procedure as required by § 301.2;

(d) The MH provider fails to take actions identified to rectify situations that have lead to abuse or neglect of consumers; or

(e) The MH provider evidences a pattern of untimely or incomplete responses to consumer grievances, or fails to complete action promised by the MH provider in response to a grievance.

304.9 The written explanation of the DMH Grievance Procedure and of each MH Provider Grievance Procedure shall include the language in § 304.7 in a type size and style that stands out from the surrounding text.

History

SOURCE: Final Rulemaking published at 50 DCR 8480 (October 10, 2003).

22-A DCMR § 305 FILING A GRIEVANCE

305.1 All consumers shall have the right to file a grievance with DMH. If a consumer's grievance involves a specific MH provider, DMH shall ensure that the MH provider has responded to the grievance in a timely manner, before initiating its prompt and impartial review of the grievance. All grievances involving a specific mental health professional shall be treated as involving the MH provider that employs or contracts with the mental health professional.

305.2 Grievances may be expressed orally or in writing. Oral grievances shall be reduced to writing. Each MH provider shall ensure consumers have access to all assistance they need or request in filling out any forms necessary for filing grievances.

(a) A grievance may be filed by the consumer or the consumer's personal representative, legal guardian, or other party acting on behalf of the consumer, when the consumer is an adult.

(b) A grievance may be filed by the consumer or the consumer's family member or legal guardian on behalf of the consumer, when the consumer is a child.

(c) The consumer, or the consumer's family member or legal guardian, when the consumer is a child, must consent to the filing of a grievance by another person in his or her behalf unless the grievance involves an allegation that the consumer is being abused or neglected.

305.3 Each consumer may be assisted throughout the grievance process, by any person chosen by the consumer. If the consumer chooses to be assisted by a peer advocate or personal representative, the consumer must designate the advocate or representative in writing and specify what protected mental health information, if any, may be released to the peer advocate or personal representative.

305.4 Peer advocates and personal representatives are subject to the requirements of federal and District laws regarding the confidentiality of protected mental health information.

305.5 A MH provider shall release information regarding a grievance to any organization or individual upon receipt of a valid authorization for disclosure from the consumer.

History

SOURCE: Final Rulemaking published at 50 DCR 8480 (October 10, 2003).

22-A DCMR § 306 MH PROVIDER GRIEVANCE PROCEDURE

306.1 Consumers with grievances concerning a MH provider from whom they are receiving services shall file the grievances with their provider. Consumers with grievances concerning rules, policies, or actions of employees that are the sole responsibility of DMH may file them with their MH provider but are not required to do so.

306.2 Each MH Provider Grievance Procedure shall incorporate, at a minimum, the following elements:

(a) Consumers shall have the opportunity to file a grievance at any time during the MH provider's normal hours of operation;

(b) Consumers shall be protected against having to file or present a grievance to the person complained about in the grievance;

(c) Consumers shall have access to peer advocates and shall have the right to representation during each stage of the grievance procedure by a peer advocate or personal representative;

(d) The consumer or his or her designee shall receive written acknowledgment of a filed grievance;

(e) Time limits shall be set the completion of each step of the Procedure, consistent with § 306.5;

(f) Prompt steps shall be specified to insure the immediate physical safety of a consumer if the circumstances surrounding a grievance raise a reasonable belief that the consumer's safety is threatened;

(g) If informal attempts to resolve a grievance are unsuccessful, the chief executive officer of the MH provider shall review the grievance and write a decision in response. The written decision shall be transmitted, with oral explanation, to the consumer or his or her designee along with a reminder of the consumer's right to appeal the grievance to DMH for external review.

306.3 Each MH provider shall establish a permanent group composed of equal numbers of consumers and staff members who shall be responsible for responding to inquiries regarding the grievance process, for attempting to resolve grievances consensually, and for assisting the chief executive officer of the MH provider in providing a response to grievances.

(a) The group or individual group members may look into individual grievances and work with the consumer filing the grievance and other parties to resolve the grievance consensually, using mediation or other dispute resolution techniques.

(b) If the grievance cannot be resolved informally, the group or individual group members may fact-find or make advisory recommendations to the chief executive officer of the MH provider.

(c) Grievances containing allegations of physical or sexual abuse may be forwarded directly to the chief executive officer of the MH provider without action by the group.

306.4 Each MH Provider shall demonstrate that consumers have played a meaningful role in the final design of the Grievance Procedure, and that consumers will be meaningfully consulted in future efforts to monitor and evaluate its effectiveness and decide upon needed modifications. The consumer/staff group required by § 306.3 may be utilized for these functions, or the MH Provider may use other means.

306.5 The chief executive officer of each MH provider shall review, investigate, and provide a substantive response to grievances within the following time frames:

(a) Within five (5) business days of the date the grievance is filed if it alleges abuse or neglect of a consumer or a denial of service to a consumer; or

(b) Within ten (10) business days of the date the grievance is filed for all other grievances. The chief executive officer of a MH provider may request an extension of the time set by paragraph (b) above for a specific number of days. The consumer filing the grievance shall have the option to grant or deny such a request.

306.6 If a consumer is dissatisfied with the response to a grievance by the chief executive officer of the MH provider or his or her designee, the consumer shall have ten (10) business days from the date of verbal notification and explanation of the response within which to appeal the grievance to DMH for external review in accordance with §§ 308 and 309.

306.7 Each MH provider shall submit a copy of each grievance to DMH on the day it is filed and shall submit a copy of any subsequent action concerning the grievance within 24 hours of the action's occurrence. Providers shall submit the information in a manner to be specified by DMH.

306.8 Each MH provider shall ensure that every staff person, including administrative, clerical, and support staff, has a clearly understood responsibility to immediately advise any consumer or other person who is articulating a grievance on behalf of a consumer, of the right to file a grievance and of the means of contacting the peer advocate program.

306.9 Each MH provider may accomplish its responsibilities with regard to implementing the MH Provider Grievance Procedure through utilization of its own staff or board members, as appropriate, or through agreement with outside staff, agencies, or organizations. The utilization of outside persons in the MH Provider Grievance Procedure shall be clearly explained to each consumer filing a grievance and to other parties filing a grievance on behalf of a consumer.

History

SOURCE: Final Rulemaking published at 50 DCR 8480 (October 10, 2003).

22-A DCMR § 307 DMH REVIEW OF GRIEVANCES

307.1 The Mental Health Authority of DMH shall review grievances that concern:

(a) The actions of employees of DMH in its capacity as Mental Health Authority for the District of Columbia; or

(b) Rules or policies that are the sole responsibility of DMH; or

307.2 Consumers may first file grievances concerning rules or policies that are the sole responsibility of DMH with their MH provider but are not required to do so.

307.3 All consumers shall have the right to file a grievance with DMH. If a consumer's grievance involves a specific MH provider, DMH shall ensure that the MH provider has responded to the grievance in a timely manner before initiating its prompt and impartial review of the grievance.

307.4 DMH shall refer appeals of consumers' grievances against MH providers to external review as described in § 308 within five (5) business days of receipt of the grievance by DMH.

307.5 The Director of DMH or the Director's designee shall respond orally and in writing to the consumer or the consumer's designee within ten (10) business days of receipt of the grievance by DMH, in grievances not involving the appeal of a consumer's grievance against a MH provider. If a consumer is dissatisfied with the DMH response to a grievance, the consumer shall have ten (10) business days from the date of verbal notification and explanation of the response within which to exercise the right to external review of the grievance according to § 308.

History

SOURCE: Final Rulemaking published at 50 DCR 8480 (October 10, 2003).

22-A DCMR § 308 EXTERNAL REVIEW OF GRIEVANCES

308.1 DMH shall contract with one or more external reviewer(s) to provide timely, neutral, and impartial review of grievances that have not been resolved to the consumer's satisfaction. The Director or his or her designee shall select the external reviewer. External reviewers shall serve at the pleasure of the Director of DMH. DMH shall provide consumers with written notice of the method, date, and time of external review, a list of participants, and contact information for the independent peer advocacy program.

(a) A consumer has the right to representation by a peer advocate, an attorney or a person of the consumer's choice throughout the external review process but DMH shall not appoint, assign or compensate a consumer's representative.

(b) A consumer, employees or representatives of providers, witnesses, or other participants in a grievance proceeding shall not be compensated by DMH for their time.

308.2 All external reviewers shall have experience or appropriate training in mediation, arbitration, and/or alternative dispute resolution.

308.3 The external reviewer may manage an assigned grievance in one of the following ways:

(a) The external reviewer may attempt to mediate a consensual resolution to the grievance. Mediation may be conducted via individual telephone calls or meetings with interested parties or via a joint meeting. The consumer has the right to representation during mediation. Necessary representatives from the MH provider, as determined by the external reviewer, shall be required to attend the mediation. The consumer may terminate the mediation at any time. If mediation is unsuccessful at resolving the grievance to the consumer's satisfaction, an external reviewer shall prepare a written advisory opinion at the request of any party to the mediation. The external reviewer who prepares a written advisory opinion pursuant to this subsection may or may not be the mediator.

(b) The external reviewer may conduct a fact-finding hearing and issue a written advisory opinion. Necessary representatives from the MH provider, as determined by the external reviewer, shall be required to attend the hearing. The consumer has the right to representation during the hearing, and may call witnesses. The MH provider also has the right to representation during the hearing at its expense, and may call witnesses. In some instances, and with the consent of the parties, the external reviewer may attempt to mediate a consensual resolution to a grievance prior to issuing an advisory opinion.

(c) The external reviewer may conduct a fact-finding process and issue a written advisory opinion without a hearing, if the consumer elects not to have one. In this case the external reviewer may request written information from the consumer or the MH provider to supplement the record. The external reviewer shall prepare a written advisory opinion based upon the information submitted and any informal conversations held with parties to the grievance.

308.4 Within five (5) business days of receipt of a consumer's request for external review, DMH shall assign an external reviewer and secure the earliest practicable date for a mediation or hearing. If a hearing is held, the external reviewer shall submit a written advisory opinion within five (5) business days of the completion of the hearing. An external reviewer may extend the time period for submission of an opinion with the express consent of all parties to the hearing.

308.5 Any written advisory opinion prepared by an external reviewer shall include:

(a) A summary of the evidence gathered during the hearing or document review;

(b) Applicable federal or District laws and regulations;

(d) Conclusions and recommendations.

308.6 A written advisory opinion prepared by the external reviewer shall be forwarded to the Director of DMH, the chief executive officer of the MH provider (if the grievance originated at or involved the MH provider), and the consumer. A copy of the written advisory opinion shall be provided to the consumer's representative, if authorized pursuant to the Mental Health Information Act of 1978, D.C. Official Code §§ 7-1201.01 et seq. Any party to the external review, including the chief executive officer of the MH provider, may, within five (5) business days of receipt of the written advisory opinion, communicate their reaction to the opinion to the Director. The Director shall, in writing, accept in full, accept in part, or reject the recommendations of the external reviewer and set time limits and responsible parties for carrying out any accepted recommendations, within ten (10) business days of receipt of the advisory opinion.

308.7 Any agreement reached in mediation shall be forwarded to the Director of DMH and/or the chief executive officer of the MH provider where the grievance originated, according to which entity has authority over the actions specified in the agreement. The Director or chief executive officer shall set any necessary time limits and responsible parties for carrying out the actions specified by the agreement, within ten (10) business days of receipt of the agreement.

308.8 The external reviewer shall report such information on each grievance as DMH may require and shall provide such information within the time limits and in the manner that DMH requires, except that statements made by parties to mediation shall not be reported.

308.9 Any party to a grievance dissatisfied with the grievance's final determination by DMH may request a fair hearing, pursuant to the D.C. Administrative Procedure Act and federal regulations.

History

SOURCE: Final Rulemaking published at 50 DCR 8480 (October 10, 2003).

22-A DCMR § 309 DMH MONITORING AND REPORTING

309.1 DMH shall periodically review the implementation of the Consumer Rights Policy, including each MH Provider Grievance Procedure.

309.2 DMH shall ensure that grievances are tracked and that responsible parties carry out actions mandated or agreed to be performed in response to grievances within prescribed time limits

309.3 DMH shall make publicly available a semi-annual report summarizing the types and dispositions of all grievances filed during the reporting period, including noteworthy trends and patterns and any other statistical information it believes would be helpful in evaluating the operation of the Grievance Procedure.

History

SOURCE: Final Rulemaking published at 50 DCR 8480 (October 10, 2003).

22-A DCMR § 399 DEFINITIONS

"Abuse" - any knowing, reckless, or intentional act or omission by a provider that causes or is likely to cause or contribute to, or which caused or is likely to have caused or contributed to, physical or emotional injury, death, or financial exploitation of a consumer.

"Consumer" - an adult, child or youth who seeks or receives mental health services or mental health supports funded or regulated by DMH. For purposes of this chapter, references to a child or youth consumer include the child's or youth's family or legal guardian.

"Core Services Agency" - a community-based provider of mental health services and mental health supports that is certified by DMH in accordance with rules published in the D.C. Register, and acts as the clinical home for consumers of mental health services by providing a single point of access and accountability for mental health rehabilitation services.

"CSA peer advocate" - a person appointed by a core services agency to assist consumers and others in filing a grievance and throughout the grievance process, who

(a) is a current or former consumer of mental health services or supports; and

(b) has been trained by DMH.

"DMH" - the Department of Mental Health, the successor in interest to the District of Columbia Commission on Mental health Services.

"Director" - the Director of DMH.

"External reviewer" - a person or organization with extensive experience in mediation, arbitration and/or alternative dispute resolution, selected by the Director, that contracts with DMH to provide neutral and impartial review and resolution of grievances.

"Governing Authority" - the designated individuals or governing body legally responsible for conducting the affairs of the MH provider.

"Grievance" -a description by any individual of his or her dissatisfaction with either DMH or a MH provider, including the denial or abuse of any consumer right or protection provided by applicable federal and District laws and regulations.

"Independent Peer advocate" - a person designated by an independent peer advocacy office established by or with the assistance of DMH to assist consumers and others in filing a grievance and throughout the grievance process, who

(a) is a current or former consumer of mental health services in the District of Columbia or elsewhere or, in the case of children and youth consumers, a guardian or family member of a current or former child or youth consumer;

(b) meets minimum qualifications established by DMH; and

(c) demonstrates knowledge about the Grievance Procedure and relevant MH Provider Grievance Procedures, and District laws and regulations regarding consumer rights and protections.

"Mental Health Authority" - the divisions, offices and employees of DMH involved in the regulatory, administrative, policy, planning, and fiscal responsibilities for the Department, and the Access Helpline or central intake functions of the Department. The Mental Health Authority is not directly involved in providing mental health services or supports and is separate from St. Elizabeths Hospital and the public core services agency. Mental Health Authority offices and divisions include the Director and Director's office, Chief Compliance Officer and Regulatory Counsel, General Counsel, Chief Financial Officer, Public Affairs, Consumer and Family Affairs, Chief Clinical Officer, Organizational Development, Office of Fiscal and Administrative Services, Office of Accountability, and Office of Delivery Systems Management.

"Mental health services" - the services funded or regulated by DMH for the purpose of addressing mental illness or mental health problems.

"Mental health supports" - the supports funded or regulated by DMH for the purpose of addressing mental illness or mental health problems.

"MH provider" - (a) any entity, public or private, that is licensed or certified by the District of Columbia to provide mental health services or mental health supports, (b) any entity, public or private, that has entered into an agreement with DMH to provide mental health services or mental health supports, or (c) St. Elizabeths Hospital or the public core services agency.

"Neglect" - any act or omission by a MH provider that causes or is likely to cause or contribute to, or which caused or is likely to have caused or contributed to, injury or death of a consumer.

"Peer advocate" -see "Independent peer advocate" and "CSA peer advocate."

"Personal representative" - a person designated by a consumer as the consumer's personal representative. A personal representative may be a family member, significant other, guardian or attorney.

"Policy" - a written statement developed by a MH Provider that gives specific direction regarding how the MH provider shall operate administratively and programmatically.

"Procedure" - a written set of instructions describing the step-by-step actions to be taken by MH provider staff in implementing a policy of the MH provider.

"Protected mental health information" - means information regulated by the District of Columbia Mental Health Information Act of 1978 effective March 3, 1979 (D.C. Law 2-136, D.C. Official Code §7-1201.1 et seq.).

"Service plan" - either the individual recovery plan (IRP) for adults or the individual service plan for children and youth (IPC).

"St. Elizabeths Hospital" -the inpatient psychiatric hospital operated by DMH.

History

SOURCE: Final Rulemaking published at 50 DCR 8480 (October 10, 2003).

22-A5 USE OF RESTRAINTS AND SECLUSION

22-A DCMR § 500 PURPOSES AND APPLICATION

500.1 The purpose of these rules is to:

(a) Provide a safe and therapeutic environment for consumers;

(b) Significantly reduce the incidence of emergencies that necessitate the use of restraints and seclusion;

(d) Employ restraints and seclusion in an emergency, only in accordance with this chapter, and other applicable federal and District laws and regulations;

(e) Reduce and minimize the use of restraints and seclusion in an emergency in favor of less restrictive behavior management techniques;

(f) Promote, facilitate and implement the use of consumer's advance instructions regarding treatment preferences in the event of a psychiatric emergency;

(g) Facilitate appropriate placements and transfers for consumers, as necessary, such that the degree of control over consumers in the treatment environment reduces or eliminates the need for repeated or sustained use of restraints and seclusion in an emergency;

(h) Promote, facilitate, and implement initial and continuing education and training programs for mental health provider staff charged with applying, monitoring, and documenting the use of restraints and seclusion in an emergency; and

(i) Aid in the development of internal and external quality improvement processes to identify and implement ways in which the use of restraints and seclusion in an emergency may be reduced or eliminated in favor of more positive behavioral management techniques with less potential risk.

500.2 The rules in this chapter are applicable to all mental health providers in the District. For purposes of this chapter, a mental health provider (MH provider(s)) is any entity that:

(a) Is operated, licensed, or certified by the Mayor to provide mental health services or mental health supports; or

(b) Has entered into an agreement with the Mayor to provide mental health services or mental health supports.

500.3 Consumers have the right to be free from restraints or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff.

500.4 Restraints include devices and techniques designed and used to control a consumer's behavior in an emergency, as further described in § 502.

500.5 Seclusion is the involuntary confinement of a consumer in a room or area where the consumer is physically prevented from leaving, as further described in § 503.

500.6 An "emergency" which may require the use of restraints or seclusion occurs when a consumer experiences a mental health crisis and is presenting an imminent risk of serious injury to self or others.

500.7 Restraints and seclusion, as further described in §§ 503 and 504 of this chapter, may only be used during an emergency by trained staff, in accordance with the requirements of this chapter, working at one of the following:

(a) A hospital when administering inpatient or emergency psychiatric services;

(b) A residential treatment center (RTC) certified pursuant to 29 DCMR § 948 or under contract with the District to provide mental health services to District residents;

(d) DMH contracted psychiatric crisis stabilization programs.

500.8 Except for the MH providers specifically identified in § 500.7, restraints and seclusion may not be used by any other MH provider under any circumstances. An MH provider not specifically authorized to use restraints or seclusion must comply with the requirements of §§ 519, 520 and 521 of this chapter.

500.9 Restraints and seclusion shall not include:

(a) General protective security measures including, without limitation, locked wards, or other special security measures adopted in youth residential treatment centers, maximum security psychiatric hospitals or forensic units in psychiatric hospitals, or specific security measures ordered by a court;

(b) Time-out as further described in § 504.2; or

History

SOURCE: Emergency and Proposed Rulemaking published at 51 DCR 8691 (September 3, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 51 DCR 11863 (December 31, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 52 DCR 5957 (June 24, 2005)[EXPIRED]; as amended by Final Rulemaking published at 52 DCR 7229 (August 5, 2005). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 500

22-A DCMR § 501 GENERAL PROVISIONS REGARDING THE USE OF RESTRAINT AND SECLUSION

501.1 Each MH provider shall comply with the requirements of this chapter regarding the use of restraints and seclusion. Each MH provider shall have a policy addressing the use of restraint and seclusion that satisfies the requirements of §519.

501.2 Restraints or seclusion shall only be used in an emergency in compliance with the following:

(a) The use of restraints or seclusion is, in the written opinion of the attending physician or physician assistant, necessary to prevent serious injury to the consumer or others;

(b) Less restrictive treatment techniques have been tried or considered and determined to be ineffective to prevent serious injury to the consumer or others; and

(c) The attending physician or physician assistant gives a written order, within one (1) hour of the initiation of either restraints or seclusion, for the use of restraints or seclusion. If the consumer's treating physician is available in person at the time the emergency arises, he or she is deemed to be the attending physician for purposes of this chapter.

501.3 Any use of restraints or seclusion with a consumer shall be:

(a) Implemented in the least restrictive manner possible;

(b) Implemented in accordance with safe and appropriate techniques, which include:

(1) The application of restraints or placement in seclusion by trained and educated MH provider staff in a manner that is designed to prevent serious harm to the consumer or others;

(2) The application of restraints or placement in seclusion that is appropriate for the severity of the consumer's condition or behavior, as well as the consumer's chronological and developmental age, size, gender, physical, mental, and emotional condition, and personal history, including any history of trauma, physical, sexual or mental abuse; and

(3) The application of restraints or placement in seclusion such that it is assured that the consumer is allowed to maintain normal bodily processes, breathing patterns, and blood circulation during the entire time the restraint is employed.

(d) Ended at the earliest possible time.

501.4 All restraints shall be sanitized after each use.

501.5 The health and safety of the consumer are of paramount importance at all times. If a consumer demonstrates a need for medical attention in the course of an episode of restraints or seclusion, medical priorities shall supersede behavioral priorities, the use of restraints or seclusions shall be terminated immediately, and the consumer shall receive immediate medical attention.

501.6 Restraints and seclusion are not treatment modalities. Neither the use of restraints nor the placement of a consumer in seclusion shall be included as a mental health support or mental health service in a consumer's service plan. However, a service plan may address the need for a reduction or elimination of the use of restraints or seclusion in an emergency, through the use of alternative behavior management techniques or other less restrictive interventions.

501.7 Restraints or seclusion shall never:

(a) Be used as a means of coercion, discipline, convenience, or retaliation;

(b) Be used in any manner that obstructs the airways or impairs breathing;

(d) Be used simultaneously with another method of restraint, unless otherwise permitted by this chapter.

501.8 An order for restraints or seclusion shall never be written in a non-emergency situation, as a standing order, or on an as-needed basis.

501.9 Restraints shall only be used in a manner consistent with the manufacturer's instructions for care and use of the devices.

501.10 The effects of and any conditions, symptoms or injuries resulting from any restraint or seclusion used with a consumer shall be documented in the consumer's clinical record.

501.11 Specific policies and procedures for employing each method of restraint and seclusion are set forth in this chapter. Any use of a restraint or seclusion on a consumer by a MH provider's staff that is not in accordance with this chapter shall constitute a violation of this chapter, and may constitute a violation of other District or federal laws or regulations.

History

SOURCE: Emergency and Proposed Rulemaking published at 51 DCR 8691 (September 3, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 51 DCR 11863 (December 31, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 52 DCR 5957 (June 24, 2005)[EXPIRED]; as amended by Final Rulemaking published at 52 DCR 7229 (August 5, 2005). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 501

22-A DCMR § 502 CONSUMER RIGHTS REGARDING THE USE OF RESTRAINTS AND SECLUSION

502.1 All MH provider staff shall treat each consumer receiving mental health services and supports with consideration and respect for the consumer's dignity, autonomy and privacy at all times.

502.2 Each consumer shall be provided a verbal explanation of the MH provider's Restraint and Seclusion Policy at intake or the next subsequent contact with the consumer. If the consumer is a minor or a legally incompetent adult, the consumer's parent(s) or legal guardian(s) shall also be given copies of the Restraint and Seclusion Policy.

502.3 Each MH provider shall communicate its restraint and seclusion policy in a language the consumer, or the consumer's parent(s) or legal guardian(s) understand. When necessary, the MH provider shall provide interpreters or translators, including those for American Sign Language.

502.4 Each MH provider shall request consumers to sign an acknowledgement of the explanation of the MH provider's Restraint and Seclusion Policy and document the acknowledgement in each consumer's clinical record.

502.5 Each consumer shall be provided the opportunity to document his or her advance instructions regarding treatment preferences in the event of a psychiatric emergency in accordance with the requirements of 22-A DCMR Chapter 1 and DMH policy on the use of advance instructions. If the consumer is a minor or legally incompetent adult, the consumer's parent(s) or legal guardian(s) shall also be given the opportunity to document advance instructions in accordance with the requirements of 22-A DCMR Chapter 1 and DMH policy on the use of advance instructions.

502.6 Advance instructions regarding treatment preferences in the event of a psychiatric emergency shall be placed in the consumer's clinical record in accordance with the requirements of 22-A DCMR Chapter 1 and DMH policy.

History

SOURCE: Emergency and Proposed Rulemaking published at 51 DCR 8691 (September 3, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 51 DCR 11863 (December 31, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 52 DCR 5957 (June 24, 2005)[EXPIRED]; as amended by Final Rulemaking published at 52 DCR 7229 (August 5, 2005). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 502

22-A DCMR § 503 RESTRAINTS GENERALLY

503.1 Restraints shall include devices and techniques designed and used to control a consumer's behavior in an emergency.

503.2 Methods of restraint that may be prescribed in an emergency for consumers receiving services from an MH provider identified in § 500.7 of this chapter include:

(a) Four-point restraints;

(b) Five-point restraints;

(d) Legally mandated restraints;

(f) Medical restraints; and

(g) Drugs used as a restraint.

503.3 Four-point restraints are the use of soft bracelets encasing the wrists and ankles of a consumer lying on a bed (face up unless medically contraindicated), which are secured to the bed frame. Only restraint devices approved by the federal Food and Drug Administration for four-point restraints may be used.

503.4 Five-point restraints are a four-point restraint with the addition of a strap, which is placed over the consumer's upper torso and under the arms and secured to the bed frame.

503.5 A physical hold is the application of physical force by a staff person without the use of any mechanical device, for the purpose of restraining the free movement of a consumer's body. A physical hold does not include briefly holding without undue force a consumer in order to calm or comfort him or her, or holding a consumer's hand to safely escort him or her from one area to another.

503.6 Legally mandated restraints are the mechanical restraint of an adult consumer during transport from a hospital to District of Columbia Superior Court or Federal Court or to a facility outside of the hospital, applied in accordance with the order of a U.S. Marshal, a judge or other law enforcement official or forensic services policy.

503.7 Medical restraints are the short-term use of physical restraint to facilitate completion of an emergency medical or surgical procedure. Medical restraint is limited to the duration of the emergency medical or surgical procedure.

503.8 A drug used as a restraint is a medication that is used to control extreme behavioral symptoms during an emergency. Drugs administered to a consumer on a regular basis as part of the consumer's regular prescribed medical regimen to treat mental, emotional or behavioral disorders or to assist the consumer in gaining self-control in accordance with the consumer's service plan shall not constitute the use of a drug as a restraint, even if the purpose of the drug is to control ongoing behavior.

History

SOURCE: Emergency and Proposed Rulemaking published at 51 DCR 8691 (September 3, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 51 DCR 11863 (December 31, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 52 DCR 5957 (June 24, 2005)[EXPIRED]; as amended by Final Rulemaking published at 52 DCR 7229 (August 5, 2005). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 503

22-A DCMR § 504 SECLUSION GENERALLY

504.1 Methods of seclusion that may be prescribed pursuant to this chapter include the confinement of a consumer alone in a room or an area from which the consumer:

(a) Is physically prevented from leaving; or

(b) Believes he or she cannot leave at will.

504.2 Time out is not a form of restraint or seclusion. Time-out means a voluntary procedure used to assist consumers to regain emotional control by providing access to a quiet area or unlocked quiet room away from his or her immediate environment. A consumer who is physically prevented from leaving an area or led to believe he or she cannot leave an area at will is in seclusion, not in time out.

504.3 Seclusion is contraindicated for consumers who:

(a) Exhibit suicidal behaviors;

(b) Exhibit self-injurious behaviors; or

History

SOURCE: Emergency and Proposed Rulemaking published at 51 DCR 8691 (September 3, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 51 DCR 11863 (December 31, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 52 DCR 5957 (June 24, 2005)[EXPIRED]; as amended by Final Rulemaking published at 52 DCR 7229 (August 5, 2005). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 504

22-A DCMR § 505 PROHIBITIONS ON THE USE OF RESTRAINTS AND SECLUSION

505.1 In employing restraints and seclusion, the following measures are strictly prohibited:

(a) The use of restraining nets;

(b) Ambulatory restraints (restraints which allow the consumer to walk around while restrained, such as wristlets or anklets);

(c) The simultaneous use of restraints and seclusion, unless the consumer is continually monitored face-to-face by a trained staff member, in accordance with the MH provider's DMH approved face-to-face monitoring policy;

(d) Restraint in the prone, face-down position unless determined medically necessary by the attending physician;

(e) "As needed" orders for restraints or seclusion;

(f) The use of restraints or seclusion in excess of twenty-four (24) hours, unless there is a court order authorizing a longer duration;

(g) The use of any restraint around a consumer's neck;

(h) Covering of the consumer's face with any material or object during the process of restraint or seclusion; and

(i) The use of unofficial restraints or seclusion, which includes any restraint or seclusion applied without the written authorization of the attending physician or physician assistant.

505.2 If an MH provider described in § 500.7 intends to simultaneously use restraint and seclusion, the MH provider shall submit its face-to-face monitoring policy to DMH's chief clinical officer for review and approval. A face-to-face monitoring policy shall require a one-on-one assignment of a trained staff person to the doorway of the seclusion room for the duration of the simultaneous use of the restraint and seclusion. An MH provider shall not simultaneously use restraint and seclusion without the prior written approval from DMH's chief clinical officer of its face-to-face monitoring policy.

History

SOURCE: Emergency and Proposed Rulemaking published at 51 DCR 8691 (September 3, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 51 DCR 11863 (December 31, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 52 DCR 5957 (June 24, 2005)[EXPIRED]; as amended by Final Rulemaking published at 52 DCR 7229 (August 5, 2005). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 505

22-A DCMR § 506 INITIATING THE USE OF FOUR-POINT AND FIVE-POINT RESTRAINTS OR SECLUSION

506.1 Unless otherwise specified in this section or in federal regulations, only a physician or a physician assistant, may order the use of restraints or seclusion. Such orders shall be in writing, except as set forth in § 506.2.

506.2 In emergency situations in which a physician or physician assistant is not immediately present, a consumer may be placed in restraints or seclusion by a registered nurse (RN) before a written physician's order is obtained. In such cases:

(a) A verbal order shall be obtained from the attending or treating physician or physician assistant and documented immediately. If a verbal order is not obtained from the attending or treating physician or physician assistant within fifteen (15) minutes, the restraints or the seclusion shall be terminated;

(b) The RN in charge shall document as soon as possible, but within one (1) hour of the emergency order:

(1) Justification for the use of restraints or seclusion;

(2) Alternative strategies which failed to manage the consumer's behavior or why other strategies were considered but deemed impractical or unsafe;

(3) The consumer's current behaviors and mental and emotional status; and

(4) The consumer's physical status;

(c) The physician or physician assistant issuing the verbal order shall conduct a face-to-face assessment of the consumer within one (1) hour of the consumer being placed into restraints or seclusion; and

(d) If the physician or physician assistant does not conduct the face-to-face assessment within one hour of initiation of the restraints or seclusion so as to confirm the initial verbal order, the consumer shall be released at that time.

506.3 The physician or physician assistant ordering the restraints or seclusion shall be available for consultation with MH provider staff throughout the period the consumer is restrained or secluded.

506.4 Any order for the use of restraints or seclusion shall not exceed the following durational limitations:

(a) Four (4) hours for adults;

(b) Two (2) hours for children and adolescents nine (9) to seventeen (17) years of age; and

506.5 Any orders for restraints or seclusion may only be renewed for up to a maximum of twenty-four (24) hours.

506.6 If the emergency precipitating the use of restraints or seclusion with the consumer continues beyond the limitations of the initial order, the RN shall immediately contact the physician or physician assistant to receive further instructions.

506.7 If the emergency precipitating the use of restraints or seclusion ends and the restraints or seclusion are discontinued before the expiration of the original order, a new order shall be obtained prior to reinitiating seclusion or reapplying restraints.

506.8 Any new order for the use of restraint or seclusion, or any order continuing the use of a specific restraint or seclusion for a consumer, or order for the use of a new restraint or placement in seclusion following expiration of an initial order for restraint or seclusion shall be given in accordance with this section.

506.9 Each written order for restraints and seclusion shall state:

(a) The name of the physician or physician assistant giving the order;

(b) The date and time the written order was given;

(c) Whether the order was for the "initial" implementation of a restraint or placement in seclusion or the "continued" use of a restraint or seclusion;

(d) The specific restraints (four-point or five-point) or form of seclusion ordered, including the authorized duration of the restraints or seclusion;

(e) Any special instructions needed due to the consumer's medical condition, physical disability, or history of abuse;

(f) If required, the need for monitoring of specific medical conditions or more frequent monitoring of vital signs; and

(g) The behavioral criteria for discontinuation of restraints or seclusion.

506.10 For each order for restraint or seclusion, the physician or physician assistant shall also document in the consumer's clinical record, a note separate from the order, which shall include:

(a) Any less restrictive techniques, such as behavioral interventions or nonphysical interventions used, attempted, or considered prior to ordering the use of restraints or seclusion, as well as the reasons those techniques were not used or were ineffective;

(b) Whether there are any pre-existing medical conditions or any physical disabilities that would place the consumer at potentially greater risk during the use of restraints or seclusion;

(c) To the extent known, whether the consumer has a history of trauma, sexual, or physical abuse that would place the consumer at greater psychological risk during the use of restraints or seclusion;

(d) The basis, including a description of the consumer's behavior and the circumstances leading to the use of restraint or seclusion, and justification for ordering the use of the specific restraint or seclusion;

(e) A summation of the consumer's mental status at the time of the face-to- face evaluation by the physician; and

(f) How the consumer was informed of the behavioral criteria for discontinuation of restraints or seclusion.

506.11 The criterion for release of a consumer from restraints or seclusion is that the consumer no longer presents an imminent risk of serious injury to self or others, rather than that a period of time has passed.

History

SOURCE: Emergency and Proposed Rulemaking published at 51 DCR 8691 (September 3, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 51 DCR 11863 (December 31, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 52 DCR 5957 (June 24, 2005)[EXPIRED]; as amended by Final Rulemaking published at 52 DCR 7229 (August 5, 2005). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 506

22-A DCMR § 507 SPECIFIC PROCEDURES FOR THE USE OF SECLUSION

507.1 When secluding a consumer, the following procedures shall be observed:

(a) All potentially dangerous articles shall be removed from the consumer's person and the seclusion area;

(b) If unclothed, the consumer shall be offered clothing at the earliest possible time;

(c) The consumer shall not be placed in any room or environment where there are potentially hazardous conditions, such as electrical outlets, frayed wires, high temperatures, high humidity, or light fixtures in disrepair; and

(d) The consumer shall be continually monitored as described in §§ 508.3 and 508.4 of this chapter, and the physical, mental, and emotional needs of the consumer shall be given prompt attention at all times.

507.2 If the MH provider secludes a consumer under the age of eighteen (18) the consumer shall be continuously monitored, face-to-face, by trained staff who shall be at the doorway window of the seclusion room for the duration of the seclusion event.

History

SOURCE: Emergency and Proposed Rulemaking published at 51 DCR 8691 (September 3, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 51 DCR 11863 (December 31, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 52 DCR 5957 (June 24, 2005)[EXPIRED]; as amended by Final Rulemaking published at 52 DCR 7229 (August 5, 2005). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 507

22-A DCMR § 508 MONITORING THE USE OF FOUR-POINT AND FIVE-POINT RESTRAINT OR SECLUSION

508.1 Within one (1) hour after initiation of the use of restraint or seclusion and following the discontinuation of any restraints or seclusion of a consumer pursuant to this chapter, the physician or physician assistant shall conduct a face- to-face assessment of the physical, behavioral, mental, and emotional status of the consumer, including without limitation:

(a) The consumer's physical, mental, and emotional state;

(b) The consumer's behavior;

(d) Any complications resulting from the use of the restraint or seclusion; and

(e) Any medications ordered and the reasons for their use.

508.2 Such examination shall be documented in the consumer's clinical record, including the date and time of the examination, the name of the individual making the examination, and the findings of the examination.

508.3 In addition to an assessment by the consumer's physician or physician assistant, a trained and competent staff person shall, in person, continuously monitor and observe and regularly assess the consumer throughout the restraint or seclusion. This monitoring and assessment shall be documented and shall include at a minimum:

(a) Fifteen (15) minute assessments for signs of injury or medical distress;

(b) Hourly assessments of nutrition and hydration needs;

(d) Elicitation of vital signs at implementation of restraints or seclusion, with vital sign checks every fifteen (15) minutes for the first thirty (30) minutes, and if stable, then hourly and then again upon release from restraints. If unable to elicit vital signs at any time, the staff shall document efforts to obtain vital signs and the reasons it could not be done;

(e) Hourly assessments of hygiene and elimination needs;

(f) Fifteen (15) minute assessments of mental health status; and

(g) Minimally, fifteen (15) minute assessments for readiness for discontinuation of restraints or seclusion.

508.4 Remote observation of a consumer via video camera or other device or technique is not permissible to meet the requirements of § 508.3.

508.5 The consumer shall be released from restraints and seclusion when there is an assessed stabilization of behavioral status such that the consumer no longer presents an imminent risk of serious injury to self or others, or when the order for restraints or seclusion expires and is not renewed, whichever is earlier,

508.6 Restraints and seclusion may be terminated upon authorization of an RN, a physician or a physician assistant, except in the case of an emergency, when any staff may remove a consumer from restraints or seclusion to administer emergency treatment, evacuate the consumer from a hazardous condition such as fire or flood, or if for any reason the restraint or seclusion is causing harm to the consumer's physical health or safety.

History

SOURCE: Emergency and Proposed Rulemaking published at 51 DCR 8691 (September 3, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 51 DCR 11863 (December 31, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 52 DCR 5957 (June 24, 2005)[EXPIRED]; as amended by Final Rulemaking published at 52 DCR 7229 (August 5, 2005). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 508

22-A DCMR § 509 POST EVENT ANALYSIS OF THE USE OF FOUR-POINT AND FIVE-POINT RESTRAINT OR SECLUSION

509.1 All staff involved in the use of restraint or seclusion shall, within twenty-four (24) hours of the application of restraint or seclusion, conduct a post event analysis among themselves regarding the events surrounding the emergency that required the use of restraints or seclusion. The post event analysis is separate from the more formal treatment team debriefing described in §§ 510 that is conducted by the consumer's team.

509.2 The MH provider's nursing supervisor, the nursing supervisor's designee or risk manager shall chair the post event analysis meeting. The post event analysis shall, at a minimum, include a discussion of:

(a) The emergency that required the use of restraints or placement in seclusion, including a discussion of the precipitating factors that led up to the use of restraint or placement in seclusion;

(b) Alternative techniques that might have prevented the use of the restraint or seclusion;

(c) The procedures, if any, that staff are to implement to prevent any recurrence of the use of restraints or seclusion; and

(d) The outcome of the intervention, including any injuries that may have resulted from the use of restraints or seclusion.

509.3 Issues, concerns, and recommendations from the post event analysis meeting, shall be documented, by the person chairing the meeting, in a manner consistent with standard peer review and continuous quality improvement practices.

History

SOURCE: Emergency and Proposed Rulemaking published at 51 DCR 8691 (September 3, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 51 DCR 11863 (December 31, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 52 DCR 5957 (June 24, 2005)[EXPIRED]; as amended by Final Rulemaking published at 52 DCR 7229 (August 5, 2005). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 509

22-A DCMR § 510 TREATMENT TEAM DEBRIEFING MEETING REGARDING THE USE OF FOUR-POINT AND FIVE POINT RESTRAINTS OR SECLUSION

510.1 The consumer's treatment team shall conduct a treatment team debriefing following each incident of restraint or seclusion. If use of restraint or seclusion occurred at a site-based mental health crisis emergency program certified by DMH or at a DMH-contracted psychiatric crisis stabilization program, the treatment team members shall be deemed to include a representative from the consumer's assigned core service agency and the consumer's ACT team, if the consumer is currently authorized to receive ACT services.

510.2 The treatment team debriefing is a face-to-face meeting, which shall include treatment team members, the consumer, and the consumer's family members or personal representatives if the consumer so consents and they are available.

510.3 The treatment team debriefing shall include discussions about the causes giving rise to the emergency requiring the use of restraint or seclusion and how this information can be used to prevent future occurrences.

510.4 The treatment team debriefing meeting shall be initiated by the consumer's treatment team within twenty-four (24) hours following each incident of restraint or seclusion, or within the next business day in the case of weekends and holidays. The treatment team debriefing shall result in the following outcomes:

(a) Assisting the consumer and staff in understanding the precipitants which may have evoked the behaviors necessitating the use of restraints or seclusion;

(b) Assisting the consumer in developing appropriate coping mechanisms or alternative behaviors that could be effectively utilized should similar situations, emotions, or thoughts present again;

(d) Developing and documenting, for inclusion in the service plan, a specific plan of interventions designed to avoid the future need for the use of restraints or seclusion.

510.5 MH provider staff shall document, in the consumer's clinical record, the time and place of the treatment team debriefing, the names of all individuals participating in the treatment team debriefing, the names of the MH provider staff excused from the treatment team debriefing and the reason for their absence, and any changes to the consumer's service plan that result from the debriefing.

510.6 The consumer shall be offered and provided any needed or desired counseling or treatment for any trauma that may have resulted from the use of restraints or seclusion.

510.7 MH provider staff shall notify the chief clinical officer or medical director for the MH provider each time restraints or seclusion for a consumer are used for a period of more than twelve (12) hours or when two (2) or more separate orders for restraints or seclusion of a consumer are given within twelve (12) hours of each other.

History

SOURCE: Emergency and Proposed Rulemaking published at 51 DCR 8691 (September 3, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 51 DCR 11863 (December 31, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 52 DCR 5957 (June 24, 2005)[EXPIRED]; as amended by Final Rulemaking published at 52 DCR 7229 (August 5, 2005). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 510

22-A DCMR § 511 PHYSICAL HOLDS

511.1 A physical hold is the application of physical force by a trained or qualified staff person without the use of any mechanical device, for the purpose of restraining free movement of a consumer's body. A physical hold does not include briefly holding without due force a consumer in order to calm or comfort him or her, or holding a consumer's hand to safely escort him or her from one are to another.

511.2 A trained or qualified staff person may use physical holds, without a physician's order, for up to fifteen (15) minutes in an emergency where physical violence against self, another person, or property is occurring. A physical hold is used solely for the purpose of preventing harm to the consumer, the staff person, others or property.

511.3 The attending or treating physician shall order any use of a physical hold that will last longer than fifteen (15) minutes.

511.4 A second trained or qualified staff person shall be assigned to observe the consumer during the use of a physical hold.

511.5 For any use of a physical hold longer than fifteen (15) minutes, the procedures set forth in §§ 506.3, 506.6, 506.7, 506.8, 506.9, 506.10, and 506.11 of this chapter shall be followed.

511.6 Any order for a physical hold shall not exceed a total of one (1) hour.

511.7 The MH provider shall conduct a post event analysis and a treatment team debriefing in accordance with the requirements of §§ 509 and 510, respectively, for any use of a physical hold longer than fifteen (15) minutes.

History

SOURCE: Emergency and Proposed Rulemaking published at 51 DCR 8691 (September 3, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 51 DCR 11863 (December 31, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 52 DCR 5957 (June 24, 2005)[EXPIRED]; as amended by Final Rulemaking published at 52 DCR 7229 (August 5, 2005). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 511

22-A DCMR § 512 MEDICAL RESTRAINTS

512.1 Medical restraints may be used to administer medical or surgical treatment to an uncooperative consumer, if:

(a) In the written opinion of a physician licensed to practice medicine in the District, medical or surgical treatment is necessary to prevent the immediate serious injury or death of the consumer; and

(b) The procedures set forth in §§ 506.3, 506.9, 506.10 and §§508.1, and 508.2, governing the use of restraints, are followed.

512.2 The MH provider shall document in the consumer's clinical record that all attempts to gain the consumer's cooperation through less restrictive means have failed, or that making such attempts would delay the necessary emergency treatment and further jeopardize the consumer's life and safety.

512.3 The documentation in the consumer's clinical record shall also describe the circumstances that give rise to the medical emergency, as well as the reasons why restraints are deemed necessary to administer the needed treatment.

512.4 In the event the consumer is a minor or an adult with a legal guardian, the parent or guardian's consent shall be obtained if possible. If the parent or guardian is not available, the MH provider shall document all attempts to gain the parent's or guardian's consent, or that making such attempts would delay the necessary emergency treatment and further jeopardize the consumer's life and safety.

512.5 The least restrictive and most comfortable restraints available shall be used as necessary to accomplish the emergency medical or surgical procedure. The restraints may only be applied for the duration of the procedure and then shall be removed.

512.6 The use of restraints to perform routine medical procedures, such as phlebotomy, urine screen, or x-ray is prohibited, unless informed consent to the restraint is obtained from the consumer or the consumer's surrogate healthcare decision- maker pursuant to 22-A DCMR, Chapter 1. The consent shall be in writing and placed into the consumer's clinical record for each procedure.

History

SOURCE: Emergency and Proposed Rulemaking published at 51 DCR 8691 (September 3, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 51 DCR 11863 (December 31, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 52 DCR 5957 (June 24, 2005)[EXPIRED]; as amended by Final Rulemaking published at 52 DCR 7229 (August 5, 2005). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 512

22-A DCMR § 513 LEGALLY MANDATED RESTRAINTS

513.1 This chapter does not govern the use of legally mandated restraints. Legally mandated restraints are restraints ordered by a court of law or restraints that are applied, monitored, and removed at the discretion of a law enforcement officer, such as a Deputy United States Marshal, an agent of the Secret Service, or an officer of the Metropolitan Police Department, with custody of a consumer, or restraints applied by hospital staff to a maximum security consumer when being transported outside the facility, in accordance with forensic services policy approved by the chief clinical officer of DMH.

513.2 Metal handcuffs and anklets are prohibited, except with maximum security consumers, who are secured by forensic services personnel in accordance with forensic services policy approved by the chief clinical officer of DMH, or the order of a judge, U.S. Marshall or other law enforcement agency with appropriate jurisdiction for transport to:

(a) The District of Columbia Superior Court or District Court of Appeals;

(b) Any Federal Court;

(c) Any facility outside of the hospital's forensic services facility, including, but not limited to facilities outside the hospital grounds.

513.3 All procedures required for application of emergency restraint, which are set forth in this chapter shall be followed, unless specifically superseded by court order or the policy of the law enforcement agency with custody of the consumer.

History

SOURCE: Emergency and Proposed Rulemaking published at 51 DCR 8691 (September 3, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 51 DCR 11863 (December 31, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 52 DCR 5957 (June 24, 2005)[EXPIRED]; as amended by Final Rulemaking published at 52 DCR 7229 (August 5, 2005). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 513

22-A DCMR § 514 DRUG(S) USED AS A RESTRAINT

514.1 Only a physician licensed to practice medicine in the District may order a drug(s) to be used as a restraint.

514.2 A drug(s) used as a restraint is permitted only in an emergency when the consumer presents an imminent risk of serious injury to self or others and when alternative techniques are determined to be ineffective to prevent serious injury to the consumer or others.

514.3 The use of drugs to control extreme behavior shall not be administered with the intention of immobilizing the consumer's movements or rendering unconscious.

514.4 The physician ordering a drug(s) to be used as a restraint shall conduct a face-to-face assessment of the consumer within one hour of administration of the medication.

514.5 Each verbal or written order for a drug(s) to be used as a restraint shall state:

(a) The name of the physician giving the order;

(b) The date and time the written order was given;

(d) The target symptom or behavior for which the drug is ordered;

(e) Any special instructions needed due to the consumer's medical condition, physical disability or history of abuse; and

(f) If required, the need for monitoring of specific medical conditions or more frequent monitoring of vital signs.

514.6 For each order, the physician, physician assistant or RN shall also document in the consumer's clinical record, a note separate from the order, which shall include:

(a) Any less restrictive techniques, such as behavioral interventions or non-physical interventions used, attempted, or considered prior to ordering the drug;

(b) Whether there are any pre-existing medical conditions or any physical disabilities that would place the consumer at potentially greater risk due to the use of the drug; and

514.7 A trained competent staff person shall regularly assess the consumer for the first two hours after the drug is administered. This assessment shall be documented and include:

(a) Assessments for signs of injury or medical distress shall be done every fifteen (15) minutes; and

(b) Elicitation of vital signs upon administering the drug with checks every fifteen (15) minutes. If unable to elicit vital signs at any time, the staff shall document efforts to obtain vital signs and the reasons it could not be done.

History

SOURCE: Emergency and Proposed Rulemaking published at 51 DCR 8691 (September 3, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 51 DCR 11863 (December 31, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 52 DCR 5957 (June 24, 2005)[EXPIRED]; as amended by Final Rulemaking published at 52 DCR 7229 (August 5, 2005). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 514

22-A DCMR § 515 USE OF RESTRAINTS OR SECLUSION WITH SPECIAL POPULATIONS

515.1 Consideration should be given to removing dentures or other dental devices either prior to the use of restraints or seclusion, or at the earliest opportunity after initiation of restraints or seclusion.

515.2 Only soft restraints may be used with frail consumers. Leather restraints should never be used with frail consumers as these may cause lesions or fractures, especially in cases of osteoporosis.

515.3 Consumers affected by mental retardation or developmental disability who become agitated or violent should be carefully assessed for an underlying medical condition that may be causing the behavioral change.

515.4 Children and youth residing in inpatient hospital settings or residential treatment centers shall receive an assessment to identify those who have experienced physical, psychological, or sexual trauma, including abuse, and those at high risk for seclusion and restraint events for any reason. The assessment shall include a review of the child or youth's medical condition and any disability.

515.5 The assessment referenced in § 515.4 shall be completed within twenty-four (24) hours of admission.

515.6 With the exception of physical holds as defined in this chapter, the use of restraint or seclusion with children or youth who have been sexually or physically abused within the past two years is strictly prohibited.

515.7 For children and youth residing in hospitals or RTCs, initial service plans shall include positive interventions to avoid the use of seclusion and restraints, especially for children most likely to lose self-control.

515.8 For consumers who are deaf or unable to speak, any use of restraint or seclusion must include constant one-to-one observation. Efforts to communicate with the person using sign language or in writing, must be made and documented in the clinical record.

History

SOURCE: Emergency and Proposed Rulemaking published at 51 DCR 8691 (September 3, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 51 DCR 11863 (December 31, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 52 DCR 5957 (June 24, 2005)[EXPIRED]; as amended by Final Rulemaking published at 52 DCR 7229 (August 5, 2005). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 515

22-A DCMR § 516 INJURY OR DEATH AS A RESULT OF RESTRAINT OR SECLUSION

516.1 If a consumer is injured during the process of being placed in restraints or seclusion or while in restraints or seclusion, MH provider staff shall:

(a) Immediately obtain medical treatment from qualified medical personnel for the consumer;

(b) Document in the consumer's clinical records the injuries and any treatment provided for these injuries;

(d) Document in the consumer's record and submit a major unusual incident report to document any injuries to staff resulting from the use of restraints or seclusion during an emergency.

516.2 Any death that occurs while a consumer is in the process of being restrained or secluded, while the consumer is in restraints or seclusion, or any death that could reasonably have been the result of the use of restraint or seclusion shall be:

(a) Documented in the consumer's clinical record;

(b) Reported immediately (but no later than one (1) hour after discovery of the death) to the DMH Office of Accountability; and

516.3 Staff involved in applying restraints or seclusion to abate an emergency that results in injury to the consumer or staff shall meet with supervisory staff to evaluate the circumstances that caused the injury and develop a plan to prevent future injuries. The meeting and evaluation of the circumstances that caused the injury and development of a plan to prevent future injuries may occur in conjunction with either the post event analysis described in § 509 or the treatment team debriefing described in § 510.

History

SOURCE: Emergency and Proposed Rulemaking published at 51 DCR 8691 (September 3, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 51 DCR 11863 (December 31, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 52 DCR 5957 (June 24, 2005)[EXPIRED]; as amended by Final Rulemaking published at 52 DCR 7229 (August 5, 2005). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 516

22-A DCMR § 517 PROTECTIVE MEASURES

517.1 Protective measures involve the use of gerichairs, chairs with trays, bed rails, straps, mitts or other devices which restrict freedom of movement or access to one's body in order to prevent falls, maintain posture and for other medical purposes.

517.2 All MH providers may use protective measures in accordance with the requirements of this chapter.

517.3 Protective measures shall be used only as a last resort when other adaptive or assistive devices, physical therapy, or environmental changes are inadequate to prevent injury to the consumer.

517.4 The application of any protective measure that involves a physical restraint (a device, material, or apparatus that the consumer cannot easily remove) may only be applied in accordance with the procedures set forth in §§ 506.1 - 506.11 and §508 of this chapter. All other protective measures may be applied pursuant to the procedures set forth in this section.

517.5 A RN may initiate the use of protective measures but shall obtain a verbal order from a physician or physician assistant, within one (1) hour of initiating protective measures. The initiation of protective measures shall be based on a documented assessment of the consumer's history and condition that indicates the strong probability that substantial harm to the consumer will occur in the absence of such measures.

517.6 If the consumer is a minor or an adult who has a legal guardian, the MH provider staff shall notify the parent(s) or legal guardian(s) that the consumer has been placed in protective measures promptly after the initiation of these measures.

517.7 Use of protective measures requires a written time limited order by the attending or treating physician. An order for protective measures may be written for up to twenty-four (24) hours.

517.8 Scheduled observations for consumers in protective measures shall be made every fifteen (15) minutes and documented in the consumer's clinical record.

517.9 Trained nursing staff shall periodically assess any consumer in protective measures. The protective measures shall be discontinued as soon as alternative measures for safety are feasible.

517.10 Physical needs of consumers in protective measures shall be promptly met. The consumer's physical condition shall be assessed, and the opportunity for personal care, including fluids, bathroom use, range of motion, meals, and hygiene shall be provided and documented throughout the use of the protective measures. The consumer shall be monitored and assisted by:

(a) Recording the consumer's physical condition every fifteen (15) minutes;

(b) Assessing for safety, circulation and comfort every fifteen (15) minutes;

(c) Providing an opportunity for hourly access to the bathroom (or more often as appropriate) while the consumer is awake;

(d) Providing an opportunity for regular meals with any needed special precautions taken;

(e) Providing an opportunity for fluids at least every one (1) hour while the consumer is awake, with fluid type and amount recorded when consumed;

(f) Providing an opportunity for range of motion of extremities every two (2) hours while the consumer is awake; and

(g) Providing an opportunity for a bath or shower at least once each twenty- four (24) hours or more often when necessary.

517.11 A service plan update is required for any consumer in protective measures in excess of twenty-four (24) hours. The service plan shall address the use of alternative interventions to reduce the need for protective measures.

517.12 All protective devices shall be sanitized after each use.

517.13 Protective devices shall only be used in a manner consistent with the manufacturer’s instructions for case and use of the devices.

History

SOURCE: Emergency and Proposed Rulemaking published at 51 DCR 8691 (September 3, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 51 DCR 11863 (December 31, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 52 DCR 5957 (June 24, 2005)[EXPIRED]; as amended by Final Rulemaking published at 52 DCR 7229 (August 5, 2005). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 517

22-A DCMR § 518 NOTIFICATION OF PARENT(S) OR LEGAL GUARDIAN(S) OF USE OR CONTINUATION OF RESTRAINTS OR SECLUSION

518.1 If the consumer is a minor or an adult with a legal guardian, the MH provider staff shall notify the parent(s) or legal guardian(s) of the consumer who has been restrained or secluded within two hours of the initiation or continuation of any restraints or seclusion.

518.2 The MH provider staff shall document in the consumer's clinical record that the parent(s) or legal guardian(s) were notified of the use of the restraints, including the date and time of notification and the name of the MH provider staff member providing the notification.

518.3 In the event the parent(s) or legal guardian(s) cannot be located, diligent effort to contact them shall be documented.

History

SOURCE: Emergency and Proposed Rulemaking published at 51 DCR 8691 (September 3, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 51 DCR 11863 (December 31, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 52 DCR 5957 (June 24, 2005)[EXPIRED]; as amended by Final Rulemaking published at 52 DCR 7229 (August 5, 2005). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 518

22-A DCMR § 519 MH PROVIDER POLICIES AND PROCEDURES

519.1 Each MH provider shall establish, maintain, and adhere to written policies and procedures regarding the use of restraints and seclusion for consumers that comply with applicable federal and District laws and regulations. A MH provider that is not specifically authorized to use restraint and seclusion pursuant to §500.7 shall establish a policy strictly prohibiting the use of restraints and seclusion at any time, although the policy shall also require reporting of the use of restraint or seclusion and staff training.

519.2 The written policies and procedures for the MH providers identified in §500.7 shall describe the following:

(a) How respect for consumers and their families will be maintained prior to, during, and after the utilization of any method of restraint or seclusion;

(b) The use of a consumer's advance instructions regarding treatment preferences in the event of a psychiatric emergency and how those treatment preferences will be honored.

(c) The process or opportunity for a consumer who is in restraints or seclusion to maintain personal care, participate in personal care processes, engage in normal bodily functioning (including access to toilets), receive nourishment and fluids, exercise limbs, have a systematic release of restrained limbs, and receive other necessary care during and immediately after the utilization of any restraints or seclusion;

(d) The process for ensuring and monitoring the safety and hygiene of a consumer who is in restraints or seclusion;

(e) The DMH-approved policy for face-to-face monitoring required by §505.2 for MH providers using restraints and seclusion simultaneously;

(f) The process for monitoring the space used for restraint or seclusion to ensure a comfortable room temperature and necessary light at all times;

(g) How the physical, mental, and emotional well being of the consumer will be promoted and maintained at all times during the use of restraint and seclusion;

(h) How the consumer's modesty, appropriate visibility to others, and comfortable body temperature will be maintained and monitored at all times during the use of restraint and seclusion;

(i) Which staff are responsible for examining and monitoring the consumer prior to, during, and after the utilization of any method of restraint or seclusion;

(j) Which staff have authority to order the initiation of and discontinuation of restraints and seclusion;

(k) What techniques staff should use prior to using restraints or seclusion;

(l) What assistance shall be provided to a consumer who has been placed in restraints or seclusion to assist the consumer in meeting the criteria for discontinuation of the restraints or seclusion, which staff are responsible for providing this assistance, and documentation requirements;

(m) Which staff are responsible for reporting any injuries or death of a consumer being placed in or while in restraints or seclusion;

(n) The training requirements for all staff that have direct contact with consumers as required by these rules;

(o) The process for debriefing the consumer and the consumer's family, if appropriate, and MH provider staff following the use of any restraint or seclusion;

(p) The process for reviewing compliance with the MH provider's restraint and seclusion policy by all MH provider staff;

(q) The process for complying with reporting requirements and other external mandates regarding the use of restraints or seclusion on consumers; and

(r) Information on how a consumer may contact the District's Protection and Advocacy program, including the name of the program and its address and phone number.

519.3 MH providers shall include consumers and families in formulating the MH provider's restraint and seclusion policy.

519.4 Each MH provider shall ensure that all MH provider staff, including administrative, clerical, and support staff, comply with the MH provider's restraint and seclusion policy.

History

SOURCE: Emergency and Proposed Rulemaking published at 51 DCR 8691 (September 3, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 51 DCR 11863 (December 31, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 52 DCR 5957 (June 24, 2005)[EXPIRED]; as amended by Final Rulemaking published at 52 DCR 7229 (August 5, 2005). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 519

22-A DCMR § 520 MH PROVIDER REPORTING REQUIREMENTS

520.1 Each MH provider shall provide certification of its compliance with this chapter to DMH within thirty (30) days of the effective date of this chapter and annually thereafter. The MH provider shall prepare its initial and annual certification of compliance with this chapter using a format approved by DMH,

520.2 If a MH provider has provided a written attestation of its compliance with federal rules and regulations governing the use of restraints and seclusion to the District's Medicaid Administration Agency (MAA), the MH provider shall also provide DMH with a copy of the MAA attestation.

520.3 Each MH provider shall report the death of a consumer or other serious injury that may have reasonably resulted from the use of restraint or seclusion to DMH in accordance with DMH's unusual incident reporting policy as set forth in §§ 516.1 and 516.2, and applicable federal and District laws and regulations.

520.4 Each use of restraint or seclusion shall be reported to the MH provider's quality improvement committee for review, discussion, trend analysis and any recommendations for programmatic or treatment changes.

520.5 The DMH Deputy Director for Accountability may require an external review of a MH provider's use of seclusion and restraint based on increasing or excessive utilization patterns, injuries to staff or consumers, or deviations from this policy.

520.6 The MH provider shall also comply with any reporting requirements deemed necessary by DMH.

History

SOURCE: Emergency and Proposed Rulemaking published at 51 DCR 8691 (September 3, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 51 DCR 11863 (December 31, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 52 DCR 5957 (June 24, 2005)[EXPIRED]; as amended by Final Rulemaking published at 52 DCR 7229 (August 5, 2005). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 520

22-A DCMR § 521 STAFF EDUCATION AND TRAINING

521.1 Each MH provider identified in § 500.7 shall design and implement a training and education program for all MH provider staff aimed at minimizing the use of restraint and seclusion and maximizing safety for consumers and MH provider staff when restraint or seclusion are used.

521.2 Each MH provider shall require all staff members to receive effective, ongoing, competency-based education and training on the following:

(a) Understanding and appropriately responding to underlying behaviors of consumers that precipitate the use of restraints or seclusion;

(b) Techniques to identify staff interactions, consumer medical conditions, and environmental factors that may trigger consumer behavior resulting in the use of restraints or seclusion;

(c) The use of de-escalation and other non-physical behavior management techniques, such as mediation, conflict resolution, active listening, and verbal and observational methods, to reduce or eliminate the use of restraints and seclusion;

(d) The safe use of restraints and seclusion, including the ability to recognize and respond to signs and symptoms of physical, mental, medical or emotional distress, or impairments or injury in consumers who are restrained or secluded; and

(e) Cardiopulmonary resuscitation (CPR), including certification and periodic re-certification in CPR.

521.3 Each MH provider identified in § 500.7 shall require all staff members who are authorized to physically apply restraints or seclusion to receive ongoing training and demonstrate competence in the safe use of restraints and seclusion, including:

(a) Acceptable techniques for physically holding a consumer;

(b) Acceptable take-down procedures; and

521.4 Each MH provider identified in § 500.7 shall require all staff members who are authorized to perform fifteen (15) minute assessments of consumers in restraints or seclusion to receive ongoing training and demonstrate competence in:

(a) Taking vital signs and interpreting their relevance;

(b) Recognizing nutritional and hydration needs;

(d) Addressing hygiene and elimination needs;

(e) Addressing physical and psychological status and comfort;

(f) Assisting consumers in meeting behavioral criteria for the discontinuation of restraints or seclusion; and

(g) Recognizing when to contact a physician or emergency medical services to evaluate or treat a consumer's physical condition.

521.5 Each MH provider identified in § 500.7 shall require all staff members who are authorized to initiate the use of restraints or seclusion, or to perform evaluations of consumers who are in restraints or seclusion to receive education about and demonstrate competence in:

(a) Recognizing how age, developmental considerations, gender issues, cultural issues, ethnicity, traumatology, and history of sexual or physical abuse may affect the way in which a consumer reacts to physical contact; and

(b) The use of behavioral criteria for the discontinuation of restraints or seclusion and how to assist a consumer in meeting the criteria.

521.6 All staff employed by MH providers shall demonstrate their competencies, as specified in this section, on an annual basis.

521.7 Each MH provider shall ensure adequate levels of staffing and appropriate staffing configurations at all times, based on factors such as the physical environment, consumer diagnosis and needs, co-occurring conditions, acuity levels, and the age or developmental status of each consumer.

521.8 Each MH provider shall include an annual evaluation of the factors set forth in § 521.2 in its staff performance evaluation or quality improvement program.

521.9 Each MH provider shall document in the staff personnel records that necessary training; education and competency have been successfully completed. Documentation shall include the date training was completed, the type of training completed, and the name of the individual certifying the completion of training.

521.10 All training programs and materials used by each MH provider shall be made available, upon written request, for review by DMH.

History

SOURCE: Emergency and Proposed Rulemaking published at 51 DCR 8691 (September 3, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 51 DCR 11863 (December 31, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 52 DCR 5957 (June 24, 2005)[EXPIRED]; as amended by Final Rulemaking published at 52 DCR 7229 (August 5, 2005). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 521

22-A DCMR § 522 VIOLATIONS OF THIS CHAPTER

522.1 If the consumer or any third party believes that the consumer's rights with respect to the use of restraints or seclusion have been violated for any reason, such consumer or third party may file a grievance in accordance with the procedures prescribed in 22-A DCMR, Chapter 3.

522.2 Violations of this chapter may subject the MH provider to sanctions to be determined by DMH. Sanctions may include reporting to the Center for Medicare and Medicaid Services and/or suspension or revocation of the MH provider's licensure or certification, depending on the nature of the violation.

History

SOURCE: Emergency and Proposed Rulemaking published at 51 DCR 8691 (September 3, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 51 DCR 11863 (December 31, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 52 DCR 5957 (June 24, 2005)[EXPIRED]; as amended by Final Rulemaking published at 52 DCR 7229 (August 5, 2005). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 522

22-A DCMR § 599 DEFINITIONS

"Assertive community treatment or "ACT" - intensive, integrated rehabilitative, crisis, treatment, and community support provided to adult consumers with serious and persistent mental illness by an interdisciplinary team, in accordance with the requirements of 22-A DCMR Chapter 34.

"Assertive Community Treatment team" or "ACT team" - the mobile inter-disciplinary team of qualified practitioners and other staff involved in providing ACT to a consumer.

"Attending physician" - the physician on duty or on call at the MH provider at the time an emergency requiring the use of restraints/seclusion occurs. In some instances, the attending physician may also be the consumer's treating physician.

"Cardiopulmonary resuscitation" - an emergency technique to revive somebody whose heart has stopped beating that involves clearing the person's airways and then alternating heart compression with mouth-to-mouth respiration.

"Consumer" - an adult, child, or youth who seeks or receives mental health services or mental health supports in the District of Columbia under Chapter 5 of Title 21 of the District of Columbia Code, or Chapter 5 of Title 24 of the District of Columbia Code, regardless of whether the person's status is voluntary, non- protesting, or involuntary.

"Consumer statement of treatment preferences" - a document or form completed by a consumer in accordance with District of Columbia Official Code § 7-1231.01 that indicates the consumer's preferences regarding the use of seclusion or restraints and less restrictive alternatives to be used or attempted in a psychiatric emergency situation. A consumer statement of treatment preferences may be contained in either a Declaration of Advance Instructions or Durable Power of Attorney for Healthcare.

"Core services agency" - a DMH-certified community-based provider of mental health rehabilitation services that has entered into a Human Care Agreement with DMH to provide specified services and serves as the clinical home for consumers enrolled in and eligible to receive mental health rehabilitation services.

"DMH" - the Department of Mental Health, the successor in interest to the District of Columbia Commission on Mental Health Services.

"Emergency" - a situation in which a consumer is experiencing a mental health crisis and is presenting an imminent risk of serious injury to self or others.

"Forensic services" - the program operated by DMH at Saint Elizabeths Hospital that provides court-ordered and legally mandated mental health services to persons who are involved in the criminal justice system and require inpatient pretrial examination and treatment; inpatient hospitalization and treatment due to a verdict of not guilty by reason of insanity and inpatient hospitalization while serving a prison sentence.

"Inpatient mental health service" - residence and treatment provided in a psychiatric hospital or unit, which is licensed or operated by the Mayor.

"Maximum security consumers" - those persons who have been committed to either DMH or Saint Elizabeths Hospital by the Criminal Division of the local or federal courts or the Department of Corrections and who reside on a maximum security unit within the forensic services program.

"Mayor" - means the Mayor of the District of Columbia or any executive branch agency the Mayor may designate for purposes of this chapter.

"Mental health provider" or "MH Provider" - any entity that is (1) operated, licensed, or certified by the Mayor to provide mental health services or mental health supports; or (2) that has entered into an agreement with the Mayor to provide mental health services or mental health supports.

"Physical hold" - the application of physical force without the use of any mechanical device, for the purpose of restraining the free movement of a consumer's body.

"Physician" - a person licensed under the laws of the District of Columbia to practice medicine, or a person who practices medicine in the employment of the government of the United States.

"Physician assistant" - a health professional who meets the qualifications for licensure as a physician assistant by the District of Columbia Board of Medicine and who is licensed in the District of Columbia as a physician assistant, or a person who practices as a physician assistant in the employment of the government of the United States.

"Registered nurse" or "RN" - a person licensed as a registered nurse in accordance with applicable District of Columbia laws and regulations or a person who practices nursing in the employment of the government of the United States.

"Restraints" - a physical restraint or a drug that is used for the purpose of restraint. Restraints do not include a physical hold of fifteen (15) minutes or less in duration.

"Seclusion" - any confinement of a consumer alone in a room or an area which the consumer is either physically prevented from leaving or from which the consumer is led to believe he or she cannot leave at will.

"Serious injury" - any significant impairment of the physical or mental condition of a person, as determined by qualified medical personnel. This includes, but is not limited to, burns, lacerations, bone fractures, substantial hematoma, and injuries to internal organs, whether self-inflicted or inflicted by someone else, as well as emotional trauma requiring specific services and supports in addition to or beyond those mental health services and supports already being received by the person.

"Service plan" - the individualized recovery plan for adults or the individualized plan of care for children/youth, which includes the consumer's treatment goals, strengths, challenges, objectives, and interventions.

"Site-based crisis emergency provider" - an MH provider certified by DMH to provide crisis emergency services in accordance with 22-A DCMR 3419 and provides crisis emergency services pursuant to the terms of a human care agreement with DMH. The modifier, "site-based" refers specifically to those services provided in the physical facility of the crisis emergency provider (in contrast to its community-based, outreach services). A site-based crisis emergency provider must have the ability to provide psychiatric emergency treatment including the continuous availability of an on-site or on-call psychiatrist, the continuous availability of a formulary of psychotropic medications, nursing staff continually available to give emergency orders for the use of restraints and the appropriate equipment.

"Staff" - those individuals with responsibility for managing a person's health care or participating in an emergency and who are employed by the MH provider on a full-time, part-time, or contract basis, including without limitation physicians, nurses, orderlies, resident physicians, interns, and direct care workers.

"Treating physician" - the physician, who may be a psychiatrist, responsible for the regular and ongoing mental health treatment of the consumer. In some instances, the consumer's treating physician may also be the attending physician.

History

SOURCE: Emergency and Proposed Rulemaking published at 51 DCR 8691 (September 3, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 51 DCR 11863 (December 31, 2004)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 52 DCR 5957 (June 24, 2005)[EXPIRED]; as amended by Final Rulemaking published at 52 DCR 7229 (August 5, 2005). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 599

22-A10 FEES AND TRAINER EXPENSES FOR THE DEPARTMENT OF BEHAVIORAL HEALTH TRAINING EVENTS

22-A DCMR § 1000 PURPOSE

1000.1 This chapter establishes the fee structure for the Department’s training events and the allowable expenses to be paid to external trainers.

History

SOURCE: Final Rulemaking published at 62 DCR 12680 (September 25, 2015). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 1000

22-A DCMR § 1001 FEES

1001.1 The Director may charge fees for training programs provided through the Department’s Training Institute that are approved for continuing education contact hours or incur costs associated with production. The Director may waive fees in his or her discretion for mandatory events or events for consumers and family members. Both governmental and non-governmental employees shall be subject to fees.

1001.2 In charging fees, the Director shall adhere to the following fee schedule:

Number of Contact Hours

Cost

2-4

Not to Exceed $60.00

5-8

Not to Exceed $120.00

10-16

Not to Exceed $240.00

17 or more

Not to Exceed $480.00

1001.3 The Director may charge a reasonable fee not to exceed five dollars ($5.00) per registrant to cover the cost of any electronic enrollment and payment system.

History

SOURCE: Final Rulemaking published at 62 DCR 12680 (September 25, 2015). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 1001

22-A DCMR § 1002 TRAINER FEES

1002.1 The Department shall not pay any trainer in excess of one-thousand five-hundred dollars ($1,500.00) a day to participate in a Department-sponsored training event. The Director may in his or her discretion waive this requirement on a case by case basis when the proposed trainer is a national expert with superior qualifications and the waiver is necessary to provide the training.

History

SOURCE: Final Rulemaking published at 62 DCR 12680 (September 25, 2015). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 1002

22-A DCMR § 1099 DEFINITIONS

1099.1 When used in this chapter, the following terms shall have the meaning ascribed:

Contact Hour – a measure of scheduled instruction or education training provided to the attendees, typically by licensed professionals, as a condition of receiving or maintaining a license, that does not include breaks or other content that does not meet the criteria set for the in the respective sponsorship authority approval guidelines.

History

SOURCE: Final Rulemaking published at 62 DCR 12680 (September 25, 2015). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 1099

22-A12 DEPARTMENT OF MENTAL HEALTH PRIORITY POPULATIONS RULE

22-A DCMR § 1200 PRIORITY POPULATIONS - GENERAL REQUIREMENTS

1200.1 The Mental Health Service Delivery Reform Act of 2001 (Act), D.C. Official Code §§ 7-1131.01 et seq., requires the Department of Mental Health (DMH) to provide or arrange systems of care to serve the needs of children and youth with mental health problems and adults with mental illness, as defined in Section 102 of the Act, D.C. Official Code § 7-1131.02.

1200.2 The Act requires DMH to promulgate rules that define priority populations in order to prioritize service response and system design to focus on consumers with the more severe forms of mental or emotional illness.

1200.3 DMH shall issue an annual plan as required by the Act that includes an explanation of how DMH will provide or arrange systems of care to serve the needs of children and youth with mental health problems and adults with mental illness.

History

SOURCE: New by emergency and proposed rulemaking at 49 DCR 1734 (February 22, 2002)[EXPIRED]; Final Rulemaking published at 49 DCR 5811 (June 21, 2002).

22-A DCMR § 1201 CHILDREN OR YOUTH WITH SERIOUS EMOTIONAL DISTURBANCE

1201.1 Children or youth with serious emotional disturbance includes children and youth under age 22 who currently have, or at any time during the prior year have had, a diagnosable mental, behavioral, or emotional disorder, including those of biological etiology that:

(a) Is or was of sufficient duration to meet diagnostic criteria specified within the DSM-IV or the ICD9-CM equivalent, except for DSM-IV "V" codes;

(b) Is neither a substance abuse disorder nor a developmental disorder, unless co-occurring with another diagnosable serious emotional disturbance;

(c) Results, resulted in, or will without treatment or other support services, result in a functional impairment that either substantially interferes with or limits the consumer's role or functioning in family, school, or community activities, or that limits the consumer from achieving or maintaining one or more developmentally-appropriate social, behavioral, cognitive, communicative, or adaptive skills; and

(d) Includes functional impairments of episodic, recurrent, and continuous duration but not temporary and expected responses to stressful events in the consumer's environment.

History

SOURCE: New by emergency and proposed rulemaking at 49 DCR 1734 (February 22, 2002)[EXPIRED]; Final Rulemaking published at 49 DCR 5811 (June 21, 2002).

22-A DCMR § 1202 PERSONS WITH SERIOUS MENTAL ILLNESS

1202.1 Persons with serious mental illness are individuals age 22 or over who currently have, or at any time during the prior year have had, a diagnosable mental, behavioral or emotional disorder (including those of biological etiology) that:

(a) Is or was of sufficient duration to meet diagnostic criteria specified within DSM-IV or the ICD-9-CM equivalent (and subsequent revisions), except for DSM-IV "V" codes;

(b) Is not a substance abuse disorder or a developmental disorder, unless co-occurring with another diagnosable mental illness; and

(c) Results, resulted in, or will without treatment or other support services result in a functional impairment that substantially interferes with or limits one or more major life activities, including basic daily living skills, instrumental living skills, and functioning in social, family and vocational or educational contexts.

History

SOURCE: New by emergency and proposed rulemaking at 49 DCR 1734 (February 22, 2002)[EXPIRED]; Final Rulemaking published at 49 DCR 5811 (June 21, 2002).

22-A DCMR § 1299 DEFINITIONS

"Basic daily living skills" - skills necessary to handle life activities, including but not limited to eating, bathing and dressing.

"Capacity" - the ability to understand and appreciate the nature and consequences of the proposed treatment, including the benefits and risks of, and alternatives to, the proposed treatment, and to make and communicate a decision regarding the proposed treatment.

"Consumer" - an adult, child or youth who seeks or receives mental health services or mental health supports funded or regulated by the Department of Mental Health.

"DMH" - the Department of Mental Health, the successor in interest to the District of Columbia Commission on Mental Health Services.

"DSM-IV" - the most recent version of the Diagnostic and Statistical Manual of Mental Disorders as amended from time to time.

"DSM-IV 'V' Codes" - "V" codes as defined in the DSM-IV.

"ICD-9-CM" - the most recent version of the International Classification of Diseases Code Manual as amended from time to time.

History

SOURCE: New by emergency and proposed rulemaking at 49 DCR 1734 (February 22, 2002) [EXPIRED]; Final Rulemaking published at 49 DCR 5811 (June 21, 2002).

22-A22 SUPPORTED HOUSING SERVICES FOR MENTAL HEALTH CONSUMERS

22-A DCMR § 2200 GENERAL PROVISIONS

2200.1 These rules establish requirements for supported housing services provided by Core Services Agencies (CSAs) and the management of supported housing assistance programs by the Department of Mental Health (Department or DMH). The Department may further implement this rule through published practice guidelines and policies.

2200.2 Supported housing services assist adults and children with mental illness or serious mental health problems with finding and maintaining appropriate independent housing arrangements in the community. Supported housing services include mental health services and supports provided by DMH-certified mental health providers, and direct financial assistance from the Department or DMH-certified mental health provider. Support is provided through a comprehensive continuum of care that is individualized, flexible, and recovery-based. The following are examples of supported housing services:

(a) A Core Services Agency (CSA) may provide housing to a consumer directly or through a specialty or subprovider;

(b) DMH, a CSA, or another government agency may provide a monetary subsidy for rent on behalf of a consumer;

(d) A CSA or other provider may provide mental health services and supports in the consumer’s home to assist with developing and improving activities of daily living; or

(e) DMH or another government agency may provide funds to a business entity to develop or provide housing for consumers enrolled with DMH.

2200.3 Each business entity seeking support from DMH to provide housing or housing supports in the District of Columbia shall be a DMH-certified CSA or be affiliated with a CSA or DMH. Affiliation with a CSA or DMH shall mean that the business entity has a written agreement with a CSA or DMH, or an entity acting on behalf of DMH that describes each party’s responsibilities specific to housing.

History

SOURCE: Final Rulemaking published at 50 DCR 3175(April 25, 2003); as amended by Final Rulemaking published at 52 DCR 7026 (July 29, 2005); as amended by Final Rulemaking published at 60 DCR 6479 (May 3, 2013).

22-A DCMR § 2201 CORE SERVICES AGENCIES RESPONSIBILITIES FOR SUPPORTED HOUSING SERVICES

2201.1 All CSAs shall assess consumers for supported housing needs as part of the treatment plan process. This includes both the development of the treatment plan and any updates and modifications based upon the status of a consumer’s recovery. The purpose of the housing assessment is to evaluate and identify each individual consumer’s living arrangement needs. The assessment shall adhere to this regulation and any Department policies, forms and practice guidelines related to supported housing.

2201.2 Supported housing assessments shall address, at a minimum, the following factors:

(a) Risk of homelessness;

(b) Risk of hospitalization;

(d) Whether current housing is a product of consumer’s personal choice;

(e) Whether current living arrangement provides necessary supports for safe and successful living; and

(f) If a change in housing is needed to support safe and successful living, the community treatment strategies to get the consumer into appropriate housing.

2201.3 If a consumer has been assessed as needing housing, or as needing housing at a different level than the housing currently occupied by the consumer, the mental health provider shall assist the consumer in applying for any public benefit, financial assistance, or housing assistance program for which the consumer is eligible, including but not limited to the District of Columbia Housing Authority (“DCHA”) Housing Choice Voucher Program and other supported housing services provided by or through the Department.

2201.4 If a consumer is receiving direct housing or a supported housing subsidy pursuant to these rules directly from a CSA or other DMH-certified mental health provider and chooses to enroll with another CSA or DMH-certified mental health provider, the provider shall not require the consumer to move from the housing because of the change in providers.

2201.5 The Department shall conduct targeted compliance reviews of CSAs’ supported housing assessments at least annually and report the results to each CSA under review. The Department shall incorporate the results into the Department’s annual quality improvement plan.

2201.6 Each CSA shall maintain and keep current, at all times, a log that lists all consumers residing in each of the CSA’s DMH supported housing as defined by these rules. This information shall be available to DMH upon request. The CSA shall provide statistical data and reports related to the provision of supported housing services as requested by the Department.

History

SOURCE: Final Rulemaking published at 50 DCR 3175(April 25, 2003); as amended by Final Rulemaking published at 52 DCR 7026 (July 29, 2005); as amended by Final Rulemaking published at 60 DCR 6479 (May 3, 2013).

22-A DCMR § 2202 HOME FIRST SUBSIDY PROGRAM FOR MENTAL HEALTH CONSUMERS

2202.1 Sections 2202 through 2299 provide standards for implementing the Department’s Home First Subsidy Program and the Department’s housing wait list. The Home First Subsidy is a locally-funded rental voucher that is paid by the Department on behalf of qualifying consumers for community-based housing meeting the requirements of this regulation. The Home First Subsidy is subject to annual appropriations limits. When a consumer is eligible for a Home First Subsidy but there are inadequate funds to issue a voucher, the consumer may be placed on the Department’s housing wait list, subject to the requirements in Section 2206.

2202.2 Nothing in these rules shall be interpreted to mean that any subsidy provided by the Department is an entitlement. Locally-funded or administered subsidies are dependent upon the availability of funds, the needs of individual consumers, and the priority populations established by the Department.

History

SOURCE: Final Rulemaking published at 50 DCR 3175(April 25, 2003); as amended by Final Rulemaking published at 52 DCR 7026 (July 29, 2005); as amended by Final Rulemaking published at 60 DCR 6479 (May 3, 2013).

22-A DCMR § 2203 WAIVER OF RULES

2203.1 Upon determination of good cause, the Director may waive any provision under this chapter subject to the statutory limitations of other federal or District laws.

History

SOURCE: Final Rulemaking published at 50 DCR 3175(April 25, 2003); as amended by Final Rulemaking published at 52 DCR 7026 (July 29, 2005); as amended by Final Rulemaking published at 60 DCR 6479 (May 3, 2013).

22-A DCMR § 2204 ELIGIBILITY CRITERIA

2204.1 The following are the minimum eligibility requirements to apply for a Home First Subsidy through the Department:

The individual is a consumer actively-engaged with a CSA or other DMH-

certified provider;

(b) The consumer is:

(i) eighteen (18) years of age or older and has been diagnosed with a serious and persistent mental illness as defined in Section 2299;

(ii) the legal guardian of a child consumer with a serious and persistent mental illness or a serious emotional disturbance, or

(iii) an emancipated minor consumer who has been diagnosed with a serious and persistent mental illness or a serious emotional disturbance;

(d) The consumer’s household income, or guardian’s household income in the case of a child consumer, does not exceed the amount specified in Subsection 2204.2;

(e) The consumer does not have any legal or equitable interest in real property;

(f) The consumer or guardian has registered for, or has a verifiable appointment to register for, permanent housing assistance through DCHA, unless otherwise ineligible to register with DCHA or the DCHA has suspended new registrations; and

(g) The consumer has a demonstrable need for the Home First Subsidy because no other suitable housing options are available.

2204.2 The eligible consumer’s or guardian’s adjusted income, as defined in Section 2299, for the sixty (60) day period immediately preceding the date of application, shall not exceed thirty percent (30%) of the Area Median Income for the Metropolitan Washington D.C. Area, as defined by the U.S. Department of Housing and Urban Development at the time of application.

2204.3 The Department may require the applicant or other household members to execute one or more authorizations to release information to verify eligibility. The release of information shall comply with D.C. Official Code § 7-1201.01 et seq., and other applicable federal and local privacy laws.

2204.4 The Department’s Home First Subsidy is a subsidy of last resort. The Department shall not authorize a Home First Subsidy if other permanent housing financial assistance is made available to the consumer, including, but not limited to, a Housing Choice Voucher or other federal or District housing subsidy program.

History

SOURCE: Final Rulemaking published at 50 DCR 3175(April 25, 2003); as amended by Final Rulemaking published at 52 DCR 7026 (July 29, 2005); as amended by Final Rulemaking published at 60 DCR 6479 (May 3, 2013).

22-A DCMR § 2205 APPLICATION PROCESS

2205.1 Each application for a Home First Subsidy shall be submitted in a format prescribed by the Department pursuant to these rules and the Department’s policies and procedures.

2205.2 Each applicant shall cooperate fully with the Department in establishing his or her eligibility, or, in the case of the applicant being a legal guardian, eligibility of the ward by providing supporting information and documentation. The application is complete when all of the information required by the Department is furnished to the Department.

2205.3 If requested by an applicant with a disability, or if the CSA or mental health provider is aware that the applicant needs assistance due to a disability, the CSA or mental health provider shall assist the applicant with any aspect of the application process necessary to ensure that the applicant with a disability has an equal opportunity to submit the application.

2205.4 Upon receipt of an application, the Department shall record the date that the application is received and shall provide a dated notice of receipt to the applicant. In the event the application is incomplete and the applicant fails to complete the application within fifteen (15) business days following notification, the Department will consider the application canceled and the CSA or mental health provider and applicant must submit a new application. The Department is not responsible for processing delays due to the applicant’s failure to submit required information.

2205.5 Once an applicant is determined eligible for a Home First Subsidy, and funding is available, the Department shall send a written eligibility determination to the applicant, the CSA, and a representative payee, if appropriate. The eligibility determination shall include, at a minimum:

(a) A statement of the eligibility determination;

(b) Written approval to search for housing;

(c) If the subsidy is one that is attached to a specific unit, contact information and further information for assessing the unit;

(d) The amount of financial contribution that the eligible consumer is required to contribute per month, if any; and

(e) The contact name and telephone number of a Department representative.

2205.6 If an applicant is determined eligible, but no Home First Subsidy is available, the Department shall send a written eligibility determination to the applicant and the CSA. This eligibility determination shall include, at a minimum:

(a) A statement of the eligibility determination;

(b) A statement identifying the date that the eligible consumer will be placed on the waiting list; and

2205.7 If an applicant is determined ineligible, the Department shall send a written determination of ineligibility to the applicant and the CSA. This ineligibility determination shall include, but is not limited to:

(a) A statement of the denial of eligibility;

(b) A statement of the factual basis for the denial;

(c) A statement of the applicant's right to request that the Department review the determination pursuant to Section 2217; and

(d) The contact name and telephone number of a Department representative.

History

SOURCE: Final Rulemaking published at 50 DCR 3175(April 25, 2003); as amended by Final Rulemaking published at 52 DCR 7026 (July 29, 2005); as amended by Final Rulemaking published at 60 DCR 6479 (May 3, 2013).

22-A DCMR § 2206 WAITING LIST

2206.1 When the Department has insufficient funds to issue new Home First Subsidies, the Department may maintain a waiting list for consumers. The Department may utilize the waiting list to manage referral of consumers to any available supported housing subsidy program.

2206.2 If the Department maintains a waiting list, the Department shall place an eligible consumer on a waiting list when:

The Department has no funds to issue any new Home First Subsidies;

No unit with an attached subsidy that meets the consumer’s specific needs is available;

(d) The eligible consumer is incarcerated, or hospitalized or otherwise not available to occupy housing at the time of application.

2206.3 Subject to the Department’s priority population in Section 2207, an eligible consumer shall be placed on the waiting list in chronological order by the date the Department receives the consumer’s completed application. Placement on the waiting list does not guarantee that a consumer will ultimately receive a Home First Subsidy.

2206.4 The eligible consumer and CSA shall provide the Department with the eligible consumer’s current mailing address and telephone number while on the waiting list. Each change of address shall be reported in writing to the Department within five (5) business days of the change.

2206.5 If the eligible consumer fails to ensure the Department has the consumer’s current mailing address and telephone number and the Department needs to contact the consumer because a subsidy becomes available for the consumer’s use, the Department will make a good faith effort to contact the consumer through the consumer’s CSA. If the consumer cannot be contacted within thirty (30) calendar days of the first day of attempted contact, the Department will then contact the next person on the list for utilization of the subsidy.

2206.6 When an eligible consumer on the waiting list is notified that a subsidized housing unit or funding for a supported housing subsidy for his or her use in accordance with this chapter is now available, the Department shall re-determine the eligibility status of the consumer.

2206.7 If an eligible consumer becomes ineligible for a supported housing subsidy in accordance with the requirements of Section 2204, the consumer will be removed from the supported housing subsidy wait list. The Department will send written notice of the removal to the consumer at his or her last known address, and to the consumer’s former CSA or other mental health provider. The consumer will have a right for review of the determination of ineligibility pursuant to Section 2217.

History

SOURCE: Final Rulemaking published at 50 DCR 3175(April 25, 2003); as amended by Final Rulemaking published at 52 DCR 7026 (July 29, 2005); as amended by Final Rulemaking published at 60 DCR 6479 (May 3, 2013).

22-A DCMR § 2207 PRIORITY POPULATIONS FOR SUPPORTED HOUSING SUBSIDIES

2207.1 The Department shall provide the following eligible consumers with priority placement for a Home First Subsidy:

(a) Consumers pending discharge from Saint Elizabeths Hospital;

(b) Consumers who are chronically homeless; and

2207.2 Nothing in this rule otherwise prohibits the Department from authorizing priority placement on a case-by-case basis, based upon compelling circumstances, for a consumer not meeting the requirements above.

History

SOURCE: Final Rulemaking published at 50 DCR 3175(April 25, 2003); as amended by Final Rulemaking published at 52 DCR 7026 (July 29, 2005); as amended by Final Rulemaking published at 60 DCR 6479 (May 3, 2013).

22-A DCMR § 2208 HOME FIRST SUBSIDY PROGRAM

2208.1 The Department may approve a Home First Subsidy in an amount equivalent to eighty percent (80%) of the 2011 Fair Market Rent Value calculated by the U.S. Department of Housing and Urban Development for the Metropolitan Washington D.C. area. An eligible consumer shall pay thirty percent (30%) of his or her adjusted income (“Total Consumer Rent Payment”) toward the total rent due under the lease. The Department may authorize an increase in the Home First Subsidy amount, subject to available appropriations.

2208.2 For each approved Home First Subsidy, the Department shall issue the housing subsidy on a monthly basis to the landlord on behalf of the eligible consumer that is equal to the rent charged by the landlord, minus the Total Consumer Rent Payment, as determined by the Department in accordance with this chapter.

2208.3 The amount of the total rent due under a lease shall not exceed the limits set by the Department pursuant to Subsection 2208.1. If utilities are included in the total rent, a higher rent may be considered for approval on a case-by-case basis.

2208.4 Rent rates established by the Department pursuant to Subsection 2208.1 shall be effective for new leases and lease renewals that occur after the effective date of this chapter.

2208.5 Subject to Section 2208.3, all utility costs, including water, gas, electric, telephone, cable, and internet access, are the consumer’s responsibility and will not be included in determining the consumer’s obligation to pay thirty percent (30%) of household income towards the monthly rent.

2208.6 If a consumer has a demonstrated need for assistance with payment of a security deposit, the Department may, subject to availability of funds, pay the security deposit on behalf of the consumer. The consumer must repay the Department in accordance with a payment plan established by the Department and documented in the Program Agreement. The Department will not assist a consumer with payment of an additional security deposit if the consumer still owes funds for assistance with a previously-paid security deposit.

2208.7 Once the Department has identified funds for a supported housing subsidy for an eligible consumer, the Department shall notify in writing the consumer, the CSA, and the consumer’s personal representative, if applicable, of the availability of the subsidy.

2208.8 Upon written notification by the Department of the availability of supported housing subsidy funds, the consumer will have ninety (90) days to submit a complete Home First Subsidy application package. The CSA is primarily responsible for ensuring the consumer completes and returns all required forms during the process. The Department shall make all forms for the supported housing subsidy package available to the CSAs. The Department may grant reasonable extensions upon a showing of good cause.

2208.9 An eligible consumer may only search for a Home First Subsidy-eligible housing after he or she receives written authorization to begin a housing search from the Department. The Department shall provide a monthly list of vacant units to the CSAs to assist consumers search for available housing with the understanding by all recipients that the list is not exhaustive and consumers and CSAs should not rely solely on the Department vacancy list to locate housing. Consumers and CSAs are encouraged to utilize other resources within the public domain to identify appropriate and available housing.

2208.10 The Department may approve a Home First Subsidy for an eligible consumer only after the following conditions are met:

(a) The eligibility status and income of the consumer is re-determined by DMH to ensure the consumer remains eligible for the supported housing subsidy;

(b) A housing unit which complies with the requirements of this chapter is available;

Section 2208.1;

(d) The housing unit has a valid business license and certificate of occupancy, as required by applicable District law;

(e) The eligible consumer and mental health provider submits to the Department a supported housing subsidy Package, which includes:

A Program Agreement signed by the eligible consumer;

A Subsidy Approval Form signed by the landlord; and

A completed Housing Pre-Inspection Checklist.

(f) The Department approves the supported housing subsidy approval form in writing; and

(g) The eligible consumer, CSA or other mental health provider provides the Department with a copy of the executed lease agreement signed by the eligible consumer and the landlord.

2208.11 If the Home First Subsidy package is approved, the Department shall notify the eligible consumer and CSA or other mental health provider that the supported housing subsidy is approved by providing the eligible consumer a copy of the supported housing subsidy approval form signed by the Department.

2208.12 If the Home First Subsidy package is not approved due to missing information, the Department shall notify the eligible consumer and CSA or other mental health provider of the reason(s) for disapproval. The consumer and CSA have ten (10) business days to provide the Department a completed Home First Subsidy package. Failure to complete or supply the missing information may result in denial of subsidy and placement on the waiting list.

2208.13 The Department shall only issue an approved Home First Subsidy in the form of non-cash payment directly to the landlord.

2208.14 The Department shall only provide a Home First Subsidy for actual rent obligations incurred by the consumer in a manner consistent with this chapter.

History

SOURCE: Final Rulemaking published at 50 DCR 3175(April 25, 2003); as amended by Final Rulemaking published at 52 DCR 7026 (July 29, 2005); as amended by Final Rulemaking published at 60 DCR 6479 (May 3, 2013).

22-A DCMR § 2209 LANDLORD PARTICIPATION

2209.01 Each landlord who agrees to accept a Home First Subsidy on behalf of an eligible consumer shall sign a Subsidy Agreement with the Department. The Subsidy Agreement shall require that the landlord:

(a) Comply with all applicable District laws and regulations, including 14 DCMR, Chapters 3 – 9;

(b) Enter into a lease agreement with an eligible consumer that complies with District law and the requirements of the Home First Subsidy program;

(c) Provide habitable housing in the District of Columbia in accordance with applicable federal and District laws relating to accessibility, health and safety, including compliance with Section 5323, “Acceptability Criteria and Exceptions to Housing Quality Standards” (“HQS”) of 14 DCMR, Chapter 53;

(d) Agree that in the event the housing is not maintained in accordance with the HQS, the Department may exercise any available remedy including suspension, abatement or termination of the supported housing subsidy, unless the HQS breach is the responsibility of the consumer;

(e) Hold harmless and release the Department from any and all claims, actions, judgments and attorney fees arising from any damage or necessary repairs to the unit or property;

(f) Agree that the Department shall not pay any claim by the landlord against the tenant;

(g) Accurately report to the Department the date of scheduled move in, move out, the contract rent of each eligible consumer, and if the eligible consumer stops paying rent, the date of the most recent rent payment;

(h) Allow DMH or its designee to conduct annual inspections of the unit;

(i) Make necessary repairs identified during the annual inspection, or any other repairs necessary to remedy any housing code violations, within thirty (30) days of notification, to avoid Department remedies including suspension, abatement or termination of the supported housing subsidy;

(j) Make repairs to life-threatening HQS or other housing code violations within twenty-four (24) hours of notice to the landlord, or the Department may suspend, abate or terminate the supported housing subsidy;

(k) Notify the Department within five (5) calendar days if the consumer is no longer living in a unit receiving the Home First Subsidy;

(l) Accept a Home First Subsidy from the Department as late as the 15th day of each month and waive penalties and fees for late payments if received by the 15th of each month;

(m) Not levy fines or penalties against the consumer, or take action against the consumer to terminate the tenancy, for late or non-payment of the Home First Subsidy or while the Department and the landlord are actively working to resolve verification and payment issues;

(n) Notify the Department as well as the consumer when initiating any legal action against the consumer;

(o) Participate in a mediation program before taking any adverse action against the consumer, if the eligible consumer also agrees to participate;

(p) Agree that the Department, in addition to other remedies, may deduct the amount of a subsidy overpayment from any amounts due the owner, including amounts due under any other supported housing subsidy payment; and

(q) Provide the Department, upon request, with a list verifying current occupancy and tenancy status for all consumers receiving a Home First Subsidy.

2209.02 A landlord shall neither demand nor accept any rent payment from the eligible consumer in excess of the Total Consumer Rent Payment, i.e., the amount approved by the Department in writing.

2209.03 A landlord who accepts a supported housing subsidy for a consumer who is no longer a tenant of the property, shall return the supported housing subsidy to the Department within fifteen (15) calendar days of receipt.

2209.04 If a landlord fails to comply with a provision of these rules, the Department and the District may exercise any of its rights and remedies under the law including recovery of overpayment, or abatement or suspension of subsidy payments.

2209.05 Nothing in this chapter shall be construed to create any legal rights, substantive or procedural, by a landlord in any matter, administrative, civil or criminal against the District. The Department’s payment of a supported housing subsidy shall not be deemed to create a relationship of partnership, joint venture, or agency between the Department, consumer, and participating landlord. The Department shall not be held liable as a result of the Department’s payment of a supported housing subsidy for the unit for any damage to the unit caused by the consumer.

History

SOURCE: Final Rulemaking published at 50 DCR 3175(April 25, 2003); as amended by Final Rulemaking published at 52 DCR 7026 (July 29, 2005); as amended by Final Rulemaking published at 60 DCR 6479 (May 3, 2013).

22-A DCMR § 2210 RECERTIFICATION

2210.1 The Department or its designee shall recertify the eligibility status of each consumer receiving a Home First Subsidy at least annually, or whenever there is a change in the consumer’s eligibility status, including change in income.

2210.2 The annual re-certification date shall be the anniversary date of the first day of the month in which the eligible consumer began receiving a Home First Subsidy.

2210.3 The Department or its designee will also examine and re-determine the eligibility status and annual income of a consumer as necessary, such as if a consumer has a change in income or in household composition prior to his or her annual re-certification date.

2210.4 The Department or its designee will examine and re-determine the Home First Subsidy payment when an increase in the rent has been proposed by the landlord and approved by the Department.

2210.5 The Department shall send written notice of the re-certification requirement and the required documentation and information and an appointment date and time for re-certification, to each eligible consumer who is receiving a Home First Subsidy through his or her CSA, at least ninety (90) calendar days before the annual re-certification date.

2210.6 If the consumer fails to appear for the first appointment, a second appointment will be scheduled within the ninety (90) day period. If the consumer fails to appear for the second scheduled appointment, absent good cause, the Home First Subsidy may be terminated in accordance with Subsection 2216.

2210.7 Each consumer shall complete written authorizations to allow the Department to obtain information necessary to verify continuing eligibility for the Home First Subsidy.

2210.8 The Department shall continue providing Home First Subsidy payments during the re-certification process.

2210.9 If the re-certification process is not completed within ninety (90) calendar days of the re-certification date due to a delay caused by an eligible consumer, the Department will notify the consumer that the Home First Subsidy will be terminated in thirty (30) days unless the re-certification process is completed before that time.

2210.10 If a consumer is receiving a Home First Subsidy and the Department moves to terminate the subsidy, the Department shall provide an eligible consumer, his or her CSA and any authorized representative, written notice of the proposed termination. An eligible consumer may appeal the proposed termination pursuant to Section 2216.

2210.11 The Department shall provide written notification to each consumer, his or her CSA and any authorized representative if the consumer’s Home First Subsidy supported housing subsidy is terminated as a result of the annual re-certification. A consumer may appeal termination of a subsidy pursuant to Section 2218.

2210.12 A re-certification that results in decrease in the amount of the Home First Subsidy (if applicable) shall be effective thirty (30) calendar days after written notice is provided to an eligible consumer. The Department shall provide written notification to each consumer, his or her CSA and any authorized representative, if the consumer’s Home First Subsidy is decreased as a result of the re-certification. The eligible consumer may appeal the reduction in the amount of the supported housing subsidy pursuant to Section 2218.

2210.13 A re-certification that results in an increase in the amount of the Home First Subsidy (if applicable) shall be effective the first day of the month following the completion of the re-certification process. The Department shall provide written notification to each consumer, his or her CSA and any authorized representative, if the consumer’s supported housing subsidy is increased as a result of the any re-certification.

2210.14 The Department may pursue all remedies against a consumer including recoupment and referral to the appropriate authorities for civil or criminal prosecution if it is determined that a consumer has concealed income or otherwise knowingly violated the certification requirements for the Home First subsidy or other supported housing programs.

2210.15 Consumers receiving supported housing subsidies from another source are required to comply with the recertification requirements of that program.

History

SOURCE: Final Rulemaking published at 50 DCR 3175(April 25, 2003); as amended by Final Rulemaking published at 52 DCR 7026 (July 29, 2005); as amended by Final Rulemaking published at 60 DCR 6479 (May 3, 2013).

22-A DCMR § 2211 CONSUMER PARTICIPATION

2211.1 Each applicant and eligible consumer may exercise rights granted pursuant to applicable District laws and regulations, including but not limited to the Department of Mental Health Consumers’ Rights Protection Act of 2001, effective December 18, 2001 (D.C. Law 14-56; D.C. Official Code § 7-1231.01 et seq.).

2211.2 As a condition of receiving a supported housing subsidy, each consumer shall sign a Program Agreement that includes the following requirements:

(a) If receiving a Home First Subsidy, maintain registration for permanent housing assistance through the DCHA (unless ineligible);

(b) Comply with the terms of the lease as required by District law;

(d) Attend an orientation session scheduled by the Department within the first three (3) months of occupancy;

(e) Pay the Total Consumer Rent Payment (if applicable) for which he or she is responsible;

(f) Permit the CSA or other mental health provider access to his or her housing unit on a monthly basis as required for completing a Housing Safety/Quality Checklist and Home Visit Report pursuant to Subsection 2207.3;

(g) Notify the Department and CSA of any change in annual income or household composition within fifteen (15) calendar days of the change, so that re-certification and recalculation of the Home First Subsidy (if applicable), if necessary, can occur pursuant to Section 2210;

(h) Report any damages or problems in the housing unit to the landlord and CSA immediately after occurrence;

(i) Refrain from illegal activities or other acts that endanger the health or safety of the consumer or any other individual on the premises;

(j) Maintain the unit in a clean, safe, and habitable condition;

(k) Provide to the Department and the landlord at least thirty (30) calendar days in advance, a written notice of intent to terminate a lease or relocate from the premises;

(l) Absent a written waiver from the Department, maintain enrollment with a CSA or other mental health provider while receiving a supported housing subsidy; and

Notify his or her representative payee of eligibility for and receipt of an supported housing subsidy, if applicable.

2211.3 The consumer is not responsible for payment of the portion of the rent owed to the Landlord that is to be paid through the Home First Subsidy as enumerated in the subsidy approval between DMH and the landlord.

2211.4 Each consumer shall be responsible for damages he or she causes to a unit or any common area, in accordance with the terms of the lease. Damages do not include normal wear and tear.

2211.5 If the consumer is receiving a supported housing subsidy other than the Home First Subsidy, the consumer must also comply with all of the requirements of that particular subsidy program.

History

SOURCE: Final Rulemaking published at 50 DCR 3175(April 25, 2003); as amended by Final Rulemaking published at 52 DCR 7026 (July 29, 2005); as amended by Final Rulemaking published at 60 DCR 6479 (May 3, 2013).

22-A DCMR § 2212 ELIGIBLE UNITS

2212.1 The Department may only provide a supported housing subsidy for units that comply with this section, and 14 DCMR, Chapters 3 - 9 as applicable.

2212.2 The following units shall not be eligible for a Home First Subsidy:

Units that do not comply with 14 DCMR, Chapters 3 - 9;

Units in which the consumer, consumer’s personal representative, or consumer’s family member has a legal or equitable interest;

Units owned by Department employees, employees of the Department’s designee, or employees of any organization or entity that has administrative responsibility for the supported housing subsidy;

Units owned by an individual employee of a CSA or a mental health provider in the DMH network;

Units on the grounds of educational institutions or units that are available only to students, staff or faculty of an educational institution;

Any unit where a consumer has no actual or legal responsibility to pay rent; and

Nursing homes.

2212.3 Additionally, supported housing subsidy programs other than the Home First Subsidy program may be limited to units with additional requirements.

History

SOURCE: Final Rulemaking published at 50 DCR 3175(April 25, 2003); as amended by Final Rulemaking published at 52 DCR 7026 (July 29, 2005); as amended by Final Rulemaking published at 60 DCR 6479 (May 3, 2013).

22-A DCMR § 2213 VOLUNTARY RELOCATION IF RECEIVING A HOME FIRST SUBSIDY

2213.1 To request relocation to another housing unit while receiving a Home First Subsidy, an eligible consumer shall submit a written request for relocation to his or her assigned CSA, other mental health provider, or Department.

2213.2 The Department may provide written approval of an eligible consumer’s request to relocate with a Home First Subsidy only if:

The request was submitted for approval before relocating;

The consumer has not yet relocated;

(c) The consumer is not in arrears of the lease, unless there are housing code violations as determined by DCRA or by a court in the current housing unit;

(d) The consumer will not incur penalties under the lease, or has reached an agreement with the landlord for the relocation;

(e) The unit is not damaged or in need of repairs beyond normal wear and tear due to the consumer’s actions;

(f) The rental amount for the new unit is consistent with the Department’s rates in accordance with Subsection 2208.1; and

The Home First Subsidy recipient is in good standing and is not currently in violation of any obligations under this chapter.

2213.3 The Department may waive the requirements above upon a showing of good cause.

History

SOURCE: Final Rulemaking published at 60 DCR 6479 (May 3, 2013).

22-A DCMR § 2214 TEMPORARY ABSENCES

2214.1 If an eligible consumer is absent from the unit for more than thirty (30) calendar days, he or she shall provide notification to the Department, CSA or other mental health provider as soon as possible, but no later than the thirtieth (30th) day of his or her absence.

2214.2 Upon receiving proper notification of an absence, the Department may continue to provide a Home First Subsidy during a temporary absence of up to ninety (90) calendar days, if the absence is a result of:

Short-term placement in an assisted living facility, nursing home or mental health facility;

Short-term inpatient treatment;

Incarceration;

Family emergency; or

Other circumstances for which the Director has determined that the absence is necessary or appropriate.

2214.3 The Department may approve in writing an extension of no more than thirty (30) additional days of absence on a case by case basis.

2214.4 The Department may terminate a Home First Subsidy if:

(a) The Department does not receive notification of a temporary absence of more than thirty (30) days from a housing unit;

(b) The absence is for a period of time beyond ninety (90) calendar days, or the date a Department approved extension expires; or

2214.5 The Department shall provide written notification at least sixty (60) days before termination to each consumer whose Home First Subsidy is subject to termination pursuant to Subsection 2216. A consumer may appeal a written notice of termination of a subsidy pursuant to Section 2218.

2214.6 Consumers who receive a supported housing subsidy other than a Home First Subsidy are subject to the requirements of that particular subsidy program for temporary absences.

History

SOURCE: Final Rulemaking published at 60 DCR 6479 (May 3, 2013).

22-A DCMR § 2215 EVICTIONS AND LEASE TERMINATIONS BY LANDLORDS

2215.1 Landlords receiving a supported housing subsidy may only terminate a program participant’s tenancy in accordance with lease terms and applicable District law.

2215.2 The Department may terminate Home First Subsidy payments to the landlord when the tenancy is terminated by the landlord in accordance with the lease and applicable District law. The consumer remains a program participant unless and until the Department terminates the Home First Subsidy pursuant to Sections 2216.

History

SOURCE: Final Rulemaking published at 60 DCR 6479 (May 3, 2013).

22-A DCMR § 2216 TERMINATION OF ASSISTANCE

2216.1 If a consumer is receiving a supported housing subsidy other than a Home First Subsidy pursuant to this chapter, the program owner of the subsidy will determine when and under what circumstances a consumer’s subsidy assistance may be terminated.

2216.2 The Department may terminate a Home First Subsidy for any of the following reasons:

(a) The consumer no longer meets the Home First Subsidy eligibility requirements described in this chapter;

(b) The consumer was offered a Housing Choice Voucher Program voucher or other permanent housing assistance through any other federal or District program or private source that allows choice in where the consumer may live;

(c) The consumer was offered and accepted other permanent housing assistance through any other federal or District program or private source;

(d) The consumer failed to permit the CSA or other mental health provider to conduct an in-home visit to his or her housing unit as required for completing a Housing Safety/Quality Checklist and Home Visit Report;

(e) The consumer fraudulently misrepresents eligibility for assistance, annual income or other information, with the intention of obtaining unauthorized assistance;

(f) The consumer is absent from the unit, as set forth in Subsection 2214 or no longer resides in the unit, including situations in which the consumer relocates from his approved unit without prior approval from the Department;

(g) The consumer is evicted from an approved unit more than once while receiving a supported housing subsidy;

(h) The consumer voluntarily withdraws from the Home First Subsidy program; or

(i) The death of a consumer.

2216.3 The Department shall provide a consumer written notice of Home First Subsidy termination, effective sixty (60) calendar days from the date the Department issues the notification. A consumer may appeal a written notice of termination pursuant to Section 2218, or file a grievance in accordance with 22-A DCMR, Chapter 3.

2216.4 Termination of the subsidy is effective no later than the first of the month following the consumer’s death.

2216.5 If the Department suspects fraud, it will refer the case to the proper authorities for investigation.

2216.6 If a consumer’s Home First Subsidy is terminated, he or she may re-apply for the in accordance with Section 2205, and upon determination of eligibility will be placed on the waiting-list pursuant to Section 2206.

History

SOURCE: Final Rulemaking published at 60 DCR 6479 (May 3, 2013).

22-A DCMR § 2217 RIGHT TO REVIEW

2217.1 The Department may afford a consumer the opportunity to seek review of the Department’s decision to deny eligibility for a supported housing subsidy.

2217.2 A consumer may request a review within fifteen (15) business days of the Department’s denial of eligibility.

2217.3 Each request for a review shall contain a concise statement of the reason why the consumer should be determined eligible to receive a supported housing subsidy, with supporting documentation, if available.

2217.4 Each administrative review shall be conducted by the Director and shall be completed within fifteen (15) business days of the receipt of the consumer’s request.

2217.5 The Director shall issue a written decision which sets forth his or her evaluation and resolution of the denial and describes the actions required of the Department and actions required of the consumer in implementing the decision.

History

SOURCE: Final Rulemaking published at 60 DCR 6479 (May 3, 2013).

22-A DCMR § 2218 RIGHT TO A HEARING IF RECEIVING A HOME FIRST SUBSIDY

2218.1 A consumer who is receiving a Home First Subsidy may request a hearing, meeting the requirements of the D.C. Administrative Procedure Act, from the Department within thirty (30) business days of receiving written notice of reduction, suspension or termination of a supported housing subsidy.

2218.2 A timely request for a hearing shall automatically stay the Department’s decision to reduce, terminate or suspend a Home First Subsidy pending the completion of a hearing.

2218.3 Each request for a hearing shall contain a concise statement of the reason why the supported housing subsidy should not be reduced, terminated or suspended.

2218.4 During the course of the hearing, the consumer shall have the right to:

(a) Present any testimony, witnesses or other evidence, both orally and in writing;

(b) Cross-examine any witness presented by the Department; and

Be represented by counsel, a relative, or other authorized personal representative, at the consumer’s expense.

2218.5 The recommendation of the hearing officer shall be issued in writing within thirty (30) business days of the hearing and shall include findings of fact based exclusively on evidence presented at the hearing and conclusions of law.

2218.6 The Director shall review the recommendations of the hearing officer and render a final decision within fifteen (15) business days of receiving the hearing officer’s recommendations. The Director shall describe the actions required of the Department and actions required of the consumer in implementing the decision.

2218.7 The Director may overrule the hearing officer in instances where he or she does not agree with findings, conclusions or recommendations presented for decision. In such cases, the reasons for the Director’s decision shall be specified in writing.

History

SOURCE: Final Rulemaking published at 60 DCR 6479 (May 3, 2013).

22-A DCMR § 2299 DEFINITIONS

2299.1 When used in this chapter, the following terms and phrases shall have the meanings ascribed:

“Actively Engaged” – a consumer is provided mental health rehabilitation services from a CSA or other DMH-certified mental health provider at least once every thirty (30) days pursuant to a treatment plan.

“Adjusted Income” – as defined in Title 14 DCMR, Subsection 6099.1.

“Annual Income” – as defined in Title 14 DCMR, Subsection 6099.1.

“Consumer” – adult, child or youth who seeks or receives mental health services or mental health supports funded or regulated by the Department.

“Core Services Agency” or “CSA” – a DMH-certified community-based mental health provider that has entered into a Human Care Agreement with DMH to provide specified mental health rehabilitation services.

“Director” – the Director of the District of Columbia Department of Mental Health.

“Department” – the District of Columbia Department of Mental Health.

“Homeless consumer” – an individual that meets the definition of consumer above and:

(a) Lacks a fixed, regular, and adequate nighttime residence; or

(b) Has a primary nighttime residence that is:

(i) a supervised, publicly or privately operated shelter designed to provide temporary living accommodations (including welfare hotels, congregate shelters, and transitional housing for the mentally ill);

(ii) an institution that provides a temporary residence for individuals intended to be institutionalized; or

(iii) a public or private place not designed for, or ordinarily used as, a regular sleeping accommodation for human beings; or

“Landlord” – any person who, alone or jointly or severally with others, meets either of the following criteria:

(a) Has legal title to any building arranged, designed, or used (in whole or in part) to house one or more habitations; or

(b) Has charge, care, or control of any building arranged, designed or used (in whole or in part) to house one or more habitations, as owner or agent of the owner, or as a fiduciary of the estate of the owner or any officer appointed by the court.

History

SOURCE: Final Rulemaking published at 50 DCR 3175(April 25, 2003); as amended by Final Rulemaking published at 52 DCR 7026 (July 29, 2005); as amended by Final Rulemaking published at 60 DCR 6479 (May 3, 2013).

22-A25 HEALTH HOME CERTIFICATION STANDARDS

22-A DCMR § 2500 HEALTH HOME PROGRAM

HEALTH HOME PROGRAM

These rules establish the requirements and process for certifying a Mental Health Rehabilitation Services (MHRS) Core Services Agency (CSA) or a Freestanding Mental Health Clinic (FSMHC) as a Health Home provider in the District of Columbia.

A Health Home is an MHRS CSA or FSMHC that serves as the coordinating entity for services offered to a person with a serious and persistent mental illness (consumer) who has or is at risk of developing co-occurring chronic medical conditions. The provider is the central point for coordinating patient-centered and population-focused care for both behavioral health and other medical services. The Health Home provider is compensated on a per member per month (PMPM) basis to coordinate care between itself as the behavioral health provider, and other physical and specialty health care providers and community-based services and supports. The purpose and goal of individualized care coordination is to increase collaboration and integration of behavioral, health and community based services, improve management of chronic conditions, and reduce avoidable health care costs, specifically for hospital admissions, readmissions and emergency room visits.

History

SOURCE: Final Rulemaking published at 63 DCR 849 (January 22, 2016); as amended by Final Rulemaking published at 66 DCR 5625 (May 3, 2019). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 2500

22-A DCMR § 2501 CERTIFICATION REQUIREMENTS

2501.1 No person or entity shall operate a Health Home unless certified in accordance with this chapter.

2501.2 The following minimum eligibility requirements shall apply to any FSMHC or CSA seeking certification as a Health Home:

Current certification as an MHRS CSA in accordance with Chapter 34 of this subtitle or FSMHC in accordance with Chapter 8 of Title 29 (Public Welfare) of the D.C. Municipal Regulations;

Current enrollment as a D.C. Medicaid provider for the delivery of MHRS or FSMHC services;

Use of the Department of Behavioral Health’s (the Department’s), data management system for all Health Home-related services and functions;

No current or pending exclusions, suspensions or debarment from any federal or D.C. healthcare program; and

Demonstrated ability through readiness assessments and training to comply with the terms and requirements of this chapter.

2501.3 A FSMHC or MHRS CSA seeking certification shall submit an application in a format established by the Department.

2501.4 The Department shall process applications for certification as a Health Home provider in accordance with the procedures for MHRS certification in Subsection 3401 of Chapter 34 of this subtitle.

2501.5 Initial certification as a Health Home program is effective for a one (1)-year period. Certification shall remain in effect until it expires, is revoked or the provider is re-certified in accordance with Section 2502 of this chapter.

2501.6 The Department’s certification shall specify the number of Health Home teams certified at each provider. A Health Home team can serve up to three hundred (300) individuals and consists of the following required staff: Health Home Director, Primary Care Liaison, and Nurse Care Manager(s). No provider shall add additional Health Home teams unless the addition is approved by the Department.

2501.7 Certification is not transferable to any other organization.

2501.8 Nothing in these rules shall be interpreted to mean that certification is a right or an entitlement. Certification as a provider depends upon the Director’s assessment of the need for additional Health Home providers.

2501.9 Corrective action plans and decertification of Health Home providers shall comply with the procedures set forth in Chapter 34 of this subtitle.

History

SOURCE: Final Rulemaking published at 63 DCR 849 (January 22, 2016); as amended by Final Rulemaking published at 66 DCR 5625 (May 3, 2019). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 2501

22-A DCMR § 2502 RECERTIFICATION REQUIREMENTS

2502.1 Recertification applications shall be processed in accordance with the requirements in Section 3401 of Chapter 34 and Section 2501 of this chapter.

2502.2 Subject to Subsection 2502.3, recertification is effective for a two (2)-year period from the date of issuance of recertification by the Department.

2502.3 The Department may conditionally recertify a Health Home for a period not to exceed one (1) year if the Health Home has not met one or more terms of its HCA during the previous certification period. The Department shall issue and enforce a Corrective Action Plan (CAP) for any conditional recertification. The Department shall not recertify any Health Home that has failed to satisfy the terms of the CAP.

2502.4 Recertification is not transferable to any other provider organization.

History

SOURCE: Final Rulemaking published at 63 DCR 849 (January 22, 2016). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 2502

22-A DCMR § 2503 EXEMPTIONS FROM CERTIFICATION STANDARDS

2503.1 Upon good cause shown, the Department may, at its discretion, exempt a provider from a certification standard if the exemption does not jeopardize the health and safety of clients, infringe on client rights, or diminish the quality of the service delivery.

2503.2 If the Department approves an exemption, such exemption shall end on the expiration date of the program certification, or at an earlier date if specified by the Department, unless the provider requests renewal of the exemption and renewal is granted by the Department prior to expiration of its certificate or the earlier date set by the Department.

2503.3 The Department may revoke an exemption that it determines is no longer appropriate.

2503.4 All requests for an exemption from certification standards must be submitted in writing to the Department.

History

SOURCE: Final Rulemaking published at 63 DCR 849 (January 22, 2016). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 2503

22-A DCMR § 2504 HEALTH HOME SERVICES ELIGIBILITY

2504.1 To be eligible for Health Home services, a consumer shall:

(a) Be eligible for Medicaid;

Be diagnosed as having a serious and persistent mental illness;

(d) Consent to be enrolled in a Health Home and authorize the disclosure of his or her mental health, physical health and other relevant information for the purpose of integrating primary and behavioral health care and services.

2504.2 Consumers may only be enrolled with one (1) Health Home at a time and may opt-out at any time. Providers shall document in writing and in forms prescribed by the Department a consumer’s informed consent to opt-in or opt-out of the Health Home program.

2504.3 The following categories of beneficiaries shall not be eligible for the Health Home program under this chapter:

(a) Consumers currently enrolled in Assertive Community Treatment (ACT) as described in Chapter 34;

(b) Consumers enrolled in the Home and Community-Based Services (HCBS) Waiver for the Elderly and Individuals with Physical Disabilities, as described in Chapter 42 of Title 29 of the District of Columbia Municipal Regulations (DCMR);

Consumers enrolled in the HCBS Waiver for Persons with Intellectual and Developmental Disabilities, as described in Chapter 19 of Title 29 DCMR;

Consumers residing in a nursing facility;

Consumers residing in an Intermediate Care Facility for Individuals with Intellectual Disabilities; and

Consumers enrolled in the My Health GPS program, as described in Chapter 102 of Title 29 DCMR. A consumer who is eligible for both this Health Home and the My Health GPS Program may choose to enroll in either program but not both.

History

SOURCE: Final Rulemaking published at 63 DCR 849 (January 22, 2016); as amended by Final Rulemaking published at 66 DCR 5625 (May 3, 2019). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 2504

22-A DCMR § 2505 HEALTH HOME SERVICES

2505.1 Health Home providers shall provide the following services to each Health Home enrollee in an individualized manner as determined by the consumer’s care plan:

(a) Comprehensive Care Management;

(b) Care Coordination;

(d) Health Promotion;

(e) Individual and Family Support Services; and

(f) Referral to Community and Social Support Services.

History

SOURCE: Final Rulemaking published at 63 DCR 849 (January 22, 2016). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 2505

22-A DCMR § 2506 COMPREHENSIVE CARE MANAGEMENT

2506.1 One of the goals of the Health Home Program is to maintain and/or improve the health of their population through the delivery of appropriate services. Comprehensive Care Management requires Health Home teams to gather demographic and health data about their consumers and tailor interventions and evidence based practices to meet the specific needs of their population. This population management approach requires the following:

(a) Construction of standardized, evidence-based protocols and clinical pathways for mental health, physical health, social, employment, and economic needs;

(b) Tracking and monitoring of the consumer’s health, social and employment status based on the protocols and pathways;

(c) Development and dissemination of reports on satisfaction, health status, cost and quality to guide Health Home service delivery and design;

(d) Development of partnerships with physical health care providers and community-based entities in order to facilitate the sharing of information and timely responses to each consumer’s needs; and

(e) Health Homes will use aggregated data to determine levels of consumer engagement, progress toward goals, and adherence to or variance from treatment guidelines. Based on this analysis, Health Homes will prioritize outreach, reminders and notifications to individuals and/or providers. Health Homes will systematically review and report quality metrics, assessment results, and service utilization in order to evaluate health status, service delivery, and consumer satisfaction.

2506.2 Comprehensive Care Management is the assessment and identification of health risks leading to the development and implementation of a care plan that addresses health risks and the individualized needs of the whole person. Care plan development will be led by qualified practitioners operating within their scope of practice with input from members of the Health Home team and external resources. Activities include but are not limited to the following:

Monitoring of the consumer and population health status and service use;

Conduct an assessment of health risks and identification of high risk sub groups;

Collect behavioral, primary, acute and long-term care information from health and social service providers, including but not limited to MHRS Diagnostic Assessments and individual recovery or treatment plans, physical assessments from PCPs, and hospital discharge planners to facilitate the creation of a person-centered care plan for every enrolled individual, that is updated at set intervals (as detailed in the DCMR) and following an unplanned inpatient stay;

Reassessment of health assessment(s) annually or more frequently as required by the consumer’s health;

Identification of service needs of consumers and construction of a person-centered comprehensive care plan addressing physical and behavioral health chronic conditions, current health status, and goals for improvement; and

Review and updates persons-centered care plan every one hundred eighty (180) days and as needed.

History

SOURCE: Final Rulemaking published at 63 DCR 849 (January 22, 2016); as amended by Final Rulemaking published at 66 DCR 5625 (May 3, 2019). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 2506

22-A DCMR § 2507 CARE COORDINATION

2507.1 Care Coordination is the facilitation or implementation of the comprehensive care plan through appropriate linkages, referrals, coordination and follow-up to needed services and support. Care Coordination provides assistance with the identification of individual strengths, resources, preferences and choices. Care Coordination is a function shared by the entire Health Home Team and may involve, but is not limited to, the facilitation or implementation of the following:

Developing strategies and supportive mental health intervention for avoiding out-of-home placement and building stronger family support skills and knowledge of the consumer’s strengths and limitations;

Providing telephonic and other electronic reminders of appointments;

Providing telephonic consults and outreach;

Communicating with family members;

Identifying outstanding items on patient visit summaries such as referrals, immunization, self-management goal support and health education needs;

Assisting with medication reconciliation;

Making appointments;

Providing patient education materials;

Assisting with arrangements such as transportation, directions and completion of durable medical equipment requests;

Obtaining missing records and consultation reports;

Participating in hospital and emergency room (ER) transition care;

Coordination with other health care providers to ensure screenings follow-up is completed;

Coordinating with Fire and Emergency Medical Services to promote appropriate utilization of emergency medical and transport services; and

Ensure that consumers continue connections to and maintain eligibility for any public benefit to which the beneficiary may be entitled, including Medicaid.

History

SOURCE: Final Rulemaking published at 63 DCR 849 (January 22, 2016); as amended by Final Rulemaking published at 66 DCR 5625 (May 3, 2019). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 2507

22-A DCMR § 2508 COMPREHENSIVE TRANSITIONAL CARE

2508.1 Comprehensive Transitional Care includes the Health Home's efforts to reduce hospital emergency department and inpatient admissions, readmissions and length of stay through planned and coordinated transitions between health care providers locations, settings and levels of care. Health Homes will increase individual’s and family members’ ability to manage care and live safely in the community, shifting the use of reactive or emergency care and treatment to proactive health promotion and self-management. Comprehensive Transitional Care includes, but is not limited to:

(a) Contact with the consumer within forty-eight (48) hours of the completed transition from inpatient settings and ER visits;

(b) Outreach to consumers to ensure appropriate follow-up after transitions;

(c) Ensuring visits for consumers with the appropriate health and community-based service providers following the completed transition;

(d) Developing strategies and supportive health interventions that reduce the risk for or prevent out-of-home placements for adults and builds stronger family support skills and knowledge of the adult’s strengths and limitations;

(e) Developing chronic health prevention and illness management strategies and plans;

(f) Reviewing the discharge summary and instructions;

(g) Ensuring that medication reconciliation has been completed;

(h) Ensuring that follow-up appointments and tests are scheduled and coordinated;

(i) Assessing the patient’s risk status for readmission or other failure to obtain appropriate community-based care;

(j) Arranging for follow-up care, if indicated in the discharge plan;

(k) Planning for appropriate clinical care post-discharge, including home health services or other necessary skilled care;

(l) Planning for appropriate housing support services post-discharge, including facilitating linkages to temporary or permanent housing;

(m) Arranging transportation for transitional care and follow-up appointments as needed;

(n) Scheduling appointments for the beneficiary with a primary care provider or appropriate specialist(s) within one (1) week of discharge; and

(o) Opting out of the Health Home Program.

History

SOURCE: Final Rulemaking published at 63 DCR 849 (January 22, 2016); as amended by Final Rulemaking published at 66 DCR 5625 (May 3, 2019). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 2508

22-A DCMR § 2509 HEALTH PROMOTION

2509.1 Health Promotion service involves the provision and facilitation of health education to the individual (family member and or significant other) specific to his/her chronic illness. The service may also involve the use of data to identify and prioritize particular areas of need within the patient population; research best-practice interventions; coordinate or refer individuals to appropriate health promotion activities in group and individual settings; evaluate the effectiveness of the interventions, and plan accordingly. Health promotion also involves ensuring the connection of the individual to peer/recovery supports including self-help/self-management and advocacy groups, to support for improving an individual’s social network, and to educational opportunities for the individual about accessing care in appropriate settings. This service may include but is not limited to:

(a) Providing consumer education and development of self-monitoring and health management related to consumers’ particular chronic conditions as well as in connection with healthy lifestyle and wellness; nutrition counseling, substance abuse prevention, smoking prevention and cessation and physical activity;

(b) Assisting with medication reconciliation;

(d) Connecting consumers with peer and recovery supports including self-help and self-management and advocacy groups;

(e) Educating the consumer about accessing care in appropriate settings, including appropriate utilization of 911 services;

(f) Assessing the consumer’s understanding of their health conditions and motivation to engage in self- management; and

(g) Using coaching and evidence-based practices such as motivational interviewing to enhance the beneficiary’s understanding of his or her health conditions and motivation to achieve health and social goals.

History

SOURCE: Final Rulemaking published at 63 DCR 849 (January 22, 2016); as amended by Final Rulemaking published at 66 DCR 5625 (May 3, 2019). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 2509

22-A DCMR § 2510 INDIVIDUAL AND FAMILY SUPPORT SERVICES

2510.1 Individual and family support services include the ways a Health Home supports the consumers and their support teams (including families and authorized representatives) in meeting the range of psychosocial needs and accessing resources (e.g., medical transportation; language interpretation; appropriate literacy materials; and other benefits to which they may be eligible or need). The services provide for continuity in relationships between the consumers/families with their physicians and other health service providers and can include communicating on the consumers’ and families’ behalf.

2510.2 Individual and Family Support Services include:

Activities that facilitate the continuity in relationships between consumer/family and physician and care manager;

Advocacy on a consumers’ behalf to identify and obtain needed resources such as medical transportation and other benefits for which they may be eligible;

Consumer education on how to self-manage their chronic condition (s);

Providing opportunities for the families to participate in consumers’ assessment and care treatment plan developments;

Efforts that ensure that Health Home services are delivered in a manner that is culturally and linguistically competent;

Efforts that promote personal independence and empower the consumers to improve their own environment and health. This may include engagement with consumers’ families in identifying solutions to improve consumers’ health and environment and helping consumers and their families with consumer’s authorizations to access the consumers’ health record information or other clinical information;

Language interpretation services;

Housing assistance services;

Providing consumers with access to their EHR or other clinical information, and providing access to their family members and authorized representatives if the beneficiary provides written authorization to do so;

Developing family support materials and services, including creating family support groups where appropriate;

Include the consumer family in the quality improvement process including surveys to capture their experience with Health Home services; and

Facilitate referrals to support services that are available in the individual’s community and assist with the establishment of and connection to natural supports.

History

SOURCE: Final Rulemaking published at 63 DCR 849 (January 22, 2016); as amended by Final Rulemaking published at 66 DCR 5625 (May 3, 2019). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 2510

22-A DCMR § 2511 REFERRAL TO COMMUNITY AND SOCIAL SUPPORT SERVICES

2511.1 Referral to Community and Social Support Services includes the provision of referrals to a wide array of support services that will help consumers overcome access or service barriers, increase self-management skills and achieve overall health. Specifically, this activity involves facilitating access to support and assistance for consumers to address medical, behavioral, educational, social, and community issues that may impact overall health.

2511.2 The types of community and social support services to which consumers will be referred to may include, but are not limited to:

Wellness programs, including smoking cessation, fitness, weight loss programs;

Specialized support groups (i.e., cancer, diabetes support groups, and others);

Substance use recovery support groups;

Housing resources;

The Supplemental Nutrition Assistance Program;

Legal assistance resources;

Faith-based organizations;

Access to employment and educational program or training;

(i) Financial assistance, such as Temporary Assistance for Needy Families or Social Security

(j) Child care; and

(k) Social integration.

History

SOURCE: Final Rulemaking published at 63 DCR 849 (January 22, 2016); as amended by Final Rulemaking published at 66 DCR 5625 (May 3, 2019). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 2511

22-A DCMR § 2512 COMPREHENSIVE CARE PLAN

2512.1 A Comprehensive Care Plan (CCP) is the document that drives the delivery of all services. The CCP shall be the plan that collates all the consumer’s services and providers of service in order to reduce any instances of duplication of service, prioritize the consumer’s goal(s) and monitor the progress of the goal(s) in the plan.

2512.2 The development of a CCP shall include:

Active participation and partnership with the consumer;

Risk factors identified from the completion of the comprehensive health assessment. The assessment includes a physical health, behavioral health, substance-use and socioeconomic assessment;

The consumer’s goals as identified by the comprehensive health assessment, prioritized and the timeframes and strategies for addressing each;

The delineation of the specific roles and responsibilities of the members of the Health Home Team who are assisting the consumer in achieving his/her goals;

The signature of all participants in the development of the CCP. The Nurse Care Manager or the Primary Care Liaison from the Health Home Team must participate in the care planning process and sign the plan; and

All services the Health Home provider delivers to the consumer.

2512.3 The CCP shall be updated every one-hundred eighty (180) days or more often if the consumer’s needs or acuity level changes.

2512.4 The CCP shall be developed in coordination with the consumer’s healthcare providers. If the Health Home team develops the CCP, the MHRS Plan of Care, developed in accordance with Section 3411 of Chapter 34 of this title, shall be incorporated into the CCP. If the MHRS team develops the care plan the Health Home team will collaborate and participate in the care planning process to ensure the care plan is comprehensive.

History

SOURCE: Final Rulemaking published at 63 DCR 849 (January 22, 2016); as amended by Final Rulemaking published at 66 DCR 5625 (May 3, 2019); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 2512

22-A DCMR § 2513 HEALTH HOME STAFFING REQUIREMENTS

2513.1 Health Homes shall have the following staff:

(a) Health Home Director;

(b) Nurse Care Manager(s); and

2513.2 The Health Home Director shall be responsible for managing the CSA’s Health Home program. The Health Home Director shall have a Master’s level education in a health-related field. There shall be a point five (.5) Full Time Equivalent staff person for every Health Home Team of three hundred (300) consumers.

2513.3 The Nurse Care Manager shall be an Advanced Practice Registered Nurse (APRN) or Registered Nurse (RN) with relevant experience and expertise in care of physical health care. The Nurse Care Manager shall lead and/or manage team-based assessment, care plan development and care plan implementation activities. The Health Home provider shall ensure one (1) full-time Nurse Care Manager per one hundred and fifty (150) enrolled Health Home consumers.

2513.4 The Primary Care Liaison shall be staffed with a licensed clinician or combination of clinicians based on the needs of the individual Health Home consumer. The Primary Care Liaison shall have experience in the care and treatment of the serious mentally ill and be a Medical Doctor, APRN, Nutritionist, Licensed Independent Clinical Social Worker, Licensed Professional Counselor, Physician Assistant or Registered Nurse. A provider may use a combination of these staff to meet the full time equivalent (FTE) requirement. The Primary Care Liaison shall be licensed in the District of Columbia. The Health Home provider shall ensure one (1) full-time Primary Care Liaison per five hundred (500) Health Home enrollees. The responsibilities of the Primary Care Liaison shall include the following:

Provide medical consultation to the Health Home team;

(b) Coordinate care with external medical and behavioral health providers; and

(c) Assist with developing effective Health Home comprehensive care management and coordination of care protocols involving community and hospital medical providers.

2513.5 All Health Homes shall provide Health Home services in accordance with their Human Care Agreement (HCA) with the Department.

2513.6 All Health Homes providers shall obtain a National Provider Identification (NPI) number for themselves and all personnel performing Health Homes services through the provider. All providers shall register themselves and all personnel performing Health Home services with the Department of Health Care Finance’s designated information system prior to billing for services.

History

SOURCE: Final Rulemaking published at 63 DCR 849 (January 22, 2016); as amended by Final Rulemaking published at 66 DCR 5625 (May 3, 2019); as amended by Final Rulemaking published at 69 DCR 013495 (November 4, 2022). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 2513

22-A DCMR § 2514 [RESERVED]

History

SOURCE: Final Rulemaking published at 63 DCR 849 (January 22, 2016); as amended by Final Rulemaking published at 66 DCR 5625 (May 3, 2019). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 2515

22-A DCMR § 2515 HEALTH HOME REIMBURSEMENT

2515.1 The Department shall require all FSMHCs and CSAs certified as a Health Home provider to enter into a HCA with the Department. All payment for services shall be implemented through terms and conditions contained in the HCA and the D.C. Medicaid program.

2515.2 Only one (1) Health Home provider will receive payment for delivering Health Home services to a consumer in a particular month. A provider may not bill for ACT services for any consumer enrolled in the Health Home.

2515.3 Reimbursement for Health Home services is on a PMPM rate as published by the Department of Health Care Finance. The month time period shall begin on the first (1st) of the month and end on the last day of the month. In order to qualify for the monthly rate, Health Home providers shall provide and document the required services provided during the month for which reimbursement is claimed.

2515.4 The Health Home shall provide monthly a minimum of one (1) Health Home service.

2515.5 For a consumer enrolled in a low-acuity band, the Health Home shall provide at a minimum one (1) care management service and one (1) other Health Home service.

2515.6 Only one (1) Health Home will receive payment for delivering Health Home services to a consumer in a particular month.

2515.7 Documentation of all required services in support of any claim for reimbursement under this Chapter shall include the active NPI number for the staff member who provided the service. All claims or attestations seeking Medicaid or local only reimbursement under this Chapter shall include the active NPI numbers for the certified provider and the rendering provider. The rendering provider is the staff member who provided the service.

History

SOURCE: Final Rulemaking published at 63 DCR 849 (January 22, 2016); as amended by Final Rulemaking published at 66 DCR 5625 (May 3, 2019); as amended by Final Rulemaking published at 69 DCR 013495 (November 4, 2022). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 2515

22-A DCMR § 2516 HEALTH HOMES RECORDS AND DOCUMENTATION REQUIREMENTS

2516.1 Each Health Home shall utilize the Department’s designated electronic health record for documenting and billing all Health Home services.

2516.2 Health Home providers shall maintain all Health Home consumer information in accordance with federal and District privacy laws and the Department’s Privacy Manual.

2516.3 Health Home providers shall document each Health Home service and activity in the consumer’s record in the Department’s designated electronic health record. Any claim for services shall be supported by written documentation which clearly identifies the following:

(a) The specific service type rendered;

(b) The date, duration, and actual time, a.m. or p.m. for both the beginning and ending times, during which the services were rendered (there is no-predetermined expectation of time spent with each service this requirement is only to verify when the service began and when it ended);

(d) The setting in which the services were rendered;

Confirmation that the services delivered are contained in the consumer’s CCP;

Identification of any further actions required for the consumer’s well-being raised as a result of the service provided;

(g) A description of each encounter or service by the Health Home team member which is sufficient to document that the service was provided in accordance with this chapter; and

(h) Dated and authenticated entries, with their authors identified, which are legible and concise, including the printed name and the signature of the person rendering the service, diagnosis and clinical impression recorded in the terminology of the International Statistical Classification of Diseases and Related Health Problems – 10 (ICD-10 CM) or subsequent revisions, and the service provided.

2516.4 No Health Home provider shall be reimbursed for a claim for services that does not meet the requirements of this section or is not documented in accordance with this section.

2516.5 Health Home providers shall implement a compliance program that regularly reviews submitted claims and identifies errors and overpayments. Health Home providers shall repay any paid claims that do not meet reimbursement criteria within sixty (60) days of discovery.

History

SOURCE: Final Rulemaking published at 63 DCR 849 (January 22, 2016); as amended by Final Rulemaking published at 66 DCR 5625 (May 3, 2019). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 2516

22-A DCMR § 2599 DEFINITIONS

2599.1 When used in this chapter, the following words shall have the meanings ascribed:

Behavioral Health Care – care that promotes the well-being of individuals by intervening and preventing incidents of mental illness, substance abuse, or other health concerns.

Chronic Physical Condition – a somatic health condition, such as asthma, cardiovascular disease, diabetes, substance use disorder, and/or Human Immunodeficiency Virus.

Comprehensive Care Plan or CCP – an individualized plan to provide health home services to address a consumer’s behavioral and physical chronic conditions, based on assessment of health risks and the consumer’s input and goals for improvement.

Consumer – a person who seeks or receives mental health services or mental health supports funded or regulated by the Department.

Core Services Agency or CSA – a community-based provider that has entered into a Human Care Agreement with the Department to provide specific MHRS in accordance with the requirements of Chapter 34 of this subtitle.

Cultural and Linguistic Competence - a set of congruent behaviors, attitudes and policies that come together in a system, agency or among professionals that enables effective work in cross-cultural situations. Culture refers to integrated patterns of health human behavior that include the language, thoughts, communications, actions, customs, beliefs, values, institutions of racial, ethnic, religious or social groups. Competence implies having the capacity to function effectively as individual and an organization within the context of the cultural beliefs, behaviors, and needs presented by consumers and their communities.

Department of Behavioral Health or DBH – the District of Columbia agency that regulates the District’s mental health and substance abuse treatment system for adults, children, and youth.

Health Home – an entity that is certified by the Department of Behavioral Health, that uses a patient-centered approach to coordinate a consumer’s behavioral, primary, acute or other specialty medical health care services.

Health Home Team – the Health Home staff that delivers services to a specific group of consumers in their assigned Health Home teams. A Health Home Team includes the Health Home Director, Primary Care Liaison, Nurse Care Manager(s) and Care Coordinator(s).

High Cost Chronic Medical Conditions – medical conditions that create the need for intensive or long-term treatment and therefore make the cost of the individual’s treatment higher than the average Medicaid beneficiary

Mental Health Rehabilitation Services or MHRS – behavioral health services provided by a Department-certified community behavioral health provider to consumers in accordance with the District of Columbia State Medicaid Plan and Chapter 34 of this subtitle.

Qualified Practitioner – a psychiatrist, psychologist, licensed independent clinical social worker, advance practice registered nurse, registered nurse, licensed professional counselor or licensed independent social worker.

Serious and Persistent Mental Illness – a diagnosable mental, behavioral, or emotional disorder (including those of biological etiology) which substantially impairs the mental health of the person or is of sufficient duration to meet diagnostic criteria specified within the DSM-V or its ICD-10-CM equivalent (and subsequent revisions) with the exception of DSM-V, "Z" codes, substance abuse disorders, intellectual disabilities and other developmental disorders, or seizure disorders, unless those exceptions co-occur with another diagnosable mental illness.

Specialty Provider – a community-based organization MHRS provider certified by Department to provide specialty services either directly or through contract.

History

SOURCE: Final Rulemaking published at 63 DCR 849 (January 22, 2016); as amended by Final Rulemaking published at 66 DCR 5625 (May 3, 2019). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 2599

22-A30 FREE STANDING MENTAL HEALTH CLINIC CERTIFICATION STANDARDS

22-A DCMR § 3000 GENERAL PROVISIONS

3000.1 Free Standing Mental Health Clinic (FSMHC) services are services provided by behavioral health practitioners within a clinic setting to eligible individuals (consumers) living in the community. The purpose of these rules is to set forth the requirements for:

Certification by the Department of Behavioral Health (Department) of organizations to provide Free Standing Mental Health Clinic (FSMHC) services;

Eligibility of individuals to receive treatment at FSMHCs;

(d) Administrative requirements for an FSMHC.

3000.2 A FSMHC shall be certified by the Department in accordance with the rules set forth in this chapter. No person or entity shall operate a FSMHC without a valid FSMHC certification.

3000.3 The transition timeline from the Department of Health Care Finance (DHCF) certification to Department of Behavioral Health certification is as follows:

Providers who were certified as an FSMHC by the Department of Health Care Finance (DHCF) prior to the publication of the Notice of Emergency and Proposed Rulemaking in the D.C. Register may retain certification under DHCF through November 2, 2020.

All DHCF certifications will expire on November 2, 2020.

Any provider wishing to continue to provide services as an FSMHC must submit a complete certification application with the Department prior to November 2, 2020 and obtain full certification by the Department by March 30, 2020.

Failure to complete the certification process within that time frame will result in the loss of certification to provide FSMHC services.

The Department will grant provisional certification to any existing FSMHC provider that submits a complete certification application by November 2, 2020. The provisional certification will expire upon full certification under this chapter, upon denial or decertification in accordance with this chapter, or the end of the certification window on March 30, 2021, whichever occurs first.

3000.4 An FSMHC shall meet the requirements of this chapter in order to obtain certification.

3000.5 Each certified FSMHC shall treat all consumers who meet the eligibility guidelines in § 3001.2 and require treatment. An FSMHC that seeks reimbursement for providing services to individuals eligible for local funding under § 3001.2 shall enter into a Human Care Agreement (HCA) with the Department prior to providing any services to those individuals.

3000.6 Upon certification, but prior to providing services, each FSMHC shall enter into a Medicaid Provider Agreement with DHCF. All Medicaid reimbursement for FSMHC services shall be through DHCF. All local dollar reimbursement for FSMHC services shall be through an HCA with the Department.

3000.7 Entities certified as an FSMHC in accordance with the requirements set forth in this chapter are eligible to apply for certification as a Health Home in accordance with the requirements set forth in 22-A DCMR §§ 2500, et seq.

3000.8 An FSMHC that is certified as a Health Home is eligible to receive reimbursement for the provision of Health Home services in accordance with the requirements set forth in 29 DCMR §§ 6900, et seq.

3000.9 The Department of Behavioral Health may exempt an applicant or Free Standing Mental Health Clinic from a certification standard if the Director determines that the exemption is reasonable and does not jeopardize the health and safety of consumers, violate consumers’ rights, or otherwise conflict with the purpose and intent of these rules. The following shall apply to all exemptions issued under this chapter:

If the Department approves an exemption, such exemption shall end on the expiration date of the provider certification or on an earlier date if specified by the Department; unless the provider requests renewal of the exemption prior to expiration of its certification or the earlier date set by the Department;

The Department may revoke an exemption that it determines is no longer appropriate; and

All requests for an exemption from certification standards shall be submitted in writing to the Department.

History

SOURCE: Final Rulemaking published at 67 DCR 11929 (October 16, 2020); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3000

22-A DCMR § 3001 ELIGIBLE CONSUMERS

3001.1 Consumers eligible for Medicaid-funded FSMHC services must meet the following requirements:

(a) Are enrolled in Medicaid, or be eligible for enrollment and have an application pending; and

(b) Are children, youth, or adults with a mental health condition or diagnosis, or at risk of developing a diagnosable mental health condition.

3001.2 Consumers eligible for locally-funded FSMHC services are those individuals who are not eligible for Medicaid or are not enrolled in any other third-party insurance program, except the D.C. Healthcare Alliance or Immigrant Children’s Program, and who meet the following requirements:

(a) Are bona fide residents of the District pursuant to D.C. Official Code § 7-1131.02(29);

(b) Are children, youth, or adults with a mental health condition or diagnosis, or at risk of developing a diagnosable mental health condition; and

For individuals eighteen (18) years of age and older, live in households with a countable income of less than two hundred percent (200%) of the federal poverty level, and for individuals under eighteen (18) years of age, live in households with a countable income of less than three hundred percent (300%) of the federal poverty level.

3001.3 Neither Medicaid nor the Department shall reimburse providers for FSMHC services provided to any consumer that does not meet the eligibility requirements set forth above.

History

SOURCE: Final Rulemaking published at 67 DCR 11929 (October 16, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3001

22-A DCMR § 3002 CERTIFICATION PROCESS

3002.1 Free Standing Mental Health Clinic (FSMHC) providers shall be certified in accordance with the requirements of this section.

3002.2 Each applicant seeking certification as an FSMHC shall submit a certification application in the format required by the Department.

3002.3 The Department shall review the certification application upon receipt to determine if it is complete. If a certification application is incomplete, the Department shall return the incomplete certification application to the applicant. An incomplete certification application shall not be regarded as a certification application. The Department shall deny any application that contains false representations or documents and the applicant shall be barred from resubmitting an application for twelve (12) months.

3002.4 Following the Department’s review and acceptance of the documentation contained in the certification application, the Department shall determine whether the applicant's services and activities meet the certification standards described in this chapter. The Department shall schedule and conduct an on-site survey of the applicant’s services to determine whether the applicant satisfies all certification standards.

3002.5 An FSMHC seeking recertification shall submit a recertification application at least ninety (90) calendar days prior to the termination of its current certification. An FSMHC that timely submits a renewal application may continue to provide FSMHC services until the Department takes action to renew or deny renewal of certification.

3002.6 The Department may also conduct an on-site survey at the time of certification renewal, or at any other time during the period of certification.

3002.7 Upon request, the Department shall be provided access to all FSMHC records, including but not limited to consumer records, claims and billing records, and FSMHC employee records, to verify compliance with certification standards, and may conduct interviews with FSMHC staff. All FSMHCs shall cooperate with the Department’s certification and compliance reviews.

3002.8 The Department shall certify an applicant and recertify an FSMHC that demonstrates substantial compliance with this chapter, for a time period that runs concurrently with the applicant or FSMHC’s accreditation period. Certification shall start from the date of issuance of certification by the Department, subject to the provider's continuous compliance with all certification standards. Certification shall remain in effect until it expires, is renewed, is revoked, or is voluntarily relinquished. The certification shall specify the effective date of the certification, the date the certification expires, and the program(s) and services that the provider is certified to provide.

3002.9 A Certification is not transferable from one organization to another.

3002.10 An applicant or FSMHC that fails to comply with these Department certification standards may receive a Statement of Deficiencies (SOD) from the Department. The SOD shall describe the areas of non-compliance, identify actions needed to bring operations into compliance, and establish a timeframe for the provider’s submission of a written Corrective Action Plan (CAP). The Department may, at its discretion, proceed directly to denial or decertification without issuing an SOD when the deficiencies relate to the health or safety of consumers, or constitute a material misrepresentation, fraud, or abuse.

3002.11 When the Department issues a SOD, the applicant or FSMHC shall submit a CAP. The CAP shall describe the actions to be taken and specify a timeframe for correcting the areas of non-compliance. The CAP shall be submitted to the Department no later than (10) business days from the date of receipt of the Department’s SOD.

3002.12 The Department shall notify the applicant or FSMHC whether the applicant or FSMHC’s CAP is accepted within ten (10) business days after receipt. Failure to comply with the CAP shall be grounds for denial or decertification.

3002.13 The Department may issue certification after it verifies that the applicant or FSMHC has complied with its CAP and meets all the certification standards.

3002.14 These rules do not create any rights or entitlements. Certification as an FSMHC depends upon the Director’s assessment of the need for additional providers(s) and availability of funds. No certifications shall be issued during the period of time that the Department has imposed a moratorium via published notice in the D.C. Register.

3002.15 The Director may deny or revoke certification if the applicant or FSMHC fails to comply with any certification standard, or if the FSMHC fails to maintain a provider agreement with DHCF.

3002.16 Certification shall be considered terminated and invalid if the FSMHC fails to apply for renewal of certification with a complete application ninety (90) calendar days prior to the expiration date of the current certification, voluntarily relinquishes certification or goes out of business.

3002.17 The FSMHC shall notify the Department within forty-eight (48) hours of any changes in its operation that affect the FSMHC's continued compliance with these certification standards, including changes in:

Ownership or control;

Services;

Key clinical staff, e.g., psychiatrist, therapists, or the FSMHC Clinical Administrator; and

Any affiliation and referral arrangements.

3002.18 Each certification application shall contain the following information:

A list of the services to be provided, target population for its services and potential referral sources;

Identification of the psychiatrist(s) who will provide clinical and administrative direction, and provide direct services;

Personnel documentation including:

Staff roster that includes for each individual the name, position, license/degree, full or part time status, and the services provided. Roster must include a full time Clinical Administrator, although one or more persons may share part time duties to equal full-time coverage.

A signed contract for each clinical staff member, or a letter signed by each clinician that attests to his/her intention to become an employee with the organization. Documents must include the time frame of the commitment and the scope of service and responsibilities that will be expected as a condition of employment.

Completed background checks on all personnel to ensure none of the individuals employed by, or affiliated with, the administration or governing board or body, if any, are excluded from participation in federal reimbursements or as a District contractor.

Completed criminal background checks as outlined in D.C. Official Code § 44-551 and Title 22-B Chapter 47 for all unlicensed individuals employed or contracted with the FSMHC.

Completed child protection registry check for all staff.

A copy of the current license and resume for each licensed practitioner and a copy of the resume(s) for the designated full-time equivalent Clinical Administrator(s).

A program manual that contains all policies listed in § 3006;

An organizational chart that clearly indicates all clinical and administrative positions within the FSMHC.

If the FSMHC is contained within a larger parent organization, the chart must clearly show how the FSMHC program fits administratively and clinically into the larger organizational structure; and

The chart shall clearly define the agency structure, staff responsibilities, lines of authority, and clinical process flow.

A job description for the psychiatrist(s) that includes a description of how the psychiatrist(s) will provide clinical and administrative direction for all services provided by the FSMHC.

3002.19 The Department may grant provisional certification or recertification to an applicant or FSMHC that has demonstrated substantial compliance with this chapter and has received provisional accreditation from the Commission on Accreditation of Rehabilitation Facilities, The Joint Commission, or the Council on Accreditation. Provisional certification shall expire upon termination of the FSMHC’s provisional accreditation period(s) unless revoked in accordance with § 3003.

History

SOURCE: Final Rulemaking published at 67 DCR 11929 (October 16, 2020); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3002

22-A DCMR § 3003 DENIAL AND DECERTIFICATION PROCESS

3003.1 The Director may deny initial certification if the applicant fails to comply with any certification standard or the application fails to demonstrate the applicant’s capacity to deliver high quality FSMHC services on a sustained and regular basis. The Director may also deny certification if the applicant proposes to operate a facility in an area already served by one or more providers. The Department’s priority shall be to grant certification to applicants with the demonstrated capacity to deliver high quality FSMHC services that will address unmet needs of the behavioral health system.

3003.2 While applicants may make minor corrections and substitutions to their applications during the certification process, evidence of one or more of the following shall constitute good cause to deny the application for certification when the circumstances demonstrate deliberate misrepresentations, organizational instability, or the lack of preparedness or capacity to meet and sustain compliance with this chapter:

An incomplete application;

False information provided by applicant or contained in an application;

One or more changes to an organizational chart during the application process;

A facility that is inadequate in health, safety, size or configuration to provide FSMHC services consistent with high quality care and privacy standards;

The lack of demonstrated experience providing FSMHC services by the applicant’s clinical leadership, practitioners, or staff;

An applicant’s lack of financial resources to carry out its commitments and obligations under this chapter for the foreseeable future;

An applicant’s failure to timely respond to the Department of Behavioral Health’s (Department’s) requests for information;

History of poor performance; or

Lack of behavioral health accreditation in accordance with § 3015.1.

3003.3 Upon written request submitted by the applicant and received by the Department within fifteen (15) business days of the certification denial, the Department shall provide an applicant an impartial administrative review of the decision. The Department shall conduct the administrative review to determine whether the certification denial complied with §§ 3003.1-3003.2. Each request for an administrative review shall contain a concise statement of the reason(s) why the certification denial was in error. The Director shall issue a written decision within fifteen (15) business days. The Director’s decision is final and not subject to further appeal. An applicant, its principals, and successor in interests shall not be allowed to reapply for certification for twelve (12) months following the date of denial.

3003.4 The Department shall decertify existing providers who fail to comply with the certification requirements contained in this chapter. Evidence of one or more of the following shall constitute good cause to decertify:

An incomplete recertification application;

False information provided by provider or contained in a recertification application;

High staff turnover during the certification period demonstrating organizational instability;

One or more documented violations of the certification standards during the certification period that evidence a provider’s lack of capacity to meet and sustain compliance with this chapter;

Claims audit error rate in excess of twenty-five percent (25%);

Poor quality of care;

A provider’s lack of financial resources to carry out its commitments and obligations under this chapter for the foreseeable future;

Failure to cooperate with Department investigations or lack of timely response to information requests; or

Failure to obtain or maintain in good standing national accreditation in accordance with § 3015.1 or meet the timelines in § 3015.2.

3003.5 Nothing in this chapter requires the Director to issue an SOD or an NOI prior to decertifying an FSMHC. If the Director finds that there are grounds for revoking an FSMHC’s certification, the Director shall issue a written notice of revocation setting forth the factual basis for the revocation, the effective date, and the FSMHC’s right to request an administrative review.

3003.6 Within fifteen (15) business days of the date on the notice of revocation, the FSMHC may request an administrative review from the Director.

3003.7 Each request for an administrative review shall contain a concise statement of the reason(s) why the FSMHC asserts that it should not have its certification revoked and include any relevant supporting documentation.

3003.8 Each administrative review shall be conducted by the Director and shall be completed within fifteen (15) business days of the receipt of the provider’s request.

3003.9 The Director shall issue a written decision and provide a copy to the FSMHC. If the Director approves the revocation of the FSMHC’s certification, the FSMHC may, within fifteen (15) business days of the receipt of the Director’s written decision, request a hearing under the D.C. Administrative Procedure Act, effective October 21, 1968 (Pub. L. 90-614, D.C. Official Code §§ 2-501 et seq.). The administrative hearing shall be limited to the issues raised in the administrative review request.

3003.10 Once certification is revoked, the FSMHC shall not be allowed to reapply for certification for a period of two (2) years following the date of the order of revocation. If an FSMHC reapplies for certification, the FSMHC must reapply in accordance with the established certification standards for the type of services provided, and show evidence that the grounds for the revocation have been corrected.

History

SOURCE: Final Rulemaking published at 67 DCR 11929 (October 16, 2020); as amended by Final Rulemaking published at 70 DCR 003050 (March 10, 2023); as corrected by Errata Notice published at 71 DCR 004474 (April 19, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3003

22-A DCMR § 3004 CERTIFICATION REQUIREMENTS: GENERAL

3004.1 The purpose of certification is to ensure that FSMHC have the necessary qualifications and capacity to provide high quality mental health services to District residents.

3004.2 The FSMHC shall conform with Federal and local laws and regulations pertaining to health and fire safety, drug procurement and distribution, disposal of medications and controlled substances, building construction, maintenance and equipment standards, sanitation, and communicable and reportable diseases.

3004.3 The FSMHC setting shall have sufficient and appropriate office space to conduct individual and group interventions including intake, therapy, and assessment in such way that the confidentiality of the consumer is maintained and preserved.

3004.4 The FSMHC shall operate and provide services in accordance with all applicable provisions of the D.C. Human Rights Act, effective June 28, 1994 (D.C. Law 2-38; D.C. Official Code §§ 2-1401.01, et seq.).

3004.5 The FSMHC shall ensure that all services, as set forth in § 3010.8 of this chapter, are provided by or under the direction of a psychiatrist. Health Home services provided by a FSMHC shall be provided in accordance with requirements set forth in 29 DCMR §§ 6900 et seq. and 22-A DCMR §§ 2500 et seq.

3004.6 The FSMHC shall comply with its Medicaid Provider Agreement and provide services to all eligible consumers who have been determined by the independently licensed behavioral health practitioner to be clinically appropriate to receive services in an outpatient mental health setting.

3004.7 The FSMHC shall comply with all requirements of the Health Insurance Portability and Accountability Act (HIPAA) and its implementing regulations, and the D.C. Mental Health Information Act (MHIA), effective March 3, 1979 (D.C. Law 2-136; D.C. Official Code § 7-1201.01).

3004.8 The FSMHC shall have the technological and administrative capacity to electronically submit claims to DHCF, the Department, and third-party payers.

3004.9 The FSMHC shall provide evidence of Commercial General Liability insurance coverage of at least one million ($1,000,000.00) per occurrence limits, three million ($3,000,000.00) aggregate; Bodily Injury and Property Damage including: premises-operations; broad form property damage, Products and Advertising Injury; contractual liability and independent providers. The provider shall maintain Completed Operations coverage for five (5) years following final acceptance of the work performed.

3004.10 The FSMHC shall electronically transmit Behavioral Health Supplemental Data (BHSD) to the Department in a form and manner as prescribed by the Department. BHSD is a compilation of individual-level behavioral health data defined in the Department’s Integrated Technology Engine (ITE) Provider Companion Guide (available at https://dbh.dc.gov/).

3004.11 The FSMHC shall timely transmit BHSD to the Department pursuant to the procedure established in the ITE through the Electronic Health Record (EHR) system.

3004.12 The Department shall provide notice of any future updates to the ITE Guide through https://dbh.dc.gov/.

History

SOURCE: Final Rulemaking published at 67 DCR 11929 (October 16, 2020); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3004

22-A DCMR § 3005 STAFFING AND ADMINISTRATION

3005.1 Each FSMHC shall be staffed with licensed behavioral health practitioners who shall be professionally responsible for the provision of the mental health services delineated in its approved provider agreement.

3005.2 Each FSMHC shall have a psychiatrist on staff who is available on a regular and emergency basis and who shall be responsible for the provision of the mental health services provided by the FSMHC.

3005.3 Each participating FSMHC's approved organizational chart and program manual shall clearly show that its services will be provided by or under the direction of a psychiatrist. The psychiatrist shall spend as much time on site as necessary to ensure consumers are getting services in a safe and efficient manner in accordance with accepted standards of medical care. “Under the direction of a psychiatrist” means the psychiatrist shall:

Assure that the services provided are medically necessary; and

Assume professional responsibility for the services provided.

3005.4 The supervision and management of consumer care shall be the responsibility of the psychiatrist, and the psychiatrist shall be available for advice and consultation with the treating staff as often as necessary to ensure adequate supervision and quality of care.

3005.5 Each participating FSMHC shall have a full-time equivalent Clinical Administrator who shall have the authority and responsibility for the conduct of the affairs of the FSMHC, except for those matters committed by the provisions of this chapter to the authority of the psychiatrist. The Clinical Administrator shall be an independently licensed behavioral health practitioner.

3005.6 The Clinical Administrator’s qualifications, authority, and duties shall be defined in writing.

3005.7 The organizational chart shall also show relationships between the clinic and outside entities, such as the following:

The Board of Directors;

Steering committees;

Advisory boards; and

Professional health or service association affiliations.

3005.8 All Free Standing Mental Health Clinics (FSMHC) shall obtain a National Provider Identification (NPI) number for itself and all personnel performing FSMHC services through the provider. All FSMHC shall register itself and all personnel performing FSMHC services with the Department of Health Care Finance’s designated information system prior to billing for services.

History

SOURCE: Final Rulemaking published at 67 DCR 11929 (October 16, 2020); as amended by Final Rulemaking published at 69 DCR 013495 (November 4, 2022). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3005

22-A DCMR § 3006 PROGRAM MANUAL

3006.1 Each FSMHC shall have a current program manual that outlines all of its policies and procedures.

3006.2 The program manual shall, at a minimum, include, the following:

A mission statement reflecting the goals and mission of the Department;

The range of services to be provided, and a description of the service delivery model;

Fee schedules;

(d) The population to be served;

(e) Operational schedules;

(f) Personnel policies as listed in § 3006.3;

(g) Other policies as listed in § 3006.4;

Financial and record-keeping procedures;

Compliance and integrity program that complies with § 3011; and

(j) Consumer rights statement that complies with the District of Columbia Mental Health Consumer Protection Act, effective December 18, 2001 (D.C. Law 14-56; D.C. Official Code § 7-1231.04).

3006.3 Minimum personnel administration requirements include the following:

(a) Written job descriptions of all staff positions, procedures for employee hiring, evaluations, grievances, and in-service training;

(b) A minimum of one (1) hour per week of supervision for all behavioral health practitioners who deliver services with supervision, as described in § 3010.9, furnished by an independently licensed behavioral health practitioner designated as the supervisor. Supervision shall cover consumer related and other activities;

(d) Written policies and procedures for emergency care.

3006.4 The program manual shall include the following policies:

Admission, Waitlist, Transfer, and Discharge Policy, which describes pre-admission, intake, screening, assessment, referral, transfer, and discharge procedures and inform all consumers of the right to freely choose the provider(s) from whom they will receive services;

Training Policy, which incorporates a written plan for staff development and organizational onboarding, including the training and performance improvement needs of all employees working in the FSMHC;

Anti-Discrimination Policy, which complies with the D.C. Human Rights Act;

Billing and Payment Policy, which requires the FSMHC provider to have the necessary operational capacity to verify the eligibility for Medicaid and other third-party payers, submit Medicaid and third-party claims timely and accurately, document information on services provided, and track payments received;

Care Coordination Policy, which establishes the roles and responsibilities of FSMHC staff in the coordination of care across behavioral health treatment and primary care treatment settings, especially in regards to transitions into or from more intensive levels of care or institutional settings;

Clinical Records Maintenance and Storage Policy, which at a minimum meets the requirements in § 3007 of this chapter;

Complaint and Grievance Policy, which establishes a well-publicized complaint and grievance system, including written policies and procedures for handling consumer, family, and practitioner complaints and grievances that conforms to the requirements in 22-A DCMR § 306;

Consent to Treatment Policy, which shall establish and adhere to policies and procedures for obtaining written informed consent to treatment from consumers which comply with applicable Federal and District laws and regulations, including 22-A DCMR Chapter 1;

(i) Cultural Competence Policy, which shall define the set of values, principles, attitudes, policies and demonstrative behaviors that will enable the FSMHC to work effectively cross-culturally;

(j) Disaster Recovery Plan, which shall establish policies and procedures for maintaining the security and privacy of protected health information and data. Each plan shall also stipulate back-up and redundant systems and measures that are designed to prevent the loss of data and information and to enable the recovery of data and information lost due to disastrous events;

(k) Infection Control Policy, which shall establish policies and procedures governing infection control that comply with applicable Federal and District laws and regulations, including, but not limited to, the blood borne pathogens standard set forth in 29 CFR § 1910.1030;

(l) Interpreter Policy, which, at a minimum, requires using a professional interpreter or interpretation service including qualified sign language interpreters in order to effectively communicate with deaf consumers and those with limited English proficiency;

(m) Medication Storage and Administration Policy, which complies with applicable Federal and District laws and regulations regarding the purchasing, receipt, storage, distribution, dispensing, administering, return, and destruction of medications and require the FSMHC to maintain all medications and prescription blanks in a secured and locked area;

(n) Consumer Choice Policy, which shall establish policies and procedures governing the means by which consumers shall be informed of the full choices of FSMHC providers and other mental health service providers available;

(o) On-Call Policy, which shall require the FSMHC to adopt procedures for handling routine, urgent, and emergency situations that include referral procedures to local emergency departments and on-call arrangements for clinical staff and physicians. The policy shall describe the availability of timely access to face-to-face crisis support services, specify how the FSMHC provider will interact and coordinate services with Department-designated crisis and emergency services, and include procedures for triaging consumers who require crisis services or psychiatric hospitalization;

(p) Staff Performance Review Policy, which shall require at a minimum annual evaluations of clinical and administrative staff performance that includes an assessment of clinical competence, as well as general organizational work requirements and an assessment of key functions as described in the job description;

(q) Primary Care Provider Communication Policy, which shall establish policies and procedures governing communication with the consumer's primary care providers, including the FSMHC provider's interface with primary health care providers, managed health care plans, and other providers of mental health services. This policy shall also describe the FSMHC provider’s activities which will enhance consumer access to primary health care and the coordination of mental health and primary health care services;

(r) Quality Improvement (“QI”) Policy, which shall describe the objectives and scope of its QI program and require provider staff, consumer and family involvement in the QI program. The QI program shall ensure and measure the following: access and availability of services; coordination of care with behavioral health treatment and primary care treatment settings; compliance with FSMHC certification standards; adequacy, appropriateness and quality of care; efficient utilization of resources; and consumer and family satisfaction with services. The FSMHC shall submit a written report to the Department annually on the outcomes identified in the QI program.

(s) Consumer Privacy and Release of Information Policy, which shall outline how the FSMHC will protect consumer’s health information and ensure compliance with the HIPAA and the MHIA. The program shall develop policies and procedures to disclose protected behavioral health information to other certified providers, primary health care providers, and other health care organizations when necessary to coordinate the care and treatment of its consumers. These procedures shall include participation in the DC Health Information Exchange (DC HIE) pursuant to the requirements set forth in § 3008.2. The program shall advise each consumer of the program’s notice of privacy practices that authorizes this disclosure to other providers and shall afford the consumer the opportunity to opt-out of that disclosure in accord with the MHIA. The program shall document the individual’s decision;

(t) Supervision and Peer Review Policy, which shall meet the requirements of § 3006.3(b) and require personnel files of clinical staff working under supervision to contain evidence that the Supervision Policy is observed;

(u) Bullying Prevention Policy, which conforms to the requirements of 4 DCMR Chapter 15; and

(v) Plan of Care Policy, which shall adhere to § 3009 of this chapter and follow best industry practices.

3006.5 The Department shall review and approve each FSMHC provider’s policies during the certification process. The FSMHC provider shall submit any policies that have been revised to the Department for review and approval during recertification.

History

SOURCE: Final Rulemaking published at 67 DCR 11929 (October 16, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3006

22-A DCMR § 3007 RECORDS

3007.1 In order to ensure that the treatment provided and reimbursed by the District is of the highest quality and fully meets all standards for certification and reimbursement, each participating FSMHC shall maintain consumer records and individual plans of care in a manner that will render them amenable to audit and review by authorized Federal, District, and Department personnel.

3007.2 The requirements of § 3007.1 shall comply with mandated access requirements in federal and local law.

3007.3 The participating FSMHC shall maintain, and make immediately available upon request by the Department and local Medicaid personnel, complete financial, claims, and medical records. Failure to cooperate may result in suspension of payment(s), referral to the Medicaid Fraud Control Unit, and termination of the provider’s contract.

3007.4 All required financial and treatment records and information shall be properly maintained for a period of at least ten (10) years following the date of treatment for which a claim for reimbursement was made, or the date at which the consumer turns eighteen (18), or until an audit or litigation has been completed, whichever is the latest date.

3007.5 All medical records shall be retained in accordance with Federal and District law.

History

SOURCE: Final Rulemaking published at 67 DCR 11929 (October 16, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3007

22-A DCMR § 3008 MEDICAL RECORDS

3008.1 All phases of the consumer’s treatment and related information shall be entered in the consumer’s medical record.

3008.2 The FSMHC shall utilize an EHR system certified by the Department of Health and Human Services Office of the National Coordinator for Health Information Technology to document all phases of the individual’s treatment and care.

3008.3 The medical records shall include, but are not limited to, the following:

(a) Complete identification data, including Medicaid number and other third-party payer information;

(b) Medical history, initial psychiatric evaluation, psychosocial assessment, and histories, and, if appropriate, social service and nursing care plans for meeting current and future personal, financial, social, and nursing needs of the consumer;

(c) A record of a screening for the presence of a co-occurring substance use disorder at intake and upon any treatment plan revision;

(d) Individual plan of care, completed in accordance with § 3009 of this chapter;

(e) Psychiatrist’s, Physician’s Assistant, or APRN’s medication orders that shall include:

The name of the medications(s);

The dosage, route and frequency of administration;

The quantity given;

The number of refills; and

The signature of the authorized staff rendering the service.

(f) Documentation of all behavioral health-related medical treatment received during treatment at the FSMHC and appropriate encounter notes related to it. Consumers on medications should have, where indicated, routine blood or other examinations to detect irregularities duly recorded;

(g) Encounter notes, to include sufficient written clinical documentation to support each therapy, service, activity, or session for which billing is made which, at a minimum, consists of:

(1) The specific service type rendered;

(2) The date, duration, and actual beginning and ending time (denoting a.m. or p.m.) during which the services were rendered;

(3) Name, title, credentials and signature of the person providing the services;

(4) A description of each encounter or service sufficient to document that the service was provided; and

A description of the consumer’s response to the intervention.

3008.4 The FSMHC shall execute a participation agreement with the District’s Health Information Exchange (HIE) and utilize the HIE to receive and transmit protected health information for consumers in accordance with the District of Columbia Mental Health Information Act of 1978, effective Mar. 3, 1979 (D.C. Law 2-136, D.C. Official Code § 7-1201.01 et seq.).

History

SOURCE: Final Rulemaking published at 67 DCR 11929 (October 16, 2020); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3008

22-A DCMR § 3009 INDIVIDUAL PLAN OF CARE

3009.1 Each FSMHC shall develop an individual plan of care for each consumer. Copies of individual plans of care shall be filed in consumer records.

3009.2 The plans of care shall include the following:

(a) A written assessment of the consumer's current mental condition, co-occurring substance use, and physical co-morbidity;

(b) A diagnosis by a licensed behavioral health practitioners able to diagnose in accordance with his or her professional license, using the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders (DSM) currently in use by the Department;

The treatment goals, strengths, challenges, objectives, and interventions;

The name and title of other staff who shall participate in carrying out the plan of care; and

The independently licensed behavioral health practitioner’s certification, by dated signature:

Of the medical necessity for all mental health services detailed in the plan; and

That outpatient treatment is an appropriate level of care for the identified consumer.

3009.3 The plan of care shall be reviewed and amended, as needed in case of a change in the consumer’s status and at least annually by the independently licensed behavioral health practitioner. The consumer’s continuing need for treatment and medical necessity of treatment shall be clearly documented. The independently licensed behavioral health practitioner shall certify by his or her signature:

(a) That the review occurred;

The medical necessity for all mental health services detailed in the plan; and

That outpatient treatment is an appropriate level of care for the identified consumer.

3009.4 The Consumer, and/or the parent or guardian, if applicable, shall sign his or her plan of care.

3009.5 The FSMHC shall complete a functional assessment for each consumer, utilizing the Daily Living Activities-20 assessment for consumers aged twenty-one (21) and older, the Child and Adolescent Functional Assessment Scale for consumers aged six (6) through twenty (20) and the Preschool and Early Childhood Functional Assessment Scale for consumers age (3) through (5), at the following times:

Intake;

Upon events that may affect a consumer’s functioning and may require a change in their treatment plan or service acuity; and

Discharge.

History

SOURCE: Final Rulemaking published at 67 DCR 11929 (October 16, 2020); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3009

22-A DCMR § 3010 REIMBURSEMENT

3010.1 In order to be reimbursed, FSMHC services shall be medically necessary, reasonable in duration, and in full compliance with this chapter. A participating FSMHC shall agree to accept as payment in full the amount determined by DHCF or the Department, as appropriate, as the fee for the authorized services provided to Medicaid consumers and other eligible consumers for whom the District of Columbia is reimbursing the provider for services. No additional charge may be made to the consumer, any member of the family, or to any other source.

3010.2 A participating FSMHC shall agree to bill any and all other known third-party payers prior to billing Medicaid or the District.

3010.3 The payment and satisfaction of any FSMHC claim will be from federal and District funds. Any false claims, statements, documents, or concealment of material facts by the FSMHC shall be referred to the DHCF Office of Program Integrity and considered grounds for denial of claims, recoupment of false claims previously paid, and decertification. These remedies are in addition to any other remedies that the law may provide for false claims.

3010.4 DHCF and the Department shall establish rates and reimburse for only those services outlined in § 3010.8 and provided under the direction of a psychiatrist. Reimbursement for Medicaid-funded and locally-funded FSMHC services shall be at the rate contained in the District of Columbia Medicaid fee schedule available online at www.dc-medicaid.com. All future updates to the service codes and rates will be included in the District of Columbia Medicaid fee schedule pursuant to the procedures established in 29 DCMR § 988. Health Home services provided by a FSMHC shall be provided in accordance with the requirements set forth in 29 DCMR §§ 6900 et seq. and 22-A DCMR §§ 2500 et seq.

3010.5 Treatment-related services, such as information and referral services, charting, internal case conferences, transportation, person and agency conferences, and similar charges shall not be reimbursable under these rules. FSMHCs certified as a Health Home shall be reimbursed for the provision of Health Home services in accordance with the requirements set forth in 29 DCMR §§ 6900 et seq. and 22-A DCMR §§ 2500 et seq.

3010.6 Recreational therapy shall not be reimbursed as an FSMHC service.

3010.7 Excluding Health Home services provided in accordance with requirements set forth in 29 DCMR §§ 6900 et seq. and 22-A DCMR §§ 2500 et seq., a participating FSMHC may be reimbursed for no more than one individual therapy session, one group therapy session, and one psychiatrist visit per person on the same day. Any other service combinations require prior approval from the Department before service delivery.

3010.8 The following services shall be reimbursable if the independently licensed behavioral health practitioner certifies that the services are medically necessary, a current plan of care outlines the required services, and the services are provided by a behavioral health practitioner acting within applicable Federal and District laws and regulations:

Diagnostic Evaluation - behavior assessment procedures used to identify the psychological, behavioral, emotional, cognitive, and social factors important to the treatment planning process;

Psychiatric Diagnostic Evaluation - integrated biophysical assessments, including history, mental status, and recommendations;

Comprehensive Psychological Testing - up to five (5) hours of psychometric and projective tests with a written report done under the direction of a psychologist;

Therapy:

Individual Psychotherapy - verbal, drug augmented, or other therapy methods provided by a behavioral health practitioner in a face-to-face involvement with one (1) consumer to the exclusion of other consumers and duties. Session length is pursuant to the Current Procedural Terminology (CPT) Manual (most current edition);

Family therapy - therapy with or without the consumer and one (1) or more family members present. Verbal or other therapy methods by a behavioral health practitioner in a personal involvement with the consumer and family to the exclusion of other consumers and duties. Session length is pursuant to the CPT Manual (most current edition). The clinic may bill Medicaid only for the Medicaid consumer; and

Group therapy - verbal or other therapy methods provided by a behavioral health practitioner in face-to-face involvement with at least three (3) and no more than twelve (12) consumers. Session length is pursuant to the Current Procedural Terminology (CPT) Manual (most current edition);

Prescription visit - A visit for review and evaluation of the medication history of the consumer and the writing or renewal of prescriptions as necessary. A minimum of ten (10) minutes shall be allotted to the visit; and

Family conferences - meeting with the family or other significant persons (school, court, or other agency officials) to interpret or explain: medical, psychiatric, or psychological examinations and procedures; other accumulated data; and advice on how to assist the patient. A minimum of fifty (50) minutes shall be allotted to personal involvement with the family or other significant persons. The FSMHC may bill Medicaid only for the Medicaid patient.

3010.9 Behavioral health practitioners for FSMHC are described below:

SERVICE

INDEPENDENTLY LICENSED BEHAVIORAL HEALTH PRACTITIONER

LICENSED BEHAVIORAL HEALTH PRACTITIONER AND OTHER BEHAVIORAL HEALTH PRACTITIONER WITH SUPERVISION

Diagnostic Evaluation

Psychiatrist

Psychologist

Licensed Independent Clinical Social Worker (LICSW)

Advanced Practice Registered Nurse (APRN)

Licensed Professional Counselor (LPC)

Licensed Marriage and Family Therapist (LMFT)

Licensed Graduate Social Worker (LGSW)

Licensed Graduate Professional Counselor (LGPC)

Licensed Independent Social Worker (LISW)

Registered Nurse (RN)

Physician Assistant

Psychology Associate

Students, interns, or residents for any of the allowed licenses for examination and assessment

Psychiatric Diagnostic Evaluation

Psychiatrist

APRN

Physician Assistant

Comprehensive Psychological Testing

Psychologist

Psychology Associate

Psychology student/intern

Therapy

Psychiatrist

Psychologist

LICSW

APRN

LPC

LMFT

LGSW

LGPC

LISW

Psychology Associate

Students, interns, or residents for any of the allowed licenses for therapy

Prescription Visits

Psychiatrist

Physician

APRN

Licensed Practical Nurse

Physician Assistant

Family Conferences

Psychiatrist

Psychologist

LICSW

APRN

LPC

LMFT

LGSW

LGPC

LISW

Psychology Associate

Students, interns, or residents for any of the allowed licenses for therapy

3010.10 All claims seeking Medicaid or local only reimbursement under this Chapter shall include the active NPI numbers for the certified provider and the rendering provider. The rendering provider is the staff member who provided the service.

History

SOURCE: Final Rulemaking published at 67 DCR 11929 (October 16, 2020); as amended by Final Rulemaking published at 69 DCR 013495 (November 4, 2022); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3010

22-A DCMR § 3011 COMPLIANCE AND INTEGRITY PROGRAM

3011.1 Each provider shall establish and adhere to a plan for ensuring compliance with the Medicaid program and this regulation. Each provider shall submit its Corporate Compliance Plan and any modifications thereto to the Department as part of the certification or recertification process. At a minimum, the plan shall:

Designate an officer or director with responsibility and authority to implement and oversee the operation of the Corporate Compliance Plan;

Require initial, and, thereafter, quarterly exclusion checks on all employees to ensure no individual is excluded from participation in a federal health care program as found on the Department of Health and Human Services “List of Excluded Individuals/Entities” (http://oig.hhs.gov/fraud/exclusion.asp) or the General Services Administration “Excluded Parties List System” (http://www.wpls.gov) or the “District of Columbia Excluded Parties List” (http://ocp.dc.gov/DC/Excluded+Parties+List) maintained by the District’s Debarment and Suspension Panel;

Require that all officers, directors, managers, and employees enforce its provisions and receive annual compliance training;

Include procedures designed to prevent and detect potential or suspected false claims, abuse or fraud in the administration and delivery of FSMHC services;

Include procedures for the confidential reporting of violations of the Corporate Compliance Plan to the Department, including procedures for the investigation and follow-up of any reported violations;

Require that the FSMHC conduct annual internal audit using RAT-STATS, a statistical software package provided free of charge by the U.S. Department of Health and Human Services Office of the Inspector General, or other comparable software program. The audit shall utilize statistically valid and random sampling and identify any overpayments. The error rate for each audit shall be calculated as provided in § 3012;

Require the FSMHC provide a copy of the internal audit and all supporting documents to the Department and to repay any overpayments identified in the provider’s internal audit within sixty (60) days;

Ensure that the identities of individuals reporting suspected violations of the Corporate Compliance Plan are protected and that individuals reporting suspected violations, fraud, or abuse are not retaliated against;

Require that confirmed violations of the compliance plan be reported to the Department within twenty-four (24) hours of confirmation;

Require any confirmed or suspected fraud and abuse under District or Federal law or regulation be reported to the Department;

Require cooperation with Department investigations of major unusual incidents, consumer deaths related to suicide, and the death of a child or youth consumer; and

Require data reporting regarding key performance indicators published annually in the D.C. Register.

History

SOURCE: Final Rulemaking published at 67 DCR 11929 (October 16, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3011

22-A DCMR § 3012 AUDITS AND REVIEWS

3012.1 This Section sets forth the requirements for audits and reviews of FSMHC services and provider records. The Department, DHCF, and the D.C. Office of the Inspector General Medicaid Fraud Control Unit, among other entities, may conduct audits and reviews of FSMHC operations, including billing and treatment. The Department and DHCF shall perform regular audits of FSMHC providers to ensure that payments are consistent with efficiency, economy, quality of care, and are made in accordance with Federal and District conditions of payment, including programmatic duties, documentation, and reimbursement requirements under this chapter.

3012.2 The audit process shall utilize statistically valid sampling methods when the audit is based on claims sampling. The audit process may review all claims by type, time-period, and/or other criteria established by the Department, DHCF, or other entities. Statistically valid and commonly accepted standards methods for calculating overpayments will be followed.

3012.3 If DHCF or the Department denies a Medicaid claim during an audit, DHCF or the Department shall recoup, by the most expeditious means available, those monies erroneously paid to the provider for denied claims, following the process for administrative review as outlined below:

DHCF and the Department shall issue a joint Notice of Proposed Medicaid Overpayment Recovery (NPMOR), which sets forth the reasons for the recoupment, including the specific reference to the particular sections of the statute, rules, or provider agreement, the amount to be recouped, and the procedures for requesting an administrative review;

The FSMHC shall have thirty (30) days from the date of the NPMOR to submit documentary evidence and written argument to DHCF against the proposed action;

The documentary evidence and written argument shall include a specific description of the item to be reviewed, the reason for the request for review, the relief requested, and documentation in support of the relief requested;

Based on review of the documentary evidence and written argument, DHCF shall issue a Final Notice of Medicaid Overpayment Recovery (FNMOR);

Within fifteen (15) days of receipt of the FNMOR, the FSMHC may appeal the written determination by filing a written notice of appeal with the Office of Administrative Hearings (OAH), 441 4th Street, N.W., Suite 450 North, Washington, D.C. 20001; and

Filing an appeal with the OAH shall not stay any action to recover any overpayment.

3012.4 If DHCF or the Department denies a locally-funded claim during an audit, DHCF or the Department shall recoup, by the most expeditious means available, those monies erroneously paid to the provider for denied claims, following the process for administrative review as outlined below:

The Department shall issue an overpayment demand letter which sets forth the reasons for the recoupment, including specific reference to the particular sections of the statute, rule, or provider agreement, the amount to be recouped and the procedures for requesting an Administrative review;

The FSMHC shall have thirty (30) days from the date of the demand letter to request an Administrative Review and submit documentary evidence and written argument to DBH against the proposed action;

The Department shall conduct an Administrative Review conducted by a group of independently licensed clinicians who have not previously examined the claims under review. The DBH Director will then make a final determination regarding the claims under review;

The Department shall mail a written determination relative to the Administrative Review not later than ten (10) days from the date of the written request for review. Any recoupment remaining after the Administrative Review will begin thirty (30) days following the date of the written determination;

Within fifteen (15) days of receipt, the FSMHC may appeal the written determination by filing a written notice of appeal with OAH; and

Filing an appeal with the OAH shall not stay any action to recover any overpayment.

3012.5 All participant, personnel, and program administrative and fiscal records shall be maintained so that they are accessible and readily retrievable for inspection and review by authorized government officials or their agents, as requested. DHCF or the Department shall retain the right to conduct announced or unannounced audits or reviews at any time and audits or reviews.

3012.6 All records and documents required to be kept under this chapter and other applicable laws and regulations which are not maintained or accessible in the operating office visited during an audit shall be produced for inspection within twenty-four (24) hours, or within a shorter reasonable time if specified, upon the request of the auditing official.

3012.7 The failure of a provider to release or to grant access to program documents and records to auditors in a timely manner, after reasonable notice by DHCF or the Department to the provider to produce the same, shall constitute grounds to terminate the Medicaid Provider Agreement. This provision in no way limits DHCF's ability to terminate any Medicaid Provider Agreement for any other reason, or for the Department to terminate an HCA for any other reason.

3012.8 As part of the audit process, providers shall grant access to necessary records to verify compliance with certification standards and conditions of payment, including but not limited:

FSMHC financial records;

Statistical data to verify costs previously reported;

Program documentation;

A record of all service authorization and prior authorizations for services;

A record for all request for change in services;

Any records listed in §§ 3008 and 3009 in addition to any other records relating to the adjudication of claims, including, the number of units of the delivered service, the period during which the service was delivered and dates of service, and the name, signature, and credentials of the service provider(s); and

Any record necessary to demonstrate compliance with rules, requirements, guidelines, and standards for implementation and administration of FSMHC services.

3012.9 Nothing in this rule affects a provider’s independent legal obligation under this chapter and Federal and District law to implement and enforce an internal auditing program that self-identifies overpayments and reimburses DHCF or other payers within sixty (60) days of discovery.

History

SOURCE: Final Rulemaking published at 67 DCR 11929 (October 16, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3012

22-A DCMR § 3013 REPORTING MAJOR UNUSUAL INCIDENTS

3013.1 An FSMHC shall immediately notify the Department of any major unusual incident that may adversely affect the health, safety, or welfare of any enrolled consumer by submitting a completed Department Major Unusual Incident (MUI) Report to the Department’s Division of Incident Management and Investigation in the manner specified by the Department.

3013.2 An FSMHC shall also provide a copy of the completed MUI Report form provided to the Department to the consumer’s parent(s) or guardian(s) of each child or youth affected by the major unusual incident.

3013.3 Major unusual incidents may include, but are not limited to, the following:

Death of a person occurring at the FSMHC;

Death of a consumer related to suicide;

Death of a child or youth in treatment at the FSMHC;

Injury to or illness of any consumer that occurs while the consumer is at the FSMHC that requires hospitalization or emergency medical treatment;

Damage to the FSMHC or to any FSMHC vehicle or equipment that interferes with the capability of the provider to protect the health, safety and welfare of the children and adults at the FSMHC;

Outbreak of or a single occurrence of communicable disease at the FSMHC that is required to be reported to DC Health in accordance with Title 22 of the District of Columbia Municipal Regulations;

Unauthorized departure of an enrolled child or youth consumer or any circumstances under which a child or youth consumer is deemed unaccounted for or missing;

Any traffic accident involving a vehicle rented, owned, maintained, or contracted by the FSMHC and in which consumers were transported at the time of the accident;

Any adverse or negative action that the provider takes against an employee, volunteer, or household member related to any substantiated crime against a consumer; and

Any other incident at the FSMHC that requires a response by emergency service personnel, such as police, fire, ambulance, or poison control.

3013.4 In the case of a traffic accident or an incident involving perceived or actual criminal activity, the FSMHC shall also file a report with the appropriate law enforcement authorities.

3013.5 Any FSMHC staff member who knows or reasonably believes that an enrolled child consumer is, has been, or is in immediate danger of being abused or neglected shall, as required by the District of Columbia Prevention of Child Abuse and Neglect Act of 1977, effective September 23, 1977 (D.C. Law 2-22; D.C. Official Code §§ 4-1321.01 et seq.), make or cause to be made an immediate oral report to:

The Child Protective Services Division of the Child and Family Services Administration (CFSA), via the CFSA twenty-four (24) hour Child Abuse and Neglect Hotline; and

The Metropolitan Police Department (MPD).

3013.6 Any FSMHC staff member who knows or reasonably believes that an enrolled adult consumer is, has been, or is in immediate danger of being abused or neglected shall, as required by the Adult Protective Services Act of 1984, effective March 14, 1985 (D.C. Law 5-156; D.C. Official Code §§ 7-1901, et seq.), make or cause to be made an immediate oral report to:

Adult Protective Services in the Department of Aging and Community Living (DACL), via the twenty-four (24) hour Adult Protective Services Hotline; and

MPD.

3013.7 In the MUI report required by this section, the staff member shall include:

The name, age, sex, and household address of the consumer who is the subject of the report;

A statement that the consumer who is the subject of the report is receiving services at the FSMHC;

The name, address, and telephone number of the FSMHC;

To the extent known, the name, age, and sex of each sibling or child living in the same household as the consumer who is the subject of the report;

To the extent known, the name, age, and sex of each parent, guardian, or other caretaker of the consumer;

The information that led the staff member to suspect that the consumer who is the subject of the report is being, or is at risk of being, abused or neglected, the nature and extent of the perceived or actual abuse or neglect, and the identity of the person(s) responsible for it;

Any other information that may be helpful in establishing whether the consumer who is the subject of the report is being, or is at risk of being, abused or neglected, the cause of the suspected abuse or neglect, and the identity of the person(s) responsible for it;

The name, title, or occupation, and contact information of the staff member making the report;

Any actions taken by the staff member or the FSMHC concerning the consumer in response to the situation; and

Any other information required by law.

History

SOURCE: Final Rulemaking published at 67 DCR 11929 (October 16, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3013

22-A DCMR § 3014 NOTICES OF INFRACTION

3014.1 The Department may issue a Notice of Infraction (NOI) for any violation of this chapter. The fine amount for any NOI issued under this chapter shall be as follows:

For the first offense five hundred dollars ($500.00);

For the second offense one thousand dollars ($1,000.00);

For the third offense two thousand dollars ($2,000.00); and

For the fourth and subsequent offenses for thousand dollars ($4,000.00).

3014.2 The administrative procedure for the appeal of an NOI issued under this chapter

shall be governed by 16 DCMR §§ 3100 et seq.

History

SOURCE: Final Rulemaking published at 67 DCR 11929 (October 16, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3014

22-A DCMR § 3015 BEHAVIORAL HEALTH ACCREDITATION

3015.1 Effective October 1, 2023, all Free-Standing Mental Health Clinic (FSMHC) providers shall obtain and maintain in good standing behavioral health accreditation with at least one (1) of the following organizations: the Commission Accreditation of Rehabilitation Facilities (CARF), the Council on Accreditation (COA), or The Joint Commission (TJC).

3015.2 The timeline for FSMHC providers to obtain accreditation in accordance with § 3015.1 shall be as follows:

By December 15, 2022, all FSMHC providers shall submit an accreditation application to CARF, COA, or TJC and provide proof of the submission to the Department;

By April 30, 2023, all FSMHC providers shall obtain a letter of good standing from CARF, COA, or TJC and submit a copy to the Department; and

By October 1, 2023, all FSMHC providers shall be fully accredited with CARF, COA, or TJC and submit proof of accreditation to the Department.

3015.3 Accreditation through CARF, COA, or TJC shall not provide a waiver to FSMHC providers for any of the standards delineated in this chapter. The Department shall retain authority to monitor for and enforce compliance with all standards established in this chapter.

History

SOURCE: Final Rulemaking published at 70 DCR 003050 (March 10, 2023); as corrected by Errata Notice published at 71 DCR 004474 (April 19, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3015

22-A DCMR § 3099 DEFINITIONS

3099.1 When used in this chapter, the following terms and phrases shall have the meanings ascribed:

Clinical Administrator – an independently licensed behavioral health practitioner, as defined in this chapter, who has the authority and responsibility for the conduct of the affairs of the FSMHC, except for those matters committed by the provisions of this chapter to the authority of the psychiatrist.

Consumer – a person eligible to receive FSMHC services as defined in this chapter.

Electronic Health Record (“EHR”) – An electronic record of patient health information from one (1) or more encounters in any care delivery setting and meeting the requirement of a designated record set under 45 C.F.R. § 164.501.

Free Standing Mental Health Clinic – a formally organized psychiatric clinic furnishing psychiatric services, under the direction of a physician (psychiatrist) who is licensed in the District of Columbia, in a facility not administered by a hospital, but organized and operated to provide mental health services on an outpatient basis.

Independently Licensed Behavioral Health Practitioner – any person who is an APRN, LICSW, LMFT, LPC, psychiatrist, or psychologist, as defined in this chapter.

Licensed Behavioral Health Practitioners – the following practitioners are licensed behavioral health practitioners for the purposes of this chapter.

“APRN” – a person licensed as an advanced practice registered nurse in accordance with applicable District laws and regulations, and who has psychiatry as a specialty area of practice, works in a collaborative protocol with a psychiatrist, or demonstrates proficiency in mental health by having at least five (5) years of experience in psychiatric care delivery.

“LGPC” – a person licensed as a graduate professional counselor in accordance with applicable District laws and regulations.

“LGSW” – a person licensed as a graduate social worker in accordance with applicable District laws and regulations.

“LICSW” – a person licensed as an independent clinical social worker in accordance with applicable District laws and regulations.

“LISW” – a person licensed as an independent social worker in accordance with applicable District laws and regulations.

“LMFT” – a person licensed as a marriage and family therapist in accordance with applicable District laws and regulations.

“LPC” – a person licensed as a professional counselor in accordance with applicable District laws and regulations.

Licensed Practical Nurse (“LPN”) – A person licensed as a practical nurse in accordance with applicable District laws and regulations.

“RN” – a person licensed as a registered nurse in accordance with applicable District laws and regulations with training and experience in mental health.

Physician’s Assistant – a person licensed as a physician’s assistant in accordance with applicable District laws and regulations, and who works under supervision of a psychiatrist.

Psychiatrist – a physician licensed in accordance with applicable District laws and regulations who has completed a residency program in psychiatry accredited by the Residency Review Committee for Psychiatry of the Accreditation Council for Graduate Medical Education and is eligible to sit for the psychiatric board examination.

Psychologist – a person licensed as a psychologist in accordance with applicable District laws and regulations.

Psychology Associate – a person registered to practice as a psychology associate under the supervision of a licensed psychologist in accordance with applicable District laws and regulations.

Medical history – a record of the following information, at a minimum, about the consumer:

(a) Major surgical procedures that have been performed on the consumer and any related complications;

(b) Any present, past, or recurring diseases; and

(c) The consumer’s current medical condition and status, including the names of physician(s) rendering current medications or other ongoing treatments to the consumer.

Medication Orders – sequential records of all medications prescribed, dispensed, or administered by appropriate clinic staff.

Mental Health Condition – having or being at risk of having a diagnosable mental or emotional disorder which impairs the mental health of the person or is of sufficient duration to meet diagnostic criteria specified within the DSM-5 or the ICD-10 equivalent (or any subsequent revisions), with the exception of intellectual disability, other developmental disorders, substance use disorders or seizure disorders, unless those exceptions co-occur with another diagnosable mental illness.

Provider – a free standing mental health clinic certified by the Department of Behavioral Health as eligible to provide services under this chapter.

Provisional Accreditation – A preliminary, conditional, or limited temporary accreditation from the Commission on Accreditation of Rehabilitation Facilities, The Joint Commission, or the Council on Accreditation.

Residents of the District – persons who voluntarily live in the District and have no intention of presently removing themselves from the District. The term “residents of the District” shall not include persons who live in the District solely for a temporary purpose. Residency shall not be affected by temporary absence from and the subsequent return or intent to return to the District. Residency shall not depend upon the reason that persons entered the District, except to the extent that it bears upon whether they are in the District for a temporary purpose.

History

SOURCE: Final Rulemaking published at 67 DCR 11929 (October 16, 2020); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3099

22-A33 DC COMMUNITY SERVICE AGENCY CONSUMER TRANSITION VOUCHER

22-A DCMR § 3300 DC COMMUNITY SERVICE AGENCY CONSUMER TRANSITION VOUCHER

3300.1 These rules establish the requirements, formula, and process for a Consumer Transition Voucher (“CTV”) payment to a Core Services Agency (“CSA”), Assertive Community Treatment ("ACT") Program or Community Based Intervention ("CBI") Program for each consumer transitioning from the D.C. Community Service Agency (“DCCSA”) as part of the Department of Mental Health’s plan to close the DCCSA. The CTV is available only to consumers who were enrolled in DCCSA and are now transferring from the DCCSA to a new Department of Mental Health (“DMH”) certified provider.

3300.2 The purpose of the CTV is to support transition services provided to consumers transferred from the DCCSA as part of the Department’s closure of the DCCSA. The CTV is intended to provide additional funds to the CSA, ACT Program, or CBI Program, whichever unit becomes the consumer’s new clinical home, to assist in the cost of additional staffing, training and service requirements for each new consumer during the transition period.

3300.3 The CTV program does not create any rights except the right of the consumer’s new clinical home to bill DMH for CTV payment for transition services rendered and to receive the CTV payment in accordance with the requirements set forth herein.

3300.4 Nothing in these rules shall be interpreted to mean that a CTV provided by DMH is an entitlement or benefit.

History

SOURCE: Final Rulemaking published at 56 DCR 4399 (May 1, 2009).

22-A DCMR § 3301 WAIVER OF RULES

3301.1 Upon determination of good cause, the Director may waive any provision under this chapter subject to the statutory limitations of other District laws. The Director shall provide each waiver in writing and shall support each waiver by documentation of the facts and the grounds upon which a waiver is based.

History

SOURCE: Final Rulemaking published at 56 DCR 4399 (May 1, 2009).

22-A DCMR § 3302 CONSUMER TRANSITION VOUCHER AMOUNT

3302.1 The CTV payment is $787.50 per newly enrolled consumer during the transition period. DMH-certified providers are eligible to submit a claim for the CTV if they enroll and conduct an initial intake of DCCSA consumers between January 21, 2009 and June 30, 2010 in accordance with the requirements set forth herein.

History

SOURCE: Final Rulemaking published at 56 DCR 4399 (May 1, 2009).

22-A DCMR § 3303 ELIGIBILITY

3303.1 A CSA, ACT Program, or CBI Program that enrolls a consumer transferring from the DCCSA during the transition period as evidenced by a CSA Transfer Event in eCura shall be eligible for the CTV by submitting a claim through the Department’s eCura system as described below in Section 3304.

3303.2 Only the consumer’s clinical home will be eligible to receive CTV payments. If a consumer enrolls in a CSA but his or her clinical home is an ACT Program or CBI not affiliated with the CSA, the ACT Program or CBI Program, as appropriate, is the clinical home of the consumer and is the authorized entity to bill for the CTV.

3303.3 For each CTV payment set forth below in Section 3304, the CSA must have a concurrent claim for an MHRS service provided to the consumer.

History

SOURCE: Final Rulemaking published at 56 DCR 4399 (May 1, 2009).

22-A DCMR § 3304 PAYMENT OF VOUCHER

3304.1 The Department has established a billing code – the Transitional Care Case Rate (“TCR”) - to be used by the consumer’s clinical home for payment of the CTV.

3304.2 The total CTV payment will be provided in increments of 50% for the first claim, 25% for the second claim, and 25% for the third claim over a minimum 3 month period. Each consumer who transitions from the DCCSA to a new clinical home must remain with the new provider for a minimum of ninety (90) days from the date of enrollment in order for the new clinical home to submit all three claims for the entire amount of the CTV. If the consumer changes providers before the entire CTV can be claimed by the new provider in accordance with Sections 3304.3 - 3304.6, the remainder of the CTV will not be available to the second, or any subsequent, providers.

3304.3 In order for any CTV payment to occur, an authorization request for the CTV will need to be included in the authorization plan for each transitioned consumer. A maximum of three (3) units of the CTV may be authorized between the initial enrollment and the 9th month following the consumer’s intake with the new CSA.

3304.4 In order for the new provider to be eligible to claim the CTV, the initial intake of the consumer by the new provider must occur within 90 days of the consumer’s transfer from the DCCSA. Upon completion of the consumer’s intake with the new provider, the new provider may submit a claim for the first unit of the CTV (50% of the CTV) using the appropriate billing code (T2022U1 - Initial Transitional Care Case Rate).

3304.5 The new provider may submit a claim for the second unit of the CTV (25% of the CTV) during the second month of services to the consumer, using the appropriate billing code (T2022U2 - Subsequent Transitional Care Case Rate). If the consumer is not seen on a monthly basis, the provider can submit a claim for the second installment of the CTV any time services are rendered to the transitioning consumer as long as it is after the conclusion of the initial month of service with the new provider and before the sixth month following the consumer’s initial intake. This claim must accompany a concurrent claim for an MHRS service to the consumer in order for the second installment to be paid.

3304.6 The new provider may submit a claim for the final unit of the CTV (25% of the CTV) using the appropriate billing code (T2022U2 - Subsequent Transitional Care Case Rate) during the third month of services to the consumer. If the consumer is not seen on a monthly basis, the provider can submit a claim for the third installment of the CTV any time services are rendered to the transitioning consumer as long as it is after the conclusion of the second month of service with the new provider and before the ninth month following the consumer’s initial intake. This claim must accompany a concurrent claim for an MHRS service to the consumer in order for the third installment to be paid.

3304.7 Claims for the CTV are subject to DMH audit/chart review to substantiate the CTV claim.

3304.8 The CTV does not affect the payment of any MHRS services provided to transitioned consumers by any MHRS provider.

History

SOURCE: Final Rulemaking published at 56 DCR 4399 (May 1, 2009).

22-A DCMR § 3399 DEFINITIONS

Assertive Community Treatment or “ACT” - Assertive Community Treatment (ACT). An evidenced-based practice model that provides a proactive, consumer driven, intensive, integrated rehabilitative, crisis, treatment, and mental health rehabilitative community support service to adult consumers with serious and persistent mental illness. Services are provided by an interdisciplinary team, with dedicated staff time and specific staff to consumer ratios in order to assist consumers to meet their goals in the community and assist with integration into the community. ACT is a specialty service.

Clinical home - a Core Services Agency or a Specialty Provider who can enroll a consumer in eCura and once enrolled assumes the clinical and fiscal responsibility for coordinating, delivering and managing the care for that consumer.

Community Based Intervention or “CBI” – time-limited, intensive, mental health services delivered to children and youth ages six (6) through twenty-one (21). CBI services are intended to prevent the utilization of an out-of-home therapeutic resource or a detention of the consumer. CBI is a specialty service. There are three (3) levels of CBI services available: Level I services shall be delivered in accordance with the Multisystemic Therapy (MST) Model; Level II and Level III services shall be delivered in accordance with the Intensive Home and Community-based Services (IHCBS) model as adopted by DMH.

Core Service Agency or “CSA” – a DMH-certified community-based MHRS provider that has entered into a Human Care Agreement with DMH to provide specified MHRS services. A CSA shall provide at least one core service directly and may provide up to three core services via contract with a sub-provider or subcontractor. A CSA may provide specialty services directly if certified by DMH as a specialty provider. However, a CSA shall also offer specialty services via an affiliation agreement with all specialty providers.

Consumer Transition Voucher or “CTV” – a consumer transition rate payment voucher established by DMH to support transition services provided to consumers transferred from the DCCSA as part of the Department’s closure of the DCCSA. The CTV is intended to provide additional funds to the CSA, ACT Program, or CBI provider, whichever unit becomes the consumer’s new clinical home, to assist in the cost of additional staffing, training and service requirements for each new consumer during the transition period.

Mental Health Rehabilitation Services or “MHRS” - mental health rehabilitative or palliative services provided by a DMH-certified community mental health provider to consumers in accordance with the District of Columbia State Medicaid Plan, the MAA/DMH Interagency Agreement, and this chapter.

Transitional Care Case Rate or “TCR” - the authorization and billing code established by DMH for providers to use to submit claims for payment of the Consumer Transition Voucher.

History

SOURCE: Final Rulemaking published at 56 DCR 4399 (May 1, 2009).

22-A34 MENTAL HEALTH REHABILITATION SERVICES PROVIDER CERTIFICATION STANDARDS

22-A DCMR § 3400 GENERAL PROVISIONS

3400.1 The Department of Behavioral Health (“Department”) is the state mental health authority with the responsibility to plan, develop, coordinate, and monitor comprehensive and integrated behavioral health systems of care for adults and for children, youth, and their families in the District, and arrange for authorized, publicly-funded behavioral health services and supports for the residents of the District. The Department entered into a Memorandum of Understanding with the Department of Health Care Finance (“DHCF”) to implement a Medicaid Rehabilitation Option for the provision of mental health rehabilitative services (“MHRS”).

3400.2 The purpose of these rules is to establish the MHRS program, including consumer eligibility, service standards, and provider certification requirements for providing MHRS.

3400.3 Each Department-certified MHRS provider shall meet and adhere to the terms and conditions of its Human Care Agreement (“HCA”) with the Department and its Medicaid provider agreement with DHCF.

History

SOURCE: Final Rulemaking published at 48 DCR 10297 (November 9, 2001); as amended by Final Rulemaking published at 51 DCR 9308 (October 1, 2004); as amended by Final Rulemaking published at 52 DCR 5682 (June 17, 2005); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3400

22-A DCMR § 3401 MHRS PROVIDER CERTIFICATION PROCESS

3401.1 The Department shall utilize the certification process to thoroughly evaluate the applicant’s capacity to provide high quality MHRS in accordance with this regulation and the needs of the District’s behavioral health system.

3401.2 No person or entity shall provide MHRS unless certified by the Department. Each applicant seeking certification as an MHRS provider shall submit a certification application to the Department. An MHRS provider seeking renewal of certification shall submit a certification application at least ninety (90) calendar days prior to the termination of its current certification. The existing certification of an MHRS provider that has submitted a timely application for renewal of certification shall continue until the Department renews or denies renewal of the certification.

3401.3 Certification shall be considered terminated if the MHRS provider:

Fails to submit a complete certification application ninety (90) calendar days prior to the expiration date of the current certification;

Voluntarily relinquishes certification; or

Terminates operations.

3401.4 Upon receipt of a certification application, the Department shall review the certification application to determine if it is complete. If a certification application is incomplete, the Department shall return the incomplete certification application to the applicant. An incomplete certification application shall not be regarded as a certification application. Absent good cause, a provider’s failure to submit a complete certification application within ninety (90) calendar days prior to expiration of the current certification shall be deemed a voluntary relinquishment of certification and trigger the Department’s closure protocol.

3401.5 Following the Department’s acceptance of the certification application, the Department shall determine whether the applicant’s services and activities meet the certification standards described in this chapter. The Department shall schedule and conduct an on-site survey of the applicant’s services to determine whether the applicant satisfies the certification standards. The Department shall have access to all records necessary to verify compliance with certification standards and may conduct interviews with staff, others in the community, and consumers.

3401.6 The Department may conduct an on-site survey at the time of certification application or certification renewal, or at any other time during the period of certification.

3401.7 Applicant or MHRS provider interference with the on-site survey, submission of false or misleading information, or lack of candor by the applicant or provider shall be grounds for an immediate suspension of any prior certification or denial of a new certification application.

3401.8 A Statement of Deficiency (“SOD”) is a written notice to an applicant or existing MHRS provider identifying non-compliance with certification standards. The intent of the SOD is to provide:

Applicants with an opportunity to correct minor deficiencies during the certification application process; or

Existing certified providers with an opportunity to correct minor deficiencies during the renewal of certification process or at any other time to avoid decertification and disruption of services to existing consumers.

3401.9 The Department will not normally issue an SOD to applicants who fail to demonstrate compliance with the standards. The Department will normally consider the applicant’s failure to comply with the initial certification requirements as evidence that the applicant is ill-prepared to assume the responsibilities of providing MHRS to District residents and deny the application.

3401.10 When utilized, the SOD shall describe the areas of non-compliance, suggest actions needed to bring operations into compliance with the certification standards, and set forth a timeframe of no more than ten (10) business days for the applicant or existing MHRS provider’s submission of a written Corrective Action Plan (“CAP”).

3401.11 The issuance of an SOD is a separate process from the issuance of a Notice of Infraction (“NOI”). NOIs shall be issued promptly upon observation of violations of this chapter, especially when they are recurrent, endanger consumer or staff health or safety, or when there is a failure to comply with core requirements of this chapter.

3401.12 The Department is not required to utilize the SOD process. It may immediately deny certification or proceed with decertification.

3401.13 An applicant or certified MHRS provider’s CAP shall describe the actions to be taken and specify a timeframe for correcting the areas of non-compliance. The CAP shall be submitted to the Department within ten (10) business days after receipt of the SOD from the Department, or sooner if specified in the SOD.

3401.14 The Department shall notify the applicant or the certified MHRS provider whether the provider’s CAP is accepted within ten (10) business days after receipt.

3401.15 The Department may only issue certification after the Department verifies that the applicant or the certified MHRS provider has remediated all of the deficiencies identified in the CAP and meets all the certification standards.

3401.16 A determination to grant full certification to a provider shall be based on the Department’s review and validation of the information provided in the application, as well as facility survey findings, any CAP, and the provider’s compliance with this chapter.

3401.17 The Department shall certify an applicant and recertify a Mental Health Rehabilitation Services (MHRS) provider that demonstrates substantial compliance with this chapter, for a time period that runs concurrently with the applicant or provider’s accreditation period. Certification shall start from the date of issuance of certification by the Department, subject to the provider's continuous compliance with all certification standards. Certification shall remain in effect until it expires, is renewed, is revoked, or is voluntarily relinquished. The certification shall specify:

The effective date of the certification and the date the certification expires;

The program(s) and services that the provider is certified to provide and in which facility; and

Whether the provider is certified as a:

Core Services Agency serving adults and/or children and youth;

Sub-provider; or

Specialty provider.

The Department may grant provisional certification to an MHRS applicant or provider that has demonstrated substantial compliance with this chapter, has met initial requirements for the evidence-based practice certification process (if applicable), and has received provisional accreditation from the Commission on Accreditation of Rehabilitation Facilities, The Joint Commission, or the Council on Accreditation.

The Provisional certification shall expire upon termination of the provider’s provisional accreditation period(s) unless revoked in accordance with § 3403.

Certification is not transferable to any other organization.

Prior to adding an MHRS service during the term of certification, the MHRS provider shall submit a certification application describing the service. Upon determination by the Department that the service is in compliance with certification standards, the Department may certify the MHRS provider to provide that service.

Nothing in these rules shall be interpreted to mean that certification is a right or an entitlement. Certification as an MHRS provider depends upon the Director’s assessment of the need for additional providers and availability of funds. An individual or entity that applies for certification during an open application period as published in the District of Columbia Register may appeal the denial of certification under this subsection by utilizing the procedures contained in §§ 3403.2 and 3403.3. The Department shall not accept any applications for which a notice of moratorium is published in the District of Columbia Register.

In the event that a certification application is under review while a moratorium is put in place, the Department will continue to process the application for a time period of no more than thirty (30) calendar days. If, after thirty (30) calendar days, the application is deemed incomplete, the provider will be granted ten (10) business days to resolve all incomplete items. Any items not resolved or provided by the due date will result in the incomplete application being returned to the applicant and the Department will take no further action to issue certification. The applicant shall then wait until the moratorium is lifted in order to submit any subsequent certification applications.

The MHRS provider shall notify the Department in writing thirty (30) calendar days prior to implementing any of the following operational changes, including all aspects of the operations materially affected by the changes:

A proposed change in the name or ownership of an MHRS provider owned by an individual, partnership, or association, or in the legal or beneficial ownership of ten percent (10%) or more of the stock of a corporation that owns or operates the MHRS provider;

A change in affiliation or referral arrangements;

A proposed change in the provider’s service location;

The proposed addition or deletion of services, which is anything that would alter or disrupt services where the consumer would be impacted by the change, or any change that would affect compliance with this regulation;

A change in the required staff qualifications for employment;

A change in the staff filling positions required by this chapter, as well as any changes in Qualified Practitioners working for the agency;

A proposed change in organizational structure; or

A proposed change in the population served.

MHRS providers shall forward to the Department within thirty (30) calendar days all inspection reports conducted by an oversight body and all corresponding corrective actions taken regarding cited deficiencies.

MHRS providers shall immediately report to the Department any criminal allegations involving provider staff.

History

SOURCE: Final Rulemaking published at 48 DCR 10297 (November 9, 2001); as amended by Final Rulemaking published at 51 DCR 9308 (October 1, 2004); as amended by Final Rulemaking published at 52 DCR 5682 (June 17, 2005); as amended by Final Rulemaking published at 61 DCR 5415 (May 30, 2014); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3401

22-A DCMR § 3402 EXEMPTIONS FROM CERTIFICATION STANDARDS

3402.1 Upon good cause shown, the Department may exempt an applicant or MHRS provider from a certification standard if the exemption does not jeopardize the health and safety of consumers, violates consumers’ rights, or otherwise conflicts with the purpose and intent of these rules.

3402.2 If the Department approves an exemption, such exemption shall end on the expiration date of the provider certification or on an earlier date if specified by the Department; unless the provider requests renewal of the exemption prior to expiration of its certification or the earlier date set by the Department.

3402.3 The Department may revoke an exemption that it determines is no longer appropriate.

3402.4 All requests for an exemption from certification standards shall be submitted in writing to the Department.

History

SOURCE: Final Rulemaking published at 48 DCR 10297 (November 9, 2001); as amended by Final Rulemaking published at 51 DCR 9308 (October 1, 2004); as amended by Final Rulemaking published at 52 DCR 5682 (June 17, 2005); as amended by Notice of Final Rulemaking published at 58 DCR 8366 (September 30, 2011); Final Rulemaking published at 66 DCR 5638 (May 3, 2019); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3402

22-A DCMR § 3403 DENIAL OF CERTIFICATION OR DECERTIFICATION PROCESS

3403.1 The Director may deny initial certification if the applicant fails to comply with any certification standard or the application fails to demonstrate the applicant’s capacity to deliver high quality MHRS on a sustained and regular basis.

3403.2 To avoid an over-concentration of providers in areas with existing providers and to encourage increased access to underserved areas of the District, the Director may deny certification if the applicant proposes to operate a facility in an area already served by one or more providers. The Department’s priority shall be to grant certification to applicants with the demonstrated capacity to deliver high quality MHRS services that will address unmet needs of the behavioral health system.

3403.3 While applicants may make minor corrections and substitutions to its application during the certification process, evidence of one or more of the following shall constitute good cause to deny the application for certification when the circumstances demonstrate deliberate misrepresentations, organizational instability, or the lack of preparedness or capacity to meet and sustain compliance with this chapter:

An incomplete application;

False information provided by applicant or contained in an application;

One or more changes to an organizational chart during the application process;

A facility that is inadequate in health, safety, size, or configuration to provide MHRS consistent with high quality care and privacy standards;

The lack of demonstrated experience providing MHRS by the applicant’s clinical leadership, practitioners, and/or staff;

An applicant’s lack of financial resources to carry out its commitments and obligations under this chapter for the foreseeable future;

An applicant’s failure to timely respond to the Department’s requests for information;

History of poor performance; or

Lack of behavioral health accreditation in accordance with § 3433.1.

3403.4 Within fifteen (15) business days of the date on the certification denial, an applicant may make a request for an administrative review of the decision from the Director. The Director shall conduct the administrative review to determine whether the certification denial complied with § 3403.1.

3403.5 Each request for an administrative review shall be in writing and contain a concise statement of the reason(s) why the applicant asserts that the certification denial was in error and any relevant supporting documentation.

The Director shall complete the administrative review within fifteen (15) business days of receipt of the applicant’s request.

The Director shall issue a written decision and provide a copy to the provider. The Director’s decision is final and not subject to further appeal.

An applicant and its executive leadership shall not be allowed to reapply for certification for twelve (12) months following the date of the initial denial or, if applicable, the date of the denial pursuant to the Director’s administrative review.

The Department shall decertify existing providers who fail to comply with the certification requirements contained in this chapter. Evidence of one or more of the following shall constitute good cause to decertify:

An incomplete recertification application;

False information provided by provider or contained in a recertification application;

High staff turnover during the certification period demonstrating organizational instability;

One or more documented violations of the certification standards during the certification period that evidence a provider’s lack of capacity to meet and sustain compliance with this chapter;

Claims audit error rate in excess of twenty-five percent (25%);

Poor quality of care;

A provider’s lack of financial resources to carry out its commitments and obligations under this chapter for the foreseeable future;

Failure to cooperate with Department investigations or lack of timely response to information requests; or

Failure to obtain or maintain in good standing national accreditation in accordance with § 3433.1 or meet the timelines in § 3433.2.

Nothing in this chapter requires the Director to issue a SOD prior to decertifying an MHRS provider. If grounds for decertification have been met, the Director will issue a written notice of decertification setting forth the factual basis for the decertification, the effective date, and right to request an administrative review.

Within fifteen (15) business days of the date on the notice of decertification, the provider may request an administrative review from the Director. The Director shall conduct the administrative review to determine whether the decertification complied with § 3403.7.

Each request for an administrative review shall contain a concise statement of the reason(s) why the provider asserts that decertification should not have occurred and any relevant supporting documentation.

Each administrative review shall be conducted by the Director and shall be completed within fifteen (15) business days of the receipt of the provider’s request.

The Director shall issue a written decision and provide a copy to the provider. If the Director approves decertification, the provider may within fifteen (15) business days of receipt of the Director’s written decision request a hearing under the D.C. Administrative Procedure Act, D.C. Official Code §§ 2-501, et seq. The administrative hearing shall be limited to the issues raised in the administrative review request. The decertification shall be stayed pending resolution of the hearing.

Upon decertification, the MHRS provider and its executive leadership shall not be allowed to reapply for certification for any new services, including the service subject to decertification, for a period of two (2) years following the later of the date of the decertification letter or the date of the decertification order (if applicable). If a provider reapplies for certification, the provider shall reapply in accordance with the established certification standards for the type of services provided and show evidence that the grounds for the revocation have been corrected.

History

SOURCE: Final Rulemaking published at 48 DCR 10297 (November 9, 2001); as amended by Final Rulemaking published at 51 DCR 9308 (October 1, 2004); as amended by Final Rulemaking published at 52 DCR 5682 (June 17, 2005); as amended by Final Rulemaking published at 59 DCR 4785 (May 11, 2012); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020); as amended by Final Rulemaking published at 70 DCR 003050 (March 10, 2023); as corrected by Errata Notice published at 71 DCR 004474 (April 19, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3403

22-A DCMR § 3404 NOTICES OF INFRACTION

3404.1 The Department may issue a NOI for any violation of this chapter. The fine amount for any NOI issued under this chapter shall be as follows:

For the first offense, five hundred dollars ($500.00);

For the second offense, one thousand dollars ($1,000.00);

For the third offense, two thousand dollars ($2,000.00); and

For the fourth and subsequent offenses, four thousand dollars ($4,000.00).

3404.2 The administrative procedure for the appeal of an NOI issued under this chapter shall be governed by 16 DCMR §§ 3100 et seq.

History

SOURCE: Final Rulemaking published at 48 DCR 10297 (November 9, 2001); as amended by Final Rulemaking published at 51 DCR 9308 (October 1, 2004); as amended by Final Rulemaking published at 52 DCR 5682 (June 17, 2005); as amended by Final Rulemaking published at 59 DCR 4785 (May 11, 2012); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3404

22-A DCMR § 3405 PROVIDER DISCONTINUATION OF SERVICES, PROVIDER CLOSURES, AND CONTINUITY OF CONSUMER CARE

3405.1 An MHRS provider shall provide written notification to the Department at least ninety (90) calendar days prior to its impending closure or discontinuation of a subset of services, or immediately upon knowledge of an impending closure or discontinuation of a subset of services less than ninety (90) calendar days in the future. This notification shall include plans for continuity of care and preservation of consumer records.

3405.2 The Department shall review the continuity of care plan and make recommendations to the MHRS provider as needed. The plan should include provision for the referral and transfer of consumers, as well as for the provision of relevant treatment information, medications, and information to the new provider. The provider shall incorporate all Department recommendations necessary to ensure a safe and orderly transfer of care.

3405.3 Closure of a provider or discontinuation of a subset of services does not absolve a provider from its legal responsibilities regarding the preservation and the storage of consumer records as described in §§ 3413.16 and 3413.31 of these regulations and all applicable Federal and District laws and regulations. A provider shall take all necessary and appropriate measures to ensure consumer records are preserved, maintained, and made available to consumers upon request after closure of a provider or discontinuation of the applicable service.

3405.4 An MHRS provider shall be responsible for the execution of its continuity of care plan in coordination with the Department.

History

SOURCE: Final Rulemaking published at 48 DCR 10297 (November 9, 2001); as amended by Final Rulemaking published at 51 DCR 9308 (October 1, 2004); as amended by Final Rulemaking published at 52 DCR 5682 (June 17, 2005); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3405

22-A DCMR § 3406 SERVICE COVERAGE

3406.1 MHRS are those rehabilitative services rendered through Department-certified MHRS providers to eligible consumers who meet medical necessity for such services.

3406.2 MHRS offer a continuum of care for people with complex needs through intensive, community-based services to reduce the functional impact of mental illness or serious emotional disturbance and support transitions to less intensive levels of care.

3406.3 MHRS are recommended by qualified practitioners licensed to diagnose mental illness or serious emotional disturbance. MHRS are rendered by qualified practitioners and credentialed staff, pursuant to the requirements in § 3416 and the applicable service specific standards set forth in this chapter.

3406.4 Rehabilitative services covered as MHRS are:

Diagnostic Assessment;

Medication/Somatic Treatment;

Counseling;

Community Support;

Crisis/Emergency Services;

Rehabilitation Day Services;

Intensive Day Treatment (IDT);

Community Based Intervention (CBI);

Assertive Community Treatment (ACT);

Psychosocial Rehabilitation Clubhouse (Clubhouse);

Child-Parent Psychotherapy (CPP);

Trauma-Focused Cognitive Behavioral Therapy (TF-CBT);

Trauma Recovery and Empowerment Model (TREM);

Trauma Systems Therapy (TST);

Clinical Care Coordination (CCC);

Functional Family Therapy (FFT); and

Intensive Care Coordination (ICC).

3406.5 MHRS providers are CSAs, sub-providers, and specialty providers that are certified in compliance with the standards set forth in this chapter.

3406.6 MHRS coverage limitations are set forth in §§ 3431 and 3432. Coverage for any MHRS is contingent on whether all of the following criteria are met:

The service shall be medically necessary;

The service shall be delivered through a certified MHRS provider;

The service shall be rendered by qualified practitioners or credentialed staff pursuant to the applicable service specific standards set forth in this chapter;

The service shall be delivered in accordance with an approved plan of care; and

The service shall be delivered in accordance with the applicable service specific standards set forth in this chapter.

History

SOURCE: Final Rulemaking published at 48 DCR 10297 (November 9, 2001); as amended by Final Rulemaking published at 51 DCR 9308 (October 1, 2004); as amended by Final Rulemaking published at 52 DCR 5682 (June 17, 2005); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020); as amended by Final Rulemaking published at 70 DCR 003050 (March 10, 2023); as corrected by Errata Notice published at 71 DCR 004474 (April 19, 2024); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3406

22-A DCMR § 3407 ELIGIBLE CONSUMERS

3407.1 Consumers eligible for Medicaid-funded MHRS shall meet the following requirements:

(a) Be enrolled in Medicaid, or be eligible for enrollment and have an application pending;

(b) Be a bona fide resident of the District, as defined in D.C. Official Code § 7-1131.02(29);

(c) Be a child or youth with mental health problems, as defined in D.C. Official Code § 7-1131.02(1F), or an adult with mental illness as defined in D.C. Official Code § 7-1131.02(24); and

(d) Be recommended as requiring MHRS by a qualified practitioner licensed to diagnose mental illness or serious emotional disturbance.

3407.2 Subject to § 3407.4, consumers eligible for locally-funded MHRS are those individuals who are not eligible for Medicaid or Medicare or are not enrolled in any other third-party insurance program except the D.C. HealthCare Alliance, and who meet the following requirements:

(a) Be a bona fide resident of the District, as defined in D.C. Official Code § 7-1131.02(29);

(b) Be a child or youth with mental health problems, as defined in D.C. Official Code § 7-1131.02(1F), or an adult with mental illness as defined in D.C. Official Code § 7-1131.02(24);

(c) Be recommended as requiring MHRS by a qualified practitioner licensed to diagnose mental illness or serious emotional disturbance; and

(d) For individuals eighteen (18) years of age and older, live in households with a countable income of less than two hundred percent (200%) of the federal poverty level, and for individuals under eighteen (18) years of age, live in households with a countable income of less than three hundred percent (300%) of the federal poverty level.

3407.3 Eligible consumers of MHRS shall have a primary mental health diagnosis as described in the International Classification of Diseases (“ICD-10”) and Diagnostic and Statistical Manual of Mental Health Disorders (“DSM-5”), or subsequent versions adopted by the Department pursuant to public notice in the District of Columbia Register.

3407.4 Consumers eligible for Medicare shall remain eligible for the following locally-funded MHRS only to the extent these services are not otherwise covered by Medicare:

Community support; and

Specialty services identified in § 3417.3.

3407.5 Providers shall not bill Medicaid and/or the Department for MHRS provided to any consumer that does not meet the eligibility requirements set forth above.

3407.6 For new enrollees and those enrollees whose Medicaid coverage has lapsed:

(a) There is an eligibility grace period of ninety (90) calendar days from the date of first service for new enrollees, or from the date of eligibility expiration for enrollees who have a lapse in coverage, until the date the Department of Human Services’ Economic Security Administration (“ESA”) makes an eligibility or renewal determination.

(b) In the event the consumer appeals a denial of eligibility or renewal by the ESA, the Director may extend the ninety (90) calendar day eligibility grace period until the appeal has been exhausted. The ninety (90) calendar day eligibility grace period may also be extended at the discretion of the Director for other good cause shown.

Upon expiration of the eligibility grace period, MHRS services provided to the consumer are no longer reimbursable by the Department. Nothing in this section alters the District’s timely-filing requirements for claim submissions.

History

SOURCE: Final Rulemaking published at 48 DCR 10297 (November 9, 2001); as amended by Final Rulemaking published at 51 DCR 9308 (October 1, 2004); as amended by Final Rulemaking published at 52 DCR 5682 (June 17, 2005); as amended by Notice of Emergency and Proposed Rulemaking published at 58 DCR 1482 (February 18, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 3476 (April 22, 2011); as amended by Final Rulemaking published at 66 DCR 5638 (May 3, 2019); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3407

22-A DCMR § 3408 ENROLLMENT INTO AND AUTHORIZATION OF MHRS

3408.1 Enrollment is the process by which the Department ascertains a consumer’s eligibility for MHRS, and, if eligible for services, adds a consumer to the MHRS system of care and assigns them to an MHRS provider.

3408.2 No later than seven (7) calendar days after enrollment, the MHRS provider shall conduct an intake appointment with the consumer. This is a face-to-face encounter that initiates the process for securing consent to treatment.

3408.3 If the MHRS provider is unable to contact the consumer, the provider shall document all steps taken in the consumer’s clinical record.

3408.4 As part of the service authorization process, the Department may review the consumer’s Plan of Care or other clinical material if additional clinical information is required in order to evaluate a consumer’s needs and whether MHRS are medically necessary.

History

SOURCE: Final Rulemaking published at 48 DCR 10297 (November 9, 2001); as amended by Final Rulemaking published at 51 DCR 9308 (October 1, 2004); as amended by Final Rulemaking published at 52 DCR 5682 (June 17, 2005); as amended by Notice of Emergency and Proposed Rulemaking published at 58 DCR 1482 (February 18, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 3476 (April 22, 2011); as amended by Notice of Final Rulemaking published at 58 DCR 8366, 8367 (September 30, 2011); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3408

22-A DCMR § 3409 CONSUMER PROTECTIONS

3409.1 Medicaid beneficiaries are entitled to Notice and Appeal rights pursuant to 29 DCMR § 9508 in cases of intended adverse action, such as an action to deny, discontinue, terminate, or change the manner or form of Medicaid-funded MHRS. The Department shall provide local-only beneficiaries the same Notice and Appeal rights.

3409.2 Each MHRS provider shall establish and adhere to a consumer rights policy authorized by its governing authority (“Consumer Rights Policy”) that complies with the requirements of 22-A DCMR § 301.1.

3409.3 Each MHRS provider shall establish and adhere to a system for distributing the Consumer Rights Policy that complies with the requirements of 22-A DCMR § 301.3.

3409.4 Each MHRS provider shall establish and adhere to a well-publicized complaint and grievance system, which includes written policies and procedures for handling consumer, family, and practitioner complaints and grievances (“Complaint and Grievance Policy”) that complies with 22-A DCMR § 306.

3409.5 Each MHRS provider shall establish and adhere to policies and procedures for obtaining written informed consent to treatment from consumers (“Consent to Treatment Policy”), which comply with applicable Federal and District laws and regulations, including 22-A DCMR Chapter 1.

3409.6 Each MHRS provider shall establish and adhere to policies and procedures governing the release of mental health information about consumers (“Release of Consumer Information Policy”), which comply with applicable Federal and District laws and regulations. For consumers with co-occurring mental health and substance use disorders (SUDs), the MHRS provider shall comply with the requirements of 42 CFR part 2 governing the confidentiality and release of SUD treatment records as applicable.

3409.7 Each MHRS provider shall establish and adhere to policies and procedures governing the use of advance instructions for mental health treatment, durable power of attorney for health care, and advance directives (“Advance Instructions Policy”) that comply with applicable Federal and District laws and regulations, including 22-A DCMR Chapter 1 and any applicable the Department policy.

3409.8 Each MHRS provider’s Advance Instructions Policy shall incorporate the development of advance instructions for mental health treatment, durable power of attorney for health care, and advance directives into the assessment planning process.

3409.9 The Department shall review and approve each MHRS provider’s Consumer Rights Statement, Complaint and Grievance Policy, Consent to Treatment Policy, Release of Consumer Information Policy, and Advance Instructions Policy, during the certification process and during recertification.

History

SOURCE: Final Rulemaking published at 48 DCR 10297 (November 9, 2001); as amended by Final Rulemaking published at 51 DCR 9308 (October 1, 2004); as amended by Final Rulemaking published at 52 DCR 5682 (June 17, 2005); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3409

22-A DCMR § 3410 CONSUMER CHOICE

3410.1 All consumers receiving MHRS shall have free choice of MHRS providers.

3410.2 Each MHRS provider shall establish and adhere to policies and procedures governing the means by which consumers shall be informed of the full choices of MHRS providers and other mental health service providers available, including information about peer support and family support services and groups and how to access these services (“MH Consumer Choice Policy”).

3410.3 The Department shall review and approve each MHRS provider’s MH Consumer Choice Policy during the certification process and during recertification.

3410.4 The MH Consumer Choice Policy shall comply with applicable Federal and District laws and regulations.

3410.5 Each MHRS provider shall:

Make its MH Consumer Choice Policy available to consumers and their families; and

Establish and adhere to a system for documenting that consumers and families receive the MH Consumer Choice Policy.

3410.6 Each CSA’s MH Consumer Choice Policy shall ensure that each consumer:

Requesting MHRS directly from the CSA is informed that the consumer may choose to have MHRS provided by any of the other the certified CSAs;

Enrolled in the CSA is informed that the consumer may choose to have MHRS provided by any of the certified sub-providers; and

Enrolled in the CSA is informed that the consumer may choose to have MHRS provided by any of the certified specialty provider.

History

SOURCE: Final Rulemaking published at 48 DCR 10297 (November 9, 2001); as amended by Final Rulemaking published at 51 DCR 9308 (October 1, 2004); as amended by Final Rulemaking published at 52 DCR 5682 (June 17, 2005); as amended by Final Rulemaking published at 57 DCR 10392, 10393 (November 5, 2010); as amended by Emergency and Proposed Rulemaking published at 58 DCR 1482 (February 18, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 3476, 3477 (April 22, 2011); as amended by Final Rulemaking published at 58 DCR 8366, 8367 (September 30, 2011); as amended by Final Rulemaking published at 64 DCR 0021 (January 6, 2017)); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3410

22-A DCMR § 3411 PLAN OF CARE DEVELOPMENT

3411.1 Each CSA shall coordinate the Plan of Care development for its enrolled consumers from the start of intake through discharge from the system of care, except that the Plan of Care development for consumers receiving:

CBI, shall be coordinated by the consumer’s CBI provider;

ACT, shall be coordinated by the consumer’s ACT provider; and

Clubhouse services, shall be coordinated by the member’s Clubhouse provider, if the member is not linked with a CSA, or a CBI or ACT provider. The Plan of Care development and implementation for such members shall be conducted in accordance with the requirements set forth in 22-A DCMR Chapter 39.

3411.2 The Plan of Care development process for consumers shall, at a minimum, include:

The completion of a Diagnostic Assessment as described in § 3418;

Development of a Plan of Care as described in § 3411;

Consideration of the consumer’s beliefs, values, and cultural norms in how, what, and by whom MHRS are to be provided;

Consideration, screening, and assessment of the consumer for treatment using an appropriate evidence-based practice (“EBP”) offered through a certified MHRS provider; and

When coordinated by the CSA, assessment of the consumer for interest in and potential eligibility for Mental Health Supported Employment services, in accordance with the requirements set forth in 22-A DCMR Chapter 37.

3411.3 Court-appointed guardians for adults, children, and youth, and the parents/guardians or family members of children and youth shall be involved in the Plan of Care development process. The families and significant others of adult consumers may participate in the Plan of Care development process to the extent that the adult consumer consents to the involvement of family and significant others.

3411.4 The provider shall approve a Plan of Care within thirty (30) calendar days from when the provider obtains consent to treatment from the enrolled consumer. Approval of a Plan of Care shall be demonstrated by the dated and authenticated signature of an independently licensed qualified practitioner.

3411.5 Each CSA, or when applicable pursuant to § 3411.1, each CBI or ACT provider, shall develop and maintain a complete and current Plan of Care for each enrolled consumer after completing intake and assessment. The Plan of Care shall at a minimum describe all of the MHRS the provider will deliver to the consumer, as well as any services to be provided by another CSA, sub-provider, or specialty provider. The CSA or, if applicable, the CBI or ACT provider, is responsible for coordinating the development of the Plan of Care with any CSA, sub-provider, or specialty provider involved in the provision of services.

3411.6 The Plan of Care shall be person-centered and include the following elements:

Overall broad, long-term goal statement(s) that captures the consumer’s and/or family’s short- and long-term goals for the future, ideally written in first-person language. This shall include the consumer’s self-identified recovery goals;

List or statement of individual or family strengths that support goal(s) accomplishment. These include abilities, talents, accomplishments, and resources;

List or statement of barriers that pose obstacles to the consumer’s and/or family’s ability to accomplish the stated goal(s). These include symptoms, functional impairments, lack of resources, consequences of behavioral health issues, and other challenges;

Statement of objectives that identify the short-term consumer and/or family changes in behavior, function, or status that can help overcome the identified barriers and are building blocks toward the eventual accomplishment of the long-term goal(s). Objective statements describe outcomes that are measurable and include individualized target dates to be accomplished within the scope of the plan;

Intervention statements that describe the treatment and recovery services to be utilized to reduce or eliminate the barriers identified in the plan and support objective and eventual goal(s) accomplishment. Interventions are specific to each objective and the consumer’s and/or family’s stage of change. Intervention statements identify who will deliver the service, what will be delivered, when it will be delivered, and the purpose of the intervention. Natural support interventions should also be included in the plan and include those non-billable supports delivered by resources outside of the formal behavioral health service-delivery system. When appropriate and applicable, EBP shall be incorporated into the intervention statement; and

Provide for the delivery of services in the least restrictive environment that is appropriate for the consumer.

History

SOURCE: Final Rulemaking published at 48 DCR 10297 (November 9, 2001); as amended by Final Rulemaking published at 51 DCR 9308 (October 1, 2004); as amended by Final Rulemaking published at 52 DCR 5682 (June 17, 2005); as amended by Final Rulemaking published at 57 DCR 10392, 10393 (November 5, 2010); as amended by Notice of Emergency and Proposed Rulemaking published at 58 DCR 1482 (February 18, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 3476, 3478 (April 22, 2011); as amended by Notice of Final Rulemaking published at 58 DCR 8366, 8369 (September 30, 2011); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3411

22-A DCMR § 3412 PLAN OF CARE IMPLEMENTATION

3412.1 The consumer and assigned staff of the CSA, or when applicable pursuant to § 3411.1, staff of the CBI or ACT provider shall discuss the Plan of Care on an ongoing basis. The assigned staff shall record an encounter note describing the consumer’s response to, participation in, and agreement to the Plan of Care in the consumer’s clinical record.

3412.2 In situations where the consumer does not demonstrate the capacity to sign or does not sign the Plan of Care, the reasons the consumer does not sign shall be recorded in the consumer’s clinical record, including each date when obtaining a signature was attempted.

3412.3 Staff shall document in the consumer’s clinical record that a consumer’s court-appointed guardian, family, and/or significant others participated in the development of the Plan of Care, as appropriate.

3412.4 Each MHRS provider shall develop policies and procedures for Plan of Care review (“Plan of Care Review Policy”). The Plan of Care Review Policy shall be part of the MHRS provider’s Treatment Planning or Recovery Planning Policy as required by § 3413.12.

3412.5 The Plan of Care Review Policy shall require that the Plan of Care be reviewed and updated every one hundred eighty (180) calendar days and at any time there is a significant change in the consumer’s condition or situation to reflect progress toward or the lack of progress toward the treatment or recovery goals. Each new Plan of Care should incorporate a review of what is working in treatment as well as challenges that have affected treatment. The Plan of Care may be reviewed more frequently, as necessary, based on the consumer’s progress or circumstances.

History

SOURCE: Final Rulemaking published at 48 DCR 10297 (November 9, 2001); as amended by Final Rulemaking published at 51 DCR 9308 (October 1, 2004); as amended by Final Rulemaking published at 52 DCR 5682 (June 17, 2005); as amended by Final Rulemaking published at 57 DCR 10392, 10393 (November 5, 2010); as amended by Notice of Emergency and Proposed Rulemaking published at 58 DCR 1482 (February 18, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 3476, 3478 (April 22, 2011); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3412

22-A DCMR § 3413 MHRS PROVIDER QUALIFICATIONS--GENERAL

3413.1 Each MHRS provider shall be established as a legally recognized entity in the District of Columbia and qualified to conduct business in the District. A certificate of good standing issued by the District of Columbia Department of Consumer and Regulatory Affairs shall be evidence of qualification to conduct business.

3413.2 Each MHRS provider shall maintain the clinical operations policies and procedures described in this section, and which shall be reviewed and approved by the Department, during the certification survey process.

3413.3 Each MHRS provider shall:

Have a governing authority, which shall have overall responsibility for the functioning of the MHRS provider;

Comply with all applicable Federal and District laws and regulations;

Hire personnel with the qualifications necessary to provide MHRS and to meet the needs of its enrolled consumers;

Ensure that independently licensed qualified practitioners are available to provide appropriate and adequate supervision of all clinical activities; and

Employ qualified practitioners that meet all professional requirements as defined by the applicable licensing, certification, and registration laws and regulations of the District or the jurisdiction where services are delivered.

3413.4 Each MHRS provider shall establish and adhere to policies and procedures for selecting and hiring staff (“Staff Selection Policy”), which shall include:

Evidence of each staff member’s licensure, certification, or registration, as applicable and as required by the job being performed;

For non-licensed staff, evidence of completion of an appropriate degree, appropriate training program, or appropriate credentials (e.g., an academic transcript or a copy of degree);

Evidence of all required criminal background checks, and for all

non-licensed staff members, application of the criminal background check requirements contained in District Official Code §§ 44-551 et seq., Unlicensed Personnel Criminal Background Check, as well as quarterly child abuse registry checks for both state of residence and state of employment;

Evidence of quarterly checks that no individual is excluded from

participation in a federally funded health care program as listed on the Department of Health and Human Services’ “List of Excluded Individuals/Entities,” the General Services Administration’s “Excluded Parties List System,” or any similar succeeding governmental list;

Evidence of completion of all communicable disease testing required by the Department and District laws and regulations;

A process by which all staff, as a condition of hiring, shall declare any present or past events that might raise liability or risk management concerns, such as malpractice actions, insurance cancellations, criminal convictions, Medicare/Medicaid sanctions, and ethical violations; and

Evidence that the provider conducts each required screening at the frequency required by District law and regulations, including quarterly exclusion checks and unlicensed employee criminal background checks every four (4) years;

Evidence of all required criminal background checks, and for all non-licensed staff members, application of the criminal background check requirements contained in District Official Code §§ 44-551 et seq., Unlicensed Personnel Criminal Background Check, as well as yearly child abuse registry checks with state of residence and state of employment.

3413.5 Each MHRS provider shall establish and adhere to written job descriptions for all positions, including, at a minimum, the role, responsibilities, reporting relationships, and minimum qualifications for each position. The minimum qualifications for each position shall be appropriate for the scope of responsibility and clinical practice described for each position.

3413.6 Each MHRS provider shall establish and adhere to policies and procedures requiring a periodic evaluation of clinical and administrative staff performance (“Performance Review Policy”) that require an assessment of clinical competence and competence in behavioral health issues, as applicable, as well as general organizational work requirements, and an assessment of key functions as described in the job description. The periodic evaluation shall also include an annual individual development plan for each staff member.

3413.7 Each MHRS provider shall establish and adhere to policies and procedures to ensure that clinical staff are licensed, certified (if applicable), or registered (if applicable) and, to the extent required by applicable laws, regulations, work under the supervision of another qualified practitioner (“Supervision and Peer Review Policy”). The Supervision and Peer Review Policy shall:

(a) Include procedures for clinical supervision, which require sufficient clinical supervision conducted by qualified practitioners permitted to supervise per applicable District laws and regulations;

(b) Require personnel files of non-licensed clinical staff and consumers’ clinical records to contain evidence that the MHRS provider is observing the requirements of the Supervision and Peer Review Policy; and

(c) Include an active peer review process to monitor quality of care delivered by qualified practitioners and credentialed staff.

3413.8 Each MHRS provider shall establish and adhere to policies and procedures governing the credentialing or privileging of staff (“Credentialing Policy”) consistent with the Department rules on privileging and competency-based credentialing systems. The Credentialing Policy shall:

Allow staff who do not possess college degrees to be credentialed for direct service work, based on educational equivalent qualifications. These qualifications include experience that provides an individual with an understanding of mental illness, and which was acquired as an adult: (1) through personal experience with the mental health treatment system, or (2) through the provision of significant supports to adults with mental illness, or children and youth with mental health problems or with serious emotional disturbance;

Facilitate the employment of persons in recovery as peer counselors and members of community support teams; and

Include an assessment of qualified practitioners’ cultural and linguistic competence.

3413.9 Each MHRS provider shall have annual training that meets the federal Occupational Safety & Health Administration (“OSHA”) regulations that govern behavioral health facilities and any other applicable infection control guidelines, including information on the use of universal precautions and on reducing exposure to hepatitis, tuberculosis, and HIV/AIDS.

3413.10 A provider shall have a current written plan for staff development and organizational onboarding, approved by the Department, which reflects the training and performance improvement needs of all employees working in that program. The plan shall address the steps the provider will take to ensure the recruitment and retention of highly qualified employees and the reinforcement of staff development through training, supervision, the performance management process, and activities such as shadowing, mentoring, skill testing, and coaching. The plan shall at a minimum include culturally competent training and onboarding activities in the following core areas:

The provider’s approach to addressing treatment or recovery services (as appropriate to certification), including philosophy, goals, and methods;

The staff member’s specific job description and role in relationship to other staff;

Emergency preparedness plan and all safety-related policies and procedures;

The proper documentation of services in individual consumer records, as applicable;

Policies and procedures governing infection control, protection against exposure to communicable diseases, and the use of universal precautions;

Laws, regulations and policies governing confidentiality of consumer information and release of information;

Laws, regulations, and policies governing reporting abuse and neglect;

Consumer rights; and

Other trainings, as deemed necessary by the Department.

3413.11 Each MHRS provider shall establish and adhere to policies and procedures defining pre-admission, intake, screening, assessment, referral, transfer, and discharge procedures (“Admission, Transfer, and Discharge Policy”) that comply with applicable Federal and District laws and regulations. The policies and procedures shall define the required documentation for screening or assessing consumers for admission to an EBP operated by the provider when the consumer’s condition requires a modification in the Plan of Care.

3413.12 Each MHRS provider shall establish and adhere to policies and procedures governing the coordination of the treatment or recovery planning process (“Treatment Planning Policy or Recovery Planning Policy”), including procedures for designing, implementing, reviewing, and revising each consumer’s Plan of Care that comply with the requirements of § 3411.

3413.13 Each MHRS provider shall establish and adhere to policies and procedures requiring that treatment be provided in accordance with the applicable service specific standards in this chapter (“Service Specific Policy”). The Service Specific Policy shall:

Address supervision requirements and required caseload ratios that are appropriate to the population served and treatment modalities employed; and

Include a written description of the services offered by the MHRS provider (“Service Description”) describing the purpose of the service, the hours of operation, the intended population to be served, recovery modalities provided by the service, treatment or recovery objectives, and expected outcomes.

3413.14 Each MHRS provider shall establish and adhere to policies and procedures governing communication with the consumer’s primary care providers (“Primary Care Provider Communication Policy”). The Primary Care Provider Communication Policy shall:

Outline the MHRS provider’s interface with primary health care providers, managed health care plans, and other providers of mental health services; and

Describe the MHRS provider’s activities which will enhance consumer access to primary health care and the coordination of mental health and primary health care services.

3413.15 Each MHRS provider shall establish and adhere to policies and procedures for handling routine, urgent, and emergency situations (“Unscheduled Service Access Policy”). The Unscheduled Service Access Policy shall:

Include referral procedures to local emergency departments;

Include staff assignment to cover walk-in hours for urgent care;

Include arrangements for access to medication-somatic treatment practitioners and other clinical staff;

Describe the availability of telephone access to an independently licensed qualified practitioner, for the consumer, or other person acting on behalf of the consumer making contact with the MHRS provider;

Describe the availability of timely access to face-to-face crisis support services;

Describe how the MHRS provider will interact and coordinate services with the Department-designated crisis and emergency service; and

Include procedures for triaging consumers who require Crisis/Emergency services or psychiatric hospitalization.

3413.16 Each MHRS provider shall establish and adhere to policies and procedures for clinical record documentation, security, and confidentiality of consumer and family information; clinical records retention, maintenance, purging and destruction; disclosure of consumer and family information; and informed consent that comply with applicable Federal and District laws and regulations (“Clinical Records Policy”). The Clinical Records Policy shall:

Require the MHRS provider to maintain all clinical records in a secured and locked storage area;

Providers shall utilize an Electronic Health Record (EHR) system certified by the Department of Health and Human Services Office of the National Coordinator for Health Information Technology to document all phases of the individual’s treatment and care.

Require the MHRS provider to maintain all clinical records for a period of ten (10) years;

Require the MHRS provider to maintain and secure a current, clear, organized, and comprehensive clinical record for every individual assessed, treated, or served that includes information deemed necessary to provide treatment, protect the MHRS provider, and comply with applicable Federal and District laws and regulations; and

Require that the clinical record contain information to identify the consumer, support the diagnosis, justify the treatment, document the course and results of treatment, and facilitate continuity of care. The clinical record shall include, at a minimum:

Consumer identification information, including enrollment information;

Identification of a person to be contacted in the event of emergency;

Basic screening and intake information;

Documentation of internal or external referrals;

Comprehensive diagnostic and psychosocial assessments;

Pertinent medical information including the name, address, and telephone number of the consumer's primary care physician;

Advance instructions and advance directives;

The Plan of Care;

For children and youth, documentation of family or legal guardian involvement in treatment planning and services or statement of reasons why it is not clinically indicated;

Methods for addressing consumers’ and families’ special needs, especially those which relate to communication, cultural, linguistic, and social factors;

Detailed description of services provided;

Progress notes;

Discharge planning information;

Appropriate consents for service;

Appropriate release of information forms; and

Signed Consumer Rights Statement.

Electronic records shall include a log function that dates, times, and authenticates each entry, access, and change to a record.

3413.17 Each MHRS provider shall execute a participation agreement with the District’s Health Information Exchange (HIE) and utilize the HIE to receive and transmit protected health information for consumers in accordance with the District of Columbia Mental Health Information Act of 1978, effective Mar. 3, 1979 (D.C. Law 2-136, D.C. Official Code § 7-1201.01 et seq.).

3413.18 Each MHRS provider shall comply with the Department’s policy on supervision, including requirements for the documentation of supervision.

3413.19 Each MHRS provider shall enter encounter notes into the clinical record with sufficient written clinical documentation to support each therapy, service, activity, or session for which billing is made which, at a minimum, consists of:

A dated, timed, and authenticated entry, entered by the person providing the service, which shall include the typed or legibly printed name of the author. The provider shall ensure all entries are authenticated by a process that verifies the author’s identity (e.g., a unique log-in used only by the author);

The date and duration [actual time, a.m. or p.m. (beginning and ending)] during which the services were rendered;

The legal name, title, credentials, and signature of the person providing the services;

The setting in which the services were rendered;

The consumer’s diagnosis and clinical impression recorded in the terminology of the ICD-10 CM (or any subsequent version adopted by the Department pursuant to written notice published in the District of Columbia Register);

Confirmation that the services delivered are contained in the consumer’s Plan of Care;

A description of each service by a qualified practitioner or credentialed staff with the consumer that is sufficient to document that the service was provided in accordance with this chapter;

A description of the consumer’s response to the service that is sufficient to show, particularly in the case of group interventions, the consumer’s unique participation in the service; and

An easily accessible log identifying a complete history for each entry, including when the record was created, signed, and the time and dates of any subsequent access and amendments.

3413.20 Each MHRS provider shall ensure that all clinical records of consumers are completed promptly, filed, and retained in accordance with the MHRS provider’s Clinical Records Policy.

3413.21 All CSA, ACT, and CBI providers shall operate an on-call system for enrolled consumers that is available twenty-four (24) hours a day, seven (7) days a week. Providers shall make the following services available five (5) days per week from 9:00 am to 6:00 pm, in the evening by appointment, and at least once a month on a Saturday for four (4) hours: Diagnostic Assessment, Medication/Somatic treatment, Counseling, and Community Support.

3413.22 Providers who deliver the following specialty services shall make their services available as follows:

MHRS SPECIALTY SERVICE

HOURS OF OPERATION

OTHER AVAILABILITY REQUIREMENTS

Rehabilitation Day Services

Thirty (30) hours per week, no less than six (6) hours per day.

Consumers authorized and referred for service shall be admitted within seven (7) business days of the referral.

Intensive Day Treatment

Seven (7) days per week, no less than five (5) hours per day.

Programs shall offer a minimum of thirty-five (35) hours of active programming per week. Consumers authorized and referred for Intensive Day Treatment shall be admitted within forty-eight (48) hours of referral.

Community Based Intervention (CBI)

Levels I, II, and III - Twenty-four (24) hours per day, seven (7) days per week.

Consumers authorized and referred for all levels of CBI shall be admitted within forty-eight (48) hours of referral.

A CBI Team member shall respond to a call from a family member or a significant other, either by telephone or face-to-face contact, within sixty (60) minutes of receiving the call.

All CBI providers shall develop a crisis intervention plan for each consumer receiving CBI.

Assertive Community

Treatment (ACT)

Twenty-four (24) hours per day, seven (7) days per week, with emergency response coverage to include psychiatric availability.

Consumers authorized and referred for ACT shall be admitted within forty-eight (48) hours of referral. At least sixty percent (60%) of ACT services shall be provided in locations other than the office, according to consumer need, preference, and clinical appropriateness. An ACT team member shall respond to a call from family or a significant other, either by telephone or face-to-face contact within sixty (60) minutes of receiving the call.

3413.23 Each MHRS provider shall establish and adhere to policies and procedures requiring the MHRS provider to make language access services available at no cost as needed for Limited or Non-English proficient consumers, (“Language Access Policy”). The Language Access Policy shall:

Document primary language information in a consumer’s clinical record at the point of entry, if known, with notations on how to engage the person in communication if unknown;

Arrange for the provision of language access services at no cost to Limited or Non-English proficient consumers;

Ensure public notices regarding language access services are posted in regularly encountered waiting rooms, reception areas, and other areas of initial contact.

Ensure that the public is aware of language interpretation services;

Provide a quarterly report on the number of enrolled consumers who receive language access services to the DBH Language Access Coordinator. The information shall include the following information:

The number of individuals who have Limited or Non-English proficiency, and the languages spoken;

The frequency with which Limited or Non-English proficient consumers come into contact with the provider;

The number and types of languages spoken by agency staff.

Provide annual training to all public access staff on how to provide ongoing language services; and

Ensure immediate notification of the DBH Language Access Coordinator when unable to meet language access needs.

3413.24 The Language Access Policy shall allow staff and contractors who do not possess valid certification from the Registry of Interpreters for the Deaf to be credentialed based on skills in mental health interpreting gained through supervised experience. For purposes of this rule, supervised experience shall include supervision by an interpreter certified by the National Registry of Interpreters for the Deaf and ongoing training in sign language interpreting, preferably related to mental health, and may include on-the-job learning prior to employment by the MHRS provider.

3413.25 Each MHRS provider shall utilize a TTY communications line (or an equivalent) to enhance the MHRS provider’s ability to respond to service requests and needs of consumers and potential consumers. MHRS provider staff shall be trained in the use of such communication devices as part of the annual language access training.

3413.26 Each MHRS provider shall establish and adhere to policies and procedures which govern the provision of services in natural settings (“Natural Settings Policy”). The Natural Settings Policy shall require the MHRS provider to document how it respects consumers’ and families’ rights to privacy and confidentiality when services are provided in natural settings.

3413.27 Each MHRS provider shall establish and adhere to anti-discrimination policies and procedures relative to hiring, promotion, and provision of services to consumers that comply with applicable Federal and District laws and regulations (“Anti-Discrimination Policy”).

3413.28 Each MHRS provider shall establish a quality improvement program (“QI program”) and adhere to policies and procedures governing quality improvement (“Quality Improvement Policy”). The Quality Improvement Policy shall require the MHRS provider to adopt a written Quality Improvement (“QI”) plan describing the objectives and scope of its QI program and requiring MHRS provider staff, consumer, and family involvement in the QI program. The Department shall review and approve each MHRS provider’s QI program at a minimum as part of the certification process. The QI program shall submit data to the Department, upon request. The QI program shall be:

Directed by a coordinator (“QI Coordinator”) who has direct access to the Chief Executive Officer or Program Director, if applicable. In addition to directing the QI program’s activities, the QI Coordinator shall also review unusual incidents, deaths, and other sentinel events; monitor and review utilization patterns; and track consumer complaints and grievances. The QI Coordinator shall be:

An individual licensed as one of the following practitioner types: Psychiatrist, Psychologist, Licensed Independent Clinical Social Worker (“LICSW”), Advanced Practice Registered Nurse (“APRN”), Licensed Professional Counselor (“LPC”), Licensed Marriage and Family Therapist (“LMFT”), Registered Nurse (“RN”), Licensed Independent Social Worker (“LISW”), Licensed Graduate Professional Counselors (“LGPC”), Licensed Graduate Social Worker (“LGSW”), or Physician Assistant; or registered as a Psychology Associate; or

An individual with a Bachelors’ Degree and a minimum of two (2) years of relevant, qualifying experience, such as experience in behavioral health care delivery or health care quality improvement initiatives.

The QI program shall measure and ensure at least the following:

Timely access to and availability of services;

Adequacy, appropriateness, and quality of care, including treatment and prevention of acute and chronic conditions;

Close monitoring of high-volume services, consumers with high risk conditions, and services for children and youth;

Coordination of care among behavioral health treatment providers, and between behavioral health providers and primary and other specialty care providers;

Compliance with all MHRS certification standards;

Consumer and family satisfaction with services; and

Any other indicators that are part of the Department QI program for the larger system.

3413.29 Each MHRS provider shall comply with the following requirements for facilities management:

Each service site of an MHRS provider shall be an adequate and appropriate facility with:

A reception area;

Consumer interview rooms for private, confidential individual and group counseling sessions and private areas for other individual treatment services;

Appropriate space for group activities and educational programs; and

Restrooms available to consumers and their families and significant others.

All areas of the MHRS provider’s service site(s) shall be kept clean and safe, and shall be appropriately equipped and furnished for the services delivered.

In-office waiting time shall be less than one (1) hour from the scheduled appointment time. Each MHRS provider shall demonstrate that it can document the time period for in-office waiting.

Each MHRS provider shall comply with applicable provisions of the Americans with Disabilities Act in all business locations.

Each MHRS provider’s main service site shall be located within reasonable walking distance of public transportation.

Each MHRS provider shall establish and adhere to a written evacuation plan to be used in fire, natural disaster, medical emergencies, bomb threats, terrorist attacks, violence in the workplace, or other disaster events for all service sites (“Disaster Evacuation Plan”).

The Disaster Evacuation Plan shall require the MHRS provider:

(1) To conduct periodic disaster evacuation drills;

(2) Ensure that all evacuation routes are clearly marked by lighted exit signs; and

(3) Ensure that all staff participate in annual training about the Disaster Evacuation Plan and disaster response procedures.

Each MHRS provider shall obtain a written certificate of compliance from the District of Columbia Department of Fire and Emergency Medical Services indicating that all applicable fire and safety code requirements have been satisfied.

Each MHRS provider shall provide physical facilities for all service site(s) that are structurally sound and meet all applicable Federal and District laws and regulations for construction, safety, sanitation, and health.

Each MHRS provider shall establish and adhere to policies and procedures governing infection control (“Infection Control Policy”). The Infection Control Policy shall comply with applicable Federal and District laws and regulations, including, but not limited to the blood borne pathogens standard set forth in 29 CFR § 1910.1030.

Each MHRS provider shall establish and adhere to policies and procedures governing the purchase, receipt, storage, distribution, return, and destruction of medication that include accountability for and security of medications located at any of its service sites (“Medication Policy”). The Medication Policy shall comply with applicable Federal and District laws and regulations regarding the purchase, receipt, storage, distribution, dispensing, return, and destruction of medications and require the MHRS provider to maintain all medications and prescription blanks in a secured and locked area.

3413.30 Each MHRS provider shall have established by-laws or other legal documentation regulating the conduct of its internal financial affairs. This documentation shall clearly identify the individual(s) that are legally responsible for making financial decisions for the MHRS provider and the scope of such decision-making authority. Each MHRS provider shall:

(a) Maintain an accounting system that conforms to generally accepted accounting principles, provides for adequate internal controls, permits the development of an annual budget, an audit of all income received, and an audit of all expenditures disbursed by the MHRS provider in the provision of services;

(b) Have an internal process for the development of interim and annual financial statements that compares actual income and expenditures with budgeted amounts, accounts receivable, and accounts payable information; and

3413.31 Each MHRS provider shall establish and adhere to policies and procedures governing the retention, maintenance, purging and destruction of its business records (“Records Retention Policy”). The Records Retention Policy shall:

(a) Comply with applicable Federal and District laws and regulations;

(b) Require the MHRS provider to maintain all business records pertaining to costs, payments received and made, and services provided to consumers for a period of ten (10) years or until all audits are completed, whichever is longer; and

(c) Require the MHRS provider to allow the Department, DHCF, the District’s Inspector General, the United States Department of Health and Human Services, the Comptroller General of the United States, or any of their authorized representatives to review the MHRS provider’s business records, including clinical and financial records.

3413.32 Each MHRS provider shall comply with the following requirements for maintaining certification, provider status, and contracts:

(a) Maintain proof of the Department certification;

(b) Maintain an active Medicaid provider status at all times;

(d) Require that its subcontractors continuously comply with the provisions of the MHRS provider’s HCA with the Department.

3413.33 Each MHRS provider, at its expense, shall:

(a) Obtain at least the minimum insurance coverage required by its HCA; and

(b) Make evidence of its insurance coverage available to the Department upon request.

3413.34 Each MHRS provider shall establish and adhere to policies and procedures governing billing and payment for MHRS (“Billing and Payment Policy”). The Billing and Payment Policy shall require the MHRS provider to have the necessary operational capacity to submit claims, document information on services provided, and track payments received. This operational capacity shall include the ability to:

(a) Verify eligibility for Medicaid and other third-party payers;

(b) Document MHRS provided by MHRS provider staff and subcontractors;

(d) Track payments for all provided MHRS.

3413.35 Each MHRS provider shall submit claims for MHRS provided to consumers described in § 3407.2 to the Department within ninety (90) calendar days of the date of service, or thirty (30) calendar days after a secondary or third-party payer has adjudicated a claim for this service. The Department shall not pay for a claim that is submitted more than one (1) year from the date of service, except when Federal law or regulations would require such payment to be made.

3413.36 Each MHRS provider shall have an established sliding fee schedule covering each of the MHRS it provides. For services provided to Medicaid-eligible consumers, no additional charge shall be imposed for services beyond that paid by Medicaid.

3413.37 Each MHRS provider shall utilize, and require its subcontractors to utilize, payments from other public or private sources, including Medicare. Payment of the Department and Federal funds to the MHRS provider shall be conditional upon the utilization of all benefits from other payment sources.

3413.38 Each MHRS provider shall operate according to all applicable Federal and District laws and regulations relating to fraud, waste, and abuse in health care, the provision of mental health services, and the Medicaid program. An MHRS provider’s failure to report potential or suspected fraud, waste or abuse may result in sanctions, cancellation of contract, or exclusion from participation as an MHRS provider. Each MHRS provider shall:

Cooperate and assist any District or Federal agency charged with the duty of identifying, investigating, or prosecuting suspected fraud, waste or abuse;

Provide the Department with regular access to the provider’s medical and billing records, including electronic medical records, within twenty-four (24) hours of a Departmental request, or, immediately in the case of emergency;

(c) Be responsible for promptly reporting suspected fraud, waste, or abuse to the Department, taking prompt corrective actions consistent with the terms of any contract or subcontract with the Department, and cooperating with DHCF or other governmental investigations; and

(d) Ensure that none of its practitioners have been excluded from participation as a Medicaid or Medicare provider. If a practitioner is determined to be excluded by the Center for Medicare and Medicaid Services (“CMS”), the provider shall notify the Department immediately.

3413.39 Each MHRS provider shall establish and adhere to a plan for ensuring compliance with applicable Federal and District laws and regulations (“Corporate Compliance Plan”), approved by the Department. Each MHRS provider shall submit any updates or modifications to its Corporate Compliance Plan to the Department for prior review and approval. Each MHRS provider's Corporate Compliance Plan shall:

(a) Designate an officer or director with responsibility and authority to implement and oversee the operation of the Corporate Compliance Plan;

(b) Require that all officers, directors, managers, and employees sign a statement that they understand the Corporate Compliance Plan;

(c) Include procedures designed to prevent and detect potential or suspected fraud, waste, or abuse in the administration and delivery of MHRS;

(d) Include procedures for the confidential reporting of violations of the Corporate Compliance Plan to the Department, including procedures for the investigation and follow-up of any reported violations;

(e) Ensure that the identities of individuals reporting suspected violations of the Corporate Compliance Plan are protected and that individuals reporting suspected violations, fraud, waste, or abuse are not retaliated against;

(f) Require that confirmed violations of the Corporate Compliance Plan be reported to the Department within twenty-four (24) hours of confirmation; and

(g) Require any confirmed or suspected fraud, waste, or abuse under state or Federal laws or regulations be reported to the Department.

3413.40 Each MHRS provider shall ensure that sufficient resources (e.g., personnel, hardware, or software) are available to support the operations of computerized systems for collection, analysis, and reporting of information, along with claims submission.

3413.41 Each MHRS provider shall have the capability to submit accurate claims, encounter data, and other submissions as necessary directly to the Department.

3413.42 Claims for MHRS provided to consumers described in § 3407.2 shall be submitted using the format required by the Department.

3413.43 Each MHRS provider shall manage protected health information in compliance with the confidentiality requirements contained in applicable Federal and District laws and regulations, including Health Insurance Portability and Accountability Act (HIPAA) and the D.C. Mental Health Information Act. The provider shall develop and implement policies and procedures to disclose protected behavioral health information to other certified providers, primary health care providers, and other health care organizations when necessary to coordinate the care and treatment of its consumers. These procedures shall include entering into an agreement with the District HIE, unless exempted pursuant to § 3402.1. The program shall advise each consumer of the program’s notice of privacy practices that authorizes the disclosure to other providers and shall afford the consumer the opportunity to opt-out of that disclosure in accord with the District of Columbia Mental Health Information Act, D.C. Official Code § 7-1203.01. The program shall document the individual’s decision.

3413.44 Each MHRS provider shall establish and adhere to a plan that contains policies and procedures for maintaining the security of data and information (“Disaster Recovery Plan”). Each MHRS provider’s Disaster Recovery Plan shall also stipulate back-up and redundant systems and measures that are designed to prevent the loss of data and information and to enable the recovery of data and information lost due to disastrous events.

3413.45 All providers shall electronically transmit Behavioral Health Supplemental Data (BHSD) to the Department in a form and manner as prescribed by the Department. BHSD is a compilation of individual-level behavioral health data defined in the Department’s Integrated Technology Engine (ITE) Provider Companion Guide (available at https://dbh.dc.gov/).

3413.46 Providers shall timely transmit BHSD pursuant to the procedure established in the ITE through the EHR system.

3413.47 The Department shall provide notice of any future updates to the ITE Guide through https://dbh.dc.gov/.

History

SOURCE: Final Rulemaking published at 48 DCR 10297 (November 9, 2001); as amended by Final Rulemaking published at 51 DCR 9308 (October 1, 2004); as amended by Final Rulemaking published at 52 DCR 5682 (June 17, 2005); as amended by Notice of Final Rulemaking published at 58 DCR 8366, 8369 (September 30, 2011); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021); as amended by Final Rulemaking published at 70 DCR 003050 (March 10, 2023); as corrected by Errata Notice published at 71 DCR 004474 (April 19, 2024); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3413

22-A DCMR § 3414 CORE SERVICES AGENCY REQUIREMENTS

3414.1 Each CSA shall comply with the certification standards described in § 3413, the service specific standards applicable to core services, and the certification standards set forth in this section, as well as the other certification standards in this chapter.

3414.2 Each CSA shall:

(a) Serve as the clinical home for the consumers it enrolls;

(b) Be responsible for ensuring that Plans of Care are developed and approved for its enrolled consumers; and

3414.3 Each CSA shall satisfy the following minimum staffing requirements:

(a) A Chief Executive Officer with professional qualifications and experience who meets the requirements established by the MHRS provider’s governing authority. The Chief Executive Officer shall be charged with responsibility for day-to-day management of the CSA, and shall be a full-time employee devoting at least twenty (20) hours a week to administrative and management functions of the CSA;

(b) A Medical Director who is a board-eligible psychiatrist, responsible for the quality of medical and psychiatric care provided by the MHRS provider. A child and youth-serving CSA may have a staff or consulting board-eligible child psychiatrist or a staff board-eligible psychiatrist with substantial child and adolescent experience as its Medical Director;

(c) A full-time Clinical Director who is an independently licensed qualified practitioner with an appropriate, relevant behavioral health advanced degree, with overall responsibility for oversight of the clinical program of the MHRS provider. The Clinical Director may also serve as the Medical Director if the Clinical Director is a board-eligible psychiatrist;

(d) A Controller, Chief Financial Officer, or designated individual responsible for executing or overseeing the financial operations of the MHRS provider. The designated financial officer shall have a Bachelors’ Degree plus two (2) years of fiscal experience and may also oversee administrative operations and information services;

(e) A medical records administrator responsible for the following:

(1) Ongoing quality control of clinical documentation;

(2) Assuring that clinical records are maintained, completed, and preserved in accordance with the MHRS provider’s Clinical Records Policy;

(3) Assuring that information on enrolled consumers is immediately retrievable; and

(4) Establishing a central records index for the MHRS provider.

3414.4 The CSA shall have an annual audit by an independent certified public accountant or a certified public accounting firm in accordance with generally accepted auditing standards. The resulting financial audit report shall be consistent with formats recommended by the American Institute of Public Accountants. The CSA shall submit a copy of the financial audit report to the Department within one hundred and twenty (120) calendar days after the end of the provider’s fiscal year.

3414.5 Each CSA shall comply with the following requirements regarding clinical operations:

The CSA shall accommodate consumer preferences and needs with respect to primary staff and team representation.

The consumer and the assigned CSA staff shall be responsible for the development and periodic review of the consumer’s Plan of Care and for the coordination the delivery of all MHRS received by the consumer.

(c) The signing independently licensed qualified practitioner shall be primarily responsible for assuring that the Plan of Care assists the consumer in developing self-care skills and achieving recovery.

(d) Each CSA shall establish and adhere to policies and procedures governing its relationship with subcontractors (“Subcontractor Policy”) in compliance with Federal and District laws and regulations. The Subcontractor Policy shall address, at a minimum, access to records, clinical responsibility and supervision, legal liability, and insurance and dispute resolution.

(e) Each CSA shall establish and adhere to policies and procedures governing the means by which family education and support will be offered and provided (“Consumer and Family Education Policy”). The Consumer and Family Education Policy shall require, at a minimum, the following:

(1) The CSA shall make family education and support available for all consumer families;

(2) Family education and support shall include general information about mental health and psychiatric illness;

(3) For adult consumers, a provider shall only disclose information about a consumer with the consent of the consumer. In the case of child, the provider shall only disclose information about a consumer with the consent of the parent or guardian in accordance with the CSA’s Release of Consumer Information Policy;

(4) The availability of appointments for family members to meet with staff and availability of family support and education groups to be scheduled at times convenient for the family; and

(5) In written materials and face-to-face contacts provide information about available and needed services, as well as how the consumer may access Crisis/Emergency Services. The materials shall be written at the 4th grade reading level and shall be printed in English and either Spanish or the secondary language conducive to facilitating communication with the majority of the CSA’s target population.

3414.6 Each CSA shall comply with the following requirements regarding service accessibility:

(a) Each CSA shall operate an on-call system for its enrolled consumers twenty-four (24) hours per day, seven (7) days per week, to respond to urgent, emergency, and routine situations (“CSA On-Call System”).

(b) Each CSA shall establish and adhere to policies and procedures governing the operation of its On-Call System (“On-Call System Policy”). The On-Call System Policy shall require the CSA to provide:

(1) Telephone access to an independently licensed qualified practitioner for consumers and their significant others to resolve problems telephonically, when possible;

(2) Timely access to an independently licensed qualified practitioner in order to provide any needed crisis support services, to include face-to-face interventions; and

(3) Linkage to Crisis/Emergency Services, including crisis stabilization services and “next day” appointments to assist the consumer to address urgent problems during the next business day.

(c) Each CSA shall, at a minimum, offer the core services as specified in § 3417.2. A CSA shall provide at least one (1) core service directly and may provide up to five (5) core services via contract with a sub-provider or subcontractor. A CSA may provide specialty services directly if certified by the Department as a specialty provider.

(d) Each CSA shall ensure that its business hours comply with the requirements of § 3413.21 and facilitate each enrolled consumer’s ability to choose an MHRS provider.

(e) Each CSA shall provide a consumer presenting with an urgent need with an independently licensed qualified practitioner for an intervention which may include face-to-face contact on the same day that the consumer presents for service.

(f) Each potential consumer presenting with a routine need shall be provided an intake appointment by a CSA within seven (7) business days of presentation for service.

(g) Each CSA shall have policies and procedures for the provision of outreach services, including means by which these services and individuals will be targeted (“Outreach Policy”). The Outreach Policy shall include procedures for protecting the safety of staff who engage in outreach activities.

(h) Each CSA shall educate consumers on EBPs and document consumers’ receipt of this information.

3414.7 Each CSA shall comply with the requirements for assessment and referral for Mental Health Supported Employment services and integration of Employment Specialists into the CSA’s treatment team, in accordance with the requirements set forth in 22-A DCMR Chapter 37.

3414.8 Each CSA shall make a play area available for children in the waiting room area.

3414.9 Each CSA shall be responsible for submitting enrolled consumers’ clinical information to the Department upon request to receive and maintain authorization for medically necessary services.

3414.10 The Department shall review and approve each CSA’s Subcontractor Policy, Consumer and Family Education Policy, On-Call System Policy, Outreach Policy, Quality Improvement Policy, and Evidence-Based Practices Information Policy as part of the certification process.

3414.11 All MHRS providers certified for ACT, CPP, FFT, Multisystemic Therapy (MST), CBI Level II and III, TF-CBT, and TST shall obtain the Department’s approval to add teams supported through a Human Care Agreement. Providers shall submit a written request which must include the staffing patterns, including supervisors, training plan and/or dates, staff-to-consumer ratio, and new capacity for the entire team including the new addition.

3414.12 All MHRS providers shall obtain a National Provider Identification (NPI) number for itself and all personnel performing MHRS services through the provider. All providers shall register itself and all personnel performing MHRS services with the Department of Health Care Finance’s designated information system prior to billing for services.

History

SOURCE: Final Rulemaking published at 48 DCR 10297 (November 9, 2001); as amended by Final Rulemaking published at 51 DCR 9308 (October 1, 2004); as amended by Final Rulemaking published at 52 DCR 5682 (June 17, 2005); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020); as amended by Final Rulemaking published at 69 DCR 013495 (November 4, 2022); as amended by Final Rulemaking published at 70 DCR 003050 (March 10, 2023); as corrected by Errata Notice published at 71 DCR 004474 (April 19, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3414

22-A DCMR § 3415 SUB-PROVIDER AND SPECIALTY PROVIDER REQUIREMENTS

3415.1 Each sub-provider and specialty provider shall comply with the certification standards described in § 3413, the service specific standards applicable to the MHRS offered by the sub-provider or specialty provider, and the other certification standards in this chapter.

3415.2 Each sub-provider and specialty provider shall establish and adhere to policies and procedures (“CSA Referral Policy”) governing its relationship with a CSA that address access to records, clinical responsibilities, legal liability, dispute resolution, and all other MHRS certification standards.

3415.3 Sub-providers shall provide one (1) or more of the core services only through a written agreement with a CSA. Sub-providers shall ensure consumers are enrolled with a CSA.

3415.4 Except for the provision of ACT, CBI, or Clubhouse services, specialty providers shall ensure consumers are enrolled with a CSA.

3415.5 Each specialty provider shall screen and assess consumers for EBP as appropriate and applicable, and shall refer them to services as necessary. Each specialty provider shall have an Evidence-Based Practices Information Policy, which includes how providers shall:

Screen and document screening consumers for EBP;

Describe the process of referring and linking consumers to another provider using a warm handoff, if the specialty provider does not render the appropriate EBP; and

Collaborate with the CSA to ensure there are periodic assessments for the need for EBP.

3415.6 Each sub-provider and specialty provider shall satisfy the following minimum staffing requirements:

A Chief Executive Officer or Program Director with professional qualifications and experience who shall meet requirements as established by the MHRS provider’s governing authority and is responsible for day-to-day management of the MHRS provider;

A sub-provider or specialty provider who provides Rehabilitation Day services shall also have a Consulting Psychiatrist who is a board-eligible psychiatrist and advises the sub-provider or specialty provider on the quality of medical and psychiatric care provided;

A Clinical Director who is an independently licensed qualified practitioner with overall responsibility for oversight of the clinical program of the sub-provider or specialty provider. If not full-time, the Clinical Director must dedicate sufficient time to execute the duties of the position;

Each sub-provider who provides either Diagnostic Assessment or Medication/Somatic Treatment shall demonstrate adequate oversight of quality of medical and psychiatric care by employing or contracting with a Medical Director or arranging for the Medical Director of the consumer’s CSA to provide such oversight; and

The required staff listed in this subsection shall be either employees of the sub-provider or specialty provider or under contract to the sub-provider or specialty provider for an amount of time sufficient to carry out the duties assigned.

3415.7 Each sub-provider and specialty provider shall establish and adhere to policies and procedures governing its collaboration with a referring CSA in the development, implementation, evaluation, and revision of each consumer’s Plan of Care, that comply with the Department rules (Collaboration Policy). The Collaboration Policy shall:

Be a part of each sub-provider and specialty provider’s Treatment Planning Policy;

Require sub-providers and specialty providers to incorporate CSA-developed Diagnostic Assessment material into the sub-provider and specialty provider’s treatment planning process, including the use of EBP as an intervention; and

Require sub-providers and specialty providers to coordinate the consumer’s treatment with the consumer’s CSA assigned staff.

3415.8 Each sub-provider shall offer core services in accordance with requirements in § 3413.21. At a minimum, the sub-provider shall offer services during these hours at its primary service site.

3415.9 At a minimum, each specialty provider shall offer access to specialty services in accordance with requirements in § 3413.22.

3415.10 Each sub-provider and specialty provider with total annual revenues at or exceeding three hundred thousand dollars ($300,000.00) shall have an annual audit by an independent certified public accountant or certified public accounting firm in accordance with generally accepted auditing standards. The resulting financial audit report shall be consistent with formats recommended by the American Institute of Public Accountants. Each sub-provider and specialty provider shall submit a copy of the financial audit report to the Department within one hundred and twenty (120) calendar days after the end of its fiscal year.

3415.11 Each sub-provider and specialty provider with total annual revenues less than three hundred thousand dollars ($300,000.00) shall submit financial statements reviewed by an independent certified public accountant or certified public accounting firm within one hundred twenty (120) calendar days after the end of its fiscal year.

3415.12 Each sub-provider and specialty provider shall only provide MHRS to consumers as specified in the consumers’ Plans of Care as designated by the consumers’ CSA.

3415.13 The Department shall review and approve the CSA Referral Policy, Collaboration Policy, and the Evidence-Based Programs Information Policy during the certification process.

History

SOURCE: Final Rulemaking published at 48 DCR 10297 (November 9, 2001); as amended by Final Rulemaking published at 51 DCR 9308 (October 1, 2004); as amended by Final Rulemaking published at 52 DCR 5682 (June 17, 2005); as amended by Notice of Final Rulemaking published at 58 DCR 8366, 8369 (September 30, 2011); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3415

22-A DCMR § 3416 QUALIFIED PRACTITIONERS AND CREDENTIALED STAFF

3416.1 Qualified practitioners and credentialed staff are permitted to provide Mental Health Rehabilitation Services (MHRS) or components of MHRS, as identified in this section, in accordance with; the applicable service specific standards set forth in this chapter.

3416.2 Qualified practitioners are behavioral health clinicians appropriately licensed, certified, or registered in the District by the Department of Health or the jurisdiction where services are delivered. A qualified practitioner shall only render those MHRS or components of MHRS that are consistent with the scope of the qualified practitioner’s license, certification, or registration. Applicable laws and regulations dictate whether and to what extent a qualified practitioner:

Is subject to supervision requirements when providing MHRS; and

May supervise other qualified practitioners or credentialed staff in the provision of MHRS.

3416.3 Credentialed staff are non-licensed staff or staff who are not qualified practitioners who are permitted to render MHRS or components of MHRS only if under the supervision of and with guidance from an appropriate qualified practitioner in accordance with applicable laws and regulations. Credentialed staff shall only render MHRS or components of MHRS that do not require a license, certification, or registration by the Department of Health or the jurisdiction in which services are delivered.

3416.4 For the purposes of this chapter:

A psychiatrist shall be a:

Licensed physician who is at a minimum a board-eligible psychiatrist;

Psychiatric resident providing care in an approved clinical rotation; or

Moonlighting psychiatric resident.

An Advanced Practice Registered Nurse (APRN) shall have psychiatry as a specialty area of practice; and

A Physician Assistant (PA) shall have a written delegation agreement with a supervising physician who is a psychiatrist.

3416.5 A psychiatric resident is a medical school graduate from a program that meets the standards for medical education found in 17 DCMR § 4602, and who:

Has completed at least one year of a psychiatric residency program that satisfies the requirements of 17 DCMR § 4611.4;

Is supervised by a licensed psychiatrist who satisfies the requirements of 17 DCMR § 4611.4; and

Complies with the standards of conduct for licensed physicians found in 17 DCMR § 4612.

3416.6 A moonlighting psychiatric resident is a medical school graduate who:

(a) Satisfies all of the requirements of § 3416.5; and

(b) Is working under the supervision of the Medical Director or Consulting Psychiatrist of a certified MHRS provider in accordance with protocols approved by the Department's Chief Clinical Officer.

History

SOURCE: Final Rulemaking published at 48 DCR 10297 (November 9, 2001); as amended by Final Rulemaking published at 51 DCR 9308 (October 1, 2004); as amended by Final Rulemaking published at 52 DCR 5682 (June 17, 2005); as amended by Notice of Emergency and Proposed Rulemaking published at 58 DCR 1482 (February 18, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 3476, 3478 (April 22, 2011); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3416

22-A DCMR § 3417 COVERED MENTAL HEALTH REHABILITATION SERVICES

3417.1 The service specific standards described in this section apply to the individual MHRS offered by each MHRS provider and reimbursed by the District in accordance with this chapter.

3417.2 Covered core services shall be Diagnostic Assessment, Medication/Somatic Treatment, Counseling, Community Support, Crisis/Emergency Services, and Clinical Care Coordination.

3417.3 Covered specialty services shall be Rehabilitation Day Services, Intensive Day Treatment (IDT), Community Based Intervention (CBI), Assertive Community Treatment (ACT), Psychosocial Rehabilitation Clubhouse (Clubhouse), Child Parent Psychotherapy (CPP), Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), Trauma Recovery and Empowerment Model (TREM), Trauma Systems Therapy (TST), Functional Family Therapy (FFT) and ICC.

History

SOURCE: Final Rulemaking published at 48 DCR 10297 (November 9, 2001); as amended by Final Rulemaking published at 51 DCR 9308 (October 1, 2004); as amended by Final Rulemaking published at 52 DCR 5682 (June 17, 2005); as amended by Final Rulemaking published at 60 DCR 12909 (September 13, 2013); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020); as amended by Final Rulemaking published at 70 DCR 003050 (March 10, 2023); as corrected by Errata Notice published at 71 DCR 004474 (April 19, 2024); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3417

22-A DCMR § 3418 DIAGNOSTIC ASSESSMENT

3418.1 A Diagnostic Assessment is an intensive clinical and functional evaluation of a consumer’s mental health condition that results in the issuance of a Diagnostic Assessment report, including a clinical formulation, with recommendations for service delivery that provides the basis for and includes the development of a Plan of Care. A psychiatrist shall supervise and coordinate all psychiatric and medical functions required by a consumer’s Diagnostic Assessment.

3418.2 A Diagnostic Assessment shall:

Determine whether the consumer is appropriate for and can benefit from MHRS based upon the consumer’s diagnosis, presenting problems, and recovery goals;

Evaluate the consumer’s level of readiness and motivation to engage in treatment;

Include the development of a Plan of Care; and

(d) Screen and assess consumers for EBP and Mental Health Supported Employment services as appropriate and applicable.

3418.3 An initial Diagnostic Assessment shall be performed by an independently licensed qualified practitioner for each consumer being considered for enrollment with a CSA.

3418.4 The Diagnostic Assessment shall include the following elements:

A chronological behavioral health history of the consumer’s symptoms, treatment, treatment response, and attitudes about treatment and recovery, emphasizing factors that have contributed to or inhibited previous recovery efforts;

For youth and adults, the chronological behavioral health history shall include both psychiatric history and substance use disorder history, treatment history for either or both diagnoses, and the consumer’s perception of the outcome;

Biological, psychological, familial, social, and environmental dimensions, and identified strengths and weaknesses in each area;

A description of the presenting problem(s), including source of distress, precipitating events, associated problems or symptoms, and recent progression;

Both a strengths summary and a problem summary, which address the following:

Risk of harm;

Functional status, including relevant emotional and behavioral conditions or complications, and self-control, self-care and interpersonal abilities, coping, and independent living skills;

Co-morbidity, including biomedical conditions and complications;

Recovery environment, including supports and stressors; and

Treatment and recovery history, including relapse potential.

Diagnoses in the DSM-5 or any subsequent version adopted by the Department pursuant to written notice published in the District of Columbia Register;

A review of the consumer’s substance use history and presenting problem(s), including an assessment of substances used and intensity of use, the likelihood and severity of withdrawal, and the medical and behavioral risks secondary to intoxication. This review shall identify or exclude substance use disorder as a co-occurring treatment need;

Assessment of the need for psychiatric hospitalization for consumers referred to psychiatric inpatient services to assure that less restrictive alternatives are considered and used when appropriate; and

Evidence of consumer participation and including families’ or guardians’ participation if appropriate.

3418.5 The Diagnostic Assessment may include psychological testing.

3418.6 Following the completion of the Diagnostic Assessment, an interpretative clinical summary of findings and recommendations for treatment shall be listed in a Diagnostic Assessment report. A Diagnostic Assessment report shall identify barriers to be addressed during treatment and recovery to reduce or eliminate identified deficits.

3418.7 The independently licensed qualified practitioner that performed the Diagnostic Assessment shall complete the Diagnostic Assessment report no later than ten (10) business days after completing the Diagnostic Assessment. The results of the Diagnostic Assessment shall be incorporated into the Plan of Care.

3418.8 A qualified practitioner shall convene the consumer, and the consumer’s family and significant others, if appropriate, to review the Diagnostic Assessment report and develop the Plan of Care.

3418.9 One (1) Diagnostic Assessment shall be allowable every one hundred and eighty (180) calendar days. Additional units of Diagnostic Assessment shall be allowable with prior authorization by the Department when there is a significant change in the consumer’s mental health status.

3418.10 Diagnostic Assessment shall not be billed on the same day as ACT.

3418.11 Diagnostic Assessment services shall be provided:

(a) At the MHRS provider’s service site;

(b) In natural settings, including the consumer’s home or community setting; or

3418.12 The following are qualified practitioners of Diagnostic Assessment who are permitted to screen, assess, and diagnose:

Psychiatrists;

Psychologists;

Licensed Independent Clinical Social Workers (LICSW);

APRNs;

Licensed Professional Counselor (LPC);

Licensed Marriage and Family Therapist (LMFT);

Licensed Graduate Professional Counselor (LGPC);

Licensed Graduate Social Worker (LGSW); and

PAs.

3418.13 The following are qualified practitioners permitted to provide screening and assessment services as part of a Diagnostic Assessment, but are not permitted to diagnose:

Registered Nurses (RN);

LISWs; and

Psychology Associates.

3418.14 Credentialed staff shall be permitted to provide screening services as a part of a Diagnostic Assessment under the supervision of an independently licensed qualified practitioner permitted to diagnose mental illness.

3418.15 MHRS providers shall complete a functional assessment utilizing the Department’s designated functional assessment tools for consumers within the following timelines and incorporate its findings into the Plan of Care:

At intake for adults;

For children/youth, within thirty (30) calendar days of intake or by the fourth (4th) visit, whichever comes first;

Every ninety (90) calendar days after any consumer’s initial assessment, and every ninety (90) calendar days thereafter;

Upon events that may affect any consumer’s functioning and may require a change in the consumer’s treatment plan and/or service acuity; and

For all consumers, at discharge.

History

SOURCE: Final Rulemaking published at 48 DCR 10297 (November 9, 2001); as amended by Final Rulemaking published at 51 DCR 9308 (October 1, 2004); as amended by Final Rulemaking published at 52 DCR 5682 (June 17, 2005); as amended by Emergency and Proposed Rulemaking published at 57 DCR 4010 (May 7, 2010)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 57 DCR 7734 (August 20, 2010)[EXPIRED]; as amended by Final Rulemaking published at 57 DCR 8698 (September 24, 2010); as amended by Notice of Emergency and Proposed Rulemaking published at 58 DCR 1482 (February 18, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 3476, 3479 (April 22, 2011); as amended by Final Rulemaking published at 66 DCR 5638 (May 3, 2019); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021); as amended by Final Rulemaking published at 72 DCR 008497 (August 1, 2025). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3418

22-A DCMR § 3419 MEDICATION/SOMATIC TREATMENT

3419.1 Medication/Somatic Treatment services are medical services and interventions, including physical examinations; prescription, supervision, or administration of mental-health related medications; monitoring and interpreting results of laboratory diagnostic procedures related to mental health-related medications; and medical interventions needed for effective mental health treatment provided as either an individual or group intervention.

3419.2 Medication/Somatic Treatment services include monitoring the side effects and interactions of a consumer’s medications and the adverse reactions which a consumer may experience and providing restorative information and direction for symptom and medication self-management.

3419.3 Group Medication/Somatic Treatment services shall be therapeutic, educational, and interactive with a strong emphasis on group member selection. These services shall facilitate therapeutic peer interaction and support as specified in the Plan of Care.

3419.4 Each Medication/Somatic Treatment provider shall offer:

A comprehensive psycho-educational program for consumers and families, as appropriate, regarding the consumer’s mental illness, emotional disturbance, or behavior disorder; treatment and recovery goals; potential benefits and risk of treatment; and self-monitoring aids; and

Consumer/family groups for restorative information, support, and enhancement of the therapeutic alliance between the consumer and the MHRS provider.

3419.5 Consumers receiving Medication/Somatic Treatment shall participate in a psychoeducational session to discuss medication side effects, adverse reactions to medications, and medication self-monitoring and management.

3419.6 Medication/Somatic Treatment shall be provided with no annual limits on services.

3419.7 Medication/Somatic Treatment shall not be billed on the same day as:

ACT; or

IDT.

3419.8 Medication/Somatic Treatment shall be provided:

At the MHRS provider’s service site;

By telemedicine pursuant to 29 DCMR § 910;

In natural settings, including the consumer’s home or community setting; or

A residential facility of sixteen (16) beds or less unless otherwise stated by the Department.

3419.9 The following are qualified practitioners of Medication/Somatic Treatment:

Psychiatrists; and

Advanced Practice Registered Nurses (APRNs).

3419.10 The following may deliver evaluation and management service under the direction of a Qualified Practitioner pursuant to § 3419.9:

Physician Assistants (PAs).

Registered Nurses (RNs); or

Licensed Practical Nurses (LPNs).

History

SOURCE: Final Rulemaking published at 48 DCR 10297 (November 9, 2001); as amended by Final Rulemaking published at 51 DCR 9308 (October 1, 2004); as amended by Final Rulemaking published at 52 DCR 5682 (June 17, 2005); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021); as amended by Final Rulemaking published at 70 DCR 003050 (March 10, 2023); as corrected by Errata Notice published at 71 DCR 004474 (April 19, 2024); as amended by Final Rulemaking published at 72 DCR 008497 (August 1, 2025). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3419

22-A DCMR § 3420 COUNSELING

3420.1 Counseling services are individual, group, or family face-to-face services for symptom and behavior management; development, restoration, or enhancement of adaptive behaviors and skills; and enhancement or maintenance of daily living skills. Adaptive behaviors and skills, and daily living skills include those skills necessary to access community resources and support systems, interpersonal skills, and restoration or enhancement of the family unit and/or support of the family. Mental health support and consultation services provided to consumer’s families are reimbursable only when such services and supports are directed exclusively to the well-being and benefit of the consumer.

3420.2 No annual limit on units of service shall apply to the provision of counseling services.

3420.3 3420.3 Counseling shall not be billed:

On the same day as:

IDT;

CBI;

ACT;

TF-CBT;

TST; or

During a Rehabilitation Day Services encounter.

3420.4 Counseling shall be provided:

At the MHRS provider’s service site;

By telemedicine pursuant to 29 DCMR § 910;

In natural settings, including the consumer’s home or community setting; or

A residential facility of sixteen (16) beds or less unless otherwise stated by the Department.

3420.5 The following are qualified practitioners of Counseling:

Psychiatrists;

Psychologists;

Licensed Independent Clinical Social Workers (LICSWs);

APRNs;

Licensed Professional Counselors (LPCs); and

Licensed Marriage and Family Therapists (LMFTs).

3420.6 The following may deliver Counseling under the supervision of a Qualified Practitioner pursuant to § 3420.5:

Licensed Independent Social Workers (LISWs);

Licensed Graduate Social Workers (LGSWs);

Licensed Graduate Professional Counselors (LGPCs); and

Psychology Associates.

History

SOURCE: Final Rulemaking published at 48 DCR 10297 (November 9, 2001); as amended by Final Rulemaking published at 51 DCR 9308 (October 1, 2004); as amended by Final Rulemaking published at 52 DCR 5682 (June 17, 2005); as amended by Notice of Emergency and Proposed Rulemaking published at 58 DCR 1482 (February 18, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 3476, 3479 (April 22, 2011); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021); as amended by Final Rulemaking published at 72 DCR 008497 (August 1, 2025). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3420

22-A DCMR § 3421 COMMUNITY SUPPORT

3421.1 Community Support services are rehabilitation and environmental supports considered essential to assist the consumer in achieving rehabilitation and recovery goals that focus on building and maintaining a therapeutic relationship with the consumer.

3421.2 Community Support services include but are not limited to:

Participation in the development and implementation of a consumer’s Plan of Care;

Assistance and support for the consumer in stressor situations;

Mental health education, support, and consultation to consumers’ families and support systems directed exclusively to the well-being and benefit of the consumer;

Individual mental health intervention for the development of interpersonal and community coping skills, including adapting to home, school, and work environments;

Assistance to the consumer in symptom self-monitoring and self-management to identify and minimize the negative effects of psychiatric symptoms, which interfere with the consumer’s daily living, financial management, personal development, or school or work performance;

Assistance to the consumer in increasing social support skills and networks that ameliorate life stresses resulting from the consumer’s mental illness or emotional disturbance and which are necessary to enable and maintain the consumer's independent living;

Development of strategies and supportive mental health intervention to avoid out-of-home placement for adults, children, and youth and to build stronger family support skills and knowledge of the adult’s, child’s, or youth’s strengths and limitations;

Development of mental health relapse prevention strategies and plans; and

Assistance with coordination of any substance use disorders, co-occurring disorders, and primary care needs.

3421.3 Community Support services may be provided by a team of staff that is responsible for an assigned group of consumers, or by staff who are individually responsible for assigned consumers.

3421.4 The Community Support provider shall maintain a staff-to-consumer ratio of no less than one (1) staff person for every twenty (20) consumers for children and youth, and one (1) staff person for every forty (40) consumers for adults.

3421.5 Community Support services provided to children and youth shall include coordination with family and significant others and with other systems of care, such as education, managed health plans (including Medicaid managed care plans), juvenile justice, and children’s protective services, when appropriate to treatment and recovery needs.

Authorization limits for Community Support services shall be as follows:

Community Support services shall require prior authorization.

The District shall reimburse no more than six (6) units of Community Support services per day.

The number of units a consumer may receive per one hundred and eighty (180) calendar day period shall be as follows:

DLA-20 Score

CAFAS/PECFAS Score

Number of Allowable Units

Number of Allowable Supplemental Units

1.0-3.0

120+

3.1-4.0

80-110

200

4.1-5.0

50-70

100

5.1+

0-40

3421.7 Community Support shall not be billed on the same day as ACT.

3421.8 Individual Community Support shall not be billed during a Rehabilitation Day Services encounter.

3421.9 Group Community Support shall not be billed on the same day as Rehabilitation Day Services.

3421.10 Community Support services shall be provided:

(a) At the MHRS provider’s service site;

(b) In natural settings, including the consumer’s home or community settings;

(c) In a residential facility of sixteen (16) beds or fewer unless otherwise authorized by the Department pursuant to the Department’s billing manual; or

(d) Via audio-only or audio-visual telemedicine pursuant to Title 29 DCMR § 910. Audio-only Community Support telemedicine services are limited to six (6) units per one hundred eighty (180) day period, unless otherwise authorized by the Department pursuant to the Department’s billing manual. Notwithstanding the foregoing sentence, providers may bill up to an additional twenty (20) audio-only Community Support telemedicine units per consumer per one hundred eighty (180) day period for collateral contacts.

3421.11 Subsections 3421.3 through 3421.9 shall not apply to Therapeutic Supported Employment services, as defined in 22-A DCMR Chapter 37, which are provided as Community Support services. Therapeutic Supported Employment services are reimbursed pursuant to any applicable authorization requirements and billing limitations set forth in 22-A DCMR Chapter 37.

3421.12 The following are qualified practitioners of Community Support:

Psychiatrists;

Psychologists;

LICSWs;

APRNs;

LISWs;

LPCs;

RNs;

LMFTs;

LGSWs;

LGPCs;

Psychology Associates; and

PAs.

3421.13 Credentialed staff shall be permitted to provide Community Support under the supervision of an independently licensed qualified practitioner.

3421.14 To qualify for Community Support services, a consumer shall meet the following clinical necessity criteria, as determined by an independently licensed qualified practitioner pursuant to § 3418:

A Diagnostic Assessment of the consumer has been performed within twelve (12) months of the request for Community Support services that contains at least one (1) of the following primary diagnoses:

Schizophrenia Spectrum, Delusional, or Other Psychotic Disorders;

Affective (Mood) Disorders;

Trauma and Stressor Related Disorders;

Obsessive-Compulsive and Related Disorders;

Personality Disorders; or

Anxiety-Related Disorders;

(b) A functional assessment of the consumer has been performed within one hundred and eighty (180) calendar days before the request for Community Support services that documents significant impairment in the consumer’s ability to perform skills necessary for independent functioning in the community due to the consumer’s diagnosis that meets the requirements of § 3421.6(c).

(c) The consumer, or a legal guardian, has agreed to receive Community Support services and is capable of developing the skills to manage symptoms and make behavioral changes; and

(d) A current Plan of Care has been created within one hundred and eighty (180) calendar days before the request for Community Support services that clearly identifies interventions, services, and benefits to be performed and coordinated through Community Support services.

3421.15 Community Support services provided in accordance with § 3421.6 for subsequent one hundred and eighty (180) calendar day periods shall require authorization from the Department, and the consumer must continue to meet the criteria in § 3421.14 and must meet one (1) or more of the following clinical necessity criteria, as determined by a qualified practitioner pursuant to § 3421.12:

Improvement in one (1) or more areas on the designated functional assessment tool;

Maintenance or stabilization of functioning in daily life, with no observed or reported regression or exacerbation of symptoms; or

3421.16 Community Support services provided in excess of the units authorized by § 3421.6 in each one hundred and eighty (180) calendar day period, shall require supplemental authorization from the Department.

With the request for supplemental authorization, the provider shall submit a clinical summary signed by a qualified practitioner that demonstrates why additional units of Community Support are needed to address the change in the consumer’s behavioral health and how the additional units of Community Support will support the Plan of Care goals.

No request for supplemental authorization shall be granted unless the consumer continues to meet the clinical necessity criteria in § 3421.14 and there is a demonstrated clinical need for additional units based on the qualified practitioner’s clinical summary and the following:

A decline in two (2) or more areas on the designated functional assessment tool; or

The consumer experienced a significant event impacting their independent functioning in the community within thirty (30) calendar days before the request for supplemental authorization is submitted, such as a hospitalization, a loss of housing, use of crisis/emergency services, or an arrest or incarceration.

3421.17 Audio-only Community Support services provided in excess of the audio-only units authorized in § 3421.10(d) shall require prior authorization from the Department. No request for additional units shall be granted unless there is a demonstrated clinical need for additional units based upon the need to increase coordination with collateral contacts due to a significant change in the consumer’s behavioral health as described in § 3421.16.

3421.18 Providers shall not provide Community Support services to consumers unless clinically necessary as set forth in this section. Consumers who require more intensive services shall be assessed for a higher level of care. Consumers who no longer clinically require Community Support services shall be transitioned to a lower level of care.

3421.19 The Department or its designee shall provide the provider and the consumer written notice of any denial of Community Support authorization. The provider or consumer may request an administrative review by the Department within fourteen (14) calendar days of the notice.

3421.20 The Department shall promptly review a request for administrative review and provide a final written decision within fourteen (14) calendar days of the request. The provider or consumer may appeal a final decision denying Community Support authorization to the Office of Administrative Hearings pursuant to the fair hearing procedures in Title 29 DCMR § 9508.

History

SOURCE: Final Rulemaking published at 48 DCR 10297 (November 9, 2001); as amended by Final Rulemaking published at 51 DCR 9308 (October 1, 2004); as amended by Final Rulemaking published at 52 DCR 5682 (June 17, 2005); as amended by Notice of Emergency and Proposed Rulemaking published at 58 DCR 1482 (February 18, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 3476, 3479 (April 22, 2011); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021); as amended by Final Rulemaking 72 DCR 002797 (March 14, 2025); as amended by Final Rulemaking published at 72 DCR 008497 (August 1, 2025); as amended by Final Rulemaking published at 72 DCR 014041 (December 19, 2025); as amended by Final Rulemaking published at 73 DCR 007822 (May 22, 2026). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3421

22-A DCMR § 3422 CRISIS/EMERGENCY SERVICES

3422.1 A Crisis/Emergency Service is an immediate response face-to-face or via telehealth in accordance with 29 DCMR § 910 to an emergency situation involving a consumer with mental illness or emotional disturbance that is available twenty-four (24) hours per day, seven (7) days per week.

3422.2 Crisis/Emergency Services are provided by a CSA to their enrolled consumers involved in an active mental health crisis and consist of immediate response to evaluate and screen the presenting situation, assist in immediate crisis stabilization and resolution, and provide the consumer's access to care at the appropriate level.

3422.3 The Crisis/Emergency Services provider shall adjust its staffing to meet the requirements for immediate response.

3422.4 Each Crisis/Emergency Services provider shall:

(a) Consult with other service providers, locate other MHRS and resources, and provide written and oral information to assist the consumer in obtaining follow-up MHRS;

(b) Be a certified MHRS provider of Diagnostic Assessment or have an agreement with a CSA as a sub-provider or specialty provider to provide hospital pre-admission screenings; and

(c) Demonstrate the capacity to assure continuity of care for consumers by facilitating follow-up mental health appointments and providing telephonic support until outpatient services occur.

3422.5 Each Crisis/Emergency Services provider shall have waiting, assessment, and treatment areas for children, youth, and families that are separate from the areas for adults.

3422.6 Each Crisis/Emergency Services provider shall establish and adhere to policies, procedures, and staffing sufficient to ensure that all individuals seeking and in need of Crisis/Emergency Services receive face-to-face services within one (1) hour of request or referral (“Crisis/Emergency Staffing Policy”). The Crisis/Emergency Staffing Policy shall:

(a) Require independently licensed qualified practitioners to be available twenty-four (24) hours per day, seven (7) days per week for telephone, face-to-face and mobile interventions for individuals needing crisis services;

(b) Delineate the criteria upon which appropriate venue for service delivery is determined;

(d) Require that all staff receive current training in persuasion, engagement, and de-escalation techniques for disruptive or aggressive acts, consumers, and situations; and

(e) Require all staff to hold current certification in cardiopulmonary resuscitation and first aid.

3422.7 Crisis/Emergency Services shall be provided with no annual limits on services.

3422.8 ACT providers shall not bill Crisis/Emergency Services when provided to one of their current consumers.

3422.9 Crisis/Emergency Services shall be provided:

At the MHRS provider’s service site;

By telemedicine pursuant to 29 DCMR § 910; or

In natural settings, including the consumer’s home or community settings.

3422.10 The following are qualified practitioners of Crisis/Emergency Services:

Psychiatrists;

Psychologists;

LICSWs;

APRNs;

LISWs;

LPCs;

RNs;

LMFTs;

LGSWs;

LGPCs;

Psychology Associates; and

PAs.

3422.11 Credentialed staff shall be permitted to provide Crisis/Emergency Services under the supervision of an independently licensed qualified practitioner.

History

SOURCE: Final Rulemaking published at 48 DCR 10297 (November 9, 2001); as amended by Final Rulemaking published at 51 DCR 9308 (October 1, 2004); as amended by Final Rulemaking published at 52 DCR 5682 (June 17, 2005); as amended by Final Rulemaking published at 53 DCR 9197 (November 10, 2006); as amended by Final Rulemaking published at 57 DCR 10392, 10394 (November 5, 2010); as amended by Notice of Emergency and Proposed Rulemaking published at 58 DCR 1482 (February 18, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 3476, 3480 (April 22, 2011); as amended by Notice of Emergency and Proposed Rulemaking published at 58 DCR 2857 (April 1, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 4159 (May 13, 2011); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021); as amended by Final Rulemaking published at 70 DCR 003050 (March 10, 2023); as corrected by Errata Notice published at 71 DCR 004474 (April 19, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3422

22-A DCMR § 3423 REHABILITATION DAY SERVICES

3423.1 Rehabilitation Day Services is a structured, clinical program intended to develop skills and foster social role integration through a range of social, psycho-educational, behavioral, and cognitive mental health interventions. Rehabilitation Day Services:

(a) Are curriculum-driven and psycho-educational and assist the consumer in the retention or restoration of independent and community living, socialization, and adaptive skills;

(b) Include cognitive-behavioral interventions and diagnostic, psychiatric, rehabilitative, psychosocial, counseling, and adjunctive treatment; and

3423.2 Rehabilitation Day Services shall:

(a) Be founded on the principles of consumer choice and the active involvement of each consumer in their mental health recovery;

(b) Provide both formal and informal structures through which consumers can influence and shape service development;

(c) Facilitate the development of a consumer’s independent living and social skills, including the ability to make decisions regarding self-care, management of illness, life, work, and community participation;

(d) Promote the use of resources to integrate the consumer into the community; and

(e) Include education on self-management of symptoms, medications and side effects, the identification of rehabilitation preferences, the setting of rehabilitation goals, and skills teaching and development.

3423.3 Each consumer shall have a person-centered plan that addresses the consumer’s needs and progress toward achievement of Rehabilitation Day Services treatment goals.

3423.4 Each Rehabilitation Day Services provider shall provide adequate space, equipment, and supplies to ensure that services can be provided effectively. Rehabilitation Day Services program space and furnishings shall be separate and distinct from other services offered within the same service site(s).

3423.5 Each Rehabilitation Day Services provider shall have policies and procedures included in its Service Specific Policies addressing the provision of Rehabilitation Day Services (“Rehabilitation Day Services Organizational Plan”) which includes:

(a) A description of the particular rehabilitation models utilized, types of intervention practiced, and typical daily curriculum and schedule; and

(b) A description of the staffing pattern, including a staffing plan to ensure that the required staff-to-consumer ratios are maintained, and a plan for coverage during unplanned staff absences.

3423.6 Each Rehabilitation Day Services provider shall have a minimum of one (1) full-time equivalent staff for every ten (10) consumers based on average daily attendance.

3423.7 At least one (1) independently licensed qualified practitioner shall be present on site at all times.

3423.8 Each Rehabilitation Day Services provider shall have a clinical supervisor or director who is an independently licensed qualified practitioner on site at least thirty (30) hours per week.

3423.9 Providers shall deliver at least one (1) hour of Rehabilitation Day Services per day to qualify for reimbursement. The District shall reimburse no more than six (6) hours of Rehabilitation Day services per day.

3423.10 Rehabilitation Day Services shall require prior authorization from the Department. Rehabilitation Day Services provided in excess of two hundred and seventy (270) units within the initial one hundred and eighty (180) day period shall require supplemental authorization from the Department. Each subsequent authorization shall not exceed two hundred and seventy (270) units within a one hundred and eighty (180) day period.

3423.11 Rehabilitation Day Services shall not be billed:

(a) On the same day as:

(1) Group Community Support;

(2) Intensive Day Treatment (IDT);

(3) Trauma-Focused Cognitive Behavioral Therapy (TF-CBT);

(4) Trauma Recovery and Empowerment Model (TREM);

(5) Trauma Systems Therapy (TST);

(6) Psychosocial Rehabilitation Clubhouse; or

(b) During:

(1) A Counseling encounter; or

(2) An Individual Community Support encounter.

3423.12 Rehabilitation Day Services shall only be provided at an MHRS provider’s service site.

3423.13 The following are qualified practitioners of Rehabilitation Day Services:

Psychiatrists;

Psychologists;

LICSWs;

APRNs;

LISWs;

LMFTs;

LPCs;

RNs;

LGSWs;

LGPCs;

Psychology Associates; and

PAs.

3423.14 Credentialed staff shall be permitted to provide Rehabilitation Day Services under the supervision of an independently licensed qualified practitioner.

History

SOURCE: Final Rulemaking published at 48 DCR 10297 (November 9, 2001); as amended by Final Rulemaking published at 51 DCR 9308 (October 1, 2004); as amended by Final Rulemaking published at 52 DCR 5682 (June 17, 2005); as amended by Notice of Emergency and Proposed Rulemaking published at 58 DCR 1482 (February 18, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 3476, 3482 (April 22, 2011); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021); as amended by Final Rulemaking published at 72 DCR 014041 (December 19, 2025). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3423

22-A DCMR § 3424 INTENSIVE DAY TREATMENT

3424.1 IDT is a facility-based, structured, intensive, and coordinated acute treatment program which serves as an alternative to acute inpatient treatment or as a step-down service from inpatient care, and is rendered by an interdisciplinary team to provide stabilization of psychiatric impairments.

3424.2 Daily physician and nursing services are essential components of IDT services.

3424.3 IDT shall:

(a) Be time-limited and provided in an ambulatory setting to consumers who are not in danger of self-harm or harming others, but who have behavioral health issues that are incapacitating and interfering with their ability to carry out daily activities;

(b) Be provided within a structured program of care which offers individualized, strengths-based, active and timely treatment directed toward alleviating the impairment which caused the admission to IDT;

(c) Be an active treatment program that consists of documented mental health interventions that address the individualized needs of the consumer as identified in the Plan of Care;

(d) Consist of structured individual and group activities and therapies that are planned and goal-oriented, and provided under active psychiatric supervision;

(e) Offer short-term day-programming consisting of therapeutically intensive, acute, and active treatment;

(f) Be comprised of services that closely resemble the intensity and comprehensiveness of inpatient services; and

(g) Include psychiatric, other medical, nursing, social work, occupational therapy, medication/somatic treatment, care coordination, and psychology services focusing on timely crisis intervention and psychiatric stabilization so that consumers can return to their normal daily lives.

3424.4 Each consumer shall participate in at least five (5) hours of IDT services per day, excluding time for adequate breaks and administrative functions, for the services to be reimbursable.

3424.5 Each consumer shall be directly evaluated by an independently licensed qualified practitioner as part of the admissions process.

3424.6 Each consumer’s care shall be supervised by an independently licensed qualified practitioner who assumes primary responsibility for the consumer's assessment, treatment planning, and treatment services.

3424.7 Each consumer shall be assigned to a full-time staff member who assists the consumer and the consumer’s family to assess the consumer’s needs and progress toward achieving the treatment goals.

3424.8 An interdisciplinary treatment team shall meet within one (1) business day of the consumer’s admission to develop an initial IDT Plan of Care.

3424.9 Each IDT Plan of Care shall be updated every three (3) business days and shall be reviewed by the interdisciplinary treatment team on a weekly basis and upon termination of treatment.

3424.10 At least one (1) independently licensed qualified practitioner shall be present on site at all times.

3424.11 Each IDT provider shall have policies and procedures included in its Service Specific Policies addressing the provision of IDT (Intensive Day Treatment Organizational Plan) which includes the following:

(a) A description of the particular treatment models utilized, types of intervention practiced, and typical daily curriculum and schedule;

(b) A description of the staffing pattern including a staffing plan to ensure that the required staff-to-consumer ratios are maintained, and a plan for coverage for unplanned staff absences; and

(c) A description of how the IDT Plan of Care is modified or adjusted to meet the needs specified in each consumer’s Plan of Care.

3424.12 The IDT provider shall maintain a minimum staff-to-consumer ratio of one (1) staff for every eight (8) consumers. The IDT provider shall maintain a minimum staffing pattern sufficient to address consumer needs, including adequate physician, nursing, social work, therapy, and psychology services to assure the availability of intensive services.

3424.13 Prior authorization by the Department shall be required for IDT services. Initial and any subsequent authorizations shall not exceed seven (7) units at a time.

3424.14 IDT shall not be billed on the same day as:

Medication/Somatic Treatment;

Counseling;

Rehabilitation Day Services;

ACT;

TF-CBT;

TREM;

TST;

Psychosocial Rehabilitation Clubhouse; or

Supported Employment services subject to the Supported Employment program standards set forth in 22-A DCMR Chapter 37.

3424.15 IDT shall only be provided at an MHRS provider’s service site.

The following are qualified practitioners of Intensive Day Treatment (IDT):

Psychiatrists;

Psychologists;

LICSWs;

APRNs;

LISWs;

LPCs;

RNs;

LMFTs;

LGSWs;

LGPCs;

Psychology Associates; and

PAs.

3424.17 Credentialed staff shall be permitted to provide IDT under the supervision of an independently licensed qualified practitioner.

History

SOURCE: Final Rulemaking published at 48 DCR 10297 (November 9, 2001); as amended by Final Rulemaking published at 51 DCR 9308 (October 1, 2004); as amended by Final Rulemaking published at 52 DCR 5682 (June 17, 2005); as amended by Final Rulemaking published at 53 DCR 9197 (November 10, 2006); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3424

22-A DCMR § 3425 COMMUNITY BASED INTERVENTION

3425.1 CBI services are time-limited, intensive, mental health services delivered to children and youth. CBI services are intended to prevent the utilization of an out-of-home therapeutic resource or a detention of the consumer. CBI services may be provided at the time a child or youth is identified for a service, particularly to meet an urgent or emergent need during their course of treatment.

3425.2 In order to be eligible for CBI services, a consumer shall have:

Insufficient or severely limited individual or family resources or skills to cope with an immediate crisis; and

Either individual or family issues, or a combination of individual and family issues, that are unmanageable and require intensive coordinated clinical and positive behavioral interventions.

3425.3 There shall be three (3) levels of CBI services available to children and youth. A provider may be certified to offer one (1) or more level(s) of CBI services. The three (3) levels of CBI services are:

CBI Level I, delivered using the MST treatment model adopted by the Department;

CBI Level II, delivered using the Intensive Home and Community-Based Services (IHCBS) model adopted by the Department; and

CBI Level III, delivered using the IHCBS model adopted by the Department.

3425.4 The CBI provider shall be responsible for coordinating the treatment planning process for all consumers authorized to receive CBI for the duration of CBI services. CBI services shall be delivered primarily in natural settings and shall include in-home services.

3425.5 The basic goals of all levels of CBI services are to:

Defuse the consumer’s current situation to reduce the likelihood of a recurrence which, if not addressed, could result in the use of more intensive therapeutic interventions;

Coordinate access to covered mental health services and other covered Medicaid services;

Provide mental health services and support interventions for consumers that develop and improve consumer and family interaction and improve the ability of parents, legal guardians, or caregivers to care for the consumer; and

Assess the needs of the consumer and transition the consumer to an appropriate level of care following the end of CBI treatment services.

3425.6 All levels of CBI services shall include the following services, as medically necessary and clinically appropriate for the consumer:

Immediate crisis response for enrolled consumers;

Stabilization and behavioral support services to:

Reduce family conflict;

Stabilize the family unit;

Maintain the consumer in the home environment;

Increase family support; and

Monitor the consumer’s medication compliance with prescribed psychiatric medications;

Environmental assessment to:

Identify risk factors that may endanger either the consumer or the consumer’s family; and

Assess the strengths of the consumer and the consumer’s family;

Individual and family support interventions that develop and improve the ability of parents, legal guardians, or significant others to care for the consumer’s behavioral and emotional disturbance(s);

Skills training related to:

Consumer self-help;

Parenting techniques to help the consumer’s family develop skills for managing the consumer’s emotional disturbance;

Problem solving;

Behavior management;

Communication techniques, including the facilitation of communication and consistency of communication for both the consumer and their family;

Medication management, monitoring, and follow-up for family members and other caregivers; and

Coordination and linkages with other covered MHRS services, behavioral health services or supports and other covered Medicaid services to prevent the utilization of more restrictive residential treatment, including one (1) or more of the following activities:

Referral of consumers to other MHRS providers;

Assisting consumers in transition to less intensive or more intensive MHRS;

Referral of consumers to providers of other Medicaid-covered services; or

Supporting and consulting with the consumer’s family or support system directed exclusively to the well-being and benefit of the consumer.

3425.7 Each level of CBI provider shall have policies and procedures included in its Service Specific Policies that address the provision of CBI (CBI Organizational Plan) which include the following:

A description of the particular treatment models utilized, types of intervention practiced, and typical daily curriculum and schedule;

A description of the staffing pattern and how staff is deployed to maintain the required staff-to-consumer ratios, including a plan for unplanned staff absences;

A requirement to directly conduct or arrange for Diagnostic Assessment services within thirty (30) calendar days before or after the initiation of CBI services. The Department may approve alternative sources to serve as the diagnostic assessment instrument if similar assessments have been conducted within the past twelve (12) months of an individual’s referral to CBI services; and

A requirement to collect and submit clinical outcome data and any other requested information using the process, timeline, and tools specified or approved by the Department.

3425.8 CBI Level I services are intended for children and youth ages twelve (12) through seventeen (17) who are experiencing serious emotional disturbance with either of the following:

A documented behavioral concern with externalizing (aggressive or violent) behaviors; or

A history of chronic juvenile offenses that has resulted or may result in involvement with the juvenile justice system.

3425.9 CBI Level I services shall not be authorized for:

Children or youth who require the safety of a hospital or other secure setting;

Children or youth in independent living programs; or

Children or youth without a long-term placement option.

3425.10 Eligible consumers of CBI Level I services shall have a permanent caregiver who is willing to participate with service providers for the duration of CBI Level I treatment services and be:

At imminent risk for out-of-home placement within thirty (30) calendar days; or

Currently in out-of-home placement due to the consumer’s disruptive behavior, with permanent placement expected to occur within thirty (30) calendar days.

3425.11 Providers shall obtain prior authorization from the Department before rendering CBI Level I services. Authorizations shall not exceed one hundred eighty (180) calendar days.

3425.12 The Department may consider reauthorization of CBI Level I services after one hundred eighty (180) calendar days in accordance with medical necessity requirements specified by the Department. Providers must obtain prior authorization from the Department before rendering CBI Level I services after one hundred eighty (180) calendar days.

3425.13 CBI Level II is intended for consumers ages birth through twenty-one (21) who meet at least one (1) of the following criteria:

A history of involvement with the Child and Family Services Agency (CFSA) or the Department of Youth Rehabilitation Services (DYRS);

A history of negative involvement with schools for behavioral-related issues;

A history of either chronic or recurrent episodes of negative behavior that has resulted or may result in out-of-home placement; or

Recently discharged or being discharged within the next thirty (30) calendar days from an inpatient setting such as a hospital or psychiatric residential treatment facility.

3425.14 The Department shall not authorize CBI Level II services for children or youth who require the safety of a hospital or other secure setting.

3425.15 Providers shall obtain prior authorization from the Department before rendering CBI Level II services. Authorizations shall not exceed one hundred and eighty (180) calendar days.

3425.16 The Department may consider reauthorization of CBI Level II services in accordance with medical necessity criteria established by the Department. Providers shall obtain prior authorization from the Department before rendering CBI Level II services after one hundred and eighty (180) days.

3425.17 CBI Level III is intended for consumers ages birth through twenty-one (21) who meet at least one (1) of the following criteria:

Have situational behavioral problems that require short-term, intensive treatment;

Are currently dealing with stressor situations such as trauma or violence and require development of coping and management skills;

Have recently experienced out-of-home placement and require development of communication and coping skills to manage the placement change;

Are undergoing transition from adolescence to adulthood and require skills and supports to successfully manage the transition; or

Were recently discharged or are being discharged within the next thirty (30) calendar days from an inpatient setting such as a hospital or psychiatric residential treatment facility.

3425.18 The Department shall not authorize CBI Level III services for children or youth who require the safety of a hospital or other secure setting.

3425.19 Providers shall obtain prior authorization from the Department before rendering CBI Level III services. Authorizations shall not exceed ninety (90) calendar days.

3425.20 The Department may consider reauthorization of CBI Level III services after ninety (90) calendar days in accordance with medical necessity requirements specified by the Department. Providers shall obtain prior authorization from the Department before rendering CBI Level III services after ninety (90) calendar days.

3425.21 Discharge from all levels of CBI services shall occur when the consumer has achieved the goals for CBI outlined in the Plan of Care, or the consumer no longer benefits from CBI services. Discharge decisions shall be based on one (1) or a combination of the following:

The consumer is performing reasonably well in relation to goals contained in the Plan of Care and discharge to a lower level of care is indicated (for example, the consumer is not exhibiting risky behaviors or family functioning has improved);

The consumer or their family or caregiver has developed the skills and resources needed to step down to a less intensive service;

The consumer is not making progress or is regressing and all realistic CBI treatment options have been exhausted;

A family member or caregiver requests discharge and the consumer is not imminently dangerous to self or others;

The consumer requires a higher level of care (for example, inpatient hospitalization or psychiatric residential treatment facility); or

The consumer does not reside in the District of Columbia (District) and:

Is not eligible to participate in the District’s Medicaid program;

Is not within the physical or legal custody of the CFSA; or

Is not within the physical or legal custody of the DYRS.

3425.22 Eligible providers of CBI Level I services shall:

Be licensed MST providers in good standing;

Be either a Network Partner that is providing the MST services and receiving MST consultation services from another MST Network Partner, or a non-Network Partner that is receiving MST consultant services from a MST Network Partner or MST Services;

Have the capacity to provide or arrange for the non-Medicaid reimbursed wraparound services required by eligible consumers;

Meet CBI Level I training requirements specified by the Department;

Have the capacity to deliver CBI Level I services to four (4) to six (6) consumers for each full-time team member; and

Be available to consumers twenty-four (24) hours per day, seven (7) days per week.

3425.23 Eligible providers of CBI Level II services shall:

Meet CBI Level II training requirements specified by the Department;

Have the capacity to provide or arrange for the non-Medicaid reimbursed wraparound services required by eligible consumers;

Have the capacity to deliver CBI Level II services to at least four (4) to six (6) consumers for each full-time team member; and

Be available to consumers twenty-four (24) hours per day, seven (7) days per week.

3425.24 Eligible providers of CBI Level III services shall:

Meet CBI Level III training requirements specified by the Department;

Have the capacity to provide or arrange for the non-Medicaid reimbursed wraparound services required by eligible consumers;

Have the capacity to deliver CBI Level III services to at least four (4) to six (6) consumers for each full-time team member; and

Be available to consumers twenty-four (24) hours per day, seven (7) days per week.

3425.25 Providers of all levels of CBI services shall:

Individually design CBI services for each consumer and their family to minimize intrusion and maximize independence;

Provide more intensive services at the beginning of treatment and decrease the intensity of treatment over time as the strengths and coping skills of the consumer and family develop;

Provide services utilizing a team approach;

Maintain appropriate back-up coverage for team member absences and facilitate substitution of team members, as necessary;

Conduct face-to-face transition planning with consumers and their families no later than thirty (30) calendar days prior to the anticipated discharge date, including meetings with providers of more intensive or less intensive services;

Conduct continuity of care planning with consumers and families prior to discharge from any level of CBI services, including facilitating follow-up mental health appointments and providing telephonic support until follow-up mental health services occur;

Provide all of the components of treatment specified in § 3425.6, as appropriate, based on each consumer’s needs;

Provide CBI services with a family-focus;

Assist the consumer and their family with the development of mental health relapse prevention strategies and plans, if none exist; and

Assist the consumer and their family with the development of a safety plan to address risk factors identified during the environmental assessment.

3425.26 Each CBI Level I team shall include:

A full-time CBI Level I clinical supervisor; and

Two (2) to four (4) full-time CBI Level I clinicians.

3425.27 The CBI Level I team clinical supervisor shall be an independently licensed qualified practitioner pursuant to § 3425.39 practicing within the scope of their license. The clinical supervisor shall be experienced in providing individual, group, marital, or family counseling or psychotherapy, and have a minimum of two (2) years of post-graduate experience working with behaviorally challenged youth and their families in community-based settings.

3425.28 The CBI Level I team clinicians shall be qualified practitioners pursuant to § 3425.39 practicing within the scope of their license.

3425.29 Each CBI Level II team shall include:

A full-time clinical supervisor dedicated at a minimum fifty percent (50%) to IHCBS; and

At a minimum, two (2) full-time clinicians dedicated to IHCBS.

3425.30 The CBI Level II team clinical supervisor shall be a Master’s level independently licensed qualified practitioner pursuant to § 3425.39 practicing within the scope of their license. The clinical supervisor shall be experienced in providing individual, group, marital, or family counseling or psychotherapy and have a minimum of two (2) years of post-graduate experience working with behaviorally challenged youth and their families in community-based settings.

3425.31 The CBI Level II team clinicians shall be qualified practitioners pursuant to § 3425.39 practicing within the scope of their license and have a minimum of one (1) year of experience working with behaviorally challenged youth and their families in community-based settings.

3425.32 Each CBI Level III team shall include:

A full-time clinical supervisor dedicated at a minimum fifty percent (50%) to IHCBS; and

At a minimum, two (2) full-time clinicians dedicated to IHCBS.

3425.33 The CBI Level III team clinical supervisor shall be a Master’s-level independently licensed qualified practitioner pursuant to § 3425.39 practicing within the scope of their license. The clinical supervisor shall be experienced in providing individual, group, marital, or family counseling or psychotherapy, with a minimum of two (2) years post-graduate experience working with behaviorally challenged youth and their families in community-based settings.

3425.34 The CBI Level III team clinicians shall be qualified practitioners pursuant to § 3425.39 practicing within the scope of their license and have a minimum of one (1) year of experience working with behaviorally challenged youth and their families in community-based settings.

3425.35 Providers of all levels of CBI services shall ensure referral to and coordination with any medically necessary substance use disorder treatment and recovery support services and any services to facilitate consumers’ transition from adolescence to adulthood.

3425.36 CBI shall not be billed on the same day as:

Counseling;

FFT;

ACT; or

TF-CBT.

3425.37 CBI Level II and CBI Level III shall not be billed on the same day as TREM.

3425.38 CBI shall be provided:

At the MHRS provider’s service site; or

In natural settings, including the consumer’s home or community settings.

3425.39 The following are qualified practitioners of CBI:

Psychiatrists;

Psychologists;

Licensed Independent Clinical Social Workers (LICSWs);

Advanced Practice Registered Nurses (APRNs);

Licensed Professional Counselors (LPCs);

Licensed Marriage and Family Therapists (LMFTs);

Licensed Graduate Social Workers (LGSWs);

Licensed Graduate Professional Counselors (LGPCs);

Licensed Independent Social Workers (LISWs); and

Psychology Associates.

3425.40 The provider shall not render CBI services in excess of thirty-two (32) units in a twenty-four (24) hour period without prior authorization from the Department. The Department may conduct clinical record reviews to verify the medical necessity of services provided.

3425.41 CBI providers shall comply with training requirements:

For CBI Level I through nationally recognized body;

For CBI Level II and CBI Level III in accordance with the Department CBI Policy; and

All other trainings provided through the Department’s Training Institute during the calendar year as requested by the Department.

History

SOURCE: Final Rulemaking published at 48 DCR 10297 (November 9, 2001); as amended by Final Rulemaking published at 51 DCR 9308 (October 1, 2004); as amended by Final Rulemaking published at 52 DCR 5682 (June 17, 2005); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021); as amended by Final Rulemaking published at 70 DCR 003050 (March 10, 2023); as corrected by Errata Notice published at 71 DCR 004474 (April 19, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3425

22-A DCMR § 3426 ASSERTIVE COMMUNITY TREATMENT

3426.1 ACT is an intensive, integrated, rehabilitative, crisis, treatment, and mental health community support service provided by an interdisciplinary team to individuals eighteen (18) and over with serious and persistent mental illness with dedicated staff time and specific staff-to-consumer ratios.

3426.2 Service coverage by the ACT team is required twenty-four (24) hours per day, seven (7) days per week.

3426.3 The consumer’s ACT team shall complete a comprehensive or supplemental assessment and develop a self-care-oriented Plan of Care (if a current and effective one does not already exist).

3426.4 Services offered by the ACT team shall include:

Medication prescription, administration, and monitoring, excluding Medications for Substance Use Disorder.

Crisis assessment and intervention;

Symptom assessment, management, and individual supportive therapy;

Substance use disorder treatment for consumers with a co-occurring substance use disorder;

Psychosocial rehabilitation and skill development;

Interpersonal, social, and interpersonal skill training;

Education, support, and consultation to consumers’ families and their support system which is directed exclusively to the well-being and benefit of the consumer;

Finding safe and affordable supportive housing;

Money management and benefits counseling and acquisition;

Coordination of medical and psychosocial services; and

Referrals and linkages to other services that address the consumer’s social determinants of health.

3426.5 ACT services shall include a comprehensive and integrated set of medical and psychosocial services for the treatment of the consumer’s mental health condition that is provided in non-office settings by the consumer’s ACT team.

3426.6 The ACT team provides community support services that are interwoven with treatment and rehabilitative services and regularly scheduled team meetings. ACT team meetings shall be held a minimum of four (4) times a week.

3426.7 ACT services and interventions shall be highly individualized and tailored to the needs and preferences of the consumer, with the goal of maximizing independence and supporting recovery.

3426.8 Each ACT provider shall have policies and procedures included in its Service Specific Policies that address the provisions of ACT (“ACT Organizational Plan”) which include the following:

A description of the particular treatment models utilized, types of intervention practiced, and typical daily curriculum and schedule; and

A description of the staffing pattern and how staff are deployed to ensure that the required staff-to-consumer ratios are maintained, including how unplanned staff absences and illnesses are accommodated.

3426.9 At a minimum, the ACT team shall include the following members:

A full-time team leader or supervisor who is the clinical and administrative supervisor of the Assertive Community Treatment (ACT) team and who is at minimum an independently licensed qualified practitioner;

A psychiatrist or a psychiatric prescriber working on a full-time or part-time basis for a minimum of four (4) hours per week per twenty (20) consumers, who provides clinical and crisis services to all consumers served by the ACT team, works with the ACT team leader to monitor each consumer’s clinical status and response to treatment, and directs psychopharmacologic and medical treatment;

An RN working on a full-time basis, who provides nursing services for all ACT team consumers. The RN works with the ACT team to monitor each consumer’s clinical status and response to treatment, and who functions as a primary practitioner on the ACT team for a caseload of consumers;

A certified addiction counselor who is working on a full-time basis and providing or accessing substance use disorder services for ACT team consumers, and who functions as a primary practitioner on the ACT team for a caseload of consumers;

A clinically trained and licensed generalist practitioner working on a full-time basis and providing individual and group supportive therapy to ACT team consumers, and who functions as a primary practitioner on the ACT team for a caseload of consumers and is a qualified practitioner;

A certified recovery coach or certified peer specialist carrying out rehabilitation and support functions who may be a consumer in recovery that has been specially credentialed based on their psychiatric and life experiences. Certified recovery coaches and certified peer specialists are fully integrated ACT team members who provide consultation to the ACT team and highly individualized services in the community, and who promote consumer self-determination and decision making; and

A vocational specialist with at least one year of training or experience who has knowledge of supported employment, vocational assessment, job exploration and marketing to recipient’s interest and strengths and securing and maintain employment.

3426.10 The ACT team shall maintain a minimum consumer-to-staff ratio of no more than ten (10) consumers per staff person, and such ratio shall take into consideration evening and weekend hours, needs of special populations, and geographical areas to be covered.

3426.11 Eligible providers of ACT services shall:

Utilize the ACT model adopted by the Department;

Meet ACT training requirements specified by the Department; and

Have culturally and linguistically competent staff.

3426.12 ACT shall require prior authorization from the Department. Initial and subsequent authorizations shall not exceed six (6) calendar months.

3426.13 ACT consumers shall receive vocational and supported employment services through their ACT team. ACT consumers shall not be eligible for Supported Employment services that are subject to the Supported Employment program standards set forth in 22-A DCMR Chapter 37.

3426.14 ACT shall not be billed on the same day as:

(a) Diagnostic Assessment;

(b) Medication/Somatic Treatment;

(d) Community Support;

(e) Intensive Day Treatment (IDT);

(f) Community Based Intervention (CBI);

(g) Trauma-Focused Cognitive Behavioral Therapy (TF-CBT);

(h) Trauma Recovery and Empowerment Model (TREM);

(i) Trauma Systems Therapy (TST); or

(j) Functional Family Therapy (FFT).

3426.15 ACT providers shall not bill Crisis/Emergency Services when provided to one of their current consumers.

3426.16 Assertive Community Treatment (ACT) shall be provided:

At the Mental Health Rehabilitation Service (MHRS) provider’s service site; or

In natural settings, including the consumer’s home or community settings; or

Through telehealth pursuant to Title 29 DCMR § 910 as permitted by § 3426.21.

3426.17 The following are qualified practitioners of ACT:

Psychiatrists;

Psychologists;

LICSWs;

APRNs;

LPCs;

LMFTs;

RNs;

LGSWs;

LGPCs;

LISWs;

Psychology Associates;

PAs; and

Certified Addiction Counselors (“CAC”) I and II.

3426.18 Credentialed staff shall be permitted to provide ACT service components under the supervision of an independently licensed qualified practitioner.

3426.19 ACT providers shall be reimbursed at a monthly rate established by the Department of Health Care Finance on the Medicaid Fee Schedule (available at https://dhcf.dc.gov/). ACT providers must document a minimum of five (5) contacts delivered to or on behalf of a consumer per calendar month and meet the requirements of § 3426.20 through § 3426.23 to receive the monthly rate for the consumer. ACT providers must document all services delivered to a consumer pursuant to § 3413.19, including those in excess of five (5) contacts per calendar month. ACT providers may submit up to (2) contacts per day in support of the five (5) contacts per calendar month.

3426.20 The following activities by the provider shall constitute one (1) contact each:

(a) Daily team meeting – The ACT provider must record each daily team meeting in each consumer’s electronic health record and may submit one (1) daily team meeting per consumer as a contact per calendar month;

(b) Contact with an Advanced Practice Registered Nurse (APRN) or Medical Doctor (MD) – The ACT provider must ensure that each consumer has at least one (1) scheduled appointment per calendar month with an APRN or MD. The ACT provider must document whether a consumer attends the scheduled APRN or MD appointment in the consumer’s electronic health record. There shall be no penalty against an ACT provider if a consumer fails to attend the APRN or MD meeting; however, missed APRN or MD appointments shall not constitute a contact. The APRN or MD contact must be delivered directly to the consumer. Collateral contacts initiated by the APRN or MD and daily team meetings attended by the APRN or MD shall not be sufficient to meet this requirement;

(c) Any face-to-face contact with a member of the ACT team during which the ACT team member delivers services consistent with the consumer’s Individual Plan of Care;

(d) A crisis/emergency service;

(e) Hospital engagement including but not limited to face-to-face contact with the consumer or a collateral contact with the hospital social worker, the psychiatrist, or the discharge planning team;

(f) A contact with a consumer’s natural support;

(g) Psychotherapy services;

(h) Psychoeducation services delivered to the consumer or to their natural support;

(j) Independent skills teaching;

(k) Case management episode;

(l) Engagement episode; and

(m) Collateral contact.

3426.21 The provider must ensure that the five (5) contacts per calendar month to or on behalf of a consumer, as specified in § 3426.19, that are submitted in support of the provider’s billing meet the following:

A minimum of three (3) contacts must be delivered to a consumer in person.

A minimum of two (2) contacts must be delivered by a qualified practitioner either in person or via audio or audio-visual telehealth pursuant to 29 DCMR § 910.

(c) A maximum of two (2) collateral contacts may be delivered in a month. Collateral contacts may be delivered via audio or audio-visual telehealth pursuant to 29 DCMR § 910.

3426.22 Reimbursement for ACT services shall be contingent on the following:

The provider must document at least five (5) contacts provided to or on behalf of a consumer during a calendar month;

The service must be prior authorized by the payer;

The service must be medically necessary;

The service must be delivered by an ACT provider certified by the Department of Behavioral Health;

All services must be delivered by qualified practitioners pursuant to § 3426.17 or credentialed staff pursuant to § 3426.18;

The service must be delivered in accordance with the consumer’s Individual Plan of Care; and

The service must be delivered in accordance with all applicable provisions of this Chapter.

3426.23 The ACT provider must ensure that each contact includes the rendering provider’s National Provider Identification Number, the name of the provider organization/group, the date of service, the length of service, the place of service, and the modality of service.

History

SOURCE: Final Rulemaking published at 61 DCR 5415 (May 30, 2014); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021); as amended by Final Rulemaking published at 70 DCR 003050 (March 10, 2023); as amended by Final Rulemaking published at 70 DCR 016660 (December 29, 2023); as corrected by Errata Notice published at 71 DCR 004474 (April 19, 2024); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024); as amended by Final Rulemaking published at 72 DCR 002797 (March 14, 2025); as amended by Final Rulemaking published at 72 DCR 008497 (August 1, 2025); as amended by Final Rulemaking published at 72 DCR 014041 (December 19, 2025). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3426

22-A DCMR § 3427 CHILD-PARENT PSYCHOTHERAPY

3427.1 Child-Parent Psychotherapy (CPP) is a relationship-based treatment intervention for young children with a history of trauma exposure or maltreatment, and their parents or caregivers. CPP helps restore developmental functioning and reduce trauma symptoms in the wake of trauma by focusing on restoring the attachment relationship that was negatively affected.

3427.2 Under CPP, clinicians assess and provide information on how parents’ or caregivers’ past experiences, including past insecure or abusive relationships, affect their relationships with their children. Sessions focus on parent/caregiver-child interactions and clinicians provide support on healthy coping, affect regulation, and increased appropriate reciprocity between parent/caregiver and child, resulting in a stronger relationship between a child and their parent or caregiver, and improvement in the child’s symptoms. CPP sessions may be longer in the first six (6) months of treatment (i.e., ninety (90) minutes per session) and decrease over time (to sixty (60) minutes per session) as the child improves their coping skills.

3427.3 The goals of CPP are to:

Reduce post-traumatic stress reactions and symptoms in children;

Improve both parent/caregiver and child functioning, as well as improve the parent/caregiver attachment relationships;

Establish a sense of safety and trust within the parent/caregiver relationship;

Return a child to a normal developmental trajectory; and

Restore parental/caregiver sensitivity and responsiveness, in order to strengthen the child-parent/caregiver relationship.

3427.4 CPP is available to children ages birth through six (6) years with a mental health diagnosis who have experienced at least one (1) traumatic event including maltreatment, the sudden or traumatic death of a caregiver, a serious accident, medical traumas, sexual abuse, physical abuse, neglect, or exposure to domestic violence, and, as a result, are experiencing behavioral, attachment, and/or mental health problems, including post-traumatic stress symptoms.

3427.5 CPP shall only be provided with the participation of the parent or caregiver.

3427.6 Providers of CPP services shall meet and maintain certification as a CPP provider from the Department-approved training entity.

3427.7 All CPP clinicians shall complete the Department-approved CPP clinical training.

3427.8 Each CPP Team shall include one (1) clinical supervisor and no more than six (6) clinicians who have successfully completed the CPP training requirements. The clinical supervisor shall be an independently licensed qualified practitioner pursuant to § 3427.15 practicing within the scope of their license.

3427.9 CPP clinicians shall be qualified practitioners pursuant to § 3427.15 practicing within the scope of their license, and holding a Master’s degree in psychology, social work, therapy, or other related field.

3427.10 CPP supervisors must be independently licensed qualified practitioners pursuant to § 3427.15 practicing within the scope of their license and trained in CCP in accordance with the CPP fidelity standards.

3427.11 CCP providers shall maintain an acceptable rating on an annual CPP fidelity audit.

3427.12 CPP may be provided without prior authorization from the Department.

3427.13 CPP shall not be billed on the same day as:

TF-CBT; or

TST.

3427.14 CPP shall be provided:

At the MHRS provider’s service site;

In natural settings, including the consumer’s home or community settings; or

In a residential facility of sixteen (16) beds or less unless otherwise stated by the Department.

3427.15 The following are qualified practitioners of CPP:

Psychiatrists;

Psychologists;

LICSWs;

APRNs;

LISWs;

LPCs;

LMFTs;

LGSWs;

LGPCs; and

Psychology Associates.

History

SOURCE: Final Rulemaking published at 67 DCR 10674 (September 4, 2020); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021); as amended by Final Rulemaking published at 70 DCR 003050 (March 10, 2023); as corrected by Errata Notice published at 71 DCR 004474 (April 19, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3427

22-A DCMR § 3428 TRAUMA-FOCUSED COGNITIVE BEHAVIORAL THERAPY

3428.1 Trauma-Focused Cognitive Behavioral Therapy (“TF-CBT”) is a psychotherapeutic intervention designed to help children, working with their parent or caregivers, overcome the negative effects of traumatic life events. The treatment focuses on parent-child interactions, parenting skills, therapeutic treatment, skills development (such as stress management, cognitive processing, communication, problem solving, and safety), and parental support. A parent/caregiver treatment component is an integral part of this treatment model. It parallels the interventions used with the child so that parent or caregivers are aware of the content covered with the child and are prepared to reinforce or discuss this material with the child between treatment sessions and after treatment has ended. A typical course of TF-CBT treatment requires children to participate in sixty (60) to ninety (90) minute individual and conjoint child parent or caregiver sessions, at a minimum one (1) time per week, over an average period of twelve (12) to sixteen (16) weeks in accordance with the evidence-based practice requirements.

The goals of TF-CBT are to:

Target symptoms of post-traumatic stress disorder that are often co-occurring with depression and behavior problems;

Address issues commonly experienced by traumatized children, such as poor self-esteem, difficulty trusting others, mood instability, and self- injurious behavior, including substance use disorder;

Increase stress management skills of youth and parent/caregiver;

Improve youth’s self-esteem, problem-solving and safety skills and decrease self-injurious and aggressive behaviors; and

Decrease caregiver trauma-related distress.

TF-CBT is available to children ages four (4) through eighteen (18) years of age with a diagnosed serious emotional disorder, who have experienced or witnessed one or more traumatic events and who are experiencing behavioral, or mental health problems, including post-traumatic stress symptoms as a result of the event.

TF-CBT is recommended to be provided with an active parent/caregiver willing to participate for the anticipated treatment period.

Providers of TF-CBT services shall maintain fidelity to the TF-CBT model adopted by the Department.

All TF-CBT Clinical team members shall complete the Department-approved TF-CBT clinical training.

Each TF-CBT Team shall include at least one (1) clinical supervisor, and no more than ten (10) clinicians who have successfully completed the TF-CBT training requirements. The clinical supervisor shall be an independently licensed qualified practitioner experienced in providing individual, group, marital, or family counseling or psychotherapy.

TF-CBT clinicians shall be qualified practitioners who hold a Master’s degree in psychology, social work, therapy, or other related field.

Services provided by credentialed staff shall be supervised by a qualified practitioner trained in TF-CBT as required by the TF-CBT requirements and documented in the TF-CBT Practice Session Checklist.

3428.2 TF-CBT may be provided without prior authorization from the Department.

3428.3 TF-CBT shall not be billed the same day as:

Counseling;

Rehabilitation Day Services;

IDT;

CBI;

ACT;

CPP-FV; or

TST.

3428.4 TF-CBT shall be provided:

At the MHRS provider’s service site;

In natural settings, including the consumer’s home or community settings; or

In a residential facility of sixteen (16) beds or less unless otherwise stated by the Department.

3428.5 The following are qualified practitioners of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT):

Psychiatrists;

Psychologists;

LICSWs;

APRNs;

LISWs;

LMFTs;

LPCs;

LGSWs;

LGPCs; and

Psychology Associates.

History

SOURCE: Final Rulemaking published at 67 DCR 10674 (September 4, 2020); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3428

22-A DCMR § 3429 TRAUMA RECOVERY AND EMPOWERMENT MODEL

3429.1 TREM is a structured group therapy intervention designed for individuals who have survived trauma and have substance use disorders and/or mental health conditions. TREM draws on cognitive restructuring, skills training, and psychoeducational and peer support to address recovery and healing from sexual, physical, and emotional abuse. A curriculum for each model outlines the topic of discussion, a rationale, a set of goals, and a series of questions to be posed to the group in addition to an experiential exercise for each session.

The components are:

Therapy sessions focused on empowerment, self-comfort, and accurate self-monitoring, as well as ways to establish safe physical and emotional boundaries;

Therapy sessions focused on the trauma experience and its consequences; and

Therapy sessions focused on skills building, including emphases on communication style, decision-making, regulating overwhelming feelings, and establishing safer, more reciprocal relationships.

3429.2 Each TREM group is population specific and on average consists of eighteen (18) to twenty-four (24) sessions, with each session at least seventy-five (75) minutes in duration. Population-specific groups include:

TREM for women;

TREM for men;

TREM for girls twelve (12) to seventeen (17) years of age;

TREM for boys twelve (12) to seventeen (17) years of age;

TREM for individuals who are lesbian, gay, bisexual, transgender, questioning, intersex, or asexual (groups for either individuals under eighteen (18) or individuals eighteen (18) and over);

TREM for male Transition Aged Youth (TAY) ages sixteen (16) to twenty-five (25) years of age; and

TREM for female TAY sixteen (16) to twenty-five (25) years of age.

3429.3 Due to the sensitive nature of the discussions, TREM requires at least two (2) facilitators to be assigned to every group to ensure the safety and continuity of the group. At least one (1) facilitator shall be an independently licensed qualified practitioner. A team approach is required to: address situations that may arise within the group; decrease burnout; provide continuity if one facilitator is absent; and to lend additional therapeutic support to the group. Qualified practitioners staff working as facilitators shall have completed Department-approved, population-specific TREM training.

3429.4 TREM may be provided without prior authorization from the Department.

3429.5 TREM shall not be billed on the same day as:

Rehabilitation Day Services;

Intensive Day Treatment;

CBI Level II and III; or

ACT.

3429.6 TREM shall be provided:

At the MHRS provider’s service site; or

In a residential facility of sixteen (16) beds or less unless otherwise stated by the Department.

3429.7 Qualified Practitioners of TREM are:

Psychiatrists;

Psychologists;

LICSWs;

APRNs with psychiatry as a specialty area of practice;

LMFTs;

LPCs;

LISWs;

LGSWs;

LGPCs; and

Psychology Associates.

3429.8 Certified Recovery Coaches, Certified Peer Specialists, and Certified Addiction Counselors I and II who have successfully completed a TREM group and Department-approved TREM training shall be authorized to support TREM services under the supervision of the two (2) group facilitators.

History

SOURCE: Final Rulemaking published at 67 DCR 10674 (September 4, 2020); as amended by Final Rulemaking published at 70 DCR 003050 (March 10, 2023); as corrected by Errata Notice published at 71 DCR 004474 (April 19, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3429

22-A DCMR § 3430 TRAUMA SYSTEMS THERAPY

3430.1 TST is a comprehensive, phase-based model for treating traumatic stress in children and adolescents that adds to individually-based approaches by specifically addressing the child’s social environment and/or system of care. TST is designed to provide an integrated highly coordinated system of services guided by the specific understanding of the nature of child traumatic stress. TST focuses on the interaction between the child’s difficulties regulating their emotions and the deficits within the child’s social environment. The three phases of the model are Safety-Focused, Regulation-Focused, and Beyond Trauma.

3430.2 On average, individual TST sessions are one (1) to three (3) sessions per week, depending on the phase of treatment. Sessions are on average forty-five (45) to sixty (60) minutes in duration.

3430.3 TST is intended for children and youth six (6) through eighteen (18) years of age, who have:

Been exposed to trauma;

Plausible trauma histories;

Difficulty regulating emotional and behavioral states;

Dysregulation that is plausibly related to the trauma history; and

Stable housing or a plan to achieve stable housing in the community.

3430.4 At a minimum, the TST team shall include:

A TST-trained supervisor who provides the clinical and administrative supervision of the TST team. The supervisor shall be an independently licensed qualified practitioner experienced in providing individual, group, marital, or family counseling or psychotherapy;

Access to a psychiatrist to monitor each youth’s clinical status and response to treatment, and to direct psychopharmacologic treatment or consult with the consumer’s psychopharmacologic treatment team. The psychiatrist shall be knowledgeable in TST (“be TST-informed”);

TST-trained therapists who provide individual therapy. Therapists shall hold a Master’s degree in psychology, social work, counseling, or other related field and shall be appropriately licensed by the jurisdiction where services are delivered and practice within the scope of their license.

TST-trained individuals who are qualified practitioners of Community-Based Intervention or who are credentialed to provide Community Support to provide crisis support, care coordination, skills building, and TST treatment plan support; and

Individuals who provide Legal Advocacy Support and who are knowledgeable in TST (“are TST-informed”).

3430.5 All TST supervisors and therapists shall have completed DBH-approved TST training.

3430.6 Providers of TST services shall maintain certification as a TST provider from a DBH-approved training entity.

3430.7 TST may be provided without prior authorization from the Department.

3430.8 TST shall not be billed on the same day as:

Counseling;

Rehabilitation Day Services;

IDT;

FFT;

ACT;

CPP; or

TF-CBT.

3430.9 TST shall be provided:

At the MHRS provider’s service site; or

In natural settings, including the consumer’s home or community settings.

3430.10 Qualified Practitioners of TST are:

Psychiatrists;

Psychologists;

LICSWs;

APRNs with psychiatry as a specialty area of practice;

LMFTs;

LPCs;

LGSWs;

LGPCs;

LISWs; and

Psychology Associates.

3430.11 Services provided by qualified practitioners who are subject to supervision requirements, per applicable licensing and registration laws and regulations, shall be supervised by a qualified practitioner who is:

Licensed to practice independently, and

Trained in TST, as required by this chapter’s TST requirements.

History

SOURCE: Final Rulemaking published at 67 DCR 10674 (September 4, 2020); as amended by Final Rulemaking published at 70 DCR 003050 (March 10, 2023); as corrected by Errata Notice published at 71 DCR 004474 (April 19, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3430

22-A DCMR § 3431 FUNCTIONAL FAMILY THERAPY

3431.1 FFT is an evidence-based proprietary therapeutic service for youth and their families to prevent youth who are already involved or at risk of becoming involved in the juvenile justice system from further penetrating the system. FFT is a strength-based model that focuses on the risk and protective factors that impact the adolescent, family and their environment. FFT providers shall ensure that services are provided in accordance with FFT fidelity standards and maintain an acceptable rating on all FFT fidelity audits.

3431.2 The FFT model adopts a phase-based approach, which must include the following phases:

Engagement;

Motivation;

Relational Assessment;

Behavioral Change; and

Generalization.

3431.3 FFT is available to youth ages eleven (11) years old to eighteen (18), who meet at least one (1) criteria from the first category, and both of the criteria from the second category:

First category:

Have a documented history of moderate to serious behavioral problems which impair functioning in at least one (1) area (for example school or home);

Exhibit significant externalizing behavior which impairs functioning in at least one (1) area (for example school or home); or

Be at risk of a disruption in placement; and

Second category:

Be willing to participate with service providers for the duration of FFT treatment services; and

Be involved with a caregiver who is willing to participate with service providers for the duration of FFT treatment services.

3431.4 To qualify for FFT, youth must be residing with or returning within thirty (30) calendar days to the home of the family/caregiver who is willing to participate in FFT treatment services.

3431.5 FFT is not appropriate for:

Children or youth who require the safety of a hospital or other secure setting;

Children or youth in congregate living programs; or

Children or youth in an emergency or respite placement.

3431.6 Eligible providers of FFT services shall:

Be certified as an FFT provider by FFT LLC;

Comply with the FFT trainings and site certification requirements specified by the Department;

Have the capacity to deliver FFT services to at least ten (10) to twelve (12) consumers for each therapist;

Be available to work a flexible schedule based on the needs of the consumer and the family or caregiver; and

Develop a crisis intervention plan for after-hours response, which shall include a Mobile Crisis Response Team.

3431.7 Each FFT Team shall include:

An FFT-trained supervisor who provides the clinical and administrative

supervision of the FFT Team and has the capacity to carry up to five (5)

cases; and

Three (3) to eight (8) FFT clinicians who have satisfied the FFT

requirements for a therapist.

3431.8 The FFT supervisor shall be a Master’s level independently licensed qualified practitioner pursuant to § 3431.12 practicing within the scope of their license and experienced in providing individual, group, marital, or family counseling or psychotherapy. The FFT supervisor shall have a minimum of two (2) years of post-graduate experience working with behaviorally challenged youth and their families in community-based settings and must have satisfied the FFT requirement for a clinical supervisor.

3431.9 FFT clinicians shall be qualified practitioners pursuant to § 3431.12 practicing within the scope of their license and have a minimum of one (1) year of experience working with behaviorally challenged youth and their families in community-based settings. FFT clinicians must satisfy all FFT requirements for FFT therapists.

3431.10 FFT shall be provided in the family home or an outpatient clinic.

3431.11 FFT shall not be billed on the same day as:

CBI;

Community Support;

TF-CBT; or

TST.

3431.12 Qualified practitioners of FFT are:

Psychiatrists;

Psychologists;

LICSWs;

APRNS;

LPCs;

Psychology Associates;

LISWs;

LMFTs;

LGSWs; and

LGPCs.

History

SOURCE: Final Rulemaking published at 67 DCR 10674 (September 4, 2020); as amended by Final Rulemaking published at 69 DCR 013495 (November 4, 2022); as amended by Final Rulemaking published at 70 DCR 003050 (March 10, 2023); as corrected by Errata Notice published at 71 DCR 004474 (April 19, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3431

22-A DCMR § 3432 CLINCIAL CARE COORDINATION

Clinical Care Coordination (CCC) adopts a “whole-person” approach to address the consumer’s needs related to their physical health, behavioral health, and social determinants of health. CCC involves coordination of care between the behavioral health clinician and the clinical personnel of an external provider (e.g., primary care, another behavioral health provider, payors, behavioral health authority, hospital).

CCC is essential to ensuring that consumers receive both the appropriate level of care and that there is continuity of care when transitioning to a different level of care or to new providers of care. The reconciliation of medications, where appropriate, is a vital component of CCC.

CCC may be rendered by a qualified practitioner pursuant to § 3432.8 practicing within the scope of their license in person or through telehealth in accordance with 29 DCMR § 910.

Qualified practitioners providing CCC shall:

Communicate treatment needs, assessments and treatment information to healthcare providers external to the consumer’s CSA or specialty provider;

Facilitate appropriate linkages for the consumer with other healthcare professionals external to the consumer’s CSA or specialty provider; and

Provide planning and Plan of Care implementation activities separate from the diagnostic assessment service when the clinician and consumer meet face-to-face or through telehealth pursuant to 29 DCMR § 910.

Providers must document CCC in an encounter note that meets the requirements of § 3413.19 and indicates the intended purpose of the service, the modality of communication, time spent reviewing or preparing records, the actions taken, and the result(s) achieved.

CCC shall be provided at a site pursuant to 29 DCMR § 910.7 or § 910.8.

The provider may only submit a claim for one (1) service if multiple practitioners participated in rendering the CCC service.

Qualified Practitioners of CCC are:

(a) Physicians;

(b) Psychologists;

(d) LGSWs;

(e) APRNs;

(f) Registered Nurses;

(g) LISWs;

(h) LPCs;

(i) Physician Assistants;

(j) Psychology Associates;

(k) LMFTs; and

(l) LGPCs.

History

SOURCE: Final Rulemaking published at 67 DCR 10674 (September 4, 2020); as amended by Final Rulemaking published at 70 DCR 003050 (March 10, 2023); as corrected by Errata Notice published at 71 DCR 004474 (April 19, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3432

22-A DCMR § 3433 BEHAVIORAL HEALTH ACCREDITATION

3433.1 Effective October 1, 2023, all MHRS providers shall obtain and maintain in good standing behavioral health accreditation with at least one (1) of the following organizations: the Commission on Accreditation of Rehabilitation Facilities (CARF), the Council on Accreditation (COA), or The Joint Commission (TJC).

3433.2 The timeline for MHRS providers to obtain accreditation in accordance with § 3433.1 shall be as follows:

By December 15, 2022, all MHRS providers must submit an accreditation application to CARF, COA, or TJC and provide proof of the submission to the Department;

By April 30, 2023, all MHRS providers must obtain a letter of good standing from CARF, COA, or TJC and submit a copy to the Department; and

By October 1, 2023, all MHRS providers must be fully accredited with CARF, COA, or TJC and submit proof of accreditation to the Department.

3433.3 Accreditation through CARF, COA, or TJC shall not provide a waiver to MHRS providers for any of the standards delineated in this chapter. The Department shall retain authority to monitor for and enforce compliance with all standards established in this chapter.

3433.4 In lieu of the requirement in 3433.1, all Clubhouse providers shall obtain and maintain in good standing Clubhouse International accreditation as set forth in Title 22-A DCMR § 3901.2.

History

SOURCE: Final Rulemaking published at 70 DCR 003050 (March 10, 2023); as corrected by Errata Notice published at 71 DCR 004474 (April 19, 2024); as amended by Final Rulemaking published at 72 DCR 008497 (August 1, 2025). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3433

22-A DCMR § 3434 REIMBURSABLE SERVICES

3434.1 Reimbursement for the provision of MHRS shall be on a per unit basis as indicated in § 3434.4.

3434.2 Each covered service shall have a unique billing code as established by the Department.

3434.3 The actual start and stop time of the service shall be used to calculate the duration of the service rounded to the nearest fifteen-minute unit.

3434.4 Reimbursement shall be limited as follows:

Mental Health Rehabilitation Services (MHRS)

LIMITATIONS AND SERVICE SETTING

BILLABLE UNIT OF SERVICE

Diagnostic

Assessment

One (1) every one hundred eighty (180) calendar days.

Additional units allowable when there is a significant change in the consumer’s mental health status.

Shall not be billed the same day as Assertive Community Treatment (ACT).

Provided only in an MHRS provider’s service site, home or community setting, or residential facility of sixteen (16) beds or less unless otherwise approved by the Department.

Per occurrence.

Medication/ Somatic Treatment

No annual limits.

Shall not be billed the same day as ACT or Intensive Day Treatment (IDT).

Provided only in an MHRS provider’s service site, home or community setting, via telemedicine, or in a residential facility of sixteen (16) beds or less unless otherwise stated by the Department.

Session length for Individual Medication/Somatic Treatment is as follows:

For new patients:

Fifteen (15) to twenty-nine (29) minutes;

Thirty (30) to forty-four (44) minutes;

Forty-five (45) to fifty-nine (59) minutes; and

Sixty (60) to seventy-four (74) minutes.

For existing patients:

Under ten (10) minutes;

Ten (10) to nineteen (19) minutes;

Twenty (20) to twenty-nine (29) minutes:

Thirty (30) to thirty-nine (39) minutes; and

Forty (40) to fifty-four (54) minutes.

Session length for Group Medication/Somatic Treatment unit is fifteen (15) minutes.

Counseling

No annual limits.

Shall not be billed the same day as IDT, Community Based Intervention (CBI), ACT, Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), or Trauma Systems Therapy (TST).

Shall not be billed during a Rehabilitation Day Services encounter.

Shall be rendered face-to-face, when consumer is present, unless there is adequate documentation to justify why the consumer was not present during the session.

May be provided in individual on-site, individual off-site, or group setting.

Provided only in an MHRS provider’s service site, home or community setting, via telemedicine, or in a residential facility of sixteen (16) beds or less unless otherwise stated by the Department.

Per occurrence

Community Support

Prior authorization required.

Shall be billed pursuant to § 3421.6.

Shall not be billed on the same day as ACT.

Individual Community Support shall not be billed during a Rehabilitation Day Services encounter.

Group Community Support shall not be billed on the same day as Rehabilitation Day Services.

Provided only in an MHRS provider’s service site, home, community setting or residential facility of sixteen (16) beds or less unless otherwise authorized by the Department.

Audio-only telemedicine shall be limited to six (6) units per one hundred eighty (180) day period, unless otherwise authorized by the Department. A provider may bill an additional 20 units of audio-only for collateral contacts, per one hundred and eighty (180) day period.

Fifteen (15) minutes. The District shall reimburse no more than six (6) units of service per day.

Crisis/ Emergency Services

No annual limits.

ACT providers shall not bill Crisis/Emergency Services when provided to one of their current consumers.

Provided only in an MHRS provider’s service site, home or community setting or via telehealth.

Provided by a Core Service Agency to their enrolled consumers.

Fifteen (15) minutes

Rehabilitation Day Services

Prior authorization required. Two hundred seventy (270) units within a one hundred eighty (180) day period. Additional units require supplemental authorization from the Department.

Each subsequent authorization shall not exceed two hundred and seventy (270) units within a one hundred and eighty (180) day period.

Shall not be billed on the same day as Group Community Support, IDT, TF-CBT, Trauma Recovery and Empowerment Model (TREM), TST, or Clubhouse.

Shall not be billed during a Counseling or Individual Community Support encounter.

Provided only in an MHRS provider’s service site.

One (1) hour. The District shall not reimburse more than six (6) hours of service per day.

IDT

Prior authorization required. Initial and subsequent authorizations shall not exceed seven (7) days at a time.

Shall not be billed on the same day as Medication/Somatic Treatment, Counseling, Rehabilitation Day Services, ACT, TF-CBT, TREM, TST, Clubhouse, or Supported Employment Services as defined in Title 22-A DCMR Chapter 37.

Provided only in an MHRS provider’s service site.

One (1) day (which shall consist of at least five (5) hours of IDT services, excluding appropriate time for breaks and administrative functions)

CBI

Prior authorization required for enrollment and continued stay (see § 3425 for details).

Shall not be billed on the same day as Counseling, ACT, FFT, or TF-CBT.

CBI Level II and III shall not be billed on the same day as TREM.

Provided only in an MHRS provider’s service site, or home or community setting.

Fifteen (15) minutes

ACT

Prior authorization required. Initial and subsequent authorizations shall not exceed six (6) calendar months.

Shall not be billed on the same day as Diagnostic Assessment, Medication/Somatic Treatment, Counseling, Community Support, IDT, CBI, FFT, TF-CBT, TREM, or TST.

ACT providers shall not bill Crisis/Emergency Services if provided to one of their current consumers.

ACT providers must deliver five (5) contacts per calendar month as defined in § 3426.19 and meet the requirements of § 3426.20 through § 3426.22 to receive the monthly rate.

Monthly rate

Child-Parent Psychotherapy (CPP)

May be provided without prior authorization.

Shall not be billed on the same day as TF-CBT or TST.

Provided only in an MHRS provider’s service site, home or community setting or residential facility of sixteen (16) beds or less unless otherwise approved by the Department.

Fifteen (15) minutes up to ninety (90) minutes once (1) per week

TF-CBT

May be provided without prior authorization.

Shall not be billed on the same day as Counseling, Rehabilitation Day Services, IDT, CBI, FFT, ACT, CPP, or TST.

Provided only in an MHRS provider’s service site, home or community setting, or residential facility of sixteen (16) beds or less unless otherwise approved by the Department.

Fifteen (15) minutes up to ninety (90) minutes once (1) per week

TREM

May be provided without prior authorization.

TREM shall not be billed on the same day as Rehabilitation Day Services, IDT, CBI Levels II and III, or ACT.

Provided only in an MHRS provider’s service site, or residential facility of sixteen (16) beds or less unless otherwise approved by the Department.

Fifteen (15) minutes

TST

May be provided without prior authorization.

TST shall not be billed on the same day as Counseling, Rehabilitation Day Services, IDT, FFT, ACT, CPP, or TF-CBT.

Fifteen (15) minutes

FFT

May be provided without prior authorization.

Shall not be billed on the same day as CBI, Community Support, TF-CBT or TST.

Fifteen (15) minutes

Clinical Care Coordination (CCC)

No annual limits.

May be provided without prior authorization.

ACT providers shall not bill CCC when provided to one of their current consumers.

May be provided in an MHRS provider’s service site, home or community setting, or via telehealth.

A provider may only claim one service if multiple clinicians from that provider agency participate in the CCC service.

Fifteen (15) minutes

Intensive Care Coordination (ICC)

Prior authorization required.

May be provided at the ICC provider’s service site; or in natural settings, including at the child/youth’s home or community settings; or at an out-of-home placement where the child/youth is pending discharge to the community.

Monthly rate

3434.5 All claims seeking Medicaid or local only reimbursement under this Chapter shall include the active NPI numbers for the certified provider and the rendering provider. The rendering provider is the staff member who provided the service.

History

SOURCE: Final Rulemaking published at 70 DCR 003050 (March 10, 2023); corrected by Errata Notice published at 70 DCR 014191 (October 27, 2023); as amended by Final Rulemaking published at 70 DCR 016660 (December 29, 2023); as corrected by Errata Notice published at 71 DCR 004474 (April 19, 2024); as amended by Final Rulemaking published at 72 DCR 002797 (March 14, 2025); as amended by Final Rulemaking published at 72 DCR 008497 (August 1, 2025); as amended by Final Rulemaking published at 72 DCR 014041 (December 19, 2025); as amended by Final Rulemaking published at 73 DCR 007822 (May 22, 2026). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3434

22-A DCMR § 3435 NON-REIMBURSABLE SERVICES

3435.1 Services not covered as MHRS include:

Room and board residential costs;

Inpatient hospital services, including hospital, nursing facility, intermediate care facility for individuals with intellectual disabilities, and institutions for mental diseases;

Transportation services;

Educational, vocational, and job training services;

Services rendered by parents or other family members;

Social or recreational services;

Screening and prevention services (other than those provided under Early and Periodic Screening, Diagnosis, and Treatment requirements);

Services that are not medically necessary;

Services that are not provided and documented in accordance with these certification standards;

Services that are not behavioral health services as described in these rules; and

Services furnished to persons other than the consumer, when those services are not directed primarily to the well-being and benefit of the consumer.

History

SOURCE: Final Rulemaking published at 70 DCR 003050 (March 10, 2023); as corrected by Errata Notice published at 71 DCR 004474 (April 19, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3435

22-A DCMR § 3436 INTENSIVE CARE COORDINATION

3436.1 ICC is a comprehensive, holistic, child/youth, and family-driven approach to case management for children and youth experiencing behavioral health challenges. ICC services shall be delivered according to the National Wraparound Initiative (NWI) High Fidelity Wraparound model. ICC services shall be provided to fidelity to the NWI model. Each ICC provider shall maintain a passing fidelity score using the Wraparound Fidelity Index.

3436.2 ICC services shall be delivered through a Wraparound Team Meeting (WTM) process. ICC shall support the child/youth and their family in defining a family vision and goals and in developing creative and individualized services and supports to help the family achieve their goals and vision. The Wraparound Team shall work directly with the child/youth and their family (including biological, kin, foster, adoptive, and fictive) to develop, implement, track, and adapt a family-driven and child/youth-guided individualized plan of care (IPC) that identifies goals and the appropriate strategies to reach the goals.

3436.3 ICC services shall be customized to each child/youth and their family and responsive to the family’s strengths, using a combination of formal and informal supports. ICC services shall involve the coordination, to the extent consistent with applicable law, of a broad range of services and supports across multiple systems, including the behavioral health system, the child welfare system, and the juvenile justice system.

3436.4 ICC services may include the coordination of Medicaid-reimbursable services such as MHRS, SUD Treatment and Recovery Services, Crisis Services, peer supports, social services, and educational services; and non-Medicaid reimbursable services paid through a child/youth’s flexible funding allotment.

3436.5 ICC service components shall include:

A comprehensive assessment;

Child/youth and family-driven identification of appropriate members for the Wraparound Team;

Development of the IPC in collaboration with the child/youth, family, and collateral contacts;

Development of a Crisis Safety Plan;

Regular contact between the care coordinator and the family, the child/youth (where appropriate) and other relevant persons in the child/youth’s life;

Facilitation of WTM at least monthly;

Face to face contact with the child/youth and family, and the ICC Care Coordinator, weekly;

Referrals to other appropriate behavioral health services and supports including housing;

Identification and development of natural supports, such as family and friends;

Assistance with navigation of other services, including social services, medical services, and educational services;

Family engagement and orientation, including family education and advocacy services and support; and

Monitoring, reviewing, and updating the IPC to reflect the changing needs of the child/youth and family.

ICC providers shall be community-based, culturally and linguistically competent and able to meet the changing needs of a child/youth and their family.

Children/youth eligible to receive ICC services shall:

Be under age twenty-two (22);

Exhibit significant functional impairment across life domains as reflected in the Department-designated standardized assessment tool; and

Exhibit at least one (1) of the following criteria:

Be at risk of placement outside of their home to include foster care, shelter care through the juvenile justice system, or a Psychiatric Residential Treatment Facility due to behavioral health needs as assessed by an independently licensed behavioral health practitioner or a school psychologist. In evaluating risk of being placed outside of home, the assessment shall evaluate the child/youth’s impairment in the following areas:

Self-Care – Basic hygiene, grooming or nutritional needs which are consistent with the maintenance of general health and wellness;

Community Functioning – Behaviors observed in the community related to personal judgement abilities and decision-making skills;

Social Relationships – The ability to maintain positive and effective relationship with peers and adults;

Family Functioning – The ability to maintain positive, healthy relationships with family members; or

School/Vocational/Work Functioning – The ability to function in the school or vocational setting. Impairment may be evidenced by poor school attendance, decline in productivity or maladaptive behavior in the school/vocational/work setting.

Be returning from a placement outside-of-home;

Receiving services or supports from two (2) or more District government agencies; or

Have had three (3) or more behavioral health hospitalizations within a six (6) month period.

3436.8 The ICC provider shall convene a Wraparound Team, which shall consist of, at a minimum, the following members:

The child/youth;

The ICC care coordinator;

The child/youth’s family, including fictive kin;

Any interested person the family wishes to include as a member of the team, which may include clergy members, family friends, and other informal support resources;

The child/youth’s medical, behavioral, and community-based providers;

A clinical staff member who is directly involved in the treatment of the child/youth for whom the IPC is being developed, if desired by the family;

Representation from outside agencies with which the child/youth is involved, including current providers of services, parole/probation officers, or educators that the child/youth and their family agree to include; and

The Child and Family Services Agency (CFSA) social worker assigned to the child/youth, if the child/youth is receiving services from CFSA.

3436.9 Each ICC team shall be staffed by an ICC care coordinator and an ICC supervisor.

3436.10 The ICC provider shall assign an ICC care coordinator to a child/youth within seventy-two (72) hours of receipt of an approved referral for ICC services from the Department or its authorized designee.

3436.11 Within fourteen (14) calendar days of the child/youth’s referral to ICC services, the ICC care coordinator shall complete a comprehensive family narrative inclusive of family strengths.

3436.12 The ICC provider shall complete a comprehensive assessment for the child/youth at the initiation of ICC services and reassess the child/youth at least annually. The assessment shall include a comprehensive history for the child/youth with information from relevant third-party sources as appropriate. The assessment shall determine the child/youth’s need for linkages to medical, educational, or social services.

3436.13 Within thirty (30) calendar days of the child/youth’s referral to ICC services, the ICC care coordinator shall convene an initial WTM and complete an IPC. The IPC shall be based on findings of the comprehensive assessment and integrate individualized set of community services and natural supports to be wrapped around the child/youth and their family to achieve the desired outcomes. The Wraparound Team shall review and update the IPC during each monthly WTM, following any comprehensive assessment, and following any crisis, to ensure that it remains appropriate to meet the family’s goals and that services are furnished in accordance with the IPC. The IPC shall include a list of the child/youth’s goals and the medical, educational, and social services actions and referrals needed to achieve them.

3436.14 The ICC care coordinator will identify and actively assist the child/youth and family to obtain and monitor the delivery of available services to support the goals established in the child/youth’s IPC, including medical, educational, social, therapeutic, or other services. The ICC care coordinator will collaborate with the other service providers and agencies (if involved) on the behalf of the child/youth and family to facilitate service delivery.

3436.15 The ICC care coordinator shall meet at least weekly with the child/youth and their family to discuss progress towards the goals established in the IPC.

3436.16 The ICC provider shall work with the child/youth and family to develop an individualized Crisis Safety Plan for each child/youth within fourteen (14) calendar days of the child/youth’s initiation of ICC services, which may include utilization of twenty-four (24) hour Crisis Services through the Child Adolescent Mobile Psychiatric Services Crisis Team. The ICC provider shall respond twenty-four (24) hours a day seven (7) days a week to crises for child/youth and their family, including assisting in implementing the child/youth’s Crisis Safety Plan during a crisis.

3436.17 Each child/youth receiving ICC services may receive up to a one thousand dollar ($1,000.00) flexible funding allotment per calendar year as needed for non-Medicaid reimbursable services and supports that are included in their treatment plan. The ICC provider shall manage these funds to ensure they are used only to support individualized needs identified and delineated in the child/youth’s IPC.

3436.18 ICC shall be provided in natural settings including the child/youth’s home, school, community, the ICC provider site, or in any out of home placement where the child/youth is currently placed and pending discharge. The ICC provider shall accommodate WTM at times that are reasonably convenient for the child/youth and their family.

The ICC provider shall discharge the child/youth from ICC services when:

ICC services are no longer indicated for the child/youth pursuant to the District-approved functional assessment tool;

The child/youth’s clinical presentation indicates that ICC services are no longer appropriate; or

The child/youth or their family refuses to continue with ICC.

3436.20 The Wraparound Team shall begin transition planning from the start of enrollment in ICC. Within sixty (60) calendar days prior to a discharge, the Wraparound Team shall update the transition plan to ensure it aligns with the current IPC, the child/youth and family’s goals and preferences, and the availability of culturally responsive and appropriate community-based services for the child/youth and their family to support continued progress and/or maintenance. Transition services may include services and support already in place while involved in ICC.

3436.21 The ICC supervisor shall:

Provide clinical and administrative oversight to the ICC team; and

Ensure that ICC services are delivered according to NWI fidelity standards and the ten (10) NWI Principles of Wraparound, available from https://nwi.pdx.edu/NWI-book/Chapters/Bruns-2.1-(10-principles-of-wrap).pdf.

The ICC care coordinator shall ensure that the plan of care reflects the decisions of the Wraparound Team and detail tasks to complete to ensure that the child/youth and their family receive the supports identified in the IPC. The ICC care coordinator shall have a maximum case load of ten (10) children/youth at any time.

ICC care coordinators shall:

Possess a Bachelor of Arts or a Bachelor of Science degree in social work, psychology or related field and have a minimum of three (3) years of experience in a human services profession; or

Have at least four (4) years of employment in a human services profession.

ICC supervisors shall:

Possess a master’s degree in social work, psychology, or other related profession;

Be an independently licensed behavioral health practitioner;

Have at least five (5) years of experience in case management;

Have at least two (2) years of supervisory experience; and

Have a supervisory certification from the National Wraparound Implementation Center (NWIC) or be enrolled and completing the certification process while employed as an ICC supervisor.

ICC providers shall ensure that all ICC care coordinators and ICC supervisors meet all training requirements established by the Department in this chapter and are certified by NWIC, and shall not utilize an ICC care coordinator or ICC supervisor who does not meet those requirements or does not maintain that certification.

ICC providers shall not deliver services before receiving prior authorization from the applicable payor.

ICC services may include contacts with individuals other than the child/youth that are directly related to at least one (1) of the following:

Identifying the child/youth’s needs and care to help the child/youth access services;

Providing the ICC case coordinator or ICC supervisor with feedback; or

Alerting the ICC case coordinator or ICC supervisor to changes in the child/youth’s needs.

ICC providers shall maintain case records that document the following for all children/youth receiving ICC services:

The name of the child/youth receiving ICC services;

The dates that the child/youth received ICC services;

The name of the person(s) providing ICC services;

The nature, content, units of the case management services received and whether goals specified in the care plan have been achieved;

Whether the child/youth and family has declined services in the care plan;

The need for, and occurrences of, coordination with other case managers;

A timeline for obtaining needed services; and

A timeline for reevaluation of the plan.

3436.29 ICC providers shall submit all data to the Department in the form and format required by the ITE Provider Extract Companion Guide, which outlines the instructions for network providers to submit BHSD (available at https://dbh.dc.gov/).

3436.30 ICC providers whose services are reimbursable under Medicaid shall be reimbursed at a per member per month rate established by the DHCF on the Medicaid Fee Schedule (available at https://dhcf.dc.gov/).

History

SOURCE: Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3436

22-A DCMR § 3499 DEFINITIONS

3499.1 The following terms in this chapter have the meaning ascribed in this section:

Advanced Practice Registered Nurse (“APRN”) – A person licensed as an advanced practice registered nurse in accordance with applicable laws and regulations of the District or jurisdiction where services are delivered.

Assertive Community Treatment team (“ACT team”) – A mobile inter-disciplinary team of qualified practitioners and other staff involved in providing ACT to a consumer.

Authorized - MHRS services that are prior authorized or reauthorized by the Department, in accordance with these standards.

Behavioral Concern – A behavioral and emotional reaction of childhood and adolescence that can range from normal to severe responses and can be categorized as troubling, disruptive, or threatening. Behavioral concerns can have varying ranges of manifestations by children that include but are not limited to poor concentration, changes in social interactions, sadness, poor academic performance, high levels of irritability, acting out aggressively, expressing anger inappropriately, and engaging in a variety of antisocial and destructive acts, including violence towards people and animals, destruction of property, lying, stealing, truancy, and running away from home.

Certified Addiction Counselor (“CAC”) – A person certified as a Certified Addiction Counselor I or II in accordance with applicable laws and regulations of the District or jurisdiction where services are delivered.

Certification – The written authorization from the Department rendering an entity eligible to provide MHRS. The Department grants certification to community-based organizations that submit an approved certification application and satisfy the certification standards.

Certification Application – The application and supporting materials prepared and submitted to the Department by a community-based organization requesting a new certification or renewal of an existing certification to provide MHRS.

Certification Standards – The minimum requirements established by the Department in this chapter that a provider shall satisfy to obtain and maintain certification to provide MHRS and receive reimbursement from the District for MHRS.

Certified Peer Specialist – An individual who has completed the Peer Specialists Certification Program requirements and is approved to deliver Peer Support Services within the District’s public behavioral health network.

Certified Recovery Coach – An individual with any DBH-approved recovery coach certification.

Child and Family Services Agency (“CFSA”) – The District agency responsible for the coordination of foster care, adoption, and child welfare services and services to protect children against abuse or neglect.

Child-Parent Psychotherapy or CPP Fidelity Audit – A process by which the implementation of CPP, in accordance with the established standards and guiding principles, are annually evaluated.

Clinical Care Coordination (“CCC”) – Coordination of care between the behavioral health clinician and the clinical personnel of an external provider (e.g., primary care, another behavioral health provider, payors, behavioral health authority, hospital).

Collateral Contact – A contact by a qualified practitioner or credentialed staff with any person other than the consumer.

Community Based Intervention Team (“CBI team”) – The interdisciplinary team of qualified practitioners and other staff involved in providing CBI to a consumer.

Community Support – Rehabilitation and environmental supports considered essential to assist the consumer in achieving rehabilitation and recovery goals that focus on building and maintaining a therapeutic relationship with the consumer.

Individual Community Support – Community Support services provided for one (1) consumer.

Group Community Support – Community Support services provided in a group setting.

Consumer – A person eligible to receive MHRS as set forth in this chapter.

Core Services – The following six (6) categories of MHRS: Diagnostic Assessment, Medication/Somatic Treatment, Counseling, Community Support, Crisis/Emergency Services, and Clinical Care Coordination.

Core Services Agency (“CSA”) – A Department-certified community-based MHRS provider that has entered into a Human Care Agreement with the Department to provide specified MHRS.

Corrective Action Plan (“CAP”) – A written plan prepared by either an applicant for certification or the certified MHRS provider describing the actions that the provider intends to take to correct or abate the violations described in an SOD issued by the Department.

CPP Fidelity Standards – The six (6) established interconnected standards of fidelity, as set forth by the developers of CCP.

Credentialed Staff – Non-licensed staff or staff who are not qualified practitioners that are credentialed by the MHRS provider to perform certain MHRS or components of MHRS under the clinical supervision of an appropriate qualified practitioner.

Crisis Support Services – Mental health services that support the consumer through a crisis, such as meeting with the consumer in the community or an emergency department to help calm the consumer; implementing the crisis plan developed for the consumer; assisting the consumer to reach an emergency department; and providing pertinent mental health information about a consumer to an emergency department to assist in addressing a crisis.

Cultural and Linguistic Competence – The ability of an MHRS provider to deliver mental health services and mental health supports in a manner that effectively responds to the languages, values, and practices present in the various cultures of the MHRS provider’s consumers.

Cultural Responsiveness – Understanding and appropriately including and responding to the combination of cultural variables and the full range of dimensions of diversity that an individual brings to interactions.

Department (“DBH”) – The Department of Behavioral Health, the successor in interest to the Department of Mental Health and the Addiction and Prevention Recovery Administration.

Department of Health Care Finance (“DHCF”) – The District’s Medicaid authority.

Department of Youth Rehabilitation Services (“DYRS”) – The District agency responsible for providing security, supervision, and residential and community support services for committed and detained juvenile offenders and juvenile persons in need of supervision.

Diagnostic Assessment Report – The report prepared by an independently licensed qualified practitioner that summarizes the results of the Diagnostic Assessment service and includes recommendations for service delivery. The Diagnostic Assessment report is used to initiate the Plan of Care.

Director – The Director of the Department of Behavioral Health.

District of Columbia (“District”) – The government of the District of Columbia.

Economic Security Administration (“ESA”) – The unit within the District of Columbia Department of Human Services that determines eligibility for medical assistance programs for District residents.

Electronic Health Record (“EHR") – An electronic record of patient health information from one (1) or more encounters in any care delivery setting and meeting the requirement of a designated record set under 45 C.F.R. § 164.501.

Enrollment – Process by which the Department adds a consumer to the MHRS system of care and assigns them to a provider after ascertaining their eligibility.

Evidence-Based Practice – A process that brings together the best available research, professional expertise, and input from consumers to identify and deliver services that have been demonstrated to achieve positive outcomes for individuals. Evidence-based programs and practices (EBPPs) are specific techniques and intervention models that have shown to have positive effects on outcomes through rigorous evaluations.

Functional Family Therapy - An evidence-based proprietary therapeutic service for children, youth, and their families to prevent children and youth who are already involved or at risk of becoming involved with the juvenile justice system from further penetrating the system.

Governing Authority – The designated individuals or governing body legally responsible for conducting the affairs of the MHRS provider.

Grievance – A description by any individual of his or her dissatisfaction with an MHRS provider, including the denial or abuse of any consumer right or protection provided by applicable Federal and District laws and regulations.

Human Care Agreement (“HCA”) – A written agreement entered into by the certified MHRS provider and the Department which establishes a contractual relationship between the parties.

ICD-10 – The 10th Revision of the International Classification of Diseases and Related Health Problems.

Independent Living Program – A residential program licensed by the District in accordance with Title 29 DCMR Chapter 63, Licensing of Independent Living Programs for Adolescents and Young Adults.

Intensive Home and Community-Based Services or IHCBS – An intensive model of treatment adopted by the Department to prevent the utilization of out-of-home treatment resources by emotionally disturbed children and youth. IHCBS is the modality adopted for CBI Levels II and III.

Licensed Independent Clinical Social Worker (“LICSW”) – A person licensed as an independent clinical social worker in accordance with applicable laws and regulations of the District or jurisdiction where services are delivered.

Licensed Independent Social Worker (“LISW”) – A person licensed as a licensed independent social worker in accordance with applicable laws and regulations of the District or jurisdiction where services are delivered.

Licensed Graduate Professional Counselor (“LGPC”) – A person licensed as a licensed graduate professional counselor in accordance with applicable laws and regulations of the District or jurisdiction where services are delivered.

Licensed Graduate Social Worker (“LGSW”) – A person licensed as a licensed graduate social worker in accordance with applicable laws and regulations of the District or jurisdiction where services are delivered.

Licensed Marriage and Family Therapist (“LMFT”) – A person licensed as a licensed marriage and family therapist under laws and regulations of the District or jurisdiction where services are delivered.

Licensed Practical Nurse (“LPN”) – A person licensed as a practical nurse in accordance with applicable laws and regulations of the District or jurisdiction where services are delivered.

Licensed Professional Counselor (“LPC”) – A person licensed as a licensed professional counselor in accordance with applicable laws and regulations of the District or jurisdiction where services are delivered.

Long-Term Placement Option – A permanent caregiver or permanent home. A group home or other residential placement is not a long-term placement option.

Medicaid – The medical assistance program approved by federal Centers for Medicare and Medicaid Services and administered by the Department of Health Care Finance, which enables the District to receive Federal financial assistance for its medical assistance program and other purposes as permitted by law.

Medical Necessity (or medically necessary) – Health care services or products that a prudent provider would provide to a client for the purpose of preventing, diagnosing, or treating an illness, injury, disease, or its symptoms in a manner that is: (a) in accordance with generally accepted standards of health care practice; (b) clinically appropriate in terms of type, frequency, extent, site, and duration; and (c) not primarily for the economic benefit of the health plans and purchasers or for the convenience of the client or treating provider.

Member – A consumer who has joined a Psychosocial Rehabilitation Clubhouse.

Mental Health Rehabilitation Services (“MHRS”) – Mental health rehabilitative services provided by a certified MHRS provider to consumers in accordance with the District of Columbia State Medicaid Plan, the Department Memorandum of Understanding with the Department of Health Care Finance and this chapter.

Mental Illness – A substantial disorder of thought, mood, perception, orientation, or memory that grossly impairs judgment, behavior, capacity to recognize reality, or ability to meet the ordinary demands of life.

MHRS Provider – An organization certified by the Department to provide MHRS. MHRS provider are CSAs, sub-providers, and specialty providers.

Mobile Crisis Response Team – A team of mental health clinicians who provide face-to-face and telephone support to children and families in crisis.

Multisystemic Therapy (“MST”) – An intensive model of treatment based on empirical data and evidence-based interventions that target specific behaviors with individualized behavioral interventions.

Natural Settings – The consumer’s home; the consumer’s residence, school, or workplace; or other locations in the community the consumer frequents, such as community centers, homeless shelters, street locations, or other public facilities. Natural settings do not include inpatient hospitals.

Natural Support – A non-professional person (including but not limited to a family member, friend, or employer) who supports a consumer in their treatment and recovery as outlined in the consumer’s person-centered Plan of Care.

Organizational Onboarding – The mechanism through which new employees acquire the necessary knowledge, skills, and behaviors to become effective performers. It begins with recruitment and includes a series of events, one of which is employee orientation, which helps new employees understand performance expectations and contribute to the success of the organization.

Out-of-home therapeutic resource – A psychiatric hospital or psychiatric residential treatment facility.

Permanent Caregiver – A natural or adoptive family or foster home that has cared for the consumer for at least six (6) consecutive months within the twelve (12) month period immediately preceding the referral for CBI. A group home or other residential placement is not a permanent caregiver.

Physician Assistant – A person licensed as a physician assistant in accordance with applicable laws and regulations of the District or jurisdiction where services are delivered.

Plan of Care (formerly called the Individual Plan of Care / Individual Recovery Plan) – The Plan of Care refers to what the DBH formerly called the IPC/IRP, and encompasses the provision of services to all consumers regardless of age.

Prior Authorization – Approval by the Department in advance for the initiation of an MHRS to a consumer.

Psychiatric residential treatment facility – Shall have the meaning ascribed in 42 CFR Subpart G, Section 483.352.

Psychiatrist – A person who is: 1) licensed as a physician in accordance with applicable laws and regulations of the District or jurisdiction where services are delivered; 2) a psychiatric resident providing care in an approved clinical rotation; or 3) a moonlighting psychiatric resident.

Psychologist – A person licensed as a psychology in accordance with applicable laws and regulations of the District or jurisdiction where services are delivered.

Psychology Associate – A person registered as a psychology associate in accordance with applicable laws and regulations of the District or jurisdiction where services are delivered.

Psychosocial Rehabilitation Clubhouse (“Clubhouse”) – MHRS specialty service that assists individuals with behavioral health diagnoses to develop social networking, independent living, budgeting, self-care, and other skills that will assist them to live in the community and to prepare for securing and retaining employment. A Clubhouse shall operate in accordance with established standards coordinated by Clubhouse International and the standards set forth in 22-A DCMR Chapter 39.

Qualified Practitioner – A Qualified Practitioner is a behavioral health clinician appropriately licensed, certified, or registered in the District with Department of Health or in the jurisdiction where services are delivered. Pursuant to service specific MHRS standards a qualified practitioner may practice MHRS within the scope of their license, certification, or registration, and any applicable supervision requirements.

Referral – A recommendation to seek or request services or evaluation between a CSA and a sub-provider or specialty provider in order to assess or meet the needs of consumers.

Registered Nurse (“RN”) – A person licensed as a registered nurse in accordance with applicable laws and regulations of the District or jurisdiction where services are delivered.

Residential Placement – A psychiatric residential treatment center, group home, independent living program, or other residence where children or youth are temporarily receiving services. A permanent home is not a residential placement.

Service specific standards – The certification standards described in §§ 3418 through 3430, which set forth the specific requirements applicable to each MHRS.

Specialty Provider – An MHRS provider certified by the Department to provide specialty services either directly or through contract.

Specialty Services – Assertive Community Treatment, Child-Parent Psychotherapy, Community Based Intervention, Functional Family Therapy, Psychosocial Rehabilitation Clubhouse, Intensive Day Treatment, Rehabilitation Day Services, Trauma-Focused Cognitive-Behavioral Therapy, Trauma Recovery and Empowerment Model, and Trauma Systems Therapy.

Statement of Deficiencies (“SOD”) – A written statement of non-compliance issued by the Department, which describes the areas in which an applicant for certification or the certified provider fails to comply with the certification standards.

Subcontractor – A licensed independent practitioner qualified to provide mental health services in the District or in the jurisdiction in services are provided. A subcontractor may provide one (1) or more core service(s) under contract with a CSA. A subcontractor may also provide specialty service(s) under contract with a specialty provider.

Sub-provider – A community-based organization certified by the Department to provide one (1) or more core services.

Supported Employment Services – Evidence-based Mental Health Supported Employment program designed for MHRS consumers for whom competitive employment has been interrupted or is intermittent as a result of a severe mental illness. Services assist consumers in obtaining and maintaining permanent part-time or full-time employment in a competitive setting. Mental Health Supported Employment service providers shall be certified and deliver services to eligible consumers according to standards set forth in 22-A DCMR Chapter 37.

TF-CBT Practice Session Checklist – An instrument used to track whether supervisors and therapists are implementing TF-CBT in accordance with the established model.

Triaging – Prioritizing the level of crisis services required by a consumer, based upon the assessed needs of the consumer.

Urgent need – A situation where, due to a mental illness, there is no immediate risk to life, health, or property, but if the situation is not addressed promptly may turn into an emergency situation. An emergency situation is where a consumer is an immediate risk to life, health, or property due to a mental illness.

History

SOURCE: Final Rulemaking published at 48 DCR 10297 (November 9, 2001); as amended by Final Rulemaking published at 51 DCR 9308 (October 1, 2004); as amended by Final Rulemaking published at 52 DCR 5682 (June 17, 2005); as amended by Final Rulemaking published at 53 DCR 9197 (November 10, 2006); as amended by Final Rulemaking published at 57 DCR 10392, 10406 (November 5, 2010); as amended by Emergency and Proposed Rulemaking published at 58 DCR 1482 (February 18, 2011) [EXPIRED]; as amended by Final Rulemaking published at 58 DCR 3476, 3482 (April 22, 2011); as amended by Final Rulemaking published at 58 DCR 8366, 8370 (September 30, 2011); as amended by Final Rulemaking published at 59 DCR 4785, 4787 (May 11, 2012); as amended by Final Rulemaking published at 60 DCR 12909 (September 13, 2013); as amended by Final Rulemaking published at 61 DCR 5415 (May 30, 2014); as amended by Final Rulemaking published at 66 DCR 5638 (May 3, 2019); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021); as amended by Final Rulemaking published at 70 DCR 003050 (March 10, 2023); as amended by Final Rulemaking published at 70 DCR 016660 (December 29, 2023); as corrected by Errata Notice published at 71 DCR 004474 (April 19, 2024); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024); as amended by Final Rulemaking published at 73 DCR 007822 (May 22, 2026). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3499

22-A35 CHILD CHOICE PROVIDER CERTIFICATION STANDARDS

22-A DCMR § 3500 GENERAL PROVISIONS

3500.1 These rules establish the requirements and process for certification of a Core Services Agency (CSA) as a Child Choice Provider (CCP) in the District of Columbia.

3500.2 Each CCP must demonstrate an understanding of and experience in family-centered practice, which includes ensuring communication when appropriate with natural parents or legal guardians as well as foster parents and kinship caregivers. Family-centered practice will be demonstrated through family engagement and involvement in all levels of the treatment-planning process, as well as family voice and choice in the treatment and services their children receive. Service delivery is family-driven.

History

SOURCE: Final Rulemaking published at 61 DCR 4398 (May 2, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3500

22-A DCMR § 3501 ELIGIBLE CONSUMERS

3501.1 Eligible consumers of CCP services include the following:

(a) Children and youth consumers determined to need MHRS services; and

(b) The families of eligible children and youth.

3501.2 Priority for mental health services by a CCP will be given to children and youth who have neglect or juvenile cases within the D.C. Superior Court system (court-involved children and youth) or are also receiving services from the DC Child and Family Services Agency (CFSA).

History

SOURCE: Final Rulemaking published at 61 DCR 4398 (May 2, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3501

22-A DCMR § 3502 CCP PROVIDER QUALIFICATIONS

3502.1 In order to be eligible for CCP certification, a provider shall meet all of the following standards:

(a) Be an active Department of Behavioral Health (DBH)-certified CSA in accordance with Chapter 34 of this title;

Be certified to provide at least one level of MHRS - Community-Based Intervention (CBI) services;

Have at least three (3) years’ experience providing mental health services to a minimum of 100 individual children in the DC metropolitan area;

Have demonstrated an acceptable level of quality of care as a CSA through compliance with at least three of the following standards:

Achieve a minimum standard of at least 70% overall Community Service Review (CSR) System Performance score in the most recent CSR prior to application, and have a written goal and supporting work plan to reach and maintain an 80% system performance score, if not already achieved;

Achieve a minimum quality score of 80% on the most recent DBH MHRS Core Service Agency Provider Scorecard prior to application;

Demonstrate an average of 80% compliance administration rate for the quarter prior to application of the utilization of the DBH approved standardized assessment instrument for enrolled child/ youth consumers and include a plan on how the agency shall maintain 80% compliance;

Demonstrate that within the six (6) months prior to the application, 70% of enrolled consumers discharged from an acute care facility receive a post-discharge appointment within seven days, and 80% of consumers discharged from an acute care facility receive a post-discharge appointment within 30 days;

Demonstrate that within the six (6) months prior to the application, 80% of Diagnostic and Assessment reports for all children are completed within 30 days of the initial interview.

3502.2 Within the first year of certification, a CCP must be:

Approved by DBH to provide at least one evidence-based practice described in Subsection 3504.1; and

Certified as a Free Standing Mental Health Clinic (FSMHC).

3502.3 The CCP shall notify DBH immediately of any changes in its operation that affect the CCP’s continued compliance with these certification standards, including changes in ownership or control, changes in service, and changes in its affiliation and referral arrangements.

3502.4 The Director may revoke certification if the CCP fails to comply with any certification standard under Subsection 3502.1, or is no longer qualified to provide an evidenced-based practice listed in Subsection 3504.1.

3502.5 Certification shall be considered terminated and invalid if the CCP fails to apply for renewal of CCP certification 90 days prior to the expiration date of the current CCP certification, voluntarily relinquishes CCP certification, goes out of business, or loses its certification as a CSA.

3502.6 If a CCP loses certification as a CCP, its status as CSA will not be affected as long as the CSA maintains compliance with the certification requirements for CSAs as described in Chapter 34 of this title.

History

SOURCE: Final Rulemaking published at 61 DCR 4398 (May 2, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3502

22-A DCMR § 3503 CCP CERTIFICATION PROCESS

3503.1 Each applicant seeking certification as a CCP shall submit a CCP certification application to the DBH in the format established by the DBH Office of Accountability. The completed application shall include:

(a) Proof of current certification as a CSA;

(b) Proof of meeting certification standards listed in Section 3502 of this chapter; and

3503.2 The certification process for organizations seeking to be certified as CCPs will be conducted in accordance with Section 3401 of Chapter 34 of this title.

3503.3 The Director may restrict the number of CCP certification applications to be accepted for consideration based upon the needs of the public mental health system.

3503.4 An applicant for CCP certification that fails to comply with the certification standards shall receive a corrective measures plan (CMP) from DBH and shall submit a written corrective action plan (CAP) in accordance with Section 3401 of Chapter 34 of this title. If a CMP is issued, the procedures of Section 3401 of Chapter 34 of this title shall be followed to bring the CCP into compliance and continue the certification process. The Director may deny certification if the applicant fails to satisfy the CMP or complete the certification requirements.

3503.5 A CCP shall be certified for a period of two (2) calendar years from the date that the certification is issued, subject to the CCP’s continuous compliance with these certification standards. Certification shall remain in effect until it expires or is revoked. Certification shall specify the effective date of the certification, and the types of services the CCP is certified to provide.

3503.6 Certification is not transferable to any other organization.

History

SOURCE: Final Rulemaking published at 61 DCR 4398 (May 2, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3503

22-A DCMR § 3504 CCP EVIDENCE-BASED PRACTICES TO BE PROVIDED AS CLINICAL INTERVENTION SERVICES

3504.1 Specific Evidence-Based Practices (EBPs) to be provided by CCPs shall include one (1) or more of the following:

(a) Multi-Systemic Therapy (MST) and Multi-Systemic Therapy for Youth with Problem Sexual Behavior (MST-PSB);

Functional Family Therapy (FFT);

Child-Parent Psychotherapy for Family Violence (CPP-FV);

Trauma-Focused Cognitive Behavioral (TF-CBT);

Transition to Independence (TIP); and

Trauma Systems Therapy (TST)

History

SOURCE: Final Rulemaking published at 61 DCR 4398 (May 2, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3504

22-A DCMR § 3505 CHILD CHOICE PROVIDER RESPONSIBILITIES

3505.1 Each CCP must maintain the required staffing and practices to satisfy the evidence-based practice standards for the respective EBP(s) that they practice. Adherence to prescribed staffing requirements and nationally established fidelity standards to each respective model service delivery is a condition of recertification. Failure to maintain the standards required for the EBPs identified by the CCP as a provided service may result in a CAP or decertification.

3505.2 Each CCP shall conduct ongoing assessments as follows:

Each enrolled child and youth must receive a Diagnostic/Assessment in accordance with the requirements of Section 3415 of Chapter 34 of this title within seven (7) business days of enrollment to a new provider;

The written report from the Diagnostic/Assessment shall be completed within ten (10) business days from the date of the diagnostic interview;

The Diagnostic/Assessment must include a completed DBH approved standardized assessment instrument for each child consumer. The DBH approved standardized assessment instrument shall be administered in accordance with DBH policy; and

(d) CCPs shall ensure that all enrolled children and youth and their families receive collaborative team-based planning process for service delivery in accordance with DBH policy on teaming.

3505.3 The CCP shall adhere to the DBH policy on continuity of care practice guidelines for children and youth.

3505.4 For court involved children and youth, each CCP shall participate in the teaming process established by the court-identified lead agency for the child.

(a) The teaming process may occur at the point of placement, at placement disruptions, or at regular intervals in the process of serving the family, and whenever there is a concern that the family’s or the child’s needs are not being met.

(b) CCP clinicians shall participate in all team meetings of children on their caseloads or with whom they have existing clinical relationships.

3505.5 A CCP shall ensure that the as a child or youth’s needs change, the child or youth’s individual plans of care are tracked, revised and adjusted as needed to ensure needs are addressed appropriately.

History

SOURCE: Final Rulemaking published at 61 DCR 4398 (May 2, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3505

22-A DCMR § 3506 REVOCATION OF CERTIFICATION

3506.1 If Certification is revoked, DBH will issue a notice of revocation, giving the CCP provider the effective date of the revocation, the reasons for the revocation, and explaining the right to an administrative review under this subsection.

3506.2 If Certification is revoked, the CCP provider may request an administrative review from DBH within fifteen (15) business days of the date on the notice of revocation.

3506.3 Each request for an administrative review shall contain a concise statement of the reason why the CCP provider should not have the certification revoked, with supporting documentation, if available.

3506.4 Each administrative review shall be conducted by the Director and shall be completed within fifteen (15) business days of the receipt of the CCP provider’s request.

3506.5 The Director shall issue a written decision which sets forth his or her evaluation and resolution of the request. If a CCP provider does not agree with the Director’s decision, the CCP provider may request a hearing under the D.C. Administrative Procedure Act. This hearing shall be limited to the issues raised in the administrative review request.

History

SOURCE: Final Rulemaking published at 61 DCR 4398 (May 2, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3506

22-A DCMR § 3599 DEFINITIONS

“Child-Parent Psychotherapy for Family Violence or “CPP-FV” – a relationship-based treatment intervention for young children with a history of trauma exposure or maltreatment, and their caregivers.

“Child Choice Provider” or “CCP” – a Mental Health Rehabilitation Service (MHRS) Core Service Agency (CSA) with a demonstrated ability to provide quality, evidence-based, innovative services and interventions to meet the most complex and changing needs of children, youth, and their families in the District, particularly those who have histories of abuse or neglect.

"Core Services Agency" or "CSA" - a DBH-certified community-based MHRS provider that has entered into a Human Care Agreement with DBH to provide specified MHRS. A CSA shall provide at least one core service directly and may provide up to three core services via contract with a sub-provider or subcontractor. A CSA may provide specialty services directly if certified by DBH as a specialty provider. However, a CSA shall also offer specialty services via an affiliation agreement with all specialty providers.

“Evidence-Based Practice” or “EBP” - preferential use of mental and behavioral health interventions for which systematic empirical research has provided evidence of statistically significant effectiveness as treatments for specific problems.

“Family” – consists of two or more people, one of whom is the householder, related by birth, marriage, or adoption and residing in the same housing unit. A family consists of all people who occupy a housing unit regardless of relationship. A family may consist of a person living alone or multiple unrelated individuals or families living together.

“Family Team” - family members and their community supports that come together to create, implement a plan with the child/youth and family. The plan builds on strength of the child/youth and family and addresses their needs, desires, and dreams.

“Functional Family Therapy” or “FFT” – an outcome-driven prevention/intervention program integrating clinical theory, home engagement, and sustaining strategies for at-risk youth ages 11-18 who have presented issues with delinquency, violence, substance abuse, conduct disorder, oppositional defiant disorder, or disruptive behavior disorder.

“Multi-Systemic Therapy or “MST” and “Multi-Systemic Therapy for Youth with Problem Sexual Behavior” or “MST-PSB” - an intensive family-and community-based treatment program that focuses on the entire world of chronic and violent juvenile offenders — their homes and families, schools and teachers, neighbourhoods and friends. MST-PSB is a clinical adaptation of Multi-Systemic Therapy (MST) that is specifically targeted to adolescents who have committed sexual offenses and demonstrated other problem behaviors. The primary objectives of MST-PSB are to decrease problem sexual and other antisocial behaviors and out-of-home placements.

“Teaming” - A process by which a group of individuals, who the family believes can help them, along with individuals who represent agencies which provide services to the family, form a working team that meets, develops and implements a plan of care that will assist the child and family to achieve their vision of the future.

“Transition to Independence Process” or “TIP” - A community-based evidence supported model which improves outcomes of youth and young adults with emotional and/or behavioral difficulties. The TIP system prepares youth and young adults for their movement into adult roles through an individualized process, engaging them in their own futures planning process, as well as providing developmentally-appropriate services and supports.

“Trauma-Focused Cognitive Behavioral Therapy” or “TF-CBT” - a model of psychotherapy that combines trauma-sensitive interventions with cognitive behavior therapy to address the bio-psychosocial needs of children diagnosed with Post Traumatic Stress Disorder (PTSD) or other problems related to traumatic life experiences. TF-CBT designed to help children, youth, and their parents overcome the negative effects of traumatic life events such as child sexual or physical abuse; traumatic loss of a loved one; domestic, school, or community violence; or exposure to disasters, terrorist attacks, or war traumas.

“Trauma Systems Therapy” or “TST” - a mental health treatment model for children and adolescents who have been exposed to trauma, defined as experiencing, witnessing, or confronting "an event or events that involved actual or threatened death or serious injury, or a threat to the physical integrity of self or others". TST focuses on the child's emotional and behavioral needs as well as the environments where the child lives (home, school, community).

History

SOURCE: Final Rulemaking published at 61 DCR 4398 (May 2, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3599

22-A36 CHILD CHOICE PROVIDERS - SPECIALIZED SERVICES AND REIMBURSEMENT RATES

22-A DCMR § 3600 PURPOSE

3600.1 This chapter establishes the specialized services and reimbursement rates for services provided by Child Choice Providers (CCPs) to children and youth in the legal care and custody of the Child and Family Services Agency (CFSA).

3600.2 Nothing in this chapter grants a Child Choice Provider agency the right to reimbursement for costs of providing these services. Eligibility for reimbursement for these services is determined solely by the Human Care Agreement (HCA) between the Department and the Child Choice Provider and is subject to the availability of appropriated funds.

3600.3 No reimbursement under this rule shall be made for services that qualify for and can be claimed as a Medicaid-reimbursable service pursuant to the HCA.

History

SOURCE: Final Rulemaking published at 57 DCR 6430 (July 23, 2010); as amended by Final Rulemaking published at 63 DCR 16080 (December 30, 2016). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3600

22-A DCMR § 3601 ELIGIBILITY FOR SERVICES

3601.1 Children and youth in the legal care and custody of Child and Family Services Agency (CFSA) are eligible for these services if they:

Are identified by a Mental Health Rehabilitation Services (MHRS) provider as needing mental health services;

Are eligible to receive services pursuant to Section 3403 of Chapter 34 (Mental Health Rehabilitation Services Provider Certification Standards) of this title; and

Have been referred to a Child Choice Provider for receipt of mental health services.

3601.2 These services may be provided to a child or youth, and his or her family, for a maximum of thirty (30) days prior to the child’s or youth’s enrollment for services, and after enrollment as needed.

3601.3 All specialized services offered by a Child Choice must receive prior approval internally from the designated qualified practitioner within the Child Choice Provider agency before services are rendered, purchased, or provided.

3601.4 Specialized services offered by a Child Choice Provider include Choice Care Coordination, Flexible Spending Child Choice Services and Travel/ Transportation.

3601.5 Child Choice Providers are providers certified pursuant to Chapters 34 (Mental Health Rehabilitation Services Provider Certification Standards) and 35 (Child Choice Provider Certification Standards) of Title 22-A DCMR, which have demonstrated key core competencies with respect to delivering high-quality, culturally-competent, evidence-based mental health services for children and youth.

History

SOURCE: Final Rulemaking published at 57 DCR 6430 (July 23, 2010); as amended by Final Rulemaking published at 63 DCR 16080 (December 30, 2016). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3601

22-A DCMR § 3602 CHOICE CARE COORDINATION

3602.1 Choice Care Coordination is care coordination provided by a Child Choice Provider to a child or youth in the legal care and custody of CFSA.

3602.2 Choice Care Coordination is the implementation of the comprehensive care plan through appropriate linkages, referrals, coordination, consultation and follow-up to needed services and support. Care Coordination consists of the following services:

Attending interdisciplinary team meetings for ongoing assessment and diagnostic services;

Providing telephonic consults and outreach;

Following up on service delivery by providers, both internal and external to the treatment program, and ensuring communication and coordination of services;

Contacting consumers who have unexcused absences from program appointments or from other critical off-site service appointments to reengage them and promote recovery efforts;

Making appointments and providing telephonic reminders of appointments;

Assisting with arrangements such as transportation;

Providing individual and family training to consumers to develop necessary coping skills to achieve and maintain recovery and support stability in placements within the community; and

Engaging in measures that ensure that services are delivered in a manner that is culturally and linguistically competent.

3602.3 Choice Care Coordination may be provided by credentialed staff supervised by a qualified practitioner in accordance with the Department of Behavioral Health policy on supervision, or by a qualified practitioner.

History

SOURCE: Final Rulemaking published at 57 DCR 6430 (July 23, 2010); as amended by Final Rulemaking published at 63 DCR 16080 (December 30, 2016). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3602

22-A DCMR § 3603 FLEXIBLE SPENDING CHILD CHOICE SERVICES

3603.1 Flexible Spending Child Choice Services (FLEXN Services) are non-Medicaid services and supports that are provided by a Child Choice Provider intended to augment, and thereby increase the therapeutic benefit of, clinical services provided to the consumers. These services and supports are resources and tools identified during therapeutic sessions to promote positive outcomes for the child or youth. These services may also be used with the child or youth and his or her family to support engagement and enhance coping skills. These resources may include but are not limited to:

Incentives and rewards to reinforce positive clinical outcomes achieved by children and youth in treatment;

Engagement efforts for encouraging children, youth, and their families to participate in treatment;

Social network supports such as a non-treatment parent/child activity that is deemed therapeutically appropriate and should lead to a positive outcome; and

Mental health modeling and training including purchasing items or services used to enhance self-esteem or to improve child safety.

3603.2 FLEXN services provided directly by the Child Choice Provider may be provided by a credentialed staff person under the supervision of a qualified practitioner in accordance with the Department’s policy on supervision. Should the Child Choice Provider utilize a vendor to purchase FLEXN services in the best interest and therapeutic need of the youth, the vendor must be provided by a business licensed to do business in the District of Columbia or neighboring jurisdiction.

History

SOURCE: Final Rulemaking published at 57 DCR 6430 (July 23, 2010); as amended by Final Rulemaking published at 63 DCR 16080 (December 30, 2016). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3603

22-A DCMR § 3604 TRAVEL/TRANSPORTATION

3604.1 Child Choice Providers utilize travel/transportation service as mileage reimbursement for travel services used for engagement activities to prevent placement disruption and promote positive outcomes with children or youth and their families placed in the care and custody of CFSA.

3604.2 Travel/transportation reimbursement is available to support services provided pursuant to this Chapter and MHRS provided in accordance with Chapter 34 of Title 22-A DCMR.

3604.3 Actual transportation shall be provided by an authorized staff according to the policies and procedures of the Child Choice Provider.

History

SOURCE: Final Rulemaking published at 63 DCR 16080 (December 30, 2016). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3604

22-A DCMR § 3605 SERVICE CODES AND RATES

3605.1 Service codes and rates for the Choice Care Coordination, FLEXN Services, and Travel/Transportation are set forth below:

SERVICE

CODE

RATE

Choice Care Coordination

H0006HU

$21.97

FLEXN Services

FLEXN

$0.01

Travel/Transportation

DBH-MILN

GSA Per Diem Schedule

History

SOURCE: Final Rulemaking published at 63 DCR 16080 (December 30, 2016). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3605

22-A DCMR § 3606 RECORDS AND DOCUMENTATION REQUIREMENTS

3606.1 Each Child Choice Provider shall utilize the Department’s data management system for documenting and billing all services provided pursuant to this chapter.

3606.2 Each Child Choice Provider shall maintain all documentation and records in accordance with the Department standards in Chapter 34 of this title, federal and District privacy laws, and the Department’s Privacy Manual.

3606.3 Child Choice Providers shall document each service and activity provided pursuant to this Chapter in the consumer’s record in the Department’s data management system. Any claim for services shall be supported by written documentation which clearly identifies the following:

(a) The specific service type rendered;

(b) The date, duration, and actual time, a.m. or p.m. (beginning and ending), during which the services were rendered;

(d) The setting in which the services were rendered;

(e) Identification of any further actions required for the consumer’s well-being raised as a result of the service provided;

(f) A description of each encounter or service by the Child Choice Provider which clearly documents how the service was provided in accordance with this chapter; and

(g) Dated and authenticated entries, with their authors identified, which are legible and concise, including the printed name and the signature of the person rendering the service, diagnosis, and clinical impression recorded in the terminology of the International Statistical Classification of Diseases and Related Health Problems-10 (ICD-10 CM) or subsequent revisions, and the service provided.

3606.4 No Child Choice Provider shall be reimbursed for a claim for services that does not meet the requirements of this section or is not documented in accordance with this section.

3606.5 Only a Child Choice Provider that has incurred expenses eligible for reimbursement in accordance with its contract with the Department may bill the Department under this regulation.

History

SOURCE: Final Rulemaking published at 63 DCR 16080 (December 30, 2016). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3606

22-A DCMR § 3607 SUBMISSION OF CLAIM; PAYMENT OF VOUCHER

3607.1 The Child Choice Provider shall submit all claims for services rendered pursuant to this chapter through the Department’s data management system.

3607.2 The Child Choice Provider shall submit appropriate documentation to support all claims under the HCA and upon request of the Department shall cooperate in any audit or investigation concerning this program.

3607.3 The Department will reimburse a Child Choice Provider for a claim that is determined by the Department to be eligible for reimbursement pursuant to the terms of the HCA between the Department and the Child Choice Provider, subject to the availability of appropriated funds.

History

SOURCE: Final Rulemaking published at 63 DCR 16080 (December 30, 2016). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3607

22-A DCMR § 3699 DEFINITIONS

3699.1 When used in this chapter, the following terms shall have the meaning ascribed:

Child Choice Provider - a Mental Health Rehabilitation Service (MHRS) Core Services Agency (CSA) certified as a Child Choice Provider pursuant to Chapter 35 (Child Choice Provider Certification Standards) of this title with demonstrated ability to provide quality, evidence-based, innovative services and interventions to meet the most complex and changing needs of children, youth, and their families in the District, particularly those who have histories of abuse or neglect.

Core Services Agency or “CSA” - a Department-certified community-based MHRS provider that has entered into a Human Care Agreement with the Department to provide specified MHRS. A CSA shall provide at least one core service directly and may provide up to three core services via contract with a sub-provider or subcontractor.

History

SOURCE: Final Rulemaking published at 63 DCR 16080 (December 30, 2016). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3699

22-A37 MENTAL HEALTH AND SUBSTANCE USE DISORDER SUPPORTED EMPLOYMENT SERVICES AND PROVIDER CERTIFICATION STANDARDS

22-A DCMR § 3700 MENTAL HEALTH AND SUBSTANCE USE DISORDER SUPPORTED EMPLOYMENT SERVICES AND PROVIDER CERTIFICATION STANDARDS

3700.1 These rules establish the requirements and process for certifying a provider as a Mental Health Supported Employment provider or a Substance Use Disorder (SUD) Supported Employment provider in the District of Columbia, in order to provide services to consumers and clients eligible under this chapter.

3700.2 Supported Employment is an evidence-based practice adopted by the Department of Behavioral Health (Department) for mental health and adapted for SUD that:

Provides ongoing work-based vocational assessment, job development, job coaching, treatment team coordination, and vocational and therapeutic follow-along supports;

Involves community-based employment consistent with the strengths, resources, priorities, concerns, abilities, capabilities, interests, and informed choice of the consumer/client;

Provides services at various work sites; and

Provides part-time and full-time job options that are diverse, competitive, integrated with co-workers without disabilities; are based in business or employment settings that have permanent status rather than temporary or time-limited status; and that pay at least the minimum wage of the jurisdiction in which the job is located.

History

SOURCE: Notice of Final Rulemaking published at 58 DCR 10330 (December 9, 2011); as amended by Final Rulemaking published at 67 DCR 10775 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3700

22-A DCMR § 3701 INITIAL CERTIFICATION REQUIREMENTS

3701.1 No person or entity shall provide Mental Health or SUD Supported Employment services to consumers/clients eligible for services under this chapter unless certified in accordance with this chapter.

3701.2 No person or entity shall apply for certification from the Department as a Mental Health Supported Employment provider unless already certified as a Mental Health Rehabilitation Services (MHRS) provider in accordance with 22-A DCMR Chapter 34.

3701.3 A person or entity seeking certification as a Mental Health Supported Employment provider shall submit an application to the Department in the format established by the Department. The completed application shall include, at a minimum:

Proof of current certification as an MHRS provider;

Proof of adequate staffing for the delivery of Mental Health Supported Employment services in accordance with § 3704 of this chapter;

Proof of a Staff Selection Policy that complies with all applicable requirements of the Staff Selection Policy set forth in 22-A DCMR Chapter 34; and

Proof of a Supported Employment Policy that states the policies and procedures related to the provider’s set-up for delivering Mental Health Supported Employment services.

3701.4 No person or entity shall apply for certification from the Department as an SUD Supported Employment provider unless already certified as:

An MHRS provider in accordance with 22-A DCMR Chapter 34; and

A Mental Health Supported Employment provider under this chapter.

3701.5 A person or entity seeking certification as an SUD Supported Employment provider shall submit an application to the Department in the format established by the Department. The completed application shall include, at a minimum:

Proof of current certification as:

An MHRS provider; and

A Mental Health Supported Employment provider.

Proof of adequate staffing for the delivery of SUD Supported Employment services in accordance with § 3704 of this chapter;

Proof of a Staff Selection Policy that complies with all applicable requirements of the Staff Selection Policy set forth in 22-A DCMR Chapter 34; and

Proof of a Supported Employment Policy that states the policies and procedures related to the provider’s set-up for delivering SUD Supported Employment services.

3701.6 The Department shall follow the applicable processes established for certification set forth in 22-A DCMR Chapter 34 to certify, deny certification, or decertify providers as Mental Health or SUD Supported Employment providers.

3701.7 Initial certification as a Mental Health or SUD Supported Employment provider shall be effective for a one (1)-year period. Certification shall remain in effect until it expires or is revoked, or the provider is recertified in accordance with § 3702 of this chapter.

3701.8 During the initial certification period, the Mental Health or SUD Supported Employment provider shall:

Participate in a baseline program evaluation conducted by the Department within thirty (30) business days after the provider has begun delivering Mental Health or SUD Supported Employment services. The evaluation shall include a fidelity assessment using the Supported Employment Fidelity Scale established by Department policy;

Enter into a contractual relationship with the Department on Disability Services’ Rehabilitation Services Administration (RSA) within six (6) months of initial certification and maintain such contract for the remainder of the certification period; and

Participate in a second program evaluation conducted by the Department six (6) months after the provider has begun delivering Mental Health or SUD Supported Employment services. The evaluation includes a fidelity assessment using the Supported Employment Fidelity Scale established by Department policy.

3701.9 A certified Mental Health or SUD Supported Employment provider receiving a fidelity score below an acceptable score as specified in Department policy during the fidelity assessments shall develop a corrective action plan to promptly address the deficiencies and shall receive technical assistance from the Department. If the Supported Employment provider’s annual score does not improve to an acceptable score within six (6) months of the previous fidelity score, the provider shall not be eligible for recertification and may be subject to decertification.

3701.10 Certification is not transferable to any other organization.

History

SOURCE: Notice of Final Rulemaking published at 58 DCR 10330, 10331 (December 9, 2011); as amended by Final Rulemaking published at 67 DCR 10775 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3701

22-A DCMR § 3702 RECERTIFICATION REQUIREMENTS

3702.1 The Department shall follow the applicable processes set forth in 22-A DCMR Chapter 34 to recertify, deny recertification, or decertify providers as Mental Health or SUD Supported Employment providers.

3702.2 A Mental Health or SUD Supported Employment provider seeking recertification from the Department shall submit an application to the Department in the format established by the Department and meet the requirements in § 3701.3 for Mental Health or § 3701.5 for SUD, respectively. The completed application shall also include proof of a current contract with the RSA.

3702.3 Recertification shall be effective for a two (2)-year period from the date of issuance of recertification by the Department, subject to the provider’s continuous compliance with the certification standards.

3702.4 During any recertification period, the Mental Health or SUD Supported Employment Program shall:

Participate in an annual program evaluation conducted by the Department. The evaluation shall include a fidelity assessment using the Supported Employment Fidelity Scale established by Department policy; and

Maintain a contractual relationship with RSA.

3702.5 A recertified Mental Health or SUD Supported Employment provider receiving a fidelity score below an acceptable score as specified in Department policy during the fidelity assessments shall develop a corrective action plan to correct the deficiencies and receive technical assistance from the Department. If the Supported Employment provider’s score does not improve to an acceptable score within six (6) months of the previous fidelity score, the provider shall not be eligible for further recertification and may be subject to decertification.

3702.6 Recertification is not transferable to any other organization.

History

SOURCE: Notice of Final Rulemaking published at 58 DCR 10330, 10332 (December 9, 2011); as amended by Final Rulemaking published at 67 DCR 10775 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3702

22-A DCMR § 3703 EXEMPTIONS FROM CERTIFICATION STANDARDS

3703.1 Upon good cause shown, the Department may exempt an applicant or current Mental Health or SUD Supported Employment provider from a certification standard if the exemption does not jeopardize the health and safety of Supported Employment consumers/clients, violate Supported Employment consumers’/ client’s rights, or otherwise conflict with the purpose and intent of these rules.

3703.2 If the Department approves an exemption, such exemption shall end on the expiration date of the provider certification or on an earlier date if specified by the Department; unless the provider requests renewal of the exemption prior to expiration of its certification or the earlier date set by the Department.

3703.3 The Department may revoke an exemption that it determines is no longer appropriate.

3703.4 All requests for an exemption from certification standards shall be submitted in writing to the Department.

History

SOURCE: Notice of Final Rulemaking published at 58 DCR 10330, 10333 (December 9, 2011); as amended by Final Rulemaking published at 67 DCR 10775 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3703

22-A DCMR § 3704 MENTAL HEALTH AND SUD SUPPORTED EMPLOYMENT SERVICES

3704.1 Both Mental Health and SUD Supported Employment providers shall deliver the following services to Supported Employment consumers/clients:

Vocational Supported Employment services:

Intake, which involves obtaining background, clinical, and employment information in order to enroll the consumer into Mental Health Supported Employment services or the client into SUD Supported Employment services and initiate a referral to RSA;

Vocational Assessment, which consists of conducting vocational assessments and assessment of person-centered employment information, in order to identify the consumer’s/client’s employment interests, preferences, and abilities;

Individualized Work Plan (IWP) Development, which includes the process of developing an IWP plan with the consumer/client, and which meets the following standards:

The consumer’s/client’s preferences, not provider expectations or decisions, drive the consumer’s/client’s employment and career planning process;

The IWP includes an employment goal and the support services required to reach the goal, such as:

Integrating employment goals into the consumer’s MHRS person-centered Plan of Care or client’s SUD person-centered Plan of Care;

Strategies to address stressor situations;

Assistance with symptom self-monitoring and self-management; and

Assistance in increasing social support skills and networks that ameliorate life stresses resulting from the consumer’s mental illness or client’s SUD and which are necessary to enable and maintain the consumer’s/client’s independent living;

The IWP shall be updated annually or any time there is a significant change in the consumer’s/client’s condition or situation that affects progress toward the IWP’s goals; and

The IWP shall be completed and signed by the consumer/client within thirty (30) calendar days of the delivery of the first Supported Employment service.

Disclosure Counseling, which helps the consumer/client examine and understand the advantages and disadvantages of disclosing one’s mental illness or SUD to their employer;

Treatment Team Coordination, which involves coordination and contact with the treatment team members of the consumer’s CSA or the client’s outpatient Level Opioid Treatment Program (OTP), Level 1, Level 2.1, or Level 2.5 provider regarding the provision of Supported Employment services;

Job Development, which involves contacting employers through various activities in order to obtain community-based employment for consumers/clients;

Job Coaching, which helps consumers/clients learn job duties once employed through on-the-job training, effective use of community resources, and consultation with the worker’s employer, co-workers, family, or supervisors as necessary; and

Vocational Follow-Along Supports, which are provided to the consumer/client or employer to help the consumer/client maintain employment including through review of job performance and problem-solving; and

Therapeutic Supported Employment services:

Therapeutic Follow-Along Supports, which are interventions related to addressing behavioral health symptoms, and which include: crisis intervention, symptom management, behavior management, and coping skills needed to improve the consumer’s/client’s ability to maintain employment; and

Benefits Counseling, which helps consumers/clients to examine and understand how employment may impact benefits such as Supplemental Security Income (SSI), Social Security Disability Insurance (SSDI), medical assistance, and other disability-related benefits, and which may also involve advocacy on behalf of the person to resolve issues.

History

SOURCE: Notice of Final Rulemaking published at 58 DCR 10330, 10334 (December 9, 2011); as amended by Final Rulemaking published at 67 DCR 10775 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3704

22-A DCMR § 3705 MENTAL HEALTH AND SUBSTANCE USE DISORDER SUPPORTED EMPLOYMENT PROVIDER STAFFING REQUIREMENTS

3705.1 A Mental Health or SUD Supported Employment provider shall have at a minimum:

One (1) Supported Employment Supervisor; and

One (1) Supported Employment Team comprised of:

One (1) Supported Employment Manager; and

Two (2) full-time Employment Specialists.

3705.2 In cases where a provider is certified as both a Mental Health Supported Employment provider and an SUD Supported Employment provider:

The Supervisor and Manager may be responsible for both Mental Health and SUD Supported Employment services, if appropriately trained in both mental health and SUD (e.g., the Manager is permitted to supervise both SUD Employment Specialists and Mental Health Employment Specialists);

Each Employment Specialist shall only provide services to one population (e.g., the Employment Specialist shall only provide Mental Health Supported Employment services, but not SUD Supported Employment Services); and

The provider shall maintain compliance with the staffing requirements and staffing ratios set forth in this subsection.

3705.3 Certified Mental Health and SUD Supported Employment providers must obtain Department approval to add Supported Employment Teams or Specialists supported through a Human Care Agreement.

3705.4 The Supported Employment Supervisor shall be responsible for overall monitoring of the Supported Employment program and provide clinical interventions and expertise in response to a Supported Employment consumer's/client's clinical and care coordination needs.

The Mental Health Supported Employment Supervisor shall be:

A qualified practitioner permitted to screen, assess and diagnose consumers in accordance with Title 22-A DCMR § 3418.12;

Appropriately licensed in the District of Columbia or the jurisdiction where the services are delivered; and

Practicing within the scope of their license.

The Substance Use Disorder (SUD) Supported Employment Supervisor shall be:

A qualified practitioner permitted to screen, assess and diagnose clients in accordance with Title 22-A DCMR § 6339.13;

Appropriately licensed in the District of Columbia or the jurisdiction where the services are delivered; and

Practicing within the scope of their license.

3705.5 One (1) full-time equivalent Supported Employment Manager shall be responsible for no more than ten (10) Supported Employment Specialists, and shall not have other supervisory responsibilities. However, in cases where the Manager supervises fewer than ten (10) Supported Employment Specialists, the Manager may spend their time on other supervisory activities on a prorated basis.

3705.6 A Mental Health or SUD Supported Employment provider shall have one (1) full-time Supported Employment Specialist for every twenty (20) Supported Employment consumers/clients. Supported Employment Specialists shall satisfy all requirements for non-licensed credentialed staff pursuant to 22-A DCMR Chapter 34.

3705.7 A Mental Health or SUD Supported Employment provider shall comply with all applicable staff requirements set forth in 22-A DCMR Chapter 34.

3705.8 Supported Employment Specialists shall carry out all phases of Supported Employment services, including:

Intake;

Vocational Assessment;

IWP Development;

Benefits Counseling;

Disclosure Counseling;

Treatment Team Coordination;

Job Development;

Job Coaching;

Vocational Follow-Along Supports; and

Therapeutic Follow-Along Supports.

3705.9 Supported Employment Supervisors, Managers, and Specialists shall be trained in evidence-based Supported Employment principles and practices. Supported Employment Managers and Specialists shall attend the Department’s Supported Employment provider meetings that are held periodically.

History

SOURCE: Notice of Final Rulemaking published at 58 DCR 10330, 10336 (December 9, 2011); as amended by Final Rulemaking published at 67 DCR 10775 (September 4, 2020); as amended by Final Rulemaking published at 69 DCR 011733 (September 30, 2022). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3705

22-A DCMR § 3706 MENTAL HEALTH AND SUD SUPPORTED EMPLOYMENT RECORDS AND DOCUMENTATION REQUIREMENTS

3706.1 Each Supported Employment provider shall establish and adhere to an Employment Record Policy for employment record documentation, security, and confidentiality of consumer/client information. The Employment Record Policy shall:

Require the Supported Employment provider to maintain all written employment records in a secured and locked storage area and any electronic records in compliance with all applicable Federal and District laws and regulations, and Department policies;

Require the Supported Employment provider to maintain secure, clear, organized, and comprehensive employment records for every consumer/client enrolled in the Supported Employment Program;

Set forth requirements for documentation maintained in the employment record;

For SUD Supported Employment providers require documentation in the Department-specified electronic health records system;

Require that the Supported Employment provider comply with a Documentation and Retention and Disaster Recovery Plan:

For providers of Mental Health Supported Employment services the Plan shall comply with all applicable provisions of the Disaster Recovery Plan and document retention requirements set forth in 22-A DCMR Chapter 34; and

For providers of SUD Supported Employment services, the Plan shall comply with all applicable provisions of the client records management and confidentiality requirements set forth in 22-A DCMR Chapter 63; and

Keep Supported Employment documents for a minimum of ten (10) years.

3706.2 The following information shall be included in the Supported Employment consumer’s/client’s employment record:

Referral and intake information;

Identifying information about the consumer/client;

Appropriate release of information forms;

Current MHRS or SUD person-centered Plan of Care which includes the consumer’s employment goals and objectives and identification of Supported Employment as a necessary service;

Individualized Work Plan (IWP);

Employment and employer contact information;

Benefits information such as receipt of Social Security and Temporary Assistance to Needy Families benefits;

Information about referrals to RSA; and

Encounter notes for each service.

3706.3 Employment Specialists shall document services on an encounter note, which shall include:

A description of the Supported Employment service(s) that is sufficient to document that the provision was in accordance with this chapter;

The time, date, and duration, including beginning and end time, of the provided services;

The name, title, and credentials of the person providing the services;

The setting in which the services were provided;

Confirmation that the provided services are in the consumer’s/client’s IWP;

A description of what supports were provided to enhance the consumer’s/client’s potential for securing employment;

Description of the consumer’s/client’s response to the Supported Employment services and supports, including the choices and perceptions of the consumer/client regarding the services provided;

Be dated and authenticated in written or electronic form by the person rendering the services; and

Include the appropriate billing codes for those particular services.

3706.4 A Mental Health or SUD Supported Employment provider shall collect and provide the following information and data to the Department monthly and upon request:

Number of consumers/clients referred to the Supported Employment provider and the source of the referral;

Number of consumers/clients enrolled in Supported Employment services;

Number of Supported Employment consumers/clients served;

Number of Supported Employment consumers/clients employed;

Number of inactive Supported Employment consumers/clients;

Number of consumers/clients on wait list;

Number of total full-time Employment Specialists;

Number of Supported Employment consumers/clients referred to RSA;

Number of Supported Employment consumers/clients participating in education programs;

Average number of hours that Supported Employment consumers/clients worked;

Average hourly wage paid to Supported Employment consumers/clients;

Number of Supported Employment consumers/clients receiving benefits (health, dental, or retirement) from employers;

Names and contact information (including locations) of employers who have hired Supported Employment consumers/clients;

Job titles and types of jobs for which Supported Employment consumers/clients have been hired; and

Any other information that the Department requires.

History

SOURCE: Notice of Final Rulemaking published at 58 DCR 10330, 10336 (December 9, 2011); as amended by Final Rulemaking published at 67 DCR 10775 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3706

22-A DCMR § 3707 MENTAL HEALTH SUPPORTED EMPLOYMENT SERVICES ELIGIBILITY

3707.1 To be eligible for Mental Health Supported Employment services, a consumer shall:

Be at least eighteen (18) years of age;

Indicate an interest in employment as determined through the diagnostic and comprehensive assessments for the Mental Health Rehabilitation Services (MHRS) program;

Have Mental Health Supported Employment identified as a needed service on a current, MHRS person-centered Plan of Care that has been reviewed by the Department;

Not be receiving MHRS Assertive Community Treatment (ACT) services; and

Be determined by the Department of Behavioral Health (the Department) as eligible for Mental Health Supported Employment services after undergoing an independent needs-based assessment pursuant to § 3708.3(b) that examines the following:

Be assessed to have mental health needs that require an improvement, stabilization, or prevention of deterioration in functioning (including ability to live independently without support), which result from the presence of a mental illness; and

Have at least one (1) of the following risk factors:

Be unable to sustain gainful employment for at least ninety (90) consecutive days as related to a history of mental illness;

An inability to obtain or maintain employment resulting from age or disability (physical or behavioral);

More than one instance of mental illness treatment in the past two (2) years; or

Be at risk for deterioration of mental illness as evidenced by one (1) or more of the following:

Persistent or chronic risk factors such as social isolation due to a lack of family or social supports, poverty, criminal justice involvement, or homelessness;

Care for mental illness requiring multiple provider types, including behavioral health, primary care, and long-term services and supports; or

A past psychiatric history with no significant functional improvement that can’t be maintained without treatment and supports.

History

SOURCE: Notice of Final Rulemaking published at 58 DCR 10330, 10337 (December 9, 2011); as amended by Final Rulemaking published at 67 DCR 10775 (September 4, 2020); as amended by Final Rulemaking published at 69 DCR 011733 (September 30, 2022); as amended by Final Rulemaking published at 70 DCR 016660 (December 29, 2023). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3707

22-A DCMR § 3708 AUTHORIZATION OF AND REFERRALS TO MENTAL HEALTH SUPPORTED EMPLOYMENT SERVICES

3708.1 MHRS Core Service Agencies (CSAs) shall assess all consumers eighteen (18) years of age and older for interest in and potential eligibility for Mental Health Supported Employment services as part of:

Developing or updating the consumer’s MHRS person-centered plan of care; or

Upon request by the consumer, family member, advocates, or other service providers.

3708.2 If a consumer is interested in Mental Health Supported Employment services, the CSA shall, in a manner specified by the Department, collect and submit the following information to the Department for its review:

The consumer’s current comprehensive assessment that documents the consumer’s interest in employment; and

The consumer’s current MHRS person-centered Plan of Care.

3708.3 To determine eligibility for Mental Health Supported Employment Services, the Department shall:

Review the consumer’s current comprehensive assessment and person centered Plan of Care; and

Conduct an independent needs-based assessment in accordance with § 3737.1(e).

3708.4 Within three (3) business days after the receipt of the consumer’s Mental Health Supported Employment referral from the Core Services Agency (CSA), the Department shall contact the consumer and their CSA to schedule an appointment for the independent needs-based assessment. The Department shall conduct the independent needs-based assessment within ten (10) business days after the receipt of the referral, unless the consumer is unavailable for all available times within ten (10) days of the referral. The Department may close the referral if the consumer does not respond to the Department’s scheduling efforts.

3708.5 The Department shall complete the independent needs-based assessment face-to-face or through telehealth as permitted by Title 29 DCMR § 910 using the Department-specified approved independent needs-based assessment tool.

3708.6 Qualified practitioners eligible to administer the independent needs-based assessment must be:

Permitted to screen, assess, and diagnose consumers in accordance with Title 22-A DCMR § 3418.12;

Appropriately licensed in the District of Columbia or the jurisdiction where the services are delivered; and

Practicing within the scope of their license.

3708.7 The Department shall complete an independent needs-based assessment annually for each consumer receiving Supported Employment services who seeks to continue services beyond three-hundred sixty-five (365) days.

3708.8 The Department shall notify the consumer and their CSA of the Mental Health Supported Employment services authorization determination within three (3) business days after the administration of the independent needs-based assessment. Medicaid beneficiaries are entitled to Notice and Appeal rights pursuant to Title 29 DCMR § 9508 in cases of intended adverse action, such as an action to deny, discontinue, terminate, or change the manner or form of Medicaid-funded Supported Employment services. The Department shall provide local-only beneficiaries the same Notice and Appeal rights as those provided to Medicaid beneficiaries in Title 29 DCMR § 9508.

3708.9 The Department, CSAs, and Mental Health Supported Employment providers shall not deny or deem consumers ineligible for Mental Health Supported Employment services on the basis of the consumer’s receipt of Supplemental Security Income (SSI)/Social Security Disability Insurance (SSDI), criminal and/or substance use history, current employment status, or physical impairments.

3708.10 If the Department authorizes the provision of Mental Health Supported Employment services, the Department shall within five (5) business days of authorization refer the consumer to the Mental Health Supported Employment provider of the consumer’s choosing. The referral shall be in writing and include the following information:

The consumer’s CSA treatment team contact information;

Contact information for the consumer, including emergency contact information; and

The consumer’s current MHRS person-centered Plan of Care.

3708.11 The Mental Health Supported Employment provider, upon receipt of the referral, shall engage the consumer within three (3) business days.

3708.12 The Mental Health Supported Employment provider must have a Wait List Policy to track and manage timely access to services. The Mental Health Supported Employment provider must immediately notify the Department if it is unable to accept new consumers.

3708.13 Department authorization of Mental Health Supported Employment services shall not exceed three-hundred sixty-five (365) calendar days. The Mental Health Supported Employment provider must notify the consumer's CSA to request a continuation of services at least forty-five (45) calendar days before the expiration of the authorization. Within five (5) business days after the request, the CSA shall provide the Department with the consumer’s most recent person-centered Plan of Care and comprehensive assessment and request that the Department conduct an independent needs-based assessment to determine the consumer’s continued eligibility for Supported Employment services. Upon receipt of the request, the Department shall conduct an independent needs-based assessment pursuant to the procedure described in §§ 3708.4 – 3708.8.

3708.14 CSAs and/or Supported Employment providers shall reassess consumers receiving Supported Employment services and review the MHRS person-centered Plan of Care any time there is a significant change in the consumer’s condition or situation that affects the progress toward the Supported Employment-related goals of the Plan of Care.

History

SOURCE: Notice of Final Rulemaking published at 58 DCR 10330, 10339 (December 9, 2011); as amended by Final Rulemaking published at 67 DCR 10775 (September 4, 2020); as amended by Final Rulemaking published at 69 DCR 011733 (September 30, 2022); as amended by Final Rulemaking published at 70 DCR 016660 (December 29, 2023). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3708

22-A DCMR § 3709 INTEGRATION WITH THE CSA TREATMENT TEAM

3709.1 Mental Health Employment Specialists shall be integrated as part of the Supported Employment consumer’s CSA treatment team. The Mental Health Employment Specialist shall attend regular treatment team meetings and maintain frequent contact with treatment team members.

3709.2 As a treatment team member, the Mental Health Employment Specialist may participate in updating the MHRS person-centered Plan of Care and is responsible for helping the consumer achieve the goals written in the Plan of Care with regard to employment.

3709.3 Services provided by the Mental Health Employment Specialist shall be consistent with the goals relating to employment included in the consumer’s MHRS person-centered Plan of Care.

History

SOURCE: Notice of Final Rulemaking published at 58 DCR 10330, 10340 (December 9, 2011); as amended by Final Rulemaking published at 67 DCR 10775 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3709

22-A DCMR § 3710 SUD SUPPORTED EMPLOYMENT SERVICES ELIGIBILITY

3710.1 To be eligible for SUD Supported Employment services, a client shall:

(a) Be at least eighteen (18) years of age;

(b) Indicate an interest in employment as determined through the ongoing or

comprehensive diagnostic assessment for the SUD treatment program;

(d) Be receiving Medicaid-funded SUD services as described in 22-A DCMR § 6301.4 or locally-funded SUD services as described in 22-A DCMR § 6301.5 in one of the following Levels of Care:

(1) Level: OTP on an outpatient basis;

(2) Level 1: Outpatient;

(3) Level 2.1: Intensive Outpatient;

(4) Level 2.5: Day Treatment;

(e) Be assessed as being able to benefit from and meaningfully engage in SUD Supported Employment services;

(f) Have SUD Supported Employment identified as a needed service on a current, SUD person-centered Plan of Care that has been reviewed by the Department; and

(g) Be determined by the Department as eligible for Substance Use Disorder (SUD) Employment services after undergoing independent needs-based assessment pursuant to § 3711.3 that examines the following:

(1) Be assessed to have substance use needs, where an assessment using the American Society of Addiction Medicine (ASAM) Criteria indicates that the client meets at least ASAM Level 1.0, indicating the need for outpatient SUD treatment; and

(2) Have at least one (1) of the following risk factors:

(A) Unable to sustain gainful employment for at least ninety (90) consecutive days as related to a history of SUD;

(B) Unable to obtain or maintain employment resulting from age or disability (physical or behavioral); or

(D) Be at risk for deterioration of SUD as evidenced by one (1) or more of the following:

(i) Persistent or chronic risk factors such as social isolation due to a lack of family or social supports, poverty, criminal justice involvement, or homelessness;

(ii) Care for SUD requiring multiple provider types, including behavioral health, primary care, and long-term services and supports; or

(iii) A past psychiatric history with no significant functional improvement that can’t be maintained without treatment and supports.

History

SOURCE: Final Rulemaking published at 67 DCR 10775 (September 4, 2020); as amended by Final Rulemaking published at 69 DCR 011733 (September 30, 2022); as amended by Final Rulemaking published at 70 DCR 016660 (December 29, 2023). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3710

22-A DCMR § 3711 AUTHORIZATION OF AND REFERRALS TO SUD SUPPORTED EMPLOYMENT SERVICES

3711.1 Providers of Level Opioid Treatment Program, Level 1, Level 2.1 and Level 2.5 shall assess all clients eighteen (18) years of age and older for interest in and potential eligibility for SUD Supported Employment services as part of:

Developing or updating the client’s SUD person-centered plan of care; or

Upon request by the client, family member, advocates, or other service providers.

3711.2 If a client is interested in SUD Supported Employment services, the SUD provider shall, in a manner specified by the Department, collect and submit the following information to the Department for review:

The client’s current comprehensive diagnostic assessment that documents the client’s interest in employment; and

The client’s current SUD person-centered Plan of Care.

3711.3 To determine eligibility for SUD Supported Employment Services, the Department shall:

Review the client’s current comprehensive diagnostic assessment and person-centered Plan of Care; and

Conduct an independent needs-based assessment in accordance with § 3710.1(g).

3711.4 Within three (3) business days after the receipt of the client's SUD Supported Employment referral from the SUD provider, the Department shall contact the client to schedule an appointment for the independent needs-based assessment. The Department shall conduct the independent needs-based assessment within ten (10) business days after the receipt of the referral, unless the consumer is unavailable for all available times within ten (10) days of the referral. The Department may close the referral if the client does not respond to the Department’s scheduling efforts.

3711.5 The Department shall complete the independent needs-based assessment face-to-face or through telehealth as permitted by Title 29 DCMR § 910 using the Department-specified approved independent needs-based assessment tool.

3711.6 Qualified practitioners eligible to administer the independent needs-based assessments must be:

Permitted to screen, assess and diagnose consumers in accordance with Title 22-A DCMR § 6339.13;

Appropriately licensed in the District of Columbia or the jurisdiction where the services are delivered; and

Practicing within the scope of their license.

3711.7 The Department shall complete an independent needs-based assessment annually for each client receiving Supported Employment services.

3711.8 The Department shall notify the client and their SUD provider of the SUD Supported Employment services authorization determination within three (3) business days after the administration of the independent needs-based assessment. Medicaid beneficiaries are entitled to Notice and Appeal rights pursuant to Title 29 DCMR § 9508 in cases of intended adverse action, such as an action to deny, discontinue, terminate, or change the manner or form of Medicaid-funded Supported Employment services. The Department shall provide local-only beneficiaries the same Notice and Appeal rights as those provided to Medicaid beneficiaries in Title 29 DCMR § 9508.

3711.9 The Department, SUD providers and SUD Supported Employment providers shall not deny or deem clients ineligible for SUD Supported Employment services on the basis of the client’s receipt of SSI/SSDI, criminal and/or substance use history, current employment status, or physical impairments.

3711.10 If the Department authorizes the provision of SUD Supported Employment services, the Department shall within five (5) business days of authorization refer the client to the SUD Supported Employment provider of the client’s choosing. The referral shall be in writing and include the following information:

The client’s SUD provider treatment team contact information;

Contact information for the client, including emergency contact information; and

The client’s current SUD person-centered Plan of Care.

3711.11 The SUD Supported Employment provider, upon receipt of the referral, shall engage the client within three (3) business days.

3711.12 The SUD Supported Employment provider must have a Wait List Policy to track and manage timely access to services. The SUD Supported Employment provider must immediately notify the Department if it is unable to accept new clients.

3711.13 Department authorization of SUD Supported Employment services shall not exceed three-hundred sixty-five (365) calendar days. The SUD Supported Employment provider must notify the client's SUD provider to request a continuation of services at least forty-five (45) calendar days before the expiration of the authorization. Within five (5) business days after the request, the SUD provider shall provide the Department with the client's most recent person-centered Plan of Care and comprehensive diagnostic assessment, and request that the Department conduct an independent needs-based assessment to determine the client's continued eligibility for Supported Employment services. Upon receipt of the request, the Department shall conduct an independent needs-based assessment pursuant to the procedure described in §§ 3711.4 – 3711.8.

3711.14 SUD and/or Supported Employment providers shall reassess clients receiving Supported Employment services and review the SUD person-centered Plan of Care any time there is a significant change in the client’s condition or situation that affects the progress toward the Supported Employment-related goals of the Plan of Care, including but not limited to a change in level of care, hospitalization, or incarceration.

History

SOURCE: Final Rulemaking published at 67 DCR 10775 (September 4, 2020); as amended by Final Rulemaking published at 69 DCR 011733 (September 30, 2022); as amended by Final Rulemaking published at 70 DCR 016660 (December 29, 2023). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3711

22-A DCMR § 3712 INTEGRATION WITH THE SUD TREATMENT TEAM

3712.1 SUD Employment Specialists shall be integrated as part of the Supported Employment client’s referring SUD provider’s treatment team. The SUD Employment Specialist shall attend regular treatment team meetings and maintain frequent contact with treatment team members.

3712.2 As a treatment team member, the SUD Employment Specialist may participate in updating the SUD person-centered Plan of Care and is responsible for helping the client achieve the goals written in the Plan of Care with regard to employment.

3712.3 Services provided by the SUD Employment Specialist should be consistent with the goals relating to employment included in the client’s SUD person-centered Plan of Care.

History

SOURCE: Final Rulemaking published at 67 DCR 10775 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3712

22-A DCMR § 3713 REIMBURSEMENT

3713.1 Mental Health and SUD Supported Employment providers, pursuant to their contract with RSA, shall seek reimbursement from RSA for the following services when provided to their Supported Employment consumers/clients while they are enrolled with RSA:

Job Development; and

Job Coaching.

3713.2 All Mental Health and SUD Supported Employment services not subject to reimbursement by RSA shall be billed by the Supported Employment provider in accordance with the remainder of this section. Reimbursement for Medicaid-funded and locally-funded Mental Health and SUD Supported Employment services described in §§ 3713.3 and 3713.4 shall be at the rate contained in the District of Columbia Medicaid fee schedule available online at www.dc-medicaid.com. All future updates to the service codes and rates will be included in the District of Columbia Medicaid fee schedule pursuant to the procedures established in 29 DCMR § 988.

3713.3 The following services shall be billed as Vocational Supported Employment:

Intake;

Vocational Assessment;

IWP Development;

Disclosure Counseling;

Treatment Team Coordination;

Job Development (if provided outside of time-period of RSA involvement);

Job Coaching (if provided outside of time-period of RSA involvement); and

Vocational Follow-Along Supports.

3713.4 The following services shall be billed as Therapeutic Supported Employment and shall be delivered by qualified practitioners or credentialed staff eligible to provide Community Support services as specified in 22-A DCMR Chapter 34:

Benefits Counseling; and

Therapeutic Follow-Along Supports.

3713.5 Prior authorization by the Department shall be required for Vocational and Therapeutic Supported Employment services. Initial and any subsequent authorizations for Vocational Supported Employment services shall not exceed ninety-six (96) units per one hundred and eighty (180) calendar day time period. Authorizations for Therapeutic Supported Employment services shall not exceed one hundred and eighty (180) calendar days.

3713.6 Vocational and Therapeutic Supported Employment Services shall not be billed on the same day as Intensive Day Treatment services, as defined in 22-A DCMR Chapter 34.

3713.7 Billing units are fifteen (15) minutes.

3713.8 Mental Health and SUD Supported Employment services shall only be provided:

At the Supported Employment provider’s service site; or

In natural settings, including the consumer’s/client’s work site or other community setting.

3713.9 All claims seeking Medicaid or local only reimbursement under this Chapter shall

include the active National Provider Identification numbers for the certified provider and the rendering provider. The rendering provider is the staff member who provided the service.

History

SOURCE: Final Rulemaking published at 67 DCR 10775 (September 4, 2020); as amended by Final Rulemaking published at 69 DCR 013495 (November 4, 2022). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3713

22-A DCMR § 3799 DEFINITIONS

3799.1 When used in this chapter, the following words shall have the meanings ascribed:

Client – a person admitted to an SUD treatment or recovery program and is assessed to need SUD treatment services or recovery support services.

Consumer – a person who seeks or receives mental health services funded or regulated by the Department.

Core Services Agency or CSA – a Department-certified MHRS provider that has entered into a Human Care Agreement with the Department to provide specific MHRS in accordance with the requirements of 22-A DCMR Chapter 34.

Department of Behavioral Health or the Department – the District of Columbia agency that regulates the District’s behavioral health system for adults, children, and youth.

Department on Disability Services’ Rehabilitation Services Administration or RSA – the District of Columbia government entity that provides employment services to those individuals with developmental and other disabilities.

Individualized Work Plan or IWP – a plan developed by the Mental Health or SUD Supported Employment provider with the consumer that includes an employment goal and the support services required to reach the goal.

Level 1 Provider – a Department-certified SUD provider that has entered into a Human Care Agreement with the Department to provide Outpatient Services in accordance with the requirements of 22-A DCMR Chapter 63.

Level 2.1 Provider – a Department-certified SUD provider that has entered into a Human Care Agreement with the Department to provide Intensive Outpatient Services in accordance with the requirements of 22-A DCMR Chapter 63.

Level 2.5 Provider – a Department-certified SUD provider that has entered into a Human Care Agreement with the Department to provide Day Treatment Services in accordance with the requirements of 22-A DCMR Chapter 63.

Mental Health Rehabilitation Services or MHRS – mental health rehabilitative services provided by a Department-certified mental health provider.

MHRS Person-Centered Plan of Care – the MHRS person-centered Plan of Care developed by a Core Services Agency pursuant to the requirements set forth in 22-A DCMR Chapter 34.

MHRS Provider – providers certified by the Department as a Core Services Agency, sub-provider, or specialty provider to deliver MHRS.

Needs-Based Assessment – an assessment conducted by a consumer’s CSA or client’s outpatient Level OTP, Level 1, Level 2.1, or Level 2.5 provider, using the Department-specified needs-based assessment tool, to help determine if a consumer or client meets the needs-based criteria for receipt of Mental Health or SUD Supported Employment services.

Outpatient Level Opioid Treatment Program or Outpatient Level OTP – a Department-certified SUD provider that has entered into a Human Care Agreement with the Department to provide Opioid Treatment Program services on an outpatient basis in accordance with the requirements of 22-A DCMR Chapter 63.

SUD Person-Centered Plan of Care – the SUD person-centered Plan of Care developed for an individual meeting the eligibility requirements described in 22-A DCMR Chapter 63 §§ 6301.4 or 6301.5 by an outpatient Level OTP, Level 1, Level 2.1, or Level 2.5 provider, pursuant to the requirements set forth in 22-A DCMR Chapter 63.

Supported Employment Fidelity Scale – the Supported Employment provider evaluation tool developed in accordance with the evidence-based practice adopted by the Department and as stated in Department policy.

History

SOURCE: Notice of Final Rulemaking published at 58 DCR 10330, 10340 (December 9, 2011); Final Rulemaking published at 67 DCR 10775 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3799

22-A38 MENTAL HEALTH COMMUNITY RESIDENCE FACILITIES

22-A DCMR § 3800 PURPOSE AND SCOPE OF CHAPTER

3800.1 The purpose of these regulations is to provide for the health, safety, and person-centered welfare of individuals with mental illness residing in mental health community residence facilities (MHCRFs). Each MHCRF shall meet the requirements of this chapter as of its effective date, unless otherwise specified in this chapter. No person shall operate an MHCRF in the District of Columbia without a license issued by the Department.

3800.2 A MHCRF is a publicly- or privately-owned community residence facility that provides twenty-four hour (24 hr.) supervised care and a home-like environment in a house or apartment building for individuals, age eighteen (18) or older:

With a principal diagnosis of mental illness;

Who require twenty-four hour (24 hr.) on-site staff supervision, monitoring, personal assistance with activities of daily living, lodging, and meals; and

Who are not in the custody of the Department of Corrections.

3800.3 There shall be three (3) principal categories of MHCRFs designed to meet different levels of resident need and preference licensed under and subject to this chapter: Supported Residence (SR), Supported Rehabilitative Residence (SRR) and Intensive Residence (IR). In addition to meeting the other requirements of this chapter, the SR shall comply with § 3857, the SRR shall comply with § 3858 and the IR shall comply with § 3859.

3800.4 In addition, this chapter provides for short-term transitional beds, which shall meet the minimum licensure requirements for a SR facility, as well as the additional requirements in § 3860. A MHCRF with transitional beds shall be designated “SR-Transitional.”

3800.5 The number of residents allowed to reside in a MHCRF shall be as follows:

An SR, SRR or IR MHCRF may have up to eight (8) residents, exclusive of staff.

Notwithstanding § 3800.5(a), an SR MHCRF with a regular license that was issued prior to December 23, 1991 may continue to house the number of residents previously authorized, up to twenty-five (25) residents exclusive of staff;

An SR with transitional beds may have up to ten (10) residents in accordance with § 3860;

The Director may grant a waiver to the residency limitations set forth in (a) or (c) upon a determination that:

The facility has demonstrated that it meets the other requirements of this chapter and will be able to meet residents’ needs and provide a home-like non-institutional environment;

The health, safety, and welfare of residents will not be adversely affected; and

The authorized increase is consistent with the occupancy limits in the Certificate of Occupancy for the facility.

3800.6 This chapter shall not apply to:

Crisis beds;

Independent living arrangements; or

Supported independent living arrangements.

3800.7 A MHCRF license is not an entitlement. The issuance of new licenses is subject to the availability of funds and the Department’s determination that new or additional MHCRFs are necessary to adequately serve the public behavioral health system.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3800

22-A DCMR § 3801 REQUIREMENT TO HOLD A MHCRF LICENSE

REQUIREMENT TO HOLD A MHCRF LICENSE

3801.1 No person shall operate or hold himself or herself out as operating a MHCRF in the District of Columbia, whether public or private, profit or not-for-profit, without being licensed as required by this chapter. Any person who violates this section is subject to civil fines and penalties in accordance with Title 16 DCMR, Chapters 31, 32, and 35.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3801

22-A DCMR § 3802 MHCRF LICENSE AND INSPECTION FEES

3802.1 Each MHCRF license shall be issued in the name of the Operator of the MHCRF business. A MHCRF license is not transferable and shall be valid only with respect to the Operator and only for the facility location identified on the license.

3802.2 Each MHCRF license shall be designated Supported Residence or SR, Supported Rehabilitative Residence or SRR, Intensive Residence or IR, or SR-Transitional and shall be issued as a regular, provisional or restricted license.

3802.3 License fees for an initial MHCRF license and for each renewal license are as follows:

(a) 1 to 5 Beds

Annual Fee $50

Late Fee $25

(b) 6 to 10 Beds

Annual Fee $75

Late Fee $37.50

Annual Fee $100

Late Fee $50

3802.4 A fee in the amount of fifty dollars ($50) shall be charged to a MHCRF for each inspection after the first follow-up annual license renewal inspection. This includes follow-up inspections based on the Operator’s prior non-compliance.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3802

22-A DCMR § 3803 DISTRICT GOVERNMENT RIGHT OF ENTRY AND INSPECTION

3803.1 The Director, any other duly authorized official of the Department, or any other District government agency having jurisdiction or responsibility over a MHCRF or a resident in a MHCRF, after presenting credentials of identification and authority issued by the Director of the relevant District agency, may, either with or without prior notice, enter and inspect the premises of the following:

(a) A MHCRF licensed pursuant to this chapter;

(b) A facility for which an Operator is applying for licensure as a MHCRF to determine the facility’s compliance with applicable requirements; and

(c) Subject to § 3803.5, any unlicensed premises that the Director or any other District agency has reason to believe is being operated or maintained as a community residence facility in violation of this chapter or other applicable laws of the District of Columbia.

3803.2 The authorized official shall have access to the following:

(a) Facility administrative, personnel, financial, and resident records required by this chapter including records required by §§ 3824, 3825, 3837, 3838, 3839, 3840, 3846, 3848, and 3850 through 3855;

(b) Facility staff;

(d) The entire premises including all indoor rooms and outdoor areas; and

(e) Any other information necessary to determine the facility’s compliance with this chapter or other applicable law.

3803.3 When conducting an inspection pursuant to this section, the authorized official may:

(a) Interview and make inquiries of staff and residents, on or off-site, relevant to compliance with all applicable requirements;

(b) Scan or make copies of any facility records, subject to federal and District law pertaining to the confidentiality of medical records; and

(c) Photograph or videotape conditions at the facility that the official reasonably believes to be in violation of this chapter or any other applicable law or regulation.

3803.4 Any licensed MHCRF Operator that refuses an authorized official entry and inspection to the premises violates this Chapter and shall be subject to fines, the suspension or revocation of the facility’s license, and the removal of residents.

3803.5 The Director may refer a case involving an unlicensed facility that the Director determines is operating as a MHCRF to the Office of the Attorney General for the District of Columbia for appropriate legal action.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3803

22-A DCMR § 3804 ELIGIBILITY REQUIREMENTS FOR LICENSURE

3804.1 In order to qualify for a MHCRF license, an Applicant shall:

(a) Submit a completed application pursuant to § 3805 to the Department together with all required documents;

(b) Ensure that the facility meets all structural and environmental requirements set forth in this chapter, or otherwise required by law, including correcting any deficiencies identified in the pre-licensure inspection pursuant to § 3806;

(c) Demonstrate that, prior to accepting residents, the Operator will have the required staff in place who have met all applicable criminal background check, education, training, reference, health, and certification requirements pursuant to § 3850;

(d) Demonstrate that, if the Operator will not personally manage the facility and serve as Residence Director, or if the Operator is a corporation, agency, or partnership, the Operator has employed a Residence Director who shall be responsible for the management and operation of the facility as provided in § 3852 and § 3853;

(e) Demonstrate that the Operator and the Residence Director (where there is a separate Residence Director) have the ability to direct and operate a MHCRF as evidenced by the applicable background checks, criminal background checks, proof of requisite education, training, certifications, experience, and letters of reference pursuant to §§ 3850 and 3851;

(f) Demonstrate the ability to comply with this chapter, the Licensure Act, and the Human Rights Act; and

(g) Demonstrate that the facility meets all applicable District of Columbia Construction Code requirements, including the Property Maintenance Code, Fire Prevention Code, and Housing Code requirements, by submitting appropriate documentation of Department of Consumer and Regulatory Affairs (DCRA) and Fire and Emergency Medical Services Department (FEMSD) inspections and approvals, as described in § 3805.4 (h) and (i) and the application for licensure.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3804

22-A DCMR § 3805 APPLICATION FOR LICENSE

3805.1 An application for licensure as a MHCRF shall be submitted in the name of the Operator, who shall have an ownership or leasehold interest in the real property where the MHCRF will be located. The application shall be in the format established by the Department. If the Operator is a corporation or agency, the Applicant shall designate an officer or director who shall act on behalf of the corporation or agency for all matters pertaining to licensure. If the Operator is a partnership, the application shall identify all partners and the designated authorized agent for the partnership.

3805.2 An application for initial licensure as a MHCRF shall be submitted to the Director at least thirty (30) days prior to the date that the Operator intends to begin operations. A renewal application shall be submitted in accordance with § 3813.

3805.3 The application shall include:

(a) The Applicant’s name, address, telephone number, e-mail address, Social Security number or federal tax identification number, birth date (or date and state of incorporation), and whether the Applicant is an individual, partnership, or corporation;

(b) The identity of the owner, and contact information, of the building in which the facility is located;

(c) The identity of the Residence Director for the facility, including Social Security number and birth date, if the Operator will not be personally managing the facility or if the Operator is a corporation, agency, or partnership;

(d) The names of the persons submitting the letters of reference for the Operator and Residence Director required by § 3805.4(a);

(e) Requested information pertaining to the building in which the facility will be operated including its address;

(f) The maximum number of beds at the facility;

(g) All documentation required under § 3805.4;

(h) Any additional information requested by the Director on the application form, including information specific to an SR, SRR, IR, or SR -Transitional;

(i) The signature of the Applicant or a legally authorized signatory of the Applicant if the Applicant is a corporation, agency or partnership; and

(j) The license fee required by § 3802.

3805.4 The application for licensure shall be accompanied by the following documents:

(a) Three (3) letters of reference on a form prescribed by the Department for the Operator and for any Residence Director of the facility. The letters of reference shall be from unrelated persons who have known the Operator or Residence Director for five (5) years or more and can verify their experience working with persons who are mentally ill;

(b) Documentation of required education, experience, training, and certifications for the Operator and Residence Director, as set forth in §§ 3850 and 3851;

(c) A Certificate of Incorporation or Certificate of Authority for corporations or documentation of appropriate partnership registration with the DCRA Corporations Division, as applicable;

(d) An original, current Certificate of Good Standing for a corporation;

(e) Verification of required insurance coverage from the company or broker providing insurance, including the dates of coverage and the specific coverage provided;

(f) Verification of compliance with criminal background check requirements, as set forth in §§ 3850.10 through 3850.14, conducted within forty-five (45) days prior to commencing work at the facility for each “unlicensed person” as defined in this chapter, including an Operator, Residence Director, employee, contract worker or volunteer, who, upon licensure of the facility, will work in the facility or have unsupervised access to the facility and residents.

(g) A copy of a valid Certificate of Occupancy from DCRA for any MHCRF that will house more than six (6) residents;

(h) Proof of a satisfactory pre-licensure inspection and approval by DCRA (and FEMSD as applicable) for Housing Code and Construction Codes compliance, including a copy of the inspection report and proof of abatement by DCRA and FEMSD of all deficiencies identified during the inspection(s). The approval shall be dated not more than forty-five (45) days prior to the date of submission. The pre-licensure inspection(s) shall demonstrate compliance with requirements of the Housing Code and Construction Codes, specifically including the Property Maintenance Code and Fire Prevention Code requirements applicable to a community residence facility;

(i) Copies of all building, electrical, plumbing, or other permits and approvals required by DCRA under the Construction Codes for new construction, renovations, repairs, or other work conducted at the facility within the twelve (12) months prior to applying for licensure;

(j) A Clean Hands Certification on a form prescribed by DCRA;

(k) A statement from the Office of Tax and Revenue that the Applicant does not owe taxes in excess of one hundred dollars ($100.00) or has entered into an approved payment plan, pursuant to the Clean Hands Act;

(l) Proof of the Applicant’s ownership of the premises where the facility will be located or, if the building is not owned by the Applicant, a copy of a current lease agreement for the building naming the Applicant as lessee and authorizing operation of a community residence facility;

(m) A copy of the standard residency contract for room, board, and care to be signed by the MHCRF and the resident, prepared in accordance with § 3824;

(n) A copy of the house rules for the facility prepared in accordance with § 3823.29;

(o) A Program Statement as described in § 3805.6;

(p) An Emergency Preparedness Plan, Continuity of Operations Plan, and health-related emergency policies and procedures as described in § 3805.7;

(q) A current staffing pattern on a form prescribed by the Department and signed by the Applicant;

(r) Documentation of required medical examinations and vaccinations, criminal background check, and education, experience, and training certifications for each staff person who will be working in the facility upon licensure, as provided in § 3850; and

(s) Proof that utility accounts are in the name of the Applicant, including water, heat, electricity, telephone, and internet service, and that payments are current where Applicant has had prior service at the facility.

3805.5 The Department in its sole discretion may accept and review a license application for a MHCRF prior to receiving documents required pursuant to §§ 3805.4(q) and (r), and may authorize the Applicant to provide the staffing pattern and documentation of staff eligibility after the Department has determined that the Applicant has satisfied the other licensure requirements set forth in §§ 3805.3 and 3805.4.

3805.6 Each Applicant shall submit a written Program Statement, on a form prescribed by the Director, which shall include a description of the following:

The MHCRF’s program and facilities, including any population-specific programs;

The services provided;

The internal process for resident grievances which shall conform to the Department’s grievance regulations;

The monthly rental fee for room, board, and care, and any fees or charges not included in the monthly rental fee;

The payment and refund policies;

The group or groups of persons to be served, including any gender, age, health, or language characteristics, and the justification for any limitations described;

Admission and discharge criteria;

Transition planning provided to residents to assist in moving to a lower level of care; and

A description of any services provided by independent contractors.

3805.7 The Application shall also include a copy of:

(a) The Emergency Preparedness Plan required by § 3833 and FEMSD;

(b) A Continuity of Operations Plan (COOP), to include a description of equipment, appliances, special supplies, and procedures that the MHCRF has in place to address extended power outages, heat emergencies, natural disasters, or other situations not addressed in the FEMSD approved plan. The MHCRF shall review and update, as necessary, the COOP annually and provide a copy to the Department at the time of licensure renewal and upon request. The COOP shall include provisions and emergency supplies for the MHCRF to remain in operation during the emergency, as well as procedures for emergency evacuation and temporary relocation of residents; and

(c) Written policies and procedures governing the care of residents in health-related emergencies, including a communicable disease episode, food poisoning outbreak, critical illness or death of a resident, or a change in the mental status of a resident that endangers himself, herself, or others.

3805.8 The Director will review each application for a MHCRF license for completeness and submission of the required documents and fee. The Director may request additional information in order to evaluate the applicant’s eligibility for a license.

3805.9 The Director may terminate review of an application that is incomplete, is not accompanied by the required fee, or is not accompanied by all required documents. The Director shall provide the Applicant with written notice stating why review has been terminated.

3805.10 The Director shall conduct background checks on the Applicant, which may include the officers, directors, or partners of a corporation, agency, partnership, or employees to determine the Applicant’s suitability or capability to operate a MHCRF. Background checks may include:

(a) Verification of professional or occupational licensure status (if applicable);

(b) Verification of training, educational credentials, and certifications;

(c) Contacts with District and other state or federal officials to determine the existence and content of outstanding warrants, complaints, criminal convictions, debts to District government, and records of civil actions or judgments; and

(d) Review of the record of regulatory compliance for other businesses owned or operated by the Applicant that provide residences, room or board, or involve care of vulnerable persons.

3805.11 Notwithstanding Subsection 3825.5, the Director may approve licenses for single sex, age specific, or other specific populations, such as the hearing impaired, where the MHCRF program is necessary to meet the special needs of the population and will not unfairly limit choices for other individuals seeking a MHCRF placement.

3805.12 At the time of license application, or renewal application, the MHCRF shall pay any outstanding Notice of Infraction (NOI) fines.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3805

22-A DCMR § 3806 INSPECTION FOR INITIAL LICENSURE

3806.1 Prior to initial licensure of a MHCRF, the Director shall conduct an on-site inspection to determine compliance with this chapter. The Director shall send a written Statement of Deficiencies identified as a result of the on-site inspection to the Applicant no later than ten (10) days after the inspection is completed.

3806.2 A MHCRF with deficiencies shall be allowed a reasonable period of time, not to exceed thirty (30) days from the date of the written Statement of Deficiencies, to correct the deficiencies while an application for initial licensure is pending. The facility may submit written proof of correction of deficiencies where appropriate.

3806.3 The Director shall conduct a follow-up inspection to determine correction of deficiencies within ten (10) days following the thirty (30) day correction period or within ten (10) days after notification by the Applicant that the deficiencies have been corrected.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3806

22-A DCMR § 3807 DENIAL OF INITIAL LICENSURE

3807.1 The Director shall deny an initial MHCRF license for a new MHCRF if the MHCRF is not in compliance with this chapter, the Applicant provided false or misleading information during the application process, or the Applicant has failed to comply with the Department’s plan of correction.

3807.2 If the Director denies an initial MHCRF license, the Director shall issue written notice to the Applicant stating the reasons for the denial. The denial shall be effective immediately.

3807.3 The Applicant may request a review of the denial by the Director within ten (10) days after service of the notice of denial. The request for review shall be in writing and shall state the reasons why the license should be granted. The Director shall consider and respond in writing to a request for review within ten (10) days after receipt of the request. The Director’s decision in response to a request shall be final.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3807

22-A DCMR § 3808 NINETY-DAY PROVISIONAL LICENSE FOR NEWLY LICENSED FACILITIES: ISSUANCE, RENEWAL, AND ACTION UPON EXPIRATION

3808.1 All Applicants approved by the Director for a new MHCRF license shall receive a ninety (90) day provisional license.

3808.2 The Director shall conduct at least one (1) inspection of the facility within ninety (90) days after it begins to operate to assess whether the facility and its operations are in compliance with this chapter.

3808.3 The Director may, in his or her discretion, renew a provisional license once for up to an additional ninety (90) days for a MHCRF that is not in full compliance with this chapter; provided The MHCRF is taking action to correct cited deficiencies in accordance with a mutually agreed-upon timetable.

3808.4 The Director may issue a regular license for not to exceed one (1) year from the date the initial provisional license was issued to a MHCRF that is in full compliance with the requirements of this chapter, as determined by the Director.

3808.5 Upon expiration of the provisional license, including an extension under § 3808.3, the Director shall deny a regular license if the MHCRF fails to demonstrate compliance with this chapter.

3808.6 If the Director denies an Applicant a regular license or renewal of a provisional license pursuant to §§ 3808.3 or 3808.5, the Applicant may make a written request for reconsideration to the Director within ten (10) days after service of the notice.

3808.7 Upon receipt of a request for reconsideration pursuant to § 3808.6, the Director shall hold an informal hearing within the Department within fifteen (15) days to consider the request. The Director shall provide reasonable notice to the Applicant of the date and time of the informal hearing and any applicable hearing procedures.

3808.8 At the informal hearing, the Applicant shall have an opportunity to present written and oral statements to the Director in response to the notice of license denial.

3808.9 The Director shall notify the Applicant in writing of the Director’s determination on the request for reconsideration within ten (10) days after the informal hearing, and shall include the reasons if the license denial is upheld.

3808.10 The Director’s determination pursuant to § 3808.9 shall be final. In his or her discretion, the Director may extend the license for a reasonable period of time to ensure the safe discharge of residents in accordance with Section 3861.

3808.11 If the MHCRF has previously held a regular license for the facility, the procedures set forth in § 3815 through § 3821 shall apply to actions by the Director to non-renew, revoke, suspend, convert, or deny a license.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3808

22-A DCMR § 3809 RE-APPLICATION AFTER LICENSE DENIAL, NON-RENEWAL, OR REVOCATION

3809.1 Except as provided in § 3809.2, an Applicant may not reapply for licensure for ninety (90) days following the Department’s denial of a license.

3809.2 An Applicant may not reapply for licensure for three (3) years from the effective date of the Director’s determination to deny renewal of or revoke the license pursuant to § 3816, or, if the Director’s determination is appealed, from the date of a final decision denying renewal of or revoking the license.

3809.3 The Director may in his or her discretion grant a waiver of the time periods set forth in this section for good cause shown.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3809

22-A DCMR § 3810 GENERAL MHCRF OPERATIONAL RESPONSIBILITIES

3810.1 The MHCRF shall not willfully fail or refuse to comply with a statute or regulation governing MHCRFs.

3810.2 The MHCRF shall cooperate with inspections by the Director or other District government officials conducted pursuant to § 3803 and shall cooperate with the Department’s investigation of a complaint made against the MHCRF.

3810.3 The MHCRF shall immediately inform the Director of any Major Unusual Incident pursuant to § 3848, the absence of required staff, a resident’s failure to take prescribed medications for more than forty-eight (48) hours, or significant deficiencies including: a lack of heat, air conditioning, water, hot water, or electricity; bug or rodent infestation; or the need to move a resident or residents due to an emergency.

3810.4 The MHCRF shall inform the Director of a change in the operation, program, or services of a MHCRF of a degree or character that may affect its licensure, including a change in the Residence Director or other staff. The MHCRF shall inform the Director as soon as feasible after the MHCRF is aware that the change will occur, but no later than five (5) days after the change.

3810.5 The MHCRF shall promptly correct deficiencies. Serious deficiencies or conditions immediately affecting resident health and safety, such as conditions described in § 3810.3, shall be corrected within twenty-four (24) hours. For purposes of this section, the MHCRF shall report a resident’s failure to take prescribed medications for more than forty-eight (48) hours to the Director and the resident’s CSA within twenty-four (24) hours of such failure.

3810.6 If the Operator of a MHCRF receives a Statement of Deficiencies, the MHCRF shall correct the deficiencies within the time frame required by the Department in accordance with § 3811, or within such extended time as the Director may grant, for good cause shown, upon written request.

3810.7 The MHCRF shall submit a signed and dated Plan of Correction on a form prescribed by the Director within five (5) days after receiving the Statement of Deficiencies. The Plan of Correction shall describe the corrective actions that the MHCRF plans to take to correct the deficiencies or verify that the deficiencies have been corrected.

3810.8 Before a person begins working or providing volunteer or other services at the MHCRF, the MHCRF shall ensure that the person has met all prerequisites and has submitted all required documents as set forth in §§ 3850, 3851 and 3852.

3810.9 If the Director receives a complaint of abuse or neglect of a resident by a Residence Director or staff member, upon direction by the Director, the MHCRF shall immediately remove the Residence Director or staff member from the MHCRF until the complaint is found to be unsubstantiated.

3810.10 If a criminal investigation or an investigation by the Department of Human Services pursuant to the Adult Protective Services Act is initiated, the removal of the Residence Director or staff member shall remain in effect until the investigation is completed and the complaint is found to be unsubstantiated. During the removal period, the Residence Director or staff member shall not be employed at another MHCRF in a direct patient care capacity.

3810.11 Each MHCRF license in an Operator's possession shall be the property of the District government. The MHCRF shall return the license to the Director upon request after license suspension, revocation, termination, replacement, or expiration.

3810.12 Each MHCRF shall maintain personnel records, resident records, administrative records, and MHCRF financial records as required by §§ 3824, 3825, 3837, 3838, 3839, 3840, 3846, 3848, 3850 through 3855. All resident and personnel records shall be maintained at the MHCRF. MHCRF financial records shall be maintained at the MHCRF or at the Operator’s business office in the District of Columbia and shall be made available to the Department upon request.

3810.13 Each MHCRF shall meet each of the specific requirements for operation of MHCRFs set forth in this chapter.

3810.14 In an emergency caused by a natural disaster, extreme heat or cold, extended power outage, or a similar situation, the MHCRF shall contact the Director as soon as possible. The MHCRF shall inform the Director whether the MHCRF is fully functional or, if there are problems or deficiencies that affect residents, how these problems are being addressed and if there is a need to temporarily transfer residents to another location.

3810.15 No MHCRF resident shall be relocated outside of the District of Columbia without the prior written approval of the Director.

3810.16 No MHCRF shall delay, hinder, obstruct, impede or otherwise interfere with the emergency relocation of residents.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3810

22-A DCMR § 3811 DEPARTMENTAL OVERSIGHT AND INVESTIGATIONS

3811.1 Any person may file a complaint with the Director alleging violations of the requirements of this chapter, and the Director may conduct unannounced investigations and inspections to determine the validity of the complaint.

3811.2 The Director shall conduct licensure inspections and review records including resident records, personnel records, administrative and financial records as authorized by §§ 3803 and 3811.1, and as required by §§ 3806, 3808.2, and 3813.3. In addition, the Director shall inspect facilities:

(a) As appropriate, when a complaint is received;

(b) In accordance with any schedule adopted by the Department; and

3811.3 The Director shall require an Operator to correct any condition that violates this chapter within fourteen (14) days after the date the Operator is notified of the violation, except where the seriousness of the condition and its impact on residents requires a shorter time period, including the conditions provided in § 3811.4. The Director, in his or her discretion, may grant a reasonable extension of time for compliance, upon written request by the MHCRF, for good cause shown.

3811.4 The Director may require an Operator to immediately correct an emergency condition affecting resident health and safety within a time specified by the Director. These conditions include, but are not limited to the a lack of heat, extreme heat, lack of water, lack of hot water, lack of electricity, a stopped toilet, a broken window or door, lack of staff coverage, or a bug or rodent infestation.

3811.5 The Director shall issue a Statement of Deficiencies to the Operator, including the deadlines for correction of the deficiencies and for the Operator’s submission of a written Plan of Correction.

3811.6 The Director, in his or her discretion, may grant a reasonable extension of time for correction of the deficiencies, upon written request by the MHCRF with good cause shown.

3811.7 Nothing in this section or § 3810 shall require the Director to issue a Statement of Deficiencies or allow the MHCRF an opportunity to abate a deficiency, prior to issuing a Notice of Infraction for violations of this chapter.

3811.8 NOIs shall be issued upon observation of violations of this chapter, especially when they are recurrent, endanger resident or staff health or safety, or when there is a failure to comply with core requirements of operating a MHCRF.

3811.9 If, after an investigation or inspection, the Director finds failure to meet or maintain the standards required by this chapter or violations of this chapter the Director may take appropriate action to deny renewal of, suspend, revoke or convert a license in accordance with the provisions of §§ 3814, 3815 or 3816.

3811.10 In addition to, or in lieu of, issuing a notice to deny renewal, suspend, revoke or convert a license, the Director may pursue any other available enforcement option, including those authorized by Section 10 of the Licensure Act (D.C. Official Code § 44-509) and the Civil Infractions Act.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3811

22-A DCMR § 3812 APPROVAL OF VARIANCES

3812.1 The Director may grant a variance from any of the requirements of this chapter, if the Applicant or Licensee can show undue hardship and the variance:

(a) Is consistent with the provisions of the Licensure Act;

(b) Will not endanger the health or safety of residents or the public; and

3812.2 An Operator seeking a variance pursuant to § 3812.1 shall submit a written request to the Director including the following:

(a) The regulatory requirement(s) from which a variance is being requested;

(b) Specific reasons why the MHCRF cannot meet the requirement(s); and

3812.3 The Director may also grant a variance, in writing, to protect the health and safety of residents when an emergency caused by a natural disaster, extreme heat or cold, an extended power outage, or similar situation requires the temporary relocation of residents to another location, the need to temporarily exceed licensed occupancy limits, or other action.

3812.4 An Operator seeking a variance pursuant to § 3812.3 shall submit a written request to the Director, with a copy to the District of Columbia Long-Term Care Ombudsman, stating:

(a) Why the variance is needed and the anticipated length of time for the variance; and

(b) The action that the Operator proposes to take to address the issue, including:

The number of residents to be transferred;

(2) The address of any temporary transfer location, the identity of its owner, the location’s number of bedrooms, its bathroom and kitchen facilities, the total number of its residents after the transfer, and the accommodations to be made for the transferred residents; and

(3) The continuity of care plan for each resident to ensure they continue to receive services without interruption.

3812.5 The Department shall grant a variance only to the extent necessary to ameliorate an undue hardship or emergency and only when compensating factors are present that give adequate protection to residents and the public health and safety consistent with applicable law.

3812.6 If the Director determines that the conditions in § 3812.1 or § 3812.3 are not met, the Director shall issue a written denial to the Operator stating the basis for denial. The decision of the Director shall be final.

3812.7 The Department shall maintain a record of all variances granted. The record shall contain a complete written explanation of the basis for each variance and shall be open to inspection by the public.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3812

22-A DCMR § 3813 RENEWAL OF LICENSE

3813.1 An Operator shall submit an application for license renewal to the Director, together with the fee required by § 3802, no later than ninety (90) days before the expiration date of the current license. The application shall meet the requirements of § 3805, except that supporting documents shall be submitted with the application in accordance with this section:

(a) Letters of reference required by § 3805.4(a), if there is a change in Residence Director;

(b) Documentation of required medical examinations, annual physician certifications, vaccinations, education, experience, and training certifications as provided in §§ 3805.4(b) and (r) for any new Residence Director or new staff, and updated information as required in § 3850 for the current Operator, Residence Director, or staff;

(d) Verification of the required insurance coverage from a company or broker providing insurance, including dates and specific coverage provided;

(e) Verification of compliance with criminal background check requirements in accordance with § 3805.4(f) and §§ 3850.10 through 3850.14 for any new hires and for any “unlicensed person” currently working at the facility or having unsupervised access to the facility and residents;

(f) New Certificate of Occupancy as required by § 3805.4(g) for a MHCRF housing more than six (6) residents, if there is an increase in occupancy;

(g) FEMSD Fire Inspection Approval, if not current;

(h) If requested by the Director after a DBH inspection of the premises, a satisfactory pre-licensure renewal inspection by DCRA, and copies of any permits for work being done on the premises, as provided in § 3805.4(h) and (i);

(i) Clean Hands Certification;

(j) A statement from the Office of Tax and Revenue that the Applicant does not owe taxes in excess of one hundred dollars ($100.00) or has entered into an approved payment plan;

(k) A copy of a current lease agreement if the premises are not owned by the Applicant; and

(l) If there have been any changes in these documents since the facility’s initial licensure or last renewal, the current standard residency contract, house rules, Program Statement, Emergency Preparedness Plan, COOP, or health emergency procedures for the facility as provided in § 3805.4(m) through (p);

(m) A current staffing pattern on a form prescribed by the Department and signed by the Applicant;

(n) Proof that utility bill payments are current for water, heat, electricity, phone, and internet service; and

(o) Current resident roster.

3813.2 If the Operator fails to timely submit a license renewal application, the MHCRF license will terminate at the end of the original license period.

3813.3 The Director shall conduct an on-site inspection of the MHCRF to determine compliance with this chapter prior to the expiration of the license. Unless notified otherwise, inspections shall be unannounced.

3813.4 The Director shall send a written Statement of Deficiencies, if any, from the on-site inspection to the Operator no later than ten (10) days after the inspection is completed.

3813.5 The MHCRF shall submit a Plan of Correction and correct the deficiencies within the time frame required by the Director pursuant to §§ 3811.3, 3811.4, and 3811.5.

3813.6 The Director shall conduct a follow-up inspection to determine correction of the deficiencies within ten (10) days after the correction deadline or within ten (10) days after notification by the MHCRF that the deficiencies have been corrected.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3813

22-A DCMR § 3814 DETERMINATION ON APPLICATION FOR RENEWAL OF MHCRF LICENSE

3814.1 The Director may issue a regular renewal license for a period not to exceed one (1) year to the Operator of a MHCRF that is in full compliance with this chapter and has no deficiencies.

3814.2 The Director may issue a regular renewal license for a period not to exceed one (1) year to an Operator of a MHCRF with minor deficiencies that can be corrected within thirty (30) days, or such other time period as the Director may require, and that is in substantial compliance with this chapter.

3814.3 The Director may issue a provisional license not to exceed ninety (90) days to the Operator of a MHCRF that is not in full compliance with this chapter provided that the MHCRF;

(a) Is taking action to correct cited deficiencies;

(b) Is taking appropriate ameliorative action in accordance with the Department-approved timetable. A provisional license may not be renewed more than once.

3814.4 The Director may issue a restricted license not to exceed ninety (90) days, pursuant to § 3815, when the MHCRF has numerous deficiencies or a single serious deficiency and the MHCRF has failed to correct the violation(s) or is not taking appropriate ameliorative actions to correct the violation(s).

3814.5 The restricted license or accompanying notice shall specify the restriction or restrictions, which may include a prohibition against the facility accepting new residents or against delivering services that it would otherwise be authorized to deliver.

3814.6 At the end of the restricted license time period, the license for the facility shall terminate if the deficiencies remain unabated.

3814.7 The Director may deny an application for renewal of a MHCRF license for any of the reasons set forth in § 3816.1.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3814

22-A DCMR § 3815 SUMMARY SUSPENSION AND LICENSURE CONVERSION HEARINGS

3815.1 The Director may, prior to a hearing:

Suspend the license of an MHCRF if the Director determines that existing deficiencies constitute an immediate or serious and continuing danger to the health, safety, or welfare of its residents;

Convert an MHCRF’s license to a provisional license if the facility has outstanding deficiencies, as set forth in § 3814.3, but is taking appropriate ameliorative actions; or

Convert its license to a restricted license as set forth in § 3814.4.

3815.2 Upon summary suspension or conversion of a license pursuant to § 3815.1, the Director shall give the MHCRF written notice of the suspension or conversion.

3815.3 The written notice of the suspension or conversion shall include a copy of the order of suspension or conversion, a statement of the grounds for the action, and notification that the MHCRF may, within seven (7) business days after receipt of the written notice, file with the Director a written request for an expedited preliminary review hearing with respect to the action. The hearing shall be held before OAH or a Hearing Officer as provided in §§ 3818.1 and 3818.2.

3815.4 If the MHCRF fails to timely request an expedited preliminary review hearing, the suspension or conversion shall remain in effect until terminated by the Director, or until a non-expedited hearing is requested and held pursuant to § 3818.

3815.5 If the MHCRF makes a timely request for an expedited preliminary review hearing, a hearing shall be convened within three (3) business days following receipt of the request.

3815.6 A request for a hearing, pursuant to § 3815.5, shall not stay the suspension or conversion order.

3815.7 At a preliminary review hearing, the Department shall have the burden of establishing a prima facie case of failure to meet or maintain the standards required by this chapter.

3815.8 At the conclusion of the hearing, the suspension or conversion order shall be either affirmed or vacated by the Administrative Law Judge (ALJ) or a Hearing Officer appointed by the Director. If affirmed, it shall remain in effect for no longer than thirty (30) days unless extended pursuant to § 3815.9. During this period, a final hearing shall be scheduled to consider the appropriateness of revocation or continuing restrictions on licensure.

3815.9 Before expiration of a suspension or conversion order, the ALJ or Hearing Officer may grant an extension for an additional thirty (30) days upon agreement of all the parties or upon good cause shown.

3815.10 Section 3818 pertaining to Conduct of Hearings shall apply to preliminary review and final hearings on summary suspensions and conversions, except that the ALJ or Hearing Officer may limit the evidence presented at expedited preliminary review hearings in accordance with the nature of the proceeding.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3815

22-A DCMR § 3816 LICENSE SUSPENSION, LICENSE REVOCATION, AND DENIAL OF RENEWAL LICENSE

3816.1 The Director may suspend, revoke, or deny renewal of the license of a facility issued pursuant to this chapter for any of the following reasons:

(a) Violation of the Licensure Act or any other applicable provision of District of Columbia or federal law, including violation of the Criminal Background Check Act, the Nursing Home and Community Residence Facility Residents Protection Act, and the Clean Hands Act;

(b) The Operator, its governing body, chief executive officer, administrator, or Residence Director has made a material misrepresentation of fact to a government official with respect to the MHCRF’s compliance with any provision of the Licensure Act, this chapter, or other provision of District of Columbia or federal law;

(d) Submission of false or misleading information to the District in connection with an application for licensure or related to licensing procedures;

(e) Failure or refusal to allow inspections pursuant to this chapter;

(f) Failure or refusal to submit information requested by the Department;

(g) Failure or refusal to obey any lawful order of the Director issued pursuant to this chapter;

(h) Conviction of the Operator, its governing body, administrator, Residence Director, the Chief Executive Officer, or other key staff member of a felony involving the management or operation of a MHCRF, or that is directly related to the integrity of the MHCRF or the public health or safety; and

(i) Any act or failure to act, which constitutes a threat to the health or safety of residents, MHCRF staff, or the public;

3816.2 Except as provided in § 3808 with respect to new provisionally licensed MHCRFs, and except for a summary suspension undertaken pursuant § 3815, every holder of a license shall be afforded notice and an opportunity for a hearing pursuant to § 3818 prior to an action of the Director to suspend, revoke, or deny renewal of a license.

3816.3 When the Director plans to suspend, revoke, or deny renewal of a license under this section, the Director shall give the Operator a written notice that includes the following:

(a) That the Director shall take the proposed action unless the Operator files a written request for a hearing, within fifteen (15) days of the receipt of the notice, with the Director and the administrative hearing body identified by the Director as described in § 3818. In lieu of requesting a hearing, the Operator may submit documentary evidence to the Director for the Department’s consideration before the Department takes final action;

(b) The Director’s reasons for the proposed action;

(c) A statement that if the Operator does not respond to the notice within fifteen (15) days, the proposed action is final and the Director may take the action proposed in the notice, without a hearing, and shall inform the Owner in writing of the action taken;

(d) A statement that if the Operator chooses to submit documentary evidence but does not request a hearing, the Director shall consider the material submitted and shall decide, without a hearing, whether to take the proposed action. The Director shall notify the MHCRF in writing of the action taken.

3816.4 An Operator that fails to file a written request for a hearing within fifteen (15) days of the receipt of the notice waives the right to contest or appeal the notice.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3816

22-A DCMR § 3817 SERVICE OF NOTICE

3817.1 Any formal notice issued by the Director, including any notice or order to deny, suspend, convert, deny renewal of or to revoke a license, and any notice of appeal rights or notice of a hearing shall be served:

(a) By personal service; or

(b) Electronic mail.

3817.2 If notice is served personally, it shall be effective when delivery is made personally to the MHCRF or its authorized agent.

3817.3 Each MHCRF granted a license shall provide a valid electronic mail address and consent to receive official correspondence, including licensing notices and infractions, at the electronic mail address.

3817.4 A MHCRF that fails to respond to or appeal any notice within the allotted time waives any right to appeal or contest the notice. If a MHCRF that has been served does not appear for a scheduled hearing and no continuance has been granted, the Administrative Law Judge or Hearing Officer may proceed to hear evidence, consider the matter, and render a decision on the basis of the evidence available.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3817

22-A DCMR § 3818 CONDUCT OF HEARINGS

3818.1 Hearings required by § 3815 and § 3816 shall be conducted in the manner required for contested cases pursuant to the District of Columbia Administrative Procedure Act, and shall be open to the public.

3818.2 Hearings shall be held before an ALJ of the OAH, provided the Director maintains an arrangement with OAH to adjudicate the Department’s licensure and appeals cases. Hearings before OAH shall be held in conformity with OAH Rules of Practice and Procedure.

3818.3 If Department cases are not heard by OAH as provided in § 3818.2, the Director shall appoint a Hearing Officer to conduct hearings required by § 3815 and § 3816.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3818

22-A DCMR § 3822 INSURANCE

3822.1 Each MHCRF shall carry the following types of insurance in at least the following amounts:

Hazards (fire and extended coverage) or resident personal effects coverage in the amount of at least five hundred dollars ($500) per resident to protect resident belongings, with aggregate coverage of at least $500 multiplied by the number of residents;

A commercial policy for general liability and professional liability for at least:

Three hundred thousand dollars ($300,000) per occurrence with a six hundred thousand dollar ($600,000) aggregate for one (1) to eight (8) beds; or

Five hundred thousand dollars ($500,000) per occurrence with a one million dollar ($1,000,000) aggregate for nine (9) or more beds; and

(c) Sexual abuse or molestation coverage to protect MHCRF residents from abuse or molestation by staff, for a limit of at least one hundred thousand dollars ($100,000) per occurrence.

3822.2 The insurance required by § 3822.1 shall be issued on an “occurrence” or “claims made” basis. If a “claims made” basis is used, the effective date shall be retroactive to the expiration date of the previous policy or the issuance date of the license.

3822.3 The MHCRF may substitute another form of policy that meets the minimum policy limits and the types of coverage required by § 3822.1, provided that the Operator can demonstrate through the Insurance Certificate, any policy endorsements, and any other documentation required by the Director that the policy will cover claims made against the MHCRF.

3822.4 Before the Director issues or renews a license, the MHCRF shall submit to the Director a certification of insurance issued by the insurance carrier verifying the policy coverage, dates of coverage, and policy limits. Where the MHCRF has been previously insured, the insurance certification shall be issued on or before the expiration date of the previous insurance policy.

3822.5 The Operator shall direct the insurance carrier to notify the Director if the policy is not renewed or is cancelled, and the Director may require proof that this direction has been given.

3822.6 The insurance shall be issued by an insurance carrier licensed to provide insurance in the District of Columbia, or through a surplus lines producer licensed in the District of Columbia.

3822.7 The insurance required by this section shall be maintained in force at all times that the MHCRF is licensed.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3822

22-A DCMR § 3823 RESIDENT’S RIGHTS AND RESPONSIBILITIES

3823.1 As a community-based residential facility, MHCRFs shall optimize resident initiative, autonomy, and independence in making individual life choices, including but not limited to daily activities, physical environment, and personal interactions. Each resident has a right to select among placement options that are identified and documented in the person-centered treatment plan based upon the individual’s needs, preferences, and the resources available for room and board. Each MHCRF shall comply with the Consumers’ Rights Act, including affording residents the consumer rights set forth in Section 204 (D.C. Official Code § 7-1231.04).

3823.2 Prior to the admission of each prospective resident, the MHCRF shall explain to the prospective resident and to the prospective resident’s representative, if any, the prospective resident’s rights and responsibilities, including the additional rights and responsibilities stated in the Consumers’ Rights Act and this section. In combination with the resident’s rights statement required in § 3823.3 below or separately, the MHCRF shall enter into a written agreement with the resident that explains the terms of occupancy including the monthly fee or rent, the discharge or transfer process, and resident appeals.

3823.3 The MHCRF shall provide to the resident, and to the resident’s representative, if any, a written statement of the resident’s rights and responsibilities which shall be signed by the resident and resident’s representative. The MHCRF shall maintain a copy of the signed statement in the resident’s record.

3823.4 A copy of the resident’s rights statement shall also be posted in a visible location in a common area of the facility where residents congregate, and individual copies shall be available to residents upon request.

3823.5 If a resident cannot read or understand English, the Operator, Residence Director, or responsible staff person shall arrange for the notice to be given orally and in writing in a language the resident can understand. The Director or the Core Services Agency shall provide assistance as needed.

3823.6 Each resident, or resident’s representative acting on the resident’s behalf, shall be permitted to register grievances or complaints without the threat of the resident’s discharge or other reprisal by the Operator or MHCRF staff.

3823.7 Each MHCRF shall provide each resident at the time of admission with a copy of any grievance or complaint procedures. These procedures shall comply with Section 212 of the Consumers’ Rights Act (D.C. Official Code § 7-1231.12) and 22-A DCMR, Chapter 3.

3823.8 Each resident shall have the right to privacy in the provision of personal and medical care and in sleeping units.

3823.9 Each resident shall have the right to actively participate in the development of the resident's Individual Recovery Plan.

3823.10 Each resident shall have the right to receive adequate and humane treatment by competent qualified staff and to be free from physical, emotional, sexual, or financial abuse, neglect, harassment, coercion, restraint and exploitation.

3823.11 Each resident shall have the right to have his or her medical and treatment records and all the information they contain kept confidential in accordance with the Mental Health Information Act and any other District or federal law that governs medical or treatment records.

3823.12 Each resident shall have the right to review copies of all treatment plans and all other medical, financial, and administrative records pertaining to the resident that the MHCRF maintains.

3823.13 Each resident shall have the right to free communication with and reasonable visitation by individuals of his or her choosing, including but not limited to a personal physician, attorney, clergy, family members, friends, significant other, personal representative, and guardian.

3823.14 Each resident shall have reasonable opportunities for social interaction with members of either sex, unless such interaction is specifically limited or withheld under the resident’s Individual Recovery Plan in accordance with Section 204 of the Consumers’ Rights Act (D.C. Official Code § 7-1231.04).

3823.15 Each resident shall have the right to send and receive sealed mail in conformity with Section 204 of the Consumers’ Rights Act (D.C. Official Code § 7-1231.04).

3823.16 Each resident shall have the right to communicate freely and confidentially with the resident's attorney, the courts, representatives of the District of Columbia Government, the D.C. Long-Term Care Ombudsman, and University Legal Services or any other organization currently responsible for advocacy under the Protection and Advocacy for Mentally Ill Individuals Act of 1986, 42 U.S.C. §§ 10801 et seq., in the District of Columbia.

3823.17 Each resident shall have reasonable access to a telephone to make and receive confidential calls.

3823.18 Each resident shall have the right to accept or refuse life sustaining medical treatment and to execute advanced directives about medical treatment decisions.

3823.19 Each resident shall have the right to refuse psychiatric treatment, including psychotropic medication, and supportive services, subject to applicable federal or District law, court order, or Department rules governing the involuntary administration of medication.

3823.20 Representatives of the District of Columbia government, the agency responsible for the protection and advocacy system for persons with mental illness, and the LTCO, upon presentation of proper identification, shall have immediate access to residents in MHCRFs.

3823.21 No resident shall have any religious belief or practice imposed upon him or her.

3823.22 Each resident shall have the right to participate in social, religious, or community activities that do not interfere with the rights of other residents or cause a substantial disruption to the normal functioning of the residence.

3823.23 Representatives of the Office of the District of Columbia LTCO Program shall have access to residents in MHCRFs in accordance with the District of Columbia Long-Term Care Ombudsman Act.

3823.24 Representatives of the agency responsible for the protection and advocacy system for persons with mental illness shall have access to residents in MHCRFs in accordance with the Protection and Advocacy for Mentally Ill Individuals Act.

3823.25 Each resident shall have the right to manage his or her own financial affairs unless the resident has a court-appointed legal guardian or conservator or a duly appointed representative payee.

3823.26 A MHCRF shall not:

(a) Solicit or refer residents to be used as research subjects;

(b) Use residents as research subjects; or

(c) Receive any money, commission, gift or other thing of value in exchange for soliciting, referring or using residents as research subjects.

3823.27 Other than routine household duties, no resident shall be required to perform unpaid work.

3823.28 Except as provided in Title 21, Chapter 5 of the District of Columbia Official Code pertaining to hospitalization of the mentally ill, each transfer, discharge or relocation of a resident within a MHCRF shall comply with Title III of the Nursing Home and Community Residence Facility Residents’ Protection Act of 1985 (D.C. Official Code, §§ 44-1003.01 to 44-1003.13) and Section 3861.

3823.29 Upon admission, each resident shall be provided a copy of the MHCRF's house rules and Program Statement.

3823.30 Each MHCRF shall have house rules that are consistent with this chapter and with Model House Rules provided to Operators by the Director. Each MHCRF shall encourage resident input and participation in the development and implementation of house rules. At a minimum, the rules shall address:

(a) The use of tobacco and alcohol;

(b) The prohibition of the use and possession of marijuana while on the MHCRF premises;

(d) Hours for viewing or listening to television, radio, CDs, DVDs, or other media;

(e) Movement of residents in and out of the facility;

(f) The prohibition against sexual relations between staff and residents; and

(g) A prohibition against children and youth under 18 residing in the MHCRF or visiting overnight at the MHCRF.

3823.31 The resident shall comply with the MHCRF's rules during his or her residency at the MHCRF, except where a rule violates other provisions of this chapter or District of Columbia law.

3823.32 Each resident shall pay the MHCRF on a monthly basis the amount that has been agreed upon in writing for the care provided to the resident as provided in § 3824.

3823.33 Each MHCRF shall assist the resident in registering and exercising the resident's right to vote.

3823.34 Each MHCRF shall, at all times, treat residents with consideration and respect for the resident’s dignity, autonomy, and privacy. Respectful treatment shall also be extended to the resident’s family members, personal representative, attorney-in-fact, and guardian.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3823

22-A DCMR § 3824 RESIDENCY CONTRACT BETWEEN MHCRF AND RESIDENT FOR ROOM, BOARD, AND CARE

3824.1 Prior to admission, the MHCRF shall give the resident and the resident’s representative, if any, a written residency contract for room, board, and care which shall be signed by the Operator or authorized Residence Director and by the resident. An individual holding an appropriate power of attorney or a court-appointed legal guardian or conservator with authority to handle the resident’s financial affairs may sign on behalf of the resident as necessary.

3824.2 The residency contract shall set forth, at a minimum, the following information and requirements:

(a) The monthly fee payable by the resident;

(b) The care and services covered by the monthly fee;

(d) Protections that address eviction processes and appeals including the Operator’s obligation to provide notice of relocations, transfers, and discharges in accordance with § 3861 of this chapter;

(e) Resident obligations upon vacating the premises and upon discharge;

(f) The residents’ right to reasonably furnish and decorate their rooms.

3824.3 A new residency contract for room, care, and board shall be signed by the parties each time there is a change in the monthly fee payable by the resident or a change in services provided by the MHCRF. Any change to the monthly fee payable by the resident shall comply with § 3838.

3824.4 Residency contracts for each resident shall be maintained at the MHCRF for no fewer than five (5) years from date of the resident’s discharge and shall be available for inspection by the Director.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3824

22-A DCMR § 3825 GENERAL ELIGIBILITY AND ADMISSION REQUIREMENTS

3825.1 A MHCRF shall admit and retain only those persons with a principal diagnosis of mental illness:

For whom the MHCRF can safely and adequately provide care; and

Who require the level of care and supervision available at the facility.

3825.2 Prior to a prospective resident’s admission and in accordance with the Mental Health Information Act, each MHCRF shall obtain the following:

A medical certification completed and signed by a licensed physician, nurse practitioner, or physician assistant within ninety (90) days prior to the prospective resident’s admission to the MHCRF. The certification shall:

(1) Verify that the prospective resident has had a physical examination within the past year;

(2) Identify the prospective resident’s known medical conditions including any significant changes in the prospective resident’s health status since the last full physical examination; and

(3) Include a statement that the prospective resident is free of any communicable disease, including tuberculosis, or that any communicable disease the prospective resident has does not pose a health risk to other residents or staff and is not in an acute stage;

The most recent diagnostic assessment for the prospective resident, completed not more than six (6) months prior to admission. Any significant changes since the most recent assessment, should be documented in a signed statement by a member of the treatment team;

Current doctor’s orders including all currently prescribed medications (medical and psychiatric), and a list of each known allergy;

Special diet instructions, if applicable;

Current IRP completed or updated within one hundred eighty (180) days prior to admission, or in accordance with an amended time frame set forth in a duly adopted Departmental policy published on the Department’s website;

(f) For prospective residents within the Department’s system of care, the Department’s approved functional assessment prepared in accordance with a tool approved by DBH that defines the level of the prospective resident’s housing and personal care needs and is consistent with the level of care provided at the MHCRF, including whether the prospective resident is capable of taking his or her own medication or needs assistance with medication administration;

(g) A copy of the prospective resident’s records and face sheet, as described in § 3846.2 including demographic information from the MHCRF, CRF, nursing home, or other institution where the prospective resident last resided;

(h) At least a seven (7) day supply of all currently prescribed medications;

(i) Identification of representative payee, legal guardian, or conservator, if applicable; and

(j) Income verification or statement of party responsible for payment.

3825.3 When a MHCRF accepts a resident on an emergency basis, the Director may extend the time within which the MHCRF must obtain documents required by § 3825.2, except that in all cases the resident shall be tested for tuberculosis and test results shall be obtained within seven (7) days of acceptance. Current medications shall be obtained within twenty-four (24) hours.

3825.4 The MHCRF shall obtain documents from the resident’s Core Services Agency or other healthcare provider and shall immediately inform the Director if a resident’s CSA is not cooperating in providing the MHCRF with documents required pursuant to § 3825.2.

3825.5 A MHCRF shall comply with the Americans with Disabilities Act and the Human Rights Act in the admission, placement, and retention of residents and in the provision of services to residents. No MHCRF shall deny admission based upon the person's age, gender, race, physical or mental disability, HIV status, religion, sexual orientation, gender identity or expression, national origin, marital status, or source of payment for the service.

3825.6 No MHCRF shall refuse to make reasonable accommodations in accordance with the Americans with Disabilities Act and the Human Rights Act necessary to admit or retain a resident who is deaf, blind, non-English speaking, non-ambulatory, or otherwise physically or mentally disabled.

3825.7 In addition to the requirements of § 3825.5, no MHCRF shall deny admission to an individual with a Department-approved level of care determination because the person:

Needs assistance with medication administration, including injections, by a licensed health care professional or Trained Medication Employee or Medication Aide certified by the D.C. Board of Nursing and those services are available to the MHCRF;

Has active substance abuse issues in addition to serious mental illness or has a history of substance abuse or has participated in a substance abuse treatment program;

Needs limited or intermittent nursing care; or

Does not currently attend or wish to attend a day program outside of the MHCRF.

3825.8 Whenever an MHCRF denies admission to a potential resident, it shall provide written reasons for the denial on the form prescribed by the Department within three (3) days to the Director, the person’s treatment team, and to the person denied admission. A copy of the written reason for the denial shall be included in the MHCRF’s records. The Director may order the person’s admission to the MHCRF if the admission is consistent with the Department-approved level of care, the MHCRF is licensed to provide the approved level of care, and the MHCRF has a vacant bed.

3825.9 An MHCRF that receives contract funding from the Department shall comply with any additional admission requirements contained in the contract.

3825.10 No MHCRF shall limit its admissions to persons served by a particular CSA or agency. Whenever a MHCRF that receives contract funding from the Department has vacancies, it shall immediately report the vacancies to the Director so that they may be listed on the Director’s current vacancy listing.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3825

22-A DCMR § 3826 ENVIRONMENTAL REQUIREMENTS

3826.1 No MHCRF shall use a name on the exterior of the building or display any logo that distinguishes the MHCRF from any other residence in the neighborhood.

3826.2 The MHCRF shall properly maintain the outside and yard areas of the premises in a clean and safe condition in compliance with § 302 of the D.C. Property Maintenance Code and, if space permits, shall have a green area including plants and trees accessible to all residents.

3826.3 Each MHCRF shall be located in an area reasonably free from noxious odors, hazardous smoke, and fumes, away from known sources of loud and irritating noises, and where interior sounds may be maintained at reasonably comfortable levels.

3826.4 The interior and exterior of each MHCRF shall be maintained in a safe, clean, orderly, attractive, and sanitary condition and shall be free from accumulations of dirt, rubbish, and objectionable odors.

3826.5 Each MHCRF shall be equipped, furnished, and maintained to provide a functional, safe, and comfortable home-like setting.

3826.6 Each MHCRF shall provide at least one (1) desk or table and one (1) chair for the use of six (6) or fewer residents, and additional desks or tables and chairs to maintain a ratio of at least one (1) desk or table and chair for every six (6) residents.

3826.7 Each resident who is enrolled on a full or part-time basis in a course of academic or vocational study shall be provided with a work area in the MHCRF that is quiet and conducive to study.

3826.8 The MHCRF shall operate and maintain an effective pest control program that complies with D.C. laws and regulations for each MHCRF to keep the premises free from insects and rodents and from debris that might provide harbor for insects and rodents. Failure to maintain an effective pest control program to prevent infestation shall be deemed a serious deficiency and shall be grounds, standing alone, for taking adverse action against a MHCRF including fines, license suspension, conversion, or revocation. The MHCRF shall replace the personal property of a resident that has been compromised due to the presence of insects or rodents in the home. No MHCRF shall employ traps or pesticides on resident bedding.

3826.9 First aid supplies shall be maintained in a place known and readily accessible to residents and employees and shall be adequate for the number of persons living in the residence.

3826.10 Staff bedrooms shall be separate from resident bedrooms and all common living areas.

3826.11 Adequate facilities shall be provided for the collection, storage, and removal of all trash and other refuse.

3826.12 Each window shall be screened.

3826.13 Each rug or carpet in the MHCRF shall be securely fastened to the floor or shall have a non-skid pad.

3826.14 Each hallway, porch, stairway, stairwell, and basement shall be kept free from any obstruction at all times.

3826.15 Each ramp or stairway used by a resident shall be equipped with a firmly secured handrail or banister.

3826.16 Plants and pets may be permitted in a MHCRF at the discretion of the MHCRF and as specified in the Program Statement. All pets shall have current vaccinations. Pets shall be examined by a licensed veterinarian within sixty (60) days of admission to a MHCRF, at least once a year thereafter, or more frequently if necessary.

3826.17 Each MHCRF shall have a functioning doorbell or knocker.

3826.18 Each exterior stairway, landing, and sidewalk used by residents shall be kept free of snow and ice.

3826.19 The MHCRF shall be free of loose or peeling paint, and the MHCRF shall comply with all D.C. Housing Code (14 DCMR § 707) and § 304.2 of the D.C. Property Maintenance Code pertaining to lose or peeling paint and to lead-based paint.

3826.20 The MHCRF shall comply with all applicable environmental laws and regulations including rules governing lead-based paint, asbestos, heating oil tanks, and hazardous waste.

3826.21 Each MHCRF shall provide residents with access to reasonable individual storage space for private use.

3826.22 Each MHCRF shall have access to a functioning facsimile machine, a computer with internet access, and a functioning e-mail address for official business, care coordination, and incident reporting purposes.

3826.23 Each MHCRF shall be equipped with both a functioning landline and mobile telephone. The telephone numbers shall be provided to residents and the Director.

3826.24 Each MHCRF shall maintain emergency supplies in a secure location at the facility to include batteries, flashlights, Sterno, an extra First Aid kit, other supplies identified in the MHCRF’s COOP required by § 3805.7, and an adequate supply of bottled water and non-perishable foods as provided in § 3834.22.

3826.25 Each MHCRF shall timely pay the expenses of the MHCRF including its mortgage, rent, utilities, and tax and insurance payments and shall not otherwise fall into arrears.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3826

22-A DCMR § 3827 STRUCTURAL AND MAINTENANCE REQUIREMENTS

3827.1 A MHCRF may be located in a single or multi-family dwelling.

3827.2 All MHCRF repairs and construction shall be done in a workmanlike manner and comply with local code requirements. Major repairs shall be performed by licensed and bonded professionals, unless a waiver is granted by the Director. The MHCRF shall comply with the D. C. Construction Codes, , and shall obtain all permits and approvals required by the Department of Consumer and Regulatory Affairs (DCRA) or any other District agency before engaging in construction, repair or installation activities including:

(a) Any new construction, alteration, repair, or addition to the structure;

(b) A change in use or occupancy, increase in load, or modification of the floor layout of the structure;

(d) Installing or repairing electrical systems or fixtures, gas-fueled appliances or equipment, refrigerating and cooling systems, and plumbing systems or fixtures.

3827.3 The Operator shall maintain the MHCRF in compliance with all applicable provisions of the D.C. Property Maintenance Code and the D.C. Housing Code, except that an Operator shall not be required to provide residents with keys to the facility pursuant to § 607.2.

3827.4 The MHCRF shall comply with all applicable accessibility requirements in the ADA.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3827

22-A DCMR § 3828 LIGHTING AND VENTILATION

3828.1 Each room in a MHCRF shall have adequate lighting, and each bedroom shall have sufficient light for reading.

3828.2 Each bathroom and hallway shall contain a nightlight, and nightlights shall be offered to residents for use in their sleeping rooms.

3828.3 Each outside entrance shall be lighted.

3828.4 All habitable rooms used for living or sleeping, including the kitchen, and all bathrooms, hallways, and stairways shall meet the lighting requirements of § 402 of the D.C. Property Maintenance Code and §§ 502 through 505 of the D.C. Housing Code (14 DCMR §§ 502 – 505), except where the D.C. Housing Code requirements are superseded by the D.C. Property Maintenance Code.

3828.5 Every space intended for human occupancy shall be provided with adequate natural or mechanical ventilation as required by § 403 of the Property Maintenance Code.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3828

22-A DCMR § 3829 PLUMBING AND WATER SUPPLY

3829.1 Each MHCRF shall ensure that its water supply and distribution system, including all plumbing and water heating facilities, conform to applicable requirements of the D.C. Construction Codes, including the D.C. Property Maintenance Code and the D.C. Plumbing Code, the D.C. Housing Code, and the D.C. Water and Sewer Authority.

3829.2 Each MHCRF shall provide adequate quantities of hot and cold water to serve the number of residents and staff in the facility.

3829.3 The temperature of hot water at each fixture used by a resident shall be automatically controlled and shall be maintained within the range of five degrees Fahrenheit (5◦F.) over or under one-hundred and twenty degrees Fahrenheit (120◦F.).

3829.4 The water supply may also include a separate or boosted supply at higher temperatures for the kitchen and for dishwashing and laundry.

3829.5 Each MHCRF shall provide hot and cold running water, under pressure, to each sink, bathtub, and shower, to each area where food is prepared and where food equipment, utensils or containers are washed, and to the laundry and bathrooms.

3829.6 The MHCRF shall report to the Department any lack of water or disconnection of service within four (4) hours if it occurs during a business day, and within twelve (12) hours if it occurs after business hours or on the weekend.

3829.7 If the water to a MHCRF is disconnected or not operating, the MHCRF shall provide bottled water for drinking, which shall be maintained in a secure location at the MHCRF at all times so that a sufficient quantity of bottled water is available. If the water to a MHCRF is disconnected or not operating for more than four (4) hours, the MHCRF shall also provide water for hand-washing and flushing the toilet. The MHCRF shall coordinate an emergency transfer of residents in the event the loss of water is expected to last more than forty-eight (48) hours.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3829

22-A DCMR § 3830 HEAT AND AIR CONDITIONING

3830.1 Each MHCRF shall have a heating and cooling system that meets the standards of, and is installed and maintained in compliance with this section, the D.C. Construction Codes, including the D.C. Property Maintenance Code, the D.C. Housing Code and any other applicable District laws or regulations. Where the standards in this section are more stringent than the standards in the D.C. Property Maintenance Code or the D.C. Housing Code, the standards in this section shall apply.

3830.2 The MHCRF shall supply sufficient heat from October 1 through May 31 to maintain the following temperatures for every occupied room throughout the residence including, bedrooms, living room, dining room, kitchen, and bathrooms:

(a) A minimum of seventy degrees Fahrenheit (70◦F.) between 6:30 a.m. and 11:00 p.m.; and

(b) A minimum of sixty-eight degrees Fahrenheit (68◦F.) between 11:00 p.m. and 6:30 a.m.

3830.3 Each heating system shall be thermostatically controlled.

3830.4 A MHCRF shall not supplement its heating system with portable room or space heaters, unless their use meets FEMSD standards.

3830.5 A fireplace shall not be utilized unless:

(a) The Operator can demonstrate that the fireplace and chimney have been inspected and determined to be safe for use within the past twelve (12) months;

(b) An annual inspection by FEMSD has not revealed any violation or deficiency in the fireplace; and

3830.6 The MHCRF shall provide air conditioning through individual units or a central system, which shall be maintained in safe and good working condition in accordance with the D.C. Property Maintenance Code. When residents are present in the facility, the MHRCRF shall provide an inside temperature no greater than seventy-eight degrees Fahrenheit (78°F) between May 15 and September 15 or whenever the outside temperature exceeds eighty-five degrees Fahrenheit (85°F).

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3830

22-A DCMR § 3831 BEDROOMS

3831.1 Each bedroom shall comply with the space and occupancy requirements for habitable rooms in the D.C. Property Maintenance Code and § 402 of the Housing Code (14 DCMR § 402), and shall require at a minimum:

If used for sleeping by only one (1) occupant, at least eighty square feet (80 sq. ft.) of habitable room area.

If used for sleeping by two (2) or more occupants, at least fifty square feet (50 sq. ft.) of habitable room area for each occupant.

3831.2 No sleeping facilities shall be permitted in any room in which there is located a furnace, space heater using an open flame, domestic water heater or gas meter.

3831.3 Each resident shall be provided a choice of roommates in accordance with his or her level of care as articulated in the person-centered planning and treatment plan. This roommate requirement may be modified if supported by a specific assessed need and justified and agreed to in the person-centered service plan. An employee of a MHCRF and a resident of the MHCRF shall not share a bedroom under any circumstances.

3831.4 Each resident shall be provided with at least the following items:

A bed, which shall not be a cot;

A mattress that was purchased new by the MHCRF, has a manufacturer’s tag or label attached to it, is in good, sanitary and intact condition without broken springs, and a new mattress cover;

A bedside table or cabinet and an individual reading lamp with at least a seventy-five (75) watt or luminance equivalent bulb;

Lockable storage space in a stationary cabinet, chest, or closet that provides at least one (1) cubic foot of space for each resident for valuables and personal items;

Sufficient suitable storage space, including a dresser and closet space, for personal clothing, shoes, accessories, and other personal items; and

A waste receptacle and clothes hamper with lid.

3831.5 Each bed shall be located in a room that is designed and utilized solely as a bedroom. Each bedroom shall have a door lockable by the resident, with only appropriate staff having keys to the door. This lockable door requirement may be modified if supported by a specific assessed need and justified and agreed to in the person-centered service plan.

3831.6 Each bed shall be placed at least three (3) feet from any other bed and from any uncovered radiator.

3831.7 Each bedroom shall have direct access to a major corridor and at least one (1) window to the outside, unless DCRA has determined that it otherwise meets the lighting and ventilation requirements for habitable rooms pursuant to the D.C. Property Maintenance Code and the D.C. Housing Code.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3831

22-A DCMR § 3832 BATHING AND TOILET FACILITIES

3832.1 Each MHCRF shall provide one (1) or more bathrooms for residents that are equipped with the following fixtures that are properly installed and maintained in good working condition:

(a) Toilet (water closet);

(b) Sink (lavatory);

(d) Grab bars in showers and bathtubs.

3832.2 Each MHCRF shall provide at least one (1) bathroom for each six (6) occupants in compliance with § 602 of the D.C. Housing Code (14 DCMR § 602), and shall comply with any subsequently adopted more stringent requirements of the D.C. Property Maintenance Code or D.C. Housing Code.

3832.3 Each MHCRF shall equip each bathroom with the following:

Toilet paper holder and adequate toilet paper;

Paper towel holder and adequate paper towels or clean hand towels;

Soap;

Mirror;

Adequate lighting;

Waste receptacle;

Floor mat;

Non-skid tub mat or decals; and

(i) Shower curtain or shower door.

3832.4 In addition to complying with § 3832.1(d), each MHCRF shall provide properly anchored grab bars or handrails near the toilet or other areas of the bathroom, if needed by any resident in the facility.

3832.5 Adequate provision shall be made to ensure each resident’s privacy and safety in the bathroom.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3832

22-A DCMR § 3833 FIRE SAFETY

3833.1 Each MHCRF shall comply with all applicable provisions of the D.C. Fire Code and the Fire Safety Provisions of the D.C. Property Maintenance Code (Chapter 7).

3833.2 Each MHCRF shall obtain an annual inspection of the facility by FEMSD, which shall determine the facility’s compliance or non-compliance with fire safety requirements; provided that fire safety inspections for new construction or substantial renovation of a structure may be performed by DCRA in accordance with DCRA and FEMSD procedures and the requirements of the Construction Codes.

3833.3 Each MHCRF shall have a written Emergency Preparedness Plan with instructions that is approved by FEMSD. The plan shall be followed in case of fire, explosion, or any other emergency and shall be available for review in each MHCRF.

3833.4 The plan shall be updated annually, as necessary, and include the following:

Written responsibilities and specific tasks for each staff member;

A plan for training staff at least twice a year on the plan;

The procedures for reporting a fire or other emergency;

Life safety strategies and procedures for notifying, relocating, or evacuating occupants;

A site plan indicating an assembly point for occupants;

Floor plans identifying the location of:

(1) Exits;

(2) Primary evacuation routes;

(3) Secondary evacuation routes;

(4) Accessible egress routes;

(5) Manual fire alarm pull stations;

(6) Fire alarm annunciators and controls; and

(7) Portable fire extinguishers;

A list of major fire hazards associated with normal use of the facility, including maintenance and housekeeping procedures;

Identification and assignment of personnel responsible for maintenance of systems and equipment installed in the facility to prevent or control fires;

The signature of the Operator; and

(j) The signature of the FEMSD official approving the plan.

3833.5 Drills testing the effectiveness of the fire plan shall be conducted:

(a) For each resident individually upon admission;

(b) For current residents within two (2) weeks of the effective date of a new or revised plan; and

(c) At least quarterly, with at least one (1) drill per shift, in accordance with the D.C. Fire Code, as referenced in § 3833.1.

3833.6 Each MHCRF shall maintain in its records the most recent fire inspection report with the date of the latest inspection of the alarm system.

3833.7 Each MHCRF shall install and maintain smoke detectors in accordance with the requirements of the D.C. Fire Code, as referenced in § 3833.1, for smoke detection devices in residential facilities, and any additional requirements of the Smoke Detector Act of 1978, effective June 20, 1978 (D.C. Law 2-81; D.C. Official Code §§ 6-751.01 et seq.) as determined by DCRA or FEMSD.

3833.8 Smoke detectors shall be installed to provide protection:

(a) In each room used for sleeping; or

(b) In each corridor outside of or adjacent to a room used for sleeping; and

3833.9 The MHCRF shall install and maintain a smoke detector system composed of interconnected smoke detectors, as required by DCRA and FEMSD pursuant to the requirements of the D.C. Fire Code.

3833.10 No MHCRF shall permit smoking in bedrooms.

3833.11 A fire extinguisher with a minimum rating of 210 (BC) that is effective in extinguishing grease and oil fires shall be located within fifteen feet (15 ft.) of any stove, oven, cooking burner, or other cooking device.

3833.12 Each MHCRF shall have at least one (1) working fire extinguisher with a minimum rating of 210 (BC) on each floor, including the basement and first floor, in a central location accessible to residents and employees.

3833.13 A fire extinguisher with a minimum rating of 210 (BC) of a type and capacity sufficient to extinguish fires originating in the main heating plant and hot water heater shall be located within five feet (5 ft.) of this equipment.

3833.14 Each fire extinguisher shall be:

Properly maintained;

Approved for its specific use by an official of the FEMSD; and

Inspected by FEMSD annually and in accordance with the International Fire and Construction Codes cited in § 3833.1.

3833.15 Each fire extinguisher shall be recharged immediately after use and properly tagged.

3833.16 Each fire extinguisher shall have attached to it a tag giving the date when the service was performed, a description of the service performed, and the name and address of the person performing the service.

3833.17 Each MHCRF shall have a fire exit that is:

Clearly designated on the MHCRF’s emergency preparedness plan;

Clearly identified for residents;

Kept clear of obstructions; and

Accessible from sleeping rooms.

3833.18 If the area or floor served by a fire exit door is to be occupied, the door shall not require a key to unlock the door from the inside and shall not require more than thirty (30) seconds to unlock.

3833.19 Each MHCRF that has residents in sleeping rooms above the second floor, or that has more than eight (8) residents in sleeping rooms above the street level, shall:

Provide access to two (2) separate means of exit for sleeping rooms above street level, at least one (1) of which shall consist of an enclosed interior stair, a horizontal exit, or a fire escape, all arranged to provide a safe path of travel to the outside of the building without traversing any corridor or space exposed to an unprotected vertical opening; or

Otherwise comply with D.C. Fire Code.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3833

22-A DCMR § 3834 DIETARY SERVICES

3834.1 Each MHCRF shall apply generally accepted principles of nutrition and food management to menu planning, food preparation and handling, kitchen maintenance, and service for residents of the facility.

3834.2 Each MHCRF shall have at least one (1) staff member who has obtained a Food Protection Manager (FPM) or Food Safety Manager (FSM) certification from an accredited national test service approved by the D.C. Department of Health. That staff member shall maintain a current certification in accordance with § 203 of the D.C. Food Code (25-A DCMR § 203).

3834.3 In addition to the requirements of § 3834.2, the MHCRF shall ensure that whenever food is being handled or served for human consumption, at least one (1) staff member is present who has a current FPM or FSM certification. That staff member shall ensure the proper preparation, handling, and service of food.

3834.4 The MHCRF shall require each certified FPM or FSM to supervise and train any staff members who are not certified as FPMs or FSMs in the storage, handling, and serving of food, and the cleaning and care of equipment used in food preparation in order to maintain sanitary conditions at all times. The kitchen, dining, and food storage areas shall be kept clean, orderly, and protected from contamination.

3834.5 Each individual engaged in food preparation, handling, or serving, shall wash their hands and exposed portions of arms frequently, and cover their hair with a net or other head covering.

3834.6 The MHCRF shall ensure that no person is involved in food preparation or service who shows signs or symptoms of a contagious illness, has exposed skin lesions, or is otherwise prohibited or restricted from performing these functions pursuant to §§ 303(a) – (e) and 300.4 – 307.10 of the D.C. Food Code (25-A DCMR § 303(a) – (e) and 300.4 - 307.10.

3834.7 The MHCRF shall provide at least three (3) meals per day that:

(a) Provide a nourishing, well-balanced and varied diet in accordance with dietary guidelines established by the United States Department of Agriculture;

(b) Are suited to the special needs of each resident; and

3834.8 The MHCRF shall prepare and post menus on a weekly basis for the residents’ review. Menus shall:

(a) Provide for a variety of foods and beverages at each meal taking into consideration the residents’ personal and cultural preferences;

(b) Be varied from week to week;

(d) Reflect meals as planned and as actually served, including hand-written notations in pen of any substitutions made.

3834.9 The MHCRF shall retain a copy of each weekly menu and receipts and invoices for food purchases for six (6) months, which shall be subject to review by the Department.

3834.10 Each meal shall be scheduled so that the maximum interval between each meal is no more than six (6) hours, with no more than fourteen (14) hours between a substantial evening meal and breakfast the following day.

3834.11 In between designated meal times, residents shall have access to food. This requirement may be modified if supported by a medically assessed need and justified in the person-centered service plan. If a resident misses a scheduled meal, appropriate food substitutions of comparable nutritional value shall be offered.

3834.12 If the MHCRF knows or is informed in advance that a resident will be away from the MHCRF during mealtime for necessary medical care, work, a day services program, or other scheduled activities or appointments, the MHCRF shall provide the resident with an appropriate meal and in-between meal snack to carry. The MHCRF shall ensure that the meal is nutritious and suited to the special needs of the resident as required by § 3834.7.

3834.13 Each food and drink item purchased, stored, prepared, or served by the facility shall be clean, wholesome, free from spoilage, prepared in a manner that is safe for human consumption, protected from contamination, and properly served in accordance with the requirements of §§ 600.1 and 700.1 of the D.C. Food Code (25-A DCMR §§ 600.1, 700.1) and this section.

3834.14 Each MHCRF shall have fresh water and clean drinking glasses available for each resident at all times.

3834.15 Each resident who needs assistance to eat or drink shall be given the assistance promptly upon receipt of meals.

3834.16 A MHCRF shall not permit smoking or use of tobacco products in the kitchen or in the vicinity of food preparation.

3834.17 Each MHCRF shall serve meals at proper temperatures. If an individual requires feeding assistance, food shall be maintained at serving temperature until assistance is provided. Food that is not promptly consumed shall be refrigerated or discarded.

3834.18 Food requiring refrigeration shall be promptly refrigerated after purchase and kept properly refrigerated until preparation for consumption or until consumed pursuant to §§ 1005.1 and 1005.2 of the D.C. Food Code (25-A DCMR §§ 1005.1 and 1005.2).

3834.19 Frozen foods shall be kept in the freezer and maintained frozen until preparation for consumption or until consumed pursuant to § 1000.1 of the D.C. Food Code (25-A DCMR § 1000.1).

3834.20 Food shall be protected from contamination by separating raw animal foods during storage, preparation, and holding from raw fruits and vegetables, cooked ready-to-eat foods, and other raw animal foods except when combining ingredients, as required by § 802 of the D.C. Food Code (25-A DCMR § 802).

3834.21 Raw animal foods, including eggs, fish, meat, poultry, and foods containing these raw animal foods shall be thoroughly cooked and heated to the temperatures required by § 900 of the D.C. Food Code (25-A DCMR § 900).

3834.22 Raw fruits and vegetables shall be thoroughly washed in water to remove soil and other contaminants before being cut, combined with other ingredients, cooked, served, or offered for human consumption as required by § 806.1 of the D.C. Food Code (25-A DCMR § 806.1).

3834.23 The MHCRF shall ensure that the facility maintains at least a three (3) day supply of perishable food and a seven (7) day supply of bottled water and nonperishable food in a safe location, based on the menus for both regular and special diets in compliance with the MHCRF’s Continuity of Operations Plan.

3834.24 Dry or staple food items shall be stored at least twelve (12) inches above the floor in a the kitchen or other dry room not subject to sewage or waste water back flow or contamination by condensation, leakage, rodents, or vermin. Food shall not be stored in a bathroom, garage, or mechanical room.

3834.25 All kitchen equipment, utensils, cookware and dishes shall be constructed of safe materials and maintained in good condition as required by § 3804.1 of the D.C. Food Code (25-A DCMR § 3804.1).

3834.26 All food contact surfaces, storage areas, counters, sinks and work surfaces shall be smooth, non-absorbent and easily cleanable, and shall be effectively cleaned and sanitized prior to preparation and serving of food and after each use as required by § 3804.2 of the D.C. Food Code (25-A DCMR § 3804.2).

3834.27 All eating utensils, pots, pans, cooking equipment, dishes, cups, glasses and other table ware shall be thoroughly cleaned and appropriately dried before use, and cleaned and properly stored after each meal to avoid contamination.

3834.28 Hot and cold water, soap, and towels shall be provided for hand washing in or adjacent to food preparation areas.

3834.29 Each MHCRF shall maintain a sufficient quantity of dishes, utensils, and cook ware to meet the needs of residents and staff.

3834.30 Receptacles for storage of garbage and refuse shall be waterproof and properly covered, and shall be emptied and cleaned regularly.

3834.31 The dining area shall have a sufficient number of tables and chairs to seat all individuals residing in the home at the same time. Dining chairs shall be sturdy, safe, without rollers unless retractable, and designed to minimize tilting.

3834.32 Each MHCRF shall promote each resident’s participation and skill development in menu planning, shopping, food storage, and kitchen maintenance, to the extent appropriate based on the resident’s IRP.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3834

22-A DCMR § 3835 THERAPEUTIC DIETS

3835.1 Each MHCRF with a resident who has been prescribed a special or therapeutic diet shall ensure that the resident’s meals are planned, prepared, and served as prescribed by the attending physician, nutritionist, or other health care practitioner.

3835.2 Each MHCRF with residents who have been prescribed a special or therapeutic diet or who have a condition, such as diabetes or hypertension, that commonly requires a special or therapeutic diet, shall consult with the resident’s CSA or other treatment team at least annually to determine whether there are new instructions pertaining to the resident’s diet.

3835.3 The MHCRF shall allow a visiting dietitian or nutritionist to have access to each resident’s record, as authorized by the Mental Health Information Act, which shall contain the physician’s prescriptions for medications and special diets. The MHCRF shall advise the visiting dietitian or nutritionist to document in the record each observation, consultation, and instruction regarding the resident’s acceptance and tolerance of each prescribed diet.

3835.4 Each MHCRF shall ensure that all dietary prescriptions from each resident’s physician, health care practitioner, dietitian, or nutritionist are maintained in the resident’s medical record and are updated at least annually.

3835.5 Each MHCRF shall ensure that all staff responsible for food preparation and service are kept informed, in writing and verbally, of any dietary restrictions, food allergies, or other special dietary needs of each resident.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3835

22-A DCMR § 3836 HOUSEKEEPING AND LAUNDRY SERVICES

3836.1 Each MHCRF shall be equipped with a washing machine and dryer in good condition in a safe, clean, and convenient location within the facility. The MHCRF shall provide adequate facilities and sufficient laundry detergent and other laundry supplies for residents and staff to properly wash and dry clothing and linens. No clothes or linens shall be air dried.

3836.2 At least three (3) washcloths, two (2) towels, two (2) sheet sets that include pillow cases, a bedspread, a new pillow, sufficient blankets, and a mattress cover shall be maintained for each resident in good and clean condition.

3836.3 Each piece of bed linen, towel, and washcloth shall be changed and cleaned as often as necessary to maintain cleanliness, provided that all towels and bed linen shall be changed at least once each week.

3836.4 Each blanket, bedspread, and mattress cover shall be cleaned regularly, whenever soiled, and before being transferred from one (1) resident to another.

3836.5 Each MHCRF shall ensure that the personal laundry of each resident is laundered in a sanitary manner, separate from bed linen. Laundry shall be done by the resident if the resident is capable or by MHCRF staff. The resident shall not be charged in excess of the resident’s monthly residence fee for room, board, and care for detergent or other supplies, use of the washer or dryer, or staff assistance,

3836.6 Clean linen and clothing shall be stored in clean, dry, dust free areas that are easily accessible to residents.

3836.7 If it becomes necessary for residents to use a laundromat because the washing machine or dryer is temporarily out of order, the MHCRF shall pay for residents’ laundry to be washed and dried.

3836.8 If the washing machine or dryer is out of order for more than forty-eight (48) hours, the Operator shall alert the Director, or his/her designee, of the outage.

3836.9 Each MHCRF shall keep a written laundry log and record the date when each resident washed and dried his or her personal laundry/clothing. At a minimum, the MHCRF shall launder residents’ clothing and bedding weekly. More frequent launderings are required when necessary to prevent or eliminate hygiene or insect problems. If a resident refuses laundry services, then the MHCRF shall note the refusal on the laundry log and coordinate with the CSA to address this issue through person-centered treatment planning.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3836

22-A DCMR § 3837 PERSONAL PROPERTY OF RESIDENTS

3837.1 This section shall apply to the personal property of residents, except for personal funds which are subject to § 3838.

3837.2 Each MHCRF shall permit each resident to bring reasonable personal possessions, including clothing, personal articles, and furnishings to his or her living quarters in the MHCRF unless the MHCRF can demonstrate that it is not practical, feasible, or safe. Rejection of resident’s personal items must be submitted to the Department for approval.

3837.3 Each MHCRF shall take appropriate measures to safeguard and account for personal property brought into the facility by a resident. Each MHCRF shall maintain a current inventory of each resident’s personal property. The MHCRF shall update this inventory whenever new items are brought into the MHCRF and at least once annually, and shall provide a copy of the inventory, signed by the resident and staff, to the resident.

3837.4 The MHCRF shall provide the resident, or the resident’s representative, with a receipt for any personal articles to be held by the MHCRF for safekeeping. The receipt shall include an approximate value for the article and the date it was deposited with the MHCRF. The MHCRF shall also maintain a record of all articles held for safekeeping.

3837.5 No MHCRF shall require a resident to give, transfer, or assign to the Operator, Residence Director, an employee or volunteer an interest in or title to any property owned by the resident. No Operator, Residence Director, employee or volunteer of the MHCRF may accept such a gift, transfer, or assignment.

3837.6 Upon each resident’s discharge, the MHCRF shall return to the resident, or the resident’s representative, any personal articles held by the MHCRF for safekeeping. The MHCRF shall also ensure that the resident is permitted to take all of his or her personal possessions from the MHCRF. The MHCRF may require the resident or resident’s representative to sign a statement acknowledging receipt of the property. A copy shall be placed in the resident’s record.

3837.7 If a resident is not able to remove all of his or her personal property when the resident moves or is transferred or discharged from the facility, the MHCRF shall securely retain the resident’s property for a minimum of ten (10) days. The ten (10) days shall be extended for an additional ten (10) days upon request of the former resident or representative.

3837.8 The MHCRF shall notify the resident’s representative, the LTCO and the CSA in writing that it has the resident’s property, so the resident, resident’s representative or CSA can make arrangements to obtain it. The MHCRF may remove the property from the bedroom occupied by the former resident, but shall store it in a secure dry location within the facility.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3837

22-A DCMR § 3838 FINANCES OF RESIDENTS

3838.1 Except as provided in § 3838.09, no MHCRF shall increase the fee for room, care, and board in a MHCRF more often than once a year, unless:

The increase is justified in writing;

The increase is caused by an unusual escalation in the expenses of the facility or the cost of services to the resident;

The resident and the Department are given sixty (60) days written notice of the effective date of the increase; and

The resident signs a new residency contract as required by § 3824, which includes the increased fee.

3838.2 Except for representative payee relationships existing prior to the effective date of this rule, no MHCRF owner, Operator, Residence Director, staff member or volunteer shall serve as a representative payee for a resident of the MHCRF. When a resident and his or her representative payee have authorized the MHCRF to handle any portion of a resident’s personal funds, including rent or the personal needs allowance, the authorization shall be in writing and signed by the resident and the resident’s representative payee at least annually. A resident's personal needs allowance shall be used solely for the resident’s personal needs pursuant to 29 DCMR § 1450 and shall not be considered income available to pay for MHCRF costs, including rent.

3838.3 Each MHCRF shall maintain a separate and accurate record of all funds the resident or the resident’s representative or representative payee deposits with the MHCRF for safekeeping in accordance with Subsection 3838.2. The record shall include the following:

(a) A written authorization signed by the resident and the resident’s representative or representative payee authorizing the MHCRF to handle the resident’s personal funds;

(b) Any instructions received from the resident’s representative or representative payee and agreed to by the MHCRF pertaining to disbursement of the funds;

(d) The date and amount of each withdrawal by the resident or disbursement by the MHCRF for the resident’s benefit, including signed receipts;

(e) The items or purposes for which disbursements were made by the MHCRF;

(f) The current balance; and

(g) The signature of the resident for each withdrawal and the signature of facility staff for each deposit and disbursement made on behalf of a resident.

3838.4 Each MHCRF shall make a copy of the records required in § 3824.2 and § 3838.3 available to the resident and the resident’s representative or representative payee:

On at least a quarterly basis;

At least ten (10) business days before the resident is to be transferred or discharged from the facility or a soon as possible prior to the discharge; and

Upon request by the resident, the resident’s representative, or representative payee.

3838.5 Upon admission of a resident, each MHCRF shall explain to the resident and the resident’s representative or representative payee how the resident’s personal needs allowance and any other personal funds shall be handled during his or her stay at the MHCRF. This explanation shall include the resident’s right to manage the money himself or herself, absent a court order appointing a guardian or conservator to administer the resident’s financial or personal affairs.

3838.6 Each MHCRF shall, upon request, make resident financial records available for inspection, review, and copying by the Department, the D.C. Department of Healthcare Finance, the LTCO, and any entity authorized by the resident to review such records.

3838.7 Upon each resident’s discharge from the MHCRF, the MHCRF shall promptly provide the resident’s remaining personal funds to the resident, the resident’s court-appointed representative to administer his or her financial and personal affairs, or the resident’s representative payee. The MHCRF shall require the resident, court-appointed representative, or representative payee to sign a statement acknowledging receipt of the funds. A copy shall be placed in the resident’s record.

3838.8 Upon each resident’s discharge from the MHCRF, the MHCRF shall promptly send rent funds, pro-rated from the date of discharge, to the new MHCRF location.

3838.9 Notwithstanding § 3838.1, any increase in a resident’s Social Security or State Optional Payment shall be distributed to the MHCRF for room, board and care in accordance with § 549 of the District of Columbia Public Assistance Act of 1982, effective April 6, 1982 (D.C. Law 4-101; D.C. Official Code § 4-205.49), unless the Department of Health Care Finance has published an increase in the personal needs allowance in 29 DCMR § 1450.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3838

22-A DCMR § 3839 MEDICATION

3839.1 When a resident is admitted, and for as long as the resident resides in the facility, the MHCRF shall maintain current doctor’s orders for every medication the resident is taking, plus a list of each known allergy and each prescribed controlled substance. The MHCRF shall obtain this information from the resident’s CSA, treatment team, or health care provider.

3839.2 The MHCRF shall keep each resident’s medications secure in a locked drawer or cabinet, separate from those of other residents, and shall ensure they are not accessible to other residents or visitors. Each medication shall be properly identified and shall be maintained under proper conditions of light and temperature as indicated on the medication’s label.

3839.3 Each medication of each resident shall be stored in its original container and shall not be transferred to another container or to another resident. Medication for external use shall be stored separately from medication for internal use.

3839.4 Each MHCRF shall comply with District and federal law and regulations governing the procurement, handling, storage, administering, recording, dispensing and disposal of medications and controlled substances.

3839.5 The Operator, Residence Director, or designated staff shall ensure that each resident who is capable of self-administering his or her medication takes his or her medication as prescribed. The staff member who supervises a resident’s self-administration of medication shall properly and promptly record and initial each dose of medication taken by the resident in the resident’s medication record.

3839.6 If a resident cannot self-administer a medication, the MHCRF shall coordinate appropriate assistance from a licensed or certified healthcare professional who is authorized to administer medication under District of Columbia law to administer the medication. The MHCRF shall ensure that the administration of the medication is recorded in the resident’s medication record.

3839.7 Each medication error or adverse reaction to a medication shall be immediately reported to the resident’s physician. If the MHCRF is unable to report to the resident’s physician, the MHCRF shall report the error or adverse response to the resident’s treatment team. In all cases, the MHCRF shall document the error or adverse response in the resident’s record, and in cases of a severe adverse reaction shall prepare and submit a Major Unusual Incident Report to the Department pursuant to § 3848.

3839.8 Each resident’s refusal of a medication shall be documented in his or her medication record and reported to the resident’s physician or treatment team.

3839.9 Each MHCRF shall remove and dispose properly of expired medication and medication that is no longer in use.

3839.10 Each MHCRF shall closely monitor each resident’s supply of medication. The MHCRF shall inform each resident’s treatment team, by phone and in writing, when the resident has only seven (7) days of medication remaining to ensure that the resident always has a sufficient supply of the medication prescribed by his or her physician. If no contact is established with the CSA within forty-eight (48) hours, the MHCRF shall inform the Director, in writing, of the resident’s medication supply.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3839

22-A DCMR § 3840 MEDICAL SERVICES

3840.1 Each resident shall have the right to choose his or her own medical and dental care, and shall provide for it at his or her own expense or under relevant provisions of the Social Security Act. Alternatively, each eligible resident may seek medical or dental care from a public agency at public expense in accordance with laws and regulations governing the agency.

3840.2 To ensure that each resident is examined by a physician at least once a year, each MHCRF shall provide written notice to the resident and the CSA ninety (90) days in advance:

Reminding each resident that he or she must provide the results of a physical examination prior to renewal of a residency contract; and

Advising the CSA that it is time for the resident’s annual physical examination.

3840.3 If the physical examination report has not been received thirty (30) days prior to the renewal date of the residency contract, the MHCRF shall inform the Director in writing.

3840.4 The physician or other licensed healthcare professional performing the annual physical examination shall provide, at a minimum, a medical certification in accordance with § 3825.2(a), prescriptions for any medications in accordance with § 3825.2(c), and any special diet instructions in accordance with § 3825.2(d).

3840.5 Each resident’s permanent records shall include copies of his or her medical certifications, all physicians’ orders and reports, and the physicians’ recommendations for the resident’s care.

3840.6 If a resident is unable to make arrangements for his or her annual medical examination or any other medical or dental examination, the Residence Director or designee shall assist the resident in making arrangements for the examinations.

3840.7 Each MHCRF shall maintain in the residence a list of the names and telephone numbers of each resident’s physician and CSA.

3840.8 If an MHCRF observes a medical condition that the resident refuses to treat, the MHCRF shall document this occurrence in the resident’s file and contact the CSA to coordinate a discussion with the resident. If no contact is established with the CSA within forty-eight (48) hours, the MHCRF shall inform the Director in writing.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3840

22-A DCMR § 3841 RESIDENT ACTIVITIES

3841.1 Each MHCRF shall encourage and arrange for suitable activities for each resident to stimulate the resident, promote his or her well-being, encourage independence, and maintain normal activity and an optimal level of functioning in coordination with the resident’s CSA. These activities may include education in independent living skills such as grocery shopping, cooking, housekeeping chores, personal and household laundering, money management, and use of recreational time.

3841.2 Each MHCRF shall, in accordance with each resident’s person-centered treatment plan, maintain normal routines and procedures, providing for sleeping periods, meal times, social and recreational activities, responsibilities, and a level of resident autonomy similar to the living patterns of independent persons in the community.

3841.3 Each MHCRF shall encourage each resident to engage in daytime activities, including education, socialization, psycho-social day programs, and employment, and shall take advantage of public and voluntary resources in promoting resident participation in meaningful life activities. In accordance with a person-centered treatment plan, each resident shall have the freedom and support to control his or her own schedule and activities.

3841.4 Each MHCRF shall have books, periodicals, games, current newspapers, radio, internet access, and a television available and accessible to residents. The MHCRF shall, to the extent possible, provide recreational and leisure activities that reflect the residents’ interests.

3841.5 Attendance at a day program shall not be mandatory for residents in a MHCRF.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3841

22-A DCMR § 3842 ASSISTING RESIDENTS TO RECEIVE MENTAL HEALTH SERVICES

3842.1 If a resident is not already enrolled with a Department-certified Core Services Agency or other provider of mental health services, the MHCRF shall encourage and assist the resident in enrolling with a CSA or other provider of the resident’s choice and shall document this assistance in the resident’s files.

3842.2 If the MHCRF learns that a resident is no longer receiving mental health services, the MHCRF shall encourage and offer to assist the resident in obtaining these services and shall document such assistance or the resident’s refusal to accept assistance in the resident’s files. The MHCRF shall immediately inform the Department when a resident has declined mental health services.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3842

22-A DCMR § 3843 SERVICE COORDINATION WITH CORE SERVICES AGENCY OR OTHER PROVIDER OF MENTAL HEALTH SERVICES AND MHCRF SERVICE COORDINATION PLAN

3843.1 Each MHCRF shall maintain regular contact with the CSA’s designated staff member to determine whether the resident’s needs are being met and shall be available to the resident and the CSA’s designated staff member to assist when issues or concerns involving the resident arise. The MHCRF shall document all contacts with the CSA in the resident’s file.

3843.2 Each MHCRF, in conjunction with the CSA’s treatment team or other mental health services provider, shall regularly monitor each resident’s progress and status at the MHCRF, which shall include planning for transition to a lower level of care.

3843.3 Each MHCRF shall grant access to and cooperate with CSA treatment team members and any licensed or certified health care practitioner assigned to deliver services to a resident, upon presentation of proper identification and credentials.

3843.4 Each MHCRF shall report to the designated CSA treatment team, or other mental health services provider, if it appears that the resident needs assistance obtaining financial services, social services, health care services, or recreational and leisure activities. The report shall be made both in writing and by phone or in person.

3843.5 If after contacting a resident’s assigned CSA treatment team or other mental health services provider, the CSA or other provider fails to provide requested medical records, or in the opinion of the MHCRF is not providing the services that should be provided, the MHCRF shall inform the Director in writing.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3843

22-A DCMR § 3844 INDIVIDUAL RECOVERY PLAN

3844.1 Each MHCRF shall participate in the development of an Individual Recovery Plan for each resident enrolled with a CSA and shall maintain a copy of the current IRP in the resident’s record.

3844.2 The MHCRF shall describe to the CSA treatment team, the following in writing:

The resident’s functional strengths and limitations in performing activities of daily living (ADLs);

Any medical or health conditions observed that are relevant to the services needed by the resident;

The resident’s behaviors and any changes in the resident’s behaviors; and

Planning actions or activities to prepare the resident for transition to a lower level of care.

3844.3 The MHCRF shall provide the information required by § 3844.2 to any other mental health, health services, or community support provider authorized by the resident.

3844.4 The resident shall have the right to participate in planning all phases of his or her IRP, may request participation of a family member, and shall be offered the opportunity to sign his or her IRP or indicate disagreement with particular aspects of the plan or the whole of the plan.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3844

22-A DCMR § 3845 RESTRAINTS and Seclusion

3845.1 No restraints or seclusion shall be used in a MHCRF.

3845.2 No resident shall be confined in a locked room.

3845.3 No resident shall be locked in or out of the facility.

3845.4 No resident shall be locked in or out of his or her bedroom at any time.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3845

22-A DCMR § 3846 RESIDENT RECORDS

3846.1 Each MHCRF shall maintain a permanent record on each resident in a secure location at the MHCRF for as long as the resident remains at the MHCRF, and shall retain it for at least three (3) years after the resident’s discharge or death. The permanent record may be maintained at an Owner’s business office in the District of Columbia after the resident’s discharge or death, provided that it shall be accessible to the Department upon request.

3846.2 Each resident’s record shall include a current face sheet which documents the following information on each resident:

Administrative and demographic information, including name, date of birth, sex, social security number, marital status, and last known address;

Medical insurance numbers, including Medicare and Medicaid, if any;

Date of admission and diagnoses;

Names, addresses, and telephones numbers of the resident’s representative(s), representative payee, if any, involved family members, and next-of-kin;

Names, addresses and telephone numbers of the resident’s current personal physician(s), dentist, and any other regular health care practitioners;

Names and up-to-date contact information for the resident’s CSA treatment team or other mental health services, substance use disorder or community support providers, and for his or her day program provider and employer, as applicable;

Religious affiliation, if any, including the names and telephone numbers of the resident’s minister, priest, or rabbi; and

Resident’s allergies.

3846.3 The MHCRF shall also maintain an accessible and up-to-date record that documents:

(a) The resident’s medication as provided in § 3839;

(b) Any special diet;

(d) Any Major Unusual Incidents directly involving the resident, reported in accordance with § 3848;

(e) All records required by § 3825.2.

3846.4 Each resident’s record shall be current with each entry legible, in ink, dated, and signed with the full name of the record keeper. Errors shall be corrected by crossing out, but shall not be erased.

3846.5 Each MHCRF shall maintain a roster of current residents and shall submit a copy of the roster to the Department when the residence is first occupied, whenever there is a change of one or more residents, and when an application for license renewal is submitted.

3846.6 Each MHCRF shall make resident records available to the Department within twenty-four (24) hours of request.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3846

22-A DCMR § 3847 CONFIDENTIALITY OF RECORDS

3847.1 Each resident’s record and any record maintained by the MHCRF that has information identifying a resident shall be confidential and maintained in a secure location at the MHCRF.

3847.2 Disclosure and re-disclosure of information pertaining to a resident’s mental health and a resident’s access to his or her own records shall be governed by the Mental Health Information Act, HIPAA, and any other District or federal law or regulation governing mental health or other health records.

3847.3 If a resident authorizes release of information to a third party, a copy of the resident’s written authorization on the form prescribed by the Department shall be maintained in the resident’s records and shall conform to the Mental Health Information Act and HIPAA.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3847

22-A DCMR § 3848 MAJOR UNUSUAL INCIDENTS AND UNUSUAL INCIDENTS

3848.1 The Operator, Residence Director, or staff member who witnesses or discovers a Major Unusual Incident (MUI) shall orally notify the Department and the resident’s representatives, if any, immediately. MUIs include death, serious illness, medical emergency, physical injury, accident, physical assault or abuse, suicide attempt, severe adverse reaction from medication, or other Major Unusual Incident involving the resident or staff. The notification shall be in compliance with this section and DMH Policy 480.1C and DMH Policy 482.1 (accessible at https://dbh.dc.gov/node/240592) or subsequently adopted Department policies concerning the reporting of abuse and neglect. The Operator, Residence Director, or staff member shall document the incident in the resident’s permanent record.

3848.2 Each oral notice required by § 3848.1 shall be followed by a written unusual incident report to the Department within twenty-four (24) hours of the MUI or on the next business day. The MUI report shall be prepared in conformity with DMH Policy 480.1C by the staff member who witnessed or discovered the incident. The MHCRF shall ensure that a copy of the unusual incident report is maintained in the residence.

3848.3 The Operator, Residence Director or staff member shall prepare and submit to the Department a follow-up report within ten (10) days of the incident if full details were not provided in the initial report or if follow-up actions were needed.

3848.4 The Operator, Residence Director, or staff member who witnesses or discovers an unusual incident that does not rise to the level of a MUI, shall report the UI in writing, to the Department in conformity with DMH Policy 480.1C, within seven (7) business days of the incident and shall maintain a copy of the report at the MHCRF.

3848.5 In addition to filing the unusual incident report required by § 3848.2 each MHCRF shall thoroughly investigate all MUIs occurring at the MHCRF, including any allegations of mistreatment by a MHCRF employee, volunteer, resident, or any other person.

3848.6 The MHCRF shall promptly report findings made and actions taken as a result of the investigation to the Department. The investigation shall be documented in a report that is signed and dated by the Operator or Residence Director.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3848

22-A DCMR § 3849 RESIDENT STATUS PROCEDURES

3849.1 Each MHCRF shall provide a resident roster to DBH as admissions occur after initial licensure until at full capacity, whenever there is a new admission or change in residents within the facility, and at the time of application for annual licensure renewal.

3849.2 Each MHCRF shall maintain a “day-night book” in which emergencies and other unusual occurrences are recorded by the responsible staff person on duty. Staff on duty shall observe and assess the behavior and well-being of each resident prior to the end or his or her work day and shall record any emergencies, unusual occurrences or significant behavioral or health concerns in the day-night book, and also alert incoming staff.

3849.3 Each MHCRF shall inform the Department whenever a resident moves from the facility, is missing for twenty-four (24) hours or more, or left the facility to visit friends or relatives and has not returned within the expected time frame. This information shall also be recorded in the day and night book.

3849.4 Each MHCRF shall notify the Department of an increase in the occupancy level at the MHCRF.

3849.5 If a resident dies, the Owner, Residence Director, and staff on duty shall:

(a) Not disturb the body;

(b) Promptly notify the resident’s attending physician, next-of-kin, legal guardian, if any, the Department, the resident’s CSA treatment team or other mental health care provider, the District’s Metropolitan Police and the LTCO;

(c) If the circumstances of the death are suspicious, the death is sudden, unexpected or unexplained, or the death is violent including accidental, homicidal or suicidal, promptly notify the Office of the Chief Medical Examiner; and

(d) Abide by the District laws governing the investigation and reporting of deaths under the jurisdiction of the Medical Examiner.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3849

22-A DCMR § 3850 MINIMUM QUALIFICATIONS FOR PERSONS WORKING IN MHCRF

3850.1 Every Residence Director and staff person employed by the MHCRF shall meet the following requirements prior to commencing work at the facility and maintain compliance with these requirements:

(a) Be at least eighteen (18) years of age;

(b) Have a high school diploma or the equivalent;

(c) Have at least one (1) year of experience working with persons with mental illness or one (1) year of education in human services, or a combination of education and experience totaling at least one (1) year;

(d) Have met criminal background check requirements as set forth in §§ 3850.10 through 3850.14;

(e) Have had a physical examination completed by a licensed physician or other licensed and qualified health care provider, and submitted a certification that he or she is free of communicable disease to the MHCRF prior to commencing work and annually thereafter;

(f) Have produced a current health certification that includes the result of an intra-dermal tuberculin skin test or chest x-ray indicating no active tuberculosis and documentation of any other screenings, immunizations or certifications that may be required by the Department of Health prior to commencing work and annually thereafter;

(g) Have a current First Aid Certificate from the Red Cross or other organization recognized by the Department, including training in the Heimlich maneuver;

(h) Have a current CPR (cardio-pulmonary resuscitation) Certificate from the Red Cross or other organization recognized by the Department;

(i) Have a current FPM or FSM certification, if engaged in any food preparation at the facility, as provided in § 3834.1 and § 3834.2;

(j) Meet any additional education, experience, licensure, or certification qualifications required pursuant to a current contract with the Department.

3850.2 The MHCRF shall also ensure timely renewal of all certifications required by §§ 3850.1 (e), (f), (g), (h) and (i), and attendance at periodic training as required by the Department, including attendance by new staff at the first Mental Health First Aide course offered by DBH after hire.

3850.3 A volunteer may provide additional support services at the MHCRF while staff is present if the volunteer meets the requirements of §§ 3850.1(a), (c), (d), (e) and (f), and, if engaged in food preparation, (i).

3850.4 No person who is not a staff member can reside at the MHCRF, unless:

(a) The MHCRF has provided written notice to the Department that the person will be residing at the facility;

(b) The individual has met the requirements of §§ 3850.1 (a), (c), (d), (e) and (f), and, if engaged in food preparation, (i); and

3850.5 A home health aide or personal care aide providing services to individual residents shall provide documentation of certification by the D.C. Board of Nursing pursuant to 17 DCMR, Chapter 93, and if providing services reimbursed by Medicaid, shall meet applicable requirements in 29 DCMR, Chapter 51.

3850.6 Each personal care aide providing services to individual residents shall provide documentation of training and certification pursuant to 29 DCMR, Chapter 50, shall be employed by a District licensed home health agency in good standing with the D.C. Department of Health, and shall be supervised by a physician or nurse in accordance with 22-B DCMR, Chapter 39.

3850.7 An individual providing other support services at a MHCRF shall have the requisite professional license or certificate to perform the applicable service.

3850.8 No person shall provide services to residents at the MHCRF who does not meet the requirements of this section, except District of Columbia licensed health care professionals or identified members of the resident’s CSA treatment team.

3850.9 No child or youth under the age of eighteen (18) shall reside in a MHCRF for any reason.

3850.10 Each MHCRF shall ensure that a criminal background check in accordance with the Criminal Background Check Act and any applicable District implementing regulations is obtained for each “unlicensed person” as defined in this chapter, who will work in the facility as an employee or contract worker or who will have unsupervised access to the facility and residents, including the Operator, the Residence Director, staff, or volunteers. Any unlicensed person who has not had a criminal background check must remain in the immediate presence of the Operator or a staff person at all times.

3850.11 The Operator shall ensure that the background check is completed and obtain verification that there is no disqualifying history prior to allowing an unlicensed person to work at the facility or have unsupervised access to the facility and residents.

3850.12 No person, who has been convicted of a disqualifying crime within the seven (7) years preceding the background check or whose name appears on one of the following registers or websites shall work at the MHCRF as an Operator, Residence Director, contractor, employee or volunteer, or have unsupervised access to the facility and residents:

(a) The Nurse Aide Abuse Registry maintained by the Mayor;

(b) The Dru Sjodin National Sex Offender Public Website, (or other sex offender registry or website subsequently mandated by District rules); or

3850.13 The MHCRF shall ensure that each unlicensed person undergoes a criminal background check every four (4) years pursuant to 22-B DCMR, Chapter 47.

3850.14 If an MHCRF learns that a person is working at the facility or has unsupervised access to the facility and residents in violation of § 3850.12 and the Criminal Background Check Act, the MHCRF shall inform DBH within forty-eight (48) hours.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3850

22-A DCMR § 3851 ADDITIONAL QUALIFICATIONS APPLICABLE TO MHCRF OPERATORS AND RESIDENCE DIRECTORS

3851.1 In addition to meeting the requirements of § 3850.1 for staff, the Operator and Residence Director shall:

Have at least two (2) years of experience in human services including one (1) year of working with persons with mental illness prior to employment;

Have a Bachelor of Arts (“B.A.”) or Bachelor of Science (“B.S.”) degree or equivalent experience in addition to the experience required in (a);

Be able to demonstrate computer literacy and competence in budget planning, financial management, and program development;

Demonstrate, through references, documentation of education and experience, and compliance with this chapter, the ability to carry out the responsibilities set forth in §§ 3852 and 3853 prior to employment;

(e) Participate in training, workshops, and seminars developed for Operators and Residence Directors by the Department within ninety (90) days after hire.

3851.2 If the Operator is incorporated, the Residence Director acting on behalf of the corporation shall meet the requirements of § 3851.1.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3851

22-A DCMR § 3852 MINIMUM STAFFING REQUIREMENTS

3852.1 Each MHCRF shall ensure that:

(a) Every person who provides direct services to residents at the MHCRF or who regularly visits the MHCRF is properly screened to ensure he or she meets the requirements of § 3850 and that all credentials are documented and current, except that the MHCRF shall not be required to review the credentials of Department or certified CSA personnel who may periodically visit and provide services at the facility;

(b) Qualified staff, who are employed by and responsible to the Operator, are on site at the MHCRF twenty-four (24) hours a day, and that the MHCRF is properly supervised by competent staff at all times. These staff shall be capable of recognizing visible changes in each resident’s physical and mental condition and taking responsible action in the case of an emergency;

(1) Its designated licensure category as set forth in §§ 3857, 3858, 3859 and 3860;

(2) The terms of any current contract with the Department for residential services; and

(3) The needs of the residents as determined by a needs-assessment conducted using a Department-selected assessment instrument;

(d) Its Residence Director is responsible for the overall management and operation of not more than five (5) MHCRFs housing not more than a total of thirty (30) residents, or such lesser number of MHCRFs and residents as may be required by contract with DBH;

(e) Volunteers, home health aides, personal care aides reimbursed by Medicaid, and any other persons not employed by the MHCRF are not used as substitutes for MHCRF staff and are not left in charge of the facility;

(f) Home health aides or personal care aides assigned to individual residents are not directed to perform and do not perform general staff duties at the facility;

(g) Employees and volunteers providing services at the MHCRF are properly supervised, trained, and directed in applying MHCRF policies and procedures, including the MHCRF Emergency Preparedness Plan, COOP, health care emergency procedures, and the requirements of this chapter;

(h) The facility is in compliance with District and federal wage and hour laws and staffing is adequate to ensure that no staff member is required to work an unreasonable number of hours without appropriate relief or staff rotation;

(i) Staff require each person, other than a resident, who enters or leaves the facility, to sign in and sign out, with his or her name, title, reason for visiting and time in and out.

3852.2 Staff shall be on-site and provide supervision, meals, and assistance with the tasks of daily living to the residents. On-site staff shall also ensure the overall health, safety, and welfare of the residents.

3852.3 The MHCRF shall not require residents to attend day programs or activities or be absent from the MHCRF during the day. Residents shall be permitted to remain in the MHCRF, work, or participate in a structured day program or other daily activity.

3852.4 Each person who requires licensure, certification, or registration to provide care to residents shall be licensed, certified, or registered under the laws and regulations of the District.

3852.5 Each employee shall be assigned duties consistent with his or her license, job description, training, and experience.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3852

22-A DCMR § 3853 RESPONSIBILITIES OF OPERATORS AND RESIDENCE DIRECTORS

3853.1 In addition to meeting the requirements of § 3852 and other requirements set forth in this chapter, each Operator and Residence Director shall be responsible for:

(a) Supervising the day-to-day management and operation of the MHCRF, including supervision of staff, hiring and firing, purchase of food and supplies, arranging repairs, medication management, sanitation, safety, laundry, dietary services, and other services relating to the health and welfare of each resident;

(b) Implementing the policies, practices, and procedures of the MHCRF, including required screening of prospective residents and staff;

(c) Ensuring that all MHCRF procedures, records and reports required by §§ 3824, 3825, 3838, 3839, 3846, and 3854 are properly developed and maintained in one (1) or more secure files at the facility;

(d) Keeping the Department informed of any changes in the phone number, facsimile number, or e-mail address for the MHCRF;

(e) Ensuring that residents are provided with a current telephone number where residents can, at all times, contact the MHCRF and the MHCRF staff person on duty to allow residents to inform the MHCRF and staff of an emergency or other concerns;

(f) Ensuring that the Department is provided with a current telephone number at which the MHCRF and MHCRF staff can be contacted at all times;

(g) Ensuring that a current listing of the following telephone numbers is posted conspicuously in the facility and readily accessible to all staff:

(1) 911;

(2) The Comprehensive Psychiatric Emergency Program (CPEP);

(3) The Department’s Office of Consumer and Family Affairs;

(4) The organization responsible for the protection and advocacy system under the federal Protection and Advocacy for Individuals with Mental Illness Act of 1986, 42 U.S.C. §§ 10801 et seq. Mentally Ill Individuals Act;

(5) Adult Protective Services; and

(6) The LTCO; and

(h) Ensuring that staff can readily access individual information on residents including the information required by § 3846.

3853.2 The Operator and Residence Director shall ensure that no employee or volunteer provides direct services to residents while the person:

Is under the influence of alcohol or any mind-altering drug, substance, or combination thereof; or

Has a communicable disease that poses a health risk to residents and cannot be safely addressed by universal precautions.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3853

22-A DCMR § 3854 PERSONNEL RECORDS

3854.1 Each MHCRF shall have written personnel policies, which shall be made available to the Department and to each staff member and shall include the following:

The hours of work, policies regarding on duty requirements, compensation time, night-time duties, work relief provisions for live-in employees, vacations, sick leave, insurance, and other benefits, if any;

A description of the duties for each category of employee;

Provisions for new staff orientation and annual in-service training of staff; and

Provisions for disciplinary action or termination for illegal activity, negligence, or misconduct that occurs on the job.

3854.2 Each MHCRF shall maintain accurate personnel records for each Residence Director, staff member, and volunteer in a secure location at the facility that shall include the following information:

Name, address, gender, and social security number;

Current professional license or registration number, if any;

Record of education, training, prior employment, and evidence of attendance at orientation, training, workshops, and seminars sponsored by the Department;

Current health certification, including results of an annual intra-dermal tuberculin skin test or chest x-ray indicating no active tuberculosis;

Verification of previous employment, if any;

Documentation that the employee or volunteer has had a criminal background check in accordance with § 3850 and has not been convicted of a disqualifying crime, in accordance with the Criminal Background Check Act and 22-B DCMR, Chapter 47;

Documentation of certification in emergency first aid, CPR, and the Heimlich Maneuver;

Documentation of certification as an FPM or FSM if engaged in food preparation;

Dates of employment;

Position held by the employee;

Documentation of any disciplinary issues;

Copy of the employment agreement between the MHCRF and employee, which shall include basic terms of employment including, at a minimum:

(1) Salary or hourly rate of pay;

(2) Hours;

(3) Duties;

(4) Benefits; and

(5) A statement that employees hold a position of trust in relation to residents, that employees shall not harass, exploit, or physically, emotionally, or sexually abuse residents, or have sexual relations with residents, and that any violation of these prohibitions shall be grounds for immediate termination and may also result in a report to Adult Protective Services and the police.

3854.3 Each MHCRF shall also maintain a record of the dates and times that each volunteer is present or assisting at the facility.

3854.4 Each MHCRF shall maintain payroll records and weekly staff schedules for each Residence Director and employee for a period of at least six (6) months and provide copies to the Department upon request.

3854.5 Each MHCRF shall maintain copies of any agreements with contractors or consultants related to the operation of the MHCRF.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3854

22-A DCMR § 3855 FINANCIAL RECORDS

3855.1 Each MHCRF shall maintain all financial records related to the building where the MHCRF is located and the MHCRF business as provided in this section.

3855.2 Each MHCRF shall immediately submit or make available mortgage, rent, utilities, tax and insurance information when requested by the Department.

3855.3 Financial records related to the building where the MHCRF is located shall include all mortgage, rent, utilities, tax and insurance payments, home repairs, and renovations and shall be maintained in an orderly file for a period of at least three (3) years.

3855.4 Other business financial records shall include receipts for food purchases, household supplies, and professional infestation treatment, and shall be maintained in an orderly file for at least one (1) year.

3855.5 Financial records shall be maintained at the facility or at the Operator’s business office in the District of Columbia and shall, upon request, be provided within twenty-four (24) hours for inspection by the Director.

3855.6 Where an Operator operates several facilities and buys food, bedding, or other household supplies for several facilities at one time, the Operator shall document on the financial records and receipts the dollar amount allocable to each MHCRF.

3855.7 Each MHCRF shall submit a financial report to the Director every six (6) months in accordance with DBH policies and directives and any current contract between DBH and the MHCRF Operator.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3855

22-A DCMR § 3856 PAYMENT OF DISTRICT FUNDS

3856.1 No District of Columbia funds for room and board shall be paid to any MHCRF or to any person residing in a MHCRF for his or her maintenance in that facility unless the MHCRF is licensed pursuant to this chapter.

3856.2 No person shall be referred by the Director or designee for the Optional State Payment who is residing in an unlicensed facility. Further, no unlicensed facility, rooming house, or boarding house shall be entitled to receive the Optional State Payment for the maintenance of a person residing in the facility, unless the facility is licensed pursuant to this chapter.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3856

22-A DCMR § 3857 SUPPORTED RESIDENCE

3857.1 A Supported Residence (SR) shall meet the minimum requirements for a home-like living environment, staffing, and resident care set forth in §§ 3800, 3850 and 3852.

3857.2 An SR shall be appropriate for a maximum of eight (8) adults with a principal diagnosis of serious and persistent mental illness who require twenty-four (24) hour supervision. A higher number of residents may be allowed where “grand-fathered” or specifically authorized by the Director pursuant to § 3800.5.

3857.3 Each person seeking residential placement in an SR shall have a principal diagnosis of mental illness and be in need of twenty-four (24) hour staff supervision to assist with ADLs, meals, lodging, and recreation. Residents may remain in the residence, work, or participate in a structured day program, or other daily activity. Attendance at a day program shall not be mandatory for persons seeking placement in an SR.

3857.4 There shall be an assigned Residence Director for each SR who shall provide or arrange for supervision and coordinate services to ensure that each resident's health, safety, and welfare are protected.

3857.5 An SR shall maintain a minimum ratio one (1) staff member for each eight (8) residents or fewer, at all times, for purposes of complying with this section and receipt of the per diem payments.

3857.6 An SR shall provide awake supervision a minimum of sixteen (16) hours a day, and shall provide awake supervision during the night when required to adequately address the needs of one or more residents experiencing a period of destabilization, an emergency, or other situation requiring prompt attention.

3857.7 The resident's treatment team and the facility’s Residence Director, in conjunction with the Department, shall determine whether a person is appropriately placed in an SR.

3857.8 The Residence Director and staff at an SR shall also meet any additional qualifications or higher staff-to-resident ratios required pursuant to a current contract between the MHCRF and the Department for SR services.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3857

22-A DCMR § 3858 SUPPORTED REHABILITATIVE RESIDENCE

3858.1 A Supported Rehabilitative Residence (SRR) shall provide on-site rehabilitative services in addition to meeting the minimum MHCRF requirements for a home-like environment, staffing, and resident care set forth in §§ 3800, 3850 and 3852.

3858.2 An SRR shall be appropriate for a maximum of eight (8) adults (unless a higher number is specifically authorized pursuant to § 3800.5) with a principal diagnosis of serious and persistent mental illness who require twenty-four (24) hour supervision and on-site rehabilitation and who may require specialized services on-site.

3858.3 Each person seeking residential placement in an SRR shall have a principal diagnosis of mental illness, be in need of twenty-four (24) hour staff supervision to assist with ADLs, meals, lodging, and recreation, and shall also require on-site rehabilitation. Residents may remain in the residence, work, or participate in a structured day program or other daily activity. Attendance at a day program shall not be mandatory for persons seeking placement in an SRR.

3858.4 Specialized services, such as medication administration, limited or intermittent nursing care, or physical therapy, shall be provided as necessary on a scheduled basis as established in the resident's IRP. These services shall be provided by appropriate and qualified:

(a) District of Columbia licensed health care professionals; or

(b) Nursing assistive personnel, such as Trained Medication Employees, Medication Aides, or Certified Nursing Assistants certified by the D.C. Board of Nursing and working within the scope of their certification with required supervision.

3858.5 An SRR shall maintain a staff to resident ratio of at least one (1) to eight (8), twenty-four (24) hours per day, and at least two (2) staff persons for every five (5) to eight (8) residents during periods of peak activity as provided in §§ 3858.6 and 3858.7. If there are four (4) or fewer residents, a second staff person is not required, except as provided in § 3858.8.

3858.6 An SRR shall determine the hours of peak activity based upon the hours that meals are served and when most residents are home and awake. At a minimum, the following are peak hours for purposes of complying with this section and receipt of the per diem payments: 6:00 a.m. to 9:00 a.m. and 5:00 p.m. to 8:00 p.m.

3858.7 The Department may approve a written MHCRF staffing plan with different peak hours upon a showing that the MHCRF is providing adequate staffing coverage based upon the residents’ individual schedules. The SRR shall maintain a record of any changes in the peak activity hours and work schedules and the reason for the changes.

3858.8 An SRR shall provide awake supervision a minimum of sixteen (16) hours a day and shall provide awake supervision twenty-four (24) hours a day when required to adequately address the needs of one or more residents experiencing a period of destabilization or residents who require twenty-four (24) hour awake supervision on an ongoing basis in order to be maintained within the SRR and in the community.

3858.9 An SRR shall have the capacity to provide one-to-one support to residents on a periodic basis, as needed, to care for and safeguard the resident and other residents of the facility.

3858.10 In addition to the general staff requirements in this chapter, staff shall be responsible for providing rehabilitative services, therapeutic support, management, and re-direction consistent with the resident’s IRP. Staff shall provide a consistent and therapeutic environment where through daily contact and interaction the resident's needs and progress are assessed.

3858.11 Rehabilitation in an SRR shall be coordinated under the direction of the resident's designated clinical treatment team in conjunction with the Residence Director and facility staff.

3858.12 There shall be an assigned Residence Director who shall provide or arrange for supervision and coordination of rehabilitative and other required services at the SRR to ensure that each resident's health, safety, and welfare are protected.

3858.13 The resident's clinical treatment team and the facility’s Residence Director, in conjunction with the Department shall determine whether a person is appropriately placed in an SRR.

3858.14 The Residence Director and staff at an SRR shall also meet any additional qualifications or higher staff-to-resident ratios required pursuant to a current contract between the MHCRF and the Department for SRR services.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3858

22-A DCMR § 3859 INTENSIVE RESIDENCE

3859.1 An Intensive Residence (IR) shall provide on-site medical assistance, nursing, and rehabilitative services, in addition to meeting the minimum MHCRF requirements for a home-like environment, staffing, and resident care set forth in §§ 3800, 3850 and 3852.

3859.2 An IR is appropriate for a maximum of eight (8) adults with a principal diagnosis of serious and persistent mental illness who have special needs due to co-morbid medical conditions that cannot be adequately provided for in an SR or SRR. These residents require twenty-four (24) hour staff supervision and enhanced care, and may need periodic one-to-one support for medical conditions or due to the intensity of psychiatric symptoms.

3859.3 An IR shall have a staff-to-resident ratio of two (2) to eight (8), 6 a.m. to 10 p.m. daily whenever a resident is present. Additional staff shall be available during times of peak activity. At a minimum, the following are peak hours for purposes of complying with this section and receipt of the per diem payments: 6:00 a.m. to 9:00 a.m. and 5:00 p.m. to 8:00 p.m.

3859.4 The Department may approve a written MHCRF staffing plan with different peak hours upon a showing that the MHCRF is providing adequate staffing coverage based upon the residents’ individual schedules. The IR shall maintain a record of any changes in the peak activity hours and work schedules and the reason for the changes.

3859.5 An IR shall have the capacity to provide one-to-one staffing when necessary as determined by the resident's treatment plan and the immediate needs of the resident and other residents in the facility.

3859.6 Awake staff is required twenty-four (24) hours per day in an IR.

3859.7 Staffing shall be provided in accordance with the special program needs of residents including geriatric, dual diagnosis, behavioral, or nursing care, and may include medical, psychiatric, nursing, behavioral, social, and recreational services.

3859.8 The Residence Director or a staff member shall be present whenever residents are at the residence. In addition, the Residence Director or designee shall arrange for clinical back-up services. The mental health professional designated to provide back-up services shall:

(a) Be available by telephone at all times;

(b) Be able to reach the residence within thirty (30) minutes in case of an emergency; and

3859.9 Each Residence Director of an IR shall meet the requirements of § 3851 and shall also meet any additional professional license or experience qualifications, or higher Residence Director-to-resident ratios required pursuant to a current contract between the MHCRF and the Department for IR services.

3859.10 Each IR shall have a full-time Registered Nurse at the facility a minimum of eight (8) hours per day. In addition, a Licensed Practical Nurse (LPN) shall be on duty at the facility the remaining sixteen (16) hours a day or whenever an RN is not on duty.

3859.11 “On call” RN nursing consultation, supervision, and support shall be available to the LPN and any other staff on duty whenever an RN is not on duty at the facility. The LPN shall be under the general supervision of a Registered Nurse at all times.

3859.12 The resident's clinical treatment team and the facility’s Residence Director in conjunction with the Department, shall determine whether a person is appropriately placed in an IR.

3859.13 An IR shall be in compliance with applicable requirements under the Americans with Disabilities Act, including accessibility requirements for bedrooms, living spaces and bathrooms.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3859

22-A DCMR § 3860 TRANSITIONAL RESIDENTIAL BEDS

3860.1 Transitional residential beds (SR-Transitional) shall be located in a Supported Residence facility and shall meet all requirements of a SR MHCRF; except that a SR-Transitional may have up to ten (10) beds in a single facility and may maintain a staff to resident ratio of one (1) to ten (10).

3860.2 A SR-Transitional is a MHCRF designed for individuals who currently require the care and supervision provided in a SR, but who have been assessed by their treatment team and DBH as having the potential to live independently with necessary recovery and transition planning assistance. A primary purpose of the SR-Transitional is to speed the transition from a higher to a lower level of care in the community.

3860.3 Individuals appropriate for placement in a SR-Transitional facility include adults who may be at risk of becoming homeless, have been recently hospitalized, have been dually diagnosed with a substance abuse disorder, or otherwise lack essential skills necessary to move immediately to permanent supported housing or independent living in the community.

3860.4 The length of stay in a SR-Transitional is intended to range from six (6) months to a maximum of one (1) year, based upon the temporary resident’s ability to accept a permanent living arrangement. The one (1) year maximum period can be extended by the Department on a monthly basis for cause, upon request by the MHCRF.

3860.5 Not more than ten (10) transitional residential beds shall be located in one (1) facility, unless a waiver is specifically authorized by the Director.

3860.6 A SR-Transitional shall assess the resident’s needs upon admission and develop a transition plan for each resident in coordination with the resident and his or her CSA. The transition plan shall include specific goals and objectives and the specific services, and behavioral and psycho-educational supports that will be provided to enable the resident to transition to supported housing or independent living.

3860.7 A SR-Transitional shall meet all requirements and provide all deliverables required by any contract between the Department and the transitional MHCRF, in addition to meeting all requirements of this chapter. In addition to the staff qualification requirements in Section 3850, each SR-Transitional Residence Director shall have at least one (1) year additional experience in working with homeless persons.

3860.8 Notwithstanding § 3860.1, the Department may require by contract that a MHCRF with transitional beds maintain a higher staff to resident ratio than a one (1) to ten (10) staff to resident ratio. Failure to comply with the ratio mandated by contract shall be a violation of this section.

3860.9 Each SR-Transitional shall work with the resident, the resident’s treatment team, and the Department to ensure that the individual is appropriately placed in a SR-Transitional and is transferred to more permanent housing as soon as appropriate.

3860.10 When applying for a MHCRF license pursuant to § 3805, the Operator shall specify that it wishes to receive a license for a SR-Transitional.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3860

22-A DCMR § 3861 MHCRF TRANSFER, DISCHARGE, AND RELOCATION

3861.1 The MHCRF shall promptly notify the Director, the resident’s CSA treatment team or other mental health care provider, and the resident’s physician when the resident’s physical or mental condition changes and the resident requires services or supports that may require discharging, or transferring the resident, or relocating the resident within the facility. Under no circumstances shall a resident be discharged, transferred, or relocated without notifying the Department.

3861.2 Every discharge, transfer, or relocation of any resident shall be in full compliance with title III of the Nursing Home and Community Residence Facility Residents’ Protection Act, including the MHCRF’s reasons for seeking to transfer, discharge, or relocate the resident, and all notice and hearing requirements.

3861.3 A discharge, transfer, or relocation of any resident shall be consistent with the resident’s IRP.

3861.4 The discharge, transfer, or relocation of a resident of a MHCRF that receives contract funds from the Department shall be subject to prior approval by the Director in addition to the other requirements of this section. Failure to do so may result in the loss of contract funds.

3861.5 Ten (10) days prior to the issuance of a twenty-one (21) day notice for an involuntary transfer or discharge, the MHCRF shall schedule a case conference with the resident and a representative of the CSA and shall notify the Director and the LTCO of the date and time of the meeting.

3861.6 Residents who are hospitalized have a right to return to the facility in accordance with the terms and conditions of subsection 3861.9.

3861.7 In the event the resident’s hospitalization does not meet the conditions of Subsection 3861.9 and the MHCRF seeks to transfer, discharge, or relocate the resident, the MHCRF shall comply with the Community Residence Facility Residents’ Protection Act and this section.

3861.8 A MHCRF shall also comply with any additional requirements for transferring or discharging residents and for allowing residents to return to a facility after hospitalization or other absence from the facility, required by a current contract for MHCRF residential services between the Department and the MHCRF.

3861.9 A MHCRF shall coordinate with a resident’s treatment team during periods of hospitalization to ensure the resident receives temporarily institutionalization benefits, if eligible. A resident who receives Supplemental Security Income and is admitted to a public institution, the primary purpose of which is the provision of medical or psychiatric care, or to a public or private Medicaid-certified medical treatment facility, shall be allowed to return to the MHCRF within ninety (90) days if:

(a) A physician has certified in writing to the Social Security Administration that he or she expects the recipient to be medically confined for ninety (90) consecutive days or less;

(b) The resident’s Supplemental Security Income has been continued during the period of hospitalization so that the resident may continue to maintain a home or living arrangement;

(d) The resident’s needs are consistent with services provided by the MHCRF as determined by the resident’s treatment team in conjunction with the resident.

3861.10 In the case of an emergency situation caused by a natural disaster, extreme heat or cold, extended power outage, or other emergency where the MHCRF cannot safely care for residents at the facility and residents need to be temporarily moved to another location, the MHCRF shall immediately notify both the LTCO and the Department and advise them of the situation and the actions the MHCRF plans to take.

3861.11 If the MHCRF is not able to make direct contact, and time or conditions do not permit it to obtain advance authorization, the MHCRF shall leave a detailed message at both numbers, including the address or addresses to which residents are being relocated, and a phone number where the Operator can be reached. The MHCRF shall comply with the notice requirements in the Community Residence Facility Residents’ Protection Act for any temporary move or relocation that is expected to exceed thirty (30) days.

3861.12 Where the MHCRF temporarily moves residents under the conditions described in § 3861.10, the MHCRF shall cooperate with the Department and the Ombudsman to facilitate immediate inspections, comply with legal requirements, and address resident needs.

3861.13 Whenever an Operator needs to temporarily move residents under the conditions described in § 3861.10, the Operator shall ensure that the temporary transfers:

Do not exceed forty-eight (48) hours unless requested by the Operator in writing and approved in writing by the Department; and

Are to locations that are:

(1) In the District of Columbia and in compliance with federal and District legal requirements;

(2) Safe for occupancy; and

(3) Equipped with adequate bathroom facilities and adequate accommodations for eating and sleeping.

3861.14 If occupancy limits are exceeded at another MHCRF to accommodate residents who have to be moved, the Operator shall ensure that the temporary increased occupancy does not create a hazard or danger for residents, and that resident needs are met.

3861.15 Once the emergency has abated, the MHCRF shall return the residents to the facility. No resident shall be permanently discharged, transferred or relocated under the emergency provisions unless the MHCRF or the Department has complied with Community Residence Facility Residents’ Protection Act.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3861

22-A DCMR § 3899 DEFINITIONS

When used in this chapter, the following terms shall have the meanings ascribed:

“Activities of daily living” – Basic life activities that include ambulating and transferring, bathing, dressing, grooming, toileting, and eating.

“Administrative Procedure Act” – the District of Columbia Administrative Procedure Act, approved October 21, 1968 (82 Stat. 1204; D.C. Official Code §§ 2-501 et seq.).

“Adult Protective Services Act” – the Adult Protective Services Act of 1984, effective March 14, 1985 (D.C. Law 5-156; D.C. Official Code §§ 7-1901 et seq.).

“Americans with Disabilities Act” – The Americans with Disabilities Act of 1990, approved July 26, 1990 (Pub. L. 101-336, 104 Stat. 328; 42 U.S.C §§ 12101 et seq.).

“Applicant” – an individual, corporation, partnership, or agency that applies for a license or renewal license to operate a MHCRF, is the Operator of the MHCRF business, and has an ownership or leasehold interest in the property where the MHCRF will be located.

“Awake supervision” – supervision by a staff person who is not sleeping or resting, is alert, on duty, and is prepared to address the needs of residents and any situations which may arise including matters requiring prompt attention and emergencies.

“Behavioral Health Establishment Act” -- the Department of Behavioral Health Establishment Act of 2013, effective December 24, 2013 (D.C. Law 20-61; D.C. Official Code §§ 7-1141 et seq.).

“Business days” – calendar days excluding Saturdays, Sundays, and legal holidays.

“Civil Infractions Act” – the Department of Consumer and Regulatory Affairs Civil Infractions Act of 1985, effective October 5, 1985 (D.C. Law 6-42; D.C. Official Code §§ 2-1801 et seq.).

“Clean Hands Act” – the Clean Hands Before Receiving A License or Permit Act of 1996, effective May 11, 1996 (D.C. Law 11-118; D.C. Official Code §§ 47-2861 et seq.).

“Community Residence Facility” – a facility that provides a sheltered living environment for individuals, eighteen (18) years of age or older, who desire or need such an environment because of their physical, mental, familial, social, or other circumstances, and who are not in the custody of the Department of Corrections. See § 2 of the Licensure Act (D.C. Official Code § 44-501). A community residence facility is included within the definition of a “community-based residential facility” under the District of Columbia Construction Codes Supplement, 12-A DCMR, § 202.

“Consumer” or “Consumers” – person or persons who seek or receive mental health services or supports funded or regulated by the Department of Behavioral Health.

“Consumers’ Rights Act” – the Mental Health Consumers’ Rights Protection Act of 2001, effective December 18, 2001 (D.C. Law 14-56; D.C. Official Code §§ 7-1231.01 et seq.).

“Core Services Agency” or “CSA” – a community-based provider of mental health services and mental health supports that is certified by the Department and that acts as a clinical home for consumers of mental health services.

“Criminal Background Check Act” – Health-Care Facility Unlicensed Personnel Criminal Background Check Act of 1998, effective April 20, 1999 (D.C. Law 12-238; D.C. Official Code §§ 44-551 et seq.).

“Crisis bed” – a bed provided in a residential setting that offers substantial quantities of psychological assistance to individuals in psychiatric crisis, until the immediate emotional crisis passes and an acceptable level of stability is regained, usually within 30 days.

“DCRA” – the District of Columbia Department of Consumer and Regulatory Affairs.

“Department” – the Department of Behavioral Health.

“Dietitian” – an individual who meets the qualifications and standards for membership in the American Dietetic Association and who applies the principles of nutrition and management to menu planning, food preparation, and service.

“Director” – the Director of the Department of Behavioral Health or the Director’s designee.

“Discharge” – termination of the resident’s stay at the MHCRF, due to action taken by the MHCRF or the Mayor, or by the choice of the resident.

“District of Columbia Construction Codes” – 2012 ICC Construction Codes as amended by the D.C. Construction Codes Supplement (2013), Title 12 DCMR, or currently adopted version of Construction Codes.

“District of Columbia Fire Prevention Code” – 2012 ICC Fire Code as amended by the D.C. Fire Code Supplement (2013), Title 12-H DCMR, or currently adopted version of the Fire Code

“District of Columbia Housing Code” – Title 14 DCMR.

“District of Columbia Property Maintenance Code” – 2012 ICC Property Maintenance Code as amended by the D.C. Property Maintenance Code Supplement (2013), Title 12-G DCMR, or currently adopted version of the Property Maintenance Code.

“Disqualifying crime” – a conviction of one of the following crimes within seven (7) seven years prior to a criminal background check: (1) murder, attempted murder, or manslaughter; (2) arson; (3) assault, battery, assault and battery, assault with a dangerous weapon, mayhem, or threats-to-do bodily harm; (4) burglary; (5) robbery; (6) kidnapping; (7) theft, fraud, forgery, extortion or blackmail; (8) illegal use or possession of a firearm; (9) rape, sexual assault, sexual battery, or sexual abuse; (10) child abuse or cruelty to children; (11) unlawful distribution, or possession with intent to distribute, of a controlled substance; or (12) the equivalent of any of the foregoing in another state or territory.

“Food Code” – District of Columbia Food and Food Operations Code, Title 25-A DCMR.

“Habitable room” – an undivided, enclosed space with natural light and ventilation, including a room for living, eating, or sleeping, that complies with applicable District of Columbia Building and Housing Codes regulations.

“Home-like environment” – an integrated residential setting that meets the requirements of 42 C.F.R. § 441.301.

“HIPAA” – the Health Insurance Portability and Accountability Act of 1996, approved August 21, 1996 (Pub. L. 104-191, 110 Stat. 1936), and the HIPAA Standards for Privacy of Individually Identifiable Health Information (the Privacy Rule), 45 C.F.R. Parts 160 and 164.

“Human Rights Act” – the District of Columbia Human Rights Act, effective December 13, 1977 (D.C. Law 2-38; D.C. Official Code §§ 2-1401 et seq.).

“Independence” – the quality of being self-reliant and free from the control of others.

“Independent living” – living alone or with friends or relatives in a private home, apartment, or rooming house.

“Individual Recovery Plan” or “IRP” – a written plan for a resident’s continued treatment and care that includes goals, objectives, and interventions developed by a multi-disciplinary treatment team in consultation with the resident.

“Licensee” – a person or entity to whom a license to operate a MHCRF has been issued.

“Licensure Act” – the Health Care and Community Residence Facility, Hospice and Home Care Licensure Act of 1983, effective February 24, 1984 (D.C. Law 5-48; D.C. Official Code §§ 44-501 et seq.).

“Limited or intermittent nursing care” – simple nursing care provided on a periodic basis in a MHCRF, including blood pressure monitoring, insulin injections, and dressing changes, provided by a licensed RN or LPN, or under the supervision of a RN or LPN by a D.C. Board of Certified Nursing Assistant, Medication Aide, or other certified nursing assistive personnel, within the scope of their certification.

“Long-Term Care Ombudsman” or “LTCO” – the person designated under the Long-Term Care Ombudsman Act and referenced in § 101(7) of the Nursing Home and Community Residence Facility Residents Protection Act to perform the functions of the Long-Term Care Ombudsman in the District of Columbia.

“Long-Term Care Ombudsman Act” – the District of Columbia Long-Term Care Ombudsman Program Act of 1988, effective March 16, 1989 (D.C. Law 7-218; D.C. Official Code §§ 7-701.01 et seq.).

“Major unusual incident” (“MUI”) – An adverse event that can compromise the health, safety, or welfare of persons, employee misconduct, fraud, and actions that are violations of law or policy.

“Mayor” – the Mayor of the District of Columbia or his or her authorized designee.

“Medication Aide” – an individual who has been certified by the District of Columbia Board of Nursing to perform nursing assistive tasks and to administer medication under the supervision of a licensed nurse. A Medication Aide has met education, experience, and examination requirements pursuant to rules to be adopted by the D.C. Board of Nursing.

“Mental Health Information Act” – the District of Columbia Mental Health Information Act of 1978, effective March 3, 1979 (D.C. Law. 2-136; D.C. Official Code §§ 7-1201.01 et seq.).

“Mental health professional” – a person who is specifically trained and, if required, licensed to provide services to mentally ill persons.

“MHCRF” – refers to Mental Health Community Residence Facility, the Operator, Residence Director, and staff members, as applicable.

“Non-ambulatory” – unable to walk or move from one place to another without personal or mechanical assistance.

“Nursing Home and Community Residence Facility Residents’ Protection Act” - the Nursing Home and Community Residence Facility Residents’ Protection Act of 1985, effective April 18, 1986 (D.C. Law 6-108; D.C. Code §§ 44-1001.01 et seq.).

“OAH Rules of Practice and Procedure” – District of Columbia Office of Administrative Hearings Rules of Practice and Procedure, Title 1, Chapter 28 of the District of Columbia Municipal Regulations. (1 DCMR, Chapter 28)

“Operator” – the person or entity that owns the MHCRF business and who applies for and holds an MHCRF license as provided in §§ 3802.1 and 3805.1.

“Optional State Payment” – A supplemental payment for room, board, and care paid to District of Columbia residents who receive Supplemental Security Income and who live in a community residence facility or an assisted living facility as provided for in § 549 of the District of Columbia Public Assistance Act of 1982, effective April 6, 1982 (D.C. Law 4-101; D.C. Official Code § 4-205.49).

“Personal assistance” – help with grooming, bathing, eating, walking, toileting, budgeting, making appointments, arranging transportation, and other activities associated with daily living. Personal assistance may involve supervision, prompting, oversight, or hands-on care.

“Provider” – a person, agency, or organization that provides health or support services to a resident, including the Department, Core Services Agencies, the Comprehensive Crisis Emergency Program, agencies that contract with the District of Columbia to provide mental health, behavioral health, medical health, and other services, hospitals, private clinics, and Medicaid providers.

“Provisional license” – a license issued for not to exceed ninety (90) days to new MHCRFs to afford sufficient time and evidence to evaluate whether the new facility is capable of complying with this chapter, or issued to a regular license holder with deficiencies as provided in this chapter.

“Regular license” – a license issued for not to exceed one (1) year to a MHCRF that is in compliance with all applicable laws and regulations.

“Relocation” – the movement of a resident from one part or room of the MHCRF where he or she resides to another, whether voluntary or involuntary, pursuant to the Nursing Home and Community Residence Facility Residents’ Protection Act.

“Representative Payee” – an individual or organization appointed by the Social Security Administration to receive Social Security or Supplemental Security Income (SSI) benefits for someone who cannot manage or direct someone else to manage his or her money. The main responsibilities of a representative payee are to use the benefits to pay for the current and foreseeable needs of the beneficiary, properly save any benefits not needed to meet current needs, and keep records of expenses.

“Residence Director” – the individual responsible for the overall management and operation of the MHCRF, including hiring and firing, purchase of food and supplies, arranging repairs, and supervision of employees and volunteers. As provided in § 3804.1(d), a distinct Residence Director is required if the Operator is a corporation or partnership, or if the Operator does not personally manage the facility.

“Resident” – a person who lives in a MHCRF and has or should have a Room, Board and Care Agreement with the Owner.

“Resident’s representative” –

(a) Any person who is knowledgeable about a resident’s circumstances and has been designated by that resident in writing to represent him or her;

(b) Any person other than a facility who has been appointed by a court either to administer a resident’s financial or personal affairs or to protect or advocate for a resident’s rights; or

(c) The Long-Term Care Ombudsman or his or her designee, if no person has been designated or appointed in accordance with subparagraphs (A) or (B) of this paragraph.

“Restraint” – any manual method or physical or mechanical device, material, or equipment attached or adjacent to the resident’s body that he or she cannot easily remove and that restricts his or her freedom of movement or normal access to his or her body. “Restraint” also includes a medication that is used in addition to or in place of the resident’s regular, prescribed drug regimen to control extreme behavior during an emergency, but does not include medications that comprise the resident’s regular, prescribed medical regimen and that are part of the resident’s service plan, even if their purpose is to control ongoing behavior.

“Restricted license” – a license issued for not to exceed 90 days which permits operation of a MHCRF but includes restrictions on the facility’s operations including a prohibition against the MHCRF accepting new residents or from delivering services that it would otherwise be authorized to deliver.

“Seclusion” – the involuntary confinement of a resident alone in a room or an area from which the resident is either physically prevented from leaving, or from which the resident is led to believe he or she cannot leave at will.

“Substantial compliance” – meets most important requirements of the rules, has only a small number of outstanding deficiencies, and is without deficiencies or violations that are life threatening, pose an immediate or serious danger to the residents or facility staff, or jeopardize public health, safety, or welfare.

“Trained Medication Employee” – an individual employed to work in a program, including a MHCRF, who has successfully completed a training program approved by the District of Columbia Board of Nursing and is certified to administer medication to MHCRF residents under the general supervision of a registered nurse licensed in the District of Columbia in accordance with Title 17 DCMR Chapter 61.

“Unlicensed person” – A person not licensed by one of the health occupation boards pursuant to the District of Columbia Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq.), Chapter 12 of D.C. Official Code Title 3, who functions in a complementary or assistance role to licensed heath care professionals in providing direct patient care or in performing common nursing tasks. The term “unlicensed person” includes nurse aides, orderlies, assistant technicians, attendants, home health aides, personal care aides, medication aides, geriatric aides, or other health aides. The term “unlicensed person” also includes housekeeping, maintenance, and administrative staff or contractors who will foreseeably come in direct contact with patients.

“Unusual incident” – Any significant occurrence or extraordinary event different from the regular routine or established procedure that does not rise to the level of a MUI.

History

SOURCE: Final Rulemaking published at 65 DCR 1633 (February 16, 2018). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3899

22-A39 PSYCHOSOCIAL REHABILITATION CLUBHOUSE CERTIFICATION STANDARDS

22-A DCMR § 3900 PSYCHOSOCIAL REHABILITATION CLUBHOUSE CERTIFICATION STANDARDS

3900.1 This chapter establishes the requirements and process for obtaining and maintaining certification to provide mental health rehabilitation services as a Psychosocial Rehabilitation Clubhouse (Clubhouse) in the District of Columbia. Clubhouse services:

(a) Are structured, specialty services provided primarily in a group rehabilitative setting;

(b) Utilize behavioral, cognitive or supportive interventions to improve a member’s potential for establishing and maintaining social relationships and obtaining occupational or educational achievements; and

3900.2 Clubhouse participants are referred to collectively as “members” and each individually as a “member.”

3900.3 Clubhouse members, with staff assistance, shall:

Operate all aspects of the Clubhouse, including food service, clerical, reception, janitorial, and other member supports and services such as employment, housing, and education;

Participate in the day-to-day decision–making and governance of the Clubhouse; and

Plan community projects and activities to engage members in the community.

3900.4 Each Clubhouse shall be organized through a Work-Ordered Day in accordance with Clubhouse Standards. The goal of the Work-Ordered Day, including all Clubhouse decision-making opportunities and activities, shall be for the members to achieve or regain the confidence and skills necessary to lead vocationally-productive and socially-satisfying lives.

3900.5 A Clubhouse shall be:

Organized and operated in accordance with the International Standards for Clubhouse Programs established by Clubhouse International, as amended from time to time;

Certified by the Department as a Clubhouse in accordance with the requirements of this chapter;

In compliance with the qualification standards described in § 3413 of this subtitle and the certification standards as required by this chapter, except an affiliation agreement with a CSA is not necessary for the provision of Clubhouse services; and

Currently accredited by Clubhouse International as a Clubhouse, or during its first thirty (30) months of operation, have applied for Clubhouse International accreditation as a Clubhouse and be declared by Clubhouse International to be in reasonable compliance with the Clubhouse International accreditation action plan.

3900.6 A Clubhouse specialty provider shall establish and adhere to policies and procedures governing its relationship with a CSA, which address access to records, clinical responsibilities, legal liability, dispute resolution, and all other MHRS certification standards (CSA Referral Policy).

3900.7 A Clubhouse specialty provider shall establish and adhere to policies and procedures governing its collaboration with the referring CSA in the development, implementation, evaluation, and revision of each consumer’s Plan of Care that comply with DBH rules (Collaboration Policy). The Collaboration Policy shall:

(a) Be a part of each Clubhouse’s Plan of Care Review Policy;

(b) Require Clubhouse specialty providers to incorporate CSA-developed Diagnostic Assessment material into the Clubhouse specialty provider’s Plan of Care process; and

3900.8 Each Clubhouse specialty provider shall offer access or referrals to core and other specialty services, as clinically indicated.

3900.9 Each Clubhouse specialty provider with total annual revenues at or exceeding three hundred thousand dollars ($300,000) shall have an annual audit by a certified public accounting firm in accordance with generally accepted auditing standards. The resulting financial audit report shall be consistent with formats recommended by the American Institute of Public Accountants. Each Clubhouse specialty provider shall submit a copy of the financial audit report to DBH ninety (90) days after the end of the fiscal year.

3900.10 Each Clubhouse specialty provider with total annual revenues less than three hundred thousand dollars ($300,000.00) shall submit financial statements reviewed by an independent certified public accountant or certified public accounting firm within one hundred twenty (120) calendar days after the end of its fiscal year.

3900.11 Each Clubhouse specialty provider shall have the capability to submit accurate claims, encounter data, and other submissions as necessary directly to the Department.

3900.12 DBH shall review and approve the CSA Referral Policy and the Collaboration Policy upon certification and recertification.

History

SOURCE: Emergency and Proposed Rulemaking published at 57 DCR 4010 (May 7, 2010)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 57 DCR 7734 (August 20, 2010)[EXPIRED]; as amended by Final Rulemaking published at 57 DCR 8698, 8699 (September 24, 2010); as amended by Final Rulemaking published at 66 DCR 5638 (May 3, 2019); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3900

22-A DCMR § 3901 CERTIFICATION APPLICATION

3901.1 No person shall operate a Psychosocial Rehabilitation Clubhouse unless certified in accordance with this chapter.

3901.2 An organization seeking certification from the Department as a Clubhouse shall submit an application to the Department in the format established by the Department. The completed application shall include:

Evidence of current accreditation as a Clubhouse by Clubhouse International, or, for the first thirty (30) months of operation, evidence of having applied for Clubhouse International accreditation as a Clubhouse and having been declared by Clubhouse International to be in reasonable compliance with the Clubhouse International accreditation action plan; and

Other evidence that may be required by the Department.

3901.3 Applications for certification as a Clubhouse shall be processed by the Department in accordance with the rules established for MHRS certification set forth in § 3401 of this subtitle.

3901.4 Certification as a Clubhouse is effective for a maximum of two (2) calendar years from the date of issuance of certification by the Department, subject to the provider’s continuous compliance with the certification requirements in this chapter and the following limitations:

Certification shall remain in effect until it expires, or is renewed or revoked;

Certification shall specify the effective date of the certification, which shall be included on the Clubhouse certification;

For new Clubhouse providers that are not yet accredited by Clubhouse International but are seeking accreditation, department certification shall be for one (1) calendar year, which can be renewed for a total of up to three (3) years; and

For existing providers accredited by Clubhouse International and seeking renewal, certification shall be for two (2) calendar years.

3901.5 Certification is not transferable to any other organization.

History

SOURCE: Emergency and Proposed Rulemaking published at 57 DCR 4010 (May 7, 2010)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 57 DCR 7734 (August 20, 2010)[EXPIRED]; as amended by Final Rulemaking published at 57 DCR 8698, 8700 (September 24, 2010); as amended by Final Rulemaking published at 66 DCR 5638 (May 3, 2019). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3901

22-A DCMR § 3902 CERTIFICATION REQUIREMENTS

3902.1 A Clubhouse providing services to members shall comply with all of the requirements set forth in Chapter 34 of this subtitle except for the requirements set forth in §§ 3411, 3412, 3413.7, 3413.12-3413.16, 3413.19, 3413.26, 3413.29(c), 3414, 3415, and 3418-3430.

3902.2 In addition to complying with the requirements set forth in § 3410.27 of this subtitle, each Clubhouse specialty provider Quality Improvement (QI) program shall be directed by a coordinator (QI Coordinator) who is a qualified practitioner and who has direct access to the Chief Executive Officer of the Clubhouse. The QI Coordinator shall review unusual incidents, deaths, and other sentinel events, monitor and review utilization patterns, and track consumer complaints and grievances. The QI Coordinator shall also collect and submit clinical outcome data using the process, timeline and tools specified or approved by DBH.

History

SOURCE: Emergency and Proposed Rulemaking published at 57 DCR 4010 (May 7, 2010)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 57 DCR 7734 (August 20, 2010)[EXPIRED]; as amended by Final Rulemaking published at 57 DCR 8698, 8701 (September 24, 2010); as amended by Final Rulemaking published at 66 DCR 5638 (May 3, 2019); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3902

22-A DCMR § 3903 CLUBHOUSE SERVICES ELIGIBILITY

3903.1 To be eligible for Clubhouse services, a consumer shall:

Be eligible for MHRS services in accordance to Chapter 34; and

Be at least eighteen (18) years of age.

History

SOURCE: Emergency and Proposed Rulemaking published at 57 DCR 4010 (May 7, 2010)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 57 DCR 7734 (August 20, 2010)[EXPIRED]; as amended by Final Rulemaking published at 57 DCR 8698, 8701 (September 24, 2010); as amended by Final Rulemaking published at 66 DCR 5638 (May 3, 2019). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3903

22-A DCMR § 3904 CLUBHOUSE SERVICES

3904.1 Clubhouse services are primarily rehabilitative in nature. Clubhouse services assist individuals with behavioral health diagnoses to develop social networking, independent living, budgeting, self-care, and other skills that will assist them to live in the community and to prepare for securing and retaining employment.

3904.2 Services within the Clubhouse may be delivered through individual (one-to-one) or group interaction between staff and members within the Clubhouse setting. Experiential opportunities through operating and maintaining the Clubhouse should include all of the formal activities engaged in during the Work-Ordered Day.

3904.3 A Clubhouse shall provide members with coping and wellness strategies to improve functioning through experiential learning opportunities, peer and professional support, and psycho-education. Areas of focus include:

(a) Identification and management of situations and prodromal symptoms to reduce the frequency, duration, and severity of psychological relapses;

(b) Competence responding to a psychiatric crisis;

(d) Independent living competencies (such as self-care, cooking, money management, personal grooming, and maintenance of living environment);

(e) Social and interpersonal abilities (such as conversational competency, developing or maintaining a positive self-image, and the ability to evaluate the motivations and feelings of others to establish and maintain positive relationships);

(f) Personal adjustment abilities to reduce dependency on professional caregivers and to enhance independence (such as stress management, leisure time management, coping with symptoms of mental illness);

(g) Cognitive and adult role competency (such as using task-oriented activities to develop and maintain cognitive abilities or to maximize adult role functioning by improving attention, concentration, and memory, enhancing the ability to learn and establishing the ability to develop empathy);

(h) Identification and development of organizational support (such as sustaining personal entitlements, locating and using community resources or other supportive programs); and

(i) Identification and development of existing natural supports for addressing personal needs (such as families, employers, and friends).

History

SOURCE: Emergency and Proposed Rulemaking published at 57 DCR 4010 (May 7, 2010)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 57 DCR 7734 (August 20, 2010)[EXPIRED]; as amended by Final Rulemaking published at 57 DCR 8698, 8701 (September 24, 2010); as amended by Final Rulemaking published at 66 DCR 5638 (May 3, 2019). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3904

22-A DCMR § 3905 CLUBHOUSE STAFF

3905.1 A provider of Clubhouse services must have one or more staff persons certified by the Psychiatric Rehabilitation Association (PRA) as a Certified Psychiatric Rehabilitation Practitioner (CPRP) or that have an equivalent certification.

3905.2 Any staff members who have not been certified from the PRA as a CPRP must have at least a bachelor’s level degree or two (2) years of work experience providing psychiatric rehabilitation services, and have received the training required by § 3912 of this chapter.

Staffing ratios must comply with Clubhouse Standards.

3905.4 Clubhouse services may be provided by a team of staff that is responsible for an assigned group of consumers, or by staff who are individually responsible for assigned consumers.

3905.5 Credentialed Clubhouse staff must be supervised by a qualified practitioner.

3905.6 The following are qualified practitioners:

Psychiatrists;

Psychologists;

Licensed Independent Clinical Social Workers (“LICSWs”);

Licensed Professional Counselors (“LPCs”);

Licensed Marriage and Family Therapists (“LMFTs”);

Physician Assistants;

Licensed Graduate Social Workers; and

Licensed Graduate Professional Counselors.

3905.7 Each Clubhouse shall satisfy the following minimum staffing requirements:

A Chief Executive Officer with professional qualifications and experience, who shall meet the requirements as established by the MHRS provider’s governing authority, and is responsible for day-to-day management of the MHRS provider;

A Consulting Psychiatrist who is a physician that has completed all training in a program in psychiatry accredited by the Accreditation Council for Graduate Medical Education, approved by the American Board of Psychiatry and Neurology, Inc., or who is board-certified in psychiatry and advises the specialty provider on the quality of medical and psychiatric care provided;

A Clinical Director who is an independently licensed qualified practitioner with overall responsibility for oversight of the clinical program of the specialty provider; and

(d) The required staff listed in this subsection shall be either employees of the Clubhouse specialty provider or under contract to the Clubhouse specialty provider for an amount of time sufficient to carry out the duties assigned.

History

SOURCE: Emergency and Proposed Rulemaking published at 57 DCR 4010 (May 7, 2010)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 57 DCR 7734 (August 20, 2010)[EXPIRED]; as amended by Final Rulemaking published at 57 DCR 8698, 8701 (September 24, 2010); as amended by Final Rulemaking published at 66 DCR 5638 (May 3, 2019); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3905

22-A DCMR § 3906 DISTRICT REIMBURSEMENT LIMITATIONS

3906.1 Clubhouse treatment duration varies but generally last up to one hundred eighty (180) days. Clubhouse treatment can continue long-term in accordance with the Plan of Care for individuals experiencing ongoing rehabilitation needs. Clubhouse services may be reimbursed according to the consumer’s Human Care Agreement (HCA) with the Department and medical necessity.

3906.2 The District shall reimburse Clubhouse providers for Clubhouse services in fifteen (15) minute-increment units for up to twenty-four (24) units per day. The services will only be reimbursable if the following requirements are met:

(a) The member has engaged in at least fifteen (15) minutes of Clubhouse services per day; and

(b) The provider prepared a daily encounter note documenting the services provided to the member per day in accordance with § 3907.3 of this chapter.

3906.3 Clubhouse services require a Plan of Care.

3906.4 Clubhouse services may not be reimbursed for the same consumer on the same day as Rehabilitation/Day Services or Intensive Day Treatment.

3906.5 The District shall only reimburse one Clubhouse on behalf of each consumer per one hundred eighty (180) day period.

3906.6 In accordance with § 3432 of this subtitle, certain services may not be reimbursed through Medicaid.

History

SOURCE: Emergency and Proposed Rulemaking published at 57 DCR 4010 (May 7, 2010)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 57 DCR 7734 (August 20, 2010)[EXPIRED]; as amended by Final Rulemaking published at 57 DCR 8698, 8703 (September 24, 2010); as amended by Final Rulemaking published at 66 DCR 5638 (May 3, 2019); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020); as amended by Final Rulemaking published at 72 DCR 008497 (August 1, 2025). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3906

22-A DCMR § 3907 DOCUMENTATION REQUIREMENTS

3907.1 Each Clubhouse shall establish and adhere to policies and procedures concerning documentation, retention, maintenance, purging and destruction of clinical and rehabilitative records; security, confidentiality, and disclosure of consumer and family information that comply with applicable federal and District laws and regulations (Rehabilitation Records Policy). The Rehabilitation Records Policy shall:

(a) Require the Clubhouse to maintain all clinical and rehabilitative records in a secured and locked storage area;

(b) Require the Clubhouse to maintain and secure a current, clear, organized, and comprehensive clinical and rehabilitative record for every individual assessed, treated, or served by the Clubhouse, including information deemed necessary to provide treatment or protect the Clubhouse, in a manner that complies with applicable federal and District laws and regulations; and

3907.2 The following documents shall be included in each member’s clinical record:

(a) Current behavioral health assessment;

(b) Referral source and reason for referral;

(c) Current Plan of Care prepared by the Clubhouse and if applicable, the Plan of Care prepared by the CSA in accordance with §§ 3411-3412 of this subtitle that includes a recommendation for Clubhouse services;

(d) Identifying information about the member, including enrollment information;

(e) Identification of individuals to be contacted in the event of emergency;

(f) Basic screening and intake information;

(g) Advance instructions and advance directives;

(h) Methods for addressing the member’s and his or her family’s special needs, especially those which relate to communication, cultural, and social factors;

(i) Detailed description of services provided;

(j) Encounter notes as required by § 3907.3 of this chapter;

(k) Discharge planning information;

(l) Appropriate consents for service;

(m) Appropriate release of information forms; and

(n) A Consumer Rights Statement signed by the member, or if applicable, the member’s guardian.

3907.3 The Clubhouse staff shall write a daily encounter note at the end of each member’s session with the member encouraged but not required to participate in its drafting. The daily encounter note shall:

(a) Identify the activities performed to enhance or support the member’s rehabilitation in social, educational, and pre-vocational domains;

(b) Identify what supportive interventions or activities were used to improve a member’s potential for establishing and maintaining social relationships or obtaining occupational or educational achievements;

Document the member’s response to that day’s experience, including the choices of and perceptions by the member regarding the service(s) provided;

Demonstrate a relationship between the activities and interventions identified in the encounter note to at least one rehabilitation goal listed in the Plan of Care;

Include the arrival and departure time of the member; and

Be signed and dated by the staff member making the entry, and at the member’s discretion, the member participating in the service.

3907.4 The Clubhouse shall provide the member’s referring agency, if applicable, with a copy of the member’s Plan of Care and any updates to the Plan of Care.

3907.5 The Clubhouse shall ensure that that all clinical and rehabilitative records of members are completed promptly, filed, and retained in accordance with the Clubhouse’s Rehabilitation Records Policy.

3907.6 The member’s referring agency shall provide the Clubhouse the member’s current Plan of Care and any updates to the Plan of Care.

History

SOURCE: Emergency and Proposed Rulemaking published at 57 DCR 4010 (May 7, 2010)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 57 DCR 7734 (August 20, 2010)[EXPIRED]; as amended by Final Rulemaking published at 57 DCR 8698, 8704 (September 24, 2010); as amended by Final Rulemaking published at 66 DCR 5638 (May 3, 2019); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3907

22-A DCMR § 3908 CLUBHOUSE REFERRALS

3908.1 Referrals to the Clubhouse may be made by a CSA, family member, advocates, other service providers, or by the consumer.

3908.2 Referrals from a CSA shall be made in writing and include the following information:

(a) Current Plan of Care;

(b) Current behavioral health assessment;

(c) Contact information for the consumer, including emergency contact information (family member, friend or guardian as applicable);

(d) Crisis Plan for the consumer (if available); and

(e) Advance Directives or instructions as described in § 3405.6 of this subtitle (if available).

3908.3 Self-referrals, referrals from a relative, other service provider or advocate shall be made in writing and include the following information:

(a) Name of the person’s CSA or current behavioral health service provider (if applicable);

(b) Current behavioral health assessment (if available);

(d) Crisis Plan (if available); and

(e) Advance Directives or instructions (if available).

3908.4 A person enrolled with a CSA must have a Diagnostic Assessment and a Plan of Care that includes Clubhouse services in order to participate in the Clubhouse.

History

SOURCE: Emergency and Proposed Rulemaking published at 57 DCR 4010 (May 7, 2010)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 57 DCR 7734 (August 20, 2010)[EXPIRED]; as amended by Final Rulemaking published at 57 DCR 8698, 8704 (September 24, 2010); as amended by Final Rulemaking published at 66 DCR 5638 (May 3, 2019); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3908

22-A DCMR § 3909 CLUBHOUSE PLAN OF CARE DEVELOPMENT PROCESS

3909.1 The Clubhouse Plan of Care development process for members shall, at a minimum, include:

(a) The completion of a Diagnostic Assessment service and required components as described in § 3418 of this subtitle, unless the referral comes from a CSA, in which case the CSA may provide the Diagnostic/Assessment report;

(b) Development of a Clubhouse Plan of Care as described in § 3910 of this chapter;

(c) Consideration of the member’s beliefs, values, and cultural norms in how, what, and by whom Clubhouse services are to be provided; and

(d) Consideration, screening, and assessment of the member for treatment via other appropriate evidence-based practices (EBP) offered through DBH MHRS providers.

3909.2 Court-appointed guardians for members, if applicable, shall be involved in the Plan of Care planning process. Family members and significant others of adult members may participate in the Plan of Care planning process to the extent that the adult member consents to the involvement of the family member and significant other.

3909.3 The Clubhouse Plan of Care shall be developed by the Clubhouse in accordance with the member’s existing MHRS Plan of Care for those members enrolled in a CSA and in cooperation with other specialty providers if applicable.

3909.4 The Clubhouse Plan of Care shall be developed by the Clubhouse for those members not enrolled in a CSA or other specialty provider.

History

SOURCE: Emergency and Proposed Rulemaking published at 57 DCR 4010 (May 7, 2010)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 57 DCR 7734 (August 20, 2010)[EXPIRED]; as amended by Final Rulemaking published at 57 DCR 8698, 8708 (September 24, 2010); as amended by Final Rulemaking published at 66 DCR 5638 (May 3, 2019); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3909

22-A DCMR § 3910 CLUBHOUSE PLAN OF CARE DEVELOPMENT

3910.1 Each Clubhouse Plan of Care shall:

Be person-centered:

Include the member’s self-identified recovery goals; and

Provide for the delivery of services in the most normative, least restrictive environment that is appropriate for the member.

3910.2 The approval of the initial Plan of Care, as demonstrated by the electronic signature and date stamp of an independently licensed qualified practitioner, shall occur within thirty (30) calendar days from when the provider obtains consent to treatment from the member.

3910.3 Each Clubhouse specialty provider shall develop and maintain a complete and current Plan of Care for each enrolled member.

3910.4 The Plan of Care shall include the following elements:

An overall broad, long-term goal statement(s) that captures the member’s short and long term goals for the future, ideally written from the member’s perspective;

A list or statement of individual and family strengths that support goal accomplishment, including abilities, talents, accomplishments, and resources;

A list or statement of barriers that pose obstacles to the member’s ability to accomplish the stated goal(s), including symptoms, functional impairments, lack of resources, consequences of substance use disorder and other challenges, which help to substantiate the medical necessity for treatment and recovery interventions;

Objective statements that identify the short-term changes in behavior, function or status that overcome the identified barriers and are building blocks toward the eventual accomplishment of the long-term goal(s) and describe outcomes that are measurable and include individualized target dates to be accomplished within the scope of the plan; and

Intervention statements that describe the Clubhouse opportunities and interventions intended to reduce or eliminate the barriers identified in the Plan of Care and support objective and eventual goal accomplishment, including natural support interventions and the non-billable supports delivered by resources outside of the formal behavioral health service-delivery system.

History

SOURCE: Emergency and Proposed Rulemaking published at 57 DCR 4010 (May 7, 2010)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 57 DCR 7734 (August 20, 2010)[EXPIRED]; as amended by Final Rulemaking published at 57 DCR 8698, 8708 (September 24, 2010); as amended by Final Rulemaking published at 66 DCR 5638 (May 3, 2019); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3910

22-A DCMR § 3911 CLUBHOUSE PLAN OF CARE IMPLEMENTATION

3911.1 Clubhouse assigned staff and the member shall discuss the Plan of Care on an ongoing basis. An encounter note describing the member’s response to, participation in and agreement to the Plan of Care shall be recorded in the member’s clinical record.

3911.2 In situations where the member does not demonstrate the capacity to sign or does not sign the Plan of Care, the reasons the member does not sign shall be recorded in the member’s clinical record, including each date when signature was attempted.

3911.3 An independently licensed qualified practitioner shall approve and sign the Plan of Care each time it is reviewed and updated.

3911.4 Documentation of participation of the member’s court-appointed guardian, family and significant others in the development of the Plan of Care shall also be included in the members's clinical record, as appropriate.

3911.5 Each Clubhouse provider shall develop policies and procedures for the Plan of Care review (Plan of Care Review Policy), which shall:

(a) Include procedures for reviewing each member’s Plan of Care and ensuring that the plan contains Goals, Objectives and Interventions designed to meet the Treatment Goals set forth in the Plan of Care with respect to the provision of Clubhouse services to the member; and

Require that the Plan of Care be reviewed and updated every one hundred eighty (180) days and at any time there is a significant change in the member’s condition or situation, which reflects progress toward or the lack of progress toward the treatment or recovery goals. The Plan of Care may be reviewed more frequently, as necessary, based on the member’s progress or circumstances.

In addition to the requirements of § 3907.4 of this chapter, each Clubhouse shall provide a copy of the Plan of Care for each member when updated to:

The member;

Legal guardian (if applicable); and

Anyone designated by the member.

History

SOURCE: Final Rulemaking published at 66 DCR 5638 (May 3, 2019); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3911

22-A DCMR § 3912 CLUBHOUSE STAFF TRAINING REQUIREMENTS

3912.1 A staff member shall receive training in accordance with the Clubhouse Standards before he or she may work independently with a member.

3912.2 A Clubhouse provider shall have a current written plan for staff development and organizational onboarding, which shall be approved by the Department, that reflects the training and performance improvement needs of all employees working in that Clubhouse. The plan shall address the steps the Clubhouse provider will take to ensure the recruitment and retention of highly qualified employees and the reinforcement of staff development through training, supervision, the performance management process, and activities such as shadowing, mentoring, skill testing and coaching. The plan shall include culturally competent training and onboarding activities in the following core areas:

The program’s approach to addressing psychosocial rehabilitation services, including philosophy, goals, and methods;

The staff member’s specific job description and role in relationship to other staff;

Emergency preparedness plan and all safety-related policies and procedures;

The proper documentation of services in individual member records, as applicable;

Policies and procedures governing infection control, protection against exposure to communicable diseases, and the use of universal precautions;

Laws and policies governing confidentiality of client information and release of information;

Laws and policies governing reporting abuse and neglect;

Consumer rights; and

(i) Other trainings deemed necessary and communicated by the Department.

History

SOURCE: Final Rulemaking published at 66 DCR 5638 (May 3, 2019). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3912

22-A DCMR § 3999 DEFINITIONS

3999.1 The definitions in § 3499 of this subtitle are incorporated by reference into and applicable to this chapter unless otherwise defined in § 3999.2.

3999.2 The following terms have the following meaning:

Clubhouse International – the international organization that establishes standards for the operation of accredited psychosocial rehabilitation Clubhouse services. Clubhouse International is responsible for evaluating and accrediting psychosocial rehabilitation clubhouse services.

Clubhouse Plan of Care – the plan developed to provide services to Clubhouse members in accordance with ICCD standards.

Clubhouse Standards – the International Standards for Clubhouse Programs established by Clubhouse International.

Core Services Agency or CSA – a Department-certified community-based MHRS provider that has entered into a Human Care Agreement with the Department to provide specified MHRS in accordance with the requirements of 22-A DCMR Chapter 34.

Consumer – an adult, children, or youth who seek or receive mental health services or mental health supports funded or regulated by the Department.

Crisis Plan – a written plan designed to describe behaviors and help prepare for a crisis before one happens.

Department or DBH – the Department of Behavioral Health, the successor in interest to the Department of Mental Health (DMH), established pursuant to the Department of Behavioral Health Establishment Act of 2013, effective December 24, 2013 (D.C. Law 20-61; D.C. Official Code § 7-1141.01 et seq.).

Member – a consumer who has joined a Psychosocial Rehabilitation Clubhouse.

Mental Health Rehabilitation Services or MHRS - mental health rehabilitative or palliative services provided by a Department-certified community mental health provider to consumers in accordance with the District of Columbia State Medicaid Plan, the MAA (now Department of Health Care Finance)/DMH (now Department of Behaviorial Health) Interagency Agreement, and this chapter.

Plan of Care – the individualized service plan for a person who is receiving MHRS.

Psychiatrist - a physician who has completed all training in a program in psychiatry accredited by the Accreditation Council for Graduate Medical Education, approved by the American Board of Psychiatry and Neurology, Inc., or who is board-certified in psychiatry. A Psychiatrist is a qualified practitioner.

Specialty services – ACT, CBI, Crisis/Emergency Services, Intensive Day Treatment, Psychosocial Rehabilitative Clubhouse, Rehabilitation Day Services, TF-CBT, TREM, and TST.

Work-Ordered Day – the structure of the day-to-day activity within a Clubhouse, organized to help members develop self-esteem, confidence and friendships, which make up the foundation of the recovery process. The general concept is that hours of operation mirror those of local businesses, and that the treatment comes with working alongside staff to jointly operate the Clubhouse.

History

SOURCE: Emergency and Proposed Rulemaking published at 57 DCR 4010 (May 7, 2010)[EXPIRED]; as amended by Emergency and Proposed Rulemaking published at 57 DCR 7734 (August 20, 2010)[EXPIRED]; as amended by Final Rulemaking published at 57 DCR 8698, 8710 (September 24, 2010); Final Rulemaking published at 66 DCR 5638 (May 3, 2019); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 3999

22-A44 MENTAL HEALTH GRANTS

22-A DCMR § 4400 GENERAL PROVISIONS

4400.1 This chapter establishes uniform requirements for transferring funds appropriated to the Department, or other things of value, to recipients outside of the District government, where the Department is authorized to make grants. Subgrants of federal funds by the Department to recipients outside of the District government shall comply with 1 DCMR, Chapter 50.

4400.2 The Director, or his or her designee, is authorized to make a grant where:

(a) A District statute authorizes the Department to support or stimulate the activity of the recipient;

(b) The Department will not be substantially involved in the activity so supported or stimulated; and

4400.3 The Department is authorized to make grants pursuant to the Department of Mental Health Establishment Amendment Act of 2001, effective December 18, 2001 (D.C. Law 14-56; D.C. Official Code §§ 7-1131.01 et seq.).

History

SOURCE: Final Rulemaking published at 54 DCR 11052 (November 16, 2007).

22-A DCMR § 4401 GRANT AVAILABILITY ANNOUNCEMENTS AND APPLICATIONS

4401.1 Except as provided in §§ 4401.3 and 4401.4, the availability of a Department grant shall be announced by one (1) of the following methods:

(a) Publication in a newspaper of general circulation in the District of Columbia;

(b) Publication in the District of Columbia Register; or

4401.2 Each grant availability announcement shall include the following:

(a) A brief description of the project for which funds may be available;

(b) The estimated total funds available;

(d) The deadline for submission of applications;

(e) The review factors to be used in selecting grant recipients;

(f) Source of funds and estimated time of funds availability;

(g) An address within the Department where detailed information may be obtained and where the application may be filed; and

(h) The time and place of a pre-application information session for prospective applicants if such a session would be useful.

4401.3 The Director may make a grant award on a sole source basis in appropriate circumstances. These circumstances include, but are not limited to, situations where:

(a) The authorizing legislation designates the grant recipient;

(b) The applicable District law defines eligibility in such a way that there is only one eligible applicant; or

(c) There is a recognized coalition of service providers through which the broadest community participation may be obtained in serving the targeted clientele.

4401.4 The Director may make a sole source award to an unsolicited proposal if:

(a) The applicant has a program or project that clearly furthers the purpose of the grant; and

(b) The proposal reflects proprietary skills or technology that are limited in availability.

4401.5 A sole source award shall not be subject to §§ 4402 and 4403.

History

SOURCE: Final Rulemaking published at 54 DCR 11052 (November 16, 2007).

22-A DCMR § 4402 APPLICATION REVIEW

4402.1 A review panel selected by the Department shall review each application to determine if it meets the requirements that apply to the particular grant.

4402.2 The review panel shall advise the Department Grant Officer and the Director of all those applications which satisfy the applicable grant requirements and shall recommend awards based on the review factors and available funding.

History

SOURCE: Final Rulemaking published at 54 DCR 11052 (November 16, 2007).

22-A DCMR § 4403 REVIEW FACTORS

4403.1 The recommendations of the review panel and the award decisions of the Director shall be based on the following criteria:

(a) Feasibility of the project;

(b) Soundness of research design, statistical technique, and procedures and methodology, if appropriate;

(1) The objectives of the proposed project are clearly defined and clearly stated;

(2) The proposed project activities appear likely to reach objectives;

(3) The proposed project would contribute to the achievement of the grant's stated policy objectives; and

(4) Provisions are made for adequate evaluation of the effectiveness of the project and for determining the extent to which the objectives are accomplished;

(d) Sufficiency of size, scope, and duration of the project to secure productive results;

(e) Expertise to perform the work, including past performance;

(f) Adequacy of resources;

(g) Reasonableness of estimated cost in relation to anticipated results; and

(h) Other factors as identified in writing by the Director prior to the award of the grant.

History

SOURCE: Final Rulemaking published at 54 DCR 11052 (November 16, 2007).

22-A DCMR § 4404 DISPOSITION OF PROPOSAL

4404.1 The Director shall make the final selection of the grant award.

4404.2 To ensure that the Department has followed the competitive process specified above, the Department Grant Officer shall review each proposed grant award before it can become final. The Grant Officer shall review:

(a) A list of proposed awards by grant number, name of organization, name of project, and award amount;

(b) A copy of the grant availability announcement issued pursuant to § 4401.1;

(d) Recommendations from the review process; and

(e) Justifications, if applicable, for awards not consistent with review panel's scores.

4404.3 In instances of proposed awards not based on competitive solicitation, the Grant Officer shall review only the name of the proposed grantee, name of the project, award amount, and justification for the absence of competition.

4404.4 The Grant Officer shall review the submitted documents within five (5) business days of submission. If the procedures have been followed and no other review is required, the Grant Officer shall recommend to the Director that the Department issue the grant(s).

4404.5 If a proposed award was not based on a competitive solicitation, the Grant Officer shall submit within five (5) business days the proposed award to the Department Fiscal Officer for review and approval prior to making a recommendation to the Director.

4404.6 Based on his or her review, the Director shall:

(a) Approve the application, in whole or in part, for such amount of funds and subject to such conditions as he or she considers necessary or desirable for the completion of the approved project;

(b) Disapprove the application; or

4404.7 The Grant Officer appointed by the Director shall notify the awardee in writing of the Director's decision.

4404.8 The Director's decision shall be final.

History

SOURCE: Final Rulemaking published at 54 DCR 11052 (November 16, 2007).

22-A DCMR § 4405 GRANT AGREEMENT

4405.1 Each grant award shall be in the form of a written grant agreement between the Director and the awardee that is consistent with those statutes and regulations that apply to the grant.

4405.2 The grant agreement shall include, but not be limited to, the following:

(a) A statement of the purpose of the grant;

(b) The amount of the grant award;

(d) Reference to provisions of statutes, rules, and regulations (including provisions of this chapter) particularly applicable to the grantee, as well as a statement that the grantee shall comply with all applicable federal and District laws and regulations;

(e) The scope of work for the grant, a description of any service or products required to be delivered under the grant, and a schedule of expected performance;

(f) Reporting requirements, both program and financial;

(g) A payment schedule;

(h) The name, address and telephone number of the Grant Officer in the Department, and of the agent for the grantee;

(i) The address to which all written communications from the Department to the grantee may be sent, including periodic payments due under the grant; and

(j) A provision that the grant may be modified by agreement of both parties.

History

SOURCE: Final Rulemaking published at 54 DCR 11052 (November 16, 2007).

22-A DCMR § 4406 CERTIFICATION OF A DRUG-FREE WORKPLACE

4406.1 By submission of its application, the grantee, if other than an individual, certifies

and agrees that with respect to all its employees under the grant it shall, no later than thirty (30) calendar days after grant award (unless a longer period is agreed to in writing), for a grant of thirty (30) calendar days or more performance duration; or as soon as possible for a grant of less than thirty (30) calendar days performance duration, but in any case, by a date prior to when the performance is expected to be completed:

(a) Publish a statement notifying such employees that the unlawful manufacture, distribution, dispensing, possession or use of a controlled substance is prohibited in the grantee's workplace and specifying the actions that will be taken against employees for violations of such prohibition;

(b) Establish a drug-free awareness program to inform such employees about the following:

(1) The dangers of drug abuse in the workplace;

(2) The grantee's policy of maintaining a drug-free workplace;

(3) Any available drug counseling, rehabilitation and employee assistance programs; and

(4) The penalties that may be imposed upon employees for drug abuse violations occurring in the workplace;

(c) Provide all employees engaged in performance of the grant with a copy of the statement required in paragraph (a) of this provision;

(d) Notify such employees in the statement required by paragraph (a) of this provision that as a condition of continued employment on the grant resulting from this solicitation, the employee shall do the following:

(1) Abide by the terms of this statement; and

(2) Notify the employer of any criminal drug statute conviction for a violation occurring in the workplace no later than five (5) calendar days after notice of such conviction;

(e) Notify the Grant Officer in writing within ten (10) days after receiving notice under paragraph (d) (2) of this provision, from an employee or otherwise receiving actual notice of such conviction;

(f) Within thirty (30) calendar days after receiving notice under paragraph (d) of this provision of a conviction, take one (1) of the following actions with respect to any employee who is convicted of drug abuse violations occurring in the workplace:

(1) Take appropriate personnel action against such employee up to and including termination; or

(2) Require such employee to satisfactorily participate in a drug abuse assistance or rehabilitation program approved for such purposes by the federal, State, or local health, law enforcement, or other appropriate agency; and

(g) Make a good faith effort to maintain a drug-free workplace through implementation of paragraphs (a) through (f) of this section.

4406.2 By submission of its application, the grantee, if an individual who is applying for a grant of any dollar value, certifies and agrees not to engage in the unlawful manufacture, distribution, dispensing, possession or use of a controlled substance in the performance of the grant.

4406.3 The grantee's failure to comply with the requirements of §§ 4406.1 and 4406.2 may, pursuant to § 4413, render the grantee subject to suspension of grant payments, termination of the grant or other available legal remedies.

History

SOURCE: Final Rulemaking published at 54 DCR 11052 (November 16, 2007).

22-A DCMR § 4407 FINANCIAL MANAGEMENT BY GRANTEES

4407.1 Each grantee shall make accurate, current, and complete disclosure of the financial results of each project or program in accordance with the financial reporting requirements of the grant agreement.

4407.2 Each grantee shall maintain records which identify adequately the source and application of funds for grant supported activities.

4407.3 The grantee's records shall contain information identifying the following:

(a) Grant awards;

(b) Any subgrant award made by the Grantee, if authorized by the grant agreement;

(d) Obligations;

(e) Unobligated balances;

(f) Assets;

(g) Outlays; and

(h) Income.

4407.4 Each grantee shall maintain effective control and accountability for all grant or subgrant assets, including cash and real personal property.

4407.5 Each grantee shall adequately safeguard all property and shall assure that it is used solely for authorized purposes.

4407.6 Each grantee's records shall compare the actual and budgeted amounts of expenditures for each grant or subgrant.

4407.7 If required by the grant officer, the grantee shall relate financial information to performance or productivity data, including the production of unit cost information.

4407.8 The grantee shall establish procedures to minimize the time elapsing between the advance of District grant funds and their disbursement by the grantee.

4407.9 Grantees advancing cash to subgrantees shall conform substantially to the same standards of timing and amount of advances as apply to advances by the District to grantees, including requirements for timely reporting of cash disbursements and balances.

4407.10 Each grantee shall establish procedures for determining the reasonableness, allowability, and allocability of costs in accordance with the applicable cost principles prescribed in OMB Circular A-122.

4407.11 Grantee accounting records shall be supported by source documentation such as canceled checks, paid bills, payrolls, contract, and subgrant award documents.

4407.12 Each grantee shall follow a systematic method to assure timely and appropriate resolution of audit findings and recommendations.

History

SOURCE: Final Rulemaking published at 54 DCR 11052 (November 16, 2007).

22-A DCMR § 4408 MONITORING BY GRANTEES

4408.1 Each grantee shall monitor grant and subgrant supported activities by reviewing each program, function or activity to assure that adequate progress is being made towards achieving the goals of the grant or subgrant.

4408.2 Each grantee shall submit an annual performance report unless the grant agreement requires more frequent reports.

4408.3 The grantee's final performance report shall be due ninety (90) days after the expiration or termination of grant support.

4408.4 The Grant Officer may waive the requirement for any performance report which is not needed, except the final report.

4408.5 The content of performance reports shall conform to any instructions issued by the Grant Officer including, to the extent appropriate to the particular grant, a brief presentation of the following for each program, function, or activity involved:

(a) A comparison of actual accomplishments to the goals established for the period;

(b) A statement of reasons if established goals are not being met;

(d) Any other pertinent information.

History

SOURCE: Final Rulemaking published at 54 DCR 11052 (November 16, 2007).

22-A DCMR § 4409 AUDITS AND DISALLOWANCES

4409.1 Appropriate District or federal personnel may conduct fiscal and program audits of the grantee.

4409.2 Each grantee shall have an annual audit performed by an auditor who is independent of the staff person who authorizes expenditure of project funds.

4409.3 Whenever an audit shows that an expenditure not allowable under the grant has been charged to the grant or that the grantee has otherwise failed to discharge its obligation to account for the expenditure of grant funds, the Grant Officer shall disallow the expenditure of the funds.

History

SOURCE: Final Rulemaking published at 54 DCR 11052 (November 16, 2007).

22-A DCMR § 4410 PAYMENT OF FUNDS BY GRANTEE

4410.1 As a condition of each grant awarded, the grantee shall agree to do the following:

(a) Repay the District for final audit disallowances within thirty (30) days from receipt of notification by a disallowance letter; and

(b) Pay interest at the most recent rate prescribed by the U.S. Department of the Treasury from the date of the disallowance letter if the repayment is not complete within the thirty (30) day period.

4410.2 A grantee may request informal dispute resolution of any disallowance determination by a Grant Officer by requesting, within thirty (30) days of the date of the disallowance notification letter, that the Director conduct a review.

4410.3 If the Director sustains the finding of the Grant Officer, interest shall be charged on the amount to be repaid as of the date of the disallowance letter.

History

SOURCE: Final Rulemaking published at 54 DCR 11052 (November 16, 2007).

22-A DCMR § 4411 CLOSE-OUT

4411.1 The Grant Officer shall close-out the grant when he or she determines that all applicable administrative actions and all required work of the grant have been completed.

4411.2 Upon termination or close-out of the grant, the Grant Officer shall promptly provide an accounting of the funds expended, obligated, and remaining under the grant to the Department fiscal officer.

4411.3 Within ninety (90) days after expiration or termination of the grant, the grantee shall submit all financial, performance, and other reports required as a condition of the grant. The Grant Officer may extend this deadline upon request of the grantee.

4411.4 The District shall make prompt payment to the grantee for allowable reimbursable costs.

4411.5 The grantee shall immediately refund to the District any balance of unobligated cash advanced that is not authorized to be retained for use on other grants.

4411.6 The close-out of a grant shall not affect the following:

(a) The Grant Officer's authority to disallow costs and recover funds on the basis of a later audit or other review;

(b) The grantee's obligation to return any funds due as a result of later refunds, correction or other transactions; or

History

SOURCE: Final Rulemaking published at 54 DCR 11052 (November 16, 2007).

22-A DCMR § 4412 RECORD RETENTION AND ACCESS

4412.1 The grantee shall retain all records for a period of at least three (3) years following final close-out of the grant, if no other period is specified in the grant agreement.

4412.2 The grantee shall make all records available to the Director for audit by the Grant Officer, other District officials, and federal officials as necessary.

History

SOURCE: Final Rulemaking published at 54 DCR 11052 (November 16, 2007).

22-A DCMR § 4413 TERMINATION AND SUSPENSION PROCEDURES

4413.1 If a grantee has materially failed to comply with the terms of a grant agreement, the Grant Officer may, after giving reasonable written notice to the grantee, do the following:

(a) Suspend the grant in whole or in part;

(b) Terminate the grant for cause; or

4413.2 The notice of suspension shall state the reasons for the suspension, any corrective action required of the grantee, and the effective date.

4413.3 The suspension may be made effective at once if a delayed effective date would be unreasonable considering the Grant Officer's responsibilities to protect the District government's interest.

4413.4 The Grant Officer may reinstate a suspended grant if the grantee has taken corrective action satisfactory to the Grant Officer, or given satisfactory evidence that corrective action will be taken.

4413.5 The Grant Officer may terminate the grant before the date of expiration if:

(a) The grantee has materially failed to comply with the terms of the grant agreement and appropriate corrective actions have not been taken during the period of suspension; or

(b) The failure to comply with the terms of the grant agreement is so serious that immediate termination is in the best interest of the District government.

4413.6 The notice of termination shall state, in writing, the reasons for the termination, together with the effective date.

4413.7 A grant may be terminated at the request of the grantee upon notification to the Grant Officer, in accordance with the provisions of the grant.

History

SOURCE: Final Rulemaking published at 54 DCR 11052 (November 16, 2007).

22-A DCMR § 4414 INFORMAL DISPUTE RESOLUTION

4414.1 The provisions contained in this section and in § 4415 shall establish an informal procedure for resolution of disputes between the grantee and the Director.

4414.2 The procedure shall apply to the following adverse determinations made by the Grant Officer:

(a) Suspension or termination of a grant in whole or in part or a refusal to reinstate a suspended grant;

(b) A disallowance of expenditures; and

(c) A denial of a noncompeting continuation of a grant award if the denial is for failure to comply with the terms of the award.

4414.3 The Grant Officer shall notify the grantee, in writing, of any adverse determination, state the reasons for the determination in sufficient detail to enable the grantee to respond, and give the grantee notice that the grantee may request a review of the adverse determination.

4414.4 A grantee may request a review of the adverse determination by submitting a written request for review to the Director no later than thirty (30) days after receipt of the notice of determination.

4414.5 The grantee's request for a review of the adverse determination shall include the following:

(a) A copy of the Grant Officer's determination;

(b) Identification of the issue in dispute;

(c) A full statement of the grantee's position regarding the issue in dispute and the pertinent facts and reasons in support of the grantee's position; and

(d) Copies of any documents supporting the grantee's claim.

4414.6 If the grantee submits a request for review, the Director shall conduct an informal hearing in accordance with the requirements of this section or he or she shall appoint a hearing officer to conduct the hearing.

4414.7 The Director shall send by certified mail a written notice to the grantee of the time and place scheduled for the informal hearing within fifteen (15) calendar days from the receipt of the grantee's request to the Department for a hearing.

4414.8 The grantee may be accompanied or represented at the informal hearing by legal counsel or other person chosen by the grantee.

4414.9 If a hearing officer conducts the hearing, he or she shall render a written recommendation to the Director regarding whether to sustain or overrule the adverse determination of the Grant Officer.

History

SOURCE: Final Rulemaking published at 54 DCR 11052 (November 16, 2007).

22-A DCMR § 4415 DECISION OF THE DIRECTOR

4415.1 The Director may require informal, non-binding mediation between the parties before issuing a final decision if, due to the nature of the dispute, the Director considers it to be in the best interests of the District.

4415.2 The Director shall appoint one (1) or more individuals who have not participated substantially in the matter in dispute to conduct the mediation described in subsection 4415.1.

4415.3 The Director shall make a final written decision based upon the grant file, other documents filed by the parties, and the testimony and evidence presented at the hearing in accordance with applicable laws and regulations.

4415.4 The final decision of the Director shall include the following:

(a) A description of the dispute;

(b) Reference to the pertinent grant terms, regulations or statutes;

(d) A determination sustaining or overruling the determination of the Grant Officer, in whole or in part, with the reason for the determination; and

(e) If all or any part of the Grant Officer's determination has been determined to be valid, a determination of any monetary settlement, the grant adjustment to be made, or other relief to be granted.

4415.5 The Director shall deliver or send by certified mail, a copy of the final decision to the grantee, and shall provide a copy to the Grant Officer for inclusion in the grant file.

History

SOURCE: Final Rulemaking published at 54 DCR 11052 (November 16, 2007).

22-A DCMR § 4499 DEFINITIONS

4499.1 When used in this chapter, the following terms shall have the meanings ascribed: Controlled Substance - a controlled substance in schedules I through V or Section 202 of the Controlled Substances Act (21 U.S.C. § 812) and as further defined, in regulation, at 21 CFR §§ 1308.11-1308.15.

Conviction - a finding of guilt (including a plea of nolo contendere) or imposition of sentence, or both, by any judicial body charged with the responsibility to determine violations of federal, state or District criminal drug statutes (criminal statute involving the manufacture, distribution, dispensing, possession or use of any controlled substance).

Department - the D.C. Department of Mental Health.

Director - the Director of the D.C. Department of Mental Health.

Drug-free Workplace - a site for the performance of work done in connection with a specific grant at which employees of the grantee are prohibited from engaging in the unlawful manufacture, distribution, dispensing, possession, or use of a controlled substance.

Employee - an employee of a grantee directly engaged in the performance of work under a District government grant.

Grantee - the recipient of a grant from the District government.

Grant Officer - an employee of the Department of Mental Health designated by the Director to manage the specified grant program in accordance with these regulations.

Individual - a grantee that has no more than one (1) employee including the grantee.

History

SOURCE: Final Rulemaking published at 54 DCR 11052 (November 16, 2007).

22-A51 [REPEALED]

22-A DCMR § 5100 [REPEALED]

History

SOURCE: Final Rulemaking published at 57 DCR 9477 (October 8, 2010); as amended by Final Rulemaking published at 60 DCR 6666 (May 10, 2013); as amended by Final Rulemaking published at 67 DCR 10775 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 5100

22-A DCMR § 5101 [REPEALED]

History

SOURCE: Final Rulemaking published at 57 DCR 9477, 9478 (October 8, 2010); as amended by Final Rulemaking published at 60 DCR 6666 (May 10, 2013); as amended by Final Rulemaking published at 61 DCR 6197 (June 20, 2014); as amended by Final Rulemaking published at 67 DCR 10775 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 5101

22-A DCMR § 5102 [REPEALED]

History

SOURCE: Final Rulemaking published at 57 DCR 9477, 9478 (October 8, 2010); as amended by Final Rulemaking published at 60 DCR 6666 (May 10, 2013); as amended by Final Rulemaking published at 67 DCR 10775 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 5102

22-A DCMR § 5103 [REPEALED]

History

SOURCE: Final Rulemaking published at 57 DCR 9477, 9478 (October 8, 2010); as amended by Final Rulemaking published at 60 DCR 6666 (May 10, 2013); as amended by Final Rulemaking published at 67 DCR 10775 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 5103

22-A DCMR § 5104 [REPEALED]

History

SOURCE: Final Rulemaking published at 57 DCR 9477, 9478 (October 8, 2010); as amended by Final Rulemaking published at 60 DCR 6666 (May 10, 2013); as amended by Final Rulemaking published at 67 DCR 10775 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 5104

22-A DCMR § 5199 [REPEALED]

History

SOURCE: Final Rulemaking published at 57 DCR 9477, 9478 (October 8, 2010); as amended by Final Rulemaking published at 60 DCR 6666 (May 10, 2013); as amended by Final Rulemaking published at 67 DCR 10775 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 5199

22-A52 COMMUNITY-BASED INTERVENTION LEVEL IV - FUNCTIONAL FAMILY THERAPY - REIMBURSEMENT

22-A DCMR § 5200 FUNCTIONAL FAMILY THERAPY REIMBURSEMENT

5200.1 The Department of Health Care Finance has published rates for Medicaid-funded services under Title 22-A District of Columbia Municipal Regulations (DCMR) Chapter 34. Those rates are contained in the District of Columbia Medicaid fee schedule available online at www.dc-medicaid.com. The Department of Behavioral Health (Department) shall reimburse providers for Functional Family Therapy (FFT) services provided to non-Medicaid beneficiaries at the same rates as those contained in the District of Columbia Medicaid fee schedule.

5200.2 Reimbursement for the local-only FFT services are set forth in the table at subsection 5200.3. The Department shall update the FFT rate to reflect any future changes by publishing a Public Notice in the District of Columbia Register and providing an opportunity for meaningful comment before implementation. The Notice shall describe the type of change, the reason for the change, the effective date of the change, and the new local only reimbursement rate.

5200.3 The Functional Family Therapy rate is as set forth below:

SERVICE

CODE

RATE

UNIT

FFT

H2033HU

$51.96

15 minutes

5200.4 All updates to the service codes and rates will be included in the District of Columbia Medicaid fee schedule pursuant to the procedures established in Title 29 DCMR Section 988, by providing notice and an opportunity for comment.

History

SOURCE: Final Rulemaking published at 61 DCR 3787 (April 11, 2014); as amended by Final Rulemaking published at 70 DCR 003050 (March 10, 2023); as corrected by Errata Notice published at 71 DCR 004474 (April 19, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 5200

22-A DCMR § 5201 REIMBURSEMENT RATE

5201.1 The Community-Based Intervention Level IV – Functional Family Therapy rate is as set forth below:

SERVICE

CODE

RATE

UNIT

CBI Level IV - FFT

H2033HU

$57.42

15 minutes

History

Source: Notice of Emergency and Proposed Rulemaking published at 57 DCR 10226, 10227 (October 29, 2010)[EXPIRED]; Notice of Final Rulemaking published at 57 DCR 11960 (December 17, 2010).

22-A DCMR § 5202 ELIGIBILITY

5202.1 Only a qualified Mental Health Rehabilitation Services (MHRS) provider who has a Human Care Agreement (HCA) with the Department, and is certified by the Department to provide CBI Level IV – FFT services, that has incurred expenses eligible for reimbursement in accordance with the requirements of Chapter 34 of this Title may bill the Department under this chapter.

History

Source: Notice of Emergency and Proposed Rulemaking published at 57 DCR 10226, 10227 (October 29, 2010)[EXPIRED]; Notice of Final Rulemaking published at 57 DCR 11960, 11961 (December 17, 2010).

22-A DCMR § 5203 SUBMISSION OF CLAIM; PAYMENT OF VOUCHER

5203.1 The FFT provider shall submit all FFT claims pursuant to this chapter and the terms of the HCA between the Department and the FFT provider.

5203.2 The FFT provider shall submit appropriate documentation to support all claims under its HCA with the Department.

5203.3 The Department will reimburse an FFT provider for a claim that is determined by the Department to be eligible for reimbursement pursuant to the terms of the HCA between the Department and the provider, subject to the availability of appropriated funds.

History

Source: Notice of Emergency and Proposed Rulemaking published at 57 DCR 10226, 10227 (October 29, 2010)[EXPIRED]; Notice of Final Rulemaking published at 57 DCR 11960, 11961 (December 17, 2010).

22-A DCMR § 5204 AUDITS

5204.1 An FFT provider shall, upon the request of the Department, cooperate in any audit or investigation concerning the FFT program and FFT claims.

History

Source: Notice of Emergency and Proposed Rulemaking published at 57 DCR 10226, 10227 (October 29, 2010)[EXPIRED]; Notice of Final Rulemaking published at 57 DCR 11960, 11961 (December 17, 2010).

22-A DCMR § 5299 DEFINITIONS

5299.1 When used in this chapter, the following terms shall have the meanings ascribed:

Functional Family Therapy (FFT) – an evidence-based proprietary therapeutic service for children, youth and their families to prevent children and youth who are already involved or youth at risk of juvenile justice system involvement from further penetrating the system. FFT is a trademarked therapeutic service that requires accreditation from FFT Inc.

Functional Family Therapy Provider – a Mental Health Rehabilitation Service (MHRS) provider that is certified by the Department to provide FFT.

History

Source: Notice of Emergency and Proposed Rulemaking published at 57 DCR 10226, 10227 (October 29, 2010)[EXPIRED]; Notice of Final Rulemaking published at 57 DCR 11960, 11961 (December 17, 2010).

22-A53 TREATMENT PLANNING SERVICES PROVIDED TO DEPARTMENT OF BEHAVIORAL HEALTH CONSUMERS IN INSTITUTIONAL SETTINGS - DESCRIPTION AND REIMBURSEMENT

22-A DCMR § 5300 PURPOSE

5300.1 This chapter establishes the reimbursement rates for the treatment planning and supportive treatment services provided by certified Mental Health Rehabilitation Services (MHRS) providers to Department of Behavioral Health (Department) consumers while the consumer is in an institutional setting. Establishment of these reimbursement rates will allow the Department to reimburse providers using non-Medicaid local funds for continuity of care services, discharge treatment planning and transitional services while the consumer is in an institutional setting.

5300.2 Institutional settings in which these services shall be provided and may be reimbursed pursuant to this rule include: an Institute for Mental Disease (IMD); a hospital; a nursing facility (nursing home or skilled nursing facility); a rehabilitation center; a Psychiatric Residential Treatment Facility (PRTF); a Residential Treatment Center (RTC); or a correctional facility for defendants or juveniles.

5300.3 Nothing in this chapter grants to an MHRS provider the right to reimbursement for costs of providing services to a consumer in an institutional setting. Eligibility for reimbursement for these services provided by an MHRS provider to a consumer in one of the institutional settings listed in Subsection 5300.2 is determined solely by the Human Care Agreement (HCA) contract between the Department and the MHRS provider and is subject to the availability of appropriated funds. Claims for reimbursement pursuant to this chapter must be submitted in accordance with the Department billing policy.

History

SOURCE: Final Rulemaking published at 61 DCR 3787 (April 11, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 5300

22-A DCMR § 5301 DESCRIPTION OF REIMBURSABLE SERVICES

5301.1 Reimbursable “Mental Health Service – Continuity of Care Treatment Planning, Institution” services (MHS-CTPI) are services to assist consumers in institutional settings. MHS-CTPI is to be used for any mental health service not for discharge treatment planning or Rehab/Day purposes provided by an MHRS provider to any consumer, including those enrolled in Assertive Community Treatment (ACT) or Community-Based Intervention (CBI) services, in an institutional setting.

5301.2 In order to be eligible for reimbursement, MHS-CTPI shall only be provided by an MHRS provider through a mental health professional or credentialed worker to a Department consumer who is in an institutional setting listed in Subsection 5300.2.

5301.3 Mental Health Service – Discharge Treatment Planning, Institution (MHS - DTPI) is a service to develop a mental health service plan for treating a consumer after discharge from an institutional setting. It includes modifying goals, assessing progress, planning transitions, and addressing other needs, as appropriate.

5301.4 In order to be eligible for reimbursement, MHS-DTPI shall only be provided by an MHRS provider through a mental health professional or credentialed worker to a Department consumer who is in an institutional setting who is not enrolled in Assertive Community Treatment (ACT) or Community-Based Intervention (CBI).

5301.5 In order to be eligible for reimbursement, MHS-DTPI (ACT) shall be provided only by a member of an MHRS Assertive Community Treatment (ACT) team to a consumer who is enrolled in ACT services and preparing for discharge from the institution setting.

5301.6 In order to be eligible for reimbursement, MHS-DTPI (CBI) shall be provided only by a member of an MHRS Community-Based Intervention (CBI) Team, all levels, to a child or youth who is enrolled in CBI and preparing for discharge from the institutional setting.

5301.7 Community Psychiatric Supportive Treatment Program – Rehab/Day Services (CPS-Rehab/Day) is a day treatment program provided in the community designed to acclimate the consumer to community living.

5301.8 In order to be eligible for reimbursement, CPS-Rehab/Day Services shall only be provided by a certified MHRS Rehabilitation/Day Services provider.

5301.9 All services must be provided in accordance with Department policies regarding care to consumers to be eligible for reimbursement.

History

SOURCE: Final Rulemaking published at 61 DCR 3787 (April 11, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 5301

22-A DCMR § 5302 REIMBURSEMENT RATE

5302.1 The rates for reimbursement are as set forth below:

CODE

SERVICE

RATE

UNIT

UNITS AUTHORIZED

H0032HK

Mental Health Service – Continuity of Care Treatment Planning, Institution for all MHRS consumers (MHS-CTPI)

$21.97

15 minutes

Up to 24 units within 180 days without prior authorization for continuity of care services

H0032

Mental Health Service – Discharge Treatment Planning, Institution for all consumers except those in ACT or CBI (MHS-DTPI)

$21.97

15 minutes

Based on medical necessity at time of authorization, for discharge planning.

H0046HT

Mental Health Service – Discharge Treatment Planning, Institution -ACT consumers (MHS-DTPI(ACT))

$38.04

15 minutes

Based on medical necessity at time of authorization for discharge planning.

H0046HTHA

Mental Health Service – Discharge Treatment Planning, Institution – CBI consumers (MHS-DTPI (CBI))

$35.74

15 minutes

Based on medical necessity at time of authorization for discharge planning.

H0037

Community Psychiatric Supportive Treatment Program – Rehab/Day Services (CPS – Rehab/Day)

$123.05

Per day, at least 3 hours

Based on medical necessity at time of authorization; only within sixty (60) days of discharge unless pursuant to court order.

History

SOURCE: Final Rulemaking published at 61 DCR 3787 (April 11, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 5302

22-A DCMR § 5303 ELIGIBILITY

5303.1 Only a certified MHRS provider with an HCA that has provided one of these identified services to a Department consumer may be reimbursed for services billed to the Department under this chapter.

5303.2 Reimbursement for MHS-CTPI requires prior authorization from the Department after 24 units billed within 180 days.

5303.3 Reimbursement for MHS-DTPI, MHS-DTPI (ACT), MHS-DTPI (CBI) and CPS-Rehab/Day requires prior authorization from the Department.

History

SOURCE: Final Rulemaking published at 61 DCR 3787 (April 11, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 5303

22-A DCMR § 5304 SUBMISSION OF CLAIM

5304.1 In order for claims to be eligible for reimbursement, the MHRS provider shall:

Submit claims through the Department’s electronic billing system pursuant to this chapter, the Department billing policy, and the terms of the HCA between the Department and the MHRS provider; and

Complete appropriate documentation to support all claims under its HCA with the Department and shall retain such documentation for a minimum of six (6) years or longer if necessary to ensure the completion of any audit.

5304.2 The Department will reimburse an MHRS provider for a claim that is determined by the Department to be eligible for reimbursement pursuant to the terms of this chapter, applicable Department policies, and the HCA between the Department and the MHRS provider, subject to the availability of appropriated funds.

History

SOURCE: Final Rulemaking published at 61 DCR 3787 (April 11, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 5304

22-A DCMR § 5305 AUDITS

5305.1 An MHRS provider shall, upon the request of the Department, cooperate in any audit or investigation concerning claims for the provision of these services. Failure to cooperate or to provide the necessary information and documentation shall result in recoupment of the reimbursement and may result in other actions available to the Department pursuant to applicable policies and the HCA.

History

SOURCE: Final Rulemaking published at 61 DCR 3787 (April 11, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 5305

22-A DCMR § 5399 DEFINITIONS

5399.1 When used in this chapter, the following terms shall have the meaning ascribed:

Assertive Community Treatment or “ACT” - Intensive, integrated rehabilitative, crisis, treatment, and mental health rehabilitative community support provided by an interdisciplinary team to adults with serious and persistent mental illness by an interdisciplinary team. ACT is provided with dedicated staff time and specific staff to consumer ratios. Service coverage by the ACT team is required twenty-four (24) hours per day, seven (7) days per week. ACT is a specialty service.

Consumer - Adult, child, or youth who seeks or receives mental health services or mental health supports funded or regulated by the Department.

Community-Based Intervention or “CBI” - Time-limited, intensive mental health services delivered to children and youth ages six (6) through twenty-one (21) and intended to prevent the utilization of an out-of-home therapeutic resource or a detention of the consumer. CBI is primarily focused on the development of consumer skills to promote behavior change in the child or youth's natural environment and empower the child or youth to cope with his or her emotional disturbance.

Continuity of Care services – Coordination of services towards the stability of consumer-provider relationships over time.

Correctional facility - A prison, jail, reformatory, work farm, detention center, or any similar facility maintained by either federal, state or local authorities for the purpose of confinement or rehabilitation of adult or juvenile criminal offenders or suspected offenders.

Hospital - A facility equipped and qualified to provide inpatient care and treatment for a person with a physical or mental illness by, or under, the supervision of physicians to patients admitted for a variety of medical conditions.

Institute for Mental Disease or “IMD” - A hospital, nursing facility, or other institution with more than 16 beds which is primarily engaged in providing diagnosis, treatment or care of persons with mental illnesses, including medical attention, nursing care and related services.

Mental Health Rehabilitation Services or “MHRS” - Mental health rehabilitative or palliative services provided by a Department-certified community mental health provider to consumers in accordance with the District of Columbia State Medicaid Plan, the provider’s Human Care Agreement with the Department, and Chapter 34 of this title.

MHRS provider - An organization certified by the Department to provide MHRS. MHRS provider includes CSAs, sub-providers, and specialty providers.

Nursing facility - A facility that primarily provides to residents skilled nursing care and related services for the rehabilitation of injured, disabled or sick persons, or on a regular basis, health-related care services above the level of custodial care to other than individuals with developmental disabilities.

Psychiatric Residential Treatment Facility or “PRTF” - A psychiatric facility that (1) is not a hospital and (2) is accredited by the Joint Commission on Accreditation of Healthcare Organizations, the Commission on Accreditation of Rehabilitation Facilities, the Council on Accreditation of Services for Families and Children, or by any other accrediting organization with comparable standards that is recognized by the state in which it is located and (3) provides inpatient psychiatric services for individuals under the age of twenty-two (22) and meets the requirements set forth in §§ 441.151 through 441.182 of Title 42 of the Code of Federal Regulations, and is enrolled by the District of Columbia Department of Health Care Finance (DHCF) to participate in the Medicaid program.

Rehabilitation facility – An inpatient facility that provides comprehensive rehabilitation services under the supervision of a physician to inpatients with physical disabilities. Services include physical therapy, occupational therapy, speech pathology, social or psychological services, and orthotics or prosthetics services.

Residential Treatment Center or “RTC” - A facility which houses youth with significant psychiatric or substance abuse problems who have proven to be too ill or have such significant behavioral challenges that they cannot be housed in foster care, day treatment programs, and other nonsecure environments but who do not yet merit commitment to a psychiatric hospital or secure correctional facility.

History

SOURCE: Final Rulemaking published at 61 DCR 3787 (April 11, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 5399

22-A54 PRIVATE HOSPITAL PROBABLE CAUSE HEARING - REIMBURSEMENT

22-A DCMR § 5400 PURPOSE

5400.1 This chapter establishes the reimbursement rate for private hospitals in the District of Columbia which, pursuant to a contract with the Department of Mental Health (Department), accept patients who are involuntarily hospitalized pursuant to D.C. Official Code § 21-524 and as a result may have a probable cause hearing at the D.C. Superior Court, which in turn will require the hospital to safely transport the patient from the hospital to the hearing and back, and also provide expert testimony for the hearing.

5400.2 Nothing in this chapter grants to a private hospital the right to reimbursement for costs of supporting a patient’s probable cause hearing. Eligibility for reimbursement for a probable cause hearing is determined solely by the contract between the Department and the private hospital, and is subject to the availability of appropriated funds.

History

SOURCE: Final Rulemaking published at 60 DCR 2166 (February 22, 2013).

22-A DCMR § 5401 REIMBURSEMENT RATE

5401.1 The Private Hospital Probable Cause Hearing Rate is as set forth below:

SERVICE

RATE

UNIT

Probable Cause Hearing

$650.00

Per Event

5401.2 The Department shall not provide any other reimbursement for any cost incurred by a private hospital with a contract with the Department beyond the event rate cited in this rule.

History

SOURCE: Final Rulemaking published at 60 DCR 2166 (February 22, 2013).

22-A DCMR § 5402 ELIGIBILITY

5402.1 Only a private hospital located in the District of Columbia who has entered into a contract with the Department to accept involuntary patients authorized by the Department for hospitalization may incur expenses eligible for reimbursement in accordance with its contract with the Department and may bill the Department under this chapter.

5402.2 A private hospital submitting a claim under this chapter may only submit claims for probable cause hearings that have actually occurred; that is, the hearing was called by a judge or magistrate judge of the D.C. Superior Court and the patient and expert witness from the hospital were present and prepared to proceed.

5402.3 The private hospital must comply with all contractual requirements in order to submit a claim for a probable cause hearing, including but not limited to the following:

Ensuring the safe and timely transport of the patient to the D.C. Superior Court or to whatever location the court has determined the hearing is to be held, and safe transport of the patient in returning to the hospital, unless there is a finding at the hearing of no probable cause and the patient elects not to return to the hospital;

Ensuring the patient’s attending psychiatrist, qualified psychologist, or other expert witness, as determined by the Office of the Attorney General (OAG), cooperates with the representative from the OAG who will be representing the Department for the probable cause hearing to prepare for the hearing. Such preparation may include reviewing and providing copies of records, answering questions, communicating with other individuals involved in the care and treatment of the patient while he or she was in the community, and discussing testimony; and

Ensuring the patient’s attending psychiatrist, qualified psychologist, or other expert witness, as determined by the Office of the Attorney General (OAG), is present for the probable cause hearing at the time the hearing is called by the court; that the witness has the original treatment records present when giving testimony at the hearing; and that the witness remains for the hearing until released by the court or the representative from the Office of the Attorney General.

History

SOURCE: Final Rulemaking published at 60 DCR 2166 (February 22, 2013).

22-A DCMR § 5403 SUBMISSION OF CLAIM; PAYMENT OF VOUCHER

5403.1 The private hospital shall submit all claims for probable cause hearings by invoice, pursuant to this chapter and the terms of the contract between the Department and the private hospital.

5403.2 The private hospital shall submit appropriate documentation to support all claims under its contract with the Department.

5403.3 The Department will reimburse a private hospital for a probable cause hearing claim that is determined by the Department to be eligible for reimbursement pursuant to the terms of the contract between the Department and the private hospital, and the rules of this chapter, subject to the availability of appropriated funds.

History

SOURCE: Final Rulemaking published at 60 DCR 2166 (February 22, 2013).

22-A DCMR § 5404 AUDITS

5404.1 A private hospital shall, upon the request of the Department, cooperate in any audit or investigation concerning the claims for a probable cause hearing.

History

SOURCE: Final Rulemaking published at 60 DCR 2166 (February 22, 2013).

22-A DCMR § 5499 DEFINITIONS

5499.1 When used in this chapter, the following terms shall have the meaning ascribed:

Private hospital – a nongovernmental hospital or institution, or part thereof, in the District of Columbia, equipped and qualified to provide inpatient care and treatment for a person with a physical or mental illness.

Probable cause hearing – a judicial proceeding in the D.C. Superior Court pursuant to D.C. Official Code § 21-525 (2008 Repl.).

History

SOURCE: Final Rulemaking published at 60 DCR 2166 (February 22, 2013).

22-A55 PER DIEM CHARGES FOR INPATIENT SERVICES AT SAINT ELIZABETHS HOSPITAL

22-A DCMR § 5500 PURPOSE

5500.1 This chapter establishes the standard per diem charge at Saint Elizabeths Hospital and the process for determining adjustments to this charge. The per diem charge established by this chapter and the process proscribed for determining adjustments to this charge are intended to establish a per diem charge that reflects the fully loaded actual cost of care for an inpatient.

History

Source: Notice of Final Rulemaking published at 57 DC12222 (December 24, 2010).

22-A DCMR § 5501 CURRENT RATE

5501.1 Beginning on the effective date of this section, the per diem charge for an inpatient at Saint Elizabeths Hospital shall be seven hundred eighty-three dollars ($783) per day. This charge is based on the fully loaded cost of care as reflected in the most recently filed Medicare cost report.

5501.2 For the purposes of the per diem charge, a consumer shall be considered an inpatient for a day if he or she appears on the census for that day. A patient shall appear on the census form if he or she is a patient in the hospital at 11:59 p.m.

History

Source: Notice of Final Rulemaking published at 57 DC12222 (December 24, 2010).

22-A DCMR § 5502 ANNUAL ADJUSTMENT

5502.1 The per diem charge shall be adjusted when a new annual Medicare cost report is filed with the Centers for Medicare and Medicaid Services’ (CMS) Fiscal Intermediary (FI) Highmark to reflect changes in cost of care.

5502.2 The adjusted per diem charge shall be based on the most recently filed Medicare cost report.

History

Source: Notice of Final Rulemaking published at 57 DC12222, 12223 (December 24, 2010)

22-A DCMR § 5599 DEFINITIONS

5599.1 When used in this chapter, the following terms shall have the meaning ascribed:

Fully loaded cost of care – the average cost per day to provide inpatient hospital services to a patient. This rate includes direct medical service costs and administrative and overhead costs.

Medicare cost report – a report that calculates the cost to provide inpatient and outpatient hospital services, as required by the Centers for Medicare and Medicaid Services (CMS).

Per diem charge – the cost per day that is to be charged by Saint Elizabeths Hospital for inpatients.

History

Source: Notice of Final Rulemaking published at 57 DC12222, 12223 (December 24, 2010)

22-A56 SUPPORTED INDEPENDENT LIVING PROGRAM - REIMBURSEMENT

22-A DCMR § 5600 PURPOSE

5600.1 This chapter establishes the daily reimbursement rate for the Supported Independent Living (SIL) service. Establishment of a daily reimbursement rate will allow the Department of Behavioral Health (Department) to contract with providers who enter into a contract with the Department to provide SIL supportive services for specific consumers at an established rate.

5600.2 Nothing in this chapter grants any right or entitlement to reimbursement to an SIL provider for the costs of SIL services. Eligibility for reimbursement for SIL services is determined solely by the Human Care Agreement (HCA) contract between the Department and the SIL provider and is subject to the availability of appropriated funds.

History

SOURCE: Final Rulemaking published at 61 DCR 840 (January 31, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 5600

22-A DCMR § 5601 REIMBURSEMENT RATE

5601.1 The SIL rate is as set forth below:

SERVICE

RATE

UNIT

Supported Independent Living

$13.50

Daily

History

SOURCE: Final Rulemaking published at 61 DCR 840 (January 31, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 5601

22-A DCMR § 5602 ELIGIBILITY

5602.1 A qualified SIL provider must be a Department-certified Mental Health Rehabilitation Services (MHRS) provider in good standing, maintain a valid Certificate of Occupancy that authorizes the number of housing units to be provided for SIL and have a valid business license on file with the Department’s Office of Accountability.

History

SOURCE: Final Rulemaking published at 61 DCR 840 (January 31, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 5602

22-A DCMR § 5603 SUBMISSION OF CLAIM; PAYMENT OF VOUCHER

5603.1 In order for claims to be eligible for reimbursement, the MHRS provider shall:

Submit claims through the Department’s electronic billing system pursuant to this chapter, the Department’s billing policy, and the terms of the HCA between the Department and the MHRS provider; and

5603.2 The Department will reimburse an MHRS provider for a claim that is determined by the Department to be eligible for reimbursement pursuant to the terms of this chapter, applicable Department policies, and the HCA between the Department and the MHRS provider, subject to the availability of appropriated funds.

History

SOURCE: Final Rulemaking published at 61 DCR 840 (January 31, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 5603

22-A DCMR § 5604 AUDITS

5604.1 An SIL provider shall, upon the request of the Department, cooperate in any audit or investigation concerning the SIL. Failure to cooperate or to provide the necessary information and documentation shall result in recoupment of the reimbursement and may result in other actions available to the Department pursuant to applicable policies and the HCA.

History

SOURCE: Final Rulemaking published at 61 DCR 840 (January 31, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 5604

22-A DCMR § 5699 DEFINITIONS

5699.1 When used in this chapter, the following terms shall have the meaning ascribed:

Consumer - Adult, child, or youth who seeks or receives mental health services or mental health supports funded or regulated by the Department.

Mental Health Rehabilitation Services or “MHRS” - Mental health rehabilitative or palliative services provided by a Department-certified community mental health provider in accordance with the District of Columbia State Medicaid Plan, the provider’s Human Care Agreement with the Department and Chapter 34 of this title.

MHRS provider - An organization certified by the Department to provide MHRS. MHRS provider includes Core Service Agencies, sub-providers, and specialty providers.

Supported Independent Living or “SIL” - Housing designed for individuals who have an ability to engage with others and in community activities. The goal of this level of care is to teach consumers how to manage their illness and enhance skills in activities of daily living in order to live safely in the community.

History

SOURCE: Final Rulemaking published at 61 DCR 840 (January 31, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 5699

22-A57 MENTAL HEALTH COMMUNITY RESIDENCE FACILITY PER DIEM

22-A DCMR § 5700 PURPOSE

5700.1 This chapter establishes the reimbursement rates for the Mental Health Community Residence Facility (MHCRF) Per Diem for the care and support of individuals with serious mental illness residing in these facilities. Establishment of this locally-funded per diem will allow the Department of Behavioral Health (the Department) to support the MHCRF network and ensure the continued availability of this critical housing resource.

5700.2 Nothing in this chapter grants to an MHCRF operator the right to reimbursement for costs of MHCRF services. Eligibility for reimbursement for supportive services is determined solely by the contract between the Department and the MHCRF operator and is subject to the availability of appropriated funds.

5700.3 MHCRFs may only operate if licensed by the Department pursuant to Title 22-B DCMR Chapter 38. MHCRFs may be licensed as Supported Residences; Supported Rehabilitative Residences; or Intensive Residences. The type of license held by the MHCRF shall determine the per diem reimbursement as set forth below.

5700.4 Because individuals who are hearing-impaired may require additional accommodations, a separate rate is established for those Supported Rehabilitative Residence MHCRFs adapted for residents who are hearing impaired.

History

SOURCE: Final Rulemaking published at 61 DCR 12771 (December 19, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 5700

22-A DCMR § 5701 REIMBURSEMENT RATE

5701.1 The MHCRF Per Diem rates effective June 14, 2024, are as set forth below:

SERVICE

CODE

RATE

UNIT

Transitional Supported Residence MHCRF Per Diem

TSR01

$ 81.70

Daily

Supported Residence MHCRF Per Diem

SR01

$ 77.90

Daily

Supported Rehabilitative Residence MHCRF Per Diem

SRR01

$126.50

Daily

Supported Rehabilitative Residence MHCRF Per Diem – Hearing Impaired

SRR02

$155.03

Daily

Intensive Residence MHCRF Per Diem

IR01

$195.05

Daily

History

SOURCE: Final Rulemaking published at 61 DCR 12771 (December 19, 2014); as amended by Final Rulemaking published at 67 DCR 2791 (March 13, 2020); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 5701

22-A DCMR § 5702 ELIGIBILITY

5702.1 Only a licensed MHCRF operator who has entered into a contract with the Department will be eligible for reimbursement under this chapter. An MHCRF shall not be eligible to receive a per diem under this chapter if the MHCRF is receiving District of Columbia contract or grant funds under a separate program.

5702.2 Only a licensed Supported Rehabilitative Residence MHCRF operator who has entered into a contract for housing individuals who are hearing impaired is eligible for the SRR02 reimbursement rate.

History

SOURCE: Final Rulemaking published at 61 DCR 12771 (December 19, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 5702

22-A DCMR § 5703 SUBMISSION OF CLAIM; PAYMENT OF INVOICE

5703.1 The licensed MHCRF operator shall submit all per diem claims under the contract, pursuant to this chapter and the terms of the contract.

5703.2 The licensed independent MHCRF operator shall submit appropriate documentation to support all claims under its contract with the Department.

5703.3 The Department will reimburse a licensed MHCRF operator for a claim that is determined by the Department to be eligible for reimbursement pursuant to the terms of the contract between the Department and the licensed MHCRF operator, subject to the availability of appropriated funds.

5703.4 No MHCRF operator shall submit claims in excess of its contract with the Department.

History

SOURCE: Final Rulemaking published at 61 DCR 12771 (December 19, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 5703

22-A DCMR § 5704 AUDITS

5704.1 A licensed MHCRF operator shall, upon the request of the Department, cooperate in any audit or investigation concerning the MHCRF Per Diem program.

History

SOURCE: Final Rulemaking published at 61 DCR 12771 (December 19, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 5704

22-A DCMR § 5799 DEFINITIONS

5799.1 When used in this chapter, the following terms shall have the meaning ascribed:

Mental Health Community Residence Facility (MHCRF) - a publicly or privately owned residence licensed in accordance with 22-B DCMR Chapter 38, that houses individuals, eighteen (18) or older, with a principal diagnosis of mental illness and who require twenty-four hour (24 hr.) on-site supervision, personal assistance, lodging, and meals and who are not in the custody of the District of Columbia Department of Corrections.

History

SOURCE: Final Rulemaking published at 61 DCR 12771 (December 19, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 5799

22-A58 INDEPENDENT MENTAL HEALTH COMMUNITY RESIDENCE FACILITY SUPPORTIVE SERVICES - REIMBURSEMENT

22-A DCMR § 5800 PURPOSE

5800.1 This chapter establishes the reimbursement rate for the Independent Mental Health Community Residence Facility Supportive Services. Establishment of a reimbursement rate will allow the Department of Mental Health (Department) to contract with independent Mental Health Community Residence Facility (MHCRF) operators who enter into a Human Care Agreement (HCA) with the Department to provide additional supportive services for specific consumers at an established rate.

5800.2 Nothing in this chapter grants to an independent MHCRF operator the right to reimbursement for costs of MHCRF services. Eligibility for reimbursement for supportive services is determined solely by the HCA between the Department and the independent MHCRF operator and is subject to the availability of appropriated funds.

History

SOURCE: Final Rulemaking published at 59 DCR 8546 (July 20, 2012).

22-A DCMR § 5801 REIMBURSEMENT RATE

5801.1 The Independent MHCRF Supportive Services rate is as set forth below:

SERVICE

RATE

UNIT

Supportive Services (Independent MHCRF)

$10.00

Daily

History

SOURCE: Final Rulemaking published at 59 DCR 8546, 8547 (July 20, 2012).

22-A DCMR § 5802 ELIGIBILITY

5802.1 Only a licensed independent MHCRF operator who has entered into a HCA with the Department to provide services to individuals who require a higher level of care, as determined by an assessment and treatment plan, will be eligible for reimbursement in accordance with its HCA with the Department, and may bill the Department under this chapter.

History

SOURCE: Final Rulemaking published at 59 DCR 8546, 8547 (July 20, 2012).

22-A DCMR § 5803 SUBMISSION OF CLAIM; PAYMENT OF VOUCHER

5803.1 The licensed independent MHCRF operator shall submit all Supportive Services claims under the HCA by invoice, pursuant to this chapter and the terms of the HCA between the Department and the licensed independent MHCRF operator.

5803.2 The licensed independent MHCRF operator shall submit appropriate documentation to support all claims under its HCA with the Department.

5803.3 The Department will reimburse a licensed independent MHCRF operator for a claim that is determined by the Department to be eligible for reimbursement pursuant to the terms of the HCA between the Department and the licensed independent MHCRF operator, subject to the availability of appropriated funds.

History

SOURCE: Final Rulemaking published at 59 DCR 8546, 8547 (July 20, 2012).

22-A DCMR § 5804 AUDITS

5804.1 A licensed independent MHCRF operator shall, upon the request of the Department, cooperate in any audit or investigation concerning the Independent MHCRF Supportive Services program.

History

SOURCE: Final Rulemaking published at 59 DCR 8546, 8547 (July 20, 2012).

22-A DCMR § 5899 DEFINITIONS

5899.1 When used in this chapter, the following terms shall have the meaning ascribed:

Mental Health Community Residence Facility (MHCRF) - a publicly or privately owned residence licensed in accordance with 22 DCMR B38, that houses individuals, eighteen (18) or older, with a principal diagnosis of mental illness and who require twenty-four hour (24 hr.) on-site supervision, personal assistance, lodging, and meals and who are not in the custody of the District of Columbia Department of Corrections.

Independent Mental Health Community Residence Facility (MHCRF) Operator – an individual or entity that is licensed to operate an MHCRF and whose only contract with the Department is for supportive services pursuant to this rule.

History

SOURCE: Final Rulemaking published at 59 DCR 8546, 8548 (July 20, 2012).

22-A62 REIMBURSEMENT RATES FOR SERVICES PROVIDED BY THE DEPARTMENT OF BEHAVIORAL HEALTH CERTIFIED SUBSTANCE ABUSE PROVIDERS

22-A DCMR § 6200 PURPOSE

6200.1 This chapter establishes the reimbursement rate for services provided to eligible District residents by Department of Behavioral Health (Department) certified substance abuse providers, as this term is defined in Chapter 23 (Certification Standards for Substance Abuse Treatment Facilities and Programs) of Title 29 (Public Health) of the District of Columbia Municipal Regulations (DCMR).

6200.2 Nothing in this chapter grants to a certified substance abuse provider the right to reimbursement for costs of substance abuse services and supports. Eligibility for reimbursement is determined solely by the Human Care Agreement between the Department and the certified substance abuse provider, and reimbursement is subject to the availability of appropriated funds.

History

SOURCE: Final Rulemaking published at 61 DCR 3548 (April 4, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6200

22-A DCMR § 6201 REIMBURSEMENT RATE

6201.1 Reimbursement for substance abuse services shall be as follows:

SERVICE

CODE

RATE per UNIT

Urinalysis (Laboratory)

H0003

15.00

Breathalyzer Collection

H0048

8.80

Urinalysis Collection

H0048 LR

8.80

Case Management

H0006

20.02

Case Management (HIV)

H0006V9

20.02

Treatment Planning

T1007

22.00

Treatment Planning - Complex IP

T1007TG

24.00

Targeted Case Management (Clinical Care Coordination)

T1017HF

22.50

Counseling Group

H0005

10.45

Counseling Group - Psycho-educational

H2027

3.51

Counseling Group - Psycho-educational (HIV)

H2027V9

3.51

Counseling On-site - Behavioral Health Therapy

H0004

26.42

Counseling, Off-site

H0004HFTN

27.45

Counseling,

Family with Client

H0004HR

26.42

Counseling, Family without Client

H0004HS

26.42

Crisis Intervention

H0007HF

36.93

CS Peer Support Group - Substance Abuse

H0038HFHQ

6.65

CS Peer Support - Substance Abuse

H0038HF

21.97

Detoxification - Outpatient - Ambulatory

H0014

24.53

Detoxification - Residential - Acute care

H0010

605.00

Behavioral Health Screening - Determine eligibility

H0002HF

85.34

Behavioral Health Screening - Evaluate Risk Rating

H0002TG

140.00

Diagnostic Assessment – In-depth - Adult

H0001HF

256.02

Diagnostic Assessment - Ongoing - Modify Tx Plan

H0001TS

85.34

Diagnostic Assessment - In-depth Exam - Youth

H0001HA

256.02

Diagnostic Assessment - Ongoing Follow-up - Youth

H0001HATS

85.34

Intensive Outpatient - All Inclusive

H0015

74.25

Intervention - Substance Abuse Recognition

H0022

27.17

Dose - Methadone - Clinic or Take-Home

H0020

8.58

Medication Assisted Therapy

H0020HF

8.58

Medication Management - Adult

H0016HF

44.65

Medication Management - Youth

H0016HAHF

44.65

Multisystemic Therapy for Juveniles (ACRA) (ages 21 – 24)

H2033HF

57.42

Multisystemic Therapy for Juveniles (ACRA) (ages 12 – 20)

H2033HAHF

57.42

Outpatient Therapy - Intensive

H0015HA

164.61

Prenatal Care, at-risk Assessment

H1000

142.56

Prenatal Care, at-risk enhanced service - Ante-partum Management

H1001

80.08

Prenatal Care, at-risk enhanced service - Care Coordination

H1002

80.08

Prenatal Care, at-risk enhanced service - Education

H1003

80.08

Prenatal Care, at-risk enhanced service - follow-up Home Visit

H1004

100.76

Residential - Long term Therapeutic

H0019

132.55

Residential - Long term Room & Board

H0043

72.90

Residential – Youth Room and Board

H0043HA

167.40

Residential Treatment - Inclusive

H0018

136.84

Residential Treatment – Inclusive (Youth)

H0018HA

197.60

Residential Treatment – Inclusive (HIV)

H0018V9

136.84

Residential Per Diem - Women w/1 child

H0043UN

210.00

Residential Per Diem - Women w/2 children

H0043UP

215.00

Residential Per Diem - Women w/3 children

H0043UQ

220.00

Residential Per Diem - Women w/4 or more children

H0043UR

225.00

2010 Recovery Support Evaluation

2010

85.00

2090 Family and Marital Services - Individual

2090

140.00

2091 Family and Marital Services - Group

2091

50.00

3010 Parenting Services – Individual

3010

90.00

3011 Parenting Services – Group

3011

50.00

3020 Child Care (1 – 2 Children)

3020

15.00

3021 Child Care (3 or more children)

3021

30.00

3040 Care Coordination

3040

35.00

3051 Transportation (Public)

3051

65.00

4050 Environmental Stability – Individual

4050

212.25

4051 Environmental Stability – Women w/children

4051

250.00

5030 Recovery Mentoring/Coaching

5030

75.00

5040 Life Skills – Individual

5040

45.00

5041 Life Skills (Group Adult)

5041

25.00

5041 Life Skills (Group – Youth)

5041

50.00

5050 Spiritual Support Group

5050

50.00

6020 HIV/AIDS Education

6020

25.00

6030 Education Services – Individual

6030

75.00

6031 Education Services – Group

6031

50.00

History

SOURCE: Final Rulemaking published at 61 DCR 3548 (April 4, 2014); as amended by Final Rulemaking published at 62 DCR 3017 (March 13, 2015). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6201

22-A63 CERTIFICATION STANDARDS FOR SUBSTANCE USE DISORDER TREATMENT AND RECOVERY PROVIDERS

22-A DCMR § 6300 GENERAL PROVISIONS

GENERAL PROVISIONS

The Department of Behavioral Health (“Department”) is the Single State Agency (“SSA”) responsible for the development and promulgation of rules, regulations, and certification standards for prevention and treatment services related to the abuse of alcohol, tobacco, and other drugs (“ATOD”) in the District of Columbia (“District”). The Department is responsible for the inspection, monitoring, and certification of all District of Columbia substance use disorder (“SUD”) treatment and recovery support service providers.

6300.2 The purpose of these rules is to establish service and certification requirements for operating a Substance Use Disorder (SUD) treatment or recovery program in the District. Each provider shall comply with all applicable Federal and District laws and regulations.

Providers seeking certification shall specify the age ranges of the clients they will be serving. Providers serving youth shall be known as Adolescent Substance Abuse Treatment Expansion Program (“ASTEP”) providers.

The SUD treatment framework in this chapter is based on levels of care established by the American Society of Addiction Medicine (“ASAM”).

No person or entity shall own or operate a program that offers or proposes to offer non-hospital SUD treatment services without being certified by the Department pursuant to this chapter. This chapter does not apply to Health Maintenance Organizations, physicians, and other licensed behavioral health and medical professionals in individual or group practice.

The Department shall issue one (1) certification for each provider that is valid only for the programs, premises, and Level(s) of Care stated on the certificate. The certificate is the property of the Department and must be returned upon request by the Department.

The Department’s staff, upon presentation of proper identification, has authority to enter the premises of a certified SUD treatment or recovery program during operating hours to conduct announced or unannounced inspections and investigations.

Providers certified as Levels 1 - 3, except Medically Monitored Inpatient Withdrawal Management (“MMIWM”), may also receive a special designation as a program serving parents with children, subject to § 6326 of this chapter.

Each certified provider shall comply with all the provisions of this chapter consistent with the scope of the authorized Level of Care.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6300

22-A DCMR § 6301 ELIGIBILITY FOR SUBSTANCE USE DISORDER SERVICES

ELIGIBILITY FOR SUBSTANCE USE DISORDER SERVICES

SUD is a chronic relapsing disease characterized by a cluster of cognitive, behavioral, and psychological symptoms indicating that the client continues using the substance despite significant substance-related problems. A diagnosis of SUD requires a client to have had persistent, substance related problem(s) within a twelve (12)-month period in accordance with the most recent version of the American Psychiatric Association’s Diagnostic and Statistical Manual (“DSM”). SUD services as described throughout this chapter include both treatment and Recovery Support Services (“RSS”).

To be eligible for SUD treatment, a client must have received a diagnosis of SUD in accordance with § 6301.1. Eligibility for Medicaid-funded or Department-funded SUD services shall be determined in accordance with § 6301.4.

To be eligible for RSS, a client must have an identified need for RSS and:

Be actively participating in the Department treatment system;

Have completed treatment; or

Have a self-identified substance use issue that is not assessed as needing

active treatment.

A client shall meet the following eligibility requirements in order to receive Medicaid-funded SUD services:

Be bona fide residents of the District, as required in 29 DCMR §2405.1(a); and

Be referred for SUD services by a treatment provider or other intake center authorized by the Department.

Be enrolled in Medicaid, or be eligible for enrollment and have an application pending; or

For new enrollees and those enrollees whose Medicaid coverage has lapsed:

There is an eligibility grace period of ninety (90) calendar days from the date of first service for new enrollees, or from the date of eligibility expiration for enrollees who have a lapse in coverage, until the date the Department of Human Services’ Economic Security Administration (“ESA”) makes an eligibility or renewal determination.

In the event the client appeals a denial of eligibility or renewal by the ESA, the Director may extend the ninety (90) calendar day eligibility grace period until the appeal has been exhausted. The ninety (90) calendar day eligibility grace period may also be extended at the discretion of the Director for other good cause shown.

Upon expiration of the eligibility grace period, SUD services provided to the client are no longer reimbursable by Medicaid. Nothing in this section alters the District’s timely-filing requirements for claim submissions.

Clients eligible for locally-funded SUD treatment are those individuals who are not eligible for Medicaid or Medicare or are not enrolled in any other third-party insurance program except the D.C. Healthcare Alliance, or who are enrolled in a third-party insurance program that does not cover SUD treatment and who meet the following requirements:

For individuals eighteen (18) years of age and older, live in households

with a countable income of less than two hundred percent (200%) of the federal poverty level, and for individuals under eighteen (18) years of age, live in households with a countable income of less than three hundred percent (300%) of the federal poverty level.

A client that does not meet the income limits of § 6301.5(a)

above may receive treatment services in accordance with the following requirements:

The client must, within ninety (90) calendar days of enrollment for services, apply to the ESA for certification, which will verify income; and

An individual with income over the limits in paragraph (a) above

may receive treatment services in accordance with rates determined by the Department.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6301

22-A DCMR § 6302 SERVICES FOR PEOPLE WITH CO-OCCURRING MENTAL ILLNESSES

A provider shall not decline to provide SUD services because of a person’s co-occurring mental illness.

All SUD treatment providers shall screen each client for SUD and mental illness during the Initial or Comprehensive Diagnostic Assessment.

If a client screens positive for a co-occurring mental illness, the SUD treatment provider shall take the following steps in addition to providing SUD treatment:

If certified to provide mental health services, offer the client mental health treatment in addition to SUD treatment with the provider. If the client declines, the provider shall make the appropriate referrals for the client to receive mental health treatment at another qualified provider.

If the provider is not certified to provide mental health services, the provider shall ensure the client is referred to an appropriate mental health provider.

If a client that screens positive for a co-occurring mental illness

receives mental health treatment at another provider, the Clinical Care Coordinator shall ensure the Plan of Care and subsequent care and treatment of the client is coordinated with the mental health provider.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6302

22-A DCMR § 6303 PROVIDER CERTIFICATION PROCESS

PROVIDER CERTIFICATION PROCESS

The Department utilizes the certification process to thoroughly evaluate an applicant’s capacity to provide high quality SUD services in accordance with this regulation and the needs of the District’s behavioral health system. Each applicant seeking certification as a provider shall submit a certification application to the Department. A certified provider seeking renewal of certification shall submit a certification application at least ninety (90) calendar days prior to the termination of its current certification. The certification of a provider that has submitted a timely application for renewal of certification shall continue until the Department renews or denies renewal of the certification application.

An applicant may apply for certification for one or more of the following Levels of Care (“LOC”):

Level: Opioid Treatment Program (“OTP”);

Level 1: Outpatient;

Level 2.1: Intensive Outpatient;

Level 2.5: Day Treatment;

Level 3.1: Clinically Managed Low-Intensity Residential;

Level 3.3: Clinically Managed Population-Specific High-Intensity Residential;

Level 3.5: Clinically Managed High-Intensity Residential Services (Adult Criteria) or Clinically Managed Medium-Intensity Residential Services (Adolescent Criteria);

Level 3.7-WM: Medically Monitored Inpatient Withdrawal Management (“MMIWM”); and

Level-R: RSS.

Providers may also be certified to provide one or more of the following specialty services based on their LOC certifications from the Department:

Medication Management;

Adolescent – Community Reinforcement Approach (“ACRA”);

Medications for Substance Use Disorder (MSUD);

Trauma Recovery and Empowerment Model (“TREM”);

Environmental Stability; and

Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT).

All certified providers, except those only certified as Level-R, shall provide all of the following core services according to the requirements of this chapter and the individual needs of the client as outlined in the Plan of Care:

Diagnostic Assessment and Plan of Care;

Clinical Care Coordination (“CCC”);

Crisis Intervention for American Society of Addiction Medicine (ASAM) Level 1, Outpatient Treatment, through Level 2.5, Day Treatment;

SUD Counseling/Therapy, including the following:

Individual Counseling/Therapy;

Group Counseling/Therapy;

Family Counseling/Therapy;

Group Counseling – Psychoeducation.

Drug Screening, as follows:

Toxicology Sample Collection;

Breathalyzer Testing.

RSS.

Certification shall be considered terminated if the provider:

Fails to submit a complete certification application ninety (90) calendar days prior to the expiration date of the current certification;

Voluntarily relinquishes certification; or

Terminates operations.

Upon receipt of a certification application, the Department shall review the certification application to determine whether it is complete. If a certification application is incomplete, the Department shall return the incomplete application to the applicant. An incomplete certification application shall not be regarded as a certification application. The Department shall not take further action to issue certification unless a complete certification application is submitted within ninety (90) calendar days prior to the expiration of the applicant’s current certification.

Following the Department’s acceptance of the certification application, the Department shall determine whether the applicant’s facility, services and activities meet the certification standards described in this chapter. The Department shall conduct an on-site survey of the applicant’s facility, services, and activities to determine whether the applicant satisfies all the certification standards. The Department shall have access to all records necessary to verify compliance with certification standards and may conduct interviews with staff, others in the community, and clients.

The Department may conduct an on-site survey at the time of initial certification or certification renewal, or at any other time during the period of certification.

Applicant or provider interference with the on-site survey, or submission of false or misleading information, or lack of candor by the applicant or provider, shall be grounds for an immediate suspension of any prior certification, or denial of a new certification application.

A Statement of Deficiency (“SOD”) is a written notice to a provider identifying non-compliance with this chapter. The intent of the SOD to is provide existing certified providers with an opportunity to correct minor deficiencies to avoid decertification and disruption of service to existing clients. When utilized, the SOD shall describe the areas of non-compliance, suggest actions needed to bring operations into compliance with the certification standards, and set forth a timeframe of no more than ten (10) business days for the provider’s submission of a written Corrective Action Plan (“CAP”).

The issuance of an SOD is a separate process from the issuance of a Notice of Infraction (“NOI”). NOIs shall be issued promptly upon observation of violations of this chapter, especially when they are recurrent, endanger client or staff health or safety or when there is a failure to comply with core requirements of operating an SUD treatment facility.

The Department is not required to utilize the SOD or NOI process. It may immediately deny certification or re-certification or proceed with decertification.

A certified provider’s CAP shall describe the actions to be taken and specify a timeframe for correcting the areas of non-compliance. The CAP shall be submitted to the Department within ten (10) business days after receipt of the SOD from the Department, or sooner if specified in the SOD.

The Department shall notify the certified provider whether the provider’s CAP is accepted within ten (10) business days after receipt. In addition to utilizing the SOD process in § 6303.10 during renewal of certification stage, the Director may utilize the same procedures at any other time to address violations of this chapter.

The Department may only issue its certification after the Department verifies that certified provider has remediated all of the deficiencies identified in the CAP and meets all the certification standards.

The Department may grant full or provisional certification to an SUD applicant after conducting on-site surveys and reviewing application materials, including CAPs. A determination to grant full certification to a provider or program shall be based on the Department’s review and validation of the information provided in the application, facility inspection findings, CAPs, and the provider or program’s compliance with this chapter.

The Department may grant provisional certification to an applicant or provider that has demonstrated substantial compliance with this chapter and has received provisional accreditation from the Commission on Accreditation of Rehabilitation Facilities, The Joint Commission, or the Council on Accreditation.

Provisional certification shall expire upon termination of the provider’s provisional accreditation period(s) unless revoked in accordance with § 6305.

6303.19 The Department shall certify an applicant and recertify a provider that demonstrated substantial compliance with this chapter, for a time period that runs concurrently with the applicant or provider’s accreditation period. Certification shall start from the date of issuance of certification by the Department, subject to the provider's continuous compliance with all certification standards. Certification shall remain in effect until it expires, is renewed, is revoked or is voluntarily relinquished. The certification shall specify the effective date of the certification, the date the certification expires, and the program(s) and services that the provider is certified to provide.

The provider shall notify the Department within forty-eight (48) hours of any changes in its operation that affect the provider’s continued compliance with this chapter, including changes in ownership or control, changes in service, and changes in its affiliation and referral arrangements.

Prior to adding an SUD service during the term of certification, the provider shall submit a certification application describing the service. Upon determination by the Department that the provider is in compliance with certification standards, the Department may certify the provider to provide that service. A provider that applies for certification during an open application period as published in the District of Columbia Register may appeal the denial of certification under this subsection by utilizing the procedures contained in § 6305. The Department shall not accept any applications for which a notice of moratorium is published in the District of Columbia Register.

In the event that a certification application is under review while a moratorium is put in place, the Department will continue to process the application for a time period of no more than thirty (30) calendar days. If, after thirty (30) calendar days, the application is deemed incomplete, the provider will be granted ten (10) business days to resolve all items of incompletion. Any items not resolved or provided by the due date will result in the incomplete application being returned to the applicant. The Department will take no further action to issue certification. The applicant must then wait until the moratorium is lifted in order to submit any subsequent certification application.

Nothing in these rules shall be interpreted to mean that certification is a right or an entitlement. New certification as a provider shall depend upon the Director’s assessment of the need for additional providers(s) and availability of funds.

Certification shall be limited to the applicant granted the certification and shall be limited to the location and services as indicated on the certificate. Certification is not transferable to any other organization.

Written notice of any change in the name or ownership of a program owned by an individual, partnership, or association, or in the legal or beneficial ownership of ten percent (10%) or more of the stock of a corporation that owns or operates the program, shall be given to the Department at least thirty (30) calendar days prior to the change in ownership.

The provider shall notify the Department in writing thirty (30) calendar days prior to implementing any of the following operational changes, including all aspects of the operations materially affected by the changes:

A proposed change in the program’s geographic location;

The proposed addition or deletion of core (§ 6303.4) or specialty (§6303.3) service components, which is anything that would alter or disrupt services where the client would be impacted by the change, or any change that would affect compliance with this regulation;

A change in the required staff qualifications for employment;

A proposed change in organizational structure;

A proposed change in the population served; or

A proposed change in program capacity and, for residential programs, a proposed change in bed capacity.

Providers shall forward to the Department within thirty (30) calendar days all inspection reports conducted by an oversight body and all corresponding corrective actions taken regarding cited deficiencies.

Providers shall immediately report to the Department any criminal allegations involving provider staff.

The Department may consider a provider’s accreditation by one or more national accrediting bodies as evidence of compliance with one or more certification standards in this chapter.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024); as amended by Final Rulemaking published at 72 DCR 008497 (August 1, 2025). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6303

22-A DCMR § 6304 CERTIFICATION: EXEMPTIONS FROM STANDARDS

Upon good cause shown, including but not limited to a conflict between a certification standard and a provider’s third-party contract or agreement, the Department may exempt a provider from a certification standard if the exemption does not jeopardize the health and safety of clients, violates a client’s rights, or otherwise conflict with the purpose and intent of these rules.

If the Department approves an exemption, such exemption shall end on the expiration date of the provider certification, or at an earlier date if specified by the Department, unless the provider requests renewal of the exemption prior to expiration of its certificate or the earlier date set by the Department.

The Department may at any time revoke an exemption if it that it determines that the exemption may jeopardize the health, safety, or welfare of the clients/consumers served, staff, volunteers, and/or the general public.

All requests for an exemption from certification standards must be submitted in writing to the Department.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6304

22-A DCMR § 6305 DENIAL OR DECERTIFICATION PROCESS

The Director may deny initial certification if the applicant fails to comply with any certification standard or the application fails to demonstrate the applicant’s capacity to deliver high quality SUD services on a sustained and regular basis. Furthermore, to avoid an over concentration of providers in areas with existing providers and to encourage increased access to underserved areas of the District, the Director may deny certification if the applicant proposes to operate a facility in an area already served by one or more providers. The Department’s priority shall be to grant certification to applicants with the demonstrated capacity to deliver high quality SUD services that will address unmet needs of the behavioral health system. While applicants may make minor corrections and substitutions to its application during the certification process, evidence of one or more of the following shall constitute good cause to deny the application for certification when the circumstances demonstrate deliberate misrepresentations, organizational instability, or the lack of preparedness or capacity to meet and sustain compliance with this chapter:

An incomplete application;

False information provided by applicant or contained in an application;

One or more changes to an organizational chart during the application process;

A facility that is inadequate in health, safety, size or configuration to provide SUD services consistent with high quality care and privacy standards;

The lack of demonstrated experience providing SUD services by the applicant’s clinical leadership, practitioners, and/or staff;

An applicant’s lack of financial resources (e.g., inability to pay all staff, or inability to provide at least ninety (90) days of running capital as dictated by the provider’s monthly operating budget, etc.) to carry out its commitments and obligations under this chapter for the foreseeable future;

An applicant’s failure to timely respond to the Department’s requests for information;

History of poor performance; or

Lack of behavioral health accreditation in accordance with § 6351.1.

Upon written request submitted by the applicant and received by the Department within fifteen (15) business days of the certification denial, the Department shall provide an applicant an impartial administrative review of the decision. The Department shall conduct the administrative review to determine whether the certification denial complied with § 6305.1. Each request for an administrative review shall contain a concise statement of the reason(s) why the certification denial was in error. The Director shall issue a written decision within fifteen (15) business days. The Director’s decision is final and not subject to further appeal. An applicant, its principals, and successor in interests shall be prohibited from reapplying for certification for twelve (12) months following the date of the certification denial.

An incomplete recertification application;

False information provided by provider or contained in a recertification application;

High staff turnover where there are two or more changes made to the leadership staff within a certification period, demonstrating organizational instability;

One or more documented violations of the certification standards during the certification period that evidence a provider’s lack of capacity to meet and sustain compliance with this chapter;

Claims audit error rate in excess of twenty-five percent (25%);

An applicant’s lack of financial resources (e.g., inability to pay all staff, or inability to provide at least ninety (90) days of running capital as dictated by the provider’s monthly operating budget) to carry out its commitments and obligations under this chapter for the foreseeable future;

Failure to cooperate with Department investigations or lack of timely response to information requests; or

Failure to obtain or maintain in good standing with national accreditation in accordance with § 6351.1, or meet the timelines in § 6351.2.

Nothing in this chapter requires the Director to issue an SOD prior to decertifying a provider. If the Director finds that there are grounds for decertification, the Director shall issue a written notice of decertification setting forth the factual basis for the decertification, the effective date, and the provider’s right to request an administrative review.

The provider may request an administrative review from the Director within fifteen (15) business days of the date on the notice of decertification.

Each request for an administrative review shall contain a concise statement of the reason(s) why the provider asserts that it should not have had its certification revoked and include any relevant supporting documentation.

Each administrative review shall be conducted by the Director and shall be completed within fifteen (15) business days of the receipt of the provider’s request.

The Director shall issue a written decision and provide a copy to the provider. If the Director denies the appeal and approves the decertification, the provider may request a hearing under the D.C. Administrative Procedure Act, within fifteen (15) business days of the receipt of the Director’s written decision. The administrative hearing shall be limited to the issues raised in the administrative review request. The decertification shall be stayed pending resolution of the hearing.

Upon decertification, the provider and its executive leadership shall not be allowed to reapply for certification for a period of two (2) years following the date of the order of revocation. If a provider reapplies for certification, the provider must reapply in accordance with the established certification standards for the type of services provided and show evidence that the grounds for the revocation have been corrected.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020); as amended by Final Rulemaking published at 70 DCR 003050 (March 10, 2023); as corrected by Errata Notice published at 71 DCR 004474 (April 19, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6305

22-A DCMR § 6306 NOTICES OF INFRACTION

The fine amount for any NOI issued under this chapter shall be as follows:

For the first offense $500.00;

For the second offense $1,000.00;

For the third offense $2,000.00;

For the fourth and subsequent offenses $4,000.00.

The administrative procedure for the appeal of an NOI issued under this chapter shall be governed by 16 DCMR §§ 3100 et seq.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6306

22-A DCMR § 6307 CLOSURES AND CONTINUITY OF CLIENT CARE

A provider shall provide written notification to the Department at least ninety (90) calendar days prior to its impending closure, or immediately upon knowledge of an impending closure less than ninety (90) calendar days in the future. This notification shall include plans for continuity of care and preservation of client records.

The Department shall review the continuity of care plan and make recommendations to the provider as needed. The plan should include provision for the referral and transfer of clients, as well as for the provision of relevant treatment information, medications, and information to the new provider. The provider shall incorporate all Department recommendations necessary to ensure a safe and orderly transfer of care.

Closure does not absolve a provider from its legal responsibilities regarding the preservation and the storage of client records as described in § 6323 of this chapter and all applicable Federal and District laws and regulations. A provider must take all necessary and appropriate measures to ensure client records are preserved, maintained, and made available to clients upon request after closure of a program.

A provider shall be responsible for the execution of its continuity of care plan in coordination with the Department.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6307

22-A DCMR § 6308 GENERAL MANAGEMENT AND ADMINISTRATION STANDARDS

Each provider shall be established as a recognized legal entity in the District of Columbia and qualified to conduct business in the District. Evidence of qualification to conduct business includes a certificate of good standing and clean hands, or an equivalent document, issued by the District of Columbia Department of Consumer and Regulatory Affairs (DCRA). Each provider shall maintain the clinical operations, policies, and procedures described in this section. These operations, policies and procedures shall be reviewed and approved by the Department during the certification survey process. Providers certified or accredited by a national body may apply for deemed status. To be considered for deemed status, a prospective provider submitting an application for certification must request “Deemed Status” on the certification application. Providers must also provide a current copy of their national accreditation certificate along with their most recent accreditation report. Deemed Status does not waive the requirement of service specific requirements and/or fiscal responsibility requirements.

All providers shall report to the Department in a form and manner prescribed by the Department’s policy on major unusual incidents, including but not limited to abuse or neglect of client or any other event that may compromise the health, safety, or welfare of clients.

Each provider shall execute a participation agreement with the District’s Health Information Exchange (HIE) and utilize the HIE to receive and transmit protected health information for individuals in accordance with 42 CFR Part 2.

6308.4 Each provider shall hire Qualified Practitioners and Credentialed Staff with the necessary qualifications to provide SUD treatment and/or RSS that meet the needs of its enrolled clients and in accordance with this chapter: Qualified Practitioners and Credentialed Staff must at all times adhere to the following:

Qualified Practitioners and Credentialed Staff are individuals permitted to provide SUD services or components of SUD services in accordance with applicable service specific standards and any other applicable standards in this chapter;

Qualified Practitioners are behavioral health clinicians appropriately licensed, certified, or registered in the District by the Department of Health. A Qualified Practitioner shall only render those SUD services or components of SUD services that are consistent with the scope of the Qualified Practitioner’s license, certification, or registration. Applicable laws and regulations dictate whether and to what extent a Qualified Practitioner:

Is subject to supervision requirements when providing SUD services; and

May supervise other Qualified Practitioners or Credentialed Staff in the provision of SUD services.

Credentialed Staff are non-licensed staff or staff who are not Qualified Practitioners who are permitted to render SUD services or components of SUD services pursuant to any applicable service specific supervision requirements. Credentialed Staff shall only render SUD services or components of SUD services that do not require a license, certification, or registration by the Department of Health.

Providers shall make services available a minimum five (5) days per week on a regular schedule for at least eight (8) hours per day, in the evening by appointment, and at least once a month on a Saturday for four (4) hours. An independently licensed clinician with the ability to provide and supervise the offered services must be available on-site during regular hours of operation.

Each provider shall have a full-time program director with authority and responsibility for the administrative direction and day-to-day operation of the program(s).

Each provider shall have a clinical director responsible for the full-time clinical direction and day-to-day delivery of clinical services provided to clients of the program(s). The clinical director must be a clinician who is licensed to practice independently in the District and supervise other clinical staff.

The program director and clinical director shall devote adequate time and authority to perform necessary duties to ensure that service delivery is in compliance with applicable standards set forth in this chapter and in applicable policies issued by the Department. The program director and clinical director shall not be the same individual.

Each provider shall establish and adhere to policies and procedures for selecting and hiring staff, including but not limited to requiring:

Evidence of licensure, certification, or registration, as applicable and as required by the job being performed;

Evidence of an appropriate degree, training program, or credentials, such as academic transcripts or a copy of degree;

Evidence of all required criminal background checks, and for all non-licensed staff members, application of the criminal background check requirements contained in District Official Code §§ 44-551 et seq., Unlicensed Personnel Criminal Background Check, as well as child abuse registry checks (for both state of residence and employment);

Evidence of quarterly checks that no individual is excluded from participation in a federally funded health care program as listed on the Department of Health and Human Services’ “List of Excluded Individuals/Entities,” the General Services Administration’s “Excluded Parties List System,” or any similar succeeding governmental list; and

Evidence of a negative result on a tuberculosis test or medical clearance related to a positive result.

Each provider shall establish and adhere to written job descriptions for all positions, including, at a minimum, the role, responsibilities, reporting relationships, and minimum qualifications for each position. The minimum qualifications established for each position shall be appropriate for the scope of responsibility and clinical practice (if any) described for each position.

Each provider shall establish and adhere to policies and procedures requiring a periodic evaluation of clinical and administrative staff performance that requires an assessment of clinical competence (if appropriate), general organizational work requirements, and key functions as described in the job description. The periodic evaluation shall also include an annual individual development plan for each staff member.

Each provider shall establish and adhere to a supervision policy to ensure that services are provided according to this chapter and Department policies on supervision and service standards as well as District laws and regulations.

Each provider shall establish and adhere to a training policy in accordance with § 6319 of this chapter.

Personnel policies and procedures shall apply to all staff and volunteers working for a provider and shall include:

Compliance with Federal and District equal opportunity laws, including the Americans with Disabilities Act and the D.C. Human Rights Act;

A current organizational flow chart reflecting each program position and,

where applicable, the relationship to the larger program or provider of which the program is a part;

Written plans for developing, posting, and maintaining files pertaining to

work and leave schedules, time logs, and on-call schedules for each functional unit, to ensure adequate coverage during all hours of operation;

A written policy requiring that a designated individual be assigned

responsibility for management and oversight of the volunteer program, if volunteers are utilized;

A written policy regarding volunteer recruitment, screening, training,

supervision, and dismissal for cause, if volunteers are utilized; and

Provisions through which the program shall make available to staff a copy

of the personnel policies and procedures.

Providers shall develop and implement procedures that prohibit the possession, use, or distribution of controlled substances or alcohol, or any combination of them, by staff during their duty hours, unless medically prescribed and used accordingly. Staff possession, use, or distribution of controlled substances or alcohol, or any combination of them, during off duty hours that affects job performance shall also be prohibited. These policies and procedures shall ensure that the provider:

Provides information about the adverse effects of the non-medical use and abuse of controlled substances and alcohol to all staff;

Initiates disciplinary action for the possession, use, or distribution of controlled substances or alcohol, which occurs during duty hours or which affects job performance; and

Provides information and assistance to any impaired staff member to facilitate his or her recovery.

Individual personnel records shall be maintained for each person employed by a provider and shall include, at a minimum, the following:

A current job description for each person, that is revised as needed;

Evidence of a negative result on a tuberculosis test or medical clearance related to a positive result;

Evidence of the education, training, and experience of the individual, and a copy of the current appropriate license, registration, or certification credentials (if any);

Documentation that written personnel policies were distributed to the employee;

Notices of official tour of duty: day, evening, night, or rotating shifts; payroll information; and disciplinary records;

Documentation that the employee has received all health care worker immunizations recommended by the District of Columbia Department of Health; and

Criminal background checks as required in § 6309.8.

All personnel records shall be maintained during the course of an individual’s employment with the program and for three (3) years following the individual’s separation from the program.

All providers shall obtain a National Provider Identification (NPI) number for themselves and all personnel performing Chapter 63 services through the provider. All providers shall register themselves and all personnel performing Chapter 63 services with the Department of Health Care Finance’s designated information system prior to billing for services.

6308.19 All providers shall electronically transmit Behavioral Health Supplemental Data (BHSD) to the Department in a form and manner as prescribed by the Department. BHSD is a compilation of individual-level behavioral health data defined in the Department’s Integrated Technology Engine (ITE) Provider Companion Guide (available at https://dbh.dc.gov/).

6308.20 Providers shall timely transmit BHSD pursuant to the procedure established in the ITE through the EHR system as described in this chapter.

6308.21 The Department shall provide notice of any future updates to the ITE Guide through https://dbh.dc.gov/.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021); as amended by Final Rulemaking published at 69 DCR 013495 (November 4, 2022); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6308

22-A DCMR § 6309 EMPLOYEE CONDUCT

All staff shall adhere to ethical standards of behavior in their relationships with clients as follows:

Staff shall maintain an ethical and professional relationship with clients at all times;

Licensed or certified staff must adhere to their professional codes of conduct, as required by District licensing laws and regulations;

Staff shall not enter into dual or conflicting relationships with individuals that might affect professional judgment, therapeutic relationships, or increase the risk of exploitation; and

The provider shall establish written policies and procedures regarding staff relationships with both current and former clients that are consistent with this section.

No staff, including licensed professionals, support personnel, and volunteers, shall engage in sexual activities or sexual contact with clients.

No staff, including licensed professionals, support personnel, and volunteers, shall engage in sexual activities or sexual contact with former clients.

No staff, including licensed professionals, support personnel, and volunteers, shall engage in sexual activities or sexual contact with clients’ relatives or other individuals with whom clients maintain a close personal relationship.

No staff, including licensed professionals, support personnel, and volunteers, shall provide services to individuals with whom they have had a prior sexual or other significant relationship.

Staff, including licensed professionals, support personnel, and volunteers, shall only engage in appropriate physical contact with clients and are responsible for setting clear, appropriate, and culturally sensitive boundaries that govern such physical contact.

No staff, including licensed professionals, support personnel, and volunteers, shall sexually harass clients. Sexual harassment includes sexual advances, sexual solicitation, requests for sexual favors, and other verbal or physical conduct of a sexual nature.

No provider or employee of a provider shall be a representative payee for any person receiving services from a treatment or RSS program.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6309

22-A DCMR § 6310 QUALITY IMPROVEMENT

QUALITY IMPROVEMENT

Each provider shall establish and adhere to policies and procedures governing quality improvement (“Quality Improvement Policy”).

The Quality Improvement Policy shall require the provider to adopt a written quality improvement (“QI”) plan describing the objectives and scope of its QI program and requiring provider staff, client, and family involvement in the QI program.

The Department shall review and approve each provider’s QI program at a minimum as part of the certification and renewal of certification process. The QI program shall submit data to the Department upon request.

The QI program shall be directed by a coordinator (“QI Coordinator”) who has direct access to the Program Director if applicable. In addition to directing the QI program’s activities, the QI Coordinator shall also review unusual incidents, deaths, and other sentinel events; monitor and review utilization patterns; and track consumer complaints and grievances. The QI Coordinator shall be one of the following:

Physician;

Psychologist;

Licensed Independent Clinical Social Worker (“LICSW”);

Advanced Practice Registered Nurse (“APRN”);

Licensed Professional Counselor (“LPC”);

Licensed Marriage and Family Therapist (“LMFT”);

Registered Nurse (“RN”);

Licensed Independent Social Worker (“LISW”);

Licensed Graduate Professional Counselor (“LGPC”);

Licensed Graduate Social Worker (“LGSW”);

Certified Addictions Counselor (“CAC”) I or II;

Physician Assistant (“PA”); or

The QI program shall be operational and shall measure and ensure at least the following:

Easy and timely access and availability of services;

Treatment and prevention of acute and chronic conditions;

Close monitoring of high-volume services, clients with high risk conditions, and services for children and youth;

Coordination of care across behavioral health treatment and primary care treatment settings;

Compliance with all certification standards;

Adequacy, appropriateness, and quality of care for clients;

Efficient utilization of resources;

Client and family satisfaction with services;

Quarterly random samplings of client outcomes, including but not limited to biological markers such as drug/alcohol screening results, in a format approved by the Department; and

Any other indicators that are part of the Department QI program for the larger system.

When the provider identifies a significant problem or quality of service issue, the provider shall notify the Department. The provider shall act to correct the problem or improve the effectiveness of service delivery, or both, and shall assess corrective or supportive actions through continued monitoring.

Providers certified through Deemed Status or accredited by nationally-recognized bodies may submit their QI program accepted by that body to fulfill the requirements in § 6310.5.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6310

22-A DCMR § 6311 FISCAL MANAGEMENT STANDARDS

Applicants or providers that are in financial distress and at risk of imminent closure represent a risk both to the Department’s clients and the behavioral health system. The Department shall not certify any applicant or re-certify any provider without evidence that the applicant or provider has sufficient financial resources (e.g., ability to provide at least ninety (90) days of running capital as dictated by the provider’s monthly operating budget) to carry out its commitments and obligations under this chapter for the foreseeable future. The provider shall have adequate financial resources to deliver all required services and shall provide documented evidence at the time of certification and renewal of certification that it has adequate resources to operate a SUD program. Documented evidence shall include federal and state tax returns, including Form 990s for non-profit organizations, for the three (3) most recent tax reporting years, and a current financial statement signed and verified by a certified public accountant.

A provider shall have fiscal management policies and procedures and keep financial records in accordance with generally accepted accounting principles.

A provider shall include adequate internal controls for safeguarding or avoiding misuse of client or organizational funds.

A provider shall have a uniform budget of expected revenue and expenses as required by the Department. The budget shall:

Categorize revenue by source;

Categorize expenses by type of service; and

Estimate costs by unit of service.

A provider shall have the capacity to determine direct and indirect costs for each type of service provided.

A written schedule of rates and charges shall be conspicuously posted and available to staff, clients, and the general public.

Fiscal reports shall provide information on the relationship of the budget to actual spending, including revenues and expenses by category and an explanation of the reasons for any substantial variance.

Providers shall correct or resolve all adverse audit findings prior to recertification.

A provider shall have policies and procedures regarding:

Purchase authority, product selection and evaluation, property control and supply, storage, and distribution;

Billing;

Controlling accounts receivable;

Handling cash;

Management of client fund accounts;

Arranging credit; and

Applying discounts and write-offs.

All business records pertaining to costs, payments received and made, and services provided to clients shall be maintained for a period of ten (10) years or until all audits and ongoing litigations are complete, whichever is longer.

All providers must maintain proof of liability insurance coverage, which must include malpractice insurance of at least three million dollars ($3,000,000.00) aggregate and one million dollars ($1,000,000.00) per incident and comprehensive general coverage of at least three million dollars ($3,000,000.00) per incident that covers general liability, vehicular liability, and property damage. The insurance shall include coverage of all personnel, consultants, or volunteers working for the provider.

Environmental Stability providers that handle client funds must maintain financial records with separate accounting for each Environmental Stability client’s funds.

A provider shall ensure that clients employed by the organization are paid in accordance with all applicable laws and regulations governing labor and employment, including those governing minimum wage.

All money earned by a client shall accrue to the sole benefit of that individual and be provided to the client or the client’s legal representative upon discharge or sooner.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6311

22-A DCMR § 6312 ADMINISTRATIVE PRACTICE ETHICS

All providers shall operate in an ethical manner, including but not limited to complying with the provisions of this section. A provider shall not offer or imply to offer services not authorized on the certification issued by the Department.

A provider shall not use any advertising that contains false, misleading, or deceptive statements or claims or that contains false or misleading information about fees.

A provider shall not offer or imply to offer services not authorized on the certification issued by the Department.

A provider shall comply with all Federal and District laws and regulations, including but limited to the False Claims Act, 31 USC §§ 3729-3733, the Anti-Kickback Statute, 42 USC § 1320a-7b, the Physician Self-Referral Law (Stark law), 42 USC § 1395nn, and the Exclusion Statute, 42 USC § 1320a-7.

The provider shall keep all employees informed of policy changes that affect performance of duties.

The provider must treat all allegations of ethical violations as major unusual incidents.

Any research must be conducted in accordance with Federal law.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6312

22-A DCMR § 6313 PROGRAM POLICIES AND PROCEDURES

Each program must document the following:

Organization and program mission statement, philosophy, purpose, and

values;

Organizational structure;

Leadership structure;

Program relationships;

Staffing;

Relationships with parent organizations, affiliated organizations, and

organizational partners;

Treatment philosophy and approach;

Services provided;

Characteristics and needs of the population served;

Performance metrics, including intended outcomes and process methods;

Contract services, if any;

Affiliation agreements, if any;

The scope of volunteer activities and rules governing the use of volunteers, if any;

Location of service sites and specific designation of the geographic area to

be served; and

Hours and days of operation of each site.

Each program shall establish written policies and procedures to ensure each of the following:

Service provision based on the individual needs of the client;

Consideration of special needs of the client and the program’s

population of focus;

Placement of clients in the least restrictive setting necessary to address the

acuity of the client’s presenting illness and circumstances; and

Facilitation of access to other more appropriate services for clients who do not meet the criteria for admission into a program offered by the provider.

Each program shall develop and document policies and procedures subject to review by the Department related to each of the following:

Program admission and exclusion criteria;

Termination of treatment and discharge or transition criteria;

Outreach;

Infection control procedures and use of universal precautions, addressing at least those infections that may be spread through contact with bodily fluids;

Volunteer utilization, recruitment, and oversight;

Crisis intervention and medical emergency procedures;

Safety precautions and procedures for participant volunteers, employees,

and others;

Record management procedures in accordance with “Confidentiality of Substance Use Disorder Patient Records” (“42 CFR Part 2”), this chapter, and any other Federal and District laws and regulations regarding the confidentiality of client records;

The on-site limitations on use of tobacco, alcohol, and other substances;

Clients’ rules of conduct and commitment to treatment regimen, including restrictions on carrying weapons and specifics of appropriate behavior while in or around the program;

Clients’ rights;

Addressing and investigating major unusual incidents;

Addressing client grievances;

Addressing issues of client non-compliance with established treatment regimen and/or violation of program policies and requirements; and

The purchasing, receipt, storage, distribution, return, and destruction of medication, including accountability for and security of medications located at any of its service site(s) (“Medication Policy”).

Gender-specific programs shall ensure that staff of that specific gender is in attendance at all times when clients are present.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6313

22-A DCMR § 6314 EMERGENCY PREPAREDNESS PLAN

Each provider shall establish and adhere to a written disaster evacuation and continuity of operations plan in accordance with the Department policy on Disaster Evacuation/Continuity of Operations Plans.

A provider shall immediately notify the Department and implement its Continuity of Operations Plan if an imminent health hazard exists because of an emergency such as a fire, flood, extended interruption of electrical or water service, sewage backup, gross unsanitary conditions, or other circumstances that may endanger the health, safety, or welfare of its clients.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6314

22-A DCMR § 6315 FACILITIES MANAGEMENT

FACILITIES MANAGEMENT

A provider shall establish and maintain a safe environment for its operation, including adhering to the following provisions:

Each provider’s service site(s) shall be located and designed to provide

adequate and appropriate facilities for private, confidential individual and group counseling/therapy sessions;

Each provider’s service site(s) shall have appropriate space for group

activities and educational programs;

In-office waiting time shall be less than one (1) hour from the scheduled

appointment time. Each provider shall also demonstrate that it can document the time period for in-office waiting;

Each provider shall comply with applicable provisions of the Americans

with Disabilities Act in all business locations;

Each service site shall be located within reasonable walking distance of

public transportation;

Providers shall maintain fire safety equipment and establish practices to

protect all occupants. This shall include clearly visible fire extinguishers, with a charge, that are inspected annually by a qualified service company or trained staff member; and

Each provider shall annually obtain a written certificate of compliance

from the District of Columbia Department of Fire and Emergency Medical Services (“FEMS”) indicating that all applicable fire and safety code requirements have been satisfied for each facility.

Each window that opens shall have a screen.

Each rug or carpet in a facility shall be securely fastened to the floor or shall have a non-skid pad.

Each hallway, porch, stairway, stairwell, and basement shall be kept free from any obstruction at all times.

Each ramp or stairway used by a client shall be equipped with a firmly secured handrail or banister.

Each provider shall maintain a clean environment free of infestation and in good physical condition, and each facility shall be appropriately equipped and furnished for the services delivered.

Each provider shall properly maintain the outside and yard areas of the premises in a clean and safe condition.

Each exterior stairway, landing, and sidewalk used by clients shall be kept free of snow and ice.

Each facility shall be located in an area reasonably free from noxious odors, hazardous smoke and fumes, and where interior sounds may be maintained at reasonably comfortable levels.

A provider shall take necessary measures to ensure pest control, including:

Refuse shall be stored in covered containers that do not create a nuisance

or health hazard; and

Recycling, composting, and garbage disposal shall not create a nuisance,

permit transmission of disease, or create a breeding place for insects or rodents.

A provider shall ensure that medical waste is stored, collected, transported, and disposed of in accordance with applicable Federal and District laws, as well as guidelines from the Centers for Disease Control and Prevention (“CDC”).

Each provider shall ensure that its facilities have comfortable lighting, proper ventilation, and moisture and temperature control. Rooms, including bedrooms and activity rooms below ground level, shall be dry and the temperature shall be maintained within a normal comfort range.

Each facility shall have potable water available for each client.

No smoking shall be allowed inside a program’s facility.

Providers’ physical design and structure shall be sufficient to accommodate staff, clients, and functions of the program(s), and shall make available the following:

A reception area;

Private areas for individual treatment services;

An area(s) for dining, if applicable; and

Separate bathrooms and/or toilet facilities in accordance with District law where the:

Required path of travel to the bathroom shall not be through another bedroom;

Windows and doors provide privacy; and

Showers and toilets not intended for individual use provide privacy.

If activity space is used for purposes not related to the program’s mission, the provider shall ensure that:

The quality of services is not reduced;

Activity space in use by other programs shall not be counted as part of the required activity space; and

Client confidentiality is protected, as required by 42 CFR Part 2 and other applicable Federal and District laws and regulations.

The use of appliances such as cell phones, computers, televisions, radios, CD players, recorders, and other electronic devices shall not interfere with the therapeutic program.

Each facility shall maintain an adequately supplied first-aid kit which:

Shall be maintained in a place known and readily accessible to clients and employees; and

Shall be adequate for the number of persons in the facility.

Each provider shall have on-site at each facility a fully functioning automatic external defibrillator (“AED”) and shall ensure that all staff are trained in how to use the AED.

Each provider shall have on-site at each facility at least one dose of naloxone that is unexpired and shall ensure that all staff are trained in how to administer the naloxone.

Each provider shall post emergency numbers near its telephones for fire, police, and poison control, along with contact information and directions to the nearest hospital.

A provider shall have an interim plan addressing safety and continued service delivery during construction.

If the facility has had work done requiring a DCRA building permit or other related permits such as plumbing or electrical within the twelve (12) months prior to application for initial certification or re-certification, the applicant shall also submit copies of the DCRA permits and post-work inspection approvals during initial certification and re-certification.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6315

22-A DCMR § 6316 MEDICATION STORAGE AND ADMINISTRATION STANDARDS

Controlled substances shall be maintained in accordance with applicable Federal and District laws and regulations.

An SUD treatment program shall implement written policies and procedures to govern the acquisition, safe storage, prescribing, dispensing, labeling, administration, and the self-administration of medication, including medications clients may bring into the program that shall have a record of the prescribing physician’s order or approval prior to the administration or self-administration of medication.

Any prescribed medication brought into a facility by a client shall not be administered or self-administered until the medication is identified and the attending practitioner’s written order or approval is documented in the client record.

Verbal orders may only be given by the attending practitioner to another physician, PA, APRN, RN, or pharmacist. Verbal orders shall be noted in the client’s record as such and countersigned and dated by the prescribing practitioner within twenty-four (24) hours.

Medication, both prescription and over-the-counter, brought into a facility must be packaged and labeled in accordance with Federal and District laws and regulations.

Medication, both prescription and over-the-counter, brought into a facility by a client that is not approved by the attending practitioner shall be packaged, sealed, stored, and returned to the client upon discharge.

The administration of medications, excluding self-administration, shall be permitted only by licensed individuals pursuant to applicable District laws and regulations.

Medications shall be administered only in accordance with the prescribing practitioner’s order.

Only a physician, APRN, RN, or PA shall administer controlled substances or injectable drugs, excluding self-administered drugs.

Program staff responsible for supervision of the self-administration of medication shall document consultations with a physician, APRN, RN, pharmacist, or referral to appropriate reference material regarding the action and possible side effects or adverse reactions of each medication under their supervision.

As applicable, a program shall provide training to the staff designated to supervise the self-administration of medication. The training shall include but not be limited to the expected action of and adverse reaction to the self-administered medication.

Only trained staff shall be responsible for observing the self-administration of medication.

Medication administration training shall be facilitated by the following Qualified Practitioners, as led by signature and date on the training certificate:

Physicians;

PAs;

APRNs; or

RNs.

A program shall ensure that medication is available to clients as prescribed.

A program shall maintain records that track and account for all medication, ensuring the following:

That each client receiving medication shall have a medication administration record, which includes the client’s name, the name of medication, the type of medication (classification), the amount of medication, the dose and frequency of administration/self-administration, and the name of staff who administered or observed the self-administration of the medication;

That documentation shall include omission and refusal of medication administration;

That the medication administration record shall note the amount of medication originally present and the amount remaining;

That documentation of medication administration shall include over-the-counter (“OTC”) drugs administered or self-administered; and

That SUD treatment programs administering controlled substances, including but not limited to methadone, shall follow the requirements of applicable Federal and District laws and regulations.

An attending practitioner shall be notified immediately of any medication error or adverse reaction. The staff responsible for the medication error shall complete an incident report, and the practitioner’s recommendations and subsequent actions taken by the program shall be documented in the client record.

A program shall ensure that all medications, including those that are self-administered, are secured in locked storage areas.

The locked medication area shall provide for separation of internal and external medications.

A program shall maintain a list of personnel who have access to the locked medication area and, where applicable, are qualified to administer medication.

A program shall comply with all Federal and District laws and regulations concerning the acquisition and storage of pharmaceuticals.

Each client’s medication shall be properly labeled as required by Federal and District laws and regulations, shall be stored in its original container, and shall not be transferred to another container or taken by clients other than the client for whom it was originally prescribed.

Medications requiring refrigeration shall be maintained in a separate and secure refrigerator, labeled "FOR MEDICATION ONLY" and shall be maintained at a temperature between thirty-six degrees Fahrenheit (36°F) and forty-six degrees Fahrenheit (46°F). All refrigerators shall have thermometers, which are easily readable, in proper working condition, and accurate within a range of plus or minus two (2°F) degrees Fahrenheit.

A program shall conspicuously post in the drug storage area the following information:

Telephone numbers for the regional Poison Control Center; and

Metric-apothecaries weight and conversion measure charts.

A program shall conduct monthly inspections of all drug storage areas to ensure that medications are stored in compliance with Federal and District laws and regulations. The program shall maintain records of these inspections for verification.

Where applicable, the program shall implement written policies and procedures for the control of stock pharmaceuticals.

The receipt and disposition of stock pharmaceuticals must be accurately documented as follows:

Invoices from companies or pharmacies shall be maintained to document the receipt of stock pharmaceuticals;

A log shall be maintained for each stock pharmaceutical that documents receipt and disposition; and

At least quarterly, each stock pharmaceutical shall be reconciled as to the amount received and the amount dispensed.

A program shall implement written procedures and policies for the disposal of medication.

Any medication left by a client at discharge shall be destroyed within thirty (30) calendar days after the client has been discharged, with the exception of Methadone and other controlled substances which must be returned to the point of issue or destroyed in accordance with Federal regulations.

The disposal of all medications shall be witnessed and documented by two (2) staff members.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6316

22-A DCMR § 6317 VEHICLE ENVIRONMENTAL AND SAFETY STANDARDS

A provider shall implement measures to ensure the safe operation of its transportation service, if applicable. These measures shall include, but are not limited to:

Automobile insurance with adequate liability coverage;

Regular inspection and maintenance of vehicles, as required by law;

Adequate first aid supplies and fire suppression equipment secured in the vehicles;

Training of vehicle operators in emergency procedures and in the handling of accidents and road emergencies; and

Verification to ensure that vehicles are operated by properly licensed drivers with driving records that are absent of serious moving violations, including but not limited to driving under the influence.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6317

22-A DCMR § 6318 FOOD AND NUTRITION STANDARDS

FOOD AND NUTRITION STANDARDS

The provisions of this section apply to any provider that prepares or serves food.

All programs that prepare food shall have a current Certified Food Protection Manager (“CFPM”) certification from the District of Columbia Department of Health, and the CFPM must be present whenever food is prepared and served.

The provider shall require each CFPM (or a Certified Food Handler (“CFH”), for providers serving food prepared off-site) to monitor any staff members who are not certified as CFPMs (or CFHs) in the storage, handling, and serving of food and in the cleaning and care of equipment used in food preparation in order to maintain sanitary conditions at all times.

The kitchen, dining, and food storage areas shall be kept clean, orderly, and protected from contamination.

A program providing meals shall maintain a fully equipped and supplied code-compliant kitchen area unless meals are catered by an organization licensed by the District to serve food.

A program may share kitchen space with other programs if the accommodations are adequate to perform required meal preparation for all programs using the kitchen.

Each food and drink item procured, stored, prepared, or served by the facility shall be clean, free from spoilage, prepared in a manner that is safe for human consumption, and protected from contamination.

Dishes, cooking utensils, and eating utensils shall be cleaned after each meal and stored to maintain their sanitary condition.

Hot and cold water, soap, and disposable towels shall be provided for hand washing in or adjacent to food preparation areas.

Each facility shall maintain adequate dishes, utensils, and cookware in good condition and in sufficient quantity for the facility.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6318

22-A DCMR § 6319 PERSONNEL TRAINING STANDARDS

Provider staff shall have annual training that meets the Occupational Safety & Health Administration (“OSHA”) regulations that govern behavioral health facilities and any other applicable infection control guidelines, including use of universal precaution and avoiding exposure to hepatitis, tuberculosis, and HIV.

An SUD treatment program shall have at least two (2) staff persons, trained and certified by a nationally recognized authority that meets OSHA guidelines for basic first aid and cardiopulmonary resuscitation (“CPR”), present at all times during the hours of operation of the program. An SUD recovery program shall have at least one (1) staff person trained and certified by a recognized authority that meets OSHA guidelines in basic first aid and CPR present at all times during the hours of operation of the program. Programs serving parents with children may have additional requirements related to first aid training, pursuant to § 6326.

A provider shall have a current written plan for staff development and organizational onboarding, approved by the Department which reflects the training and performance improvement needs of all employees. The plan must address the steps the organization will take to ensure the recruitment and retention of highly qualified employees and the reinforcement of staff development through training, supervision, the performance management process, and activities such as shadowing, mentoring, skill testing and coaching. The plan must, at a minimum, include culturally competent training and onboarding activities in the following core areas:

The program’s approach to addressing treatment or RSS (as appropriate to its certification), including philosophy, goals and methods;

The staff member’s specific job description and role in relationship to other staff;

The emergency preparedness plan and all safety-related policies and procedures;

The proper documentation of services in client records, as applicable;

Policies and procedures governing infection control, protection against exposure to communicable diseases, and the use of universal precautions;

Laws, regulations, and policies governing confidentiality of client information and release of information, including 42 CFR Part 2;

Laws, regulations, and policies governing reporting abuse and neglect;

Client rights; and

Other trainings directed by the Department.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6319

22-A DCMR § 6320 CLIENT RIGHTS AND PRIVILEGES, INCLUDING GRIEVANCES

A program shall protect the following rights and privileges of each client:

Right to be admitted and receive services in accordance with the Human Rights Act of 1977, effective December 13, 1977 (D.C. Law 2-38; D.C. Code §§ 2-1401.01 et seq.);

Right to make choices regarding provider, treatment, medication, and advance directives, when necessary;

Right to receive prompt evaluation, care, and treatment, in accordance with the highest quality standards;

Right to receive services and live in healthy, safe, and clean place;

Right to be evaluated and cared for in the least restrictive and most integrated environment appropriate to a client’s needs;

Right to participate in the treatment planning process, including decisions concerning treatment, care, and other services, and to receive a copy of the Plan of Care;

Right to have records kept confidential;

Right to privacy;

Right to be treated with respect and dignity in a humane treatment environment;

Right to be safe from harm and from verbal, physical, or psychological abuse;

Right to be free of discrimination;

Right to be paid commensurate wages for work performed in compliance with applicable Federal and District laws and regulations;

Right to own personal belongings;

Right to refuse treatment and/or medication;

Right to give, not give, or revoke already-given consent to treatment, supports, and/or release of information;

Right to give, not give, or revoke informed, voluntary, written consent of the client or a person legally authorized to act on behalf of the client to participate in research; the right to protection associated with such participation; and the right and opportunity to revoke such consent;

Right to be informed, in advance, of charges for services;

Right to be afforded the same legal rights and responsibilities as any other citizen, unless otherwise stated by law;

Right to request and receive documentation on the performance track record of a program with regard to treatment outcomes and success rates;

Right to provide feedback on treatment and RSS, including evaluation of providers;

Right to assert grievances with respect to infringement of these rights, including the right to have such grievances considered in a fair, timely, and impartial manner;

Right to receive written and oral information on client rights, privileges, program rules, and grievance procedures in a language understandable to the client;

Right to access services that are culturally appropriate, including the use of adaptive equipment, sign language, interpreter, or translation services, as appropriate; and

Right to vote.

A program shall post conspicuously a statement of client rights, program rules, and grievance procedures. The grievance procedures must inform clients that they may report any violations of their rights to the Department and shall include the telephone numbers of the Department and any other relevant agencies for the purpose of filing complaints.

At the time of admission to a program, staff shall explain program rules, client rights, and grievance procedures. Program staff shall document this explanation by including a form, signed by the client and witnessed by the staff person, in the client’s record.

A program shall develop and implement written grievance procedures to ensure a prompt, impartial review of any alleged or apparent incident of violation of rights or confidentiality. The procedures shall be consistent with the principles of due process and Department requirements, and shall include but not be limited to:

Reporting the allegation or incident to the Department within twenty-four (24) hours of it coming to the attention of program staff;

Completing the investigation of any allegation or incident within thirty (30) calendar days;

Providing a copy of the investigation report to the Department within twenty-four (24) hours of completing the investigation of any complaint; and

Cooperating with the Department with any inquiries or investigations related to alleged violations of clients’ rights conducted by Department staff.

Medicaid beneficiaries are entitled to Notice and Appeal rights pursuant to 29 DCMR § 9508 in cases of intended adverse action such as an action to deny, discontinue, terminate, or change the manner or form of Medicaid-funded SUD services. The Department shall provide local-only beneficiaries the same Notice and Appeal rights as those provided to Medicaid beneficiaries in 29 DCMR § 9508.

The provider shall give the client or legal guardian a written statement concerning client’s rights and responsibilities (“Client’s Rights Statement”) in the program. The client or guardian shall sign the statement attesting to his or her understanding of these rights and responsibilities as explained by the staff person who shall witness the client’s or guardian’s signature. This document shall be placed in the client’s record.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6320

22-A DCMR § 6321 CLIENT CHOICE

CLIENT CHOICE

Each provider shall establish and adhere to policies and procedures governing the means by which clients shall be informed of the full choices of providers and how to access these services (“Client Choice Policy”).

The Department shall review and approve each provider’s Client Choice Policy during the certification process.

The Client Choice Policy shall comply with applicable Federal and District laws and regulations.

Each provider shall:

Make its Client Choice Policy available to consumers and their families; and

Establish and adhere to a system for documenting that clients and families receive the Client Choice Policy.

Each providers’ Client Choice Policy shall ensure that each client requesting SUD services directly from the provider is informed that the client may choose to have SUD services provided by any of the other certified providers that offer the appropriate LOC for that client.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6321

22-A DCMR § 6322 CLIENT RECORDS MANAGEMENT AND CONFIDENTIALITY

CLIENT RECORDS MANAGEMENT AND CONFIDENTIALITY

A program shall create and maintain an organized record for each client receiving services. Providers shall utilize an EHR system certified by the Department of Health and Human Services Office of the National Coordinator for Health Information Technology to document all phases of the client’s treatment and care.

All records must be secured in a manner that provides protection from unauthorized disclosure, access, use, or damage in accordance with both Federal and District laws and regulations.

All client records shall be kept confidential and shall be handled in compliance with 42 CFR Part 2, and Federal and District laws and regulations regarding the confidentiality of client records.

Each provider shall have a designated privacy officer responsible for ensuring compliance with privacy requirements.

A program shall ensure that all staff and clients, as part of their orientation, are informed of the privacy requirements.

A decision to disclose protected health information (“PHI”), under any provisions of Federal or District laws or regulations that permit such disclosure, shall be made only by the Privacy Officer or his/her designee with appropriately administered consent procedures.

A program shall implement policies and procedures for the release of identifying information consistent with Federal and District laws and regulations regarding the confidentiality of client records including 42 CFR Part 2, the District of Columbia Mental Health Information Act, and the Health Insurance Portability and Accountability Act (“HIPAA”).

In order to facilitate treatment and care coordination, the program shall encourage all enrolled clients to authorize the release of information to other certified providers, primary health care providers, and other health care organizations engaged in treating the client.

The program director shall designate a staff member to be responsible for the maintenance and administration of records.

A program shall arrange and store records according to a uniform system approved by the Department.

A program shall maintain records such that they are readily accessible for use and review by authorized staff and other authorized parties.

A program shall organize the content of records so that information can be located easily and so that Department surveys and audits can be conducted with reasonable efficiency.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6322

22-A DCMR § 6323 STORAGE AND RETENTION OF CLIENT RECORDS

STORAGE AND RETENTION OF CLIENT RECORDS

A provider shall retain client records (either original or accurate reproductions) until all litigation, adverse audit findings, or both, are resolved. If no such conditions exist, a provider shall retain client records for at least ten (10) years after discharge.

Records of minors shall be kept for at least ten (10) years after such minor has reached the age of eighteen (18) years.

The provider shall establish a Document Retention Schedule with all medical records retained in accordance with Federal and District laws and regulations.

If the records of a program are maintained on computer systems, the computer system shall:

Have a backup system to safeguard the records in the event of operator or equipment failure, natural disasters, power outages, and other emergency situations;

Identify the name of the person making each entry into the record;

Be secure from inadvertent or unauthorized access to records in accordance with 42 CFR Part 2 and other Federal and District laws and regulations regarding the confidentiality of client records;

Limit access to providers who are involved in the care of the client and who have permission from the client to access the record; and

Create an electronic trail when data is released.

A program shall maintain records that safeguard confidentiality in the following manner:

Records shall be stored with access controlled and limited to authorized staff and authorized agents of the Department;

Written records that are not in use shall be maintained in either a secured room, locked file cabinet, safe, or other similar container;

The program shall implement policies and procedures that govern client access to their own records;

The policies and procedures of a program shall only restrict a client’s access to their record or information in the record after an administrative review with documented clinical justification;

Clients shall receive copies of their records as permitted under 42 CFR Part 2;

All staff entries into the record shall be clear, complete, accurate, and recorded in a timely fashion;

All entries shall be dated and authenticated by the recorder with full signature and title;

All non-electronic entries shall be typewritten or legibly written in indelible ink that will not deteriorate from photocopying;

Any documentation error shall be marked through with a single line and initialed and dated by the recorder; and

Limited use of symbols and abbreviations shall be pre-approved by the program and accompanied by an explanatory legend.

Any records that are retained off-site must be kept in accordance with this chapter. If an outside vendor is used, the provider must submit the vendor’s name, address, and telephone number to the Department.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6323

22-A DCMR § 6324 CLIENT RECORD CONTENTS

CLIENT RECORD CONTENTS

At a minimum, all client records shall include:

Documentation of the referral and initial screening interview and its

findings;

The client’s consent to SUD services;

The Client’s Rights Statement;

Documentation that the client received:

An orientation to the program’s services, rules, confidentiality practices, and client’s rights; and

Notice of privacy practices and opt-out forms.

Confidentiality forms and releases signed to permit the facility to obtain and/or release information;

Diagnostic interview and assessment record, including any Department-approved screening and assessment tools;

Evaluation of medical needs and, as applicable, medication intake sheets and special diets which shall include:

Documentation of physician’s orders for medication and treatment, change of orders, and/or special treatment evaluation;

For drugs prescribed following admissions, any prescribed drug

product by name, dosage, and strength, as well as date(s) medication was administered, discontinued, or changed; and

For any prescribed “OTC” medications following admissions, any OTCs by product name, dosage, and strength, as well as date(s) medication was administered, discontinued, or changed.

Assessments and individual treatment plans pursuant to the LOC and the client’s needs, including recovery plans, if applicable;

Encounter notes, which provide sufficient written documentation to support each therapy, service, activity, or session for which billing is made that, at a minimum, consists of:

The specific service type rendered;

Dated and authenticated entries with their authors identified, that include the duration, and actual time (beginning and ending as well as a.m. or p.m.), during which the services were rendered. To constitute a valid signature, digital signatures must include a date and time stamp contemporaneous with the signature function and must be recorded and readily retrievable in the electronic system’s audit log;

Name, title, and credentials (if applicable) of the person providing the services;

The setting in which the services were rendered;

Confirmation that the services delivered are contained in the client’s treatment or recovery plan and are identified in the encounter note;

A description of each encounter or intervention provided to the client, which is sufficient to document that the service was provided in accordance with this chapter;

A description of the client’s response to the intervention sufficient to show, particularly in the case of group interventions, their unique participation in the service; and

Provider’s observations.

Documentation of all services provided to the client as well as activities directly related to the individual treatment or recovery plan that are not included in encounter notes;

Documentation of missed appointments and efforts to contact and reengage the client;

Documentation of any personal articles of the client held by the provider for safekeeping and any statements acknowledging receipt of the property;

Emergency contact information of individuals to contact in case of a client emergency with appropriate consent to share information;

Documentation of all referrals to other agencies and the outcome of such referrals;

Documentation establishing all attempts to acquire necessary and relevant information from other sources;

Pertinent information reported by the client, family members, or significant others regarding a change in the client’s condition and/or an unusual or unexpected occurrence in the client’s life;

Drug test results and incidents of drug use;

Discharge summary and aftercare plan;

Outcomes of care and follow-up data concerning outcomes of care;

Documentation of correspondence including with other medical, community providers, human service, social service, and criminal justice entities as it pertains to a client’s treatment and/or recovery; and

Documentation of a client’s representative payee or legal guardian, as applicable.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6324

22-A DCMR § 6325 RESIDENTIAL TREATMENT AND RECOVERY PROGRAMS

RESIDENTIAL TREATMENT AND RECOVERY PROGRAMS

The provisions of this section apply only to residential treatment programs and environmental stability programs, as defined by this chapter.

Each residential provider, except providers only offering environmental stability, must obtain a Certificate of Need (“CON”), from the District of Columbia State Health Planning and Development Agency (“SHPDA”).

The CON must be submitted as part of the certification application packet.

Each residential treatment program serving children and youth under eighteen (18) must obtain written approval from the Office of the State Superintendent of Education (“OSSE”).

Residential treatment and environmental stability providers shall comply with all applicable construction codes and housing codes, and zoning requirements applicable to the facility, including all Certificate of Occupancy, Basic Business License (“BBL”), and Construction Permit requirements.

Each newly established residential treatment and environmental stability provider shall provide proof of a satisfactory pre-certification inspection by DCRA for initial certification, dated not more than forty-five (45) calendar days prior to the date of submission to the Department, for District of Columbia Property Maintenance Code (12-G DCMR) and Housing Code (14 DCMR) compliance, including documentation of the inspection date and findings and proof of abatement certified by DCRA of all deficiencies identified during the inspection. This requirement can be met by submission of a Certificate of Occupancy or a BBL dated within the past six (6) months, provided that that applicant can demonstrate that DCRA performed an onsite inspection of the premises.

For existing residential treatment and recovery programs that are applying for re- certification, the applicants shall also provide proof of current BBLs.

Residential facilities’ physical design and structure shall be sufficient to accommodate staff, clients, and functions of the program and shall make available an area(s) for indoor social and recreational activities.

A program that provides overnight accommodations shall not operate more beds than the number for which it is authorized by the Department.

Other than routine household duties, no client shall be required to perform unpaid work.

Upon admission to a residential program, each client shall be provided a copy of the program’s house rules.

Each residential program shall have house rules consistent with this chapter and that include, at a minimum, rules concerning:

The use of tobacco;

The use of the telephone;

Utilizing, viewing or listening to cell phones, television, radio, computers, CDs, DVDs, or other media such as social media;

Movement of clients in and out of the facility, including a requirement for escorted movements by program staff or another agency-approved escort;

A policy that addresses search and drug testing upon return to the facility; and

The prohibition of sexual relations between staff/volunteers and clients.

Each residential program shall be equipped, furnished, and maintained to provide a functional, safe, and comfortable home-like setting.

The dining area shall have a sufficient number of tables and chairs to seat all individuals residing in the facility at the same time. Dining chairs shall be sturdy, non-folding, without rollers unless retractable, and designed to minimize tilting.

Each residential program shall permit each client to bring reasonable personal possessions, including clothing and personal articles, to the facility unless the provider can demonstrate that it is not practical, feasible or safe.

Each residential facility shall provide clients with access to reasonable individual storage space for private use.

Upon each client’s discharge from a residential program, the provider shall return to the client, or the client’s representative, any personal articles of the client held by the provider for safekeeping. The provider shall also ensure that the client is permitted to take all of his or her personal possessions from the facility. The provider may require the client or client’s representative to sign a statement acknowledging receipt of the property. A copy of that receipt shall be placed in the client’s record.

Each residential program shall maintain a separate and accurate record of all funds that the client or the client’s representative or representative payee deposits with the provider for safekeeping. This record shall include the signature of the client for each withdrawal and the signature of facility staff for each deposit and disbursement made on behalf of a client.

Each residential facility shall be equipped with a functioning landline or mobile telephone for use by clients. The telephone numbers shall be provided to clients and to the Department.

Staff bedrooms shall be separate from client bedrooms and all common living areas.

Each facility housing a residential program shall have a functioning doorbell or knocker.

Each bedroom shall comply with the space and occupancy requirements for habitable rooms in 14 DCMR § 402.

The provider shall ensure each client has the following items:

A bed, which shall not be a cot;

A mattress that was new when purchased by the provider, has a manufacturer’s tag or label attached to it, and is in good, intact condition with unbroken springs and clean surface fabric;

A bedside table or cabinet and an individual reading lamp with at least a seventy-five (75) watt, or its LED light bulb equivalent, rate of capacity;

Storage space in a stationary cabinet, chest, or closet that provides at least one (1) cubic foot of space for each client for valuables and personal items;

Sufficient suitable storage space, including a dresser and closet space, for personal clothing, shoes, accessories, and other personal items; and

A waste receptacle and clothes hamper with lid.

Each bed shall be placed at least three (3) feet from any other bed and from any uncovered radiator.

Each bedroom shall have direct access to a major corridor and at least one window to the outside, unless the DCRA, or a successor agency responsible for enforcement of the D.C. Housing Code, has determined that it otherwise meets the lighting and ventilation requirements of the D.C. Housing Code for habitable rooms.

Each facility housing a residential program shall provide one or more bathrooms for clients that are equipped with the following fixtures, properly installed and maintained in good working condition:

Toilet (water closet);

Sink (lavatory);

Shower or bathtub with shower, including a handheld shower; and

Grab bars in showers and bathtubs.

Each residential facility shall provide at least one (1) bathroom for each six (6) occupants in compliance with 14 DCMR § 602.

Each bathroom shall be adequately equipped with the following:

Toilet paper holder and toilet paper;

Paper towel holder and paper towels or clean hand towels;

Soap;

Mirror;

Adequate lighting;

Waste receptacle;

Floor mat;

Non-skid tub mat or decals; and

Shower curtain or shower door.

Each residential provider shall ensure that properly anchored grab bars or handrails are provided near the toilet or other areas of the bathroom, if needed by any resident in the facility.

Adequate provision shall be made to ensure each client’s privacy and safety in the bathroom.

Each residential program shall promote each client’s participation and skill development in menu planning, shopping, food storage, and kitchen maintenance, if appropriate.

Each residential program shall provide appropriate equipment (including a washing machine and dryer) and supplies on the premises or through a laundry service to ensure sufficient clean linen and the proper sanitary washing and handling of linen and clients’ personal clothing.

Each program shall ensure that every client has at least three (3) washcloths, two (2) towels, two (2) sheet sets that include pillowcases, a bedspread, a pillow, a blanket, and a mattress cover in good and clean condition.

Each blanket, bedspread, and mattress cover shall be cleaned regularly, whenever soiled, and before being transferred from one resident to another.

Each piece of bed linen, towel, and washcloth shall be changed and cleaned as often as necessary to maintain cleanliness, provided that all towels and bed linen shall be changed at least once each week.

No person who is not a client, staff member, or child of a client (only in the case of programs for parents and children) may reside at a facility that houses a residential treatment program.

Providers shall ensure that clients can access all scheduled or emergency medical and dental appointments.

Providers serving parents and children must take precautions to ensure child safety, including but not limited to protection for windows, outlets, and stairways.

Each facility housing a program that provides services for parents with children shall have extra supplies for babies, including but not limited to diapers, wipes, baby soap, baby food and formula.

The following provisions apply only to residential treatment programs, except environmental stability programs, as defined by this chapter:

A program that provides overnight accommodations shall ensure that

evening and overnight shifts have at least two (2) staff members on duty.

Children and youth under eighteen (18) may not reside at an adult

residential treatment facility or visit overnight at a facility not certified to serve parents and children. This information must be included in the house rules.

Each provider shall maintain a current inventory of each client’s personal

property and shall provide a copy of the inventory, signed by the client and staff, to the client.

Each provider shall take appropriate measures to safeguard and account

for personal property brought into the facility by a client.

Each provider shall provide the client, or the client’s representative, with a

receipt for any personal articles to be held by the provider for safekeeping that includes and the date it was deposited with the provider and maintain a record of all articles held for safekeeping.

Each residential treatment program shall have a licensed dietitian or

nutritionist available, a copy of whose current license shall be maintained on file, to provide the following services:

Review and approval of menus;

Education for clients with nutrition deficiencies or special needs;

Coordination with medical personnel, as appropriate; and

A nutritional assessment for each client within three (3) calendar days of admission unless the client has a current assessment or doctor’s order for dietary guidelines.

The provider shall provide at least three (3) meals per day and between meal snacks that:

Provide a nourishing, well-balanced diet in accordance with

dietary guidelines established by the United States Department of Agriculture;

Are suited to the special needs of each client; and

Are adjusted for seasonal changes, particularly to allow for the use of fresh fruits and vegetables.

The provider shall ensure that menus are written on a weekly basis, that the menus provide for a variety of foods at each meal, and that menus are varied from week to week. Menus shall be posted for the clients’ review.

The provider shall ensure that a copy of each weekly menu is retained for a period of six (6) months. The menus retained shall include special diets and reflect meals as planned and as actually served, including handwritten notations of any substitutions. The provider shall also retain receipts and invoices for food purchases for six (6) months. The records required to be retained by this subsection are subject to review by the Department.

Each meal shall be scheduled so that the maximum interval between each meal is no more than six (6) hours, with no more than fourteen (14) hours between a substantial evening meal and breakfast the following day.

If a client refuses food or misses a scheduled meal, appropriate food substitutions of comparable nutritional value shall be offered.

If a client will be away from the program during mealtime for necessary medical care, work, or other scheduled appointments, the program shall provide an appropriate meal and in-between-meal snack for the client to carry with him or her and shall ensure that the meal is nutritious as required by these rules and suited to the special needs of the client.

A residential treatment program providing meals shall implement a written Nutritional Standards Policy that outlines their procedures to meet the dietary needs of its clients, ensuring access to nourishing, well-balanced, and healthy meals. The policy shall identify the methods and parties responsible for food procurement, storage, inventory, and preparation.

The Nutritional Standards Policy shall include procedures for clients unable to have a regular diet as follows:

Providing clinical diets for medical reasons, when necessary;

Recording clinical diets in the client’s record;

Providing special diets for clients’ religious needs; and

Maintaining menus of special diets or a written plan stating how special diets will be developed or obtained when needed.

A residential treatment program shall make reasonable efforts to prepare meals that consider the cultural background and personal preferences of the clients.

Meals shall be served in a pleasant, relaxed dining area that accommodates families and children.

Under the supervision of a Qualified Practitioner, all Level 3 programs except MMIWM programs shall:

Provide training in activities of daily living;

Provide therapeutic recreational activities designed to help the client learn ways to use leisure time constructively, develop new personal interests and skills, and increase social adjustment; and

Ensure that staff providing activities listed in subparagraphs (1) and (2) have a high school degree or a GED and at least twenty (20) hours of in-service training per year regarding issues of substance abuse.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6325

22-A DCMR § 6326 PROGRAMS SERVING PARENTS AND CHILDREN

PROGRAMS SERVING PARENTS AND CHILDREN

In addition to core requirements and other standards described in this chapter, a program providing SUD treatment services to parents and their children shall comply with the provisions of this section.

The provider shall specify in its certification application the age range of the children that will be accepted in the program of parents with children, and ensure that it satisfies Federal and District laws and regulations governing care for children including those listed in this section.

The Department will include in the program certification a designation as a program serving parents with children, and specify the age range of children that may be accepted when the parents are admitted into the program.

Programs shall ensure that children are supervised at all times. Programs shall ensure that parents designate an alternate caretaker who is not in the program to care for the children in case of emergency.

Programs serving parents and young children (ages zero [0] to five [5]) shall also serve pregnant women.

Programs shall ensure all parents and children are connected to a primary care provider and any other needed specialized medical provider and shall facilitate medical appointments and treatment for parents and children in the program.

Programs shall ensure that childcare/daycare is available for children, provided while the parent participates in treatment services either directly or through contractual or other affiliation.

A program that directly operates a child development facility shall be licensed in accordance with District laws and regulations.

Programs that serve parents with children shall ensure that school-age children are in regular attendance at a public, independent, private, or parochial school, or in private instruction in accordance with District laws and regulations, and support the parent’s engagement with the child’s school.

Programs that serve parents with school-age children shall ensure that children have access to tutoring programs.

Before a parent and child can be admitted to a program serving parents and children, the program shall ensure that it has a copy of the child’s current immunization records, which must be up to date. A sixty (60) calendar day grace period will be provided to a parent(s) or child experiencing homelessness.

Programs that serve parents with children shall record information about the children residing in or attending the program who are not formally admitted for treatment, including but not limited to the following, as applicable:

Individualized education plans (“IEPs”);

Report cards;

Health records; and

Information linking the child to the course of treatment for the parent, as clinically indicated.

Programs shall develop policies and procedures for determining the need to formally admit or refer a child.

A program that is also certified to treat children and youth shall establish a separate record for each child when a clinical determination is made to formally admit the child.

An individualized Plan of Care shall be developed for any child who is formally admitted to the program.

The program shall obtain informed consent consistent with District law and regulations prior to rendering services.

Service delivery and program administration staff shall demonstrate experience and training in addressing the needs of parents and children.

All services delivery staff shall receive periodic training regarding therapeutic issues relevant to parents and children. At least two (2) times per year, the program shall provide or arrange training on each of the following topics:

Child development; and

The appropriate care and stimulation of infants, including drug-affected newborn infants.

Service delivery staff shall maintain current training in first aid and CPR for infants and children.

Programs shall ensure that an annual medical evaluation is performed for each parent and child.

Programs shall ensure that recommendations by a physician or APRN are followed.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6326

22-A DCMR § 6327 PROVIDER REQUIREMENTS FOR OPIOID TREATMENT PROGRAMS

PROVIDER REQUIREMENTS FOR OPIOID TREATMENT PROGRAMS

In accordance with 42 CFR Part 8, Certification of Opioid Treatment Programs (“OTPs”), all OTPs must be certified by the U.S. Substance Abuse and Mental Health Services Administration (“SAMHSA”), the Drug Enforcement Administration (“DEA”), and accredited by a national accreditation body that has been approved by SAMHSA.

OTPs shall comply with Federal requirements for opioid treatment, as specified in 42 CFR Part 8, and shall comply with Federal and District laws and regulations for maintaining controlled substances as specified in Chapter 10, Title 22-B DCMR and 21 CFR Part 1300, respectively.

OTPs shall submit to the Department photocopies of all applications, reports, and notifications required by Federal laws and regulations.

OTPs shall ensure the following:

That access to electronic alarm areas where drug stock is maintained shall

be limited to a minimum number of authorized, licensed personnel;

That each employee shall have his or her own individual code to access

alarmed stock areas, which shall be erased upon separation from the provider;

That all stored drugs (liquid, powder, solid, and reconstituted), including

controlled substances, shall be clearly labeled with the following information:

Name of substance;

Strength of substance;

Date of reconstitution or preparation;

Manufacturer and lot number;

Manufacturer’s expiration date, if applicable; and

If applicable, reconstituted/prepared drug’s expiration date according to the manufacturer’s expiration date or one (1) year from the date of reconstitution or preparation, whichever is shorter.

Take-home medications shall be labeled and packaged in accordance with Federal and District laws and regulations and shall include the following information:

Treatment program’s name, address, and telephone number;

Physician’s name;

Client’s name;

Directions for ingestion;

Name of medication;

Dosage in milligrams;

Date issued; and

Cautionary labels, as appropriate.

Containers of drugs shall be kept covered and stored in the appropriate locked safe, with access limited by an electronic alarm system that conforms to the DEA requirements and District laws and regulations.

The Department shall be notified of any theft, suspected theft, or any significant loss of controlled substances, including spillage. Copies of DEA forms 106 and 41 shall be submitted to the Department.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6327

22-A DCMR § 6328 LEVELS OF CARE: GENERAL REQUIREMENTS

LEVELS OF CARE: GENERAL REQUIREMENTS

All individuals seeking SUD services must be assessed and referred to a particular LOC in accordance with the Department-approved assessment tool(s) and ASAM criteria.

Each provider shall ensure that the client receives treatment in accordance with ASAM criteria and this chapter.

Each provider shall ensure that all staff comply with all Federal and District laws and regulations pertaining to scope of practice, licensing requirements, and supervision requirements.

All treatment shall be:

Person-centered;

Provided only if determined to be medically necessary in accordance with the Plan of Care; and

Provided as part of organized or structured treatment services.

Prior to transitioning to a new LOC, at a minimum, an Ongoing Diagnostic Assessment must be performed to ensure that the client is appropriate for the new LOC.

The Clinical Care Coordinator shall ensure appropriate client referrals, authorizations, and transitions to new LOCs.

6328.7 A certified provider shall not deny admission for services to an otherwise qualified client because that person is receiving MSUD services even if the MSUD services are provided by a different provider.

6328.8 All providers shall offer all Food and Drug Administration (FDA) approved forms of MSUD to any client who meets the criteria for and selects MSUD as part of their Plan of Care, in accordance with certification under this chapter or other Federal and District laws and regulations. If a provider is not certified to offer the client’s choice of medication in accordance with this chapter or under any other Federal and District laws and regulations, then the provider shall refer the client to another provider able to offer MSUD that meets the client's needs.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020); as amended by Final Rulemaking published at 72 DCR 008497 (August 1, 2025). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6328

22-A DCMR § 6329 PROVIDER REQUIREMENT: INTAKE AND ASSESSMENT

PROVIDER REQUIREMENT: INTAKE AND ASSESSMENT

Intake and Assessment is a not a LOC but a core responsibility of all certified treatment providers. All certified treatment providers, with the exception of those certified at Level R only, shall provide an initial health screening and intake and assessment in accordance with this chapter. The intake and assessment shall include the following:

Presenting problem;

Substance use history;

Immediate risks related to serious intoxication or withdrawal;

Immediate risks for self-harm, suicide and violence;

Past and present mental disorders, including posttraumatic stress disorder and other anxiety disorders, mood disorders, and eating disorders;

Past and present history of violence and trauma, including sexual victimization and interpersonal violence;

Legal history, including whether a client is court-ordered to treatment or under the supervision of the Department of Corrections;

Employment and housing status;

Once assessed, the provider shall refer the client to the appropriate LOC as outlined by ASAM. The client has a choice about which provider will provide services at that LOC. If the client does not select the provider that conducted the initial assessment as the place to receive services, the provider shall make a referral, seek authorization of services, and arrange transportation to the chosen provider if the client selects same day services. The provider shall have a policy and procedure that clearly outlines an intake process and an emergency intake process, including a procedure to refer individuals who are not clinically appropriate for its program.

All treatment providers shall provide the following services:

Initial Assessment (if the client does not remain with assessing provider);

SUD Counseling/Therapy;

Crisis Intervention;

Ongoing or Comprehensive Diagnostic Assessment (if the client remains at assessing provider);

Drug Screening;

CCC; and

RSS.

Treatment providers shall ensure appropriate staff is on duty to assess clients for acute withdrawal symptoms and to provide medical triage. Providers shall have proper infrastructure to conduct testing and screening and proper storage for testing kits.

Medical triage is the process of determining the priority of a client’s treatment needs via the following activities:

Obtaining general medical history including co-occurring medical concerns; assessing medical stability and providing clearance for treatment;

Checking vital signs including blood pressure, blood glucose, temperature, pulse, etc.;

Assessing any urgent or emergent medical concerns and addressing as appropriate including but not limited to calling and engaging 911;

Assessing for withdrawal symptoms/need for detox;

Conducting medication review to ensure that medications match bottle name and identified medical concern including physical health and psychiatric medications;

Screening and assessing for emergent psychiatric concerns; determining current degree of mental health treatment;

Urine pregnancy testing for all women of childbearing age and referral for pre-natal care if pregnant and has no provider;

Conducting tuberculosis screens;

Collecting urine for screening;

Using ASAM criteria to make recommendations for medically necessary and clinically appropriate treatment;

Collaborating with counselors regarding appropriate level of care; initiating the Treatment Assignment Protocol;

Linking all clients that test positive to medical services via a warm transition; and

Maintaining an updated list of HIV medical providers in the District.

Providers shall screen all clients for RSS.

Providers shall obtain client’s informed consent to treatment consistent with District laws and regulations.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6329

22-A DCMR § 6330 LEVEL OF CARE 1: OPIOID TREATMENT PROGRAMS

LEVEL OF CARE 1: OPIOID TREATMENT PROGRAMS

6330.1 Opioid Treatment Programs (OTPs) provide MOUD and other treatment services for clients that meet diagnostic criteria for:

(a) Active moderate to severe opioid use disorder (OUD);

(b) Being in OUD remission; or

6330.2 MOUD are medications, including opioid agonist medications, approved by the FDA, for use in the treatment of OUD. OTPs shall not preclude clients who refuse SUD Counseling/Therapy from receiving MOUD. OTPs shall administer MOUD in accordance with 42 Code of Federal Regulations Part 8.

6330.3 OTPs shall obtain informed consent for MOUD treatment. OTPs shall present the client with information about the proposed medication, including its purpose, side effects, and potential risks and benefits, as well as information about feasible alternative treatments and other medications approved to treat OUD. OTPs shall document a client’s written or verbal informed consent in the client’s medical records.

6330.4 Minors may consent to MOUD at an OTP without parental or guardian consent or court authorization only under the following circumstances:

(a) If the parent or guardian is not available to consent, and the treating physician determines that the medication is medically necessary and the minor has the capacity to give informed consent;

(b) If requiring parental or guardian consent would jeopardize the health or safety of the minor, and the treating physician determines the minor has the capacity to give informed consent and the medication is medically necessary; or

(c) If the parent or guardian refuses consent, and the treating physician determines the minor has the capacity to give informed consent and the medication is medically necessary. The OTP shall notify the parent or guardian in writing of the decision to administer the medication to the minor under this paragraph.

6330.5 OTPs may administer MOUD in an office, through a mobile unit, or as a take-home regimen. OTPs shall ensure that all MOUD administrations are documented in the medical record and include the unit of medication and therapeutic guidance. For clients receiving a take-home regimen, therapeutic guidance shall include guidance related to storage and self-administration.

6330.6 OTPs shall provide clinically appropriate treatment services tailored to each client’s Plan of Care. OTPs shall provide an array of OUD treatment services that include:

(a) Diagnostic Assessment and Plan of Care in accordance with § 6339;

(b) MOUD in accordance with § 6346;

(d) CCC in accordance with § 6340;

(e) Drug Screening in accordance with § 6343 and including at least eight (8) random drug screens per year, per client;

(f) Crisis Intervention in accordance with § 6341; and

(g) RSS in accordance with § 6344.

6330.7 Providers shall have a physician, Physician Assistant (PA), Advanced Practice Registered Nurse (APRN), or Registered Nurse (RN) on duty during all clinic hours. A physician shall be available on-call during all clinic hours, if not present on site.

6330.8 An OTP shall provide a mechanism to address a client’s medical or psychiatric emergencies occurring outside of program hours of operation, including an emergency system to obtain dosage levels and other pertinent client information, twenty-four (24) hours a day, seven (7) days a week. OTPs shall provide every client an identification card that identifies the pharmacotherapy being administered through the OTP. The card shall include the provider’s emergency contact information so that appropriate clinical information and dosing information can be obtained in an emergency.

6330.9 OTPs shall ensure that each client undergoes a complete, fully documented physical and behavioral health evaluation within fourteen (14) calendar days following admission, and at least yearly thereafter and in accordance with the Plan of Care. Evaluations shall include:

(a) Screening for imminent risk of harm to self or others;

(b) Review of patient-identified goals, MOUD dosing, treatment response, and other SUD treatment needs;

(c) Assessment of the client’s need for any necessary adjustments to treatment interventions, including MOUD and other relevant physical and psychiatric treatment needs and goals; and

(d) Updates to client’s person-centered Plan of Care to incorporate recommendations from these assessments, as needed.

6330.10 OTPs shall address in the client’s Plan of Care the client’s needs and interests in harm reduction interventions, physical and mental health care, and health-related social supports, including education, vocational training, employment, housing, and other recovery support services. The OTP shall specify the recommended service frequency and update the Plan of Care to address the client’s progress, treatment response, and changes in their current life, needs, and interests in medical, psychological, and socio-economic services.

6330.11 An OTP shall provide counseling on preventing exposure to, and the transmission of, HIV for each client admitted or readmitted to the program.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020); as amended by Final Rulemaking published at 72 DCR 008497 (August 1, 2025). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6330 District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6330

22-A DCMR § 6331 LEVEL OF CARE 1: OUTPATIENT

LEVEL OF CARE 1: OUTPATIENT

Level 1 Outpatient providers shall have the capacity to provide up to eight (8) hours of SUD treatment services per week, per client, in accordance with this section and medical necessity based on ASAM criteria. Level 1 Outpatient is the appropriate LOC for individuals who are assessed as meeting the ASAM criteria for Level 1 and:

Recognize their SUD and are committed to recovery;

Are transitioning from a higher LOC;

Are in the early stages of change and not yet ready to commit to full recovery;

Have a co-occurring condition that is stable; or

Have achieved stability in recovery and can benefit from ongoing monitoring and disease management.

6331.2 Level 1 Outpatient providers may also be certified in the following specialty services:

Adolescent Community Reinforcement Approach in accordance with § 6347 of this chapter for services to youth and young adults with co-occurring substance use and mental health disorders ages twelve (12) to twenty-one (21) for youth providers and twenty-two (22) to twenty-four (24) for adult providers.

MET/CBT in accordance with § 6352 of this chapter for services to a child/youth up to age twenty-three (23) with a cannabis use disorder.

Level 1 Outpatient treatment duration varies with the severity of the patient’s SUD and their response to treatment but generally lasts up to one hundred and eighty (180) days for an initial authorization. Level 1 treatment can continue long-term in accordance with the Plan of Care, for clients needing long-term disease management.

Level 1 Outpatient services are determined by a Diagnostic Assessment, performed in accordance with § 6339.

Unless clinically inappropriate or a client does not consent, all providers shall adhere to the service requirements for this LOC.

Level 1 Outpatient shall include the following mix of services in accordance with the client’s Plan of Care and this chapter (unless the client is receiving ACRA services in which case SUD Counseling/Therapy and CCC shall be provided in accordance with § 6347):

Diagnostic Assessment and Plan of Care in accordance with § 6339.

SUD Counseling/Therapy in accordance with § 6342;

CCC in accordance with § 6340;

Drug Screening in accordance with § 6343;

Crisis Intervention in accordance with § 6341; and

RSS in accordance with § 6344.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6331

22-A DCMR § 6332 LEVEL OF CARE 2.1: INTENSIVE OUTPATIENT PROGRAM (IOP)

LEVEL OF CARE 2.1: INTENSIVE OUTPATIENT PROGRAM (IOP)

Level 2.1 Intensive Outpatient Program (IOP) providers shall have the capacity to provide between nine (9) and nineteen (19) hours of a mixture of SUD treatment services per week for adults and between six (6) and nineteen (19) hours of treatment services per week for adolescents in accordance with this section and medical necessity based on ASAM criteria. IOP is the appropriate LOC for clients who are assessed as meeting the ASAM criteria for Level 2.1 and:

Recognize their SUD and are committed to recovery;

Are transitioning from a different LOC; or

Have stable medical or psychiatric co-occurring conditions.

Unless clinically inappropriate or a client does not consent, all providers shall adhere to the service requirements for this LOC.

Level 2.1 IOP includes the following mix of core services, in accordance with the client’s Plan of Care:

Diagnostic Assessment and Plan of Care in accordance with § 6339;

SUD Counseling/Therapy in accordance with § 6342;

CCC in accordance with § 6340;

Drug Screening in accordance with § 6343;

Crisis Intervention in accordance with § 6341; and

RSS in accordance with § 6344.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6332

22-A DCMR § 6333 LEVEL OF CARE 2.5: DAY TREATMENT

LEVEL OF CARE 2.5: DAY TREATMENT

Level 2.5 Day Treatment providers shall have the capacity to provide a minimum of twenty (20) hours of a mixture of SUD treatment services per week, per client, in accordance with this section and medical necessity based on ASAM criteria. Day Treatment is the appropriate LOC for clients who are assessed as meeting the ASAM criteria for Level 2.5 and:

Have unstable medical or psychiatric co-occurring conditions; or

Have issues that require daily management or monitoring but can be addressed on an outpatient basis.

Unless clinically inappropriate or a client does not consent, all providers shall adhere to the service requirements for this LOC.

Level 2.5 Day Treatment includes the following mix of core services as indicated on the Plan of Care and in accordance with this chapter:

Diagnostic Assessment and Plan of Care in accordance with § 6339;

SUD Counseling/Therapy in accordance with § 6342;

CCC in accordance with § 6340;

Drug Screening in accordance with § 6343;

Crisis Intervention in accordance with § 6341; and

RSS in accordance with § 6344.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6333

22-A DCMR § 6334 LEVEL OF CARE 3.1: CLINICALLY MANAGED LOW-INTENSITY RESIDENTIAL

LEVEL OF CARE 3.1: CLINICALLY MANAGED LOW-INTENSITY RESIDENTIAL

Level 3.1 Clinically Managed Low-Intensity Residential providers shall have the capacity to provide a minimum of five (5) hours of a mixture of SUD treatment services per week, per client, in accordance with this section and medical necessity based on ASAM criteria. Level 3.1 providers must be staffed with independently licensed clinicians who are competent to treat SUD and mental illness. A physician must be available on-site or by telephone twenty-four (24) hours a day, seven (7) days a week. Level 3.1 Clinically Managed Low-Intensity Residential is the appropriate LOC for clients who are assessed as meeting the ASAM criteria for Level 3.1 and:

Are employed, in school, in pre-vocational programs, actively seeking employment, or involved in a structured day program;

Recognize their SUD and are committed to recovery or are in the early stages of change and not yet ready to commit to full recovery but need a stable supportive living environment to support their treatment or recovery;

May have a stable co-occurring physical or mental illness;

Who meet the ASAM criteria for Level 3.1, or its equivalent, as approved by the Department; and

Who are capable of self-care but are not ready to return to family or independent living.

Unless clinically inappropriate or a client does not consent, all providers shall adhere to the minimum service requirements for this LOC.

Level 3.1 Clinically Managed Low-Intensity Residential includes the following mix of core and specialty services, as indicated on the Plan of Care and in accordance with this chapter:

Diagnostic Assessment and Plan of Care in accordance with § 6339;

SUD Counseling/Therapy in accordance with § 6342;

CCC in accordance with § 6340;

Drug Screening in accordance with § 6343;

[REPEALED];

Medication Management in accordance with § 6345; and

RSS in accordance with § 6344.

The provider shall conduct discharge planning shall for all clients discharged from Level 3.1. Discharge planning criteria shall include at least the following activities prior to discharge from a Level 3.1 program:

A review of the client’s behavioral health, social, and physical needs;

Completion of referrals to appropriate community services providers, to address the client’s identified needs;

If the client desires, the provider shall arrange for appointments with community providers which shall be made as soon as possible after discharge; and

Each client shall be given the opportunity to participate in the development of his or her discharge plan, including selecting appropriate community providers. With the consent of the client, and when clinically appropriate, reasonable attempts shall be made to contact family members for their participation in the discharge planning process. No client or family member shall be required to agree to a discharge. A provider shall make a notation in the client’s record if any objection is raised to the discharge plan.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6334

22-A DCMR § 6335 LEVEL OF CARE 3.3: CLINICALLY MANAGED POPULATION-SPECIFIC HIGH-INTENSITY RESIDENTIAL

LEVEL OF CARE 3.3: CLINICALLY MANAGED POPULATION-SPECIFIC HIGH-INTENSITY RESIDENTIAL

Level 3.3 Clinically Managed Population-Specific High-Intensity Residential providers shall have the capacity to provide a minimum of twenty (20) hours of mixture of SUD treatment services per week, per client, in accordance with this section and medical necessity based on ASAM criteria. Level 3.3 providers must be staffed with physicians, PA or APRN and qualified practitioners able to deliver the necessary mixture of SUD services. One or more clinicians must be available on-site or by telephone twenty-four (24) hours a day, seven (7) days a week. Level 3.3 Clinically Managed Population-Specific High-Intensity Residential is the appropriate LOC for clients who are assessed as meeting the ASAM criteria for Level 3.3 and:

Need a stable supportive living environment to support their treatment or recovery;

Have co-occurring or other issues that have led to temporary or permanent

cognitive impairments and would benefit from slower-paced repetitive treatment; or

Have unstable medical or psychiatric co-occurring conditions.

Unless clinically inappropriate or a client does not consent, all providers shall adhere to the minimum service requirements for this LOC.

Level 3.3 Clinically Managed Population-Specific High-Intensity Residential includes the following mix of services, as indicated on the Plan of Care and in accordance with this chapter:

Diagnostic Assessment and Plan of Care in accordance with § 6339;

SUD Counseling/Therapy in accordance with § 6342;

CCC in accordance with § 6340;

Drug Screening in accordance with § 6343;

[REPEALED];

Medication Management in accordance with § 6345; and

RSS in accordance with § 6344.

The provider shall conduct discharge planning for all clients discharged from Level 3.3. Discharge planning criteria shall include at least the following activities prior to discharge from a Level 3.3 program:

A review of the client’s behavioral health, social, and physical needs;

Completion of referrals to appropriate community services providers to address the client’s identified needs;

If the client desires, the provider shall arrange for appointments with community providers which shall be made as soon as possible after discharge; and

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6335

22-A DCMR § 6336 LEVEL OF CARE 3.5: CLINICALLY MANAGED HIGH-INTENSITY RESIDENTIAL (ADULT)/ CLINICALLY MANAGED MEDIUM-INTENSITY RESIDENTIAL (YOUTH)

LEVEL OF CARE 3.5: CLINICALLY MANAGED HIGH-INTENSITY RESIDENTIAL (ADULT)/ CLINICALLY MANAGED MEDIUM-INTENSITY RESIDENTIAL (YOUTH)

Level 3.5 Clinically Managed High-Intensity Residential/Clinically Managed Medium-Intensity Residential providers shall have the capacity to provide a minimum of twenty-five (25) hours of a mixture of SUD treatment services per week, per client, in accordance with this section and medical necessity based on ASAM criteria. One or more clinicians must be available on-site or by telephone twenty-four (24) hours a day, seven (7) days a week. Level 3.5 is the appropriate LOC for clients who are assessed as meeting the ASAM criteria for Level 3.5, need a twenty-four (24) hour supportive treatment environment to initiate or continue their recovery process, and:

Have co-occurring or severe social/interpersonal impairments due to substance use; or

Significant interaction with the criminal justice system due to substance use.

Unless clinically inappropriate or a client does not consent, all providers shall adhere to the minimum service requirements for this LOC.

Level 3.5 includes the following mix of services, as indicated on the Plan of Care and in accordance with this chapter:

Assessment and Plan of Care in accordance with § 6339;

SUD Counseling/Therapy in accordance with § 6342;

CCC in accordance with § 6340;

Drug Screening in accordance with § 6343;

[REPEALED];

Medication Management in accordance with § 6345; and

RSS in accordance with § 6344.

Discharge planning shall be conducted for all clients discharged from Level 3.5. Discharge planning criteria shall include at least the following activities prior to discharge from a Level 3.5 program:

A review of the client’s behavioral health, social, and physical needs;

Completion of referrals to appropriate community services providers to address the client’s identified needs;

If the client desires, the provider shall arrange for appointments with community providers which shall be made as soon as possible after discharge; and

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6336

22-A DCMR § 6337 LEVEL OF CARE 3.7-WM: MEDICALLY MONITORED INPATIENT WITHDRAWAL MANAGEMENT (MMIWM)

LEVEL OF CARE 3.7-WM: MEDICALLY MONITORED INPATIENT WITHDRAWAL MANAGEMENT (MMIWM)

MMIWM is twenty-four (24) hour, medically directed evaluation and withdrawal management service. This service is for clients with sufficiently severe signs and symptoms of withdrawal from psychoactive substances who require medical monitoring and nursing care, but for whom hospitalization is not indicated.

MMIWM shall include the following services in accordance with ASAM criteria, as clinically appropriate:

Medication Management in accordance with § 6345;

CCC in accordance with § 6340;

MSUD in accordance with § 6346;

Drug Screening in accordance with § 6343;

[REPEALED];

RSS, in accordance with § 6344, which must be billed separately;

SUD Counseling/Therapy, in accordance with § 6342, which must be billed separately; and

Comprehensive Diagnostic Assessment, in accordance with § 6339, which must be billed separately.

Discharge planning shall be conducted for all clients discharged from MMIWM. Discharge planning criteria shall include at least the following activities prior to discharge from a MMIWM program:

A review of the client’s behavioral health, social, and physical needs;

Completion of referrals to appropriate community services providers, including additional residential treatment, to address the client’s identified needs;

If the client desires, the provider shall arrange for appointments with community providers which shall be made as soon as possible after discharge; and

MMIWM providers shall have a physician on staff that is able to respond within one (1) hour of notification.

MMIWM providers shall have medical staff (physician, PA, APRN, or RN) on duty twenty-four (24) hours per day, seven (7) days per week providing directed evaluation, care, and treatment in an inpatient setting. Medical staff shall have a client-to-staff ratio of 12-to-1 during daytime operating hours, a 17-to-1 ratio during evening hours, and a 25-to-1 ratio during the night shift.

A withdrawal management service Level 3.7 provider shall offer twenty-four (24) hour medically supervised evaluation and withdrawal management.

MMIWM shall have psychiatric services available on-site, through consultation or referral as medically necessary according the client’s needs for treatment and recovery.

MMIWM shall have psychosocial and medical services delivered by appropriate staff in accordance with § 6337.4, who can administer withdrawal management services to a client by: (1) monitoring the decreasing amount of alcohol and toxic agents in the body; (2) managing the withdrawal symptoms; and (3) motivating the client to participate in an appropriate treatment program for alcohol or other drug dependence.

Qualified practitioners of Medically Monitored Inpatient Withdrawal Management (MMIWM) are:

Physicians;

Psychologists;

PAs;

RNs;

LICSWs;

LISWs;

LGSWs;

APRNs;

LPCs;

LMFTs;

LGPCs;

Psychology Associates; and

CACs I or II.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024); as amended by Final Rulemaking published at 72 DCR 008497 (August 1, 2025). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6337

22-A DCMR § 6338 LEVEL OF CARE-R: RECOVERY SUPPORT SERVICES

LEVEL OF CARE-R: RECOVERY SUPPORT SERVICES

RSS covers the provision of non-clinical services for clients in treatment or in need of supportive services to maintain their recovery.

RSS providers shall provide the following core RSS:

Recovery Support Evaluation; and

RSS.

RSS providers may provide the following specialty services, in accordance with their certification:

Environmental Stability.

RSS are for clients who have an identified need for RSS and:

Are actively participating in the Department treatment system;

Have completed treatment; or

Have a self-identified substance use issue that is not assessed as needing

active treatment.

If a client is assessed as needing treatment and is not currently enrolled in treatment, he or she must be referred to an SUD provider for treatment in addition to receiving RSS.

The duration of Level-R RSS varies but lasts as long as needed, with a reassessment every one hundred and eighty (180) calendar days.

RSS are determined by a Recovery Support Evaluation, performed in accordance with § 6349 of this chapter.

Unless clinically inappropriate or a client does not consent, all providers shall adhere to the minimum service requirements for this LOC.

Each recovery program must have a recovery program manager who is responsible for overseeing all services provided within the recovery program.

Each recovery program must have a comprehensive curriculum for its RSS that has been approved by the Department.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6338

22-A DCMR § 6339 CORE SERVICE: DIAGNOSTIC ASSESSMENT AND PLAN OF CARE

CORE SERVICE: DIAGNOSTIC ASSESSMENT AND PLAN OF CARE

Diagnostic Assessment and Plan of Care services include two distinct actions: (1) the assessment and diagnosis of the client, and (2) the development of the Plan of Care. A Diagnostic Assessment and Plan of Care Service may be (1) Comprehensive or (2) Ongoing.

The Diagnostic Assessment portion of this service includes the evaluation and ongoing collection of relevant information about a client to determine or confirm an SUD diagnosis and the appropriate LOC. The assessment shall serve as the basis for the formation of the Plan of Care, which establishes medical necessity and is designed to help the client achieve and sustain recovery. The assessment instrument shall incorporate ASAM criteria.

All assessment services must include a Plan of Care, including the development of or an update to a Plan of Care and necessary referrals. Updates to the Plan of Care shall occur, at a minimum:

Every one hundred and eighty (180) days for all clients in OTP and Level 1 programs;

Every sixty (60) days for clients in Level 2.1 programs;

Every thirty (30) days for clients in Level 2.5 programs;

Every ninety (90) days for clients in Level 3.1 or 3.3 programs;

Every twenty-eight (28) days for clients in Level 3.5 programs; and

Every five (5) days for clients in Level 3.7 programs.

Providers shall use a tool(s) approved by the Department for both the Diagnostic Assessment and Plan of Care.

Diagnostic Assessment and Plan of Care services shall be provided in certified SUD treatment programs or community settings.

The Plan of Care shall be person-centered and include the following elements:

Overall broad, long-term goal statement(s) that captures the client’s and/or family’s short- and long-term goals for the future, ideally written in first-person language. This shall include the client’s self-identified recovery goals;

List or statement of individual or family strengths that support goal(s) accomplishment. These include abilities, talents, accomplishments, and resources;

List or statement of barriers that pose obstacles to the client’s and/or family’s ability to accomplish the stated goal(s). These include symptoms, functional impairments, lack of resources, consequences of behavioral health issues, and other challenges;

Statement of objectives that identify the short-term client and/or family changes in behavior, function, or status that can help overcome the identified barriers and are building blocks toward the eventual accomplishment of the long-term goal(s). Objective statements describe outcomes that are measurable and include individualized target dates to be accomplished within the scope of the plan;

Intervention statements that describe the treatment and recovery services to be utilized to reduce or eliminate the barriers identified in the plan and support objective and eventual goal(s) accomplishment. Interventions are specific to each objective and the client’s and/or family’s stage of change. Intervention statements identify who will deliver the service, what will be delivered, when it will be delivered, and the purpose of the intervention. Natural support interventions should also be included in the plan and include those non-billable supports delivered by resources outside of the formal behavioral health service-delivery system. When appropriate and applicable, EBP shall be incorporated into the intervention statement;

Provide for the delivery of services in the least restrictive environment that is appropriate for the client;

The client or legal guardian’s signature on the plan (if the client refuses to

sign the Plan of Care, the Clinical Care Coordinator shall document the reason(s) in the Plan of Care); and

Signatures of all interdisciplinary team members participating in the development of the Plan of Care. A Plan of Care is valid when electronically signed and dated by an independently licensed clinician working within the scope of their license.

For individuals receiving only RSS services, their Plan of Care shall be signed by those Qualified Practitioners described in §6344.11.

For clients who are determined appropriate for an outpatient level of care (outpatient OTP, Level 1, Level 2.1, and Level 2.5) and who meet the eligibility requirements described in §§ 6301.4 or 6301.5, the outpatient provider delivering such services shall, as a part of the development or updating of the Plan of Care, comply with the requirements set forth in 22-A DCMR Chapter 37 regarding:

Assessment of the client for interest in, potentially eligibility for, and referral to SUD Supported Employment services, and

Integration of Employment Specialists into the SUD provider’s treatment team.

An Initial Assessment/Diagnostic and Plan of Care service (“Initial Assessment”) is a behavioral health assessment that (1) identifies the client’s need for SUD treatment, (2) determines the appropriate LOC of SUD treatment, and (3) initiates the course of treatment. The following provisions apply to an Initial Assessment:

The provider shall use and complete an assessment tool approved by the Department that meets the ASAM biopsychosocial requirements. The assessment should result in identification of the necessary LOC and an appropriate provider referral, documented in the designated electronic record format.

The provider shall record any medications used by the client;

Staff must have an in-person encounter with the client to conduct the initial assessment;

Providers must obtain and document client's understanding and agreement, evidenced by the client’s signature, for consent to treatment, assessment, provider choice, the client bill of rights, and release of information; and

A treatment provider will complete an Initial Assessment and refer the client to the appropriate LOC or treat the client 1) if the client is found appropriate for the LOC available at that provider, and 2) the client chooses to receive services at that provider.

A Comprehensive Diagnostic Assessment is a behavioral health assessment that collects, compiles, and integrates sufficiently detailed information to successfully guide level of care decisions, the place of care process, and the provision of services.

Providers shall ensure appropriate staff (physician, PA, APRN, or RN) is available to assess clients for acute withdrawal symptoms and provide medical triage. Providers shall use a Department-approved assessment tool to determine the need for withdrawal management. Providers shall have infrastructure to conduct health testing and screening as appropriate, and storage for testing kits. If the provider does not have the infrastructure or medical personnel on their staff the provider shall enter into an affiliation agreement or contract with a medical provider for these services, or show the Department documentation that they are part of an integrated care setting that offers the services.

The following provisions apply to the Comprehensive Diagnostic Assessment:

When a client enters his or her first LOC within a treatment episode, the provider shall perform a Comprehensive Diagnostic Assessment to determine their treatment and recovery needs, unless a Comprehensive Diagnostic Assessment completed within the last sixty (60) days is available to the treating provider; in that case, an ongoing assessment may be completed. A Comprehensive Diagnostic Assessment consists of a biopsychosocial assessment and the development of a Plan of Care. ASAM biopsychosocial elements include, but are not limited to:

History of the presenting episode;

Family history;

Developmental history;

Alcohol, tobacco, other drug use, addictive behavior history;

Personal/social history;

Legal history;

Psychiatric history;

Medical history;

Spiritual history;

Review of systems;

Mental status examination;

Medical triage;

Formulation and diagnosis;

Survey of assets, vulnerabilities, and supports;

Treatment recommendations; and

Health screenings/testing including:

HIV;

Hepatitis;

Tuberculosis (if referred for residential and detox); and

Pregnancy (If applicable).

A Comprehensive Diagnostic Assessment shall include the use of a Department-approved assessment tool and a detailed diagnostic formulation. The Comprehensive Diagnostic Assessment will document the client’s strengths, resources, mental status, identified problems, current symptoms as outlined in the DSM, and RSS needs. The Comprehensive Diagnostic Assessment will also confirm the client’s scores on the ASAM criteria and confirm that the assigned LOC is most applicable to the client’s needs. The diagnostic formulation shall include presenting symptoms for the previous twelve (12) months, including mental and physical health symptoms, degree of severity, functional status, and differential diagnosis. This information forms the basis for the development of the individualized person-centered Plan of Care as defined in § 6339.

A Comprehensive Diagnostic Assessment must be performed in-person by an interdisciplinary team consisting of the client and at least one Qualified Practitioner allowed to diagnose in accordance with their license.

The approval of the Plan of Care is demonstrated by the electronic signature and date stamp of an independently licensed Qualified Practitioner. A completed Plan of Care is required to establish medical necessity.

A Comprehensive Diagnostic Assessment and Plan of Care must be completed within seven (7) calendar days of the client’s admission to a provider. Providers at Level 3.7-MMIWM must complete a Comprehensive Diagnostic Assessment within forty-eight (48) hours of the client’s admission, or prior to discharge or transfer to another LOC, whichever comes first.

Within twenty-four (24) hours of the client’s admission at a new LOC, during the period prior to the completion of the Comprehensive Diagnostic Assessment, the provider shall review the client’s prior Department-approved Diagnostic Assessment to assist with developing a Plan of Care.

The Plan of Care (valid for seven (7) calendar days) will validate treatment until the Comprehensive Diagnostic Assessment is completed. A Qualified Practitioner as listed in § 6339 shall develop the Plan of Care. A Comprehensive Diagnostic Assessment and Plan of Care shall include client understanding and agreement, documented by the client’s signature, for consent to treatment, assessment, provider choice, client bill of rights, and release of information.

Ongoing Diagnostic Assessment and Plan of Care occurs at regularly scheduled intervals depending on the LOC. The following provisions apply to ongoing assessments:

An Ongoing Diagnostic Assessment and Plan of Care, conducted using a tool(s) approved by the Department, provides a review of the client’s strengths, resources, mental status, identified problems, and current symptoms as outlined in the most recent DSM.

An Ongoing Diagnostic Assessment will confirm the appropriateness of the existing diagnosis and revise the diagnosis, as warranted. The Ongoing Diagnostic Assessment will also revise the client’s scores on all dimensions of the ASAM criteria, as appropriate, to determine if a change in LOC is needed and make recommendations for changes to the Plan of Care.

An Ongoing Diagnostic Assessment includes a review and update of the Plan of Care with the client to reflect the client’s progress, growth, and ongoing areas of need.

The Ongoing Diagnostic Assessment and Plan of Care is also used prior to a planned transfer to a different LOC and for discharge from a course of service.

The Ongoing Diagnostic Assessment can be used for a review and documentation of a client’s physical and mental status for acute changes that require an immediate response, such as a determination of a need for immediate hospitalization.

The Clinical Care Coordinator shall determine the frequency of Ongoing Diagnostic Assessments and Plan of Care services.

An Ongoing Diagnostic Assessment and Plan of Care must be completed in-person with the client and at least one Qualified Practitioner with the license and capability to develop a diagnosis.

The Ongoing Diagnostic Assessment requires documentation of the assessment tools, updated diagnostic formulation, and the Plan of Care update. The diagnostic formulation shall include presenting symptoms since previous assessment (including mental and physical health symptoms), degree of severity, functional status, and differential diagnosis. The Plan of Care update shall address current progress toward goals for all problematic areas identified in the Diagnostic Assessment and adjust interventions and RSS as appropriate.

Qualified Practitioners of Diagnostic Assessment and Plan of Care who are permitted to screen, assess, and diagnose are:

Physicians;

Psychologists;

LICSWs;

LGPCs;

LGSWs;

LPCs;

LMFTs;

APRNs; and

PAs.

Qualified Practitioners of Diagnostic Assessment and Plan of Care who are

permitted to provide screening and assessment services, but who are not permitted to diagnose are:

Psychology Associates;

CACs I and II;

RNs; and

LISWs.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6339

22-A DCMR § 6340 CORE SERVICE: CLINICAL CARE COORDINATION

CORE SERVICE: CLINICAL CARE COORDINATION

The CCC service adopts a “whole-person” approach to address the client’s needs related to physical health, behavioral health, and social determinants of health. CCC involves coordination of care between the behavioral health clinician and the clinical personnel of an external provider (e.g., primary care, another behavioral health provider, hospital).

CCC occurs when the practitioner, through direct face-to-face contact, video-conferencing, or telephone, communicates treatment needs, assessments, and treatment information to external health care providers and facilitates appropriate linkages with other health care professionals, including transitions into or from higher levels of care or institutional settings. CCC also includes treatment planning and plan of care implementation activities that are separate from the diagnostic assessment service, when the clinician and client are meeting face-to-face or through video-conference.

The Clinical Care Coordinator is responsible for ensuring that the client is at the appropriate LOC. If the client fails to make progress or has met all of their treatment goals, the Clinical Care Coordinator shall ensure timely assessment and transfer to a more appropriate LOC.

The CCC service must be documented in an encounter note that indicates the intended purpose of that particular service, the actions taken, and the result(s) achieved.

CCC shall be provided in certified SUD treatment programs or community settings.

Qualified Practitioners of Clinical Care Coordination (CCC) are:

Physicians;

Psychologists;

LICSWs;

LGSWs;

APRNs;

LMFTs;

RNs;

LISWs;

LPCs;

PAs;

Psychology Associates; and

LGPCs.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6340

22-A DCMR § 6341 CORE SERVICE: CRISIS INTERVENTION

CORE SERVICE: CRISIS INTERVENTION

Crisis Intervention is an immediate short-term treatment intervention, which assists a client to resolve an acute personal crisis that significantly jeopardizes the client’s treatment, recovery progress, health, or safety. Crisis Intervention does not necessarily lead to a change in LOC or a change to the Plan of Care; however, if a change is needed, this service may be followed by an Ongoing Diagnostic Assessment.

Crisis Intervention is a service available at ASAM Level 1, Outpatient Treatment, through Level 2.5, Day Treatment, and can be provided to any client in treatment, even if the service is not included on the Plan of Care.

Crisis Intervention services must be documented using an encounter note that explains the crisis and the response.

Crisis Intervention services shall be provided in certified SUD treatment programs or community settings.

Qualified Practitioners of Crisis Intervention are:

Physicians;

Psychologists;

LICSWs;

LGSWs;

APRNs;

RNs;

PAs;

Psychology Associates;

LISWs;

LPCs;

LGPCs;

LMFTs; and

CACs I and II.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6341

22-A DCMR § 6342 CORE SERVICE: SUBSTANCE USE DISORDER COUNSELING/THERAPY

CORE SERVICE: SUBSTANCE USE DISORDER COUNSELING/THERAPY

SUD Counseling/Therapy shall include Individual, Family, and Group Therapy.

Providers shall deliver SUD Counseling/Therapy in certified SUD treatment programs or community settings.

The following practitioners may provide SUD Counseling/Therapy:

Qualified Practitioners of SUD Counseling/Therapy are:

(1) Psychiatrist;

(2) Physicians;

(3) Psychologists;

(4) Advanced Practice Registered Nurses (APRNs);

(5) Licensed Independent Clinical Social Workers (LICSWs);

(6) Licensed Marriage and Family Therapists (LMFTs); and

(7) Licensed Professional Counselors (LPCs).

The following may deliver SUD Counseling/Therapy under the supervision of a Qualified Practitioner:

(1) Psychology Associates;

(2) Certified Addiction Counselors (CACs) I and II;

(3) Licensed Graduate Social Workers (LGSWs);

(4) Licensed Graduate Professional Counselors (LGPCs); and

(5) Licensed Independent Social Workers (LISWs).

Individual SUD Counseling/Therapy is a face-to-face service for symptom and behavior management, development, restoration, or enhancement of adaptive behaviors and skills, and enhancement or maintenance of daily living skills to facilitate long-term recovery.

Individual SUD Counseling/Therapy addresses the specific issues identified in the Plan of Care. Individual counseling/therapy shall:

Be documented in an encounter note; and

Not be conducted within the same or overlapping time period as Medication Management.

Group Counseling/Therapy includes Cognitive Behavioral Groups, Support Groups, and Interpersonal Process Groups. Cognitive Behavioral Groups have a trained facilitator utilizing a specific therapeutic model to alter thoughts and actions that lead to substance use. Support Groups uplift members and provide a forum to share pragmatic information about managing day to day life. Interpersonal Process Groups delve into major developmental issues that contribute to SUD or interfere with recovery.

The following provisions apply to Group SUD Counseling:

Group SUD Counseling/Therapy addresses the specific issues identified in the Plan of Care;

The focus of the group SUD Counseling/Therapy session shall be driven by the participants;

A maximum of fifteen (15) individuals may participate in a single group SUD counseling/therapy session; and

Group SUD Counseling/Therapy shall not be billed during recreational activities.

6342.8 Family Counseling/Therapy is a planned, goal-oriented therapeutic interaction between a Qualified Practitioner and the client’s family, with or without the client present. The aim of Family Counseling/Therapy is to improve the client’s functioning with their family and to cultivate the awareness, skills, and supports to facilitate long-term recovery. Family Counseling/Therapy shall address specific issues identified in the client’s Plan of Care. Providers delivering Family Counseling/Therapy shall:

Document services using an encounter note. If the client is not present, providers shall note how the session benefited the client;

Document the relationship of the participant(s) to the client in the encounter note; and

Ensure Family Counseling/Therapy participants other than the client meet the definition of "family member" in § 6351.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021); as amended by Final Rulemaking published at 72 DCR 008497 (August 1, 2025). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6342

22-A DCMR § 6343 CORE SERVICE: DRUG SCREENING

CORE SERVICE: DRUG SCREENING

Drug Screening consists of toxicology sample collection and breathalyzer and urine testing to determine and detect the use of alcohol and other drugs.

Providers must have their own drug screening policy.

Toxicology sample collection involves the collection of biological specimens for drug analysis. The following provisions apply to toxicology sample collection:

The handling of biological specimens requires a chain of custody in accordance with Federal and District laws and regulations from the point of collection throughout the analysis process to ensure the integrity of the specimen;

Toxicology sample collection shall be conducted to verify abstinence or use of substances to inform treatment;

Toxicology sample collection shall include an in-person encounter with the client;

Documentation of the toxicology sample collection service requires an encounter note, laboratory request, and recorded laboratory results from an approved laboratory;

Chain of custody for the toxicology specimen must be observed and documented in accordance with Federal and District laws and regulations; and

Individuals collecting the samples must be properly trained to do so.

Breathalyzer testing is the collection and documentation of valid breath specimens for alcohol analysis in accordance with Department standards. A Breathalyzer is conducted to test for blood alcohol content to inform treatment for a client. The following provisions apply to Breathalyzer services:

Breathalyzer testing requires an in-person collection of the sample;

Breathalyzer testing must be documented with an encounter note and recorded results;

The chain of custody must be kept in accordance with District guidelines; and

Individuals collecting the samples must be properly trained.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6343

22-A DCMR § 6344 CORE SERVICE: RECOVERY SUPPORT

CORE SERVICE: RECOVERY SUPPORT

RSS are strength-based supports for those with addictions and those in recovery from SUD. These services are provided to assist clients with implementation of their recovery plan through direct contact interventions provided to an individual or a group of individuals.

RSS activities facilitate implementation of the Plan of Care and administrative facilitation of the client’s service needs, including but not limited to:

Scheduling and tracking appointments;

Facilitating transportation,

Collecting information about the client’s progress;

Goal setting and monitoring;

Making referrals;

Assisting with linkages;

Assisting with the completion of benefits, housing or financial forms;

Assisting clients with strategy development and coping skills;

Providing clients with encouragement and emotional support;

Providing education around social skill development and drug free social activities, life skills, relapse prevention, employment preparation, money management, health and wellness, and family reunification; and

Providing Group SUD Counseling-Psychoeducation sessions including lectures, audio-visual presentations, and handouts to develop coping skills that support recovery and problem-solving strategies for managing SUD. The subject of the counseling must be relevant to the client’s needs as identified in their Plan of Care. Providers shall complete an encounter note for each participant including the client's response to the group. No more than thirty (30) clients may participate in a single session.

In addition to the activities listed in § 6344.2, RSS-HIV entails providing clients access to testing and referrals for HIV and infectious diseases and linkage of services with medical care or specialty services related to an infectious disease. A client does not need to be diagnosed with an infectious disease to receive this service.

Additional key service functions of RSS include:

Attending interdisciplinary team meetings for Diagnostic Assessment services;

Following up on service delivery by providers external to the treatment program and ensuring communication and coordination of services;

Contacting clients who have unexcused absences from program appointments or from other critical off-site service appointments to re-engage them and promote recovery efforts;

Locating and coordinating services and resources to resolve a client’s crisis;

Providing training in the development of life skills necessary to achieve and maintain recovery; and

Participating in discharge planning.

Each RSS must be documented using an encounter note that is sufficient to justify the time and service provided.

RSS shall be provided in certified SUD treatment programs or community settings.

The duration of RSS varies but lasts as long as needed, with a reassessment every one hundred and eighty (180) days according to the client’s recovery goals.

The need for RSS is determined by the completion of a Diagnostic Assessment service or a Recovery Support Evaluation and shall be authorized in the client’s Plan of Care.

Each RSS program must have a program manager who is responsible for overseeing all services provided within the program.

Each RSS program shall have a comprehensive curriculum that has been approved by the Department.

The following are qualified practitioners of RSS:

Physicians;

Psychologists;

LICSWs;

LGSWs;

APRNs;

LISWs;

LPCs;

LGPCs;

LMFTs;

Psychology Associates; and

CACs I and II.

The following Credentialed Staff shall be permitted to provide RSS:

Recovery Coaches;

Certified Peer Specialists; and

Individuals with at least a GED or high school diploma, two (2) years of relevant, qualifying full-time-equivalent experience in human service delivery who demonstrates skills in developing positive and productive community relationship, and the ability to negotiate complex service systems to obtain needed services and resources for individuals.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021); as amended by Final Rulemaking published at 72 DCR 008497 (August 1, 2025). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6344

22-A DCMR § 6345 SPECIALTY SERVICE: MEDICATION MANAGEMENT

SPECIALTY SERVICE: MEDICATION MANAGEMENT

Medication Management shall include the coordination and evaluation of medications consumed by clients, monitoring potential side effects, drug interactions, compliance with doses, and efficacy of medications.

Medication Management also includes the evaluation of a client’s need for MSUD, the provision of prescriptions and ongoing medical monitoring/evaluation related to the use of psychoactive drugs.

Medication Management is used to inform treatment and to assist with withdrawal management, as clinically appropriate.

All providers certified as MMIWM or at any of the Level 3 certifications shall also be certified to provide Medication Management.

Medication Management requires in-person interaction with the client and may not be conducted at the same or overlapping times as any other service.

The Qualified Practitioner performing the Medication Management service or the Clinical Care Coordinator, if not the same individual, must coordinate with the client’s primary care practitioner unless the client’s record documents that the client refused to provide consent for the coordination.

Documentation of Medication Management shall include an encounter note and appropriately completed medication fields in the record, if applicable.

Medication Management shall be provided in certified SUD treatment programs or community settings.

Qualified Practitioners of Medication Management are:

Physicians; and

APRNs.

6345.10 The following may deliver Medication Management under the direction of a Qualified Practitioner:

Physician Assistants (PAs).

Registered Nurses (RNs); or

Licensed Practical Nurses (LPNs).

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020); as amended by Final Rulemaking published at 72 DCR 008497 (August 1, 2025). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6345

22-A DCMR § 6346 MEDICATIONS FOR SUBSTANCE USE DISORDER

6346.1 MSUD is the use of FDA-approved medications in accordance with the client’s Plan of Care for the treatment of SUD, including OUD. OTPs shall not preclude clients who refuse SUD Counseling/Therapy from receiving MSUD. Providers shall administer MSUD in accordance with all governing Federal regulations.

6346.2 Clients receiving MSUD must meet diagnostic criteria for:

Active moderate to severe SUD;

Being in SUD remission; or

Being at high risk for recurrence or overdose.

6346.3 Providers shall ensure that clients receiving MSUD understand and provide written or verbal informed consent and document the informed consent in the client’s medical record.

6346.4 Providers may deliver MSUD in-office, through a mobile unit, or as a take-home regimen in accordance with all governing Federal regulations. Providers shall ensure that all MSUD administrations include the unit of medication and therapeutic guidance in accordance with § 6346.5 and all governing Federal regulations. For clients receiving a take-home regimen, therapeutic guidance shall include guidance related to storage and self-administration.

6346.5 Therapeutic guidance provided during MSUD shall include:

Safeguarding medications;

Possible side-effects and interaction with other medications;

Impact of missing doses;

Monitoring for withdrawal symptoms and other adverse reactions;

Appearance of medication and method of ingestion; and

For clients receiving a take-home regimen, therapeutic guidance shall include additional guidance related to storage and self-administration.

6346.6 The provision of MSUD shall be accompanied by SUD treatment services in accordance with the client’s Plan of Care.

6346.7 Providers shall document MSUD services through medication log updates and an encounter note for each visit, including therapeutic guidance.

6346.8 Qualified Practitioners of MSUD are:

(a) Physicians; and

(b) APRNs.

6346.9 The following may deliver MSUD under the direction of a Qualified Practitioner:

(a) PAs.

(b) RNs; or

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020); as amended by Final Rulemaking published at 72 DCR 008497 (August 1, 2025). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6346

22-A DCMR § 6347 SPECIALTY SERVICE: ADOLESCENT — COMMUNITY REINFORCEMENT APPROACH

SPECIALTY SERVICE: ADOLESCENT — COMMUNITY REINFORCEMENT APPROACH

Adolescent – Community Reinforcement Approach (“ACRA”) is a specialty service that is provided in conjunction with Level 1 or Level 2.1 Outpatient treatment as a more targeted approach to treatment for youth and young adults, ages twelve (12) to twenty-four (24) years old with co-occurring mental health and SUD. ACRA services include approximately ten (10) individual sessions with the adolescent, two (2) individualized sessions with the caregiver and two (2) sessions with the adolescent and caregiver together in accordance with the procedures outlined in the ACRA evidence-based practice certification model.

The provider must have the following ACRA-certified staff for each ACRA team:

A clinical supervisor, with ACRA clinical supervisor certification, who is also a Master’s-level qualified practitioner; and

One (1) to four (4) clinicians with ACRA clinician certification who are either Master’s-level qualified practitioners or Bachelor’s-level qualified practitioners with at least five (5) years’ experience working with behaviorally-challenged youth.

ACRA practitioners must comply with the supervision, taping, feedback and coaching requirements of the ACRA certification.

A minimum of four units of ACRA services should be provided once per week. Level 1 or 2.1 services shall be provided as clinically appropriate.

ACRA generally lasts up to six (6) months with the first three (3) months of services provided in the office setting and the last three (3) months of service provided in the home or community setting, based on the client’s needs and progress.

Qualified Practitioners of Adolescent Community Reinforcement Approach (ACRA) are:

Physicians;

Psychologists;

LICSWs;

LGSWs;

APRNs;

LMFTs;

LISWs;

LPCs;

LGPCs;

Psychology Associates; and

CACs I and II.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6347

22-A DCMR § 6348 SPECIALTY SERVICE: TRAUMA RECOVERY AND EMPOWERMENT MODEL

SPECIALTY SERVICE: TRAUMA RECOVERY AND EMPOWERMENT MODEL

Trauma Recovery and Empowerment Model (“TREM”) is a structured group therapy intervention designed for clients who have survived trauma and have substance use disorders and/or mental health conditions. TREM draws on cognitive restructuring, skills training, and psychoeducational and peer support to address recovery and healing from sexual, physical, and emotional abuse.

A curriculum for each model outlines the topic of discussion, a rationale, a set of goals, and a series of questions to be posed to the group in addition to an experiential exercise for each session. The components are:

Therapy sessions focused on empowerment, self-comfort, and accurate self-monitoring, as well as ways to establish safe physical and emotional boundaries;

Therapy sessions focused on the trauma experience and its consequences; and

Therapy sessions focused on skills building, including emphases on communication style, decision-making, regulating overwhelming feelings, and establishing safer, more reciprocal relationships.

Each TREM group is population specific and on average consists of eighteen (18) to twenty-four (24) sessions, with each session at least seventy-five (75) minutes in duration. Population-specific groups include:

TREM for women;

TREM for men;

TREM for girls twelve (12) to eighteen (18) years of age;

TREM for boys twelve (12) to under eighteen (18) years of age; or

TREM for individuals who are lesbian, gay, bisexual, transgender, or questioning (groups for either individuals under eighteen (18) or individuals eighteen (18) years of age and over).

Due to the sensitive nature of the discussions, TREM requires at least two (2) facilitators to be assigned to every group to ensure the safety and continuity of the group. At least one (1) facilitator must be a qualified practitioner licensed to practice independently. A team approach is required to: address situations that may arise within the group; decrease burnout; provide continuity if one facilitator is absent; and to lend additional therapeutic support to the group. Qualified practitioners working as facilitators must have completed Department-approved, population-specific TREM training.

Qualified Practitioners of TREM are:

Psychiatrists;

Psychologists;

LICSWs;

APRNs;

LMFTs;

LPCs;

LISWs;

LGSWs;

LGPCs; or

Psychology Associates.

Recovery Coaches, Certified Peer Specialists, and CACs I and II who have successfully completed a TREM group and Department-approved TREM training shall be authorized to support TREM services under the supervision of the two group facilitators.

TREM shall be provided at the SUD treatment provider’s site or in a residential facility of sixteen (16) beds or less unless otherwise stated by the Department.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6348

22-A DCMR § 6349 RECOVERY SUPPORT – EVALUATION, ALCOHOL OR DRUG ASSESSMENT

RECOVERY SUPPORT – EVALUATION, ALCOHOL OR DRUG ASSESSMENT

A Recovery Support Evaluation is a process used to evaluate and document a client’s individual recovery support service needs, develop a comprehensive individual Recovery Support Plan, and monitor client progress on achievement of goals and objectives every one hundred and eighty (180) days.

The purpose of the Recovery Support Evaluation is to identify domains that require support, using a Department-approved recovery support assessment tool, and to develop a Recovery Support Plan.

Recovery Support Evaluation requires an in-person encounter with the client and must be performed by staff trained to use the recovery support assessment tool.

Required elements of a Recovery Support Evaluation include the completion of a Department-approved recovery support assessment tool and Recovery Support Plan.

Providers must document completion and client signatures for: consents, completion of the recovery support assessment tool and Recovery Support Plan, client bill of rights, and release of information.

A Recovery Support Evaluation shall take at least forty (40) minutes to complete.

A maximum of two (2) occurrences of Recovery Support Evaluation are allowed every six (6) months. Additional Recovery Support Evaluations require approval from the Department.

The Clinical Care Coordinator is responsible for ensuring coordination if a client is receiving treatment and recovery services from different providers. A client receiving treatment and recovery services from different providers may receive Initial, Comprehensive, or Ongoing Assessment and a separate Recovery Support Evaluation as clinically indicated.

A client receiving treatment and recovery services from the same provider shall not require a separate Recovery Support Evaluation or Recovery Support Plan.

A Recovery Support Evaluation shall be provided in certified SUD treatment programs or community settings.

Qualified Practitioners of Recovery Support Evaluation are:

Physicians;

Psychologists;

LICSWs;

LGSWs;

APRNs;

LMFTs;

LISWs;

LPCs;

LGPCs;

Psychology Associates; and

CACs I and II.

The following Credentialed Staff shall be permitted to provide Recovery Support Evaluation:

Recovery Coaches;

Certified Peer Specialists;

Individuals with at least a bachelor’s degree from an accredited college or university in social work, counseling, psychology, or closely related field and training or relevant experience in substance use; or

Individuals with at least four (4) years of relevant, qualifying full-time-

equivalent experience in human service delivery who demonstrates skills in developing positive and productive community relationships and the ability to negotiate complex service systems to obtain needed services and resources for individuals.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6349

22-A DCMR § 6350 ENVIRONMENTAL STABILITY, SUPPORTED HOUSING

ENVIRONMENTAL STABILITY, SUPPORTED HOUSING

6350.1 The Environmental Stability service provides a structured and stable living environment and recovery support system that includes recovery housing for up to six (6) months. The objective of Environmental Stability is to prepare the client for independent living upon completion of the Environmental Stability Service.

6350.2 Eligible clients for this service must:

Be drug- and alcohol-free (with the exception of prescribed medication) for thirty (30) days prior to admission;

Maintain sobriety throughout the program;

Be age eighteen (18) or older and in recovery from a diagnosed SUD;

Be employed, be receiving alternate income, or be participating in a structured training class or workforce-development program or a combination of both training and employment as deemed clinically appropriate;

Deposit thirty percent (30%) of net income into the client’s escrow account for the purposes of post-environmental-stability independent living;

Be enrolled and active in other certified RSS; and

Be prior authorized by the Department.

6350.3 The Environmental Stability provider shall comply with the Department’s drug testing policy.

6350.4 Each Environmental Stability facility shall be for a single parent with a child or children.

6350.5 Environmental Stability providers must comply with the applicable of provisions of § 6325 of this chapter governing residential recovery programs.

6350.6 No Environmental Stability program shall use a name on the exterior of the building or display any logo that distinguishes the facility from any other residence in the neighborhood.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6350

22-A DCMR § 6351 BEHAVIORAL HEALTH ACCREDITATION

6351.1 Effective October 1, 2023, all SUD providers shall obtain and maintain in good standing behavioral health accreditation with at least one (1) of the following organizations: the Commission on Accreditation of Rehabilitation Facilities (CARF), the Council on Accreditation (COA), or The Joint Commission (TJC).

6351.2 The timeline for SUD providers to obtain accreditation in accordance with § 6351.1 shall be as follows:

By December 15, 2022, all SUD providers must submit an accreditation application to CARF, COA, or TJC and provide proof of the submission to the Department;

By April 30, 2023, all SUD providers must obtain a letter of good standing from CARF, COA, or TJC and submit a copy to the Department; and

By October 1, 2023, all SUD providers must be fully accredited with CARF, COA, or TJC and submit proof of accreditation to the Department.

6351.3 Accreditation through CARF, COA, or TJC shall not provide a waiver to SUD providers for any of the standards delineated in this Chapter. The Department shall retain authority to monitor for and enforce compliance with all standards established in this chapter.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020); as amended by Final Rulemaking published at 70 DCR 003050 (March 10, 2023); as corrected by Errata Notice published at 71 DCR 004474 (April 19, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6351

22-A DCMR § 6352 SPECIALTY SERVICE: MOTIVATIONAL ENHANCEMENT THERAPY AND COGNITIVE BEHAVIORAL THERAPY

6352.1 MET/CBT is a short-term intervention designed for children/youth with cannabis use disorders to increase their motivation to change a substance use behavior and the underlying thoughts or feelings that may trigger maladaptive substance use behaviors. MET/CBT is compatible with a multi-method approach and can be successfully combined with other treatment models.

Children/youth eligible to receive MET/CBT must:

Be no older than twenty-three (23);

Have a diagnosis of cannabis use disorder;

Be eligible for ASAM Level 1 or 2.1 Intensive Outpatient Program;

Have a need for MET/CBT pursuant to a Diagnostic Assessment and authorized in the client’s Plan of Care; and

Not have a severe mental illness, or serious emotional disturbance, that is severe enough to prevent full participation in treatment.

6352.3 MET/CBT shall include individual Motivational Enhancement Therapy (MET) sessions of at least sixty (60) minutes per session and group-based Cognitive Behavioral Therapy (CBT) sessions of at least seventy-five (75) minutes per session.

6352.4 The MET sessions are intended to enhance a child/youth’s motivation to address their cannabis use and to prepare them for group sessions, and focus on the following:

Building rapport between the client and clinician;

Exploring the client’s experiences with using cannabis or other substances;

Discussing substance use and associated health and wellness problems including mental health symptoms;

Exploring the client’s attitudes about change, including ambivalent attitudes, and identifying reasons to change;

Reflecting on and identifying benefits and costs of stopping or reducing cannabis use and other substance use;

Developing a change plan and raising self-awareness of the client’s values;

Providing the client with clear set of strategies for making important life decisions; and

Specifying how a supporter can help the client achieve and maintain change.

6352.5 The CBT sessions shall assist clients in developing skills useful for stopping or reducing cannabis use and focus on the following:

Increasing awareness of triggers and related factors that increase the likelihood of engaging in substance use and other maladaptive behaviors;

Learning assertive communication skills for refusing offers of cannabis and effectively communicating needs and boundaries;

Developing a plan for healthy, drug-free replacement activities;

Establishing a social network that will support recovery;

Developing coping strategies with high-risk situations and triggers;

Practicing specific skills for addressing cravings; and

Recovering from a recurrence to use, should one occur.

6352.6 Providers may deliver MET/CBT services in schools, treatment programs, community settings and residential settings.

6352.7 Providers may deliver MET/CBT without prior authorization.

6352.8 Qualified Practitioners of MET/CBT are:

Psychiatrists;

Psychologists;

Licensed Graduate Professional Counselors;

Licensed Graduate Social Workers;

Licensed Independent Clinical Social Workers;

Licensed Marriage and Family Therapists; and

Licensed Professional Counselors.

6352.9 Qualified practitioners shall have at least one (1) year of experience working with children/youth with SUD or co-occurring mental health symptoms.

6352.10 Clinical supervisors of qualified practitioners delivering MET/CBT shall be independently licensed behavioral health qualified practitioners with at least two (2) years of experience working with children/youth with SUD and/or co-occurring mental health symptoms.

6352.11 Qualified practitioners and clinical supervisors shall complete Department-approved, population-specific MET/CBT training.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6352

22-A DCMR § 6353 [REPEALED]

[REPEALED]

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6353

22-A DCMR § 6399 DEFINITIONS

6399.1 Admission – Entry into the SUD treatment or recovery support services program after completion of Initial Diagnostic Assessment and a determination that an individual is eligible for the program.

Advanced Practice Registered Nurse (“APRN”) – A person licensed or authorized to practice as an advanced practice registered nurse pursuant to the District of Columbia Health Occupations Revisions Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq. (2016 Repl. & 2019 Supp.)), and who has demonstrated proficiency in SUD treatment, as evidenced by specialized training or a minimum of 5 years of experience in SUD care delivery.

Affiliation Agreement – A legal agreement between a provider and another entity that describes how they will work together to benefit clients.

Aftercare Plan – A plan developed with a client and their treatment team to identify goals and action steps the client can use to move forward with their recovery once they leave treatment services.

Alternate Income – Supplemental Security Income (SSI), unemployment insurance, child support, non-SSI social security, pensions and retirement income, and veterans’ benefits.

Applicant – A program that has applied to the Department for certification as an SUD treatment or recovery program.

Assessment – A process that gathers information and engages with the client to enable the provider to determine the presence or absence of a co-occurring disorder.

Certification – The process of establishing that the standards described in this chapter are met; or approval from the Department indicating that an applicant has successfully complied with all requirements for the operation of a substance use disorder treatment or recovery program in the District.

Certified Addiction Counselor (“CAC”) – A person certified to provide SUD counseling services in accordance with Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq. (2016 Repl. & 2019 Supp.)). A CAC may be certified as a CAC I or CAC II and is supervised in accordance with Title 17 DCMR § 8715.

Child Development Facility – A center, home, or other structure that provides care, supervision, and guidance for children up to fifteen (15) years of age on a regular basis, regardless of its designated name. A Child Development Facility does not include a public or private elementary or secondary school engaged in legally required educational and related functions.

Client – A person admitted to an SUD treatment or recovery program and is assessed to need SUD treatment services or recovery support services.

Clinical Care Coordination – Coordination of care between the behavioral health clinician and the clinical personnel of an external provider (e.g., primary care, another behavioral health provider, or hospital).

Clinical Care Coordinator – A licensed or certified Qualified Practitioner who has the overall responsibility for the development and implementation of the client’s Plan of Care, is responsible for identification, coordination, and monitoring of non-SUD-treatment clinical services, and is identified in the client’s Plan of Care.

Clinical Staff – Staff who are licensed, certified, or registered by the District Department of Health, Health Regulation and Licensing Administration.

Communicable Disease – Any disease as defined in Title 22-B, § 201 of the District of Columbia Municipal Regulations.

Continuity of Care Plan – A plan that provides for the ongoing care of clients in the event that a certified provider is no longer able to provide adequate care.

Co-Occurring Disorders – The presence of concurrent diagnoses of substance use disorder and a mental illness.

Core Service – All of the following services that shall be provided by all treatment providers under this chapter: Diagnostic Assessment and Plan of Care, Clinical Care Coordination, Crisis Intervention, SUD Counseling/Therapy, Drug Screening, and RSS.

Crisis – An event that significantly jeopardizes the client’s treatment, recovery progress, health, or safety.

Department – The District of Columbia Department of Behavioral Health.

Director – The Director of the District of Columbia Department of Behavioral Health.

Discharge – The time when a client’s active involvement with a provider is terminated.

Discharge Planning – Activities with or on behalf of an individual to arrange for appropriate follow-up care to sustain recovery after being discharged from a program, including educating the individual on how to access or reinitiate additional services, as needed.

District – The District of Columbia.

Drug – Substances that have the likelihood or potential to be misused or abused, including alcohol, prescription drugs, and nicotine.

Facility – Any physical premises which houses one or more SUD treatment or recovery programs.

Family Counseling/Therapy – A planned, goal-oriented therapeutic interaction between a Qualified Practitioner and the client’s family, with or without the client present.

Family Member – Individual identified by the client as a person with whom the client has a significant relationship and whose participation is important to the client’s recovery.

Group SUD Counseling/Therapy – A therapeutic service that facilitates disclosure of issues that permit generalization to a larger group; promotes help-seeking and supportive behaviors; encourages productive and positive interpersonal communication; and develops motivation through peer support, structured confrontation, and constructive feedback.

Individual Substance Use Disorder Counseling/Therapy – A face-to-face service with an authorized Qualified Practitioner for symptom and behavior management, development, restoration, or enhancement of adaptive behaviors and skills, and enhancement or maintenance of daily living skills to facilitate long-term recovery.

In-service Training – Activities undertaken to achieve or improve employees’ competency to perform present jobs or to prepare for other jobs or promotions.

Interdisciplinary Team – Members of the provider staff who provide services to the client, including the client, the client’s CCC, a CAC, and at least one QP with the license and ability to diagnose.

Licensed Graduate Professional Counselor (“LGPC”) – A person licensed as a graduate professional counselor in accordance with Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq. (2016 Repl. & 2019 Supp.)) applicable District laws and regulations. An LGPC is a Qualified Practitioner only for providers not providing services pursuant to a Human Care Agreement with the Department and must be appropriately supervised.

Licensed Graduate Social Worker (“LGSW”) – A person licensed as a graduate social worker in accordance with Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq. (2016 Repl. & 2019 Supp.)).

Licensed Independent Clinical Social Worker (“LICSW”) – A person licensed as an independent clinical social worker in accordance with Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq. (2016 Repl. & 2019 Supp.)).

Licensed Independent Social Worker (“LISW”) – A person licensed as a licensed independent social worker in accordance with Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq. (2016 Repl. & 2019 Supp.)).

Licensed Marriage and Family Therapist (“LMFT”) – A person licensed as a marriage and family therapist in accordance with Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq. (2016 Repl. & 2019 Supp.)).

Licensed Practical Nurse (“LPN”) – A person licensed as practical nurse in accordance with Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq. (2016 Repl. & 2019 Supp.)).

Licensed Professional Counselor (“LPC”) – A person licensed as a professional counselor in accordance with Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq. (2016 Repl. & 2019 Supp.)).

Major Unusual Incidents – Adverse events that can compromise the health, safety, and welfare of persons; employee misconduct; fraud; and actions that are violations of law and policy.

Medicaid – The medical assistance program, as approved by the Federal Centers for Medicare and Medicaid Services and administered by the Department of Health Care that enables the District to receive Federal financial assistance for its medical assistance program and other purposes as permitted by law.

Medical Necessity (or Medically Necessary) – Health care services or products that a prudent provider would provide to a client for the purpose of preventing, diagnosing, or treating an illness, injury, disease, or its symptoms in a manner that is: (a) in accordance with generally accepted standards of health care practice; (b) clinically appropriate in terms of type, frequency, extent, site, and duration; and (c) not primarily for the economic benefit of the health plans and purchasers or for the convenience of the client or treating provider.

Medical Triage – The process of determining the priority of a client’s treatment needs.

Medical Waste – Any solid waste that is generated in the diagnosis, treatment, or immunization of human beings or in the testing of biologicals, including but not limited to: soiled or blood-soaked bandages, needles used to give shots or draw blood, and lancets.

Medications for Opioid Use Disorder (MOUD) – FDA-approved medications to treat OUD.

Medications for Substance Use Disorder (MSUD) – The use of FDA-approved medications for the treatment of SUDs, including OUD.

Mental Illness – A diagnosable mental, behavioral, or emotional disorder (including those of biological etiology) which substantially impairs the mental health of the person or is of sufficient duration to meet diagnostic criteria specified within the most recent Diagnostic and Statistical Manual (DSM) or its most recent International Classification of Diseases equivalent.

Notice of Infraction – An action taken by agencies to enforce alleged violations of regulatory provisions.

Opioid – A psychoactive substance in the narcotic class derived from opium, including natural and synthetic compounds. Substances in this class may produce pharmacological effects such as physical withdrawal symptoms.

Organizational onboarding – Mechanism through which new employees acquire the necessary knowledge, skills, and behaviors to become effective performers. It begins with recruitment and includes orientation, which helps new employees understand performance expectations and contribute to the success of the organization.

Organized Treatment Services – Treatment that consists of a scheduled series of structured, face-to-face or group therapeutic sessions organized at various levels of intensity and frequency to assist clients in achieving the goals identified in the person-centered plans of care. Also may be called structured treatment services.

Outcomes of Care – The results of a course of treatment, including abstinence or reduction of abuse of substances, elimination or reduction of criminal activity, reduction of antisocial activity associated with SUD, reduction of need for health care services, reduction of need for SUD treatment, increase in pro-social involvement, and increase in productivity and employment.

Outpatient Services – Therapeutic services that are medically necessary, provided to a client according to an individualized Plan of Care, and do not require the client’s admission to a hospital or a non-hospital residential facility. The term "outpatient services" refers to services that may be provided: on an ambulatory basis in a hospital; on an outpatient basis in a non-hospital residential facility; an outpatient treatment facility; or the office of a provider licensed to provide SUD treatment services.

Outreach – Efforts to inform and facilitate access to a program’s services.

Parent – A person who has custody of a child as a natural parent, stepparent, adopted parent, or has been appointed as a guardian for the child by a court of competent jurisdiction.

Plan of Care – The individualized Plan of Care that is the result of the Diagnostic Assessment. All services must be guided by a valid Plan of Care. The Plan of Care includes the client’s treatment goals, strengths, challenges, objectives, and interventions. The Plan of Care is based on the client’s identified needs as reflected by the Diagnostic Assessment, the client’s expressed needs, and referral information.

Pharmacist – A person licensed or authorized to practice pharmacy pursuant to Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq. (2016 Repl. & 2019 Supp.)).

Physician – A person licensed or authorized to practice medicine pursuant to Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq. (2016 Repl. & 2019 Supp.)).

Physician Assistant (“PA”) – A person licensed as a Physician Assistant pursuant to Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq. (2016 Repl. & 2019 Supp.)).

Privacy Officer – A person designated by an organization that routinely handles protected health information, to develop, implement, and oversee the organization’s compliance with the U.S. Health Insurance Portability and Accountability Act (HIPAA) privacy rules, 42 CFR Part 2, and the District’s Mental Health Information Act.

Program – An SUD Treatment or Recovery Support Services Program certified by the Department at a specific LOC to provide SUD treatment or recovery support services.

Program Director – An individual having authority and responsibility for the day-to-day operation of an SUD treatment or recovery program.

Protected Health Information (“PHI”) – Any written, recorded, electronic (ePHI), or oral information which either (1) identifies, or could be used to identify, a client; or (2) relates to the physical or mental health or condition of a client, provision of health care to a client, or payment for health care provided to a client. PHI does not include information in the records listed in 45 CFR § 160.103.

Provider – An entity certified by the Department to provide either SUD treatment or recovery support services or both. A single provider may operate multiple programs.

Psychiatrist – A physician who has completed all training in a program in psychiatry accredited by the Accreditation Council for Graduate Medical Education, approved by the American Board of Psychiatry and Neurology, Inc., or is board certified in psychiatry.

Psychologist – A person licensed to practice psychology in accordance with applicable District laws and regulations.

Psychology Associate – A person registered as a Psychology Associate in accordance with Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq. (2016 Repl. & 2019 Supp.)).

Qualified Practitioner – a behavioral health clinician appropriately licensed, certified, or registered in the District with Department of Health. Pursuant to service specific standards a qualified practitioner may render services within the scope of their license, certification, or registration, and any applicable supervision requirements.

Recovery Coach – An individual who participated in an educational training for at least 30 hours from a program approved by the Department.

Recovery Support Plan – A document developed during a Recovery Support Evaluation that outlines the client’s needs, goals, and recovery support services to be utilized to achieve those goals. The Recovery Support plan assists a client in recovery to develop goals and objectives to maintain their sobriety in the community with supports from family, community and recovery support programs.

Recovery Support Services (“RSS”) – Non-clinical services provided to a client by a certified RSS provider to assist the client in achieving or sustaining recovery from an SUD.

Registered Nurse (“RN”) – A person licensed as a registered nurse in accordance with Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq. (2016 Repl. & 2019 Supp.)).

Representative Payee – An individual or organization appointed by the Social Security Administration to receive Social Security or Supplemental Security Income (“SSI”) benefits for someone who cannot manage or direct someone else to manage his or her money.

Research – Experiments including new interventions of unknown efficacy applied to clients whether behavioral, psychological, biomedical, or pharmacological.

Residential Program – Any SUD treatment or recovery support services program which houses clients overnight, including Level 3 treatment programs and environmental stability programs.

Screening – A determination of the likelihood that a client has co-occurring substance use and mental disorders or that their presenting signs, symptoms, or behaviors may be influenced by co-occurring issues. The purpose is not to establish the presence or specific type of such a disorder, but to establish the need for an in-depth assessment. Screening is a formal process that typically is brief and occurs soon after the client presents for services.

Specialty Service – Any of the following services that SUD providers may provide under this chapter and that require additional certification, specifically, Medication Management, ACRA, MSUD, TREM, and Environmental Stability.

Substance Use Disorder (“SUD”) – A chronic relapsing disease characterized by a cluster of cognitive, behavioral, and psychological symptoms indicating that the client continues using a substance despite significant substance-related problems. A diagnosis of SUD requires a client to have had persistent, substance related problem(s) within a twelve (12)-month period in accordance with the most recent version of the DSM.

SUD Services – All of the services described in this chapter, including treatment services, specialty services and Recovery Support Services.

Supported Employment Services – Program services designed for SUD clients for whom competitive employment has been interrupted or is intermittent as a result of a substance use disorder. Services assists consumers in obtaining and maintaining permanent part-time or full-time employment in a competitive setting.

Treatment – A therapeutic effort to improve a client’s cognitive or emotional conditions or the behavior of a client, consistent with generally recognized principles or standards in the SUD treatment field, provided or supervised by a Qualified Practitioner.

Withdrawal Management – A program designed to achieve systematic reduction in the degree of physical dependence on alcohol or drugs.

History

SOURCE: Final Rulemaking published at 62 DCR 12056 (September 4, 2015); as amended by Final Rulemaking published at 67 DCR 011585 (October 9, 2020); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024); as amended by Final Rulemaking published at 72 DCR 008497 (August 1, 2025). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6399

22-A64 REIMBURSEMENT RATES FOR SERVICES PROVIDED BY THE DEPARTMENT OF BEHAVIORAL HEALTH CHAPTER 63 CERTIFIED SUBSTANCE USE DISORDER PROVIDERS

22-A DCMR § 6400 PURPOSE

6400.1 This chapter establishes the reimbursement rate for services provided to eligible District residents ages twenty-one (21) and older by Department of Behavioral Health (Department) certified substance use disorder providers, as this term is defined in Chapter 63 (Certification Standards for Substance Use Disorder Treatment and Recovery Providers) of Subtitle A (Mental Health) of Title 22 (Health) of the District of Columbia Municipal Regulations (DCMR).

6400.2 Establishment of these reimbursement rates will allow the Department to reimburse providers using non-Medicaid local funds for services provided in accordance with the Human Care Agreement to those clients who are not eligible for Medicaid funding, and for those services that are not reimbursable by Medicaid. Reimbursement rates using non-Medicaid local funds are equivalent to the reimbursement rates for equivalent services that may be reimbursable by Medicaid.

6400.3 Nothing in this chapter grants to a certified substance use disorder provider the right to reimbursement for costs of substance use disorder services and supports. Eligibility for reimbursement is determined solely by the Human Care Agreement between the Department and the certified substance use disorder provider, and reimbursement is subject to the availability of appropriated funds.

History

SOURCE: Final Rulemaking published at 63 DCR 6936 (May 6, 2016). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6400

22-A DCMR § 6401 REIMBURSEMENT RATE

6401.1 The Department of Health Care Finance has published rates for Medicaid-funded services under Title 22-A District of Columbia Municipal Regulations (DCMR), Chapter 63. Those rates are contained in the District of Columbia Medicaid fee schedule available online at www.dc-medicaid.com. The Department of Behavioral Health (“the Department”) shall reimburse providers for Chapter 63 services provided to non-Medicaid beneficiaries at the same rates as contained in the District of Columbia Medicaid fee schedule.

6401.2 Reimbursement for the local-only substance use services provided under Title 22-A DCMR Chapter 63, which include: (a) Multi-systemic Therapy for Transition Age Youth and (b) Environmental Stability, as well as Chapter 63-adjacent (c) Residential Room and Board, are set forth in the table below. The Department shall publish notice of all future updates to these codes and rates through a Public Notice in the D.C. Register and provide for meaningful comment before implementation. The Notice shall describe the type of change, the reason for the change, the effective date of the change, and the new local only reimbursement rate.

SERVICE

CODE

RATE per UNIT ($)

UNIT

Multi-Systemic

Therapy for Transition Age Youth (TAY) (ACRA) (Ages 21-24)

H2033HF

63.11

15 min.

Residential Treatment, Room & Board

H0043

101.14

Per diem

Residential Treatment, Room & Board, Woman w/1 child

H0043UN

210.00

Per diem

Residential Treatment, Room & Board, Woman w/2 children

H0043UP

215.00

Per diem

Residential Treatment, Room & Board, Woman w/3 children

H0043UQ

220.00

Per diem

Residential Treatment, Room & Board, Women w/4 or more children

H0043UR

225.00

Per diem

Environmental Stability, Supported Housing, Individual

H0044HF

849.00

Per month

Environmental Stability, Supported Housing, Woman w/children

H0044HFUN

1000.00

Per

month

6401.3 Reimbursement for the following tests provided to non-Medicaid clients shall be the rate contained in the District of Columbia Medicaid fee schedule available online at www.dc-medicaid.com:

(a) HIV-1 and HIV-2 Single Result Testing (86703);

(b) Urine Pregnancy Test (81025);

(d) Hepatitis C Test (86803);

(e) Presumptive Drug Test, Optical Observation (80305);

(f) Presumptive Drug Test, Assisted Direct Optical Observation (80306); and

(g) Presumptive Test by Instrument Chemistry Analyzers (80307).

6401.4 Reimbursement for the following tests provided to non-Medicaid clients shall be the rate contained in the District of Columbia Medicaid fee schedule available online at www.dc-medicaid.com:

(a) Definitive Drug Testing 1-7 Drug Classes (G0480); and

(b) Definitive Drug Testing 8-14 Drug Classes (G0481).

6401.5 All future updates to the service codes and rates will be included in the District of Columbia Medicaid fee schedule pursuant to the procedures established in Title 29 DCMR, Section 988, by providing notice and an opportunity for comment.

History

SOURCE: Final Rulemaking published at 63 DCR 6936 (May 6, 2016); as amended by Final Rulemaking published at 66 DCR 2322 (February 22, 2019); as amended by Final Rulemaking published at 67 DCR 11430 (October 2, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6401

22-A DCMR § 6402 REIMBURSEMENT RATE FOR CLIENTS WHO ARE DEAF OR HARD-OF-HEARING

6402.1 Reimbursement for the local-only substance use services provided under Title 22-A DCMR Chapter 63, which include: (a) Multi-systemic Therapy for Transition Age Youth and (b) Environmental Stability, as well as Chapter 63-adjacent (c) Residential Room and Board provided to clients who are deaf or hard-of-hearing are set forth in the table below. The Department shall publish all future updates to these codes and rates through a Public Notice in the D.C. Register, which provides an opportunity for meaningful comment. The Notice shall describe the type of change, the reason for the change, the effective date of the change, and the new local only reimbursement rate.

SERVICE

CODE

RATE per

UNIT ($)

UNIT

Multi-systemic Therapy for Transition Age Youth (TAY) (ACRA) (ages 21 – 24)

H2033HFHK

77.52

15 min.

Residential Treatment, Room & Board

H0043HK

98.42

Per diem

Residential Treatment, Room & Board, Woman w/1 child

H0043UNHK

283.50

Per diem

Residential Treatment, Room & Board, Woman w/2 children

H0043UPHK

290.25

Per diem

Residential Treatment, Room & Board, Woman w/3 children

H0043UQHK

297.00

Per diem

Residential Treatment, Room & Board - Women w/4 or more children

H0043URHK

303.75

Per diem

Environmental Stability, Supported Housing, Individual

H0044HFHK

849.00

Per month

Environmental Stability, Supported Housing, Woman w/children

H0044HFUNHK

1000.00

Per month

History

SOURCE: Final Rulemaking published at 63 DCR 6936 (May 6, 2016); as amended by Final Rulemaking published at 67 DCR 11430 (October 2, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6402

22-A DCMR § 6403 ADDITIONAL REIMBURSEMENT REQUIREMENTS

6403.1 The following provisions apply to the reimbursement of substance user disorder (SUD) providers billing the Department or the Department of Health Care Finance pursuant to this chapter, except where otherwise noted.

6403.2 Reimbursement for Short-term MMIWM services shall not exceed five (5) days unless a longer stay is authorized by the Department.

6403.3 H0010 or H0010HK shall be billed for locally-funded clients in MMIWM. Residential treatment room and board (H0043 and H0043HK) is not a separate service for these clients and shall not be billed in addition to MMIWM.

6403.4 H0010U1 or H0010U1HK shall be billed for Medicaid clients in MMIWM. Residential treatment room and board (H0043 and H0043HK) shall be billed separately for these clients in order to be reimbursed.

6403.5 Reimbursement will not be provided for the following services for clients in MMIWM:

Medication Management;

Clinical Care Coordination;

Medication Assisted Treatment;

Drug Screening; and

Crisis Intervention.

6403.6 The Department shall reimburse an SUD provider for a maximum of one (1) Initial Diagnostic Assessment per client within a thirty (30)-day period.

6403.7 The Department shall reimburse an SUD provider for a maximum of one (1) Comprehensive Diagnostic Assessment per client per level of care (LOC).

6403.8 The Department shall reimburse an SUD provider for a maximum of two (2) Ongoing Diagnostic Assessments per client per sixty (60) days.

6403.9 Comprehensive Diagnostic Assessment and Ongoing Diagnostic Assessment shall not be billed on the same day.

6403.10 Clinical Care Coordination shall not be billed in conjunction with staff’s clinical supervision or at the same time as any Diagnostic Assessment service.

6403.11 The following reimbursement limits shall apply, per LOC, to Crisis Intervention:

Level 1: Eighty (80) units;

Level Opioid Treatment Program (“OTP”): One hundred and forty-four (144) units;

Level 2: One hundred and twenty (120) units; and

Level 3: One hundred and sixty (160) units.

6403.12 The following reimbursement limits shall apply, per LOC, to SUD Counseling/Therapy. The Department may approve additional units with justification.

Level 1: Thirty-two (32) units per week;

Level 2: Eighty (80) units per week; and

Level 3: One hundred (100) units per week.

6403.13 No more than ninety-six (96) units of Medication Management shall be billed per LOC. Medication Management shall not be billed for observing the self-administration of medication.

6403.14 The following provisions apply to reimbursement for all medications dispensed in OTPs:

(a) Medication shall be billed on a per-dose basis; and

(b) A single fifteen (15)-minute administration session may be billed when an individual is receiving take-home doses.

6403.15 The following provisions further apply to reimbursement of methadone administered in OTPs:

A client can be dispensed a maximum of one dose per day;

An initial and second authorization can be authorized for a maximum of ninety (90) days each; subsequent authorizations cannot exceed one hundred and eighty (180) days each; and

(c) Prior authorization from the Department is required for reimbursement of more than two- hundred and fifty (250) units of medication in one calendar year. The maximum quantity of medication and administration services over a twelve (12)-month period is three hundred and sixty-five (365) units.

6403.16 All claims seeking Medicaid or local only reimbursement under this Chapter shall include the active National Provider Identification (NPI) numbers for the certified provider and the rendering provider. The rendering provider is the staff member who provided the service.

History

SOURCE: Final Rulemaking published at 67 DCR 11430 (October 2, 2020); as amended by Final Rulemaking published at 69 DCR 013495 (November 4, 2022). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6403

22-A65 TRANSITION PLANNING ELIGIBILITY, PROVIDER CERTIFICATION, AND SERVICE STANDARDS

22-A DCMR § 6500 GENERAL PROVISIONS

6500.1 The Department of Behavioral Health (Department) is the state authority with the responsibility to plan, develop, coordinate, and monitor comprehensive and integrated behavioral health systems of care for adults and for children, youth, and their families in the District. The Department is also responsible for arranging for authorized, publicly-funded behavioral health services and supports for the residents of the District.

6500.2 The purpose of these rules is to establish the transition planning service, including client/consumer eligibility, provider certification requirements, and service standards.

6500.3 No person or entity shall provide the transition planning service to clients/consumers eligible for the service under this chapter unless first certified by the Department in accordance to this chapter.

6500.4 Each transition planning provider shall meet and adhere to the terms and conditions of its Medicaid Provider Agreement with the Department of Health Care Finance (DHCF).

History

SOURCE: Final Rulemaking published at 68 DCR 876 (January 15, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6500

22-A DCMR § 6501 ELIGIBILITY FOR TRANSITION PLANNING SERVICE

6501.1 To be eligible for the Medicaid-funded transition planning service, individuals shall meet the following requirements:

Be:

A child or youth with mental health problems, as defined in D.C. Official Code § 7-1131.02(1F);

An adult with mental illness as defined in D.C. Official Code § 7-1131.02(24); or

An individual with a substance use disorder (SUD), as defined in Subsection 6301.1 of Chapter 63 of this subtitle;

Be a bona fide resident of the District, as defined in D.C. Official Code § 7-1131.02(29);

Be enrolled in Medicaid or be eligible for enrollment and in the process of applying;

Be experiencing an institutional treatment stay described in § 6501.2; and

Not be enrolled in any one of the following District programs:

Medicaid managed care;

Home and Community-Based Services Waiver for Persons who are Elderly and Individuals with Physical Disabilities, as described in Title 29 DCMR Chapter 42;

Home and Community-Based Services Waiver for Individuals with Intellectual and Developmental Disabilities, as described in Title 29 DCMR Chapter 19;

DC Health Home, as described in Title 22-A DCMR Chapter 25; or

My Health GPS, as described in Title 29 DCMR Chapter 102.

6501.2 An individual meeting the criteria described in § 6501.1 shall be eligible for the transition planning service if they are experiencing an institutional stay in an inpatient hospital or residential SUD treatment setting related to a primary mental health or SUD diagnosis, and the service is rendered to the individual within thirty (30) calendar days ahead of and/or on the day of discharge from the:

Inpatient hospital setting into an outpatient or community-based setting, or SUD residential treatment setting; or

SUD residential treatment setting into an outpatient or community-based setting, or a lower level SUD residential treatment setting.

History

SOURCE: Final Rulemaking published at 68 DCR 876 (January 15, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6501

22-A DCMR § 6502 PROVIDER CERTIFICATION PROCESS

6502.1 The Department shall utilize the certification process to thoroughly evaluate the applicant’s capacity to provide a high quality transition planning service in accordance with this Chapter and the needs of the District’s behavioral health system.

6502.2 Each applicant seeking certification as a transition planning provider shall submit a certification application to the Department in the format established by the Department. A certified transition planning provider seeking renewal of certification shall submit an application at least ninety (90) calendar days prior to expiration of its current certification. The existing certification of a provider that has submitted a timely application for renewal of certification shall continue until the Department renews or denies renewal of the certification.

6502.3 Certification shall be considered terminated if the transition planning provider:

Fails to submit a complete certification application ninety (90) calendar days prior to the expiration date of its current certification;

Voluntarily relinquishes certification; or

Terminates operations.

6502.4 Upon receipt of a certification application, the Department shall review the certification application to determine whether it is complete. If a certification application is incomplete, the Department shall return the incomplete application to the applicant. An incomplete certification application shall not be regarded as a certification application. The Department shall not take further action to issue certification unless a complete certification application is submitted within ninety (90) calendar days prior to the expiration of the applicant’s current certification.

6502.5 Following the Department’s acceptance of the certification application, the Department shall review the application and may conduct a survey to determine whether the applicant meets the certification standards described in this chapter. The Department shall have access to all records necessary to verify compliance with certification standards and may conduct interviews with staff, others in the community, and clients/consumers served.

6502.6 The Department may conduct announced or unannounced surveys at any time during the period of certification.

6502.7 Applicant or transition planning provider interference with a survey, submission of false or misleading information, or lack of candor by the applicant or provider shall be grounds for an immediate suspension of any prior certification, or denial of a new certification application.

6502.8 A Statement of Deficiency (SOD) is a written notice to an applicant or existing transition planning provider identifying non-compliance with certification standards. The intent of the SOD is to provide:

Applicants with an opportunity to correct minor deficiencies during the certification application process; or

Existing certified providers with an opportunity to correct minor deficiencies at any time to avoid decertification and disruption of services.

6502.9 The Department will not normally issue an SOD to applicants who fail to demonstrate compliance with certification standards. The Department will normally consider the applicant’s failure to comply with the initial certification requirements as evidence that the applicant is ill-prepared to assume the responsibilities of providing the transition planning service to District residents and deny the application.

6502.10 When utilized, the SOD shall describe the areas of non-compliance, suggest actions needed to bring operations into compliance with the certification standards, and establish a timeframe of no more than ten (10) business days for the applicant’s or existing transition planning provider’s submission of a written Corrective Action Plan (CAP).

6502.11 The issuance of an SOD is a separate process from the issuance of a Notice of Infraction (NOI). NOIs shall be issued promptly upon observation of violations of this chapter, especially when they are recurrent, endanger client/consumer or staff health or safety, or when there is a failure to comply with core requirements of this chapter.

6502.12 The Department is not required to utilize the SOD process. The Department may immediately deny certification or proceed with decertification.

6502.13 An applicant or certified transition planning provider’s CAP shall describe the actions to be taken and specify a timeframe for correcting the areas of non-compliance. The CAP shall be submitted to the Department within ten (10) business days after receipt of the SOD from the Department, or sooner if specified in the SOD.

6502.14 The Department shall, within ten (10) business days after receipt, notify the applicant or certified provider whether the CAP is accepted.

6502.15 The Department may only issue certification after the Department verifies that the applicant or certified transition planning provider has remediated all of the deficiencies identified in the CAP and meets all the certification standards in this chapter.

6502.16 A determination to grant certification shall be based on the Department’s review and validation of the information provided in the application, as well as any survey findings, any CAP, and the provider’s compliance with this chapter.

6502.17 The Department shall certify an applicant and recertify a provider that demonstrated substantial compliance with this chapter, for a time period that runs concurrently with the applicant or provider’s accreditation period. Certification shall start from the date of issuance of certification by the Department, subject to the provider's continuous compliance with all certification standards. Certification shall remain in effect until it expires, is renewed, is revoked or is voluntarily relinquished. The certification shall specify the effective date of the certification, the date the certification expires, and the program(s) and services that the provider is certified to provide.

6502.18 Certification is not transferable to any other organization.

6502.19 A person or entity that applies for certification during an open application period as published in the District of Columbia Register may appeal the denial of certification under this subsection by utilizing the procedures contained in §§ 6504.3 and 6504.4. The Department shall not accept any applications for which a notice of moratorium is published in the District of Columbia Register.

6502.20 In the event that a certification application is under review while a moratorium is put in place, the Department shall continue to process the application for a time period of no more than thirty (30) calendar days. If, after thirty (30) calendar days, the application is deemed incomplete, the applicant shall be granted ten (10) business days to resolve all items of incompletion. Any items not resolved or provided by the due date shall result in the incomplete application being returned to the applicant and the Department shall take no further action to issue certification. The applicant shall then wait until the moratorium is lifted to submit any subsequent certification application.

6502.21 Nothing in these rules shall be interpreted to mean that certification is a right or an entitlement. New certification as a provider depends upon the Director’s assessment of the need for additional transition planning providers.

6502.22 The transition planning provider shall notify the Department within two (2) business days of any changes in its operations that affect the provider’s continued compliance with these certification standards, including changes in:

(a) Ownership or control,

(b) Staff rendering transition planning services, and

6502.23 A provider shall immediately report to the Department any criminal allegations involving provider staff.

6502.24 All providers shall obtain a National Provider Identification (NPI) number for itself and all personnel performing Chapter 65 services through the provider. All providers shall register itself and all personnel performing Chapter 65 services with the Department of Health Care Finance’s designated information system prior to billing for services.

6502.25 The Department may grant provisional certification to a transition planning applicant or provider that has demonstrated substantial compliance with this chapter and has received provisional accreditation from the Commission on Accreditation of Rehabilitation Facilities, The Joint Commission, or the Council on Accreditation. Provisional certification shall expire upon termination of the provider’s provisional accreditation period unless revoked in accordance with § 6504.

History

SOURCE: Final Rulemaking published at 68 DCR 876 (January 15, 2021); as amended by Final Rulemaking published at 69 DCR 013495 (November 4, 2022); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6502

22-A DCMR § 6503 EXEMPTIONS FROM CERTIFICATION STANDARDS

6503.1 Upon good cause shown, the Department may exempt an applicant or current transition planning provider from a certification standard, if the exemption does not:

Jeopardize the health and safety of clients/consumers and/or staff,

Violate clients’/consumers’ rights, or

6503.2 If the Department approves an exemption, such exemption shall end on the expiration date of the provider’s certification or on an earlier date if specified by the Department; unless the provider requests renewal of the exemption prior to expiration of its certification or the earlier date set by the Department.

6503.3 The Department may at any time revoke an exemption that it determines is no longer appropriate.

6503.4 All requests for an exemption from certification standards shall be submitted in writing to the Department.

History

SOURCE: Final Rulemaking published at 68 DCR 876 (January 15, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6503

22-A DCMR § 6504 DENIAL OR DECERTIFICATION PROCESS

6504.1 The Director may deny initial certification if the applicant fails to comply with any certification standard or the application fails to demonstrate the applicant’s capacity to deliver a high quality transition planning service on a sustained and regular basis.

6504.2 An applicant may make minor corrections and substitutions to its application during the certification process. However, evidence of one (1) or more of the following shall constitute good cause to deny the application for certification when the circumstances demonstrate deliberate misrepresentations, organizational instability, or the lack of preparedness or capacity to meet and sustain compliance with this chapter:

An incomplete application;

False information provided by applicant or contained in an application;

One or more changes to an organizational chart during the application process;

The lack of demonstrated experience providing transition planning services by the applicant’s clinical leadership, practitioners, and/or staff;

An applicant’s lack of financial resources to carry out its commitments and obligations under this chapter for the foreseeable future;

An applicant’s failure to respond in a timely manner to the Department’s requests for information;

History of poor performance; or

Lack of behavioral health accreditation in accordance with § 6513.1.

6504.3 Within fifteen (15) business days of the date on the certification denial, an applicant may make a request for an administrative review of the decision from the Director. Each request for an administrative review shall be in writing and contain a concise statement of the reason(s) why the applicant asserts that the certification denial was in error and any relevant supporting documentation.

6504.4 The Director shall complete the administrative review within fifteen (15) business days of receipt of the applicant’s request, to determine whether the certification denial complied with this subsection. The Director shall issue a written decision and provide a copy to the provider. The Director’s decision shall be final and not subject to further appeal.

6504.5 An applicant and its executive leadership shall be prohibited from reapplying for certification for twelve (12) months following the date of the initial denial or, if applicable, the date of the denial pursuant to the Director’s administrative review.

6504.6 The Department shall decertify existing transition planning providers who fail to comply with the certification requirements contained in this chapter. Evidence of one (1) or more of the following shall constitute good cause to decertify:

An incomplete recertification application;

False information provided by provider or contained in a recertification application;

High staff turnover where there are two (2) or more changes made to the leadership staff within a certification period, demonstrating organizational instability;

One or more documented violations of the certification standards during the certification period that evidence a provider’s lack of capacity to meet and sustain compliance with this chapter;

Claims audit error rate in excess of twenty-five percent (25%);

Poor quality of services;

A provider’s lack of financial resources to carry out its commitments and obligations under this chapter for the foreseeable future, as evidenced by an inability to pay all staff, or an inability to provide at least ninety (90) days of running capital as dictated by the provider’s monthly operating budget;

Failure to cooperate with Department investigations or lack of timely response to information requests; or

Failure to obtain or maintain in good standing national accreditation in accordance with § 6513.1 or meet the timelines in § 6513.2.

6504.7 Nothing in this chapter requires the Director to issue an SOD prior to decertifying a transition planning provider. If the Director finds that there are grounds for decertification, the Director shall issue a written notice of decertification setting forth the factual basis for the decertification, the effective date, and the provider’s right to request an administrative review.

6504.8 Within fifteen (15) business days of the date on the notice of decertification, the provider may request an administrative review from the Director. Each request for an administrative review shall be in writing and contain a concise statement of the reason(s) why the provider asserts that decertification should not have occurred and any relevant supporting documentation.

6504.9 The Director shall complete the administrative review within fifteen (15) business days of receipt of the provider’s request, to determine whether the decertification complied with this subsection. The Director shall issue a written decision and provide a copy to the provider.

6504.10 If the Director denies the appeal and approves the decertification, the provider may within fifteen (15) business days of receipt of the Director’s written decision request a hearing under the D.C. Administrative Procedure Act, D.C. Official Code §§ 2-501, et seq. The administrative hearing shall be limited to the issues raised in the administrative review request. The decertification shall be stayed pending resolution of the hearing.

6504.11 Upon decertification, the transition planning provider and its executive leadership shall be prohibited from reapplying for certification for a period of two (2) years following the later of the date of the decertification letter or the date of the decertification order (if applicable). If a provider reapplies for certification, the provider shall reapply in accordance with the established certification standards and show evidence that the grounds for the revocation have been corrected.

History

SOURCE: Final Rulemaking published at 68 DCR 876 (January 15, 2021); as amended by Final Rulemaking published at 70 DCR 003050 (March 10, 2023); as corrected by Errata Notice published at 71 DCR 004474 (April 19, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6504

22-A DCMR § 6505 NOTICES OF INFRACTION

6505.1 The Department may issue an NOI for any violation of this chapter. The fine amount for any NOI issued under this chapter shall be as follows:

For the first (1st) offense, five hundred dollars ($500.00);

For the second (2nd) offense, one thousand dollars ($1,000.00);

For the third (3rd) offense, two thousand dollars ($2,000.00); and

For the fourth (4th) and subsequent offenses, four thousand dollars ($4,000.00).

6505.2 The administrative procedure for the appeal of an NOI issued under this chapter shall be governed by 16 DCMR §§ 3100 et seq.

History

SOURCE: Final Rulemaking published at 68 DCR 876 (January 15, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6505

22-A DCMR § 6506 PROVIDER DISCONTINUATION OF SERVICES

6506.1 A transition planning provider shall provide written notification to the Department at least ninety (90) calendar days before its discontinuation of the transition planning service, or immediately upon knowledge of an impending discontinuation of service less than ninety (90) calendar days in the future. This notification shall include plans for continuity of care for current clients/consumers and preservation of clients’/consumers’ records.

6506.2 The Department shall review the continuity of care plan and make recommendations to the provider. The provider shall incorporate all Department recommendations necessary to ensure a safe and orderly transfer of care.

6506.3 Discontinuation of the transition planning service does not absolve a provider from its legal responsibilities regarding the preservation and storage of client/consumer records as described in §§ 6509.6, 6509.8, and 6509.9, and all other applicable Federal and District laws and regulations. A provider shall take all necessary and appropriate measures to ensure client/consumer records are preserved, maintained, and made available to the clients/consumers upon request after discontinuation of services.

History

SOURCE: Final Rulemaking published at 68 DCR 876 (January 15, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6506

22-A DCMR § 6507 GENERAL TRANSITION PLANNING PROVIDER STANDARDS

6507.1 No person or entity shall apply for certification, and no transition planning provider shall apply for recertification or be permitted to maintain certification as a transition planning provider, if they are:

Not enrolled in the District’s Medicaid program, in accordance with the requirements of Title 29 Chapter 94, as a(n):

Mental Health Rehabilitation Services (MHRS) provider;

Adult Substance Abuse Rehabilitative Services (ASARS) provider;

Free Standing Mental Health Clinic (FSMHC); or

Federally Qualified Health Center (FQHC); or

Subject to exclusion, suspension, termination, or sanction(s) as described in Title 29 DCMR Chapter 13 and Title 29 DCMM Chapter 94.

6507.2 An applicant for initial certification as a transition planning provider shall demonstrate meeting, at the time of application submission, the following standards:

Provides health home services pursuant to either Title 22-A DCMR Chapter 25 or Title 29 DCMR Chapter 69 or renders care coordination services;

Has at least three (3) years of experience providing mental health and/or SUD treatment services to a minimum of three hundred (300) individuals per calendar year in the DC metropolitan area;

Within the six (6) years prior to application submission, has assisted with the discharge of at least one hundred (100) individuals with complex needs from inpatient or residential mental health or SUD treatment settings, and achieved a thirty (30)-day readmission rate that does not exceed twenty percent (20%) for mental health or SUD-related admissions;

Within the six (6) months prior to application submission, for the population served by the applicant, the applicant rendered transition support, case management, or care coordination services to at least eighty percent (80%) of individuals who had inpatient or residential mental health or SUD treatment admissions; and

As evidenced by summary data from anytime within the previous three (3) calendar years, the ability to track and monitor:

The number of clients/consumers who have transitioned to a higher or lower level of care for treatment of a mental health or SUD diagnosis, including admissions to an inpatient or residential treatment setting; and

The responses to/outcomes of the inpatient or residential mental health or SUD treatment admissions.

6507.3 A transition planning provider shall render the service to individuals in all three (3) populations described in § 6501.1(a), for whom the provider receives a referral. Circumstances in which a provider shall be exempt from the requirement to render the service are when:

The referred individual does not consent to receive the transition planning service;

The referred individual is discharged from the institution or leaves the institution against medical advice, prior to the transition planning provider having initiated contact with the discharging institution in the time-frame specified in § 6507.4; or

Any other situation specified by the Department.

6507.4 Upon notification of a referral, a transition planning provider shall contact the discharging institution in the following time-frame:

If the provider is notified before 3:00 p.m., the provider shall contact the institution on the same day; and

If the provider is notified at 3:00 p.m. or after, the provider shall contact the institution by 10:00 a.m. the next day.

6507.5 A transition planning provider shall respond to referrals and render services, as appropriate, seven (7) days per week, three hundred sixty-five (365) days per year. The provider shall at a minimum be available to respond to client/consumer and discharging entity communications during the hours of 8:15 a.m.-5:00 p.m. The provider shall respond on the same day if such communication was received before 3:00 p.m., or by 10:00 a.m. the next day if the communication was received at 3:00 p.m. or after.

6507.6 A transition planning provider shall operate according to all applicable Federal and District laws and regulations relating to fraud, waste, and abuse in health care and the Medicaid program. A provider’s failure to report potential or suspected fraud, waste, or abuse may result in sanctions or exclusion from participation as a transition planning provider. Each transition planning provider shall:

Cooperate and assist any District or Federal agency charged with the duty of identifying, investigating, or prosecuting suspected fraud, waste, or abuse;

Be responsible for promptly reporting suspected fraud, waste, or abuse to the Department, taking prompt corrective actions, and cooperating with DHCF or other governmental investigations; and

Ensure that none of its practitioners have been excluded from participation as a Medicaid or Medicare provider. If a practitioner is determined to be excluded by the Center for Medicare and Medicaid Services (CMS), the provider shall notify the Department immediately.

6507.7 A transition planning provider shall comply with all Federal and District laws and regulations related to administrative practice ethics, including but not limited to, the False Claims Act, 31 U.S.C. §§ 3729-3733; the Anti-Kickback Statute, 42 U.S.C. § 1320a-7b; the Physician Self-Referral (Stark) Law, 42 U.S.C. § 1395nn; and the Exclusion Statute, 42 U.S.C. § 1320a-7.

6507.8 A transition planning provider shall have the necessary operational capacity to submit claims, document information on services provided, and track payments received with applicable Department and DHCF requirements.

6507.9 Each provider shall execute a participation agreement with the District’s Health Information Exchange (HIE) and utilize the HIE to receive and transmit protected health information for consumers and clients in accordance with the District of Columbia Mental Health Information Act of 1978, effective Mar. 3, 1979 (D.C. Law 2-136, D.C. Official Code § 7-1201.01 et seq.) and 42 CFR Part 2, as applicable.

6507.10 A transition planning provider shall incorporate the service into the quality improvement and quality assurance policies and procedures required under its respective FSMHC, MHRS, or SUD provider certification, or the applicable Federal and District laws, regulations, and policies governing FQHCs.

6507.11 A transition planning provider shall incorporate the service into the liability insurance coverage required under its respective FSMHC, MHRS, or SUD provider certification, or the applicable Federal and District laws, regulations, and policies governing FQHCs.

6507.12 A transition planning provider shall follow the same corporate compliance and fiscal management standards and business record-keeping procedures as required under its respective FSMHC, MHRS, or SUD provider certification, or the applicable Federal and District laws, regulations, and policies governing FQHCs.

6507.13 All providers shall electronically transmit Behavioral Health Supplemental Data (BHSD) to the Department in a form and manner as prescribed by the Department. BHSD is a compilation of individual-level behavioral health data defined in the Department’s Integrated Technology Engine (ITE) Provider Companion Guide (available at https://dbh.dc.gov/).

6507.14 Providers shall timely transmit BHSD pursuant to the procedure established in the ITE through the EHR system as described in this chapter.

6507.15 The Department shall provide notice of any future updates to the ITE Guide through https://dbh.dc.gov/.

History

SOURCE: Final Rulemaking published at 68 DCR 876 (January 15, 2021); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6507

22-A DCMR § 6508 CLIENT/CONSUMER RIGHTS AND PROTECTIONS

6508.1 Each transition planning provider shall establish and adhere to policies and procedures related to client/consumer rights and protections, including obtaining informed consent from clients/consumers and addressing complaints and grievances (Client/Consumer Rights Policy). The transition planning provider shall ensure that the Client/Consumer Rights Policy establishes requirements for compliance with all applicable Federal and District laws and regulations, including but not limited to:

22-A DCMR Chapter 1, 22-A DCMR § 301.3, and 22-A DCMR § 306, when rendering services to individuals with a primary mental health diagnosis; and

22-A DCMR §§ 6320.1(a) through 6320.1(k), 6320.1(n) through 6320.1(w), 6320.2 through 6320.4, and 6320.6 when rendering services to clients with a primary SUD diagnosis.

6508.2 Each transition planning provider shall establish and adhere to policies and procedures to ensure clients’/consumers’ right to access services that are culturally appropriate, including through use of adaptive equipment or sign language interpreter or translation services, as appropriate (Language Access Policy). The policy shall comply with the Americans with Disabilities Act of 1990 and Amendment Act of 2010, 42 U.S.C. §§ 12101, et seq. and the Language Access Act, D.C. Code §§ 2-1931, et seq.

6508.3 A transition planning provider shall develop and adopt a “Client/Consumer Choice Policy,” which shall establish policies and procedures governing how:

Clients/consumers shall be informed of the full choices of the following providers and how to access them:

Transition planning providers, and

Post-discharge providers for needed treatment services identified during the discharge planning process; and

A provider shall accommodate a client/consumer request to receive the transition planning service from a different staff member, if available and to the extent feasible.

6508.4 Medicaid beneficiaries are entitled to Notice and Appeal rights pursuant to Title 29 DCMR § 9508 in cases of intended adverse action, such as an action to deny, discontinue, terminate, or change the manner or form of the Medicaid-funded transition planning service.

6508.5 The following provider policies shall be submitted to the Department for review and approval during the certification and recertification process:

Client/Consumer Rights Policy;

Language Access Policy. Providers who are:

MHRS providers may submit their MHRS “Language Access Policy” to demonstrate compliance, if the provider extends the policy to apply to the transition planning service; and

FSMCHs may submit their “Interpreter Policy” to demonstrate compliance, if the provider extends the policy to apply to the transition planning service; and

Client/Consumer Choice Policy.

History

SOURCE: Final Rulemaking published at 68 DCR 876 (January 15, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6508

22-A DCMR § 6509 CONFIDENTIALITY, CONTENTS, AND MANAGEMENT OF CLIENT/CONSUMER RECORDS

6509.1 A transition planning provider shall create and maintain a record that meets the standards described in §§ 6509.3 and 6509.4 for each client/consumer who was referred to them, regardless of whether the provider ultimately delivered a reimbursable service.

6509.2 In the event that the provider does not initiate provision of the transition planning service, for reasons described in § 6507.3, the provider shall document the specific reason in the client/consumer record.

6509.3 All information related to provision of the transition planning service shall be entered into the client’s/consumer’s record. This shall at a minimum include the following elements, unless not applicable per § 6509.2:

Complete identification data, including Medicaid number;

Emergency contact information;

The client’s/consumer’s behavioral health diagnoses and any known physical health diagnoses;

The results of any assessments that were completed by the discharging institution or the transition planning provider;

The discharge plan, which includes documentation of the needed services and supports identified during the discharge planning process. The discharging institution’s discharge plan, summary, instruction, or other documentation may serve as the discharge plan for purposes of this chapter. If the discharging institution does not create such document for inclusion in the client/consumer record, the transition planning provider shall develop a discharge plan with the necessary information and detail;

Documentation of all rendered transition planning service components and related encounter notes meeting the standards set forth in § 6501.4;

Documentation of any treatment or support services provider(s) with a current relationship with the client/consumer;

Documentation of all referrals to treatment and support services providers;

Documentation of correspondence with other medical, human service, social service, educational, and criminal justice entities as it pertains to a consumer’s/client’s treatment and recovery;

For children and youth, documentation of family member or guardian involvement in the transition planning service or a statement of reasons why it was not indicated or if the provider was unable to secure participation;

The client’s/consumer’s consent to the transition planning service;

The signed Consumer Rights or Client’s Rights Statement, whichever is applicable;

Documentation that the client/consumer received the transition planning provider’s notice of privacy practices; and

Signed confidentiality forms and releases to permit the transition planning provider to obtain and/or release information.

6509.4 Encounter notes shall sufficiently document in writing each activity conducted involving a transition planning service component. At a minimum each note shall consist of:

A dated, timed, and authenticated entry with the author identified, that includes the date, duration, and actual beginning and ending time (denoting a.m. or p.m.) during which the service component was rendered; entered by the person providing the service. The provider shall ensure all entries are authenticated by a process that verifies the author’s identity (e.g., a unique log-in used only by the author);

Name, title, credentials, and signature of the person providing the service component;

The specific service component rendered;

A description of each encounter or activity sufficient to document that the service component was provided, and is in support of the needs identified in the discharge plan;

A description of the client/consumer response to the encounter when the service component involves direct client/consumer contact; and

The setting or means by which the service component was rendered (e.g., in person, telephonically, via email).

6509.5 Providers shall utilize an EHR system certified by the Department of Health and Human Services Office of the National Coordinator for Health Information Technology to document all phases of the consumer/client’s treatment and care.

6509.6 Each provider shall develop and implement a “Confidentiality and Release of Information Policy” that describes the policies and procedures for storing and managing client/consumer information in compliance with the confidentiality requirements contained in all applicable Federal and District laws and regulations, including the Health Insurance Portability and Accountability Act (HIPAA), the D.C. Mental Health Information Act, and 42 CFR. Part 2. This shall include policies and procedures for requiring the provider to:

Encourage consumers/clients to authorize the disclosure of protected behavioral health information to other health care and human services providers to facilitate access to and coordinate treatment and support services;

Advise each client/consumer of the provider’s notice of privacy practices;

Give mental health consumers the opportunity to opt-out of disclosures in accordance to the District of Columbia Mental Health Information Act, D.C. Code § 7-1203.01 and document the consumers’ decisions; and

(d) Secure all records in a manner that provides protection from unauthorized disclosure, access, use, or damage.

6509.7 The Confidentiality and Release of Information Policy shall be submitted to the Department for review and approval during the certification and recertification process.

6509.8 A transition planning provider shall have in place back-up and redundant systems and measures to prevent the loss of data, enable data recovery, and safeguard client/consumer records in the event of operator or equipment failure, natural disasters, power outages, and other emergency situations.

6509.9 A transition planning provider shall retain each client/consumer record in accordance with the following requirements:

When the client/consumer is an adult, for at least ten (10) years after the date of the last encounter;

When the client/consumer is a minor, for at least ten (10) years after the minor has reached the age of eighteen (18) years; and

(c) In case of litigation or adverse audit findings, until all such litigation or adverse audit findings have been resolved, or in accordance with the timeframes described in (a) and (b), whichever is later.

History

SOURCE: Final Rulemaking published at 68 DCR 876 (January 15, 2021); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6509

22-A DCMR § 6510 TRANSITION PLANNING STAFFING AND SUPERVISION STANDARDS

6510.1 A transition planning provider shall have the necessary expertise to deliver a high quality service to eligible individuals in each of the three (3) populations described in § 6501.1(a).

6510.2 A transition planning provider shall follow best practices in case management and care coordination, including ensuring that the staff rendering the transition planning service can:

Establish rapport quickly and communicate effectively with clients/consumers, family members, natural supports, and providers;

Function effectively as a member of a multi-disciplinary team;

Conduct brief, evidenced-based, and developmentally appropriate screenings and conduct or arrange for more detailed assessments when indicated;

Create and/or implement integrated service plans for access to the array of linked services, and ensure exchange of information among clients/consumers, family members, natural supports, and providers;

Provide services in a culturally competent manner;

Effectively navigate the local system of healthcare delivery, coverage, and financing; and

Use information technology to support integrated service delivery and information exchange.

6510.3 A transition planning provider shall establish and adhere to policies and procedures for selecting and hiring staff (Staff Selection Policy) that comply with the Staff Selection Policy requirements described in 22-A DCMR Chapter 34. FSMHCs, and MHRS and ASARS providers are deemed to be in compliance with this requirement, if they incorporate the transition planning service into the staff selection policies required under their respective FSMHC, MHRS, or SUD provider certifications.

6510.4 A transition planning provider shall follow the same personnel records and management policies required under its respective FSMHC, MHRS, or SUD provider certification, or the applicable Federal and District laws, regulations, and policies governing FQHCs.

6510.5 A transition planning provider shall establish a written plan for organizational onboarding and staff training and development, which reflects the training and performance improvement needs of its employees. The plan shall at a minimum include culturally competent training and onboarding activities in the following core areas:

The provider’s approach to service provision, including philosophy, goals, and methods;

The staff member’s specific job description and role in relationship to other staff;

Policies and procedures governing infection control, protection against exposure to communicable diseases, and the use of universal precautions;

Laws, regulations, and policies governing confidentiality of client/consumer information and release of information, including the D.C. Mental Health Information Act, HIPAA and 42 CFR Part 2;

Laws, regulations, and policies governing reporting abuse and neglect;

(f) Consumer/client rights; and

Other trainings, as deemed necessary by the Department.

6510.6 A transition planning provider shall establish and adhere to written job descriptions for all positions, including at a minimum the role, responsibilities, reporting relationships, and minimum qualifications for each position, as well as any ongoing training requirements. The minimum qualifications for each position shall be appropriate for the scope of responsibility and any clinical practice described for each position.

6510.7 A transition planning provider shall follow the same policies and procedures for periodic staff performance evaluations as required under its respective FSMHC, MHRS, or SUD provider certification, or the applicable Federal and District laws, regulations, and policies governing FQHCs.

6510.8 Individuals who meet the following criteria shall be qualified to render the transition planning service when under supervision of a clinician described in § 6510.9, in accordance with applicable laws and regulations:

Individuals who are:

Certified Recovery Coaches;

Certified Peer Specialists; or

Hold at least a bachelor’s degree from an accredited college or university in social work, counseling, psychology, or closely related field; and

Have at least at least two (2) years of relevant, qualifying full-time-equivalent experience in human service delivery;

Demonstrate skills in developing positive and productive community relationships;

Have the ability to negotiate complex service systems to obtain needed services and resources for individuals; and

Are trained within six (6) months of hiring and every other year thereafter in:

The ASAM Criteria;

The Diagnostic and Statistical Manual of Mental Health Disorders (DSM);

Motivational Interviewing; and

The Transtheoretical Model

6510.9 Individuals who meet the following criteria shall be qualified to supervise individuals described in § 6510.8, as well as render the transition planning service themselves, in accordance with applicable scope of practice and supervision regulations:

Be one of the following independently licensed clinician types:

Physician;

Psychologist;

Licensed independent clinical social worker (LICSW);

Advanced Practice Registered Nurse (APRN);

Licensed professional counselor (LPC); or

Licensed marriage and family therapist (LMFT); and

Have:

A minimum of three (3) years of experience in behavioral health care delivery, and

Demonstrated knowledge in navigating local resources and systems in serving consumers/clients with mental health and/or substance use disorders.

6510.10 Clinicians acting as supervisors shall provide clinical support and clinical and administrative oversight in accordance with applicable scope of practice and supervision regulations. For consumers/clients who have more complex needs and multi-system involvement, the supervisor may need to become directly involved in the provision of transition planning service components.

6510.11 If the transition planning service is to be rendered by individuals described in § 6510.8, a provider shall develop and establish policies and procedures related to supervision (Supervision Policy) in accordance with applicable scope of practice and supervision regulations, which shall require:

Supervisor-Supervisee Written Agreements developed with participation of both the supervisor and supervisee, that include the following information:

Supervision frequency, length, format, and purpose;

How the supervisor shall evaluate the supervisee’s performance and the individual goals designed to improve the performance; and

The supervisor and supervisee’s rights and responsibilities in supervision;

Supervisors to document supervision sessions and include at a minimum the following information:

Date, length, and format of session (i.e., group or individual);

Name and signature of the supervisor; and

Highlights and needed follow-up;

A minimum of four (4) hours of supervision to full-time employees per month, prorated to two (2) hours minimum for part time-employees (working twenty (20) hours or less per week);

The content of discussions to be related to service delivery and outcomes and include a review of clinical records to ensure they are current, appropriate, and complete;

A supervisor-supervisee staffing ratio that meets the following requirements:

One (1) supervisor shall have no more than ten (10) full-time supervisees or twelve (12) part-time/full-time supervisees; and

The mix within supervisor-supervisee and client/consumer assigned ratios shall be adequately distributed to address the complexity of the case, intensity of the service, and staff capacity; and

The provider to develop an internal system for supervisee access to a supervisor in the evenings and on weekends, as well as during normal business hours. This shall include circumstances and events that call for direct contact with the supervisor.

6510.12 The following provider policies shall be submitted to the Department for review and approval during the certification and recertification process:

(a) Staff Selection Policy, if not already deemed in compliance as described in § 6510.3; and

(b) Supervision Policy.

History

SOURCE: Final Rulemaking published at 68 DCR 876 (January 15, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6510

22-A DCMR § 6511 TRANSITION PLANNING SERVICE COMPONENTS

6511.1 The transition planning service provides individuals not otherwise connected to care coordination or case management programs with similar support prior to being discharged from certain institutional treatment settings into lower levels of care. The transition planning service connects clients/consumers to treatment and support services that promote their recovery and reduce the chances of avoidable inpatient or residential treatment readmissions. The transition planning service consists of activities related to development of a discharge plan, including assessment of the client’s/consumer’s needs post-discharge, and care coordination and case management related to implementation of the identified needs. Transition planning provider activities, as appropriate and applicable to an individual client/consumer, include, but are not limited to the following:

Discharge plan development:

Participation in the discharging facility’s discharge planning process and treatment team meetings;

Ensuring participation by the client/consumer (and parent or guardian, if applicable) in the discharge planning, and where appropriate, promoting participation by family members and other natural supports;

Promoting participation by providers of needed post-discharge services and supports, if already identified;

If not already completed, participating in and/or conducting the following activities using a person-centered planning approach:

Assessments of clients’/consumers’ strengths and challenges, which, if applicable, shall include use of a Department-approved functional assessment tool;

Assessments of needed services and supports, e.g., financial (e.g., Supplemental Security Income), environmental (e.g., housing or transportation), medical (e.g., mental health, SUD, or physical health), social (e.g., legal or educational) and emotional; and

For clients/consumers who have been readmitted following a stay within the past thirty (30) calendar days, in depth reviews or case conferences to inform the discharge planning process and reduce readmission risks and increase the likelihood of obtaining appropriate follow-up care;

Identifying available resources (e.g., informal, District, or other community resources) to address identified needs;

Making recommendations on the discharge plan to the rest of discharge planning team;

Meeting with the client/consumer (and/or family/natural supports, when applicable and appropriate) outside of treatment team meetings to collect information relevant to discharge plan development and establish the transition planning provider as a resource; and

Ensuring medication reconciliation has been conducted; and

Collaborating with the discharging facility on and leading activities related to implementation of the discharge plan, such as:

Verification that the client’s/consumer’s insurance covers their medication(s), and that the client/consumer has sufficient medication and prescriptions to bridge the time-period between discharge and a follow-up medication-somatic appointment;

Meeting with the client/consumer (and/or family/natural supports, when applicable and appropriate), to:

Promote understanding of the discharge plan and discuss the status of implementation; and

Provide education regarding diagnoses and what to do in case of post-discharge problems;

Working with the client/consumer, and parent or guardian when applicable and appropriate, to select post-discharge service providers, based on the client’s/consumer’s needs;

Re-establishing, as appropriate, any pre-existing linkages to providers;

Coordinating with the discharging entity to ensure needed health care appointments have been made; and

Ensuring necessary supports (e.g., transportation) are in place, making arrangements if necessary, for clients/consumers to transfer to lower levels of care or attend post-discharge appointments;

Engaging in care coordination with the health care providers who will be treating the client/consumer post-discharge;

Working to ensure that any needed prior authorization(s) for service(s) are in place on the day of the client’s/consumer’s discharge;

Coordinating with the discharging entity to assist in acquisition of other needed services and supports, e.g., housing, public benefits; and

Ensuring post-discharge providers of treatment and supports receive the relevant discharge plan information.

6511.2 In order to be eligible for reimbursement for rendering a transition planning service, the provider shall meet the following requirements:

The transition planning service components are rendered anytime during the thirty (30) calendar days prior to and/or on the day of the client’s/consumer’s discharge from an institutional stay that meets the requirements described in § 6501.2;

For clients/consumers who are discharged within forty-eight (48) hours after the transition planning provider is notified of the need for the service, the provider shall at a minimum render the following service components:

Participate in the discharging facility’s discharge planning process, including any treatment team meeting(s);

Meet with the client/consumer (and/or parent or guardian, when applicable and appropriate), to conduct applicable activities described in §§ 6511.1(a)(7) and 6511.1(b)(2), unless the consumer/client (or parent or guardian) refuses to meet despite having consented to the transition planning service. In such cases the provider shall document the refusal. Any first meeting with the client/consumer shall be in-person, unless not permitted or feasible due to documented, extenuating circumstances; and

Conduct implementing activities related to at least one (1) of the needs identified in the discharge plan; and

For clients/consumers whose discharge occurs more than forty-eight (48) hours after the transition planning provider is notified of the need for the service, the provider shall at a minimum render the following service components:

All components described in § 6511.2(b); and

If not already completed, participating in and/or leading completion of:

Person-centered assessments of clients’/consumers’ strengths and challenges, which, if applicable, shall include use of a Department-approved functional assessment tool; and

Person-centered assessments of needed services and supports, e.g., financial (e.g., Supplemental Security Income), environmental (e.g., housing or transportation), medical (e.g., mental health, SUD, or physical health), social (e.g., legal or educational) and emotional.

(d) All claims seeking Medicaid or local only reimbursement under this Chapter shall include the active NPI numbers for the certified provider and the rendering provider. The rendering provider is the staff member who provided the service.

History

SOURCE: Final Rulemaking published at 68 DCR 876 (January 15, 2021); as amended by Final Rulemaking published at 69 DCR 013495 (November 4, 2022). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6511

22-A DCMR § 6512 MAJOR UNUSUAL INCIDENT REPORTS

6512.1 A transition planning provider shall immediately notify the Department of any major unusual incident that may adversely affect the health, safety, or welfare of the client/consumer to whom they are rendering the transition planning service. The transition planning provider shall submit a completed Department Major Unusual Incident (MUI) Report form to the Department’s Division of Incident Management and Investigation email address.

6512.2 In cases where the affected client/consumer is a child or youth, the transition planning provider shall also provide a copy of the completed MUI Report form to the client’s/consumer’s parent(s) or guardian(s).

6512.3 Major unusual incidents may include, but are not limited to, the following:

Death of the client/consumer during the time-period in which the individual is a client/consumer of the transition planning provider;

Injury to or illness of any client/consumer that requires hospitalization or emergency medical treatment and which occurs while the client/consumer is with the transition planning provider;

Unauthorized departure of a child or youth client/consumer or any circumstances under which a child or youth client/consumer is deemed unaccounted for or missing during the time-period in which the individual is a client/consumer of the transition planning provider;

Any traffic accident involving a vehicle rented, owned, maintained, or contracted by the transition planning provider, in which the client/consumer was being transported at the time of the accident; and

Any other incident involving the client/consumer while they are with the transition planning provider, that requires a response by emergency service personnel, such as police, fire, ambulance, or poison control.

6512.4 In the case of a traffic accident or an incident involving perceived or actual criminal activity, the transition planning provider shall also file a report with the appropriate law enforcement authorities.

6512.5 Any transition planning provider staff member who knows or reasonably believes that a child or youth client/consumer is, has been, or is in immediate danger of being abused or neglected shall, as required by the District of Columbia Prevention of Child Abuse and Neglect Act of 1977, effective September 23, 1977 (D.C. Law 2-22; D.C. Official Code §§ 4-1321.01, et seq.), make or cause to be made an immediate oral report to:

The Child Protective Services Division of the Child and Family Services Administration (CFSA), via the CFSA twenty-four (24) hour Child Abuse and Neglect Hotline; and

The Metropolitan Police Department (MPD).

6512.6 Any transition planning provider staff member who knows or reasonably believes that an adult client/consumer is, has been, or is in immediate danger of being abused or neglected shall, as required by the Adult Protective Services Act of 1984, effective March 14, 1985 (D.C. Law 5-156; D.C. Code §§ 7-1901, et seq.), make or cause to be made an immediate oral report to:

Adult Protective Services in the Department of Aging and Community Living (DACL), via the twenty-four (24) hour Adult Protective Services Hotline; and

MPD.

6512.7 In the MUI Report required by this section, the transition planning provider staff member shall include:

The name, age, sex, household address, and institutional treatment provider address of the client/consumer who is the subject of the report;

A statement that the client/consumer who is the subject of the report is receiving services from the transition planning provider;

The name, address, and telephone number of the transition planning provider;

If the major unusual incident involves an allegation of child abuse, the transition planning provider shall provide the following information:

The information that led the transition planning provider staff member to suspect that the client/consumer who is the subject of the report is being or is at risk of being abused or neglected, the nature and extent of the perceived or actual abuse or neglect, and the identity of the person(s) responsible for it;

Any other information that may be helpful in establishing whether the client/consumer who is the subject of the report is being or is at risk of being abused or neglected, the cause of the suspected abuse or neglect, and the identity of the person(s) responsible for it;

To the extent known, the name, age, and sex of each sibling or child living in the same household as the client/consumer who is the subject of the report; and

To the extent known, the name, age, and sex of each parent, guardian, or other caretaker of the client/consumer.

The name, title, occupation, and contact information of the transition planning provider staff member making the report;

Any actions taken by the transition planning provider staff member or the transition planning provider concerning the client/consumer in response to the situation; and

(g) Any other information required by law.

History

SOURCE: Final Rulemaking published at 68 DCR 876 (January 15, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6512

22-A DCMR § 6513 BEHAVIORAL HEALTH ACCREDITATION

6513.1 Effective October 1, 2023, all transition planning providers shall obtain and maintain in good standing behavioral health accreditation with at least one (1) of the following organizations: the Commission on Accreditation of Rehabilitation Facilities (CARF), the Council on Accreditation (COA), or The Joint Commission (TJC).

6513.2 The timeline for transition planning providers to obtain accreditation in accordance with § 6513.1 shall be as follows:

By December 15, 2022, all transition planning providers must submit an accreditation application to CARF, COA, or TJC and provide proof of the submission to the Department;

By April 30, 2023, all transition planning providers must obtain a letter of good standing from CARF, COA, or TJC and submit a copy to the Department; and

By October 1, 2023, all transition planning providers must be fully accredited with CARF, COA, or TJC and submit proof of accreditation to the Department.

6513.3 Accreditation through CARF, COA, or TJC shall not provide a waiver to transition planning providers for any of the standards delineated in this chapter. The Department shall retain authority to monitor for and enforce compliance with all standards established in this chapter.

History

SOURCE: Final Rulemaking published at 70 DCR 003050 (March 10, 2023); as corrected by Errata Notice published at 71 DCR 004474 (April 19, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6513

22-A DCMR § 6599 DEFINITIONS

When used in this chapter, the following terms shall have the meaning ascribed:

Adult Substance Abuse Rehabilitative Services (ASARS) Provider – A provider certified in accordance with 22-A DCMR Chapter 63 who delivers rehabilitative services for SUD as covered by the District’s Medicaid State Plan.

Advanced Practice Registered Nurse (APRN) – A person licensed or authorized to practice as an advanced practice registered nurse pursuant to the District of Columbia Health Occupations Revisions Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq. (2016 Repl. & 2018 Supp.)).

Applicant – A person or entity that has applied to the Department for certification as a transition planning provider.

ASAM Criteria – The American Society of Addiction Medicine (ASAM) Criteria are guidelines for placement, continued stay, transfer, or discharge of individuals with substance use disorder and co-occurring conditions.

Certified Peer Specialist – An individual who has completed the Peer Specialist Certification Program requirements and is approved to deliver peer support services within the District’s public behavioral health network.

Certified Recovery Coach – A Certified Recovery Coach is an individual with any DBH-approved recovery coach certification.

Client – An individual with an SUD diagnosis who is receiving treatment or support services from a Department-certified provider.

Clinician – An individual licensed by the District Department of Health, Health Regulation and Licensing Administration (HRLA) to provide clinical services.

Consumer – An individual with a mental health diagnosis who is receiving treatment or support services from a Department-certified provider.

Department – The District of Columbia Department of Behavioral Health.

Director – The Director of the District of Columbia Department of Behavioral Health.

District – The District of Columbia.

DSM – The Diagnostic and Statistical Manual of Mental Health Disorders, Fifth Edition (DSM-5), or subsequent versions, used to diagnose and classify behavioral health disorders.

Electronic Health Record (EHR) – An electronic record of patient health information from one (1) or more encounters in any care delivery setting and meeting the requirement of a designated record set under 45 C.F.R. § 164.501.

Family Member – Individual identified by the client/consumer as a person with whom the individual has a significant relationship and whose participation is important to the individual’s recovery.

Federally Qualified Health Center (FQHC) – A provider delivering FQHC services in accordance with 29 DCMR Chapter 45.

Free Standing Mental Health Clinic (FSMHC) – A provider certified to deliver FSMHC services in accordance with 22-A DCMR Chapter 30.

Inpatient Hospital Setting – An acute care hospital providing inpatient hospital services as defined in 42 CFR § 440.10, or a psychiatric hospital that is an institution for mental diseases as defined in 42 CFR § 435.101 and which is providing inpatient hospital services.

Licensed Independent Clinical Social Worker (LICSW) – A person licensed as an independent clinical social worker in accordance with Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq. (2016 Repl. & 2019 Supp.)).

Licensed Marriage and Family Therapist (LMFT) – A person licensed as a marriage and family therapist in accordance with Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq. (2016 Repl. & 2019 Supp.)).

Licensed Professional Counselor (LPC) – A professional counselor licensed in accordance with Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq. (2016 Repl. & 2019 Supp.)).

Medicaid – The medical assistance program, as approved by the Federal Centers for Medicare and Medicaid Services (CMS) and administered by the Department of Health Care Finance (DHCF) that enables the District to receive Federal financial assistance for its medical assistance program and other purposes as permitted by law.

Mental Health Rehabilitation Services Provider (MHRS) Provider – A provider certified to deliver MHRS in accordance with 22-A DCMR Chapter 34.

Motivational Interviewing – Motivational Interviewing (MI) is a directive, client/consumer-centered counseling approach for eliciting behavior change by helping clients/consumers explore and resolve ambivalence.

Notice of Infraction (NOI) – An action taken by agencies to enforce alleged violations of regulatory provisions.

Psychologist – A person licensed to practice psychology in accordance with applicable District laws and regulations.

Residential SUD Treatment Setting – An SUD treatment program, including ASAM Levels 3.1, 3.3, 3.5, and 3.7-WM, which houses clients overnight.

Statement of Deficiency (SOD) – A written statement of non-compliance issued by the Department, which describes the areas in which an applicant for certification or the certified provider fails to comply with the certification standards pursuant to this chapter.

SUD Provider Certification – Having approval from the Department to operate an SUD treatment or recovery support program in the District pursuant to the requirements set forth in 22-A DCMR Chapter 63.

Transtheoretical Model – The Transtheoretical Model of behavior change is an integrative theory of therapy that assesses an individual's readiness to act on a new, healthier behavior, and provides strategies or processes of change to guide the individual. The model is composed of constructs such as: stages of change, processes of change, levels of change, self-efficacy, and decisional balance.

History

SOURCE: Final Rulemaking published at 68 DCR 876 (January 15, 2021); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 6599

22-A73 DEPARTMENT OF MENTAL HEALTH PEER SPECIALIST CERTIFICATION

22-A DCMR § 7300 PURPOSE AND APPLICATION

7300.1 These rules establish the Department of Behavioral Health’s (Department) requirements for training and certifying Peer Specialists (“Certified Peer Specialists”), who will be employed by Department-certified community mental health agencies to provide Medicaid reimbursable mental health rehabilitation services (MHRS) and other mental health supports and services to adult and children and youth mental health consumers and their families under the supervision of a qualified mental health professional in the District of Columbia (District).

7300.2 Medicaid-reimbursable MHRS shall be provided in accordance with the requirements of the District’s State Medicaid Plan, Chapter 34 of this subtitle, and the federal guidelines governing the provision of services by Certified Peer Specialists.

7300.3 Other mental health services and supports provided by Certified Peer Specialists to consumers or their families shall be provided in accordance with the requirements of this chapter, Chapter 34 of this subtitle, the consumer’s treatment plan, and other applicable guidance, under the supervision of a qualified health care professional. Such services shall be reimbursed through local funds in accordance with the MHRS provider’s Human Care Agreement (HCA).

7300.4 The MHRS and other mental health services and supports rendered by Certified Peer Specialists shall be referred to in this chapter as “Peer Support Services.”

7300.5 Certified Peer Specialists, certified in accordance with this chapter, must also meet all MHRS non-licensed staff requirements as specified in Sections 3413 and 3416 in Chapter 34 of this subtitle in order to be employed as a Certified Peer Specialist by a Department-certified mental health provider.

7300.6 The purposes of training and certifying Peer Specialists are to:

(a) Ensure that Certified Peer Specialists receive the initial training and continuing education necessary to demonstrate minimum levels of competence in the provision of Peer Support Services;

(b) Ensure that Certified Peer Specialists receive supervision required to deliver mental health rehabilitation services in accordance with the requirements of federal and District law and the State Medicaid Plan; and

(c) Promote professional and ethical practice for Certified Peer Specialists by enforcing adherence to a code of ethics as set forth in Section 7306.

7300.7 These rules apply to individuals seeking certification as a Certified Peer Specialist, mental health providers who supervise or employ Certified Peer Specialists, and the Department.

History

SOURCE: Final Rulemaking published at 58 DCR 11096 (December 23, 2011); as amended by Final Rulemaking published at 61 DCR 7002 (July 11, 2014); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 7300

22-A DCMR § 7301 GENERAL PROVISIONS

7301.1 The Department’s Office of Consumer and Family Affairs (OCFA) shall administer the certified peer specialist certification program (Certification Program).

7301.2 The Certification Program consists of structured training designed to provide applicants with the skills necessary to provide Peer Support Services. The training at a minimum includes the completion of seventy (70) hours of classroom work as described in Section 7307 and an eighty (80) hour supervised field practicum described in Section 7308.

7301.3 Applicants who desire to receive a specialty designation may be required to take additional training in accordance with the standards set by the Department.

7301.4 After successful completion of the classroom work and a field practicum, or appropriate waiver in accordance with Section 7305, an applicant shall take a written and oral examination. The OCFA shall develop the written and oral examination, which shall be administered in accordance with Section 7309.

5 Applicants who complete the required classroom work, field practicum and receive a passing score on the written and oral examination will be granted certification by the Department as a peer specialist (Certified Peer Specialist).

7301.6 The Department may offer a specialty designation for Certified Peer Specialists in accordance with the identified needs of the Department. Certified Peer Specialists may qualify for the specialty designation upon completion of the Certified Peer Specialist program, additional training, and any other requirements established by the Department. Specialty designations may include:

Certified Peer Specialist – Family: an individual who is or has been a parent or legal guardian of a child or youth who is receiving or has received mental health services, and is able to provide services to children or youth and the parents or legal guardians currently receiving mental health services.

Certified Peer Specialist – Youth: an individual who was a consumer of mental health services before the age of twenty-two (22), and is able to provide services to children or youth currently receiving mental health services.

Certified Peer Specialist – Recovery: for those individuals with a history of substance abuse who are able to provide services to other individuals currently receiving services for substance abuse.

7301.7 The Department will provide notice to the public of upcoming training for Certified Peer Specialists, to include information on the application process and what, if any, specialty designations are being offered.

History

SOURCE: Final Rulemaking published at 58 DCR 11096 (December 23, 2011); as amended by Final Rulemaking published at 61 DCR 7002 (July 11, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 7301

22-A DCMR § 7302 PEER SPECIALIST CERTIFICATION COMMITTEE

7302.1 The Department shall establish a Peer Specialist Certification Committee (PSCC).

7302.2 The PSCC shall be comprised of nine (9) members. Four (4) of the members of PSCC shall be mental health consumers (Consumer Members), at least one (1) of whom must also be a Department employee. An additional two (2) of the members of the PSCC shall be parents or legal guardians of children or youth who were or currently are mental health consumers in the District. The remaining one third (1/3) or three (3) of the members of the PSCC shall be representatives from the mental health provider or advocacy communities (Public Members). All of the members of the PSCC must be residents of the District of Columbia.

7302.3 Each PSCC member shall be appointed by the Director of the Department or designee to serve for a three (3) year term.

7302.4 The nine (9) PSCC members shall be divided into three (3) membership classes, for purposes of ensuring that only one third (1/3) of the membership changes each year. Three (3) PSCC members shall be appointed to serve a one (1) year term (the “Class 1 members”); three (3) PSCC members shall be appointed to serve a two (2) year term (the “Class 2 members”); and three (3) PSCC members shall be appointed to serve a three (3) year term (the “Class 3 members”). There shall be at least one (1) Consumer Member in each membership class. At the expiration of the first term after the adoption of these rules, the Class 1 PSCC members shall serve three (3) year terms and Class 2 PSCC members shall serve three (3) year terms.

7302.5 Any PSCC member appointed to fill a vacancy shall be appointed only for the unexpired portion of that term. PSCC members may continue to serve beyond the end of their terms until they are reappointed or replaced.

7302.6 The PSCC shall select a presiding member at the beginning of each fiscal year. The presiding member shall:

Be responsible for ensuring that the PSCC carries out its responsibilities with respect to the administration of the Certification Program;

Convene periodic meetings of the PSCC to conduct the activities described in Subsection 7302.8 below; and

Serve as the chairperson for each PSCC meeting.

7302.7 The OCFA shall provide administrative support to the PSCC. Administrative support shall include:

Review of applications for the Certification Program to determine completeness;

Documenting the proceedings at all PSCC meetings; and

Documenting all recommendations to the Department regarding any of the PSCC activities described in Subsection 7302.8.

7302.8 The PSCC shall:

(a) Review all applications for participation in the Certification Program;

(b) Interview all candidates for the Certification Program;

(d) Review requests from applicants to waive some or all of the Certification Program requirements based upon prior training or experience;

(e) Approve or deny requests from applicants to waive some or all of the Certification Program requirements;

(f) Make recommendations to the Department about the training curriculum for the Certification Program training and subsequent amendments to the curriculum;

(g) Make recommendations to the Department about the field practicum for the Certification Program and subsequent changes to the protocol for conducting the field practicum;

(h) Make recommendations to the Department about appropriate continuing education courses for Certified Peer Specialists;

(i) Make recommendations to the Department about recertification or revocation of Peer Specialist Certification; and

(j) Establish by-laws reflecting its duties, authorities, composition, and manner of operations.

7302.9 Members of the PSCC shall serve voluntarily and without compensation.

History

SOURCE: Final Rulemaking published at 58 DCR 11096 (December 23, 2011); as amended by Final Rulemaking published at 61 DCR 7002 (July 11, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 7302

22-A DCMR § 7303 CORE COMPETENCIES

7303.1 The Department’s peer specialist certification program is structured to provide participants with an opportunity to develop the following core competencies:

Interpersonal skills;

Practical assessment skills and fundamental knowledge of mental health and substance abuse disorders;

(d) Ability to document services provided including preparation of encounter notes required by Subsection 3413.19 of Chapter 34 of this subtitle;

(e) Computer skills;

(f) Understanding the unique role of the peer, using self as a therapeutic presence;

(g) Ethics and Professionalism;

(h) Recovery and Wellness Recovery Action Planning (WRAP) or similar planning;

(i) Advocacy skills; and

(j) Cultural competency and sensitivity.

7303.2 Core competencies are developed through a combination of life experience, successful completion of required classroom work or the equivalent, and successful completion of the field practicum or the equivalent.

History

SOURCE: Final Rulemaking published at 58 DCR 11096 (December 23, 2011); as amended by Final Rulemaking published at 61 DCR 7002 (July 11, 2014); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 7303

22-A DCMR § 7304 PEER SPECIALIST QUALIFICATIONS

Eligible applicants for the Peer Specialist Certification training shall:

Be a District resident who is at least eighteen (18) years of age;

Have at least a high school diploma or a general equivalency diploma (GED); and

Be either

A self-disclosed current or previous consumer of mental health services or

(2) Be a parent or legal guardian of a child or youth consumer who was or is currently a consumer of mental health services (for Certified Peer Specialist – Family); and

Demonstrate either

(1) Personal recovery and ability to help others with their recovery; or

(2) An understanding of the public mental health system for a child or youth with serious emotional disturbance, and involvement with multiple public systems.

History

SOURCE: Final Rulemaking published at 58 DCR 11096 (December 23, 2011); as amended by Final Rulemaking published at 61 DCR 7002 (July 11, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 7304

22-A DCMR § 7305 APPLICATION PROCESS

7305.1 Applicants must submit a completed application to the OCFA in the format prescribed by the Department. The OCFA, in consultation with the PSCC shall announce when it is accepting applications. The application shall include:

Evidence of education, which may include, but is not limited to a copy of a high school diploma, general equivalency diploma or a diploma, or a certificate from an accredited institution;

Completed personal essay on the topic(s) identified in the application; and

Two (2) personal references.

7305.2 The OCFA shall review each application for completeness. Incomplete applications shall be returned to the applicant.

7305.3 Applications deemed complete by the OCFA shall be forwarded to the PSCC for review.

7305.4 After review of the complete applications, the PSCC shall schedule personal interviews with each applicant that submitted a complete application.

7305.5 The PSCC shall select candidates for the Peer Specialist Certification program from the applicants based upon the completed application, written essay, personal references, and the personal interview. Each applicant shall receive written notice of selection or non-selection.

7305.6 An applicant may request a waiver of the requirement to complete any or all of the classroom work and the field practicum based upon prior coursework or certification as a peer specialist or equivalent granted by the Department or another jurisdiction, or based upon prior or current work experience. An applicant requesting a waiver shall include a waiver request with the application and written essay.

7305.7 A waiver request shall:

Identify the core competency or competencies that the applicant already possesses;

Include an explanation of the basis for the request to waive training relating to the core competency addressed by a particular course included in the training curriculum or the work experience that is covered by the field practicum; and

Provide documentation of prior training, or verification by an instructor or fellow participant, certification or work experience that is cited as the basis for the request to waive classroom work or the field practicum.

7305.8 Waiver requests shall be submitted to the PSCC for consideration as part of the application package. The PSCC shall determine if a full or partial waiver shall be granted. The decision regarding a waiver request will be addressed in the written notice of selection or non-selection provided to each candidate.

7305.9 Applicants for the Certified Peer Specialist – Family and Certified Peer Specialist – Youth Certification Programs shall successfully pass all background checks required for working with children prior to the start of the Peer Specialist Certification training.

History

SOURCE: Final Rulemaking published at 58 DCR 11096 (December 23, 2011); as amended by Final Rulemaking published at 61 DCR 7002 (July 11, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 7305

22-A DCMR § 7306 CODE OF ETHICS

7306.1 The Department has adopted a code of ethics for Certified Peer Specialists. Each Certified Peer Specialist is required to comply with the code of ethics and shall sign a copy of the code of ethics.

7306.2 The code of ethics includes the following principles, which are intended to guide Certified Peer Specialists in their various professional roles, relationships, and levels of responsibility. Certified Peer Specialists shall:

Be responsible for helping fellow mental health consumers or fellow guardians or parents meet their own needs, wants, and goals in personal recovery or recovery of their children;

Maintain high standards of personal conduct in a manner that fosters their own personal recovery, or recovery of their family member;

Openly share with consumers and colleagues their personal recovery stories from mental illness or from involvement with a family member with mental illness and be able to identify and describe the supports that promote their personal recovery or the recovery of their family member;

At all times, respect the rights and dignity of those they serve;

Never intimidate, threaten, harass, or use undue influence, physical force or verbal abuse, or make unwarranted promises of benefits to the individuals they serve;

Not practice, condone, facilitate or collaborate in any form of discrimination in violation of federal or District law;

Respect the privacy and confidentiality of those they serve;

Advocate for the full integration of consumers into the communities of their choice and promote their inherent value to those communities;

Not enter into dual relationships or commitments that conflict with the interests of those they serve;

Comply with the Department’s policies regarding the protection of consumers from abuse or neglect;

Not abuse substances;

Not work at a mental health agency where they or their child, ward or other relative is receiving mental health services; and

Not accept gifts of any value from consumers or family members of consumers they serve.

History

SOURCE: Final Rulemaking published at 58 DCR 11096 (December 23, 2011); as amended by Final Rulemaking published at 61 DCR 7002 (July 11, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 7306

22-A DCMR § 7307 REQUIRED CLASSROOM TRAINING

7307.1 All candidates must complete the seventy (70) hours of required classroom training. The required classroom training is delivered in modules by instructors designated by the Department or equivalent approved by the PSCC. Classroom training shall address the core competencies set forth in Section 7303.

7307.2 Instructors shall submit notice of successful completion of classroom training by a participant to OCFA.

7307.3 OCFA shall notify each candidate when all required classroom training is complete and the candidate is eligible to complete the field practicum.

7307.4 Candidates who have applied for and been accepted into a specialty designation program must complete, in addition to the required seventy (70) hours of classroom training, additional classroom training in accordance with the requirements set by the Department.

History

SOURCE: Final Rulemaking published at 58 DCR 11096 (December 23, 2011); as amended by Final Rulemaking published at 61 DCR 7002 (July 11, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 7307

22-A DCMR § 7308 FIELD PRACTICUM SUPERVISION AND ACTIVITIES

7308.1 Completion of the classroom work described in Section 7307 is a pre-requisite to participating in the eighty (80) hour field practicum, conducted in accordance with this section and with Department field practicum guidelines.

7308.2 The purpose of the field practicum is to provide candidates with an opportunity to apply the skills and knowledge acquired from the classroom work in a mental health service setting.

7308.3 The field practicum site shall be a certified Mental Health Rehabilitation Services (MHRS) provider. The field practicum site shall identify a qualified mental health practitioner to serve as the field practicum supervisor.

7308.4 The candidate’s field practicum shall be supervised by a qualified mental health professional, who has completed peer specialist supervisory orientation offered by the Department.

7308.5 The field practicum supervisor shall:

Ensure that the consumer(s) (and his or her family if appropriate) receiving peer support services delivered by the candidate during the field practicum has consented to the delivery of such services by a candidate for certification as a peer specialist;

Ensure that peer support services delivered by the candidate during the field practicum are consistent with the Plan of Care for the consumer receiving the services; and

Ensure that the candidate has an opportunity to participate in treatment planning and care coordination activities during the field practicum.

7308.6 The field practicum supervisor shall maintain a log of all supervisory meetings with a candidate in accordance with the OCFA’s guidelines.

7308.7 The field practicum supervisor shall provide the following supervision to a candidate during the field practicum:

A minimum of one (1) hour of face-to-face supervision with each candidate once a week with additional support as needed or requested;

Establish the field practicum objectives and guidelines for the candidate within the first week of the practicum;

Supervise the candidate throughout the field practicum overseeing the full range of field practice;

Document all supervision activities in accordance with the OCFA’s guidelines; and

Maintain regular contact with the candidate and OCFA, as needed, relevant to progress in achieving field practicum objectives.

7308.8 During the field practicum, the candidate shall at a minimum complete the following:

Orientation to the field practicum site and its policies and procedures regarding the delivery of services;

Shadow a mental health staff during work with consumers on a significant activity, such as intake appointments, home visits, accompanying a consumer to court, medical appointments or related activities;

Work directly with mental health consumers or the parent/legal guardian or foster parent, as applicable; and

Participate as a full member of the interdisciplinary team providing services.

7308.9 After the candidate successfully completes the field practicum, the field practicum supervisor shall complete, sign, and submit the Practicum Verification Form to the OCFA within five (5) days.

7308.10 The field practicum supervisor shall communicate regularly with the OCFA during the field practicum and notify OCFA of any concerns about successful completion of the field practicum in advance. OCFA will work with the field practicum supervisor and the candidate to develop and implement interventions to address those concerns.

7308.11 The Field Practicum Supervisor shall notify OCFA, in writing, if the candidate fails to complete the field practicum.

History

SOURCE: Final Rulemaking published at 58 DCR 11096 (December 23, 2011); as amended by Final Rulemaking published at 61 DCR 7002 (July 11, 2014); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 7308

22-A DCMR § 7309 CERTIFICATION EXAMINATION

7309.1 Participants who have successfully completed the required classroom work and field practicum are eligible to take the certification examination. Participants who have received a full waiver of the classroom work and the field practicum are also eligible to take the certification examination.

7309.2 The OCFA shall administer the certification examination.

7309.3 A participant must achieve a total score of eighty five (85%) percent or better to pass the certification examination. The OCFA will notify participants of the results of the examination in writing within ten (10) days after the exam.

7309.4 Participants who do not pass the certification examination are eligible to re-take the examination within four (4) weeks after receipt of notice of failure from the OCFA.

7309.5 A participant who does not pass the certification examination after two (2) attempts may apply to complete some or all of the classroom work or the field practicum again. If the application is granted, the participant must complete the additional training prior to taking the certification examination again.

History

SOURCE: Final Rulemaking published at 58 DCR 11096 (December 23, 2011); as amended by Final Rulemaking published at 61 DCR 7002 (July 11, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 7309

22-A DCMR § 7310 AWARDING OF PEER SPECIALIST CERTIFICATION

7310.1 The OCFA shall verify that applicants have:

Successfully completed the required classroom work;

Successfully completed a field practicum;

Received a passing score on the certification examination; and

Signed the Peer Specialist Code of Ethics.

7310.2 After verifying that an applicant has met the requirements of this chapter for certification as a mental health peer specialist, the OCFA shall issue certificates, signed by the Director of the Department to each Certified Peer Specialist as evidence of completion of the Certification Program.

7310.3 Those applicants who have completed the specialty designation shall receive a certificate with that designation (e.g., Certified Peer Specialist – Family).

7310.4 Certification as a Certified Peer Specialist shall be valid for two (2) years from the date of issuance.

History

SOURCE: Final Rulemaking published at 58 DCR 11096 (December 23, 2011); as amended by Final Rulemaking published at 61 DCR 7002 (July 11, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 7310

22-A DCMR § 7311 MAINTAINING CERTIFICATION AND CONTINUING EDUCATION

7311.1 Certified Peer Specialists shall complete at least twenty (20) hours of continuing education units (CEUs) within the two (2)-year certification period to maintain certification and be eligible for recertification.

7311.2 OCFA shall publish an annual list of approved classes, seminars, conferences, workshops, and other activities related to mental health and recovery that qualify as acceptable CEU’s for Certified Peer Specialists. Other courses may qualify for CEU credit with prior approval from OCFA.

7311.3 Certified Peer Specialists shall report attendance at approved classes to the OCFA. The OCFA shall maintain records of CEUs for each Certified Peer Specialist.

History

SOURCE: Final Rulemaking published at 58 DCR 11096 (December 23, 2011); as amended by Final Rulemaking published at 61 DCR 7002 (July 11, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 7311

22-A DCMR § 7312 RECERTIFICATION PROCESS

7312.1 OCFA shall send a notice to each Certified Peer Specialist about the pending expiration of his or her certification at least one hundred twenty (120) days prior to expiration.

7312.2 A Certified Peer Specialist shall submit an application for recertification in the format approved by the Department to the OCFA at least sixty (60) days prior to the expiration of certification. The application for recertification shall include information about CEUs completed during the certification period.

7312.3 The OCFA shall submit the recertification application to the PSCC for review as set forth in Subsection 7302.8(i).

7312.4 The PSCC shall make a written recommendation to the OCFA regarding recertification of a Certified Peer Specialist. The OCFA shall make the final determination regarding recertification of a Certified Peer Specialist.

7312.5 The Department may decline to renew certification as a Certified Peer Specialist in the following circumstances:

(a) Violation of any principles of the code of ethics as set forth in Section 7306 above;

(b) Failure to provide evidence of completed CEUs as required by Subsection 7311.1 above;

(c) A determination that the individual is currently excluded, debarred, suspended, or otherwise ineligible to participate in the Federal healthcare programs, or Federal procurement or non-procurement programs, or has been convicted of a criminal offense that falls within the ambit of 42 U.S.C. § 1320a-7a but has not yet been excluded, debarred, suspended or otherwise declared ineligible; or

(d) Any other set of facts which, in the exercise of the Director’s reasonable judgment, substantially interferes with the Certified Peer Specialist’s ability to perform essential job functions.

7312.6 The OCFA shall provide written notice to the Certified Peer Specialist about renewal of certification. A copy of the notification shall be provided to any mental health services agency that employs the Certified Peer Specialist.

7312.7 Recertification as a Certified Peer Specialist shall be valid for two (2) years from the date of the written notification issued by the OCFA.

7312.8 If the PSCC recommends that the certification not be renewed, it will provide the basis for the recommendation to the OCFA in writing, including any documentary evidence. The OCFA shall, in turn, provide written notice to the Certified Peer Specialist that:

(a) A recommendation has been made to deny the recertification; and

(b) The basis for that recommendation, including any written documentation.

7312.9 The Certified Peer Specialist may provide a response in writing to the OCFA within fifteen (15) days of receipt of the written notice with any objections, including any supporting documentation, to the recommendation of non-renewal.

7312.10 The OCFA will issue its final decision on the recertification within fifteen (15) days after the date on which the Certified Peer Specialist’s response was received or due, whichever is earlier. If the certification is not renewed, a copy of the notification shall be provided to any mental health services agency that employs the Certified Peer Specialist.

7312.11 If the OCFA’s final decision is to deny recertification, the Certified Peer Specialist’s certification will expire on the original date of expiration.

7312.12 The Certified Peer Specialist may appeal a decision not to renew his or her certification to the Director of the Department. All appeals shall be in writing and must be submitted within ten (10) business days of the OCFA issuing its decision.

7312.13 Filing an appeal with the Director will not extend a certification beyond the original date of expiration. If an appeal is filed and the Director determines that the certification should be renewed, the period of recertification will begin from the date of the expiration of the original certification (if already expired) or from the date of the decision, if the original certification has not expired.

History

SOURCE: Final Rulemaking published at 58 DCR 11096 (December 23, 2011); as amended by Final Rulemaking published at 61 DCR 7002 (July 11, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 7312

22-A DCMR § 7313 REVOCATION OF CERTIFICATION

7313.1 The Department may elect to revoke certification as a Certified Peer Specialist for the same circumstances stated in Subsection 7312.5, including:

(a) Violation of any principles of the code of ethics as set forth in Section 7306;

(b) Failure to provide evidence of completed CEUs as required by Subsection 7311.1;

(d) Any other set of facts which, in the exercise of the Director’s reasonable judgment, substantially interferes with the Certified Peer Specialist’s ability to perform essential job functions.

7313.2 The PSCC will make a written recommendation, including any documentary evidence regarding revocation to OCFA’s Director.

7313.3 The OCFA shall provide written notice to the Certified Peer Specialist that:

(a) The PSCC has recommended his or her certification be revoked; and

(b) The basis for that recommendation, including any written documentation.

7313.4 The Certified Peer Specialist may provide a response in writing to the OCFA within thirty (30) days of receipt of the written notice with any objections, including any supporting documentation, to the recommendation for revocation.

7313.5 The OCFA will issue its final decision on the revocation in writing to the Certified Peer Specialist within thirty (30) days after the date on which the Certified Peer Specialist’s response was received or due, whichever is earlier. If the certification is revoked, a copy of the notification shall be provided to any mental health services agency that employs the Certified Peer Specialist.

7313.6 Revocation shall be effective on the date of the OCFA decision.

7313.7 The Certified Peer Specialist may appeal the decision to revoke his or her certification to the Director of the Department. All appeals shall be in writing and must be submitted within ten (10) business days of the OCFA issuing its decision.

7313.8 If an appeal is filed and the Director determines that the certification is not to be revoked, the certification will be reinstated to the effective date of the revocation.

History

SOURCE: Final Rulemaking published at 58 DCR 11096 (December 23, 2011); as amended by Final Rulemaking published at 61 DCR 7002 (July 11, 2014). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 7313

22-A DCMR § 7314 CERTIFIED PEER SPECIALIST SUPERVISION

7314.1 Certified Peer Specialists shall participate on the treatment team and provide those components of MHRS identified in Chapter 34 of this subtitle as services that may be delivered by credentialed staff.

7314.2 A qualified practitioner shall provide clinical and administrative supervision to a Certified Peer Specialist. The qualified practitioner providing supervision shall be identified as a Peer Specialist Supervisor.

7314.3 The number of Certified Peer Specialists supervised by a Peer Specialist Supervisor shall be determined by each MHRS provider based upon the needs of the population served and program location. A full-time equivalent Peer Specialist Supervisor shall supervise no more than seven (7) full-time employees (FTE) peer specialists.

7314.4 Certified Peer Specialists shall receive at least six (6) hours of direct supervision and mentoring from the Peer Specialist Supervisor prior to working directly with consumers and before working off-site.

7314.5 Peer Specialist Supervisors shall maintain a log of supervisory meetings with each Certified Peer Specialist in accordance with the OCFA’s guidelines.

7314.6 Peer Specialist Supervisors shall provide at least the following supervision to each Certified Peer Specialist:

Conduct at least (1) one face to-face meeting for a minimum of one (1) hour with each Certified Peer Specialist per week for the purposes of providing clinical supervision;

Provide additional supervision or supervisory meetings and support as needed or requested by the Certified Peer Specialist; and

Ensure that the Certified Peer Specialist completes required training for maintenance of certification.

7314.7 The Peer Specialist Supervisor shall:

Ensure that when Peer Support Services are identified as part of a consumer’s Plan of Care, the Plan of Care:

Specifies individualized goals and objectives pertinent to the consumer’s recovery and community integration in language that is outcome oriented and measurable;

Identifies interventions directed to achieving the individualized goals and objectives;

Specifies the Certified Peer Specialist’s role in relating to the consumer and involved others; and

Identifies both the specific components of MHRS that will be provided by the Certified Peer Specialist, and the frequency of delivery;

Ensure that the Certified Peer Specialist participates in treatment planning activities for consumers whose Plans of Care include or are expected to include Peer Support Services;

Ensure that delivery of services is consistent with the requirements of the Plan of Care; and

Ensure that Peer Support Services delivered by the Certified Peer Specialist are coordinated with the other mental health services provided to the consumer.

History

SOURCE: Final Rulemaking published at 58 DCR 11096 (December 23, 2011); as amended by Final Rulemaking published at 61 DCR 7002 (July 11, 2014); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 7314

22-A DCMR § 7399 DEFINITIONS

7399.1 When used in this chapter, the following words and phrases shall have the meanings ascribed:

Applicant – a person who has submitted an application to participate in the Peer Specialists Certification Program.

Candidate – an applicant whose application to participate in the Peer Specialists Certification Program has been approved.

Certification – a designation awarded by the Department of Behavioral Health to individuals who have successfully completed the requirements of the Peer Specialist Certification Program.

Certified Peer Specialists – peers who have completed the Peer Specialists Certification Program requirements and are approved to deliver Peer Support Services within the District’s public mental health system.

District – District of Columbia.

Plan of Care – developed in accordance with the requirements of Chapter 34 of this subtitle. The Plan of Care includes the consumer’s treatment goals, strengths, challenges, objectives, and interventions.

Mental Health Provider - any entity, public or private, that is licensed or certified by the District of Columbia to provide mental health services or mental health supports or any entity, public or private, that has entered into an agreement with the Department to provide mental health services or mental health support.

Mental Health Rehabilitation Services or MHRS - rehabilitative or palliative mental health services administered by the Department and rendered by certified MHRS providers to eligible consumers who require such services intended for the maximum reduction of mental disability and restoration of a consumer to his or her best possible functional level.

Peers – individuals with psychiatric disabilities receiving or who have received mental health services.

Peer Support Services – MHRS that may be delivered by qualified credentialed staff but specifically delivered by Certified Peer Specialists.

Qualified Practitioner – a (i) psychiatrist; (ii) psychologist; (iii) licensed independent clinical social worker; (iv) advanced practice registered nurse; (v) licensed marriage and family therapist; (vi) registered nurse; (vii) licensed professional counselor; (viii) licensed independent social worker; or (ix) certified addiction counselor.

Wellness Recovery Action Plan or WRAP – The Wellness Recovery Action Plan was developed by a group of people who experience mental health difficulties, and put into practice by Mary Ellen Copeland. It is a program of self- management and recovery, and it is unique to every individual who uses it. A WRAP is designed by the consumer and may involve selected supporters (family and friends) and health care providers to assist and support the consumer through the work on the plan.

History

SOURCE: Final Rulemaking published at 58 DCR 11096 (December 23, 2011); as amended by Final Rulemaking published at 61 DCR 7002 (July 11, 2014); as amended by Final Rulemaking published at 67 DCR 10674 (September 4, 2020); as amended by Final Rulemaking 68 DCR 012400 (November 26, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 7399

22-A76 DEPARTMENT OF MENTAL HEALTH OFFICER-AGENT CERTIFICATION

22-A DCMR § 7600 PURPOSE AND APPLICATION

7600.1 These rules establish an Officer-Agent Certification Committee and the requirements for individuals to become certified Department of Mental Health (DMH) Officer-Agents in the District of Columbia.

7600.2 These rules apply to DMH and other District agencies, mental health providers and individuals who seek Officer-Agent Certification.

History

SOURCE: Final Rulemaking published at 55 DCR 007561 (July 11, 2008).

22-A DCMR § 7601 GENERAL PROVISIONS

The Department of Mental Health (DMH) certifies eligible individuals as accredited Officer-Agents in the District of Columbia. An Officer-Agent has the authority, when there is reason to believe that a person is mentally ill and, because of such illness, is likely to injure self or others if is not immediately detained, to:

(a) Without a warrant, take the person into custody;

(b) Transport the person to a public or private hospital, or to the DMH; and

History

SOURCE: Final Rulemaking published at 55 DCR 007561 (July 11, 2008).

22-A DCMR § 7602 DMH OFFICER-AGENT ELIGIBILITY

7602.1 DMH will train and certify eligible persons to be accredited DMH Officer-Agents.

7602.2 To be eligible for certification as an accredited DMH Officer-Agent a person must be one of the following:

(a) (i) A qualified practitioner with a mental health provider approved by DMH; or

(ii) A paramedic nominated by the District of Columbia Fire and Emergency Medical Services Agency (FEMS), or be nominated by another District agency approved by DMH as needing DMH Officer-Agents; or

(b) (iii) A DMH staff member from a DMH program approvedby the DMH Chief Clinical Officer as needing DMH Officer-Agents; and

(b) Approved by the DMH Officer-Agent Certification Committee (OACC).

History

SOURCE: Final Rulemaking published at 55 DCR 007561 (July 11, 2008).

22-A DCMR § 7603 DMH OFFICER-AGENT CERTIFICATION TRAINING REQUIREMENTS

7603.1 DMH Officer-Agent Certification Training shall be conducted by a psychiatrist and an attorney both of whom must be licensed to practice in the District of Columbia and be approved by the DMH OACC.

7603.2 The DMH Officer-Agent Certification training shall include:

(a) Reviewing the clinical definition of "mental illness;"

(b) Determining when a mental illness is likely to cause a person to injure self or others;

(d) Defining cultural competency;

(e) Reviewing the process of applying for admission for emergency observation pursuant to D.C. Official Code Section 21-521, Emergency Hospitalization through preparation of a valid FD-12 application; and

(f) Testifying in court regarding an FD-12 application.

7603.3 DMH Officer-Agent Certification Training shall be offered at least twice a year.

History

SOURCE: Final Rulemaking published at 55 DCR 007561 (July 11, 2008).

22-A DCMR § 7604 DMH OFFICER-AGENT CERTIFICATION

7604.1 After an eligible person successfully completes the DMH Officer-Agent Certification Training, the eligible person will be certified for a period of up to two (2) years (subject to his or her continued employment with the nominating mental health provider, District Agency, or DMH program).

7604.2 Each DMH Officer-Agent will be issued a certificate and a photo identification with a two (2) year expiration date.

7604.3 DMH Officer-Agents may be required to repeat the DMH Officer-Agent Certification Training prior to the expiration of their two (2) year certification in order to be recertified.

History

SOURCE: Final Rulemaking published at 55 DCR 007561 (July 11, 2008).

22-A DCMR § 7605 DMH OFFICER AGENT CERTIFICATION COMMITTEE

7605.1 DMH shall establish an Officer-Agent Certification Committee (OACC) to provide peer review, quality control of the FD-12 applications, and Officer-Agent certification process.

7605.2 The OACC shall be chaired by the DMH Chief Clinical Officer or designee.

7605.3 The OACC shall be comprised of no more than twelve (12) members appointed by the DMH Chief Clinical Officer.

7605.4 At least five (6) of the OACC members shall be government representatives from the following offices:

(a) DMH Chief Clinical Office

(b) DMH Community Services Agency

(d) DMH Homeless Outreach

(e) DMH Mental Health Litigation Section

(f) District Fire and Emergency Services

7605.5 The DMH Chief Clinical Officer may appoint up to six (6) members who are non-government mental health providers

7605.6 The OACC shall:

(a) Approve curriculum for the certification;

(b) Ensure nominees meet the eligibility criteria for certification;

(d) Meet as needed, as determined by the chair of the OACC, to review and evaluate FD-12 applications and the certification process;

(e) Recommend recertification of Officer-Agents if appropriate; and

(f) Make recommendations for revocation of Officer-Agent certification to the DMH Chief Clinical Officer.

7605.7 Members who are not government employees shall be appointed for terms of 3 years.

7605.8 Members shall serve without compensation.

History

SOURCE: Final Rulemaking published at 55 DCR 007561 (July 11, 2008).

22-A DCMR § 7606 DMH CHIEF CLINICAL OFFICER AUTHORITY

7606.1 The DMH Chief Clinical Officer shall have the authority to:

(a) Determine the total number of persons to be certified as DMH Officer-Agents;

(b) Revoke an Officer-Agent certification; and

(c) Determine which DMH programs, mental health providers, and District agencies, other than DMH, may have DMH Officer-Agents.

History

SOURCE: Final Rulemaking published at 55 DCR 007561 (July 11, 2008).

22-A DCMR § 7607 DMH OFFICER-AGENT REPORTING REQUIREMENTS

7607.1 District agencies, mental health providers, and DMH programs that employ DMH Officer-Agents will:

(a) Maintain a list of current DMH Officer-Agents in their employment;

(b) Maintain a copy of all FD-12 applications completed by their respective Officer-Agents; and

7607.2 DMH Comprehensive Psychiatric Emergency Program (CPEP) will:

(a) Maintain a copy of all FD-12 applications that it receives; and

(b) Provide copies of all completed FD-12 applications that it receives to the OACC on a monthly basis.

History

SOURCE: Final Rulemaking published at 55 DCR 007561 (July 11, 2008).

22-A DCMR § 7608 DEFINITIONS

7608.1 When used in this chapter, the following terms and phrases shall have the meanings ascribed:

"Certification" - successful completion of DMH Officer-Agent Training and a determination that a person has met requisite qualifications established by the OACC.

"CPEP" - DMH Comprehensive Psychiatric Emergency Program.

"District" - District of Columbia.

"DMH Officer -Agent" - a person who has been certified by DMH pursuant to DCMR Title 22, Chapter 76.

"FD-12" - Application form used for emergency admission for observation and diagnosis.

"Mental Health Provider" - any individual or entity, public or private, that is licensed or certified by the District of Columbia to provide mental health services or mental health supports, or any individual or entity, public or private, that has entered into an agreement with DMH to provide mental health services or mental health supports.

"Mental Illness" - a psychosis or other disease which substantially impairs the mental health of a person.

"Qualified Practitioner" - (1) a psychiatrist; (ii) a psychologist; (iii) an independent clinical social worker; (iv) an advanced practice registered nurse; (v) a registered nurse; (vi) a licensed professional counselor; (vii) an independent social worker; and (viii) an addiction counselor.

"Revoke" - to nullify or cancel DMH Officer-Agent certification.

History

SOURCE: Final Rulemaking published at 55 DCR 007561 (July 11, 2008).

22-A80 CERTIFICATION STANDARDS FOR BEHAVIORAL HEALTH STABILIZATION PROVIDERS

22-A DCMR § 8000 GENERAL PROVISIONS

8000.1 The Department of Behavioral Health (“Department”) is the Single State Agency responsible for developing and promulgating rules, regulations, and certification standards for mental health and substance use treatment and recovery providers in the District of Columbia (“District”).

8000.2 The purpose of this rule is to set forth the requirements for certification as Department-certified behavioral health stabilization providers. Behavioral health stabilization providers are community-based and treat individuals in the District who are experiencing a behavioral health crisis but who do not require hospitalization.

8000.3 The provisions of this chapter apply to all behavioral health stabilization programs as defined by this chapter unless stated otherwise.

8000.4 Each provider shall meet and adhere to the terms and conditions of its Medicaid Provider Agreement with the Department of Health Care Finance (“DHCF”).

8000.5 No person or entity shall own or operate a behavioral health stabilization program that offers or proposes to offer behavioral health stabilization services unless certified by the Department pursuant to this chapter.

8000.6 The Department shall issue one (1) certification for each provider that is valid only for the programs stated on the certificate. The certificate is the property of the Department and must be returned upon request by the Department.

8000.7 The Department’s staff, upon presentation of proper identification, shall enter the premises of a behavioral health stabilization program to conduct announced or unannounced inspections and investigations.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8000

22-A DCMR § 8001 ELIGIBILITY FOR BEHAVIORAL HEALTH STABILIZATION SERVICES

8001.1 Providers certified under this chapter shall provide behavioral health stabilization services to any individual who presents in a behavioral health crisis, regardless of insurance status or ability to pay.

8001.2 An individual shall meet the following eligibility requirements to receive Medicaid-funded behavioral health stabilization services:

(a) Be bona fide residents of the District, as defined in D.C. Official Code § 7-1131.02(29); and

(b) Be enrolled in Medicaid, or be eligible for enrollment and have an application pending; or

There is an eligibility grace period of ninety (90) calendar days from the date of first service for new enrollees, or from the date of eligibility expiration for enrollees who have a lapse in coverage, until the date the District’s Economic Security Administration (“ESA”) makes an eligibility or recertification determination.

In the event an individual appeals a denial of eligibility or recertification by the ESA, the Director may extend the ninety (90) calendar day eligibility grace period until the appeal has been exhausted. The ninety (90) calendar day eligibility grace period may also be extended at the discretion of the Director for other good cause shown.

Upon expiration of the eligibility grace period, services provided to the individual are no longer reimbursable by Medicaid. Nothing in this section alters the Department’s timely-filing requirements for claim submissions.

8001.3 To qualify for locally-funded services, individuals must not be eligible for Medicaid or Medicare, not be enrolled in any other third-party insurance program except the D.C. HealthCare Alliance, or be enrolled in an insurance program that does not cover medically necessary services. All individuals receiving locally-funded services must also meet the following requirements:

For individuals eighteen (18) years of age and older, live in households with a countable income of less than two hundred percent (200%) of the Federal poverty level, and for individuals under eighteen (18) years of age, live in households with a countable income of less than three hundred percent (300%) of the Federal poverty level.

(b) An individual who does not meet the income limits in paragraph (a)

above may receive treatment services in accordance with the following requirements:

The individual must, within ninety (90) days of enrollment for services, apply to the Department of Human Services Economic Security Administration for certification to verify income; and

(ii) The individual may receive treatment services in accordance with rates determined by the Department.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8001

22-A DCMR § 8002 PROVIDER CERTIFICATION PROCESS

8002.1 The Department shall utilize the certification process to thoroughly evaluate the applicant’s capacity to provide high quality behavioral health stabilization services in accordance with this chapter and the needs of the District’s behavioral health system.

8002.2 Each applicant seeking certification as a provider shall submit a certification application to the Department. A certified provider seeking renewal of certification shall submit a certification application at least ninety (90) calendar days prior to expiration of its current certification. The certification of a provider that has submitted a timely application for renewal of certification shall continue until the Department renews or denies renewal of the certification application.

8002.3 An applicant may apply for certification for one (1) or more of the following program types:

Comprehensive Psychiatric Emergency Program;

Psychiatric Crisis Stabilization Program;

Adult Mobile Crisis and Outreach Program; or

Youth Mobile Crisis Intervention Program.

8002.4 Certification shall be considered terminated if the provider:

Fails to submit a complete certification application ninety (90) calendar days prior to the expiration date of the current certification;

Voluntarily relinquishes certification; or

Terminates operations.

8002.5 Upon receipt of a certification application, the Department shall review the certification application to determine whether it is complete. If a certification application is incomplete, the Department shall return the incomplete application to the applicant. An incomplete certification application shall not be regarded as a certification application. The Department shall not take further action to issue certification unless a complete certification application is submitted within ninety (90) calendar days prior to the expiration of the applicant’s current certification.

8002.6 At the time of initial certification and certification renewal, the Department shall conduct an on-site survey of the applicant’s facility, services, and activities to determine whether the applicant satisfies all the certification standards in this chapter. The Department shall have access to all records necessary to verify compliance with certification standards and may conduct interviews with staff, others in the community, and individuals served. Nothing in this section shall limit the Department’s right to conduct on-site surveys at any other time during the certification period.

8002.7 Applicant or provider interference with the on-site survey, submission of false or misleading information, or lack of candor by the applicant or provider shall be grounds for an immediate suspension of any prior certification, or denial of a new certification application.

8002.8 A Statement of Deficiency (“SOD”) is a written notice to a provider identifying non-compliance with certification standards. The intent of the SOD is to provide existing certified providers with an opportunity to correct minor deficiencies to avoid decertification and disruption of service.

8002.9 When utilized, the SOD shall describe the areas of non-compliance, suggest actions needed to bring operations into compliance with the certification standards, and establish a timeframe of no more than ten (10) business days for the provider’s submission of a written Corrective Action Plan (“CAP”). The issuance of an SOD is a separate process from the issuance of a Notice of Infraction (“NOI”). The Department shall issue NOIs promptly upon observation of violations of this chapter, especially when they are recurrent, endanger individual or staff health or safety or when there is a failure to comply with core requirements of operating a behavioral health stabilization program.

8002.10 The Department is not required to utilize the SOD process. The Department may immediately deny certification or re-certification or proceed with decertification.

8002.11 A certified provider’s CAP shall describe the actions to be taken and specify a timeframe for correcting the areas of non-compliance. The provider shall submit the CAP to the Department within ten (10) business days after receipt of the SOD from the Department, or sooner if specified in the SOD.

8002.12 The Department shall notify the certified provider whether the provider’s CAP is accepted within ten (10) business days after receipt. The Department shall utilize the SOD process at any time to address a certified provider’s violation(s) of this chapter.

8002.13 The Department may only issue its renewal after the Department verifies that the certified provider has remediated all of the deficiencies identified in the CAP and meets all the certification standards in this chapter.

8002.14 The Department may grant full or provisional certification to an applicant after conducting on-site surveys and reviewing application materials. A determination to grant full certification to a provider or program shall be based on the Department’s review and validation of the information provided in the application, as well as facility inspection findings, CAPs, and the provider or program’s compliance with this chapter.

8002.15 The Department may grant provisional certification to an applicant or provider that has demonstrated substantial compliance with this chapter and has received provisional accreditation from the Commission on Accreditation of Rehabilitation Facilities, The Joint Commission, or the Council on Accreditation.

8002.16 Provisional certification shall expire upon termination of the provider’s provisional accreditation period unless revoked in accordance with § 8004.

8002.17 The Department shall certify an applicant and recertify a provider that demonstrated substantial compliance with this chapter, for a time period that runs concurrently with the applicant or provider’s accreditation period. Certification shall start from the date of issuance of certification by the Department, subject to the provider's continuous compliance with all certification standards. Certification shall remain in effect until it expires, is renewed, is revoked or is voluntarily relinquished. The certification shall specify the effective date of the certification, the date the certification expires, and the program(s) and services that the provider is certified to provide.

8002.18 The provider shall notify the Department within forty-eight (48) hours of any changes in its operation that affect the provider’s continued compliance with these certification standards, including but not limited to changes in ownership or control, changes in service, and changes in its affiliation and referral arrangements.

8002.19 Prior to adding a new program during the term of certification, the provider shall submit a certification application describing the program. The Department may certify a provider to provide the new program and its required services after the Department determines that the provider is in compliance with the certification standards under this chapter.

8002.20 A provider that applies for certification during an open application period as published in the District of Columbia Register may appeal the denial of certification under this subsection by utilizing the procedures contained in § 8004. The Department shall not accept any applications for which a notice of moratorium is published in the District of Columbia Register.

8002.21 In the event that a certification application is under review while a moratorium is put in place, the Department will continue to process the application for a time period of no more than thirty (30) calendar days. If, after thirty (30) calendar days, the application is deemed incomplete, the provider will be granted ten (10) business days to resolve all items of incompletion. Any items not resolved or provided by the due date will result in the incomplete application being returned to the applicant. The Department will take no further action to issue certification. The applicant must then wait until the moratorium is lifted to submit any subsequent certification application.

8002.22 Nothing in these rules shall be interpreted to mean that certification is a right or an entitlement. New certification as a provider depends upon the Director’s assessment of the need for additional providers(s) and availability of funds.

8002.23 Certification shall be limited to the applicant granted the certification and shall be limited to the location and programs as indicated on the certificate. Certification is not transferable to any other organization.

8002.24 Written notice of any change in the name or ownership of a provider or program owned by an individual, partnership, or association, or in the legal or beneficial ownership of ten percent (10%) or more of the stock of a corporation that owns or operates a provider or program, shall be given to the Department at least thirty (30) calendar days prior to the change in ownership.

8002.25 The provider shall notify the Department in writing thirty (30) calendar days prior to implementing any of the following operational changes, including all aspects of the operations materially affected by the changes:

A proposed change in the program’s geographic location;

The proposed addition or deletion of programs and related services, which is anything that would alter or disrupt services where the individual would be impacted by the change, or any change that would affect compliance with this regulation;

A change in the required staff qualifications for employment;

A proposed change in organizational structure;

A proposed change in the population served; or

A proposed change in program capacity and, for residential programs, a proposed change in bed capacity.

8002.26 A provider shall forward to the Department within thirty (30) calendar days all inspection reports conducted by an oversight body and all corresponding corrective actions taken regarding cited deficiencies.

8002.27 A provider shall immediately report to the Department any criminal allegations involving provider staff or volunteers.

8002.28 Existing behavioral health stabilization programs applying for re-certification shall provide proof of current Basic Business Licenses (“BBL”(s)) issued by the Department of Consumer and Regulatory Affairs (“DCRA”) as described in §8007.

8002.29 All providers shall obtain a National Provider Identification (NPI) number for itself and all personnel performing Chapter 80 services through the provider. All providers shall register itself and all personnel performing Chapter 80 services with the Department of Health Care Finance’s designated information system prior to billing for services.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021); as amended by Final Rulemaking published at 69 DCR 013495 (November 4, 2022); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8002

22-A DCMR § 8003 CERTIFICATION: EXEMPTIONS FROM STANDARDS

8003.1 Upon good cause shown, including but not limited to a conflict between a certification standard and a provider’s third-party contract or agreement, the Department may exempt a provider from a certification standard if the exemption does not jeopardize the health and safety of individuals or staff, violates an individual’s rights, or otherwise conflict with the purpose and intent of these rules.

8003.2 If the Department approves an exemption, such exemption shall end on the expiration date of the program certification, or at an earlier date if specified by the Department, unless the provider requests renewal of the exemption prior to expiration of its certificate or the earlier date set by the Department.

8003.3 The Department shall revoke an exemption at any time if it determines that the exemption may jeopardize the health, safety or welfare of the individuals served, staff, volunteers and/or the general public.

8003.4 All requests for an exemption from certification standards must be submitted in writing to the Department.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8003

22-A DCMR § 8004 DENIAL OR DECERTIFICATION PROCESS

8004.1 The Director may deny initial certification if the applicant fails to comply with any certification standard or the application fails to demonstrate the applicant’s capacity to deliver high quality behavioral health stabilization services on a sustained and regular basis. Furthermore, to avoid an over concentration of providers in areas with existing providers and to encourage increased access to underserved areas of the District, the Director may deny certification if the applicant proposes to operate a facility in an area already served by one (1) or more providers. The Department’s priority shall be to grant certification to applicants that will address unmet needs of the behavioral health system. While applicants may make minor corrections and substitutions to its application during the certification process, evidence of one (1) or more of the following shall constitute good cause to deny the application for certification when the circumstances demonstrate deliberate misrepresentations, organizational instability, or the lack of preparedness or capacity to meet and sustain compliance with this chapter:

An incomplete application;

False information provided by applicant or contained in an application;

One (1) or more changes to an organizational chart during the application process;

A facility that is inadequate in health, safety, size or configuration to provide services consistent with high quality care and privacy standards;

The lack of demonstrated experience providing behavioral health stabilization services by the applicant’s clinical leadership, practitioners, or staff;

An applicant’s lack of financial resources (e.g., inability to all pay staff, or inability to provide at least ninety (90) days of running capital as dictated by the provider’s monthly operating budget, etc.) to carry out its commitments and obligations under this chapter for the foreseeable future;

An applicant’s failure to timely respond to the Department’s request for information;

History of poor performance; and

Lack of behavioral health accreditation in accordance with § 8031.1.

8004.2 Upon written request submitted by the applicant and received by the Department within fifteen (15) business days of the certification denial, the Department shall provide an applicant an impartial administrative review of the decision. The Department shall conduct the administrative review to determine whether the certification denial complied with § 8004.1. Each request for an administrative review shall contain a concise statement of the reason(s) why the certification denial was in error. The Director shall issue a written decision within fifteen (15) business days. The Director’s decision is final and not subject to further appeal. An applicant and its principals shall not be allowed to reapply for certification for twelve (12) months following the date of denial.

8004.3 An applicant and its executive leadership shall not be allowed to reapply for certification for twelve (12) months following the date of the initial denial or, if applicable, the date of the denial pursuant to the Director’s administrative review.

8004.4 The Department shall decertify existing providers who fail to comply with the certification requirements contained in this chapter. Evidence of one (1) or more of the following shall constitute good cause to decertify:

(a) An incomplete recertification application;

(b) False information provided by provider or contained in a recertification application;

(c) High staff turnover where there are two or more changes made to the leadership staff within a certification period, demonstrating organizational instability;

(d) One (1) or more documented violations of the certification standards during the certification period that evidence a provider’s lack of capacity to meet and sustain compliance with this chapter;

(e) Claims audit error rate in excess of twenty-five percent (25%);

(f) A provider’s lack of financial resources to carry out its commitments and obligations under this chapter for the foreseeable future; evidenced by an inability to all pay staff, or an inability to provide at least ninety (90) calendar days of running capital as dictated by the provider monthly operating budget;

(g) Failure to cooperate with Department investigations or lack of timely response to information requests; or

(h) Failure to obtain or maintain in good standing national accreditation in accordance with § 8031.1 or meet the timelines in § 8031.2.

8004.5 Nothing in this chapter requires the Director to issue a SOD or a Notice of Infraction (“NOI”) prior to decertifying a provider. If the Director finds that there are grounds for decertification, the Director shall issue a written notice of decertification setting forth the factual basis for the decertification, the effective date, and the provider’s right to request an administrative review.

8004.6 The provider may request an administrative review from the Director within fifteen (15) business days of the date on the notice of decertification.

8004.7 Each request for an administrative review shall contain a concise statement of the reason(s) why the provider asserts that it should not have had its certification revoked and include any relevant supporting documentation.

8004.8 Each administrative review shall be conducted by the Director and shall be completed within fifteen (15) business days of the receipt of the provider’s request.

8004.9 The Director shall issue a written decision and provide a copy to the provider. If the Director denies the appeal and approves the decertification, the provider may request a hearing under the D.C. Administrative Procedure Act, within fifteen (15) business days of the receipt of the Director’s written decision. The administrative hearing shall be limited to the issues raised in the administrative review request. The decertification shall be stayed pending resolution of the hearing.

8004.10 Upon decertification, the provider and its executive leadership shall not be allowed to reapply for certification for a period of two (2) years following the date of the order of revocation. If a provider reapplies for certification, the provider must reapply in accordance with the established certification standards for the type of services provided and show evidence that the grounds for the revocation have been corrected.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021); as amended by Final Rulemaking published at 70 DCR 003050 (March 10, 2023); as corrected by Errata Notice published at 71 DCR 004474 (April 19, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8004

22-A DCMR § 8005 NOTICES OF INFRACTION

8005.1 The Department may issue an NOI for any violation of this chapter. The fine amount for any NOI issued under this chapter shall be as follows:

For the first offense five hundred dollars ($500.00);

(b) For the second offense one thousand dollars ($1,000.00);

(d) For the fourth and subsequent offenses four thousand dollars ($4,000.00).

8005.2 The administrative procedure for the appeal of an NOI issued under this chapter shall be governed by 16 DCMR §§ 3100 et seq.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8005

22-A DCMR § 8006 CLOSURES AND CONTINUITY OF CARE

8006.1 A provider shall provide written notification to the Department at least ninety (90) calendar days before its impending closure, or immediately upon knowledge of an impending closure less than ninety (90) calendar days in the future. This notification shall include plans for continuity of care and preservation of individuals’ records.

8006.2 The Department shall review the continuity of care plan and make recommendations to the provider. The plan must include provision for the referral and transfer of individuals, and for the provision of relevant treatment information, medications, and information to the new provider. The provider shall incorporate all Department recommendations necessary to ensure a safe and orderly transfer of care.

8006.3 Closure does not absolve a provider from its legal responsibilities regarding the preservation and the storage of individual records as described in § 8022 of this chapter and all applicable Federal and District laws and regulations. A provider must take all necessary and appropriate measures to ensure individuals’ records are preserved, maintained, and made available to the individuals upon request after closure of a program.

8006.4 A provider shall be responsible for the execution of its continuity of care plan in coordination with the Department.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8006

22-A DCMR § 8007 GENERAL MANAGEMENT AND ADMINISTRATION STANDARDS

8007.1 Each provider shall be a recognized legal entity in the District of Columbia and qualified to conduct business in the District. Evidence of qualification to conduct business includes a BBL and Clean Hands Certification issued by DCRA. The provider shall provide evidence of the BBL and Clean Hands Certification to the Department at certification and recertification.

8007.2 Each provider shall maintain the clinical operations, policies, and procedures described in this section. These operations, policies, and procedures shall be reviewed and approved by the Department during the certification and recertification process.

8007.3 All certified providers shall report to the Department in a form and manner prescribed by the Department's policy on major unusual incidents, including but not limited to abuse or neglect of individuals or any other event that may compromise the health, safety, or welfare of an individual.

8007.4 Each provider shall:

Comply with all applicable Federal and District laws and regulations; and

(b) Hire personnel with the necessary qualifications to provide behavioral health stabilization services to meet the needs of individuals in crisis and the standards established in this chapter.

8007.5 All behavioral health stabilization programs shall operate twenty-four (24) hours per day, seven (7) days per week, year-round.

8007.6 Each provider shall have a clinical director responsible for the clinical direction and day-to-day delivery of clinical services provided to individuals of the program(s). The clinical director must be a clinician licensed to practice independently in the District of Columbia. The clinical director must be full-time, and able to supervise other clinical staff.

8007.7 The clinical director and/or a program director, depending on the provider needs, shall have authority and responsibility for the administration and day-to-day operation of the program(s).

8007.8 The program director shall devote adequate time and authority to ensure that service delivery complies with all applicable standards set forth in this chapter.

8007.9 Each provider shall establish and adhere to a Staff Selection Policy for selecting and hiring staff, which shall include but not be limited to:

(a) Evidence of licensure, certification, or registration, as applicable and as

required by the job being performed;

Evidence of an appropriate degree, training program, or credentials, such as academic transcripts or a copy of degree;

Evidence of all required criminal background checks and child abuse registry checks (for both state of residence and employment). Non-licensed staff shall comply with the criminal background check requirements contained in District Official Code §§ 44-551 et seq. and 22-B DCMR §§ 4700 et seq.;

Evidence of quarterly checks to determine whether an individual should be excluded from participation in a Federal health care program as listed on the Department of Health and Human Services List of Excluded Individuals/ Entities or the General Services Administration Excluded Parties List System, or any similar succeeding governmental list; and

Evidence of a negative result on a tuberculosis test or medical clearance related to a positive result.

8007.10 Each provider shall establish and adhere to written job descriptions for all positions, including at a minimum the role, responsibilities, reporting relationships, and minimum qualifications for each position. The minimum qualifications established for each position shall be appropriate for the scope of responsibility and clinical practice (if any) described for each position.

8007.11 Each provider shall establish and adhere to a Performance Review Policy, which shall require a periodic evaluation of clinical and administrative staff performance, an assessment of clinical competence (if appropriate), general organizational work requirements, and key functions as described in the job description. The periodic evaluation shall also include an annual individual development plan for each staff member.

8007.12 Each provider shall establish and adhere to a supervision policy to ensure that services are provided according to this chapter and Department policies on supervision and service standards as well as Distract laws and regulations.

8007.13 Each provider shall establish and adhere to a training policy in accordance with § 8018 of this chapter.

8007.14 Personnel policies and procedures shall apply to all staff and volunteers and shall include:

(a) Compliance with Federal and District equal opportunity laws, including the Americans with Disabilities Act (42 USC § 12101) and the D.C. Human Rights Act (D.C. Official Code §§ 2-1401.1 et seq.);

(b) A current organizational flow chart reflecting each program position and, where applicable, the relationship to the larger program or provider of which the program is a part;

(c) Written plans for developing, posting, and maintaining files pertaining to work and leave schedules, time logs, and on-call schedules for each functional unit, to ensure adequate coverage during all hours of operation;

(d) A written policy requiring that a designated individual be assigned responsibility for management and oversight of the volunteer program, if volunteers are utilized;

(e) A written policy regarding volunteer recruitment, screening, training, supervision, and dismissal for cause, if volunteers are utilized; and

(f) Provisions through which the program shall make available to staff a copy of the personnel policies and procedures.

8007.15 Providers shall develop and implement procedures that prohibit the possession, use, and distribution of controlled substances and alcohol by staff during their duty hours, unless medically prescribed and used accordingly. Staff possession, use, or distribution of controlled substances or alcohol during off duty hours that affects job performance shall be prohibited. These policies and procedures shall ensure that the provider:

(a) Provides information about the adverse effects of the non-medical use and abuse of controlled substances and alcohol to all staff;

(b) Initiates disciplinary action for the possession, use or distribution of controlled substances or alcohol, which occurs during duty hours or which affects job performance; and

8007.16 The provider shall maintain individual personnel records for each person employed by the provider including, at a minimum, the following:

(a) A current job description for each person, that is revised as needed;

(b) Evidence of a negative result on a tuberculosis test or medical clearance related to a positive result;

(c) Evidence of the education, training, and experience of the individual, and a copy of the current appropriate license, registration, or certification credentials (if any);

(d) Documentation that written personnel policies were distributed to the employee;

(e) Notices of official tour of duty: day, evening, night, or rotating shifts; payroll information; and disciplinary records;

(f) Documentation that the employee has received all health care worker immunizations recommended by the District of Columbia Department of Health; and

(g) Criminal background checks as required in Title 22-B, District of Columbia Municipal Regulation, §§ 4700 et seq. and 22-B DCMR §§ 4700 et seq.

8007.17 The provider shall maintain all personnel records during the course of an individual’s employment with the provider and for three (3) years following the individual’s separation from the provider.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8007

22-A DCMR § 8008 EMPLOYEE CONDUCT

8008.1 All staff shall adhere to ethical standards of behavior in their relationships with individuals as follows:

(a) Staff shall maintain an ethical and professional relationship with individuals at all times;

(b) Licensed or certified staff shall adhere to their professional codes of conduct, as required by District licensing laws and regulations;

(c) Staff shall not enter into dual or conflicting relationships with individuals that might affect professional judgment, therapeutic relationships, or increase the risk of exploitation; and

(d) The provider shall establish written policies and procedures regarding staff relationships with both current and former individuals that are consistent with this section.

8008.2 No staff, including licensed professionals, support personnel, and volunteers, shall engage in sexual activities or sexual contact with individuals in the program.

8008.3 No staff, including licensed professionals, support personnel, and volunteers, shall engage in sexual activities or sexual contact with individuals formerly served by the program.

8008.4 No staff, including licensed professionals, support personnel, and volunteers, shall engage in sexual activities or sexual contact with individuals’ relatives or other individuals with whom individuals maintain a close personal relationship.

8008.5 No staff, including licensed professionals, support personnel, and volunteers, shall provide services to individuals with whom they have had a prior sexual or other significant relationship.

8008.6 Staff, including licensed professionals, support personnel, and volunteers, shall only engage in appropriate physical contact with individuals in the program and are responsible for setting clear, appropriate, and culturally sensitive boundaries that govern such physical contact.

8008.7 No staff, including licensed professionals, support personnel, and volunteers, shall sexually harass any individual. Sexual harassment includes, but is not limited to, sexual advances, sexual solicitation, requests for sexual favors, and other verbal or physical conduct of a sexual nature.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8008

22-A DCMR § 8009 QUALITY IMPROVEMENT

8009.1 Each provider shall establish and adhere to policies and procedures governing quality improvement (“Quality Improvement Policy”).

8009.2 The Quality Improvement Policy shall require the provider to adopt a written quality improvement (“QI”) plan describing the objectives and scope of its QI program and require provider staff, individual, and family involvement in the QI program.

8009.3 The Department shall review and approve each provider’s QI program at a minimum as part of the certification and recertification process. The QI program shall submit data to the Department upon request.

8009.4 The QI program shall be directed by a coordinator (“QI Coordinator”) who has direct access to the Program Director. In addition to directing the QI program’s activities as detailed in § 8009.5, the QI Coordinator shall also review unusual incidents, deaths, and other sentinel events; monitor and review utilization patterns; and track individuals’ complaints and grievances. The QI Coordinator shall be:

(a) A Physician;

(b) A Psychologist;

(d) An Advanced Practice Registered Nurse (“APRN”);

(e) A Licensed Professional Counselor (“LPC”);

(f) A Licensed Marriage and Family Therapist (“LMFT”);

(g) A Registered Nurse (“RN”);

(h) A Licensed Independent Social Worker (“LISW”);

(i) A Licensed Graduate Professional Counselor (“LGPC”);

(j) A Licensed Graduate Social Worker (“LGSW”);

(k) A Certified Addiction Counselor (“CAC”) I or II;

(l) A Physician Assistant (“PA”); or

(m) An individual with a Bachelors’ Degree and a minimum of two (2) years of relevant, qualifying experience, such as experience in behavioral health care delivery or health care quality improvement initiatives.

8009.5 The QI program shall be operational and shall measure and ensure at least the following:

(a) Easy and timely access and availability of services;

(b) Close monitoring and review of high volume or repeat utilizers of behavioral health stabilization services;

(c) Coordination of care with Core Service Agencies (“CSAs”), Assertive Community Treatment (“ACT”) providers, Community Based Intervention (“CBI”) providers, Clubhouse providers, and/or substance use treatment and recovery provider, when applicable;

(d) Compliance with all certification standards;

(e) Adequacy, appropriateness, and quality of care for individuals in the program;

(f) Efficient utilization of resources;

(g) Individual and family satisfaction with services; and

(h) Any other indicators that are part of the Department QI program for the larger system.

8009.6 When the provider identifies a significant problem or quality of service issue, the provider shall notify the Department, act to correct the problem or improve the effectiveness of service delivery, or both, and shall assess corrective or supportive actions through continued monitoring.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8009

22-A DCMR § 8010 FISCAL MANAGEMENT STANDARDS

8010.1 Applicants or providers that are in financial distress and at risk of imminent closure represent a risk both to individuals served by the Department and the behavioral health system. The Department shall not certify any applicant or re-certify any provider without evidence that the applicant or provider has sufficient financial resources (e.g., ability to provide at least ninety (90) calendar days of running capital as dictated by the provider’s monthly operating budget) to carry out its commitments and obligations under this chapter for the foreseeable future. The provider shall have adequate financial resources to deliver all required services and shall provide documented evidence at the time of certification and recertification that it has adequate resources to operate behavioral health stabilization program. Documented evidence shall include Federal and District tax returns, including Form 990s for non-profit organizations, for the three (3) most recent tax reporting years, and a current financial statement.

8010.2 A provider shall have fiscal management policies and procedures and keep financial records in accordance with generally accepted accounting principles.

8010.3 A provider shall include adequate internal controls for safeguarding or avoiding misuse of individual or organizational funds.

8010.4 A provider shall have a uniform budget of expected revenue and expenses as required by the Department. The budget shall:

(a) Categorize revenue by source;

(b) Categorize expenses by type of service; and

8010.5 A provider shall have the capacity to determine direct and indirect costs for each type of service provided.

8010.6 The provider shall conspicuously post and make available to all a written schedule of rates and charges.

8010.7 Fiscal reports shall provide information on the relationship of the budget to actual spending, including revenues and expenses by category and an explanation of the reasons for any substantial variance.

8010.8 Providers shall correct or resolve all adverse audit findings prior to recertification.

8010.9 A provider shall have policies and procedures regarding:

(a) Purchase authority, product selection and evaluation, property control and supply, storage, and distribution;

(b) Billing;

(d) Handling cash;

(e) Management of individual fund accounts;

(f) Arranging credit; and

(g) Applying discounts and write-offs.

8010.10 All business records pertaining to costs, payments received and made, and services provided to individuals shall be maintained for a period of ten (10) years or until all audits and ongoing litigations are complete, whichever is longer.

8010.11 All providers must maintain proof of liability insurance coverage, which must include malpractice insurance of at least three million dollars ($3,000,000.00) aggregate and one million dollars ($1,000,000.00) per incident and comprehensive general coverage of at least three million dollars ($3,000,000.00) per incident that covers general liability, vehicular liability, and property damage. The insurance shall include coverage of all personnel, consultants, or volunteers working for the provider.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8010

22-A DCMR § 8011 ADMINISTRATIVE PRACTICE ETHICS

8011.1 All providers shall operate in an ethical manner, including but not limited to complying with the provisions of this section.

8011.2 A provider shall not offer or imply to offer services not authorized on the certification issued by the Department.

8011.3 A provider shall not use any advertising that contains false, misleading, or deceptive statements or claims or that contains false or misleading information about fees.

8011.4 A provider shall comply with all Federal and District laws and regulations, including but not limited to the False Claims Act, 31 USC §§ 3729-3733, the Anti-Kickback Statute, 42 USC § 1320a-7b, the Physician Self-Referral Law (Stark law), 42 USC § 1395nn, and the Exclusion Statute, 42 USC § 1320a-7.

8011.5 The provider shall inform all employees of any policy change that affects the performance of their duties.

8011.6 The provider shall treat all alleged ethical violations as major unusual incidents.

8011.7 The provider, and its personnel, consultants or volunteers must conduct any research in accordance with all Federal law and regulations.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8011

22-A DCMR § 8012 PROGRAM POLICIES AND PROCEDURES

8012.1 Each program must document the following:

(a) Organization and program mission statement, philosophy, purpose, and

values;

(b) Organizational and leadership structure;

(d) Relationships with parent organizations, affiliated organizations, and

organizational partners;

(e) Treatment philosophy and approach;

(f) Services provided;

(g) Characteristics and needs of the population served;

(h) Performance metrics, including intended outcomes and process methods;

(i) Contract services, if any;

(j) Affiliation agreements, if any;

(k) The scope of volunteer activities and rules governing the use of

volunteers, if any; and

(l) Location of service sites and specific designation of the geographic area to

be served.

8012.2 Each program shall establish written policies and procedures subject to review by the Department to ensure each of the following:

(a) Service provision based on the individual’s needs;

(b) Consideration of special needs of the individual served and the program's

population of focus;

(c) Placement of individuals in the least restrictive setting necessary to address the acuity of the individual’s presenting illness and circumstances; and

(d) Facilitation of access to other more appropriate services for individuals who do not meet the criteria for admission into a program offered by the provider.

8012.3 Each program shall develop and document policies and procedures subject to review by the Department related to each of the following:

(a) Program admission and exclusion criteria;

(b) Termination of treatment and discharge or transition criteria;

(c) Infection control procedures and use of universal precautions, addressing at least those infections that may be spread through contact with bodily fluids;

(d) Volunteer utilization, recruitment, and oversight;

(e) Crisis intervention and medical emergency procedures;

(f) Safety precautions and procedures for participant volunteers, employees,

and others;

(g) Record management procedures in accordance with "Confidentiality of Substance Use Disorder Patient Records" (“42 CFR Part 2”), as applicable, the Health Insurance Portability and Accountability Act (“HIPAA”) (42 U.S.C. §§ 1320d et seq., and the regulations promulgated under HIPAA, including 45 CFR Part 160, 162 and 164), the D.C. Mental Health Information Act of 1978, effective March 3, 1979 (D.C. Law 2-136; D.C. Official Code §§ 7-1201.01 et seq.), this chapter, and any other Federal and District laws and regulations regarding the confidentiality of individuals’ records;

(h) The on-site prohibition on use of tobacco, alcohol, and other substances;

(i) Individuals’ rules of conduct and commitment to treatment regimen, including restrictions on carrying weapons and specifics of appropriate behavior while in or around the program;

(j) Individuals’ rights;

(k) Addressing and investigating major unusual incidents;

(l) Addressing individuals’ grievances;

(m) Addressing issues of an individual’s non-compliance with established treatment regimen and/or violation of program policies and requirements;

(n) The purchasing, receipt, storage, distribution, return, and destruction of medication, including accountability for and security of medications located at any of its service site(s);

(o) Selecting and hiring staff; and

(p) Quality improvement.

8012.4 Gender-specific programs shall ensure that staff of that specific gender is in attendance at all times when individuals are present in the program.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8012

22-A DCMR § 8013 EMERGENCY PREPAREDNESS PLAN

8013.1 Each provider shall establish and adhere to a written disaster evacuation and continuity of operations plan in accordance with the Department policy on Disaster Evacuation/Continuity of Operations Plans.

8013.2 A provider shall immediately notify the Department and implement its continuity of operations plan if an imminent health hazard exists because of an emergency such as a fire, flood, extended interruption of electrical or water service, sewage backup, gross unsanitary conditions, or other circumstances that may endanger the health, safety, or welfare of the individuals served.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8013

22-A DCMR § 8014 FACILITIES MANAGEMENT

8014.1 A provider shall establish and maintain a safe environment for its operation, including adhering to the following provisions:

(a) Each provider’s service site(s) shall be located and designed to provide

adequate and appropriate facilities for private, confidential individual and group counseling/therapy sessions;

(b) Each provider’s service site(s) shall have appropriate space for group

activities and educational programs;

with Disabilities Act (42 USC § 12101) in all business locations;

(d) Each service site shall be located within reasonable walking distance of

public transportation;

(e) Providers shall maintain fire safety equipment and establish practices to

protect all occupants. This shall include clearly visible fire extinguishers with a charge that are inspected annually by a qualified service company or trained staff member; and

(f) Each provider shall annually obtain a written certificate of compliance

from the District of Columbia Department of Fire and Emergency Medical Services indicating that all applicable fire and safety code requirements have been satisfied for each facility.

8014.2 Each window that opens shall have a screen.

8014.3 Each rug or carpet in a facility shall be securely fastened to the floor or shall have a non-skid pad.

8014.4 Each hallway, porch, stairway, stairwell, and basement shall be kept free from any obstruction at all times.

8014.5 Each ramp or stairway used by individuals in the program shall be equipped with a firmly secured handrail or banister.

8014.6 Each provider shall maintain a clean environment free of infestation and in good physical condition.

8014.7 Each facility shall be appropriately equipped and furnished for the services delivered.

8014.8 Each provider shall properly maintain the outside and yard areas of the premises in a clean and safe condition.

8014.9 Each exterior stairway, landing, and sidewalk shall be kept free of snow and ice.

8014.10 Each facility shall be located in an area reasonably free from noxious odors, hazardous smoke and fumes, and where interior sounds may be maintained at reasonably comfortable levels.

8014.11 A provider shall take necessary measures to ensure pest control, including:

(a) Refuse shall be stored in covered containers that do not create a nuisance

or health hazard; and

(b) Recycling, composting, and garbage disposal shall not create a nuisance,

permit transmission of disease, or create a breeding place for insects or rodents.

8014.12 A provider shall ensure that medical waste is stored, collected, transported, and disposed of in accordance with applicable Federal and District laws and guidelines from the Centers for Disease Control and Prevention (“CDC”).

8014.13 Each provider shall ensure that its facilities have comfortable lighting, proper ventilation, and moisture and temperature control. Rooms, including bedrooms and activity rooms below ground level, shall be dry and the temperature shall be maintained within a normal comfort range.

8014.14 Each facility shall have potable water available for each individual.

8014.15 The physical design of the provider’s structure shall be sufficient to accommodate staff, individuals receiving services and the program(s). Each location shall make available the following:

(a) A reception area;

(b) Private areas for individual treatment services;

(d) Separate bathrooms and/or toilet facilities in accordance with District law where the:

(i) Required path of travel to the bathroom shall not be through another bedroom;

(ii) Windows and doors provide privacy; and

(iii) Showers and toilets not intended for individual use provide privacy.

8014.16 If activity space is used for purposes not related to the program’s mission, the provider shall ensure that:

(a) The quality of services is not reduced;

(b) Activity space in use by other programs shall not be counted as part of the required activity space; and

(c) Individual confidentiality is protected, as required by HIPAA, the D.C. Mental Health Information Act, 42 CFR Part 2, and all other applicable Federal and District laws and regulations.

8014.17 The use of appliances such as cell phones, computers, televisions, radios, CD players, recorders, and other electronic devices shall not interfere with the therapeutic program.

8014.18 Each facility shall maintain an adequately supplied first-aid kit which:

(a) Shall be maintained in a place known and readily accessible to individuals in the program and employees; and

(b) Shall be adequate for the number of persons in the facility, including individuals, staff, consultants and volunteers.

8014.19 Each provider shall post emergency numbers near its telephones for fire, police, and poison control, along with contact information and directions to the nearest hospital.

8014.20 Each provider shall have on site at each facility a fully functioning automatic external defibrillator (“AED”) and shall ensure that all staff are trained in how to use the AED.

8014.21 Each provider shall have on-site at each facility at least two (2) unexpired doses of naloxone at all times and shall ensure that all staff are trained in how to administer the naloxone.

8014.22 A provider shall have an interim plan addressing safety and continued service delivery during construction.

8014.23 As part of each certification and re-certification application, the provider shall present the Department permits (including DCRA building permit(s)) and post-work inspection(s) for all plumbing and electrical work completed at the program facility during the last twelve (12) months.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8014

22-A DCMR § 8015 MEDICATION STORAGE AND ADMINISTRATION STANDARDS

8015.1 Providers shall maintain all controlled substances in accordance with applicable Federal and District laws and regulations.

8015.2 Providers shall implement written policies and procedures to govern the acquisition, safe storage, prescribing, dispensing, labeling, administration and self-administration of medication. This section shall include medications individuals bring to the program.

8015.3 A provider shall ensure that any prescription medication that an individual brings to the program has a record of the prescribing physician’s order, including the prescribing physician’s approval to self-administer the medication, if applicable.

8015.4 No medication brought into the facility may be administered or self-administered until the medication is identified and the attending practitioner’s written order or approval is documented in the individual’s record.

8015.5 Verbal orders may only be given by the attending practitioner to another physician, PA, APRN, RN, or pharmacist. Verbal orders shall be noted in the individual’s record as such and countersigned and dated by the prescribing practitioner within twenty-four (24) hours. However, pursuant to District law and regulations, orders for seclusion or restraint shall always be made as written orders.

8015.6 Providers shall ensure that medication, both prescription and over-the-counter, brought into a facility is packaged and labeled in accordance with Federal and District laws and regulations.

8015.7 Providers shall ensure that medication, both prescription and over-the-counter, brought into a facility by an individual that is not approved by the attending practitioner is packaged, sealed, stored, and returned to the individual upon discharge.

8015.8 The administration of medications, excluding self-administration, shall be permitted only by licensed individuals pursuant to applicable Federal and District laws and regulations.

8015.9 Medications shall be administered only in accordance with the prescribing practitioner’s order.

8015.10 Only a physician, APRN, RN, or PA shall administer controlled substances or injectable drugs, excluding self-administered drugs.

8015.11 Program staff responsible for supervising the self-administration of medication shall document consultations with a physician, APRN, RN, or pharmacist, or referral to appropriate reference material regarding the action and possible side effects or adverse reactions of each medication.

8015.12 A program shall provide training to the staff designated to supervise the self-administration of medication. The training shall include but not be limited to the expected action of and adverse reaction to self-administered medications.

8015.13 Medication administration training shall be facilitated by the following Qualified Practitioners, as led by signature and date on the training certificate:

(a) Physicians;

(b) PAs;

(d) RNs.

8015.14 Only staff trained pursuant to the requirements of this chapter shall be responsible for observing the self-administration of medication.

8015.15 A program shall ensure that medication is available to individuals as prescribed.

8015.16 A program shall maintain records that track and account for all medication, ensuring the following:

(a) That each individual receiving medication shall have a medication administration record, which includes the individual’s name, the name of medication, the type of medication (including classification), the amount of medication, the dose and frequency of administration/self-administration, and the name of staff who administered or observed the self-administration of the medication;

(b) That documentation shall include each omission and refusal of medication administration;

(c) That the medication administration record shall note the amount of medication originally present and the amount remaining after each dose;

(d) That documentation of medication administration shall include all over-the-counter drugs administered or self-administered; and

(e) That behavioral health stabilization providers who are administering controlled substances, including but not limited to initiating Medications for Substance Use Disorders (MSUD), shall follow the requirements of all applicable Federal and District laws and regulations.

8015.17 An attending practitioner shall be notified immediately of any medication error or adverse reaction. The staff responsible for the medication error shall complete a major unusual incident report (“MUI”). The provider shall document the practitioner’s recommendations and the program’s subsequent actions in response to the medication error or adverse reaction in the individual’s record.

8015.18 A program shall ensure that all medications, including those that are self-administered, are secured in locked storage areas.

8015.19 The locked medication area shall provide for separation of internal and external medications.

8015.20 A program shall maintain lists of personnel with access to the locked medication area and personnel qualified to administer medication.

8015.21 A program shall comply with all Federal and District laws and regulations concerning the acquisition and storage of pharmaceuticals.

8015.22 Each individual’s medication shall be properly labeled as required by Federal and District laws and regulations, shall be stored in its original container, and shall not be transferred to another container or taken by anyone other than the individual for whom it was originally prescribed.

8015.23 Medications requiring refrigeration shall be maintained in a separate and secure refrigerator, labeled "FOR MEDICATION ONLY" and shall be maintained at a temperature between thirty-six degrees Fahrenheit (36°F) and forty-six degrees Fahrenheit (46°F). All refrigerators shall have thermometers, which are easily readable, in proper working condition, and accurate within a range of plus or minus two (2°F) degrees Fahrenheit.

8015.24 A program shall conspicuously post in the drug storage area the following information:

(a) Telephone numbers for the regional Poison Control Center; and

(b) Metric-apothecaries weight and conversion measure charts.

8015.25 A program shall conduct monthly inspections of all drug storage areas to ensure that medications are stored in compliance with Federal and District laws and regulations. The program shall maintain records of these inspections for verification.

8015.26 Where applicable, the program shall implement written policies and procedures for the control of stock pharmaceuticals.

8015.27 The receipt and disposition of stock pharmaceuticals must be accurately documented as follows:

(a) Invoices from companies or pharmacies shall be maintained to document the receipt of stock pharmaceuticals;

(b) A log shall be maintained for each stock pharmaceutical that documents receipt and disposition; and

(c) At least quarterly, each stock pharmaceutical shall be reconciled as to the amount received and the amount dispensed.

8015.28 A program shall implement written procedures and policies for the disposal of medication.

8015.29 Any medication left by the individual at discharge shall be destroyed within thirty (30) calendar days after the individual has been discharged, with the exception of methadone and other controlled substances which must be returned to the point of issue or destroyed in accordance with Federal regulations.

8015.30 The disposal of all medications shall be witnessed and documented by two (2) staff members.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021); as amended by Final Rulemaking published at 72 DCR 008497 (August 1, 2025). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8015

22-A DCMR § 8016 VEHICLE ENVIRONMENTAL AND SAFETY STANDARDS

8016.1 A provider shall implement measures to ensure the safe operation of transportation, if applicable. These measures shall include, but are not limited to:

(a) Automobile insurance with adequate liability coverage;

(b) Regular inspection and maintenance of vehicles, as required by law;

(d) Training of vehicle operators in emergency procedures and in the handling of accidents and road emergencies; and

(e) Annual verification that all authorized motor vehicle operators have valid, unexpired and unrestricted motor vehicle license to operate assigned vehicles.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8016

22-A DCMR § 8017 FOOD AND NUTRITION STANDARDS

8017.1 The provisions of this section apply to any provider that prepares or serves food to individuals.

8017.2 All programs that prepare food shall have a current Certified Food Protection Manager (“CFPM”) certification from the Department of Health. The CFPM must be present whenever food is prepared and served.

8017.3 The provider shall require each CFPM (or a Certified Food Handler (“CFH”), for providers serving food prepared off-site) to monitor any staff members who are not certified as CFPMs (or CFHs) in the storage, handling, and serving of food and in the cleaning and care of equipment used in food preparation in order to maintain sanitary conditions at all times.

8017.4 The kitchen, dining, and food storage areas shall be kept clean, orderly, and protected from contamination.

8017.5 A program providing meals shall maintain a fully equipped and supplied code-compliant kitchen area unless meals are catered by an organization licensed by the District to serve food.

8017.6 A program may share kitchen space with other programs if the accommodations are adequate to perform required meal preparation for all programs using the kitchen.

8017.7 Each food and drink item procured, stored, prepared, or served by the facility shall be clean, free from spoilage, prepared in a manner that is safe for human consumption, and protected from contamination.

8017.8 A program providing meals shall clean dishes, cooking utensils, and eating utensils after each meal and store them to maintain to maintain their sanitary condition.

8017.9 Each facility shall provide hot and cold water, soap, and disposable towels for hand washing in or adjacent to food preparation areas.

8017.10 Each facility shall maintain adequate dishes, utensils, and cookware in good condition and in sufficient quantity for the facility.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8017

22-A DCMR § 8018 PERSONNEL TRAINING STANDARDS

8018.1 Behavioral health stabilization staff shall have annual training that meets the Occupational Safety & Health Administration (“OSHA”) regulations that govern behavioral health facilities and any other applicable infection control guidelines, including use of universal precaution and avoiding exposure to hepatitis, tuberculosis, and HIV.

8018.2 A behavioral health stabilization provider shall have at least two (2) staff persons trained and certified by a nationally recognized authority that meets OSHA guidelines for basic first aid and cardiopulmonary resuscitation (“CPR”) present at all times.

8018.3 A behavioral health stabilization provider shall have a current written plan for staff development and organizational onboarding, approved by the Department, which reflects the training and performance improvement needs of all employees working in that program. The plan should address the steps the provider will take to ensure the recruitment and retention of highly qualified employees and the reinforcement of staff development through training, supervision, the performance management process, and activities such as shadowing, mentoring, skill testing, and coaching. The plan shall include culturally competent training and onboarding activities in the following core areas:

(a) The program’s approach to addressing behavioral health stabilization services, including philosophy, goals and methods;

(b) The staff member’s specific job description and role in relationship to other staff;

(d) The proper documentation of services in individuals’ records, as applicable;

(e) Policies and procedures governing infection control, protection against exposure to communicable diseases, and the use of universal precautions;

(f) Laws, regulations, and policies governing confidentiality of individual information and release of information, including HIPAA, the D.C. Mental Health Information Act, and 42 CFR Part 2 (as applicable);

(g) Laws, regulations, and policies governing reporting abuse and neglect;

(h) Individual rights; and

(i) Other trainings as directed by the Department.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8018

22-A DCMR § 8019 INDIVIDUALS’ RIGHTS AND PRIVILEGES, INCLUDING GRIEVANCES

8019.1 A program shall protect the following rights and privileges of each individual:

(a) Right to be admitted and receive services in accordance with the District of Columbia Human Rights Act;

(b) Right to make choices regarding provider, treatment, medication, and advance directives;

(d) Right to receive services and live in a healthy, safe, and clean environment;

(e) Right to be evaluated and cared for in the least restrictive and most integrated environment appropriate to an individual’s needs;

(f) Right to participate in the treatment planning process, including decisions concerning treatment, care, and other services, and to receive a copy of the Plan of Care;

(g) Right to have records kept confidential;

(h) Right to privacy;

(i) Right to be treated with respect and dignity in a humane treatment environment;

(j) Right to be safe from harm and from verbal, physical, or psychological abuse;

(k) Right to be free of discrimination;

(l) Right to own personal belongings;

(m) Right to refuse treatment and/or medication;

(n) Right to give, not give, or revoke already-given consent to treatment, supports, and/or release of information;

(o) Right to give, not give, or revoke informed, voluntary, written consent of the individual or a person legally authorized to act on behalf of the individual to participate in research; the right to protection associated with such participation; and the right and opportunity to revoke such consent;

(p) Right to be informed in advance of charges for services;

(q) Right to be afforded the same legal rights and responsibilities as any other citizen, unless otherwise stated by law;

(r) Right to request and receive documentation on the performance track record of a program with regard to treatment outcomes and success rates;

(s) Right to provide feedback on services and supports, including evaluation of providers;

(t) Right to assert grievances with respect to infringement of these rights, including the right to have such grievances considered in a fair, timely, and impartial manner;

(u) Right to receive written and oral information on individual rights, privileges, program rules, and grievance procedures in a language understandable to the individual;

(v) Right to access services that are culturally appropriate, including the use of adaptive equipment, sign language, interpreter, or translation services, as appropriate; and

(w) Right to vote.

8019.2 A provider shall conspicuously post a statement of individual rights, program rules, and grievance procedures. The grievance procedures must inform individuals that they may report any violations of their rights to the Department and shall include the telephone numbers of the Department and any other relevant agencies for the purpose of filing complaints.

8019.3 At the time of admission, staff shall explain program rules, individual’s rights, and grievance procedures. Program staff shall document this explanation by including a form, signed by the individual and witnessed by the staff person, in the individual’s record.

8019.4 A program shall develop and implement written grievance procedures to ensure a prompt, impartial review of any alleged or apparent incident of violation of rights or confidentiality. The procedures shall be consistent with the principles of due process and Department requirements and shall include but not be limited to:

(a) Reporting the allegation or incident to the Department within twenty-four (24) hours of it coming to the attention of program staff;

(b) The completion of the investigation of any allegation or incident within thirty (30) calendar days;

(c) Providing a copy of the investigation report to the Department within twenty-four (24) hours of completing the investigation of any complaint; and

(d) Cooperating with the Department in completion of any inquiries related to individuals’ rights conducted by Department staff.

8019.5 Medicaid beneficiaries are entitled to Notice and Appeal rights pursuant to 29 DCMR § 9508 in cases of intended adverse action such as an action to deny, discontinue, terminate, or change the manner or form of Medicaid-funded services. The Department shall provide local-only beneficiaries the same Notice and Appeal rights as those provided to Medicaid beneficiaries in 29 DCMR § 9508.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8019

22-A DCMR § 8020 INDIVIDUALS’ CHOICE

8020.1 Each provider shall establish and adhere to policies and procedures governing the means by which individuals receiving services shall be informed of the full choices of providers and how to access these services (“Choice Policy”).

8020.2 The Department shall review and approve each provider’s Choice Policy during the certification and recertification process.

8020.3 The Choice Policy shall comply with applicable Federal and District laws and regulations.

8020.4 Each provider shall:

(a) Make its Choice Policy available to individuals and their families; and

(b) Establish and adhere to a system for documenting that individuals and families receive the Choice Policy.

8020.5 The providers’ Choice Policy shall ensure that each individual presenting for services is informed that they may choose to have services provided by any certified providers that offer appropriate services for that individual.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8020

22-A DCMR § 8021 RECORDS MANAGEMENT AND CONFIDENTIALITY

8021.1 A program shall create and maintain an organized record for each individual receiving services.

8021.2 All records must be secured in a manner that provides protection from unauthorized disclosure, access, use, or damage in accordance with Federal and District laws and regulations.

8021.3 Each individual’s records shall be kept confidential and shall be handled in compliance with HIPAA, the Mental Health Information Act, and 42 CFR Part 2 (if applicable), and all other Federal and District laws and regulations regarding the confidentiality of an individual’s records.

8021.4 Each provider shall have a designated Privacy Officer responsible for ensuring compliance with privacy requirements.

8021.5 A program shall inform staff and individuals receiving services of this chapter’s privacy requirements during orientation.

8021.6 A provider’s decision to disclose protected health information (“PHI”) must comply with Federal and District laws and regulations and shall be made only by the Privacy Officer or his/her designee with appropriately administered consent procedures.

8021.7 A program shall ensure its policies and procedures comply with the Department’s Privacy Policy and shall implement policies and procedures governing the release of PHI consistent with Federal and District laws and regulations regarding the confidentiality of individual records, including 42 CFR Part 2, the D.C. Mental Health Information Act, and HIPAA.

8021.8 Each provider shall execute a participation agreement with the District’s Health Information Exchange (HIE) and utilize the HIE to receive and transmit protected health information for individuals in accordance with the District of Columbia Mental Health Information Act of 1978, effective Mar. 3, 1979 (D.C. Law 2-136, D.C. Official Code § 7-1201.01 et seq.).

8021.9 For non-substance use treatment (“SUD”) programs, the behavioral health stabilization provider shall develop policies and procedures to disclose protected behavioral health information to other certified providers, primary health care providers, and other health care organizations when necessary to coordinate the care and treatment of its individuals. These procedures may include entering into an agreement with an HIE. The program shall advise each prospective individual of the program’s notice of privacy practices that authorizes this disclosure to other providers and shall afford the individual the opportunity to opt-out of that disclosure in accord with the D.C. Mental Health Information Act. The program shall document the individual’s decision.

8021.10 The program director shall designate a staff member to be responsible for the maintenance and administration of records.

8021.11 A program shall arrange and store records according to a uniform system approved by the Department.

8021.12 A program shall maintain records such that they are readily accessible for use and review by authorized staff and other authorized parties.

8021.13 A program shall organize the content of records so that information can be located easily and so that Department surveys and audits can be conducted with reasonable efficiency.

8021.14 Providers shall utilize an Electronic Health Record (EHR) system certified by the Department of Health and Human Services Office of the National Coordinator for Health Information Technology to document all phases of the individual’s treatment and care.

8021.15 All providers shall electronically transmit Behavioral Health Supplemental Data (BHSD) to the Department in a form and manner as prescribed by the Department. BHSD is a compilation of individual-level behavioral health data defined in the Department’s Integrated Technology Engine (ITE) Provider Companion Guide (available at https://dbh.dc.gov/).

8021.16 Providers shall timely transmit BHSD to the Department pursuant to the procedure established in the ITE through the EHR system.

8021.17 The Department shall provide notice of any future updates to the ITE Guide through https://dbh.dc.gov/.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8021

22-A DCMR § 8022 STORAGE AND RETENTION OF RECORDS

8022.1 A program shall retain individuals’ records (either original or accurate reproductions) until all litigation, adverse audit findings, or both, are resolved. If no such conditions exist, a program shall retain individuals’ records for at least ten (10) years after the individual’s discharge.

8022.2 Records of minors shall be kept for at least ten (10) years after the minor has reached the age of eighteen (18) years.

8022.3 The provider shall establish a Document Retention Schedule with all medical records retained in accordance with Federal and District laws and regulations.

8022.4 The provider shall give the individual or legal guardian a written statement concerning individual’s rights and responsibilities (“Rights Statement”) in the program during orientation. The individual or guardian shall sign the statement attesting that they understand their rights and responsibilities. A provider staff member shall be available to answer an individual or legal guardian’s questions about the Rights Statement and to witness the individual’s or guardian’s signature. This document shall be placed in the individual's record.

8022.5 If program records are maintained on computer systems, the system shall:

(a) Have a backup system to safeguard the records in the event of operator or equipment failure, natural disasters, power outages, and other emergency situations;

(b) Identify the name of the person making each entry into the record;

(c) Be secure from inadvertent or unauthorized access to records in accordance with HIPAA, the D.C. Mental Health Information Act, 42 CFR Part 2 (if applicable), and all Federal and District laws and regulations regarding the confidentiality of individual records;

(d) Limit access to providers who are involved in the care of the individual and who have permission from the individual to access the record; and

(e) Create an electronic trail when data is released.

8022.6 A program shall maintain records that safeguard confidentiality in the following manner:

(a) Records shall be stored with access controlled and limited to authorized staff and authorized agents of the Department;

(b) Written records that are not in use shall be maintained in either a secured room, locked file cabinet, safe, or other similar container;

(d) The provider’s policies and procedures shall only restrict an individual’s access to their record or information in the record after an administrative review with clinical justification has been made and documented;

(e) Individuals shall receive copies of their records as permitted under HIPAA, the D.C. Mental Health Information Act, and 42 CFR Part 2;

(f) All staff entries into the record shall be clear, complete, accurate, and recorded in a timely fashion;

(g) All entries shall be dated and authenticated by the recorder with full signature and title;

(h) All non-electronic entries shall be typewritten or legibly written in indelible ink that will not deteriorate from photocopying;

(i) Any documentation error shall be marked through with a single line and initialed and dated by the recorder; and

(j) Limited use of symbols and abbreviations shall be pre-approved by the program and accompanied by an explanatory legend.

8022.7 Any records that are retained off-site must be kept in accordance with this chapter. If an outside vendor is used, the provider must submit the vendor’s name, address, and telephone number to the Department.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8022

22-A DCMR § 8023 RECORD CONTENTS

8023.1 As applicable, all records shall include:

(a) Documentation of the referral and initial screening and its

findings;

(b) The individual’s consent to services (if applicable);

(d) The Rights Statement;

(e) Documentation that the individual received:

(i) An orientation to the program’s services, rules, confidentiality practices, and individual’s rights; and

(ii) Notice of privacy practices and opt-out form.

(f) Confidentiality forms and releases signed to permit the facility to obtain and/or release information;

(g) Diagnostic interview and assessment record, including any Department-approved screening and assessment tools;

(h) Evaluation of medical needs and, as applicable, medication intake sheets and special diets which shall include:

(i) Documentation of physician’s orders for medication and treatment, change of orders, and/or special treatment evaluation;

(ii) For drugs prescribed following admissions, any prescribed drug

product by name, dosage, and strength, as well as date(s) medication was administered, discontinued, or changed; and

(iii) For any prescribed over-the-counter (“OTC”) medications following admissions, any OTCs by product name, dosage, and strength, as well as date(s) medication was administered, discontinued, or changed.

(i) Assessments and individual treatment plans pursuant to the presenting behavioral health situation and the individual’s needs, including crisis diversion or safety plans, if applicable;

(j) Encounter notes, which provide sufficient written documentation to support each therapy, service, activity, or session for which billing is made that, at a minimum, consists of:

(i) The specific service type rendered;

(ii) Dated and authenticated entries with their authors identified, that include the duration, and actual time (beginning and ending as well as a.m. or p.m.), during which the services were rendered. To constitute a valid signature, digital signatures must include a date and time stamp contemporaneous with the signature function and must be recorded and readily retrievable in the electronic system’s audit log;

(iii) Name, title, and credentials of the person providing the services;

(iv) The setting in which the services were rendered;

(v) Confirmation that the services delivered are contained in the individual’s record and are identified in the encounter note;

(vi) A description of each encounter or intervention provided to the individual, which is sufficient to document that the service was provided in accordance with this chapter;

(vii) A description of the individual’s response to the intervention sufficient to show, particularly in the case of group interventions, the individual’s unique participation in the service; and

(viii) Provider’s observations.

(k) Documentation of all services provided to the individual as well as activities directly related to the individual’s care that are not included in encounter notes;

(l) Documentation of missed appointments and efforts to contact and reengage the individual;

(m) Documentation of any personal articles of the individual held by the provider for safekeeping and any statements acknowledging receipt of the property;

(n) Documentation of all referrals to other agencies and the outcome of such referrals if known;

(o) Documentation establishing all attempts to acquire necessary and relevant information from other sources;

(p) Pertinent information reported by the individual, family members, or significant others regarding a change in the individual’s condition and/or an unusual or unexpected occurrence in the individual’s life;

(q) Drug test results and incidents of drug use;

(r) Discharge summary and aftercare plan;

(s) Outcomes of care and follow-up data concerning outcomes of care;

(t) Documentation of correspondence including with other medical providers, community providers, human services, social service, and criminal justice entities pertaining to an individual’s treatment and follow-up services; and

(u) Documentation of an individual’s legal guardian, as applicable.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8023

22-A DCMR § 8024 BEHAVIORAL HEALTH STABILIZATION PROGRAMS: GENERAL REQUIREMENTS

8024.1 All behavioral health stabilization programs shall, at a minimum, assess individuals during intake to determine if the individual may suffer from a mental illness or SUD. Assessment shall include an initial health screening that incorporates the following, as applicable:

(a) Presenting problem, including source of distress, precipitating events, associated problems or symptoms, and recent progression;

(b) Immediate risks for self-harm, suicide and violence;

(d) Immediate risks related to serious intoxication or withdrawal;

(e) Past and present mental disorders, including posttraumatic stress disorder (“PTSD”) and other anxiety disorders, mood disorders, and eating disorders;

(f) Past and present experience of violence and trauma, including sexual victimization and interpersonal violence;

(g) Legal history, including whether an individual is court-ordered to treatment or under the supervision of the Department of Corrections; and

(h) Employment and housing status.

8024.2 If an individual screens positive for SUD, the provider shall do the following:

(a) Offer the opportunity for the individual to receive SUD treatment in addition to behavioral health stabilization services, if the provider also offers the applicable services. If the individual declines, the provider shall make referrals for the individual to receive SUD treatment at another qualified provider; or

(b) If the provider does not offer treatment for SUD, the provider shall ensure the individual is referred to an appropriate SUD provider.

8024.3 A certified provider shall not deny admission for services to an individual because that individual is receiving MSUD services.

8024.4 Each provider shall ensure that all staff comply with all Federal and District laws and regulations pertaining to scope of practice, licensing requirements, and supervision requirements.

8024.5 Behavioral health stabilization facilities’ physical design and structure shall have sufficient area(s) for indoor social and recreational activities.

8024.6 Behavioral health stabilization providers shall comply with all construction codes housing codes and zoning requirements applicable to the facility, including all Certificate of Occupancy, BBL, and Construction Permit requirements.

8024.7 Each newly established behavioral health stabilization provider shall provide proof of a satisfactory pre-certification inspection by DCRA for initial certification, dated not more than forty-five (45) calendar days prior to the date of submission to the Department, including proof that the provider is in compliance with the District of Columbia Property Maintenance Code (12-G DCMR) and Housing Code (14 DCMR), documentation of the inspection date, findings and proof of abatement certified by DCRA of all deficiencies identified during the inspection (as applicable). This requirement may be met by submission of a Certificate of Occupancy or a BBL dated within the past six (6) months, provided that the applicant can demonstrate that DCRA performed an onsite inspection of the premises.

8024.8 A provider that offers overnight accommodations shall not operate more beds than the number for which it is authorized by the Department.

8024.9 Other than routine household duties, no individual shall be required to perform unpaid work.

8024.10 Each behavioral health stabilization program shall have rules consistent with this chapter and that include rules concerning the following, as appropriate:

(a) The use of tobacco, alcohol, and other substances;

(b) The use of the telephone;

(c) Utilizing, viewing, or listening to cell phones, television, radio, computers, CDs, DVDs, or other media such as social media;

(d) Movement of individuals in and out of the facility, including a requirement for escorted movements by program staff or another agency-approved escort;

(e) A policy that addresses search and drug testing upon return to the site; and

(f) The prohibition of sexual relations between staff or volunteers and individuals served.

8024.11 Each provider shall make available the rules defined in §8024.10.

8024.12 A program that provides overnight accommodations shall ensure that evening and overnight shifts have at least two (2) staff members on duty. A clinician shall be on-call or on-site at all times.

8024.13 Each provider shall operate according to all applicable Federal and District laws and regulations relating to fraud, waste, and abuse in health care, the provision of mental health services and the Medicaid program. A provider’s failure to report potential or suspected fraud, waste or abuse may result in sanctions, cancellation of a contract, or exclusion from participation as a behavioral health stabilization provider. Each provider shall:

(a) Cooperate and assist any District or Federal agency charged with the duty of identifying, investigating, or prosecuting suspected fraud, waste or abuse;

(b) Provide the Department with regular access to the provider’s medical and billing records, including electronic medical records, within twenty-four (24) hours of a Departmental request, or, immediately in the case of emergency;

8024.14 Each provider shall establish and adhere to policies and procedures requiring the provider to make language access services available at no cost as needed for Limited or Non-English proficient individuals, (“Language Access Policy”). The Language Access Policy shall:

(a) Document primary language information in an individual’s clinical record at the point of entry, if known, with notations on how to engage the individual in communication if unknown;

(b) Arrange for the provision of language access services at no cost to Limited or Non-English proficient individual;

(c) Ensure public notices regarding language access services are posted in regularly encountered waiting rooms, reception areas, and other areas of initial contact;

(d) Ensure that the public is aware of language interpretation services;

(e) Provide a quarterly report on the number of enrolled individuals who receive language access services to the Department’s Language Access Coordinator. The information shall include the following information:

(i) The number of individuals who have Limited or Non-English proficiency, and the languages spoken;

(ii) The frequency with which Limited or Non-English proficient individuals come into contact with the provider; and

(iii) The number and types of languages spoken by agency staff.

(f) Provide annual training to all public access staff on how to provide ongoing language services; and

(g) Ensure immediate notification of the DBH Language Access Coordinator when unable to meet language access needs.

8024.15 The Language Access Policy shall allow staff and contractors who do not possess valid certification from the Registry of Interpreters for the Deaf to be credentialed based on skills in mental health interpreting gained through supervised experience. For purposes of this rule, supervised experience shall include supervision by an interpreter certified by the National Registry of Interpreters for the Deaf and ongoing training in sign language interpreting, preferably related to mental health, and may include on-the-job learning prior to employment by the provider.

8024.16 Each provider shall utilize a Tele Typewriter (“TTY”) communications line (or an equivalent) to enhance the provider’s ability to respond to service requests and needs of individuals. Provider staff shall be trained in the use of such communication devices as part of the annual language access training.

8024.17 Each provider shall establish and adhere to anti-discrimination policies and procedures relative to hiring, promotion, and provision of services to individuals that comply with applicable Federal and District laws and regulations (“Anti-Discrimination Policy”).

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021); as amended by Final Rulemaking published at 72 DCR 008497 (August 1, 2025). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8024

22-A DCMR § 8025 COMPREHENSIVE PSYCHIATRIC EMERGENCY PROGRAM (CPEP) REQUIREMENTS

8025.1 A comprehensive psychiatric emergency program (“CPEP”) shall directly provide or ensure the provision of psychiatric emergency services, which shall include assessments, brief and extended stabilization visits, and extended observation visits for individuals eighteen (18) years of age and older experiencing a behavioral health crisis.

8025.2 Psychiatric emergency services shall be provided by the CPEP twenty-four (24) hours per day, seven (7) days per week year-round. Services shall include psychiatric and medical evaluations and assessments which are used to determine the appropriateness of admission to and retention in the CPEP.

8025.3 A CPEP shall not operate more than sixteen (16) beds.

8025.4 Each CPEP shall permit, as appropriate, each individual served to bring reasonable personal possessions, including clothing and personal articles, to the facility unless the provider demonstrates that it is not practical, feasible, or safe.

8025.5 Each CPEP shall, as appropriate, provide individuals with access to reasonable individual storage space for private use.

8025.6 Upon an individual’s discharge, the CPEP shall return, as appropriate, to the individual or the individual’s representative any personal articles held by the provider for safekeeping. The provider shall also ensure that the individual is permitted to take all of their personal possessions from the facility. The provider may require the individual or the individual’s representative to sign a statement acknowledging receipt of the property. A copy of that receipt shall be placed in the individual’s record.

8025.7 Each CPEP shall maintain, as appropriate, a separate and accurate record of all funds that the individual, individual’s representative or representative payee deposits with the provider for safekeeping. This record shall include the signature of the individual for each withdrawal and the signature of facility staff for each deposit and disbursement made on behalf of an individual served.

8025.8 Each CPEP shall be equipped with a functioning landline or mobile telephone for use by individuals served, as appropriate. The telephone numbers shall be provided to residents and to the Department.

8025.9 Each CPEP shall ensure each individual’s privacy and safety in the bathroom.

8025.10 Each CPEP shall ensure that individuals can access all scheduled or emergency medical and dental appointments.

8025.11 Each CPEP shall inventory each individual’s personal property, secure any valuables and medications, and maintain a current written inventory of secured property. Each CPEP shall ensure that both the staff and individual (and guardian as appropriate) sign the written inventory. The CPEP shall provide a copy of the written inventory to the individual (or guardian, as appropriate) upon request copy of which shall be provided, signed by the individual and staff, to the individual. The written inventory shall note any personal articles to be held by the provider for safekeeping.

8025.12 Each CPEP shall take appropriate measures to safeguard and account for personal property brought into the facility.

8025.13 Each item of bed linen, towel, and washcloth shall be changed and cleaned as often as necessary to maintain cleanliness.

8025.14 Each CPEP shall offer at least three (3) meals per day and in-between-meal snacks that:

(a) Are nourishing and well-balanced in accordance with dietary guidelines established by the United States Department of Agriculture;

(b) Are suited to the special needs of each individual; and

8025.15 Each meal shall be scheduled so that the maximum interval between each meal is no more than six (6) hours, with no more than fourteen (14) hours between a substantial evening meal and breakfast the following day.

8025.16 If an individual refuses food or misses a scheduled meal, the CPEP shall offer appropriate food substitutions of comparable nutritional value.

8025.17 If an individual will be away from the CPEP during mealtime for necessary medical care, work, or other scheduled appointments, the program shall provide an appropriate meal and in-between-meal snack for the individual to carry with him or her and shall ensure that the meal is nutritious as required by these rules and suited to the individual’s special needs.

8025.18 A CPEP shall implement a written Nutritional Standards Policy that outlines their procedures to meet the dietary needs of the individuals in its program, ensuring access to nourishing, well-balanced, and healthy meals. The policy shall identify the methods and parties responsible for food procurement, storage, inventory, and preparation.

8025.19 The Nutritional Standards Policy shall include procedures for individuals unable to have a regular diet as follows:

(a) Providing clinical diets for medical reasons, when necessary;

(b) Recording clinical diets in the individual’s record;

(d) Maintaining menus of special diets or a written plan stating how special diets will be developed or obtained when needed.

8025.20 A CPEP shall make reasonable efforts to prepare meals that consider the cultural background and personal preferences of the individuals.

8025.21 Any individual with a need for medical or surgical care or treatment which cannot be provided in the CPEP shall be transported to a hospital for appropriate observation and treatment.

8025.22 Any CPEP certified pursuant to this chapter shall receive and retain voluntary and involuntarily admissions for any individual experiencing a behavioral health crisis that is likely to result in serious harm to the individual or others and for whom immediate observation, care, and treatment in the CPEP is appropriate. No individual may be involuntarily retained in a CPEP for more than twenty-four (24) hours unless the individual is admitted for extended observation in accordance with § 8025.29(c).

8025.23 The CPEP shall develop a contingency plan with other local affiliated hospitals, emergency medical services, and law enforcement for the diversion of admissions during periods of high demand and overcrowding.

8025.24 The CPEP clinical director or their designee may prevent new admissions to the CPEP emanating from emergency medical services, ambulance services, and law enforcement if the program’s ability to deliver quality service would be jeopardized. The CPEP clinical director or their designee shall review the continued necessity for such prevention at least once every twenty-four (24) hours.

8025.25 In order to assure that individuals admitted to the CPEP are adequately supervised and are cared for in a safe and therapeutic manner, the CPEP shall meet each of the following requirements:

(a) Appropriate professional staff shall be available to assist in emergencies on at least an on-call basis at all times; and

(b) A psychiatrist shall be available on-site at all times.

8025.26 A CPEP shall continuously employ an adequate number of staff and an appropriate staff composition to carry out its goals and objectives as well as to ensure the continuous provision of sufficient ongoing and emergency supervision. A CPEP shall submit a staffing plan to the Department as part of its certification and recertification process, which shall include the qualifications and duties of each staff position by title. The staffing plan and its rationale shall be subject to approval by the Department.

8025.27 The CPEP shall have on-site the following types and numbers of staff:

(a) At least one (1) board-certified or board-eligible psychiatrist (24-hour coverage);

(b) At least two (2) registered nurses (24-hour coverage);

(c) At least one (1) clinician licensed to practice independently in the District of Columbia (at minimum during business hours);

(d) At least two (2) staff to provide mental health counseling services who at a minimum meet the qualifications described in §§ 8025.39 or 8025.40 (24-hour coverage); and

(e) A sufficient number of security personnel (24-hour coverage).

8025.28 A CPEP shall only use restraint and seclusion in compliance with all governing Federal and District laws and regulations.

8025.29 A CPEP shall provide the following array of visits in accordance with the individual’s needs:

(a) Brief psychiatric crisis visit:

(i) A brief psychiatric crisis visit includes a face-to-face interaction between an individual experiencing a behavioral health crisis and CPEP staff operating within the scope of their licensure to determine the services required. It shall include a mental health diagnostic examination, and, as appropriate, treatment interventions on the individual’s behalf and a discharge plan. Other activities include medication monitoring, observation, and care coordination with other providers.

(ii) A brief psychiatric crisis visit requires documentation using at least one encounter note explaining the array of services provided during the visit.

(iii) A brief psychiatric crisis visit may last up to four (4) hours. If an individual cannot be reasonably treated and discharged in less than four (4) hours, the individual shall be admitted to an extended psychiatric crisis visit in accordance with § 8025.29(b).

(b) Extended psychiatric crisis visit:

(i) An extended psychiatric crisis visit includes a face-to-face interaction between an individual experiencing a behavioral health crisis and CPEP staff operating within the scope of their licensure to determine the services required. It shall include a psychiatric or mental health diagnostic examination; psychosocial assessment; and medical examination; which results in a comprehensive psychiatric emergency treatment plan and a discharge plan. Other activities include any clinically indicated examinations and assessments as appropriate for the individual’s presenting problems, medication monitoring, observation, and care coordination with other providers.

(ii) An extended psychiatric crisis visit requires documentation using at least one encounter note explaining the array of services provided during the visit.

(iii) An extended psychiatric crisis visit may last up to twenty-four (24) hours. If an individual cannot be reasonably treated and discharged in that time, the individual shall be admitted to an extended observation visit in accordance with § 8025.35(c).

(i) An extended observation visit includes a face-to-face interaction between an individual experiencing a behavioral health crisis and CPEP staff operating within the scope of their licensure to determine the services required. This shall include a psychiatric or mental health diagnostic examination; psychosocial assessment; and medical examination; which results in a comprehensive psychiatric emergency treatment plan and a discharge plan. Other activities include any clinically indicated examinations and assessments as appropriate for the individual’s presenting problems, medication monitoring, observation, and care coordination with other providers.

(ii) An extended observation visit requires documentation using at least one encounter note explaining the array of services provided during the visit.

(iii) An extended observation visit is used for individuals retained in a CPEP for more than twenty-four (24) hours but not to exceed seventy-two (72) hours, voluntarily or involuntarily. If an individual cannot be reasonably treated and discharged in that time, the individual shall be transferred to a hospital for inpatient treatment.

8025.30 Brief psychiatric visits, extended psychiatric visits, and extended observation visits shall not be billed on the same day as one another.

8025.31 The duration of psychiatric emergency services varies with the severity of the individual’s symptoms and their response to treatment but shall not last more than seventy-two (72) hours in total at a CPEP.

8025.32 Qualified Practitioners of services delivered in accordance with brief psychiatric visits, extended psychiatric visits, and extended observation visits and within their scope of practice are:

(a) Psychiatrists;

(b) Physicians;

(d) LICSWs;

(e) APRNs;

(f) RNs;

(g) PAs;

(h) LISWs;

(i) LPCs;

(j) LGSWs;

(k) LGPCs;

(l) Psychology Associates;

(m) Certified Peer Specialists; and

(n) Certified Recovery Coaches.

8025.33 Credentialed staff shall be permitted to provide CPEP services under the supervision of an independently licensed practitioner.

8025.34 Discharge planning shall be conducted for all individuals discharged from a CPEP who require additional mental health services after a brief or extended psychiatric visit and individuals admitted to extended observation beds who require additional mental health services. Discharge planning criteria shall include at least the following activities prior to discharge from the CPEP:

(a) A review of the individual’s psychiatric, social, and physical needs;

(b) Completion of referrals to appropriate community services providers, where the individual so desires, to address the individual’s identified needs;

(c) If the individual so desires, the CPEP shall arrange for appointments with community providers which shall be made as soon as possible after release from the CPEP; and

(d) The CPEP shall give each individual the opportunity to participate in the development of his or her discharge plan, including development of a crisis plan. With the consent of the individual and when clinically appropriate, the CPEP shall make reasonable attempts to contact family members for their participation in the discharge planning process. However, no individual or family member shall be required to agree to a discharge. The CPEP shall make a notation in the individual’s record if any objection is raised to the discharge plan.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8025

22-A DCMR § 8026 PSYCHIATRIC CRISIS STABILIZATION PROGRAM REQUIREMENTS

8026.1 Psychiatric crisis stabilization services offer therapeutic, community-based, home-like treatment for individual age eighteen (18) or older living in the community; who are in need of support to ameliorate psychiatric symptoms; who are voluntary; and, based upon a psychiatric assessment conducted on-site, are deemed appropriate for residential services within a structured, closely monitored temporary setting.

8026.2 Psychiatric crisis stabilization services shall provide an opportunity for individuals to move out of a stressful situation into a safe and secure therapeutic environment in order to prevent acute psychiatric hospitalization or to maintain stabilization following a hospital stay.

8026.3 Psychiatric crisis stabilization programs shall ensure that all referrals are screened by a psychiatrist upon admission and that there is documented evidence of the need for psychiatric crisis stabilization services.

8026.4 Each program shall be equipped, furnished, and maintained to provide a functional, safe, and comfortable home-like setting.

8026.5 Psychiatric crisis stabilization programs shall permit, as appropriate, each individual served to bring reasonable personal possessions, including clothing and personal articles, to the facility unless the provider demonstrates that it is not practical, feasible, or safe.

8026.6 Each program shall, as appropriate, provide individuals with access to reasonable individual storage space for private use.

8026.7 Upon an individual’s discharge, the provider shall return to the individual or the individual’s representative as appropriate, any personal articles held by the provider for safekeeping. The provider shall also ensure that the individual is permitted to take all of their personal possessions from the facility. The provider may require the individual or the individual’s representative to sign a statement acknowledging receipt of the property. The provider shall place a copy of that in the individual’s record.

8026.8 Each program shall maintain, as appropriate, a separate and accurate record of all funds that the individual, individual’s representative or representative payee deposits with the provider for safekeeping. This record shall include the signature of the individual for each withdrawal and the signature of facility staff for each deposit and disbursement made on behalf of an individual served.

8026.9 Each program site shall be equipped with a functioning landline or mobile telephone for use by individuals served, as appropriate. The telephone numbers shall be provided to residents and to the Department.

8026.10 Staff break rooms shall be separate from resident bedrooms.

8026.11 Each program site shall have a functioning doorbell or knocker.

8026.12 Each bedroom shall comply with the space and occupancy requirements for habitable rooms in 14 DCMR § 402.

8026.13 The provider shall ensure each individual has the following items:

(a) A bed, which is not a cot;

(b) A mattress that was new when purchased by the provider, has a manufacturer's tag or label attached to it, and is in good, intact condition with unbroken springs and clean surface fabric;

(c) A bedside table or cabinet and an individual reading lamp with at least a seventy-five (75) watt, or its LED light bulb equivalent, rate of capacity;

(d) Storage space in a stationary cabinet, chest, or closet that provides at least one (1) cubic foot of space for each individual served for valuables and personal items;

(e) Sufficient suitable storage space, including a dresser and closet space, for personal clothing, shoes, accessories, and other personal items; and

(f) A waste receptacle and clothes hamper with lid.

8026.14 Each bed shall be placed at least three (3) feet from any other bed and from any uncovered radiator.

8026.15 Each bedroom shall have direct access to a major corridor and at least one (1) window to the outside, unless DCRA, or a successor agency responsible for enforcement of the D.C. Housing Code, has determined that it otherwise meets the lighting and ventilation requirements of the D.C. Housing Code for habitable rooms.

8026.16 Each facility housing a residential program shall provide one (1) or more bathrooms for individuals that are equipped with the following fixtures, properly installed and maintained in good working condition:

(a) Toilet (water closet);

(b) Sink (lavatory);

(d) Grab bars in showers, bathtubs, and by the toilets.

8026.17 Each program site shall provide at least one (1) bathroom for each six (6) occupants in compliance with 14 DCMR § 602.

8026.18 Each bathroom shall be adequately equipped with the following:

(a) Toilet paper holder and toilet paper;

(b) Paper towel holder and paper towels or clean hand towels;

(d) Mirror;

(e) Adequate lighting;

(f) Waste receptacle;

(g) Floor mat;

(h) Non-skid tub mat or decals; and

(i) Shower curtain or shower door.

8026.19 The provider shall ensure each individual’s privacy and safety in the bathroom.

8026.20 Each residential program shall promote each individual’s participation and skill development in menu planning, shopping, food storage, and kitchen maintenance, if appropriate.

8026.21 Each residential program shall provide appropriate equipment (including a washing machine and dryer) and supplies on the premises or through a laundry service to ensure sufficient clean linen and the proper sanitary washing and handling of linen and the individual’s personal clothing.

8026.22 Each program shall ensure that every individual has at least three (3) washcloths, two (2) towels, two (2) sheet sets that include pillow cases, a bedspread, a pillow, a blanket, and a mattress cover in good and clean condition.

8026.23 Each blanket, bedspread, and mattress cover shall be cleaned regularly, whenever soiled, and before being transferred from one resident to another.

8026.24 Each piece of bed linen, towel, and washcloth shall be changed and cleaned as often as necessary to maintain cleanliness, provided that all towels and bed linen shall be changed at least once each week.

8026.25 Only individuals being served and staff members may reside at each program site.

8026.26 Providers shall ensure that individuals can access all scheduled or emergency medical and dental appointments.

8026.27 Each provider shall inventory each individual’s personal property and secure any valuables and medications, etc., and maintain a current written inventory of secured property, a copy of which shall be provided, signed by the individual and staff, to the individual.

8026.28 Each provider shall take appropriate measures to safeguard and account for personal property brought into the facility by a resident.

8026.29 Each provider shall provide the individual, or the individual’s representative, with a receipt for any personal articles to be held by the provider for safekeeping. The provider shall document the date that the personal articles were deposited with the provider and maintain a record of all articles held for safekeeping.

8026.30 Each piece of bed linen, towel, and washcloth shall be changed and cleaned as often as necessary to maintain cleanliness, provided that all towels and bed linen shall be changed at least once each week.

8026.31 No person who is not an individual served by the program, staff member, or child of an individual served by the program may reside at a facility that houses a residential program.

8026.32 Each residential program shall have a licensed dietitian or nutritionist available, a copy of whose current license shall be maintained on file, to provide the following services:

(a) Review and approval of menus;

(b) Education for individuals with nutrition deficiencies or special needs;

(d) A nutritional assessment for each individual within three (3) calendar days of admission unless the individual has a current assessment or doctor’s order for dietary guidelines.

8026.33 The provider shall offer at least three (3) meals per day and in-between-meal-snacks that:

(a) Are nourishing and well-balanced in accordance with dietary guidelines established by the United States Department of Agriculture;

(b) Are suited to the special needs of each individual; and

8026.34 The provider shall ensure that menus are written on a weekly basis, that the menus provide for a variety of foods at each meal, and that menus are varied from week to week. Menus shall be posted for the individuals’ review.

8026.35 The provider shall retain a copy of each weekly menu for a period of six (6) months. The menus retained shall include special diets and reflect meals as planned and as actually served, including handwritten notations of any substitutions. The provider shall also retain receipts and invoices for food purchases for six (6) months. The records required to be retained by this subsection are subject to review by the Department.

8026.36 Each meal shall be scheduled so that the maximum interval between each meal is no more than six (6) hours, with no more than fourteen (14) hours between a substantial evening meal and breakfast the following day.

8026.37 If an individual refuses food or misses a scheduled meal, the provider shall offer appropriate food substitutions of comparable nutritional value.

8026.38 If an individual will be away from the program during mealtime for necessary medical care, work, or other scheduled appointments, the program shall provide an appropriate meal and in-between-meal snack for the individual to carry with him or her and shall ensure that the meal is nutritious as required by these rules and suited to the special needs of the individual.

8026.39 A residential program providing meals shall implement a written Nutritional Standards Policy that outlines their procedures to meet the dietary needs of the individuals in its program, ensuring access to nourishing, well-balanced, and healthy meals. The policy shall identify the methods and parties responsible for food procurement, storage, inventory, and preparation.

8026.40 The Nutritional Standards Policy shall include procedures for individuals unable to have a regular diet as follows:

(a) Providing clinical diets for medical reasons, when necessary;

(b) Recording clinical diets in the individual’s record;

(d) Maintaining menus of special diets or a written plan stating how special diets will be developed or obtained when needed.

8026.41 A program shall make reasonable efforts to prepare meals that consider the cultural background and personal preferences of the individuals.

8026.42 Meals shall be served in a pleasant, relaxed dining area.

8026.43 The dining area shall have a sufficient number of tables and chairs to seat all individuals residing in the facility at the same time. Dining chairs shall be sturdy, non-folding, without rollers unless retractable, and designed to minimize tilting.

8026.44 Upon admission, a program shall submit new or revised Plan of Care, along with a Discharge Plan, to the Department with the authorization request.

8026.45 Psychiatric crisis stabilization programs shall provide the following services necessary to assess, treat, medicate, and stabilize residents:

(a) Comprehensive Nursing Assessment and Plan of Care:

(i) Programs shall provide or ensure a comprehensive health assessment is completed within twenty-four (24) hours of admission in order to determine medical necessity for primary health care and coordinate care with the health care provider;

(ii) A nurse shall perform ongoing assessment of individuals as clinically indicated. A nurse shall coordinate development of a new or revised Plan of Care, and monitor that care is rendered as outlined in the Plan of Care. A nurse shall perform medication evaluations, including the administration and monitoring of medications, obtaining consent to accept medications, and educating individuals as to the benefits, risks, an/d side effects of the medications prescribed. If an individual experiences a change in clinical status, the nurse must work with the on-call psychiatrist regarding a change in Plan of Care;

(iii) Pursuant to the requirements set forth in 22-A DCMR §§ 3411 and 3412:

(A) CSAs, ACT providers, or CBI providers shall coordinate the Plan of Care for individuals enrolled in MHRS; and

(B) For individuals only receiving Clubhouse services, who are not linked with a CSA, ACT provider, or CBI provider, the Clubhouse shall coordinate the Plan of Care;

(iv) Services provided at a psychiatric crisis stabilization program shall be coordinated with the individual’s assigned CSA, ACT provider, CBI provider, or Clubhouse provider (whichever is applicable), to ensure continuity of care; and

(v) If the individual is not yet enrolled with a CSA, ACT provider, or CBI provider; or is only enrolled with a Clubhouse provider, the psychiatric crisis stabilization provider shall work with the Department to enroll in MHRS services and establish a new Plan of Care.

(b) Psychiatric Consultation and Assessment:

(i) A psychiatrist shall be available for consult by telephone twenty-four (24) hours per day, seven (7) days per week year-round. A psychiatrist shall be available on-site at least part-time (fifteen [15] hours per week);

(ii) A psychiatric assessment shall be performed within twenty-four (24) hours of admission;

(iii) A psychiatrist shall provide ongoing psychiatric management for the duration of an individual’s stay. A psychiatrist shall conduct a review of a newly admitted individual’s status after forty-eight (48) hours, and then every seventy-two (72) hours thereafter, at a minimum, unless there is a change of status that requires more frequent visits;

(iv) A psychiatrist shall perform medication evaluations, including the prescribing, monitoring, and titration of medications; including obtaining consent to accept medications and educating individuals as to the benefits, risks, and side effects of the medications prescribed;

(v) A psychiatrist shall facilitate admission of individuals to inpatient settings as required; and

(vi) A psychiatrist shall oversee the clinical care of all individuals served in a psychiatric crisis stabilization program.

(c) Crisis Counseling: Crisis counseling is immediate and short-term psychological care designed to assist individuals in a behavioral health crisis situation. Crisis counseling focuses on minimizing the stress of the precipitating event, providing emotional support, and improving the individual’s coping strategies.

(d) Medication Monitoring: This includes monitoring the side effects and interactions of medication and the adverse reactions which an individual may experience, and providing education and direction for symptom and medication self-management.

(e) Discharge planning shall be conducted for all individuals discharged from a psychiatric crisis stabilization program. Discharge planning criteria shall include at least the following activities prior to discharge from the program:

(i) A review of the individuals’ psychiatric, social, and physical needs;

(ii) Completion of referrals to appropriate community services providers, where the individual so desires, to address the individual’s identified needs;

(iii) If the individual so desires, the provider shall arrange for appointments with community providers which shall be made as soon as possible after leaving the psychiatric crisis stabilization program. When an appointment for behavioral health services cannot be made within a reasonable period of time, the psychiatric crisis stabilization provider shall coordinate with a mobile crisis and outreach team to provide crisis stabilization services until the initial appointment occurs; and

(iv) Each individual shall be given the opportunity to participate in the development of his or her discharge plan. If clinically appropriate, the provider shall immediately and intensely engage the individuals’ family and community supports in post-discharge planning. However, no person or family member shall be required to agree to an individual’s discharge. The provider shall note any person who objects to the individual’s discharge plan or any part thereof in the individual’s record.

8026.46 Qualified practitioners of psychiatric crisis stabilization services in accordance with this chapter and with their scope of practice are:

(a) Psychiatrists;

(b) Psychologists;

(d) APRNs;

(e) RNs;

(f) PAs;

(g) LISWs;

(h) LPCs;

(i) Psychology Associates;

(j) LGSWs; and

(k) LGPCs.

8026.47 Credentialed staff shall be permitted to provide psychiatric crisis stabilization services under the supervision of an independently licensed practitioner.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8026

22-A DCMR § 8027 ADULT MOBILE CRISIS AND OUTREACH PROGRAMS

8027.1 Mobile crisis and outreach providers, or community response teams (“teams”), shall be dispatched into a home or community setting where a crisis may be occurring to begin the process of assessment and treatment. Teams shall provide acute behavioral health crisis interventions and behavioral health outreach services to individuals in the community while minimizing the individual’s involvement as appropriate with law enforcement, emergency room use, or hospitalizations.

8027.2 Crisis intervention services provide rapid response, assessment, and treatment of behavioral health crisis situations that involve adults.

8027.3 Behavioral health outreach services identify individuals in the community who need behavioral health and other social services. Providers make repeated visits to individuals to build relationships and connect them to needed services.

8027.4 Teams shall identify individuals in need of behavioral health services and begin the process of engaging them in treatment, including screening for mental health and substance use service needs, developing rapport, support while assisting with immediate needs, and referrals to appropriate resources. Teams shall assist with connections to treatment, care coordination, and other social services as required. Teams shall also administer First Aid, CPR, and naloxone as appropriate.

8027.5 Teams shall be available on-call twenty-four (24) hours per day, seven (7) days per week and shall be staffed with two (2) individuals per team at all times pursuant to § 8027.12, one (1) of whom must be licensed. In the event services are needed to complete an FD-12, only one (1) DBH-certified officer-agent need participate.

8027.6 Teams shall serve all who present for services, regardless of insurance status or ability to pay.

8027.7 Teams shall offer services in a community setting, including the individual’s home, on the streets, residential facilities, hospitals, and nursing homes, for assessing the individual’s immediate behavioral health needs.

8027.8 Each provider shall establish and adhere to policies and procedures which govern the provision of services in natural settings (“Natural Settings Policy”), including the individual’s home or community setting. The Natural Settings Policy shall require the provider to document how it respects individual’s and families’ rights to privacy and confidentiality when services are provided in natural settings.

8027.9 Teams shall include co-response with local law enforcement as appropriate.

8027.10 An Officer Agent shall complete and follow all FD-12 protocol for individuals who appear to be in imminent danger of harming themselves or others due to mental illness.

8027.11 Adult mobile crisis and outreach providers shall ensure all team members participate in the Department’s Officer Agent training.

8027.12 Adult mobile crisis and outreach programs shall provide the following services:

(a) Mobile crisis interventions, subject to the following provisions:

(i) Rapid response, assessment, and resolution of behavioral health crisis situations involving adults. Services shall optimize clinical interventions by meeting individuals in home or community settings.

(ii) Face-to-face or telephonic service provided to individuals involved in an active behavioral health crisis. The provider shall rapidly respond to, evaluate and screen the presenting situation, assist in immediate stabilization and resolution, reduce the risk of immediate danger to the individual or others, and ensure necessary referrals for the individual’s access to care at the appropriate level.

(iii) Mobile crisis interventions that are short-term and provide follow-up stabilization services, including additional therapeutic responses as needed, psychiatric consultation, and referrals and linkages to all medically necessary behavioral health services and supports.

(iv) Mobile crisis intervention activities shall also include, as appropriate:

(A) Screening for eligibility and referral for SUD and/or mental health services;

(B) Pre-arrest diversion;

(D) Linkage to additional stabilization services;

(E) Secure access to higher levels of care; and

(F) Assistance identifying natural supports and community supports during a crisis.

(v) Mobile crisis intervention services require documentation using at least one (1) encounter note explaining the array of services provided during the service.

(b) Behavioral health outreach services, subject to the following provisions:

(i) The behavioral health outreach service shall include an initial evaluation and assessment for individuals in the community who are unable or unwilling to use clinic- or hospital-based services, or for individuals for whom hospitalization is not clinically appropriate. Other activities include linkages to other services or providers; providing emotional support; life skills education; and therapeutic interventions as appropriate.

(ii) Teams shall offer these services in a community setting, including the individual’s home and on the streets.

(iii) Behavioral health outreach encounters shall also include, as appropriate:

(A) Linkage to relevant insurance and public assistance programs;

(B) Counseling;

(D) Screening for eligibility and referral for SUD and/or mental health services.

(iv) Behavioral health outreach services require documentation using at least one (1) encounter note explaining the array of services provided during the service.

8027.13 Qualified practitioners of adult mobile crisis and behavioral health outreach services in accordance with this chapter and with their scope of practice are:

(a) Physicians;

(b) Psychologists;

(d) APRNs;

(e) PAs;

(f) RNs;

(g) LISWs;

(h) LPCs;

(i) LMFTs;

(j) LGPCs;

(k) LGSWs;

(l) Psychology Associates;

(m) CACs I and II;

(n) Certified Peer Specialists;

(o) Certified Recovery Coaches;

(p) An individual with at least a bachelor’s degree from an accredited college or university in social work, counseling, psychology, or closely related field, and training or relevant experience in substance use or mental health; or

(q) An individual with at least four (4) years of relevant, qualifying full-time-

equivalent experience in behavioral health service delivery who demonstrates skills in developing positive and productive community relationships and the ability to negotiate complex service systems to obtain needed services and resources for individuals.

8027.14 Credentialed staff shall be permitted to provide psychiatric crisis stabilization services under the supervision of an independently licensed practitioner.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8027

22-A DCMR § 8028 YOUTH MOBILE CRISIS INTERVENTION PROGRAMS

8028.1 Youth mobile crisis intervention providers are dispatched into a home or community setting where children or youth may be experiencing a behavioral health crisis to begin assessment and treatment. Providers shall administer acute behavioral health crisis stabilization and psychiatric assessments to children, youth, and their families as necessary. Services shall be provided in the community, schools, or other settings as necessary, while avoiding unnecessary law enforcement involvement, emergency room use, or hospitalizations.

8028.2 Providers shall engage children and youth in treatment, including screening for mental health and SUD service needs, developing rapport, and providing support, while assisting with immediate needs and providing referrals to appropriate resources, including longer-term mental health or SUD rehabilitative services. Providers shall assist with connections to treatment, care coordination, and other social services as required.

8028.3 Youth mobile crisis intervention provider teams shall be available on-call twenty-four (24) hours per day seven (7) days per week year round. The youth mobile crisis intervention provider shall be staffed with two (2) individuals per team at all times pursuant to § 8028.15, one (1) of whom must be licensed. In the event services are needed to complete an FD-12, only one (1) DBH-certified officer-agent need participate. Youth mobile crisis intervention provider teams shall maintain sufficient resources and supports for communication and mobile capabilities. One (1) independently licensed practitioner must be available twenty-four (24) hours per day, seven (7) days per week. A psychiatrist shall be available by phone or for in-person assessment as needed and as clinically indicated.

8028.4 Youth mobile crisis intervention provider teams shall facilitate linkages to other social services, medical care, and any additional behavioral health services as needed. Youth mobile crisis provider teams shall assist families in enrolling children and youth in any other needed services in their community.

8028.5 Youth mobile crisis intervention provider teams shall offer services in a community setting, including the individual’s home, on the streets, schools, residential facilities, hospitals, and nursing homes.

8028.6 Each provider shall establish and adhere to policies and procedures which govern the provision of services in natural settings (“Natural Settings Policy”), including the individual’s home or community setting. The Natural Settings Policy shall require the provider to document how it respects individuals’ and families’ rights to privacy and confidentiality when services are provided in natural settings.

8028.7 An Officer Agent shall complete an FD-12 and follow all FD-12 protocol for individuals who appear to be in imminent danger of harming themselves or others due to mental illness.

8028.8 In addition to the provider and service requirements in this chapter, youth mobile crisis intervention providers are also responsible to:

(a) Provide and maintain a crisis hotline to receive crisis calls directly by a live person, twenty-four (24) hours per day, seven (7) days per week year-round;

(b) Provide systematic response for crisis call intake, triage, and deployment determinations;

(c) Provide and fully document phone support, crisis consultation, information sharing, and follow-up to all calls that are not deployed;

(d) Maximize parent and caregiver in crisis intervention and any follow-up;

(e) Respond to calls for District youth placed in foster care homes in Virginia and Maryland that are within a fifty (50) mile radius of the District;

(f) Provide and document a follow-up contact, as clinically indicated, with the individual within 24 (twenty-four) hours of the initial call or deployment;

(g) Provide population-appropriate approaches for evaluation and assessment of children and youth experiencing a behavioral health crisis;

(h) Implement a standardized crisis assessment tool;

(i) Provide specialized clinical training in Crisis Theory, Risk Assessment, and Intervention for staff;

(j) Provide a minimum of two (2) Certified Peer Specialists;

(k) Attend all trainings the Department determines are relevant to the nature and scope of service;

(l) Minimize placement disruption;

(m) Provide children, youth, and their families with education on conflict resolution, triggers, coping skills, and problem-solving techniques;

(n) Develop a crisis, safety, and continuity of operations plan for deploying teams;

(o) Ensure all team members participate in the Department’s Officer Agent training;

(p) Partner with mental health, substance use, and other community-based providers in the District;

(q) Provide access to psychiatric consultation by phone or in-person as needed;

(r) If the youth is enrolled with a CSA and/or CBI provider, notify the CSA and/or CBI provider within twenty four (24) hours of the initial call or deployment and collaborate with the CSA and/or CBI provider thereafter; and

(s) If the youth is not currently enrolled with a CSA and/or CBI provider, facilitate enrollment with a new CSA and/or CBI provider and initiate further assessment and corresponding treatment as clinically appropriate.

8028.9 Youth mobile crisis intervention programs shall provide the following service:

(a) Mobile crisis interventions, subject to the following provisions:

(i) Mobile crisis interventions that provide rapid response, assessment, and resolution of behavioral health crisis situations that involve children, youth, and their families. Services shall optimize clinical interventions by meeting individuals in home or community settings and reducing the risk of immediate danger to the individual or others.

(ii) A mobile crisis intervention is a short-term, face-to-face, or telephonic service provided to individuals involved in an active behavioral health crisis and consists of any or all of the following activities:

(A) Rapid response to evaluate and screen the presenting situation;

(B) Therapeutic responses to de-escalate and stabilize the immediate behavioral health crisis;

(D) Facilitate community tenure while the individual is waiting for a first visit with another provider;

(E) Crisis support in schools;

(F) Screening for eligibility and referral for SUD services;

(G) Psychiatric consultation;

(H) Development of a safety plan or crisis diversion plan;

(I) Linkage to additional stabilization services; and

(J) Assistance identifying natural supports and community supports during a crisis.

8028.10 Youth mobile crisis provider teams shall provide consultation, information, and ongoing follow-up to ensure individuals are provided the supports that best meet their needs. For calls that do not require deployment, the youth mobile crisis provider team shall continue to monitor whether deployment is necessary to prevent further disruption or crisis.

8028.11 Youth mobile crisis provider teams shall provide clear information to the caller on deployment availability and status, including estimated time for deployment. Teams shall respond to the scene of a crisis within one (1) hour of the time of the call for sites within the District and up to one hour (1) and forty-five (45) minutes of calls outside of the District.

8028.12 For children and youth in CFSA custody, teams shall coordinate with the assigned CFSA social worker, including but not limited to youth in the following situations:

(a) Children and youth at risk of a placement disruption; and

(b) Children and youth at risk of acute care hospitalization.

8028.13 Qualified practitioners of youth mobile crisis outreach services in accordance with this chapter and with their scope of practice are:

(a) Physicians;

(b) Psychologists;

(d) APRNs;

(e) PAs;

(f) RNs;

(g) LISWs;

(h) LPCs;

(i) LMFTs;

(j) LGPCs;

(k) LGSWs;

(l) Psychology Associates;

(m) CACs I and II;

(n) Certified Peer Specialists;

(o) Certified Recovery Coaches;

(q) An individual with at least four (4) years of relevant, qualifying full-time-

8028.14 Credentialed staff shall be permitted to provide youth mobile crisis services under the supervision of an independently licensed practitioner.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8028

22-A DCMR § 8029 REIMBURSEMENT

8029.1 Reimbursement rates using non-Medicaid local funds are equivalent to the reimbursement rates for equivalent services that may be reimbursable by Medicaid, pursuant to rates as established by the Department of Health Care Finance.

8029.2 All claims seeking Medicaid or local only reimbursement under this Chapter shall include the active NPI numbers for the certified provider and the rendering provider. The rendering provider is the staff member who provided the service.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021); as amended by Final Rulemaking published at 69 DCR 013495 (November 4, 2022). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8029

22-A DCMR § 8030 NON-REIMBURSABLE SERVICES

8030.1 Services not covered as behavioral health stabilization services include, but are not limited to:

(a) Room and board residential costs;

(b) Inpatient hospital services, including hospital, nursing facility, intermediate care facility for individuals with intellectual disabilities, and institutions for mental diseases;

(d) Educational, vocational, and job training services;

(e) Services rendered by parents or other family members;

(f) Social or recreational services;

(g) Universal screening and prevention services (other than those provided under Early and Periodic Screening, Diagnosis, and Treatment requirements);

(h) Services that are not medically necessary;

(i) Services that are not provided and documented in accordance with these certification standards;

(j) Services that are not behavioral health stabilization services as described in these rules; and

(k) Services furnished to persons other than the individual, when those services are not directed primarily to the well-being and benefit of the individual.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8030

22-A DCMR § 8031 BEHAVIORAL HEALTH ACCREDITATION

8031.1 Effective October 1, 2023, all behavioral health stabilization providers shall obtain and maintain in good standing behavioral health accreditation with at least one (1) of the following organizations: the Commission on Accreditation of Rehabilitation Facilities (CARF), the Council on Accreditation (COA), or The Joint Commission (TJC).

8031.2 The timeline for behavioral health stabilization providers to obtain accreditation in accordance with § 8031.1 shall be as follows:

By December 15, 2022, all behavioral health stabilization providers shall submit an accreditation application to CARF, COA, or TJC and provide proof of the submission to the Department;

By April 30, 2023, all behavioral health stabilization providers shall obtain a letter of good standing from CARF, COA, or TJC and submit a copy to the Department; and

By October 1, 2023, all behavioral health stabilization providers shall be fully accredited with CARF, COA, or TJC and submit proof of accreditation to the Department.

8031.3 Accreditation through CARF, COA, or TJC shall not provide a waiver to behavioral health stabilization providers for any of the standards delineated in this chapter. The Department shall retain authority to monitor for and enforce compliance with all standards established in this chapter.

History

SOURCE: Final Rulemaking published at 70 DCR 003050 (March 10, 2023); as corrected by Errata Notice published at 71 DCR 004474 (April 19, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8031

22-A DCMR § 8099 DEFINITIONS

Assertive Community Treatment Provider (“ACT provider”) – A Department-certified provider that has entered into a Human Care Agreement with the Department to provide Assertive Community Treatment services in accordance with the requirements of 22-A DCMR Chapter 34.

Affiliation Agreement – A legal agreement between a provider and another entity that describes how they will work together to benefit individuals served.

Aftercare Plan – A plan developed with an individual and their treatment team to identify goals and action steps the individual can use to move forward once they leave treatment services.

Applicant – A program that has applied to the Department for certification as a behavioral health stabilization provider.

Assessment – A process that gathers information and engages with the individual to enable the provider to determine the presence or absence of a mental health or substance use condition or co-occurring disorder.

Behavioral Health Crisis – An unplanned event during which an individual struggles to manage their psychiatric or substance use related symptoms without de-escalation or other intervention. Also includes situations in which an individual’s daily life challenges result in or put them at risk of an escalation in symptoms.

Certification – The process of establishing that the standards described in this chapter are met; or approval from the Department indicating that an applicant has successfully complied with all requirements for the operation of a behavioral health stabilization program in the District.

Certified Recovery Coach – A Certified Recovery Coach is an individual with any Department-approved recovery coach certification.

Clinician – Individuals licensed by the District Department of Health, Health Regulation and Licensing Administration (“HRLA”) to provide clinical services.

Clubhouse Provider – A Department-certified provider that has entered into a Human Care Agreement with the Department to provide Clubhouse services in accordance with the requirements of 22-A DCMR Chapter 34 and 22-A DCMR Chapter 39.

Communicable Disease – Any disease as defined in Title 22-B, § 201 of the District of Columbia Municipal Regulations (“DCMR”).

Community Based Intervention Provider (“CBI provider”) – A Department-certified provider that has entered into a Human Care Agreement with the Department to provide Community Based Intervention services in accordance with the requirements of 22-A DCMR Chapter 34.

Continuity of Care Plan – A plan that provides for the ongoing care of individuals in the event that a certified provider is no longer able to provide adequate care.

Core Services Agency (“CSA”) – A Department-certified MHRS provider that has entered into a Human Care Agreement with the Department to provide specific MHRS in accordance with the requirements of 22-A DCMR Chapter 34.

Credentialed Staff – Non-licensed staff who are permitted to provide behavioral health stabilization services or components of behavioral health stabilization services if under the supervision of an independently licensed practitioner in accordance with applicable laws and regulations.

Crisis – An event that significantly jeopardizes an individual’s treatment, recovery, health, or safety.

Department – The District of Columbia Department of Behavioral Health.

Director – The Director of the District of Columbia Department of Behavioral Health.

Discharge – The time when an individual’s active involvement with a program is terminated.

District – The District of Columbia.

Drug – Substances that have the likelihood or potential to be misused or abused, including alcohol, prescription drugs, and nicotine.

Facility – Any physical premises which houses one (1) or more behavioral health stabilization programs.

Family Member – A person with whom the individual in/seeking treatment has a significant relationship and whose participation is important to the individual’s recovery.

Full-Time – An individual employed on average at least thirty (30) hours per week.

Human Care Agreement (“HCA”) – A written agreement entered into by the certified behavioral health stabilization provider and the Department which establishes a contractual relationship between the parties. Licensed Graduate Professional Counselor (“LGPC”) – A person licensed as a graduate professional counselor in accordance with Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq. (2016 Repl. & 2019 Supp.)).

Licensed Professional Counselor (“LPC”) – A professional counselor licensed in accordance with Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq. (2016 Repl. & 2019 Supp.)).

Major Unusual Incidents (“MUI”) – Adverse events that can compromise the health, safety, and welfare of persons; employee misconduct; fraud; and actions that are violations of law and policy.

Medicaid – The medical assistance program, as approved by the Federal Centers for Medicare and Medicaid Services (“CMS”) and administered by DHCF, that enables the District to receive Federal financial assistance for its medical assistance program and other purposes as permitted by law.

Medical Necessity (or Medically Necessary) – Health care services or products that a prudent provider would provide to an individual to prevent, diagnose, or treat an illness, injury, disease, or its symptoms in a manner that is: (a) in accordance with generally accepted standards of health care practice; (b) clinically appropriate in terms of type, frequency, extent, site, and duration; and (c) not primarily for the economic benefit of the health plans and purchasers or for the convenience of the individual or treating provider.

Mental Health Rehabilitation Services (“MHRS”) – The Department’s rehabilitative services as covered by the District’s Medicaid State Plan.

Mental Illness – A diagnosable mental, behavioral, or emotional disorder (including those of biological etiology) which substantially impairs the mental health of the person or is of sufficient duration to meet diagnostic criteria specified within the most recent Diagnostic and Statistical Manual (“DSM”) or its most recent International Classification of Diseases equivalent.

Mobile Crisis Intervention – A home- or community-based service that addresses a behavioral health crisis by using therapeutic communication, interactions, and supporting resources to interrupt and/or ameliorate acute behavioral health distress and associated behaviors.

Notice of Infraction (“NOI”) – An action taken by agencies to enforce alleged violations of regulatory provisions.

Organizational Onboarding – Mechanism through which new employees acquire the necessary knowledge, skills, and behaviors to become effective performers. It begins with recruitment and includes a series of events, one (1) of which is employee orientation, which helps new employees understand performance expectations and contribute to the success of the organization.

Parent – A person who has custody of a child such as a natural parent, stepparent, adopted parent, or a person who has been appointed as a guardian for the child by a court of competent jurisdiction.

Physician Assistant – A person licensed or authorized to practice as a physician assistant pursuant to Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq. (2016 Repl. & 2019 Supp.)).

Privacy Officer – A person designated by an organization that routinely handles protected health information, to develop, implement, and oversee the organization’s compliance with the U.S. Health Insurance Portability and Accountability Act (“HIPAA”) privacy rules, 42 CFR Part 2, and the District’s Mental Health Information Act.

Program – An entity that provides behavioral health stabilization services as certified by the Department.

Program Director – An individual having authority and responsibility for the day-to-day operation of a behavioral health stabilization program.

Protected Health Information (“PHI”) – Any written, recorded, electronic (“ePHI”), or oral information which either (1) identifies, or could be used to identify, an individual; or (2) relates to the physical or mental health or condition of an individual, provision of health care to an individual, or payment for health care provided to an individual. PHI does not include information in the records listed in 45 CFR § 160.103.

Provider – An entity certified by the Department to administer behavioral health stabilization programs.

Provisional Accreditation – A preliminary, conditional, and/or limited temporary accreditation from the Commission on Accreditation of Rehabilitation Facilities, The Joint Commission, or the Council on Accreditation.

Psychiatrist – A person licensed as a psychiatrist in accordance with Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq. (2016 Repl. & 2019 Supp.)).

Psychologist – A person licensed to practice psychology in accordance with applicable District laws and regulations.

Psychology Associate – A person registered as a psychology associate in accordance with applicable laws and regulations.

Qualified Practitioner – Staff authorized to provide treatment and other services based on the definition of the service.

Residential Program – Any behavioral health stabilization program which houses individuals overnight; this includes CPEPs and psychiatric crisis stabilization programs.

Screening – A determination of the likelihood that an individual has co-occurring substance use and mental disorders or that their presenting signs, symptoms, or behaviors may be influenced by co-occurring issues. Screening is a formal process that typically is brief and occurs soon after the individual presents for services.

Substance Use Disorder (“SUD”) – A chronic relapsing disease characterized by a cluster of cognitive, behavioral, and psychological symptoms indicating that the individual continues using a substance despite significant substance-related problems. A diagnosis of SUD requires an individual to have had persistent, substance related problem(s) within a twelve (12)-month period in accordance with the most recent version of the DSM.

Treatment – A therapeutic effort to improve an individual’s cognitive or emotional conditions or the behavior of an individual, consistent with generally recognized principles or standards in the behavioral health stabilization field, provided or supervised by a Qualified Practitioner.

History

SOURCE: Final Rulemaking published at 68 DCR 1623 (February 5, 2021); as amended by Final Rulemaking published at 71 DCR 014542 (November 29, 2024). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8099

22-A81 REIMBURSEMENT RATES FOR SERVICES PROVIDED BY THE DEPARTMENT OF BEHAVIORAL HEALTH CHAPTER 80 CERTIFIED BEHAVIORAL HEALTH STABILIZATION PROVIDERS

22-A DCMR § 8101 REIMBURSEMENT RATE

8101.1 The Department of Health Care Finance has published rates for Medicaid-funded services under Title 22-A District of Columbia Municipal Regulations (DCMR), Chapter 80. Those rates are contained in the District of Columbia Medicaid fee schedule available online at www.dc-medicaid.com. The Department of Behavioral Health (“the Department”) shall reimburse providers for Chapter 80 services provided to non-Medicaid beneficiaries at the same rates as contained in the District of Columbia Medicaid fee schedule.

8101.2 Reimbursement for the local-only services provided under Title 22-A DCMR Chapter 80, which includes Psychiatric Crisis Stabilization Room and Board, are set forth in the table below. This rate is the same as the local-only substance use service rate provided under Title 22-A DCMR Chapter 64, Residential Room and Board, Code H0043. The Department shall update the Psychiatric Crisis Stabilization Room and Board rate to reflect any future changes to the Chapter 64 substance use service rate by publishing a Public Notice in the D.C. Register and providing an opportunity for meaningful comment before implementation. The Notice shall describe the type of change, the reason for the change, the effective date of the change, and the new local only reimbursement rate.

SERVICE

CODE

RATE per UNIT ($)

UNIT

Psychiatric Crisis Stabilization Room and Board

S9485- U2

See Title 22-A District of Columbia Municipal Regulations (DCMR), Chapter 64, Residential Treatment, Room & Board (H0043)

Per diem

8101.3 All future updates to the service codes and rates will be included in the District of Columbia Medicaid fee schedule pursuant to the procedures established in Title 29 DCMR, Section 988, by providing notice and an opportunity for comment.

History

SOURCE: Final Rulemaking published at 67 DCR 14199 (December 4, 2020). District of Columbia Municipal Regulations Mental Health 22-A DCMR § 8101

22-B PUBLIC HEALTH AND MEDICINE

22-B1 PROTECTION OF PUBLIC HEALTH

22-B DCMR § 100 RESERVED

History

SOURCE: This section has been moved to 25 DCMR I.

22-B DCMR § 101 HEALTH NUISANCES: WATER SUPPLY

101.1 It shall be considered a nuisance injurious to health to throw or place any defiling or poisonous substance, decayed animal or vegetable matter, or filth into, or cause or allow the substance to pass or enter into, any spring, well, or river water used by the public for drinking or cooking purposes, or into the water of any public reservoir or water pipe within the District so that the water is rendered impure and unwholesome.

101.2 Any person who commits or creates a nuisance as defined in §101.1 shall, upon conviction, be fined not less than five dollars ($5) nor more than fifty dollars ($50) for each separate offense.

101.3 Any wells, springs, or waters used for drinking or cooking purposes, which are impure and unwholesome, or which have been rendered impure and unwholesome by any defiling or poisonous substance shall be considered a nuisance injurious to health.

101.4 Any person who maintains or continues a nuisance as defined in §101.3, after due notice from the Mayor to abate the nuisance, shall, upon conviction, be fined not less than ten dollars ($10) nor more than fifty dollars ($50) for each offense.

History

SOURCE: 8 DCRR §§5 and 6 (1965).

22-B DCMR § 102 HEALTH NUISANCES: SEWERS AND DRAINAGE

102.1 Neither the owner nor occupant of any lot, building, or other structure in the District shall allow any drain pipe, soil pipe, fixture, or passage of any description, for the drainage of all or part of the lot, building, or structure, into any public sewer or into any public or private sewage disposal system, to leak and to permit the escape of all or any part of its contents, elsewhere than into the public sewer or into the sewage disposal system with which the drain pipe, soil pipe, fixture, or passage is connected.

102.2 Neither the owner nor occupant of any lot, building, or other structure in the District shall permit any drain pipe, soil pipe, fixture, or passage of any description for the drainage of all or part of the lot, building, or structure, into the public sewer or into any public or private sewage disposal system, to become obstructed or to remain obstructed, so as to prevent the free passage of all drainage entering it into the public sewer or into the sewage disposal system with which the drain pipe, soil pipe, fixture, or passage is connected.

102.3 Any person violating any of the provisions of §§102.1 and 102.2 shall, upon conviction, be punished by a fine of not more than forty dollars ($40) for each offense.

102.4 All water closets and privies connected with any house, building, or premises within the District in and upon which people live, or where they congregate or assemble, or where any kind of business is done, that are kept in an uncleanly and foul condition, and from which offensive smells and noxious gases arise; and all water closets located within and being a part of any house or building not provided with proper sewer traps so as to prevent the return and escape of noxious gases and offensive odors from any public or private sewer connection with the house or building; shall be considered nuisances injurious to health.

102.5 Any person creating, keeping, and maintaining a nuisance as defined by §102.4 shall, after due notice served by the Mayor to abate the nuisance within twenty-four (24) hours or within a reasonable time as may be determined by the Mayor, and upon conviction, be punished by a fine of not less than five dollars ($5) nor more than twenty-five dollars ($25) for each and every day the nuisance is allowed to remain unabated.

102.6 No person shall place any refuse matter or permit any refuse matter to be placed in any water closet, bath tub, washstand, sink, cesspool, downspout, or other fixture in the District that is connected with any public sewer or with any sewage disposal field, when the connection is obstructed or defective and permits the escape of the refuse material elsewhere than into the public sewer and the disposal field.

102.7 Any person violating the provisions of §102.6 shall, upon conviction, be punished by a fine of not less than five dollars ($5) nor more than twenty-five dollars ($25) for each and every offense.

History

SOURCE: 8 DCRR §§10, 10a, 11, and 11.5 (1965).

22-B DCMR § 103 RESERVED

History

SOURCE: This section has been moved 25 DCMR J.

22-B DCMR § 104 RESERVED

History

SOURCE: This section has been moved to 25 DCMR J.

22-B DCMR § 105 HEALTH NUISANCES: MANUFACTURING

105.1 All establishments or places of business for tanning, skinning, scouring, or dressing hides or leather within the District that are in a filthy condition, or from which noisome odors or noxious gases arise, shall be considered nuisances injurious to health.

105.2 Any person who erects, creates, maintains, or continues a nuisance as defined in §105.2, and who fails to abate the nuisance after due notice from the Mayor, shall, upon conviction, be fined not less than ten dollars ($10) nor more than fifty dollars ($50) for each offense.

105.3 Any of the following activities in the District shall be considered a nuisance injurious to health:

(a) Boiling of offal, swill, bones, fat, tallow, or lard;

(b) Crushing, grinding, or burning of bones or shells;

(d) Making or boiling varnish or oil;

(e) Making lamp-black, turpentine, or tar;

(f) Distilling ardent, alcoholic, or fermented spirits;

(g) Storing or keeping scraps, fat, grease, or other offensive animal matter;

(h) Rendering or drying out dead, undressed, and slaughtered animals; and

(i) Any other business or trade, whereby noisome stenches and odors and noxious gases arise or are generated.

105.4 Any person who causes, erects, creates, maintains, or continues a nuisance as defined in §105.3, and who fails to abate the nuisance after due notice from the Mayor, shall, upon conviction, be fined not less than ten dollars ($10) nor more than one hundred dollars ($100) for each offense.

105.5 Unclean and filthy slaughterhouses, rooms, buildings, or places where sheep, hogs, cattle, or other animals are slaughtered within the District shall be considered nuisances injurious to health.

105.6 Any person creating, keeping, or maintaining a nuisance as defined by §105.5, who fails to abate the nuisance after due notice from the Mayor, shall, upon conviction, be fined not less than ten dollars ($10) nor more than fifty dollars ($50) for each offense.

105.7 Crushing or breaking stone within the District by machines or otherwise, in a manner that creates offensive and deleterious dust shall be considered a nuisance injurious to health.

105.8 Any person creating or maintaining a nuisance as defined in §105.7, who fails to abate the nuisance after due notice from the Mayor, shall, upon conviction, be fined not less than ten dollars ($10) nor more than fifty dollars ($50) for each offense.

History

SOURCE: 8 DCRR §§2-23 (1965).

22-B DCMR § 106 HEALTH NUISANCES: ENFORCEMENT

106.1 No person owning or having possession or control of any land in the District shall allow water to stand on that land in any manner whatsoever that endangers the health of persons living in the vicinity of the land.

106.2 Any person who violates the provision of §106.1 shall, upon conviction, be punished by a fine not to exceed fifty dollars ($50).

106.3 Upon receiving information or obtaining knowledge of the existence of any thing or things declared by this title to be nuisances, or any thing or things that may be declared nuisances by any ordinance or resolution enacted or adopted by the Mayor, the Director of Human Services (Director) shall notify the persons committing, creating, keeping, or maintaining the nuisance to remove it, or cause it to be removed, within twenty-four (24) hours, or within whatever reasonable time as may be determined by the Mayor, after the notice is given.

106.4 If the responsible person does not remove the nuisance within the time prescribed in the notice required by §106.3, the Director shall remove the nuisance or cause it to be removed.

106.5 All costs and expenses of removal of a nuisance shall be paid by the persons committing, creating, keeping, or maintaining the nuisance.

106.6 If the person or persons committing, creating, keeping, or maintaining a nuisance fail to pay the accrued costs and expenses of removing it within ten (10) days after removal, the Director shall collect the costs by suit at law.

106.7 Upon the Mayor's request, all fines and penalties imposed by this title shall be collected by prosecution in the Superior Court of the District of Columbia, by information filed in the court.

106.8 Whenever an alleged nuisance is shown to the satisfaction of the court to be continuing and existing, the person creating or maintaining the nuisance shall, upon conviction, in addition to the fine imposed, be ordered by the court to abate or remove the nuisance.

History

SOURCE: 8 DCRR §§26 and 27 (1965).

22-B DCMR § 107 RESERVED

History

SOURCE: This section has been moved to 25 DCMR I.

22-B DCMR § 108 RESERVED

22-B DCMR § 109 RESERVED

22-B DCMR § 110 NON-RESIDENTIAL PROPERTY

110.1 The owner of any premises or building in the District used for other than residential purposes shall provide and furnish the premises or building with adequate facilities for heating, ventilating, and lighting.

110.2 Adequate heating facilities shall mean the provision and maintenance in good repair of either of the following:

(a) A central heating facility;

(b) A non-portable, flue-connected heating facility; or

110.3 Each of the heating facilities described in §110.2 shall be capable of maintaining a minimum temperature of seventy degrees Fahrenheit (70° F.) in buildings or parts of buildings used for habitation or sedentary work, and of sixty-five degrees Fahrenheit (65° F.) in buildings or parts of buildings used for heavy work; provided, that the following requirements are met:

(a) Each heating facility shall be designed and installed so as to permit the control of temperature resulting from the use of the facility in a manner that the maximum resulting temperature in the premises heated by the facility will not exceed the maximum temperature in the "Comfort Chart" contained in the Guide of the American Society of Heating and Ventilating Engineers; and

(b) The temperatures referred to in this subsection shall be measured with all usually closed outside openings in a normal manner.

110.4 The owner of any premises or building in the District used for other than residential purposes shall provide, furnish, and maintain proper and sufficient water closets or privies for the premises or building.

110.5 Every water closet compartment, privy, toilet room, or bathroom shall have a waterproof floor surface and wall base.

110.6 The base required by §110.5 shall be at least three inches (3 in.) in height, and the floor surface shall consist of one (1) of the following:

(a) Smooth-finished tile or masonry effectively sealed so as to have a non-porous surface, laid in a manner to be free from cracks or open joints, and tightly joined to the base;

(b) Tongue-and-groove hardwood flooring that is tightly laid without open cracks or joints, tightly joined to the base, and both the base and surface covered with a seal coat of waterproof finish; or

(c) Linoleum, plastic, or rubber floor covering, or linoleum, asphalt, rubber, or plastic floor tiles, firmly cemented to a smooth, substantial sub-floor, laid without overlapping or open joints, and tightly joined to the base.

110.7 For the purposes of this section, "linoleum" shall mean a floor covering made of special preparations of linseed oil, gum, coloring matter, and wood flour, firmly affixed to a cloth or felt-paper base. This term shall not include enameled and cottonlinter composition coverings.

110.8 The owner of any premises or building in the District used for other than residential purposes shall keep the roof of the building tight and in good repair.

110.9 The owner of any premises or building in the District used for other than residential purposes shall cause the yard or area, or both, to be graded and paved so that all drainage flows freely from all parts of the building into the sewer traps that may have been provided for that purpose. If there are no sewer traps, the drainage shall flow away from any inhabited building on the premises.

110.10 Every person occupying any premises or any part of any premises in the District (or if the premises are not occupied, the owner of the premises) shall keep the premises and all buildings, yard, stables, grounds, and outhouses connected with the premises clean and wholesome.

110.11 If, upon inspection by the Director, it is determined that any premises, or any part of a premises, or any building, yard, stable, grounds, alley, or outhouse connected with the premises, is not in a clean and wholesome condition, the occupant or occupants of the premises or part (or the owner of the premises) shall be notified of the condition and shall be required to place the premises in a clean and wholesome condition.

110.12 Any person who fails or neglects to correct an uncleanly or unwholesome condition within the time allowed by the notice required by §110.11 shall be liable to the penalties provided in this section.

110.13 No owner, proprietor, lessee, manager, or superintendent of any store, factory, workshop, or other structure or place of employment where workmen or workwomen are employed for wages, shall cause, permit, or allow the facility, or any portion, apartment, or room of the facility, to be overcrowded, or inadequate, faulty, or insufficient in respect of lighting, heating, or ventilation.

110.14 Every store, factory, workshop, or place of employment shall be kept in a clean and wholesome condition and, as far as practicable, free from all gases, vapors, dust, or other impurities generated by manufacturing processes or otherwise, and injurious to health.

110.15 Where both males and females are employed, separate toilets and hand washing facilities shall be provided for each sex.

110.16 No person shall use any building in the District for any purpose for which it has not been lawfully used for a period of at least thirty (30) days immediately preceding the promulgation of the authorizing regulations, unless the building is located and constructed in accordance with the requirements of the laws, building regulations, and health ordinances in force in the District governing the location and construction of buildings intended to be used for that purpose.

110.17 The Director shall examine or cause to be examined any building supposed or reported to be in an unsanitary condition, and record the following information:

(a) The results of the examination;

(b) The location of the building;

(d) The names of the building's owner and lessee and occupant.

110.18 If after the examination, the Director deems any structure or building, or part of a structure of a building or an appurtenance to the building, in a condition that endangers the health of the building's inmates, or those living in the vicinity, the Director shall serve the following written notices:

(a) A notice to the occupants requiring them to vacate the building; and

(b) A notice to the owner, agent, or other party having interest in the building, requiring the building to be put in proper condition within a time as the Director specifies.

110.19 After receiving notice as provided in §110.18, the interested party or parties shall comply with it.

110.20 Any person who fails to comply with the Director's order as provided in §110.18 shall be subject to the penalties as provided by §§110.25 through 110.27 of this section, unless an appeal is made as provided in §§110.21 through 110.24 of this section.

110.21 Upon deposit of thirty dollars ($30) to cover fees for an examining commission, the interested party may appeal within forty-eight (48) hours in writing to the Mayor, who shall appoint a commission to determine the question at issue.

110.22 The commission as required in §110.21 shall consist of two (2) disinterested and competent physicians and one (1) architect, all residents of the District, who shall be paid for their services.

110.23 Payment for services as required by §110.22 shall not exceed ten dollars ($10) to each person, and shall be made upon the certificate of the Director.

110.24 In case of a decision adverse to the appellant, it shall be the duty of the appellant to comply with the decision upon being duly notified of the decision in writing by the Director.

110.25 Any person violating, or aiding or abetting in violating, any of the provisions of this section, or interfering with or preventing any inspection authorized by this section, shall be deemed guilty of a misdemeanor; and shall, upon conviction in the Court of General Sessions, be punished by a fine of not less than five dollars ($5) nor more than forty-five dollars ($45).

110.26 For provisions of health regulations applying to the use and occupancy of buildings and grounds used for residential purposes, see the D.C. Housing Code (DCMR 14).

110.27 For provisions of health regulations applying to minimum width of dwelling, see Art. 202-05 of the D.C. Building Code (DCMR 12).

History

SOURCE: 8 DCRR §§ C-110, C-120, C-130, C-140, C-150, and C-160 (1965). EDITOR’S NOTE: The Building Code referenced in this section has been superseded by the Construction Codes Approval and Amendments Act of 1986, D.C. Code, 2001 Ed. §§ 6-1401 to 6-1409 , effective March 21, 1987. Please refer to those sections of the D.C. Code for current provisions relating to building and other construction codes.

22-B DCMR § 111 SWIMMING POOLS AND BATHING PLACES

111.1 Any application for a permit to construct, remodel, or repair a swimming pool or other bathing place within the District shall be submitted to the Department for recommendation before the permit is issued by the Superintendent of Licenses and Permits.

111.2 Any application for a license to operate a swimming pool or other bathing place in the District shall be submitted to the Department for approval before the license is issued.

111.3 Whenever, in the opinion of the Director, changes in the design or operation of a swimming pool or other bathing place are required in order to protect the health and safety of the users, the person, firm, or corporation in charge of the swimming pool or bathing place shall be notified in writing as to the changes that are required.

111.4 A time limit for the required changes shall be set forth in the notice required by §111.3 and, if the changes are not made within the specified time limit, the swimming pool or bathing place shall be emptied, and the water supply inlet pipe line valves shall be closed and sealed.

111.5 Every person, firm, or corporation maintaining or operating a swimming pool or other bathing place shall have a competent person in charge of the facility who shall be known as the "pool operator," and who shall hold a valid pool operator's permit and be present on the premises at all times during the periods the facility is open to use.

111.6 Application for a pool operator's permit shall be made to the Director on forms provided for that purpose.

111.7 Every pool operator shall be required to demonstrate to the satisfaction of the Director that the operator is competent and has a sufficient knowledge of the proper operation of swimming pools or other bathing places.

111.8 When the requirements of §§111.5 through 111.7 are met, the Director shall issue a "Pool Operator's Permit" which shall state that the operator has been examined and is believed to be a competent person to be placed in charge of the certain swimming pool or bathing place that the person will operate.

111.9 The pool operator's permit shall be posted or displayed in a manner approved by the Director so that it readily can be seen by all of the users of the swimming pool or bathing place.

111.10 It shall be unlawful to operate any swimming pool or other bathing place in the District in any manner other than in accordance with good standard practice and as approved by the Director.

111.11 Any swimming pool or other bathing place that is used only by one (1) family and no other persons shall be required to comply with only §§111.1 through 111.2 of this chapter.

111.12 If it is found that the provisions of this section are not being complied with, and, in the opinion of the Director, that noncompliance endangers the life, safety, or health of the users of any swimming pool or other bathing place, the Director may revoke any operating permit issued as required by this section.

111.13 If it is found that any condition exists which, in the opinion of the Director, endangers the life, safety, or health of the users of any swimming pool or other bathing place, the Director may revoke any operating permit issued as required by this section.

111.14 Any swimming pool or other bathing place that is not open to the public or general use shall not be required to comply with §§111.5 through 111.9 of this section.

111.15 Any person operating a swimming pool or other bathing place without a permit, or violating, or aiding or abetting any violation of any of the provisions of this section, shall upon conviction in Police Court be fined not less that twenty-five dollars ($25) nor more than four hundred dollars ($400) for each offense.

111.16 Civil fines, penalties, and fees may be imposed as alternative sanctions for any infraction of the provisions of this chapter pursuant to titles I-III of the Department of Consumer and Regulatory Affairs Civil Infractions Act of 1985. Adjudication of any infraction of this chapter shall be pursuant to titles I-III of the Department of Consumer and Regulatory Affairs Civil Infractions Act of 1985.

History

SOURCE: 8 DCRR §§ C-410, C-420, C430, C-440, C-450, and C-460 (1965); as amended by the Department of Consumer and Regulatory Affairs Civil Infractions Act of 1985 Technical and Clarifying Amendments Act of 1990 § 8, D.C. Law 8-237.

22-B DCMR § 112 LAUNDRIES

112.1 Each person who commonly launders for pay, on the premises which he or she occupies, the clothing, or the sheets, pillow cases, table napkins, or other similar articles belonging to any other person, shall report that fact to the Director in writing within five (5) days of occupying the premise and using it to provide laundering services.

112.2 The written notice required in §112.1 shall include the following information:

(a) The lauderer's name;

(b) The location of the launderer's premises; and

(c) The number of persons or families living independently of one another whom the launderer serves, if less than ten (10) in number.

112.3 Any person violating any of the provisions of this section, upon conviction, shall be punished by a fine of not more twenty-five dollars ($25).

History

SOURCE: 8 DCRR § D-310 (1965).

22-B DCMR § 113 RESERVED

22-B DCMR § 114 RESERVED

22-B DCMR § 115 RESERVED

History

SOURCE: This Section has been moved to 25 DCMR H.

22-B DCMR § 116 RESERVED

22-B DCMR § 117 RESERVED

History

SOURCE: This section has been moved to 25 DCMR H.

22-B DCMR § 118 LEAD PAINT

118.1 It shall be unlawful for any person to apply to any toy, article of furniture, or interior or exterior surface of any habitation, paint or any other similar surface-coating material containing lead compounds of which the lead content (calculated as the metal) exceeds five-tenths of one percent (0.5%) of the total weight of the contained solids or dried paint film.

118.2 It shall be unlawful for any person to offer for sale or sell any paint or other similar surface-coating material intended, or packaged in a form suitable for use, on toys, furniture, or in or around habitable premises, which contains lead compounds of which the lead content (calculated as the metal) exceeds five-tenths of one percent (0.5%) of the total weight of the contained solids or dried paint film.

118.3 For the purposes of this section, "exterior surface" shall mean any surface on the exterior of any residential building; including, but not limited to, any portion of a window, window frame, door, door frame, wall, stair, porch, balcony, rail, or other guard or appurtenance.

118.4 For the purposes of this section, "interior surface" shall mean any surface in the interior of any residential building; including, but not limited to, any portion of a window, window frame, door, door frame, wall, ceiling, stair, rail, spindle, balustrade, or other guard or appurtenance.

118.5 Any person who violates any provision of this section shall, upon conviction, be punished by a fine not to exceed three hundred dollars ($300) or by imprisonment not to exceed ten (10) days for each violation.

118.6 Any physician who diagnoses or treats a case of lead intoxication shall, within seventy-two (72) hours, report the case to the Director on a form prescribed and furnished by the Director.

118.7 [Repealed] D.C. Law 6-83, 32 DCR 7276 (December 13, 1985).

History

SOURCE: Commissioner’s Order 70-116 (April 1, 1970), 16 DCR 441 (May 18, 1970); as amended by Regulation No. 73-1 (January 31, 1973), 19 DCR 591 (February 20, 1973); and by 8 DCRR § C-160 (1965); and by the Preventive Health Services Amendments Act of 1985 § 7, D.C. Law 6-83, 32 DCR 7276 (December 13, 1985).

22-B DCMR § 119 ILLEGAL USE OF GLUES CONTAINING A SOLVENT HAVING THE PROPERTY OF RELEASING TOXIC VAPORS OR FUMES

119.1 No person shall, for the purpose of causing a condition of intoxication, inebriation, excitement, stupefaction, or the dulling of his or her brain or nervous system, intentionally smell or inhale the fumes from any glue containing a solvent which has the property of releasing toxic vapors or fumes; provided, that nothing in this section shall be interpreted as applying to the inhalation of any anesthesia for medical or dental purposes.

119.2 For the purposes of this section, the term "person" shall include individuals, partnerships, corporations, associations, executors, administrators, guardians, trustees and agents.

119.3 For the purposes of this section, the phrase "glue containing a solvent having the property of releasing toxic vapors or fumes" shall include any glue, cement, or other adhesive containing one (1) or more of the following chemical compounds:

(a) Acetone;

(b) An acetate;

(d) Butyl alcohol;

(e) Ethyl alcohol;

(f) Ethylene dichloride;

(g) Isopropyl alcohol;

(h) Methyl alcohol;

(i) Methyl ethyl ketone;

(j) Pentachlorophenol;

(k) Petroleum ether; and

(l) Toluene.

119.4 No individual shall, for the purpose of violating §119.1, use, or possess for the purpose of so using, any glue containing a solvent having the property of releasing toxic vapors or fumes.

119.5 No person, except a person who is, at the time of sale, actually employed by or engaged in operating a bona fide commercial establishment at a fixed location, shall sell to any other person any tube or other container of glue containing a solvent having the property of releasing toxic vapors or fumes, and all sales of such glue not made in or from such an establishment are hereby prohibited.

119.6 No person shall sell, give, or otherwise transfer to any other person under the age of eighteen (18), except with the written consent of the parent or guardian of such other person, any glue containing a solvent having the property of releasing toxic vapors or fumes; provided, that nothing contained under this section shall be considered applicable to the following situations:

(a) The sale of a model kit containing a tube or other container of any such glue;

(b) The sale of a tube or other container of any such glue immediately in conjunction with the sale of a model kit requiring the use of approximately such quantity or glue for the assembly of a model; and

(c) The transfer of a tube or other container of such glue from a parent to his or her child or from a guardian to his or her ward.

119.7 Each person who, in one (1) transaction, or in two (2) or more transactions closely connected in time, sells to any other person, two (2) or more containers of glue containing a solvent having the property of releasing toxic vapors or fumes, shall upon the occurrence of the second or subsequent transaction, require such other person to exhibit means of identification of himself or herself, and shall record in a register conforming with requirements established by the Chief of Police the name, address, and description of such other person.

119.8 The record required by §119.6 shall be kept for a period of not less than six (6) months, and shall be available for inspection during normal business hours by officers and members of the Metropolitan Police Force.

119.9 Any person who violates any provision of this section shall upon conviction be punished by a fine not exceeding three hundred dollars ($300) or by imprisonment for not more than ten (10) days (Commissioners’ Order 64-225).

History

SOURCE: Police Regulations art. 46, §§ 1 - 7 (May 1981).

22-B DCMR § 120 RESERVED

22-B DCMR § 121 RESERVED

22-B DCMR § 122 RESERVED

22-B DCMR § 123 RESERVED

22-B DCMR § 124 ACUPUNCTURE

124.1 The practice of acupuncture shall be limited to physicians and dentists licensed to practice in the District of Columbia for the period of one (1) year.

124.2 The Director of the Department of Human Services shall develop an examination and other criteria for licensure of practitioners of acupuncture who are neither licensed to practice medicine or dentistry in the District of Columbia. The regulations shall be forwarded to the Council within one (1) year after enactment.

124.3 The Director of the Department of Human Services shall recommend minimum standards for clinics specializing in acupuncture treatment. The recommendations shall be forwarded to the Council within six (6) months of enactment of this section.

History

SOURCE: Regulation No. 74-38 (December 13, 1974), 21 DCR 1305 (December 24, 1974).

22-B DCMR § 125 REPORTING OF CANCER AND OTHER MALIGNANT NEOPLASTIC DISEASES

125.1 The purpose of this section is to provide for the reporting of cases of cancer and other malignant neoplastic diseases to the Director.

125.2 This section shall be applicable to all cases of cancer, sarcoma, lymphoma (including Hodgkin's Disease), leukemia, and all other malignant neoplasms.

125.3 For the purposes of this section, unless otherwise provided, the following terms shall have the meaning ascribed:

(a) The term "Act" means the Act of Congress codified at D.C. Code, 2001 Ed. §§ 7-301 to 7-304, as amended;

(b) The term "Disease" mean any of the disease enumerated in §125.2;

(d) The term "Director" mean the Director of Public Health, or his or her designated agent.

125.4 Each case of any disease listed in §125.2 shall be reported to the Director, on a form prescribed and furnished by the Director, by the physician, or other person responsible for the care of a patient, confidentially, in writing, after a determination has been made that a patient is suffering from any of the diseases cited in §125.2.

125.5 Information pertaining to the medical history of a reported case, in addition to that forwarded to the Director as required by §125.4, shall be furnished upon request of the Director.

125.6 [Repealed] D.C. Law 6-83, 32 DCR 7276 (December 13, 1985).

History

SOURCE: Commissioners’ Order 61-1117 (June 20, 1961), 8 DCRR §§ 8-5:201 to 8-5:205 (1965); as amended by the Preventive Health Services Amendments Act of 1985 § 7, D.C. Law 6-83, 32 DCR 7276 (December 13, 1985).

22-B DCMR § 129 IMMUNIZATION: REPORTS AND GENERAL PROVISIONS

129.1 Each health care provider and health organization shall report the administration of each dose of any immunization to the Department within twenty-four (24) hours after the administration of the immunization.

129.2 For purposes of this section, the term “health organization” means any entity in the District of Columbia that provides vaccinations, including organizations with a COVID-19 Vaccination Provider Agreement with the Centers for Disease Control and Prevention (CDC) and receiving publicly funded COVID-19 vaccine.

129.3 To comply with reporting requirement in § 129.1, a health care provider or health organization shall use the system designated by the Department for reporting the administration of a vaccine to the Department, such as the District of Columbia Immunization Information System (DOCIIS).

129.4 Each report shall include the following information:

(a) Demographic information for each person vaccinated, including:

(1) The person’s full name, including any suffix, nickname, or alternate surname that may apply;

(2) The person’s date of birth and, for newborns, the name of the hospital that delivered the newborn;

(3) The person’s social security number, if applicable;

(4) The person’s Medicaid number, if applicable;

(5) The name of the person’s parent or guardian, if the person is younger than eighteen (18) years of age;

(6) The person’s address;

(7) The person’s phone number;

(8) The person’s race or ethnicity;

(9) The person’s insurance status and the name of the insurer, if applicable; and

(10) The person’s gender;

(b) New and historical immunization data, including:

(1) The type of each vaccine administered;

(2) The date the vaccine was administered;

(3) The manufacturer and lot number of the vaccine;

(4) Verification that the vaccine information statement was given to the recipient of the vaccine and the publication date of the vaccine information statement for the vaccine given; and

(5) The funding source of the vaccine;

The provider’s ID;

The provider’s name;

(3) The provider’s address;

(4) The provider’s phone number; and

(5) The name of the person who administered the vaccine; and

(d) Medical and clinical information, including:

(1) Any adverse reaction to active immunization;

(2) Information about medical contraindications, including:

(A) Whether contraindication is temporary or permanent; and

(B) The antigen for which there was a contraindication;

(3) Information about exemption from vaccination, including:

(A) Reason for the exemption;

(B) The antigen for which the exemption applies;

(4) Copy of laboratory results as evidence of immunity; and

(5) Varicella disease status including certification of infection with varicella that includes either:

(A) A copy of laboratory results indicating varicella disease or immunity to varicella; or

(B) A health care provider's diagnosis or verified history of varicella or herpes zoster disease that includes the month and year of the disease.

129.5 Each of the following entities shall report the immunization history of an individual to the Department in the manner and form the Department prescribes:

(a) Each public, private, parochial, or charter school shall submit certification of immunization for each noncompliant student as determined by the Department within ten (10) business days after notification from the Department; and

(b) Each child development facility shall submit certification of immunization for each noncompliant child as determined by the Department within ten (10) business days after notification from the Department.

129.6 A post-secondary institution is not required to report active immunization, but the Department encourages post-secondary institutions to report immunizations for students currently enrolled in the institution.

129.7 Information disclosed to the Department pursuant to §§ 129.1, 129.4, 129.5 and 129.6 shall be kept confidential and shall not be used or disclosed to a third party, except as provided in this subsection:

(a) The Department may use patient-specific immunization information to produce aggregate immunization coverage reports;

(b) The Department may use immunization information to produce official immunization records for individuals;

(c) The Department may use or disclose individually identifiable immunization information without the consent of the person to whom the information pertains to notify the following individuals or entities of due dates for immunizations or missed or overdue immunizations according to the schedule recommended by the Advisory Committee on Immunization Practices (ACIP) to the following:

(1) The person;

(2) The person’s parent or guardian;

(3) The person’s health care provider or insurer;

(4) A child development facility in which the person is enrolled;

(5) A school in which the person is enrolled; and

(d) Except as provided in paragraphs (a) through (c) of this subsection, the Department may disclose a person’s individually identifiable information to a third party only with the written consent of the person, or the person’s parent or guardian if the person is under eighteen (18) years of age or an unemancipated adult.

129.8 Notwithstanding the requirements of §§ 130 through 154 specifying minimum and maximum intervals between administration of vaccinations, a vaccine administered four (4) days or less than the minimum interval or age shall be a valid dose. This subsection shall not apply to the minimum intervals between live antigen vaccinations, including:

(a) Measles, mumps, rubella (MMR); and

(b) Varicella.

129.9 A vaccine administered five (5) or more days before the minimum interval or age shall not be counted as a valid dose and shall be repeated as age and interval-appropriate. Subsequent doses shall be repeated or spaced, as age and interval appropriate, in accordance with §§ 130 through 154, and the recommendations of ACIP, if applicable.

129.10 A combination vaccine may be administered as an alternate for any dose of the vaccine series for which it is licensed.

129.11 A person claiming religious exemption from immunization for a child shall file the religious exemption form at the beginning of each school year for each child for which the exemption is claimed. A person electing to opt-out of immunization with the HPV vaccination for a child shall file the HPV vaccination opt-out form at the beginning of each school year for each child for which there is an opt-out to be filed.

129.12 When a health care provider administers a vaccine in the course of his or her employment by a health organization, the health organization and the health care provider are jointly responsible for compliance with this section.

129.13 Any health care provider or health organization that fails to comply with the provisions of this section shall be subject to criminal, civil, and administrative penalties authorized by law, including:

(a) Sanctions or penalties for violating D.C. Official Code § 7-2307, including civil fines and summary suspension or revocation of licenses, registrations, and certificates;

(b) Disciplinary action by the appropriate licensing body; and

(c) Suspension or termination of participation of the health care provider or health organization in the District of Columbia COVID-19 Vaccination Program.

History

SOURCE: Final Rulemaking published at 55 DCR 5253 (May 2, 2008); as amended by Final Rulemaking published at 61 DCR 12782 (December 19, 2014); as amended by Final Rulemaking published at 68 DCR 012467 (November 26, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 129

22-B DCMR § 130 REQUIRED IMMUNIZATIONS FOR STUDENTS UNDER SEVEN (7) YEARS OF AGE

130.1 Before a child under seven (7) years of age enters school or a child development center, the parent or guardian of the child shall have the child immunized according to the requirements in sections 131 through 137. The doses of immunization shall follow these regulations or the recommendations of the ACIP published after the date of these regulations. The Director strongly recommends that a parent or guardian of a child who does not attend a school or child development center immunize the child in the same manner required for children who do attend a school or child development center.

History

SOURCE: Final Rulemaking published at 44 DCR 1656 (March 21, 1997); Final Rulemaking published at 55 DCR 5253 (May 2, 2008).

22-B DCMR § 131 DIPHTHERIA, TETANUS, WHOLE-CELL OR ACELLULAR PERTUSSIS

131.1 The first dose of diphtheria, tetanus, whole-cell pertussis (DTP) or diphtheria, tetanus, acellular pertussis (DTaP) shall be administered not earlier than six (6) weeks of age and not later than two (2) months of age.

131.2 The second dose of DTP or DTaP shall be administered not earlier than four (4) weeks after the first dose and not later than two (2) months after the first dose.

131.3 The third dose of DTP or DTaP shall be administered not earlier than four (4) weeks after the second dose and not later than two (2) months after the second dose.

131.4 A fourth dose of DTP or DTaP shall be administered:

(a) Not earlier than six (6) months after the third dose;

(b) Not earlier than twelve (12) months of age; and

131.5 A booster, or fifth dose of DTP or DTaP, shall be administered:

(a) Not earlier than six (6) months after the previous dose;

(b) Not earlier than four (4) years of age; and

131.6 A fifth dose of DTP or DTaP shall not be required for a student who received the fourth dose on or after four (4) years of age.

131.7 Any licensed DTaP or DTP vaccine or combination vaccine may be administered as an alternate for any dose of the series for which it is licensed.

131.8 For a student under seven (7) years of age, pediatric diphtheria tetanus (DT) vaccine may be administered instead of DTaP or DTP only when the provider follows current acceptable guidelines for valid contraindications for pertussis vaccine, as recommended by the ACIP. If DT is administered instead of DTaP or DTP, a physician or Advance Practice Nurse shall also provide a signed medical exemption request for pertussis to the student's parent or guardian for the certification required by D.C. Official Code § 38-502.

131.9 If a student receives pediatric DT instead of DTaP or DTP, the number and timing of the doses needed to complete the DT series shall be as follows:

(a) If the first dose of DT is administered at twelve (12) months of age or younger, four (4) doses shall be administered, with the remaining three (3) doses being given according to the schedule stated in §§ 131.2 to 131.4;

(b) If the first dose of DT is administered after twelve (12) months of age, three (3) doses shall be administered. The second dose shall be administered no earlier than four (4) weeks after the first dose but not later than two (2) months after the first dose. The third dose shall be administered six (6) months after the second dose; and

(c) If the third or fourth dose of DT was administered before four (4) years of age, the student shall have a booster dose at age four (4) and not later than five (5) years of age.

History

SOURCE: Final Rulemaking published at 44 DCR 1656 (March 21, 1997); Final Rulemaking published at 55 DCR 5253 (May 2, 2008).

22-B DCMR § 132 ORAL OR INACTIVATED POLIO (OPV OR IPV)

132.1 Each student under seven (7) years of age who receives his or her primary immunization shall have either oral poliovirus vaccine (OPV) or inactivated polio vaccine (IPV) administered according to §§ 132.2 to 132.6.

132.2 The first dose shall be administered no earlier than six (6) weeks of age and not later than two (2) months of age.

132.3 The second dose shall be administered no earlier than four (4) weeks after the first dose and not later than two (2) months after the first dose.

132.4 The third dose shall be administered two (2) months after the second dose and by nineteen (19) months of age, but no earlier than four (4) weeks after the second dose.

132.5 A supplementary fourth dose shall be administered at four (4) years of age and by the fifth birthday, but no earlier than four (4) weeks after the third dose. If the third dose of a primary series of all OPV or all IPV was given on or after four (4) years of age, a fourth dose shall not be required. If the fourth dose was given before four (4) years of age and not earlier than four (4) weeks after the third dose, no additional dose shall be required.

132.6 If a combination of OPV and IPV doses are administered as part of a series, a total of four (4) doses shall be administered, regardless of the student's present age or the student's age at administration of the primary series. The fourth dose shall be administered no earlier than four (4) weeks after the third dose.

History

SOURCE: Final Rulemaking published at 44 DCR 1656, 1657 (March 21, 1997); Final Rulemaking published at 55 DCR 5253 (May 2, 2008).

22-B DCMR § 133 MEASLES, MUMPS, RUBELLA (MMR)

133.1 The first dose of measles, mumps, and rubella (MMR) vaccine shall be administered no earlier than twelve (12) months of age and not later than sixteen (16) months of age.

133.2 The second dose of MMR shall be administered at four (4) years of age and by the fifth birthday, but no earlier than twenty-eight (28) days after the first dose. The Department recommends administration of the second dose at the next pediatric visit after the first dose, but no earlier than twenty-eight (28) days after the first dose.

133.3 If single antigen measles, mumps, and rubella vaccines are used, two (2) doses of each vaccine shall be administered, with a minimum interval of twenty-eight (28) days between dose (one) 1 and dose (two) 2. A dose of MMR, Varicella, one of the single-antigen measles, mumps, rubella, or any other live parenteral vaccines shall not be administered less than twenty-eight (28) days apart, unless administered on the same day.

History

SOURCE: Final Rulemaking published at 44 DCR 1656, 1659 (March 21, 1997); Final Rulemaking published at 55 DCR 5253 (May 2, 2008).

22-B DCMR § 134 HAEMOPHILUS INFLUENZA TYPE B (HIB)

134.1 The first dose of Haemophilus influenza type B (Hib) shall be administered no earlier than six (6) weeks of age and not later than two (2) months of age.

134.2 The second dose of Hib shall be administered no earlier than one (1) month after the first dose and not later than two (2) months after the first dose.

134.3 The third dose of Hib shall be administered no earlier than one (1) month after the second dose and not later than two (2) months after the second dose. The third dose shall not be required, if the PRP-OMP (PedvaxHIB) vaccine was administered for the first and second doses.

134.4 If different brands of licensed Hib conjugate vaccines are administered for the first two (2) doses, a total of three (3) doses shall be required to complete the primary series. Any combination of licensed Hib conjugate vaccines for use in infants may be administered to complete the primary series.

134.5 A booster dose of Hib shall be administered no earlier than two (2) months after the previous dose and at twelve (12) months of age and by sixteen (16) months of age.

134.6 An unvaccinated infant between the ages of seven (7) and eleven (11) months shall receive two (2) doses of Hib to complete the primary series, administered no earlier than one (1) month apart but not later than two (2) months apart. A booster dose shall be administered no earlier than two (2) months after the previous dose at twelve (12) months of age and by sixteen (16) months of age.

134.7 An undervaccinated infant between the ages of seven (7) and eleven (11) months shall complete the series according to the requirements of §§ 134.2, 134.3, and 134.5.

134.8 An unvaccinated or undervaccinated infant between twelve (12) and fourteen (14) months of age shall receive one (1) dose of Hib, followed by a booster dose. The booster dose shall be administered two (2) months after the previous dose.

134.9 An unvaccinated student between fifteen (15) months and five (5) years of age shall receive a single dose of Hib. A booster dose shall not be required.

134.10 The Hib vaccine shall not be required for a student five (5) years of age or older regardless of Hib vaccination status.

History

SOURCE: Final Rulemaking published at 44 DCR 1656, 1659 (March 21, 1997); Final Rulemaking published at 55 DCR 5253 (May 2, 2008).

22-B DCMR § 135 HEPATITIS B

135.1 The first dose of hepatitis B is recommended at birth, but shall be administered not later than at one (1) month of age.

135.2 The second dose shall be administered no earlier than one (1) month after the first dose and by three (3) months of age.

135.3 The third dose shall be administered no earlier than two (2) months after the second dose, at least four (4) months after the first dose, not earlier than 24 weeks of age, and by nineteen (19) months of age.

History

SOURCE: Final Rulemaking published at 44 DCR 1656, 1660 (March 21, 1997); Final Rulemaking published at 55 DCR 5253 (May 2, 2008).

22-B DCMR § 136 VARICELLA (CHICKENPOX)

136.1 The first dose of varicella is recommended at twelve (12) months of age, but shall be administered not earlier than twelve (12) months of age and by sixteen (16) months of age. A dose of MMR, varicella, one of the single-antigen measles, mumps, rubella, or any other live parenteral vaccine shall not be administered less than twenty-eight (28) days apart, unless administered on the same day.

136.2 Beginning with the 2008/2009 school year, a second dose of varicella shall be administered at four (4) years of age and by the fifth birthday. An interval of three (3) months is recommended between each dose of varicella-containing vaccine given between twelve (12) months and twelve (12) years of age. If the second dose was given twenty-eight (28) days or more after the first dose, the second dose does not need to be repeated. A dose of MMR, varicella, one of the single-antigen measles, mumps, rubella, or any other live parenteral vaccine shall not be administered less than twenty-eight (28) days apart, unless administered on the same day.

136.3 The varicella vaccination shall not be required for a student who has written certification of infection with varicella that includes either:

(a) Copy of laboratory results as evidence of varicella disease or immunity to varicella; or

(b) A health care provider's diagnosis or verified history of varicella or herpes zoster disease that includes the month and year of the disease.

History

SOURCE: Final Rulemaking published at 44 DCR 1656, 1661 (March 21, 1997); Final Rulemaking published at 55 DCR 5253 (May 2, 2008).

22-B DCMR § 137 PNEUMOCOCCAL CONJUGATE 7-VALENT VACCINE (PCV7)

137.1 Beginning with the 2008/2009 school year, pneumococcal conjugate 7-valent vaccine (PCV7) shall be required for all students under the age of five (5) years.

137.2 The first dose of PCV7 shall be administered no earlier than six (6) weeks of age and not later than two (2) months of age.

137.3 The second dose of PCV7 shall be administered no earlier than one (1) month after the first dose and not later than two (2) months after the first dose.

137.4 The third dose of PCV7 shall be administered no earlier than one (1) month after the second dose and not later than two (2) months after the second dose.

137.5 A booster dose of PCV7 shall be administered not earlier than two (2) months after the previous dose, not earlier than twelve (12) months of age, and by sixteen (16) months of age.

137.6 An unvaccinated student between seven (7) and eleven (11) months of age shall receive two (2) doses of PCV7 to complete the primary series, administered no earlier than one (1) month apart but not later than two (2) months apart. A booster dose shall be administered no earlier than two (2) months after the previous dose at twelve (12) months of age and by sixteen (16) months of age.

137.7 An undervaccinated student between seven (7) and eleven (11) months of age who has received one (1) or two (2) doses of PVC7 before age seven (7) months, shall receive one (1) dose administered no earlier than one (1) month after the previous dose but not later than two (2) months after the previous dose. A booster dose shall be administered no earlier than two (2) months after the previous dose at twelve (12) months of age and sixteen (16) months of age.

137.8 An unvaccinated student between twelve (12) and twenty-three (23) months of age shall receive two (2) doses of PCV7 administered two (2) months apart.

137.9 An undervaccinated student between twelve (12) and twenty-three (23) months of age who has received one (1) dose of PCV7 before twelve (12) months of age shall receive two (2) doses administered two (2) months apart.

137.10 An undervaccinated student between twelve (12) and twenty-three (23) months of age who has received one (1) dose of PCV7 on or after age twelve (12) months shall receive one (1) dose of PCV7 administered two (2) months after the previous dose.

137.11 An undervaccinated student between twelve (12) and twenty-three (23) months of age, who has received two (2) or three (3) doses of PCV7 before age twelve (12) months, shall receive one (1) dose two (2) months after the previous dose.

137.12 An unvaccinated student twenty-four (24) months of age or older but not yet five (5) years of age shall receive a single dose of PCV7. A booster dose shall not be required.

137.13 An undervaccinated student twenty-four (24) months of age or older but not yet five (5) years of age who has an incomplete schedule shall receive one (1) dose of PCV7 two (2) months after the previous dose.

137.14 The PCV7 vaccine shall not be required for a student five (5) years of age or older regardless of PCV7 vaccination status.

History

SOURCE: Final Rulemaking published at 55 DCR 5253 (May 2, 2008).

22-B DCMR § 138 HEPATITIS A

138.1 Beginning with the 2009/2010 school year, two (2) doses of hepatitis A vaccine shall be administered to each student born on or after January 1, 2005.

138.2 The first dose of hepatitis A shall be administered no earlier than twelve (12) months of age and by twenty-four (24) months of age.

138.3 The second dose of hepatitis A shall be administered not earlier than six (6) months and not later than twelve (12) months after the first dose and by thirty-five (35) months of age.

138.4 An unvaccinated or undervaccinated student more than twenty-four (24) months of age and less than age seven (7) shall receive two (2) doses of hepatitis A vaccine administered not less than six (6) months apart and not later than twelve (12) months after the first dose.

History

SOURCE: Final Rulemaking published at 55 DCR 5253 (May 2, 2008).

22-B DCMR § 139 RESERVED

22-B DCMR § 140 REQUIRED IMMUNIZATIONS FOR STUDENTS BETWEEN SEVEN (7) YEARS OF AGE AND SEVENTEEN (17) YEARS OF AGE

140.1 A student seven (7) years of age or older and not yet eighteen (18) years of age shall receive immunizations before entry into a school, child care facility, or post high school program according to the requirements of §§ 141 through 145. Doses of immunizations shall be spaced according to these rules or the recommendations of the federal Advisory Committee on Immunization Practices (ACIP) published after the date of these rules.

History

SOURCE: Final Rulemaking published at 44 DCR 1656, 1662 (March 21, 1997); Final Rulemaking published at 55 DCR 5253 (May 2, 2008).

22-B DCMR § 141 TETANUS, DIPHTHERIA (TD); TETANUS, DIPHTHERIA, ACELLULAR PERTUSSIS (TDAP)

141.1 A student who has not received primary immunization for tetanus, diphtheria and pertussis by seven (7) years of age shall receive tetanus, diphtheria (Td)-containing vaccine as follows:

(a) Until the beginning of the 2008/2009 school year, each student shall receive a total of three (3) doses of Td-containing vaccine. The first and second doses shall be administered not less than four (4) weeks and not more than eight (8) weeks apart. The third dose shall be administered not less than six (6) months and not more than seven (7) months after the second dose. It is recommended that one dose be Tdap vaccine for students eleven (11) years of age or older.

(b) After the 2008/2009 school year, the student shall receive a total of three (3) doses of Td-containing vaccine. The first and second doses shall be administered not less than four (4) weeks and not more than eight (8) weeks apart. The third dose shall be administered not less than six (6) months and not more than seven (7) months after the second dose. Tdap shall be administered in place of one (1) dose Td-containing vaccine, preferably the first dose, for students eleven (11) years of age or older.

141.2 DTP, DT, or DTaP doses administered before age seven (7) may satisfy § 141.1, unless given before the appropriate age or at less than the required minimum interval between doses. If the last dose of DT-containing vaccine was given before four (4) years of age, one additional dose of Td or Tdap shall be administered.

141.3 Beginning with the 2008/2009 school year, if the last dose of the primary DT-containing immunization series or booster was administered before age seven (7), a Tdap booster dose shall be administered no sooner than five (5) years after the previous dose at eleven (11) years of age, but no later than the twelfth (12) birthday. If the last dose of the primary DT-containing immunization series or booster was administered on or after age seven (7), a Tdap booster dose shall be administered no earlier than five (5) years and not later than six (6) years after the last DT-containing immunization.

141.4 A Td or Tdap-containing booster shall be administered at ten (10) years after the primary series or the last booster and by eleven (11) years of age. Tdap shall be used for one (1) dose beginning with the 2008/2009 school year.

History

SOURCE: Final Rulemaking published at 44 DCR 1656, 1662 (March 21, 1997); Final Rulemaking published at 55 DCR 5253 (May 2, 2008).

22-B DCMR § 142 ORAL OR INACTIVATED POLIO (OPV OR IPV)

142.1 A student who has not received a primary immunization with an all IPV or all OPV series shall receive a total of three (3) vaccine doses. Each dose shall be administered not less than four (4) weeks apart.

142.2 OPV or IPV doses administered before the age of seven (7) may satisfy §142.1, unless given before the appropriate age or at less than the required minimum interval between doses.

142.3 If a combination of OPV and IPV doses are administered as part of a series, a total of four (4) doses are required, regardless of current age or age at administration of primary series. The fourth dose shall be administered no earlier than four (4) weeks and not later than eight (8) weeks after the third dose.

142.4 For each student eighteen (18) years of age or older, the polio immunization vaccine is recommended but not required.

History

SOURCE: Final Rulemaking published at 44 DCR 1656, 1662 (March 21, 1997); Final Rulemaking published at 55 DCR 5253 (May 2, 2008).

22-B DCMR § 143 MEASLES, MUMPS, RUBELLA (MMR)

143.1 For a student who has not received a primary immunization, two (2) doses shall be administered. The second dose shall be administered not earlier than twenty-eight (28) days and not later than eight (8) weeks after the first dose.

143.2 MMR doses administered before the age of seven (7) may satisfy § 143.1, unless given before twelve (12) months of age or at an interval of less than twenty-eight (28) days between doses.

143.3 If single antigen measles, mumps, and rubella vaccines were administered, two (2) doses of each vaccine shall be administered not less than twenty-eight (28) days apart. A dose of any one (1) of the single antigen vaccines and a dose of another of the single antigen vaccines shall not be administered less than twenty-eight (28) days apart, unless administered on the same day. A dose of MMR, Varicella, one of the single-antigen measles, mumps, and rubella vaccines, or any other live parenteral vaccine shall not be administered less than twenty-eight (28) days apart, unless administered on the same day.

History

SOURCE: Final Rulemaking published at 44 DCR 1656, 1663 (March 21, 1997); Final Rulemaking published at 55 DCR 5253 (May 2, 2008).

22-B DCMR § 144 HEPATITIS B

144.1 A student who has not received a primary immunization shall receive a total of three (3) doses. The second dose shall be administered not earlier than four (4) weeks and not later than eight (8) weeks after the first dose. The third dose shall be administered no earlier than eight (8) weeks after the second dose and no earlier than sixteen (16) weeks after the first dose.

144.2 Hepatitis B doses administered before the age of seven (7) may satisfy § 144.1, unless administered at less than the required age or minimum interval between each dose.

144.3 As an alternative to the requirements of §§ 144.1 and 144.2, an unvaccinated student between eleven (11) and fifteen (15) years of age may receive a two (2) 1mL-dose schedule of ten (10) micrograms per milliliter (mcg/mL) of Recombivax HB given between four (4) and six (6) months apart. This alternative shall apply only for students vaccinated between eleven (11) and fifteen (15) years of age. The first dose shall be administered between eleven (11) and fifteen (15) years of age, and the second dose shall be administered before age sixteen (16). The student's parent or legal guardian shall provide written certification of proper administration of the two (2)-dose schedule to the student's school. The certification shall include correct formulation for both doses administered according to the correct schedule.

History

SOURCE: Final Rulemaking published at 44 DCR 1656, 1664 (March 21, 1997); Final Rulemaking published at 55 DCR 5253 (May 2, 2008).

22-B DCMR § 145 VARICELLA (CHICKENPOX)

145.1 A student under thirteen (13) years of age who has not received primary immunization shall receive one (1) dose of varicella vaccine. Beginning with the 2008/2009 school year, a student under thirteen (13) years of age shall receive a second dose of varicella administered at three (3) months and by four (4) months after the previous dose. If the second dose was given twenty-eight (28) days or more after the first dose, then the second dose does not need to be repeated. Varicella shall not be administered within twenty-eight (28) days of receiving a dose of MMR, one of the single-antigen measles, mumps, or rubella vaccines, or any other live parenteral vaccine, unless administered on the same day.

145.2 A student thirteen (13) years of age or older who has not previously received a varicella vaccine shall receive two (2) doses administered not less than twenty-eight (28) days and not more than two (2) months apart. Varicella shall not be administered within twenty-eight (28) days of receiving a dose of MMR or one of the single-antigen measles, mumps, or rubella vaccines, unless administered on the same day.

145.3 Beginning with the 2008/2009 school year, a student thirteen (13) years of age or older who has previously received one (1) dose of varicella vaccination shall receive a second dose not less than twenty-eight (28) days and not more than two (2) months after the previous dose. Varicella shall not be administered within twenty-eight (28) days of receiving a dose of MMR or one of the single-antigen measles, mumps, or rubella vaccines, unless administered on the same day.

145.4 Varicella doses administered before the age of seven (7) may satisfy the requirements of §§ 145.1, 145.2, or 145.3, unless given before twelve (12) months of age or at an interval of less than twenty-eight (28) days between doses.

145.5 The varicella vaccination shall not be required for a student who has written certification of infection with varicella that includes either:

(a) Copy of laboratory report as evidence of varicella disease or immunity to varicella; or

(b) A health care provider's diagnosis or verified history of varicella or herpes zoster disease that includes the month and year of the disease.

History

SOURCE: Final Rulemaking published at 44 DCR 1656, 1665 (March 21, 1997); Final Rulemaking published at 55 DCR 5253 (May 2, 2008).

22-B DCMR § 146 HUMAN PAPILLOMAVIRUS (HPV)

146.1 Beginning with the 2014/2015 school year, a student enrolling in grade six (6) shall receive the first dose of HPV vaccine at age eleven (11). Students enrolling in grades seven (7) through twelve (12) who have not previously been immunized for HPV shall receive the vaccine before enrollment or provide an opt-out form, as provided in § 146.4.

146.2 The second dose of HPV vaccine shall be administered not less than four (4) weeks after the first dose and by two (2) months after the first dose.

146.3 A third dose of HPV vaccine shall be administered not less than twelve (12) weeks after the second dose and by six (6) months after the first dose.

146.4 The parent or legal guardian of a student required to receive a vaccine under this section may opt out of the vaccination for any reason by signing a form provided by the Department that states that the parent or legal guardian has been informed of the HPV vaccination requirement and has elected not to participate. A student eighteen (18) years of age or older may opt out on his or her own behalf by signing a form provided by the Department that states that the student has been informed of the HPV vaccination requirement and has elected not to participate.

History

SOURCE: Final Rulemaking published at 55 DCR 5253 (May 2, 2008); as amended by Final Rulemaking published at 61 DCR 12782 (December 19, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 146

22-B DCMR § 147 MENINGOCOCCAL

147.1 Beginning with the 2009/2010 school year, one dose of quadrivalent meningococcal vaccine shall be administered at eleven (11) years of age and by twelve (12) years of age.

147.2 Previous doses of quadrivalent meningococcal vaccine may satisfy § 147.1 unless given before the appropriate age.

History

SOURCE: Final Rulemaking published at 55 DCR 5253 (May 2, 2008).

22-B DCMR § 148 REQUIRED IMMUNIZATIONS FOR STUDENTS EIGHTEEN (18) YEARS OF AGE AND OLDER

148.1 The required immunizations for each student eighteen (18) years of age and older, and prior to entry into a school or post high school program shall be as set forth in sections 148 through 152. Doses of immunizations shall be spaced according to these regulations or the recommendations of the federal Advisory Committee on Immunization Practices (ACIP) published after the effective date of these regulations.

History

SOURCE: Final Rulemaking published at 44 DCR 1656, 1666 (March 21, 1997); Final Rulemaking published at 55 DCR 5253 (May 2, 2008).

22-B DCMR § 149 TETANUS, DIPHTHERIA (TD), ACELLULAR PERTUSSIS (TDAP)

149.1 A student who has not received primary immunization shall receive three (3) doses of diphtheria-tetanus-containing vaccine. Beginning with the 2008/2009 school year, Tdap shall be used for one of the three (3) diphtheria-tetanus-containing vaccines in the series, preferably, the first dose. The first and second doses shall be administered not less than four (4) weeks apart. The third dose shall be administered not less than six (6) months after the second dose.

149.2 DTP, DT, DTaP, Td or Tdap doses administered before the age of eighteen (18) may satisfy § 148.1, unless administered before the appropriate age or at less than the required minimum interval between doses. If the last dose of diphtheria-tetanus-containing vaccine was given before four (4) years of age, an additional dose of Td/Tdap shall be administered not less than six (6) months after the previous dose. Beginning with the 2008/2009 school year, Tdap shall be used for one (1) dose.

149.3 A Td/Tdap diphtheria-tetanus-containing booster dose shall be administered at ten (10) years after the primary series or the last booster and by eleven (11) years of age. Beginning with the 2008/2009 school year, Tdap shall be used for one dose.

History

SOURCE: Final Rulemaking published at 44 DCR 1656, 1666 (March 21, 1997); Final Rulemaking published at 55 DCR 5253 (May 2, 2008).

22-B DCMR § 150 MEASLES, MUMPS, RUBELLA (MMR)

150.1 A student born in 1957 or later who has not received primary immunization shall receive two (2) doses of MMR. The second dose shall be administered not sooner than twenty-eight (28) days and not later than two (2) months after the first dose.

150.2 MMR administered before the age of eighteen (18) may satisfy § 150.1, unless given before twelve (12) months of age or at less than twenty-eight (28) days between each dose.

150.3 If single antigen measles, mumps, and rubella vaccines are used, two (2) doses of each vaccine shall be administered not less than twenty-eight (28) days apart. A dose of any one (1) of the single antigen vaccines and a dose of another of the single antigen vaccines shall not be administered less than twenty-eight (28) days apart, unless administered on the same day. MMR shall not be administered within twenty-eight (28) days after a dose of varicella or one of the single-antigen measles, mumps, or rubella vaccines, unless administered on the same day.

History

SOURCE: Final Rulemaking published at 44 DCR 1656, 1667 (March 21, 1997); Final Rulemaking published at 55 DCR 5253 (May 2, 2008).

22-B DCMR § 151 HEPATITIS B

151.1 A student who has not received a primary immunization shall receive a total of three (3) doses of hepatitis B vaccine. The second dose shall be administered not earlier than four (4) weeks after the first dose and not later than eight (8) weeks after the first dose. The third dose shall be administered not earlier than eight (8) weeks and not later than sixteen (16) weeks after the second dose and not earlier than sixteen (16) weeks after the first dose.

151.2 Prior doses of Hepatitis B, including administration of a two (2) dose schedule of Recombivax HB pursuant to § 144.3, may satisfy §151.1, unless administered at less than the required minimum interval between doses.

History

SOURCE: Final Rulemaking published at 44 DCR 1656, 1667 (March 21, 1997); Final Rulemaking published at 55 DCR 5253 (May 2, 2008).

22-B DCMR § 152 VARICELLA (CHICKENPOX)

152.1 A student thirteen (13) years of age or older who has not previously received a varicella vaccine shall receive two (2) doses administered not less than twenty-eight (28) days and not more than two (2) months apart. Varicella shall not be administered within twenty-eight (28) days of receiving a dose of MMR or one of the single-antigen measles, mumps, or rubella vaccines, unless administered on the same day.

152.2 Beginning with the 2008/2009 school year, a student eighteen (18) years of age or older who has previously received one (1) dose of varicella vaccination shall receive a second dose not earlier than twenty-eight (28) days and not later than two (2) months after the previous dose. Varicella shall not be administered within twenty-eight (28) days of receiving a dose of MMR or one of the single-antigen measles, mumps, or rubella vaccines, unless administered on the same day.

152.3 Varicella doses administered before the age of eighteen (18) may satisfy the requirements of §§ 152.1 or 152.2, unless given before twelve (12) months of age or at an interval of less than twenty-eight (28) days between doses.

152.4 The varicella vaccination shall not be required for a student who has written certification of infection with varicella that includes either:

(a) A copy of a laboratory report as evidence of varicella disease or immunity to varicella; or

(b) A health care provider's diagnosis or verified history of varicella or herpes zoster disease that includes the month and year of the disease.

History

SOURCE: Final Rulemaking published at 44 DCR 1656, 1668 (March 21, 1997); Final Rulemaking published at 55 DCR 5253 (May 2, 2008).

22-B DCMR § 153 MENINGOCOCCAL

153.1 Except as provided in § 153.3, beginning with the 2008/2009 school year, each first-year student enrolled in a school of post-secondary education in the District of Columbia and living, or who may live, in on-campus student housing shall receive one (1) dose of meningococcal vaccine.

153.2 A school of post-secondary education in the District of Columbia shall:

(a) Notify a student eighteen (18) years of age or older or the parent or legal guardian of a student less than eighteen (18) years old, in writing, of the requirement for meningococcal vaccination. Notice shall be given at the time the school accepts a student for admission or when a student registers for classes, if students are not required to apply for admission before registering for courses.

(b) Include written notice of the requirement for meningococcal vaccination in:

(1) Admission acceptance information;

(2) Student health-related information and materials;

(3) Resident life information and materials;

(4) The student handbook; and

(5) The college catalog.

(c) Provide information about the risks of contracting meningococcal disease and about the availability and effectiveness of meningococcal vaccine to:

(1) A student eighteen (18) years of age or older who resides in, or may reside in, on-campus student housing; or

(2) The parent or legal guardian of a student less than eighteen (18) years of age who resides in, or may reside in, on campus housing.

(d) Keep on file in the student's records any waiver form a student submits, or parent or guardian submits on behalf of a student, requesting waiver of the requirements of § 153.1.

153.3 A student eighteen (18) years of age or older, or the parent or legal guardian of a student less than eighteen (18) years of age, may obtain a waiver from the requirements in § 153.1 if the individual submits a form with information stated in § 153.4 to the school of post-secondary education.

153.4 A form requesting waiver of the requirements of § 153.1 shall include the following information:

(a) A statement that the applicant is:

(1) Eighteen (18) years of age or older and applying on his or her own behalf; or

(2) The parent or legal guardian of a student who is less than eighteen (18) years of age;

(b) A statement that the applicant has received and reviewed the information provided by the school of post-secondary education on the risk of contracting meningococcal disease and the availability and effectiveness of meningococcal vaccine;

(c) A statement that the applicant refuses meningococcal vaccine on his or her own behalf, if the applicant is eighteen years of age or older, or on behalf of a student who is less than eighteen (18) years of age;

(d) Spaces on the form for the following:

(1) The applicant's printed name;

(2) The printed name of the student, if the student is different from the applicant

(3) The applicant's Signature; and

History

SOURCE: Final Rulemaking published at 55 DCR 5253 (May 2, 2008).

22-B DCMR § 154 ALTERNATIVE EVIDENCE OF IMMUNITY

154.1 Laboratory evidence of immunity for each vaccine-preventable disease may be accepted in lieu of the required immunizations for each disease described in sections 130 through 153 and may be required in particular circumstances.

History

SOURCE: Final Rulemaking published at 44 DCR 1656, 1669 (March 21, 1997); Final Rulemaking published at 55 DCR 5253 (May 2, 2008).

22-B DCMR § 199 DEFINITIONS

Advisory Committee on Immunization Practices (ACIP) - the advisory body that makes recommendations on the use of vaccines in the United States including age appropriate immunizations and the proper interval between vaccinations.

Combination vaccine - a vaccine that merges into a single product the antigens that prevent different diseases or that protect against multiple strains of infections agents causing the same disease.

Day - a calendar day, unless otherwise indicated.

Department - the District of Columbia Department of Health.

Diphtheria tetanus acellular pertussis (DTaP) - an inactivated vaccine that provides protection from contracting diphtheria, tetanus, and pertussis, containing acellular pertussis in a single dose that is intended for use only in children under seven (7) years of age.

Diphtheria tetanus whole-cell pertussis (DTP) - an inactivated vaccine that provides protection from contracting diphtheria, tetanus, and pertussis, containing whole-cell pertussis in a single dose and was intended for use only in children under seven (7) years of age. This vaccine is no longer routinely administered in the United States.

District of Columbia Immunization Information System (DOCIIS) - the system for reporting the administration of a vaccine to the District of Columbia Department of Health.

Health Care Provider - a person licensed in the District of Columbia to give health care including a Registered Nurse, Medical Doctor, Nurse Practitioner, Pharmacist, or Physician Assistant.

Hib - an inactivated vaccine to immunize against hemophilus influenza type B.

Human papilloma virus (HPV) - an inactivated vaccine that provides protection from contracting certain forms of the human papilloma virus.

Immunity – the ability of a person to resist being infected by a disease or toxin by the action of specific antibodies or sensitized white blood cells.

Immunization – the process by which a person becomes protected against a disease through vaccination. This term is often used interchangeably with vaccination or inoculation.

Inactivated polio vaccine (IPV) - an inactivated vaccine that provides protection from contracting polio that is administered by syringe.

Live oral polio vaccine (OPV) - an attenuated, live-virus vaccine containing that is administered orally and provides protection from contracting polio, but may also cause polio in rare cases. This vaccine is no longer routinely administered in the United States.

Measles mumps rubella (MMR) - an attenuated, live-virus vaccine containing a combination of measles, mumps, and rubella viruses.

Meningococcal vaccine - an inactivated serigroup-specific quadrivalent meningococcal vaccine against serigroups A, C, Y, and W-135.

Month - a period of thirty (30) consecutive days.

On-campus student housing - housing provided to students, regardless of the fee, that is owned, rented, or contracted for and operated by a school of post-secondary education, or through written agreement, with an agent of the school of post-secondary education.

PCV-7 - an inactivated heptavalent pneumococcal conjugate vaccine composed of purified polysaccharides of seven (7) serotypes (C4, 6B, 9V, 14, 18C, 19F, and 23 F).

Primary immunization - the initial series of immunizations a child receives at age appropriate intervals excluding booster doses.

School year - the period established by the District of Columbia Schools, Public Charter Schools, or a private or parochial school as the beginning and end dates of a regular school program, typically spanning parts of two calendar years.

Student - a child enrolled in a public, private, parochial, or charter school in the District of Columbia or a child enrolled in a child development center in the District of Columbia.

Tetanus diphtheria-containing (Td-containing) - an inactivated vaccine that contains at least tetanus and diphtheria toxoids and provides protection from contracting diphtheria and tetanus in a single dose that is intended for children over seven (7) years of age.

Tetanus diphtheria acellular pertussis (Tdap) - a vaccine that provides protection from contracting tetanus, diphtheria, and pertussis, containing acellular pertussis in a single dose that is intended for children over seven (7) years of age.

Undervaccinated - the circumstance of having received an incomplete immunization series.

Unvaccinated - the circumstance of having received no immunizations in an antigen series.

Vaccination - the act of introducing a vaccine into the body to produce immunity to a specific disease.

Vaccine - a product that stimulates a person’s immune system to produce immunity to a specific disease that are administered through needle injections, by mouth, or by spray into the nose.

History

SOURCE: Final Rulemaking published at 55 DCR 5253 (May 2, 2008); as amended by Final Rulemaking published at 68 DCR 012467 (November 26, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 199

22-B2 COMMUNICABLE AND REPORTABLE DISEASES

22-B DCMR § 200 GENERAL PROVISIONS

200.1 The purpose of this chapter is to prevent and control the spread of communicable diseases.

200.2 This chapter shall be applicable to all cases or suspected cases, contacts, or carriers of the communicable diseases denominated in this chapter insofar as reporting, restriction of movement, isolation, or quarantine are concerned.

200.3 This chapter may be supplemented by other regulations applicable to special situations involving the employment of persons in certain institutions, industries, and establishments, or the management of certain patients in institutions or establishments.

200.4 Civil fines, penalties, and fees may be imposed as alternative sanctions for any infraction of the provisions of this chapter pursuant to titles I-III of the Department of Consumer and Regulatory Affairs Civil Infractions Act of 1985. Adjudication of any infraction of this chapter shall be pursuant to titles I-III of the Department of Consumer and Regulatory Affairs Civil Infractions Act of 1985.

200.5 [REPEALED].

History

SOURCE: Commissioners’ Order 61-1117 (June 20, 1961), published as Health Regulations at §§ 8-5:101-205; as amended by § 488 of the Department of Consumer of Regulatory Affairs Civil Infractions Act of 1985, effective October 5, 1985 (D.C. Law 6-42; 32 DCR 4450, 4482 (August 2, 1985)); as amended by § 7 of the Preventive Health Services Amendments Act of 1985, effective February 21, 1986 (D.C. Law 6-83; 32 DCR 7276, 7285 (December 13, 1985)); as amended by Final Rulemaking published at 63 DCR 15116 (December 9, 2016). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 200

22-B DCMR § 201 COMMUNICABLE DISEASE SURVEILLANCE

201.1 The following diseases shall be considered communicable diseases for the purpose of communicable disease surveillance and shall be reported by telephone to the Director immediately upon provisional diagnosis or the appearance of suspicious symptoms, and confirmed in writing within twenty-four (24) hours:

(a) Animal bites;

(b) Anthrax (Bacillus anthracis);

(d) Cholera (Toxigenic Vibrio cholerae 01 or 0139);

(e) Diphtheria;

(f) Encephalitis, acute arboviral (e.g. Eastern Equine Encephalitis, St. Louis Encephalitis, Western Equine Encephalitis)

(g) Hantavirus pulmonary syndrome (HPS);

(h) Hemolytic uremic syndrome;

(i) Hepatitis A;

(j) Influenza-associated mortality (patients less than eighteen (18) years of age);

(k) Influenza A, novel;

(l) Listeriosis;

(m) Measles (Rubeola);

(n) Meningitis (Neisseria meningitidis);

(o) Meningococcal disease, invasive:

(p) Middle East Respiratory Syndrome (MERS);

(q) Mumps:

(r) Pertussis (Whooping cough);

(s) Plague (Yersinia pestis);

(t) Poliovirus infection;

(u) Rabies (animal or human);

(v) Rubella (German measles), including congenital rubella syndrome;

(w) Severe Acute Respiratory Syndrome (SARS);

(x) Shiga toxin-producing Escherichia coli (STEC);

(y) Smallpox;

(z) Staphylococcal infections in newborns (nosocomial);

(aa) Tularemia;

(bb) Typhoid fever (Salmonella typhi);

(cc) Vibriosis (non-cholera Vibrio species infections);

(dd) Viral hemorrhagic fevers (Ebola or other);

(ee) Yellow fever;

(ff) An outbreak that may be of public health concern (including health care associated and foodborne, as defined in § 299.1); and

(gg) An emerging infectious disease or an unusual occurrence of any disease.

201.2 The following diseases shall be considered communicable diseases for the purpose of communicable disease surveillance and shall be reported to the Director in writing within twenty-four (24) hours after provisional diagnosis or the appearance of suspicious symptoms:

(a) Brucellosis;

(b) Campylobacteriosis;

(d) Dengue;

(e) Haemophilus influenza, invasive disease:

(f) Hansen's disease (Leprosy);

(g) Lymphogranuloma venerium (LGV, including atypical LGV);

(h) Meningitis, (aseptic or viral, fungal, and bacterial (other than N. meningitidis));

(i) Psittacosis (Ornithosis);

(j) Q Fever:

(k) School or childcare facility-associated diseases: the following are reportable when there are three (3) or more cases that occur within a seven (7) day period in the school or childcare facility:

(1) Conjunctivitis (Pink Eye);

(2) Gastrointestinal illness;

(3) Hand, foot, and mouth disease;

(4) Head lice;

(5) Impetigo;

(6) Pinworm (Enterobiasis);

(7) Ringworm (Tinea);

(8) Scabies; or

(9) Streptococcal non-invasive, Group A (Scarlet fever and strep throat);

(l) Streptococcal infection, invasive (Pneumococcal disease);

(m) Tetanus; and

(n) Zika virus disease (including congenital Zika virus infection).

201.3 The following diseases shall be considered communicable diseases for the purpose of communicable disease surveillance and shall be reported to the Director in writing within forty-eight (48) hours after diagnosis or the appearance of suspicious symptoms:

(a) Babesiosis;

(b) Chancroid;

(d) Chlamydia tracomatis infection (including PID, perinatal, and trachoma);

(e) Coccidioidomycosis;

(f) Cryptosporidiosis;

(g) Cyclosporiasis;

(h) Ehrlichiosis;

(i) Giardiasis;

(j) Gonococcal infection;

(k) Granuloma inguinale;

(l) Hepatitis (acute B, C);

(m) Human immunodeficiency virus (HIV) infection, and pregnancies in HIV- infected women);

(n) Kawasaki disease;

(o) Legionellosis;

(p) Leptospirosis;

(q) Lyme Disease (Borrelia Burgdorferi);

(r) Malaria;

(s) Meliodosis;

(t) Powassan virus;

(u) Rickettsiosis, spotted fever (e.g. Rocky Mountain Spotted Fever);

(v) Salmonellosis;

(w) Shigellosis;

(x) Syphilis (all stages congenital);

(y) Toxic shock syndrome (Staphylococcal, Streptococcal, and other);

(z) Trichinosis (Trichinellosis);

(aa) Tuberculosis;

(bb) Urethritis, atypical;

(cc) Vaccine adverse events; and

(dd) West Nile virus.

201.4 Coronavirus disease (COVID-19) shall be considered a communicable disease for the purpose of communicable disease surveillance and shall be reported electronically to the Department of Health immediately upon a laboratory-confirmed diagnosis using a laboratory antigen test, a nucleic acid amplification test, or a polymerase chain reaction laboratory test.

History

SOURCE: Commissioners’ Order 61-1117 (June 20, 1961), published as Health Regulations at §§ 8-5:101-205; as amended by Commissioners’ Order 65-868 (June 22, 1965); as amended by Final Rulemaking published at 47 DCR 10209 (December 29, 2000); as amended by Final Rulemaking published at 48 DCR 472 (January 19, 2001); as amended by Final Rulemaking published at 50 DCR 6169 (August 1, 2003); as amended by Final Rulemaking published at 55 DCR 5979 (May 23, 2008); as amended by Final Rulemaking published at 56 DCR 848 (January 23, 2009); as amended by Final Rulemaking published at 63 DCR 15116 (December 9, 2016); as amended by Final Rulemaking published at 68 DCR 011091 (October 22, 2021); as amended by Final Rulemaking published at 71 DCR 005422 (May 10, 2024). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 201

22-B DCMR § 202 REPORTING OCCURRENCES

202.1 The physician, veterinarian, or other person in charge of a communicable disease case shall report the case to the Director within the period of time required and in the manner prescribed in § 201.

202.2 In the report required in § 202.1, the physician, veterinarian, or other person in charge of the case shall include a statement of the person's instructions concerning isolation, restriction of movement, and quarantine in detail. The statement may be limited to stating that the instructions were in accordance with the provisions of this chapter and with the latest edition of "Control of Communicable Diseases Manual", published by the American Public Health Association.

202.3 A physician, veterinarian, or other person having information of a carrier or contact shall report that information to the Director.

202.4 Each infected adult person, and each parent, guardian, or person in charge of an infected person or animal shall be advised by the physician, veterinarian, or other person in charge, of the applicable requirements for isolation, restriction of movement, and quarantine.

202.5 The physician or other person in charge of a communicable disease case involving a human being shall advise each infected adult person and parent, guardian, or other individual having responsibility for isolation and quarantine.

202.6 The veterinarian or other person in charge of a communicable disease case involving an infected animal shall advise the individual having responsibility for the care of the animal of the applicable requirements for isolation and quarantine.

202.7 The control and management of any carrier, contact, or infected person or animal shall be in accordance with good medical and public health practice.

202.8 Meeting the requirements of this section and observance of the provisions of the latest edition of "Control of Communicable Diseases Manual", published by the American Public Health Association, shall be prima facie evidence that the control and management of any carrier, contact, or infected person or animal has been in accordance with good medical and public health practice.

202.9 When reporting to the Department, the report shall be filed on a form approved by the Director, and the following information shall be furnished as completely as possible:

(a) Information regarding the person submitting the report, including first and last name, phone number, facility name, facility address, name of the provider who saw the patient, and the date the report was sent;

(b) Patient information, including first and last name, date of birth, gender, home address, race or ethnicity, telephone number, and school or place of occupation;

(c) Disease, condition, or symptom information, including the name of the suspected or confirmed disease, date of symptom onset, date of diagnosis, and supporting laboratory documentation; and

(d) Other epidemiologic information the Director may request.

202.10 Any physician treating or caring for a person with a communicable disease shall report immediately the name, address, and other relevant information to the Director under the following circumstances:

(a) When the person is delinquent in treatment;

(b) When the person violates isolation or quarantine; or

202.11 [REPEALED].

202.12 Any change in the location of a case shall be reported to the Director by phone or in writing within twenty-four (24) hours of the change.

202.13 In addition to the reporting required by subsections 202.1 through 202.12, the Public Health Laboratory shall report within twenty-four (24) hours after completion of each test result each positive or negative SARS-CoV-2 test result to the District of Columbia Health Information Exchange established by Chapter 87 of Title 29 of the District of Columbia Municipal Regulations.

202.14 In addition to the reporting required by subsections 202.1 through 202.12, each clinical laboratory operating in the District of Columbia, a clinical laboratory providing services to a health care facility located in the District of Columbia, or a clinical laboratory providing services to a health care provider located in the District of Columbia shall report each positive or negative SARS-CoV-2 test result to the District of Columbia Health Information Exchange established by Chapter 87 of Title 29 of the District of Columbia Municipal Regulations.

History

SOURCE: Commissioners’ Order 61-1117 (June 20, 1961), published as Health Regulations at §§ 8-5:101-205; as amended by Final Rulemaking published at 55 DCR 5979 (May 23, 2008); as amended by Final Rulemaking published at 63 DCR 15116 (December 9, 2016); as amended by Final Rulemaking published at 68 DCR 011091 (October 22, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 202

22-B DCMR § 203 RABIES AND ANIMAL BITES

203.1 A veterinarian or other person who has reason to suspect any of the following shall report that fact immediately by telephone to the Director, and shall immediately follow the telephone report with a written report to the Director:

(a) A dog or other animal is suffering with rabies;

(b) A dog or other animal has been bitten by or exposed to a dog or other animal suffering with rabies; or

203.2 A report of an event described in § 203.1 made to a member of the Metropolitan Police Department, the D.C. Department of Health Animal Services Animal Care and Control Field Services Division, or a privately owned veterinary hospital or clinic, shall be communicated immediately by telephone to the Director and shall immediately be followed with a written report to the Director.

203.3 The report required by § 203.1 shall contain the following information in addition to any information required by § 202.9:

(a) The name, contact information, and the place of residence of the person owning or harboring the dog or other animal;

(b) The place where the dog or other animal can be found; and

203.4 When the Director has reason to believe that a dog or other animal is rabid, or has been bitten by a suspected rabid animal, or has bitten a person or exposed a person to rabies, the Director shall notify the owner or possessor of the exposed dog or other animal.

203.5 After receiving notification from the Director as required by § 203.4, the owner or possessor of the animal that was bitten by another animal shall quarantine it on his or her premises, or, if the Director deems necessary, at a place the Director designates at the expense of the owner or possessor. The length of quarantine for the animal that was bitten (“bitten animal”) shall be determined based on information available about the animal that initiated the bite (“biting animal”), according to the following criteria:

(a) The location of the biting animal is known and the biting animal is not displaying signs of rabies:

(1) If the biting animal is proven to be up-to-date in its rabies vaccination, then neither the biting animal nor the bitten animal need to be quarantined; or

(2) If the biting animal is not proven to be up-to-date in its rabies vaccination, it shall be quarantined for ten (10) days. The quarantine period for the bitten animal shall be forty-five (45) days when the bitten animal is proven to have received at least one (1) rabies vaccination, or shall be at least four (4) months when the bitten animal has no proof of rabies vaccination but is vaccinated within ninety-six (96) hours of the potential exposure. The quarantine period for the bitten animal may be discontinued at the discretion of the Director if the biting animal does not display signs of rabies virus disease after completing the ten (10) day quarantine period;

(b) The location of the biting animal is known and the biting animal is displaying signs of rabies:

(1) The quarantine period for the bitten animal shall be forty-five (45) days when the bitten animal is proven to be up-to-date in its rabies vaccination, provided it is also vaccinated within ninety-six (96) hours after the exposure. The quarantine period for the bitten animal may be discontinued if the biting animal is proven to not have rabies through a diagnostic laboratory test; or

(2) The quarantine period for the bitten animal shall be four (4) months when the bitten animal has no proof of rabies vaccination, provided the animal is vaccinated within 96 hours of the exposure. If the bitten animal is vaccinated more than 96 hours after exposure, the quarantine shall be extended to six (6) months. The quarantine period for the bitten animal may be discontinued if the biting animal is proven to not have rabies virus disease through a diagnostic laboratory test;

(1) The quarantine period for the bitten animal shall be forty-five (45) days when the bitten animal is proven to have received at least one (1) rabies vaccination, provided that the animal is vaccinated for rabies on the first day of the quarantine period; or

(2) The quarantine period for the bitten animal shall be at least four (4) and no more than six (6) months (depending on the nature of the potential exposure as determined by the referring veterinarian and the Department of Health) when the bitten animal has no proof of rabies vaccination, provided that the animal is vaccinated for rabies during the final month of the quarantine period.

203.6 A person who has been bitten by a dog or other domestic animal shall initiate rabies post-exposure prophylaxis based on the vaccination history and disease state of the biting animal and the recommendation of the Director. After receiving notification from the Director under § 203.4, the owner or possessor of the biting animal shall quarantine the animal for ten (10) days, regardless of the rabies vaccination status, on his or her premises, or, if the Director deems necessary, at a place the Director designates at the owner or possessor’s expense. During this period, the biting animal shall not be vaccinated for rabies.

203.7 A health care provider with a patient who presents for a bite or exposure to a potentially rabid animal shall immediately initiate rabies post-exposure prophylaxis. The provider may discontinue treatment only when a rabies test on the biting animal is negative, or the animal is proven adequately vaccinated.

203.8 A person who captures wildlife that has bitten a person or animal, or caused a potential rabies exposure to a person or animal, shall bring the captured animal to the Animal Care and Control Agency for immediate euthanasia. The Animal Care and Control Agency shall submit tissue samples of the animal to the Department of Forensic Sciences for rabies testing.

203.9 A person holding an animal for quarantine under this section shall make the animal available for observation and examination by a licensed veterinarian or an official appointed by the Director, to determine the presence of symptoms of rabies on the first and last days of a quarantine period, at the person’s expense. An animal under quarantine that exhibits clinical signs of rabies during the quarantine period shall be transported to the Animal Care and Control Agency for humane euthanasia. The Animal Care and Control Agency shall submit tissue samples of the animal to the Department of Forensic Sciences for rabies testing.

203.10 A person holding a quarantined animal shall not release, remove from the District, or otherwise dispose of the animal during the quarantine period. If the animal dies during the quarantine period, the person holding the animal shall notify and make the entire animal available to the Animal Care and Control Agency for examination, testing, and ultimate disposal.

History

SOURCE: Commissioners’ Order 61-1117 (June 20, 1961), published as Health Regulations at §§ 8-5:101-205; as amended by Final Rulemaking published at 63 DCR 15116 (December 9, 2016). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 203

22-B DCMR § 204 RINGWORM OF THE SCALP

204.1 Whenever a school child has, or is suspected of having, ringworm of the scalp, the child shall be excluded from school and shall not return to school until a certificate has been obtained at the Ringworm Clinic of the Department of Human Services, from any other clinic under the direction of a licensed physician, or from a licensed physician.

204.2 The certificate required in §204.1 shall indicate that the diagnosis has been made on the basis of an examination under the Wood's Lamp, by a culture, or by some other method approved by the Director.

204.3 A certificate may be issued during treatment according to the terms of the certificate, and may be withdrawn immediately when evidence exists of a noncompliance with its terms.

204.4 Any school child who is a contact in the household of a school child having or suspected of having ringworm of the scalp shall be examined and, if necessary, be placed under treatment by the private physician, a hospital clinic, or the Department.

History

SOURCE: Regulation No. 70-4 (February 27, 1970), 8 DCRR § 8-5:1-7(c) (1965).

22-B DCMR § 205 TESTS FOR SYPHILIS AND GONORRHEA REQUIRED DURING PREGNANCY

205.1 Unless the person in charge of a case of pregnancy includes in the patient's case history a written statement giving the medical reasons why a serological test for syphilis and a laboratory test for gonorrhea performed at the times specified in this section would be harmful to the patient, that person shall include both of these tests in the management of the case at the first visit of that patient's pregnancy is established as a certainty.

205.2 When it is determined that tests for syphilis and gonorrhea have been performed within thirty (30) days before the visit at which pregnancy is established, the serological test need not be performed at that time.

205.3 Any person in charge of a case of pregnancy during the last trimester shall include in the management of the case a serological test for syphilis and a laboratory test for gonorrhea, notwithstanding the fact that either or both tests have already been performed during the pregnancy.

205.4 Any person required by the provisions of this section to make a written report of a case of venereal disease shall submit the report to the Director in a sealed envelope, marked "Confidential."

205.5 The name of the person reported as having a case of venereal disease may be referred to by number.

205.6 Whenever the person reporting a case of venereal disease elects to report by number instead of by name, a record shall be kept of the case in the files of the person reporting under the same number for a period of not less than three (3) years from the date of diagnosis.

205.7 The record required in § 205.6 shall be made available to the Director upon request.

205.8 The reports and records incident to a case of venereal disease shall be used for statistical and public health purposes only, and the Director shall not disclose the identity of the person so reported except under order of a court or with the written permission of the person.

History

SOURCE: Commissioners’ Order 61-1117 (June 20, 1961), published as Health Regulations at §§ 8-5:101-205; as amended by Commissioners’ Order 64-1285A (September 3, 1964); as amended by § 6 of the Preventive Health Services Amendments Act of 1985, effective February 21, 1986 (D.C. Law 6-83; 32 DCR 7276, 7283 (December 13, 1984)); as amended by Final Rulemaking published at 47 DCR 10209 (December 29, 2000); as corrected by Final Rulemaking published at 48 DCR 472 (January 19, 2001). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 205

22-B DCMR § 206 HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION

206.1 All Human Immunodeficiency Virus (HIV) infection cases and pregnancies in HIV-infected women (including Acquired Immune Deficiency Syndrome (AIDS)) shall be reported to the Director of the Department of Health or his or her designee.

206.2 Physicians and others licensed to practice in the District under the District of Columbia Health Occupations Revision Act of 1985 (D.C. Official Code §§ 3-1201.01 et seq.), in charge of an AIDS diagnosis, shall report the AIDS diagnosis to the Director within forty-eight (48) hours of diagnosis and furnish information the Director deems necessary to complete a confidential case report. Additionally, physicians and others licensed under the District of Columbia Health Occupations Revision Act of 1985 shall report a HIV positive test result to the Director or his or her designee. The physician or provider, laboratory, blood bank, or other entity or facility that provides HIV testing shall report all cases of HIV infection to the Director or his or her designee. A physician, physician’s assistant, nurse-midwife, and other person licensed to practice in the District under the District of Columbia Health Occupations Revision Act of 1985 (D.C. Official Code §§ 3-1201.01 et seq.), who attends to, treats, examines, or provides perinatal treatment to a pregnant woman infected with HIV shall report the pregnancy to the Director within forty-eight (48) hours of diagnosis of the pregnancy and furnish information the Director deems necessary to complete a confidential case report.

206.3 The reports required by Subsection 206.2 shall include the patient's name, address of residence, including city, state, and zip code, gender, race or ethnicity, mode of exposure, place or country of birth, date of birth, date of diagnosis of HIV or AIDS and opportunistic infections, the name and telephone number of the person making the report, and the name of the entity providing health or medical services.

206.4 Upon receiving a report of the existence of an HIV infection, potential AIDS case, or the existence of a pregnancy in an HIV-infected woman, the Director or his or her designee shall make any investigation that he or she may deem necessary for the purpose of determining the source of the infection and the nature of the HIV treatment. To facilitate the investigation, any entity providing health or medical services shall make medical records and histories available to the Director for inspection.

206.5 Information on HIV cases reported under this section shall be used for statistical, public health, epidemiological, and surveillance purposes only. Pregnancy information reported under this section shall be used for public health purposes to ensure the health of the pregnant woman and prevent the transmission of a communicable disease. The Director, or his or her designee, shall not disclose the identity of any person with an HIV infection or reported AIDS case or pregnancy status without the person’s written permission.

206.6 The Department of Health shall ensure continued reasonable access to anonymous HIV testing through alternative testing sites in consultation with HIV planning groups and affected stakeholders, including representatives of persons living with HIV and HIV/AIDS service providers.

History

SOURCE: Final Rulemaking published at 30 DCR 5152 (October 7, 1983); as amended by Final Rulemaking published at 30 DCR 6178 (December 2, 1983); as amended by Final Rulemaking published at 47 DCR 10209 (December 29, 2000); as amended by Final Rulemaking published at 48 DCR 472 (January 19, 2001); as amended by Final Rulemaking published at 53 DCR 9288 (November 17, 2006); as amended by Final Rulemaking published at 55 DCR 5980 (May 23, 2008); as amended by Final Rulemaking published at 60 DCR 11629 (August 9, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 206

22-B DCMR § 207 HEPATITIS B TESTING AND VACCINATION

207.1 A provider that attends to, treats, or examines a pregnant woman or provides perinatal treatment shall:

(a) Take a blood sample during the first prenatal visit and submit the sample to a laboratory approved by the Department for testing for Hepatitis B Surface Antigen (HBsAg);

(b) Take a blood sample at the time of delivery if the woman has not had prior perinatal services or no documentation of HBsAg status, and submit the sample to a laboratory approved by the Department for testing HBsAg;

(d) Make a report according to the requirements of Subsection 201.5.

207.2 A provider that delivers a newborn shall:

(a) Document the mother's Hepatitis B status in the newborn's records;

(b) Immunize the newborn for the Hepatitis B virus; and

207.3 A newborn whose mother tests positive for HBsAg shall:

(a) Receive Hepatitis B immunoglobulin (HBIG) and Hepatitis B vaccine within twelve (12) hours of birth according to the recommendations of the Advisory Committee on Immunization Practices (ACIP);

(b) Receive a complete Hepatitis B series according to the schedule found at 22-B DCMR § 135; and

(c) Receive post-vaccination testing for the presence of HBsAg and Hepatitis B Surface Antibody (HBsAb) three (3) months after the last dose of Hepatitis B vaccine but not earlier than nine (9) months of age and no later than nineteen (19) months of age.

207.4 A newborn whose mother's HBsAg status is unknown shall:

(a) Receive Hepatitis B vaccine without HBIG within twelve (12) hours of birth;

(b) Receive HBIG as soon as possible but no later than seven (7) days after birth if the newborn's mother tests positive for HBsAg;

(d) Receive post-vaccination testing for the presence of HBsAg and Hepatitis B Surface Antibody (HBsAb) three (3) months after the last dose of Hepatitis B vaccine but not earlier than nine (9) months of age and no later than nineteen (19) months of age.

207.5 A full-term medically stable newborn weighing two thousand grams (2000g) or more born to a mother who is HBsAg-negative shall:

(a) Receive Hepatitis B vaccine before hospital discharge; and

(b) Receive a complete Hepatitis B series according to the schedule found at 22-B DCMR § 135.

207.6 A pre-term newborn weighing less than two thousand grams (2000g) born to a mother who is HBsAg-negative shall:

(a) Receive the first dose of Hepatitis B vaccine one (1) month after birth or at hospital discharge; and

(b) Receive a complete Hepatitis B series according to the schedule found at 22-B DCMR § 135.

207.7 In addition to the reporting requirements of Subsection 201.5, a provider shall also report the following in the manner and form the Director requires:

(a) The date and time that Hepatitis B vaccine was administered;

(d) The manufacturer of the vaccine; and

(e) The vaccine lot number.

207.8 A newborn's parent or legal guardian shall be deemed to have consented to Hepatitis B vaccination, unless the newborn's parent or legal guardian submits a signed request for exemption that states the reasons for the exemption. A newborn may be exempted from vaccination if:

(a) The newborn's mother tested negative for HBsAg;

(b) The newborn's parent or legal guardian objects in good faith and in writing that immunization would violate his or her religious beliefs; or

(c) The newborn's parent or legal guardian provides the written certification of a physician that immunization is medically inadvisable.

207.9 Information disclosed to the Department pursuant to this section shall be kept confidential and shall not be disclosed to a third party, except as provided in this subsection. The Department may use and disclose information received pursuant to this section as follows:

(a) The Director may use patient-specific immunization information:

(1) To produce aggregate immunization coverage reports and to track Hepatitis B levels;

(2) To ensure that newborns receive Hepatitis B immunization;

(3) To conduct follow-up on infants born to HBsAg positive mothers; and

(4) For statistical and public health purposes.

(b) Except as provided in subsection (a), the Director may disclose a person's individually identifiable information to a third party only with written consent of the person, or the person's parent or guardian if the person is under eighteen (18) years of age or an unemancipated adult.

History

SOURCE: Final Rulemaking published at 55 DCR 5980 (May 23, 2008). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 207

22-B DCMR § 208 HEALTH CARE ASSOCIATED INFECTIONS

208.1 Acute care, ambulatory, long-term acute care, skilled nursing, and outpatient renal dialysis facilities shall permit the Director access through the National Healthcare Safety Network (NHSN) to data on health care-associated infections (HAIs)). Each of these facilities shall report the following HAIs according to the definitions provided in the most current edition of the NHSN manual (http://www.cdc.gov/nhsn/).

(a) Central line-associated bloodstream infections (CLABSIs);

(b) Catheter-associated urinary tract infections (CAUTIs);

(1) SSI: Abdominal hysterectomy; and

(2) SSI: Colon surgery;

(d) Methicillin-resistant Staphylococcus aureus (MRSA);

(e) Clostridium difficile (C.difficile);

(f) Carbapenem-resistant enterobacteriacae (CRE); and

(g) An infection considered of public health concern by the Director.

208.2 All health care facilities shall report a confirmed or suspected HAI outbreak (as defined in § 299.1) to the Director by telephone or in writing within twenty-four (24) hours.

History

SOURCE: Final Rulemaking published at 56 DCR 848 (January 23, 2009); as amended by Final Rulemaking published at 63 DCR 15116 (December 9, 2016). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 208

22-B DCMR § 209 COMMUNICABLE DISEASES CONTRACTED BY STUDENTS, SCHOOL EMPLOYEES, CONTRACTORS, INTERNS, AND VOLUNTEERS

209.1 Each school shall encourage its students to adhere to the following preventive measures designed to minimize the transmission of communicable diseases:

(a) Use tissues for coughs and sneezes, or cough and sneeze into the elbow;

(a-1) COVID-19:

(1) A student exhibiting symptoms of COVID-19 may return to school after a negative COVID-19 test or upon submitting a licensed practitioner’s note stating the student’s symptoms are due to an alternate diagnosis; or

(2) A student diagnosed with asymptomatic (no symptoms) COVID-19 may return to school after five (5) full days (with the first full day being the day after the positive COVID-19 test was administered) provided that the student does not develop symptoms of COVID-19 and wears a well-fitting mask through the tenth (10th) day (unless two (2) negative COVID-19 antigen tests are obtained at least forty-eight (48) hours apart); or

(3) A student diagnosed with symptomatic COVID-19 who had mild illness (without shortness of breath or the need for prescription medications) may return to school after five (5) full days (with the first full day being the day after symptom onset) provided that the student has been fever-free for at least twenty-four (24) hours without use of fever-lowering medications, other symptoms have improved, and the student wears a well-fitting mask through the tenth (10th) day (unless two (2) negative COVID-19 antigen tests are obtained at least forty-eight (48) hours apart); or

(4) A student diagnosed with symptomatic COVID-19 who had worse than mild illness may return to school after ten (10) full days (with the first full day being the day after symptom onset) provided that the student has been fever-free for at least twenty-four (24) hours without use of fever-lowering medications and other symptoms have improved; or

(5) A student diagnosed with symptomatic COVID-19 who is immunocompromised may return to school after ten (10) full days (with the first full day being the day after symptom onset) provided that the student has been fever-free for at least twenty-four (24) hours without use of fever-lowering medications, and other symptoms have improved; or

(6) A student who has returned to school after exclusion but whose symptoms of COVID-19 recur or worsen shall begin the exclusion period again per subsections 209.4(a-1)(2) through (5).

(b) Wash hands with soap and water before eating and after using the toilet; and

209.2 Each school shall provide students with developmentally appropriate information regarding communicable diseases including Chlamydia, Gonorrhea, Human Papillomavirus (HPV), Human Immunodeficiency Virus (HIV), and other sexually transmitted infections. This information shall include instruction in measures designed to prevent the spread of communicable diseases.

209.3 Each school shall contact the parent or guardian of a minor student who exhibits any of the following symptoms, which may indicate the beginning of a communicable disease, for possible referral for medical examination:

(a) Sore throat;

(b) Runny eyes;

(d) Nausea;

(e) Vomiting;

(f) Diarrhea;

(g) Fever;

(h) Chills;

(i) Severe or chronic cough;

(j) Rash;

(k) Jaundice; and

(l) Weeping or draining sores that cannot be covered.

209.4 A school official who suspects that a student has one of the following communicable diseases shall refer the student to the school nurse [or contact a parent or guardian if the school nurse is unavailable]. A school shall exclude a student diagnosed with a communicable disease and re-admit the student as follows:

(a) Conjunctivitis (“pink eye”):

(1) A student diagnosed with a viral infection may return to school after any redness and discharge have disappeared;

(2) A student diagnosed with a bacterial infection may return to school twenty-four (24) hours after commencing antibiotic treatment if a licensed practitioner provides a note attesting to the diagnosis, the onset of treatment, and that the child is cleared to return to school; or

(3) A student diagnosed with allergic conjunctivitis may return to school upon submitting a licensed practitioner’s note stating the diagnosis;

(b) Acute diarrhea:

(1) A student with infectious diarrhea (e.g., Salmonella, Shigella, E. coli) may return to school when diarrhea ends or upon submitting a health care provider’s note providing medical clearance to return to school;

(2) A student with non-infectious diarrhea (e.g., inflammatory bowel disease, food allergy, reaction to medication) may return to school when diarrhea ends and with instruction to thoroughly wash hands with soap and water after using the toilet and before handling food;

(c) A student with a clinical syndrome such as meningitis or pneumonia resulting from Haemophilus influenza type B (Hib) may return to school twenty-four (24) hours after completing [antibiotic] treatment and submitting a licensed practitioner’s note attesting to the diagnosis and completion of treatment;

(d) Hepatitis:

(1) A student with Hepatitis A may return to school one (1) week after onset of illness or jaundice and upon submitting a licensed practitioner’s note providing medical clearance to return to school;

(2) A student with Hepatitis B or C may return to school upon submitting a licensed practitioner’s note providing medical clearance to return to school;

(e) A student diagnosed with Impetigo (bacterial infection of the skin) may return to school twenty-four (24) hours after beginning antibiotic therapy, provided all lesions are covered, and upon submitting a licensed practitioner’s note stating that the student is undergoing treatment;

(f) A student diagnosed with Measles may return to school four (4) days after the appearance of rash and upon submitting a licensed practitioner’s note providing medical clearance to return to school;

(g) A student diagnosed with Meningitis may return to school upon submitting a licensed practitioner’s note providing medical clearance to return to school;

(h) A student diagnosed with Methicillin-resistant Staphylococcus aureus (MRSA) may return to school provided that all wound drainage (“pus”) is covered and contained;

(i) A student diagnosed with Mumps may return to school five (5) days after the onset of swelling and upon submitting a licensed practitioner’s note providing medical clearance to return to school;

(j) A student diagnosed with Pediculosis (infestation by live head lice) may remain in class that day; however parents or guardians should commence treatment at the conclusion of the school day. The child may return to school upon submitting to the school nurse a parent’s or guardian’s note attesting to the fact that the student is undergoing treatment. A student with only Nits (eggs) shall not be excluded from school; however the school nurse, principal or designee shall send a note to the parents or guardians advising them to monitor the child for re-infestation.

(k) A student diagnosed with Pertussis (“whooping cough”) may return to school three (3) weeks after the onset of symptoms, if untreated, or five (5) days after beginning antibiotic therapy and submitting a licensed practitioner’s note attesting to the beginning of therapy;

(l) A student diagnosed with Pinworms may return to school twenty-four (24) hours after the first treatment and upon submitting a licensed practitioner’s note stating that the student is under treatment;

(m) A student diagnosed with Ringworm may return to school upon submitting a licensed practitioner’s note stating that the student is under treatment;

(n) A student diagnosed with Rubella (German measles) may return to school seven (7) days after the rash appears;

(o) A student diagnosed with Scabies (“itch mite”) may return to school upon submitting a licensed practitioner’s note stating that the student’s treatment for scabies with a prescription lotion has been completed;

(p) A student diagnosed with Strep infection (scarlet fever, strep throat) may return to school twenty-four (24) hours after beginning antibiotic treatment, provided the student is without fever for twenty-four (24) hours, and upon submitting a licensed practitioner’s note affirming the start of treatment, and providing medical clearance for the student to return to school;

(q) Tuberculosis:

(1) A student diagnosed with active Tuberculosis may return to school upon providing a written recommendation to return to school from the Tuberculosis Control Program of the Department of Health; and

(2) A student diagnosed with latent Tuberculosis may return to school after initiating treatment and upon submission of a licensed practitioner’s note giving medical clearance to return; or

(r) A student diagnosed with Varicella (chickenpox), even if previously vaccinated, may return to school after lesions have crusted and upon submission of a licensed practitioner’s note giving medical clearance to return.

209.5 A person shall not disclose a student’s individually identifiable health information without written authorization from the parent or guardian of a minor student or from a student eighteen (18) years of age or older to anyone other than:

(a) The Department of Health;

(b) A school nurse;

(d) The student’s primary health care provider; or

(e) A school principal or designee.

209.6 A school shall inform the Director of the Department of Health within two (2) hours when any student has contracted any of the following diseases:

(a) Measles;

(b) Meningococcal meningitis;

(d) Pertussis;

(e) Rubella;

(f) Tuberculosis; or

(g) Hepatitis A or any other food-borne illness.

209.7 To the extent permitted by law or regulation, a school shall report cases of Chlamydia, Gonorrhea, HIV, and other communicable diseases contracted by students to the Director of the Department of Health.

209.8 A school shall exclude a school employee, contractor, intern, or volunteer and re-admit as follows:

A school employee, contractor, intern, or volunteer exhibiting symptoms of COVID-19 may return to school after a negative COVID-19 test or upon submitting a licensed practitioner’s note stating symptoms are due to an alternate diagnosis; or

(b) A school employee, contractor, intern, or volunteer diagnosed with an asymptomatic (no symptoms) COVID-19 may return to school after five (5) full days (with the first day being the day after the positive COVID-19 test was administered) provided that the individual does not develop symptoms of COVID-19 and wears a well-fitting mask through the tenth (10th) day (unless two (2) negative COVID-19 antigen tests are obtained at least forty-eight (48) hours apart); or

(c) A school employee, contractor, intern, or volunteer diagnosed with symptomatic COVID-19 who had mild illness (without shortness of breath or the need for prescription medications) may return to school after five (5) full days (with the first day being the day after symptom onset) provided that the individual has been fever-free for at least twenty-four (24) hours without use of fever-lowering medications, other symptoms have improved, and the individual wears a well-fitting mask through the tenth (10th) day (unless two (2) negative COVID-19 antigen tests are obtained at least forty-eight (48) hours apart); or

(d) A school employee, contractor, intern, or volunteer diagnosed with symptomatic COVID-19 who had worse than mild illness may return to school after ten (10) full days (with the first day being the day after symptom onset) provided that the individual has been fever-free for at least twenty-four (24) hours without use of fever-lowering medications and other symptoms have improved; or

(e) A school employee, contractor, intern, or volunteer diagnosed with symptomatic COVID-19 who is immunocompromised may return to school after ten (10) full days (with the first day being the day after symptom onset) provided that the individual has been fever-free for at least twenty-four (24) hours without use of fever-lowering medications, and other symptoms have improved; or

(f) A school employee, contractor, intern, or volunteer who has returned to school after exclusion but whose symptoms of COVID-19 recur or worsen shall begin the exclusion period again per subsections 209.8(b) through (e).

History

SOURCE: Final Rulemaking published at 61 DCR 12274 (November 28, 2014); as amended by Final Rulemaking published at 69 DCR 014826 (December 2, 2022). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 209

22-B DCMR § 210 INVESTIGATIONS AND ENFORCEMENT

210.1 Upon receiving a report of the existence of a case or suspected case of a communicable disease, or of a communicable disease contact or carrier, the Director shall make any investigation that he or she deems necessary for the purpose of determining the source of infection and of determining if the proper management and control measures are in effect.

210.2 In order to make an investigation under this section, the Director may enter upon and inspect any public or private property in the District.

210.3 Where the Director has probable cause to believe that sectors of a communicable disease or sources of a communicable disease have been identified, the Director shall cause to be instituted whatever preventive measures as the Director may deem necessary to eradicate immediately the vectors and sources of the communicable disease.

210.4 Any person having or suspected of having a communicable disease, or any person who is suspected of being a communicable disease contact or carrier, shall, when directed by the Director, submit to an examination for the purpose of determining the existence of a communicable disease.

210.5 A person suspected of having a communicable disease, or a person who is suspected of being a communicable disease contact or carrier, shall submit specimens or permit the obtaining of authentic specimens of body secretions, excretions, body fluids, and discharges for laboratory examinations, when required by the Director. These specimens shall be authenticated, when required by the Director.

210.6 The Director may authorize or order a placard to be posted on the premises occupied by any person affected with a communicable disease.

210.7 No placard authorized or ordered by the Director to be posted shall be mutilated, defaced, obliterated, concealed, or removed, except by authorization of the Director.

210.8 The Director shall issue a Removal and Detention Order and take whatever further proceedings may be required by Sections 1 through 14 of the Act (D.C. Official Code §§ 7-131 through 7-144 (2001 ed.)), whenever the Director has probable cause to believe that any person is affected with, or is a carrier of, a communicable disease, and whenever the Director has probable cause to believe that that person is likely to be dangerous to the life or health of any other person because of the following reasons:

(a) Improper facilities or the lack of facilities for isolation; or

(b) Because of the person's non-cooperation or carelessness, including his or her refusal to submit to examination or refusal to be properly treated or cared for, the person is likely to be a danger to public health.

210.9 Each infected person, contact, or carrier shall comply with the instructions given him or her by the physician or other person responsible for the control of a case of communicable disease.

210.10 Each parent, guardian, or person in charge of an infected person or infected animal, carrier, or contact shall comply with instructions given by the physician, veterinarian, or other person in charge of the case concerning the control of the infected person or infected animal, carrier, or contact.

History

SOURCE: Commissioners’ Order 61-1117 (June 20, 1961), published as Health Regulations at §§ 8-5:101-205; as amended by Final Rulemaking published at 55 DCR 5980 (May 23, 2008). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 210

22-B DCMR § 211 LABORATORIES AND BLOOD BANKS

211.1 Physicians and others licensed under the District of Columbia Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 to 3-1213.01 (2001 ed.)), to practice in the District may submit communicable disease specimens for test and report findings to the Department's laboratory or to any other laboratory approved by the Director.

211.2 A laboratory that tests a communicable disease specimen shall report its findings directly to the person who submitted the specimen.

211.3 Whenever a test made in a public or private laboratory is positive for syphilis, the person responsible for the operation of the laboratory shall report the positive test to the Director in writing within twenty-four (24) hours, giving the following information:

(a) The name of the person requesting the test;

(b) The address of the person requesting the test; and

211.4 Whenever a test made in a public or private laboratory is positive for HIV or is indicative of an HIV diagnosis, including CD4 and viral load tests, the person responsible for the operation of the laboratory shall report the positive test to the Director or an agent of the Director or his or her designee, in writing, within forty-eight (48) hours, giving the following information:

(a) The name of the subject of the test;

(b) The name and address of the physician or provider requesting the test;

(d) All other information required under this section.

211.5 Each public or private laboratory shall keep a record of its findings showing evidence of communicable disease for a period of at least one (1) year.

211.6 During the one (1) year period in which records of a communicable disease are kept, the records shall be available for inspection by the Director at any reasonable time.

211.7 If the person requesting a communicable disease test and report has elected to report to the Director by number, the person shall use the same number in requesting the laboratory for the test and report; and the laboratory shall use the same number in its records.

211.8 Whenever, in the course of its operations, a blood bank determines that a specimen of blood tests positive for syphilis, the physician in charge of the blood bank shall report the positive test in writing to the Director within twenty-four (24) hours. Whenever, in the course of its operations, a blood bank determines that a specimen is positive for HIV, the physician or provider in charge of the blood bank shall report the positive test in writing to the Director or his/her designee within forty-eight (48) hours.

211.9 Whenever any written report is required by this section, the report and records of the report shall comply with the special requirements contained in § 205.1 of this chapter, in addition to the other requirements of this section.

211.10 All bacteriological laboratories in the District, including bacteriological laboratories in public or private hospitals, shall report within forty-eight (48) hours in writing to the Director of Human Services, all positive acid fast bacilli results whenever determined by smear or culture or otherwise.

211.11 The reports required in § 211.10 shall be filed by the Director of the laboratory or the Director's designee, and shall contain, in addition to the bacteriological findings, the following information:

(a) The full name and address of the patient; and

(b) The name of the physician or facility responsible for the diagnosis, referral, or treatment of the patient.

History

SOURCE: Commissioners’ Order 61-1117 (June 20, 1961), published as Health Regulations at §§ 8-5:101-205; as amended by Commissioners’ Order 63-640 (March 5, 1963), published as Health Regulation § 8-5:112; as amended by Regulation No. 73-23, published at 20 DCR 543 (November 30, 1973), as published as Health Regulation § 8-5:1-112; as amended by Final Rulemaking published at 47 DCR 10209 (December 29, 2000); as amended by Final Rulemaking published at 48 DCR 472 (January 19, 2001); as amended by Final Rulemaking published at 53 DCR 9288 (November 17, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 211

22-B DCMR § 212 CLEANSING OF PREMISES

212.1 Upon release from isolation, removal to a hospital, or any other change of location of any person affected with diphtheria, smallpox, tuberculosis, or any salmonella infection, the room or rooms which have been occupied by the person shall be cleansed, disinfected, or renovated in a manner prescribed and approved by the Director.

212.2 The Director may require whatever cleansing, disinfection, or renovation as he or she determines is necessary to protect the public health in connection with any case of communicable disease.

212.3 No person shall occupy a room formerly occupied by a person affected by a communicable disease until after the terminal cleansing as prescribed by this section.

History

SOURCE: Commissioners’ Order 61-1117 (June 20, 1961), published as Health Regulations at §§ 8-5:101-205. District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 212

22-B DCMR § 213 PERSONS AFFECTED BY COMMUNICABLE DISEASES

213.1 No person who is affected by, or believed by the Director upon probable cause to be affected by, a communicable disease in a communicable form; and no person who is, or is believed by the Director upon probable cause to be, a carrier of a communicable disease; shall actively engage in any occupation in which the person is likely to be dangerous to the lives or health of other persons.

213.2 No operating proprietor or manager of any business shall permit any person who is, or is believed by the Director upon probable cause to be, a carrier of a communicable disease, to engage or continue to be engaged in any occupation in which the person is likely to be dangerous to the lives or health of other persons.

213.3 Except when specifically authorized otherwise by the Director, no person affected with chickenpox, diphtheria, measles, mumps, meningococcus meningitis, poliomyelitis, smallpox, or whooping cough shall ride or be transported during the communicable period of his or her disease in any of the following common carriers:

(a) Airplane;

(b) Railway train;

(d) Bus;

(e) Taxicab; or

(f) Any other carrier provided for public transportation.

History

SOURCE: Commissioners’ Order 61-1117 (June 20, 1961), published as Health Regulations at §§ 8-5:101-205. District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 213

22-B DCMR § 214 DEATHS OF AFFECTED PERSONS

214.1 In cases of death from cholera, anthrax, diphtheria plague (bubonic and pneumonic), smallpox, or louse-borne typhus fever, the physician issuing the certificate of death shall give immediate notice by telephone of the death to the Director.

214.2 The body of a person who died from a disease listed in this section shall not be moved from the place of death except after issuance of a permit by the Director, as required under this title.

214.3 Prior to being transported from the place of death to a licensed undertaker's establishment, the body of a person who died of a disease listed in this section shall have all of its orifices filled with absorbent cotton, and shall be wrapped in a sheet saturated with a 1:500 solution of bichloride of mercury or other equally effective germicidal agent.

214.4 Within twelve (12) hours after transportation of a body of a person who died of a disease listed in this section to a licensed undertaker's establishment, the body shall be treated by one (1) of the following methods:

(a) Embalmed arterially and placed in a casket, which shall be sealed permanently; or

(b) Cremated.

214.5 A public funeral service for a person who has died of any of the diseases listed in this section shall not be held in the presence of the body unless the body has been embalmed and placed in a sealed casket.

214.6 Quarantined persons shall not attend a public funeral service; but may, at the discretion of the Director, be taken to places of burial provided they do not mingle with the nonquarantined persons present.

History

SOURCE: Commissioners’ Order 61-1117 (June 20, 1961), published as Health Regulations at §§ 8-5:101-205. District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 214

22-B DCMR § 215 MONITORING AND REPORTING THE OCCURRENCE OF CANCER

215.1 Each health care provider and health care facility shall report benign tumors of the brain and central nervous system and all malignant cancers as follows:

(a) Each health care provider and health care facility shall report within six (6) months of diagnosis or first contact, any patient diagnosed with or treated for benign tumors of the brain or central nervous system or any malignant cancers, or for whom cancer treatment planning was performed but the patient opted for no treatment.

(b) Each health care provider and health care facility shall report within six (6) months of diagnosis or first contact, any patient diagnosed with or treated for benign tumors of the brain or central nervous system or any malignant cancers, or who expired with cancer as a cause of death; and

(c) Each health care provider and health care facility shall make available to the Director or an agent of the Director all information necessary to verify the information in any report submitted pursuant to this section.

215.2 The information required to be submitted by this section may be submitted by the health care facility, health care provider, or an agent retained by the health care facility or health care provider for this purpose.

215.3 Each report of an initial diagnosis or the treatment of cancer shall include the following:

(a) Patient Information:

(1) Name, including maiden name, if applicable;

(2) Legal residence and mailing address at the time of initial diagnosis;

(3) Sex;

(4) Social security number;

(5) Date of birth;

(6) Place of birth;

(7) Race or ethnic group; and

(8) Marital status; and

(b) Diagnostic Information:

(1) Diagnosis;

(2) Histologic type, behavior and grade of cancer;

(3) Primary site of the cancer;

(4) Date of the diagnosis;

(5) Extent of disease, including the American Joint Commission on Cancer (AJCC) stage and the National Cancer Institute's Surveillance, Epidemiology and End Results (SEER) stage;

(6) Type of diagnosis and confirmation;

(7) Laterality;

(8) Tissue pathology;

(9) Initial treatment, including surgery, radiation, chemotherapy, hormonal therapy, or biological therapy; and

(10) Sequence of the cancer; and

(1) Name of the health care facility or health care facility provider;

(2) Patient's medical record number;

(3) Name of the attending physician;

(4) Name of the person submitting the report;

(5) Patient's history of tobacco use (current, former, or never);

(6) Patient's current, former, and usual occupational status; and

(7) Any other information considered pertinent by the Director.

215.4 Each report required by Subsection 215.1 shall be submitted electronically by a secured form of transmission approved by the North American Association of Central Cancer Registries (NAACCR) to the DC Central Cancer Registry within the Department.

History

SOURCE: Final Rulemaking published at 47 DCR 3493 (May 19, 2000); as amended by Final Rulemaking published at 61 DCR 4939 (May 16, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 215

22-B DCMR § 216 QUALITY ASSURANCE/ACCESS TO RECORDS

216.1 A District of Columbia Central Cancer Registrar or other person designated by the Director is authorized to visit any health care facility or health care provider to review and duplicate reports required by this chapter or records that contain information required to be submitted pursuant to this chapter to ensure the completeness and accuracy of the information.

216.2 A health care facility or health care provider that treats or diagnoses cancer in the District shall make the following reports available to the D.C. Registrar for review or duplication, upon request:

(a) Reports of tissue or cellular analysis performed to determine the presence or absence of cancer;

(b) Results of radiological examinations, including x-rays, performed to determine the presence or absence of cancer;

(c) Reports of diagnoses of cancer and reasons for the diagnoses, including any diagnostic report of the primary clinician or consultant;

(d) Portions of medical records that contain specific information required to be reported pursuant to these rules; and

(e) Any other record or report necessary to ensure the completeness and accuracy of information provided in reports required by these rules.

History

SOURCE: Final Rulemaking published at 47 DCR 3493 (May 19, 2000); as amended by Final Rulemaking published at 61 DCR 4939 (May 16, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 216

22-B DCMR § 217 CONFIDENTIALITY

217.1 The Department shall use information from reports submitted pursuant to these rules for statistical and public health purposes only.

217.2 No person shall disclose or re-disclose identifying information included in a cancer report submitted pursuant to this chapter unless:

(a) Disclosure of the information is essential to safeguard the physical health of others;

(b) The person who is the subject of the identifying information gives his or her prior, written permission;

(c) The person with whom the identifying information is shared is a state cancer registry that provides assurances that the confidentiality of the identifying information will be preserved; or

(d) A court finds, upon clear and convincing evidence and after granting the person who is the subject of the identifying information an opportunity to contest the disclosure, that disclosure is essential to safeguard the physical health of other.

History

SOURCE: Final Rulemaking published at 47 DCR 3493 (May 19, 2000). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 217

22-B DCMR § 218 PENALTIES

218.1 Any person who willfully does not comply with the reporting requirements set forth in § 215 or the access to records required in § 216 shall be guilty of a misdemeanor, and upon conviction, subject to a fine not to exceed one thousand dollars ($ 1,000).

218.2 Any person who willfully violates the confidentiality provisions set forth in § 217 shall be guilty of a misdemeanor and, upon conviction, subject to a fine not to exceed five thousand ($ 5,000) dollars, imprisonment for not more than ninety (90) days, or both.

History

SOURCE: Final Rulemaking published at 47 DCR 3493 (May 19, 2000). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 218

22-B DCMR § 219 MATERNAL MORTALITY REPORTING

219.1 Each health care facility shall report to the Department all maternal mortalities, as defined in § 299.1.

219.2 All health care facilities shall report all maternal mortalities required by § 219.1 in writing within five (5) days after death and before final disposition of the corpse.

History

SOURCE: Final Rulemaking published at 67 DCR 1951 (February 21, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 219

22-B DCMR § 220 SEVERE MATERNAL MORBIDITY

220.1 Each health care facility shall report to the Department each severe maternal morbidity, as defined in § 299.

220.2 Each health care facility shall report each severe maternal morbidity in writing within five (5) days of the end of each event causing that maternal morbidity.

History

SOURCE: Final Rulemaking published at 67 DCR 14001 (November 27, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 220

22-B DCMR § 221 CLINICAL LABORATORY GENOMIC SEQUENCING OF SARS-CoV-2

221.1 A clinical laboratory operating in the District of Columbia, a clinical laboratory providing services to a health care facility located in the District of Columbia, or a clinical laboratory providing services to a health care provider located in the District of Columbia must conduct genomic sequencing using a widely accepted methodology for SARS-CoV-2 and in compliance with subsection 221.2 when a resident of the District of Columbia tests positive for SARS-CoV-2 based on a polymerase chain reaction (PCR) testing if the clinical laboratory has the capacity to conduct genomic sequencing.

221.2 Each clinical laboratory operating in the District of Columbia, a clinical laboratory providing services to a health care facility located in the District of Columbia, or a clinical laboratory providing services to a health care provider located in the District of Columbia conducting genomic sequencing for SARS-CoV-2 shall:

(a) Conduct genomic sequencing on a minimum of ten percent (10%) of specimens from residents of the District of Columbia that are positive for SARS-CoV-2 for each period of time starting at 12:00 midnight on Sunday through 11:59 p.m. on the next Saturday;

(b) Submit all genomic sequencing results for residents of the District of Columbia to the Department of Health and the Public Health Laboratory; and,

(c) Store all specimens from residents of the District of Columbia that are positive for SARS-CoV-2 for a minimum of thirty (30) calendar days; provided, that if the clinical laboratory lacks the capacity or capability to store positive SARS-CoV-2 specimens for thirty (30) days, the clinical laboratory may request a hardship waiver from the Department of Health.

221.3 A clinical laboratory operating in the District of Columbia, a clinical laboratory providing services to a health care facility located in the District of Columbia, or a clinical laboratory providing services to a health care provider located in the District of Columbia that lacks the capacity to conduct genomic sequencing shall submit all specimens positive for SARS-CoV-2 for residents of the District of Columbia to the Public Health Laboratory.

History

SOURCE: Final Rulemaking published at 68 DCR 011091 (October 22, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 221

22-B DCMR § 222 SARS-CoV-2 TESTING FOR IN-PERSON WORK AND LEARNING

222.1 A person who is not fully vaccinated and who must report, in person, to work in the District of Columbia is not required to have an order from a physician or other authorized health professional in order to be receive SARS-CoV-2 testing. Such person may be tested for SARS-CoV-2 without an order from a physician or other authorized health professional once in every seven (7) day period.

222.2 A person who is not fully vaccinated and who must report, in person, to learn in the District of Columbia is not required to have an order from a physician or other authorized health professional in order to be receive SARS-CoV-2 testing. Such person may be tested for SARS-CoV-2 without an order from a physician or other authorized health professional once in every seven (7) day period if there is not a testing of a proportion of students each week for screening testing.

222.3 Each person tested pursuant to this section may be responsible for payment for some or all of the costs of SARS-CoV-2 testing when any third-party is not required to pay for the testing.

History

SOURCE: Final Rulemaking published at 68 DCR 011091 (October 22, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 222

22-B DCMR § 223 SARS-CoV-2 VACCINE ADMINISTRATION

223.1 An individual, including a medical assistant or a health technician, who is not licensed, registered, or certified to practice a health occupation pursuant to Chapter 12 of Subtitle I of Chapter 3 of the District of Columbia Official Code, is authorized to administer a SARS-CoV-2 vaccine provided that:

(a) The individual has successfully completed training, provided by a licensed health professional authorized by an existing scope of practice of a health profession to administer a vaccination in the District of Columbia, on the administration of the SARS-CoV-2 vaccine;

(b) A licensed health professional authorized by an existing scope of practice of a health profession to administer a vaccination in the District of Columbia must supervise the individual at the vaccination site;

(c) The licensed health professional reasonably determines that the individual is able to administer the SARS-CoV-2 vaccine under appropriate supervision;

(d) The individual administers the SARS-CoV-2 vaccine at the vaccination site under the general supervision of a licensed health professional supervising the unlicensed person at the vaccination site; and

(e) The training, authorization, and supervision are appropriately documented in the records maintained by the vaccination site.

History

SOURCE: Final Rulemaking published at 68 DCR 011091 (October 22, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 223

22-B DCMR § 224 CONTINUING EDUCATION FOR SARS-CoV-2 VACCINE COUNSELING

224.1 In addition to any other continuing education requirements and subject to subsection 224.2, a person licensed to practice one of the following professions must complete two (2) hours of continuing education on SARS-CoV-2 vaccines, including, but not limited to, SARS-CoV-2 vaccine safety, best practices for counseling patients about SARS-CoV-2 vaccines, and SARS-CoV-2 vaccine efficacy and effectiveness, on or before September 30, 2021:

(a) Advanced Practice Registered Nurse;

(b) Audiologist;

(d) Dentist;

(e) Dietician;

(f) Doctor of Osteopath;

(g) Licensed Clinical Social Worker;

(h) Licensed Graduate Professional Counselor;

(i) Licensed Graduate Social Worker;

(j) Licensed Independent Clinical Social Worker;

(k) Licensed Practical Nurse;

(l) Licensed Professional Counselor;

(m) Long Term Care Administrator;

(n) Marriage and Family Therapist;

(o) Medical Doctor;

(p) Nutritionist;

(q) Occupational Therapist;

(r) Optometrist;

(s) Pharmacist;

(t) Physical Therapist;

(u) Physician Assistant;

(v) Podiatrist;

(w) Psychologist;

(x) Registered Nurse;

(y) Respiratory Care Therapist; or

(z) Speech Language Pathologist.

224.2 The hours of continuing education required by subsection 224.1 may be counted as hours required for public health priorities training hours or optional training hours where applicable.

History

SOURCE: Final Rulemaking published at 68 DCR 011091 (October 22, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 224

22-B DCMR § 230 COVID-19 VACCINATION REQUIREMENTS FOR HEALTHCARE WORKERS

230.1 Each of the persons described in § 230.2, unless granted an exemption under § 231 of this chapter, shall:

Receive the first and second dose of the Pfizer-BioNTech COVID-19 vaccine, or receive a second dose of a different COVID-19 vaccine listed in this subsection, within the time period established in the dosing schedule for the vaccine;

Receive the first dose and second dose of the Moderna COVID-19 vaccine, or a dose of a different COVID-19 vaccine listed in this subsection, within the time period established in the dosing schedule for the vaccine;

Receive one (1) dose of the Janssen COVID-19 vaccine; or

(d) Receive the first and second dose of the Novavax COVID-19 vaccine or receive a second dose of a different COVID-19 vaccine listed in this subsection, within the time period established in the dosing schedule for the vaccine.

230.2 The following persons who have been hired by, employed by, contracted with, or granted privileges or credentials by facilities governed by § 11200 of Subtitle B (Public Health and Medicine) of Title 22 (Health) of the District of Columbia Municipal Regulations (“DCMR”), are subject to the requirements set forth in § 230.1:

Each person licensed pursuant to section 501(a)(1) of the District of Columbia Health Occupations Revisions Act of 1985 (“Health Occupations Act”), effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code § 3-1205.01(a)(1)), to practice acupuncture, advanced practice addiction counseling, assisted living administration, audiology, certified midwife, certified professional midwife, chiropractic, cytotechnology, dental hygiene, dentistry, dietetics, histotechnology, home health care administration, marriage and family therapy, massage therapy, medical laboratory technology, medicine, naturopathic medicine, nutrition, nursing home administration, occupational therapy, optometry, pharmaceutical detailing, pharmacy, physical therapy, podiatry, practical nursing, professional counseling, psychology, registered nursing, respiratory care, social work, speech-language pathology, veterinary medicine, or to practice as an anesthesiologist assistant, athletic trainer, personal fitness trainer, pharmacy intern, physician assistant, physical therapy assistant, polysomnographic technologist, occupational therapy assistant, surgical assistant, professional art therapy, or as a trauma technologist, or to practice any other profession for which licensure is required by section 501(a)(1) of the Health Occupations Act (D.C. Official Code § 3-1205.01(a)(1));

(b) Each person registered pursuant to section 501(a)(2) of the Health Occupations Act (D.C. Official Code § 3-1205.01(a)(2)) to practice as an audiology assistant, dental assistant, nursing assistive personnel (including certified nurse aide and certified home health aide), pharmacy technician, phlebotomist, psychology associate, polysomnographic technician or trainee, speech-language pathology assistant, or speech-language pathology clinical fellow, or to practice any other profession for which registration is required by § 501(a)(2) of the Health Occupations Act (D.C. Official Code § 3-1205.01(a)(2));

(c) Each person certified pursuant to § 501(a)(3) of the Health Occupations Act (D.C. Official Code § 3-1205.01(a)(3)) to practice as an addiction counselor I, addiction counselor II, advanced practice registered nursing, veterinary technician, or a veterinary euthanasia technician, or to practice any other profession for which certification is required by § 501(a)(3) of the Health Occupations Act (D.C. Official Code § 3-1205.01(a)(3));

(d) Each person certified pursuant to section 6 of the Emergency Medical Services Act of 2008 (“Emergency Medical Services Act”), effective March 25, 2009 (D.C. Law 17-357; D.C. Official Code § 7-2341.05), to perform the duties of emergency medical services personnel;

(e) Each person certified pursuant to section 7 of the Emergency Medical Services Act (D.C. Official Code § 7-2341.06) to perform the duties of flight emergency medical services personnel;

(f) Each person certified pursuant to section 9 of the Emergency Medical Services Act (D.C. Official Code § 7-2341.08) to perform the duties of an emergency medical services instructor; and

(g) Each person who is an “unlicensed person” as that term is defined by section 2(7) of the Health-Care Facility Unlicensed Personnel Criminal Background Check Act of 1998, effective April 20, 1999 (D.C. Law 12-238; D.C. Official Code § 44-551(7)), regardless of whether the person is an employee or contractor of a “facility,” as that term is defined by section 2(1C) of the Health-Care Facility Unlicensed Personnel Criminal Background Check Act of 1998, effective April 20, 1999 (D.C. Law 12-238; D.C. Official Code § 44-551(1C)). The term “unlicensed person” includes, but is not limited to, unlicensed nurse aides, orderlies, assistant technicians, attendants, home health aides, personal care aides, medication aides, geriatric aides, medical assistants, health technicians, other health aides, housekeeping staff, maintenance staff, and administrative staff.

230.3 An employer or contractor may impose COVID-19 vaccination requirements on its employees and contractors that are stricter than the requirements imposed by this section, such as by requiring its employees and contractors to obtain additional vaccinations against COVID-19 or requiring that unvaccinated employees or contractors be tested regularly for COVID-19.

230.4 An employer or contractor may impose COVID-19 vaccination requirements on its employees and contractors that are stricter than the requirements imposed by this section, such as by requiring its employees and contractors to be vaccinated against COVID-19 by a date earlier than required by this section, not providing an emergency use authorization exemption from the COVID-19 vaccination requirement, and requiring that unvaccinated employees or contractors be tested regularly for COVID-19.

History

SOURCE: Final Rulemaking published at 68 DCR 013014 (December 10, 2021); as amended by Final Rulemaking published at 70 DCR 002436 (February 24, 2023). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 230

22-B DCMR § 231 EXEMPTIONS FROM COVID-19 VACCINATION REQUIREMENTS FOR HEALTHCARE WORKERS

231.1 A person who is otherwise required to be vaccinated against COVID-19 pursuant to § 230 shall be exempt from the COVID-19 vaccination requirement if the person is granted an exemption from a healthcare facility governed by § 11200 of Subtitle B (Public Health and Medicine) of Title 22 (Health) of the District of Columbia Municipal Regulations (“DCMR”) that has hired, employed, contracted with, or granted privileges or credentials to the individual, for one of the following reasons:

The person objects in good faith and in writing that the person’s vaccination against COVID-19 would violate a sincerely held religious belief and the vaccination would in fact violate a sincerely held religious belief of the person;

The person has obtained and submitted written certification from a physician, or other licensed health professional who may order an immunization, that being vaccinated against COVID-19 is medically inadvisable due to the person’s medical condition and it is in fact medically inadvisable for the person to receive a COVID-19 vaccine due to the person’s medical condition. If the condition making the vaccine medically inadvisable is temporary, the physician or other licensed health professional should specify in the certification the date on which, or the change in condition upon which, taking the vaccine would no longer be medically inadvisable; or

The person has submitted documentation showing that the person has received a COVID-19 vaccine or a course of vaccination approved by the World Health Organization.

231.2 A person requesting an exemption pursuant to § 231.1 must submit documentation to the healthcare facility governed by § 11200 of Subtitle B (Public Health and Medicine) of Title 22 (Health) of the DCMR that has hired, employed, contracted with, or granted privileges or credentials to the individual, that satisfactorily demonstrates that the exemption is warranted.

231.3 An exemption requested pursuant to § 231.1 shall be effective upon a written document issued by a healthcare facility governed by § 11200 of Subtitle B (Public Health and Medicine) of Title 22 (Health) of the DCMR that has hired, employed, contracted with, or granted privileges or credentials to the individual, granting the exemption.

231.4 An exemption for the COVID-19 vaccination previously granted by the Director of the District of Columbia Department of Health, or his or her designee, prior to the effective date of this rulemaking, shall remain effective for two (2) years after it is granted. Thereafter, a person who is otherwise required to be vaccinated against COVID-19 pursuant to § 230 shall be exempt from the COVID-19 vaccination requirement if the person is granted an exemption from a healthcare facility governed by § 11200 of Subtitle B (Public Health and Medicine) of Title 22 (Health) of the DCMR that has hired, employed, contracted with, or granted privileges or credentials to the individual.

History

SOURCE: Final Rulemaking published at 68 DCR 013014 (December 10, 2021); as amended by Final Rulemaking published at 70 DCR 002436 (February 24, 2023). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 231

22-B DCMR § 299 DEFINITIONS

299.1 When used in this chapter, the following words and phrases shall have the meanings ascribed:

ACIP - the Advisory Committee on Immunization Practices of the CDC.

Act - An Act to authorize the Commissioners of the District of Columbia to make regulations to prevent and control the spread of communicable and preventable diseases, approved August 11, 1939 (53 Stat. 1408 ch. 691; D.C. Official Code § 7-131 et seq. (2001 ed.)), as amended.

Cancer - any malignant disease that is listed in the 9th Edition of the "International Classification of Disease-Oncology" published by the World Health Organization, except benign neoplasms and basal cell and squamous cell carcinoma of the skin, and each form of in situ carcinoma of the cervix uteri including codes from the International Classification of Disease, Ninth Revision, Clinical Modification (ICD-9-CM) and the International Classification of Disease for Oncology, Second Edition (ICD-O-2).

Carrier - a person or animal harboring in his or her or its body the specific infectious agent of a communicable disease without manifest symptoms and being a potential source or reservoir of infection for man.

CDC—the Centers for Disease Control and Prevention, a federal agency responsible for protecting America from threats to health, safety, and security, whether foreign or domestic.

Cleansing - the removal of infectious agents and the organic materials on which or in which infectious agents may find favorable conditions for prolonging life and virulence. Cleansing is accomplished by washing or scrubbing with hot water and a suitable detergent, by thorough airing and drying, and by exposure to sunlight.

Communicable disease - any disease denominated a communicable disease, including without limitation any illness due to an infectious agent or its toxic product, which is transmitted directly or indirectly to a well person from an infected person, animal, or ectoparasite; or any illness due to an infectious agent or its toxic product which is transmitted through the agency of an intermediate host, vector, or by exposure within the immediate environment. Communicable disease also shall mean any disease occurring as an outbreak of illness or toxic conditions, regardless of etiology in an institution or other identifiable group of people.

Contact - any person or animal that has associated with a person or animal infected by a communicable disease, or with an object contaminated by the infectious agent of a communicable disease, in a manner that would provide the person or animal the opportunity of acquiring the disease.

Department - District of Columbia Department of Health.

Director - Director, District of Columbia Department of Health.

Disinfection - the process of destroying the vitality of a disease-producing agent outside the body of a person or animal.

Foodborne disease outbreak—an incident in which two or more persons experience a similar illness resulting from ingestion of a common food.

Health care associated infection (HAI)—an infection that develops in a patient or resident in a healthcare facility that was not present or incubating at the time of admission.

Health care associated infection outbreak (HAI outbreak)—the occurrence of more cases of infections than expected in a given healthcare facility area among a specific group of people over a particular period of time, or when the number of infections in a healthcare facility is higher than the baseline rate for that facility.

Health Care Facility - A clinic, freestanding ambulatory care facility, freestanding laboratory, hospital, nursing home, or therapeutic radiological center.

Health care provider or provider - a health care clinic, a physician, a health maintenance organization, a nurse, a hospital, a charitable organization that provides medical care or advice, or any other entity that provides medical care or advice.

HBIG - hepatitis B immunoglobulin.

HBsAb - a serological laboratory test marker indicating immunity to Hepatitis B infection.

HBsAg - a serological laboratory test marker indicating infection with the Hepatitis B virus.

Infectious agent—a disease-causing organism (e.g. prion, virus, bacterium, fungus, or parasite).

Invasive—isolated from blood, bone, cerebrospinal fluid, joint, pericardial, peritoneal, or pleural fluid.

Isolation - the separation of infected persons or animals, or persons or animals suspected of being infected, from other persons or animals for the period of communicability of the particular communicable disease. The separation shall be in places and under conditions that will prevent the direct or indirect conveyance of the infectious agent from the infected persons or animals to susceptible persons or animals, or to persons or animals who may spread the infectious agent to others.

Maternal Mortality:

(a) A pregnancy-associated death or pregnancy-related death, as those terms are defined in section 2 of the Maternal Mortality Review Committee Establishment Act of 2018, effective June 5, 2018 (D.C. Law 22-111; D.C. Official Code § 7-671.01)); or

(b) A death of a woman that resulted from Severe Maternal Morbidity.

Mayor - the Mayor of the District of Columbia, or the Mayor's designated agent.

National Healthcare Safety Network (NHSN)—a secure internet-based surveillance system that houses national healthcare-associated infection data and is managed by the Center for Disease Control and Prevention’s Division of Healthcare Quality Promotion.

Newborn - an infant born in the District who is under 4 weeks of age.

Novel influenza A - a virus subtype that is different from currently circulating human influenza H1 and H3 viruses. Novel subtypes include H2, H5, H7, and H9. Influenza H1 and H3 subtypes originating from non-human species or from genetic reassortment between animal and human viruses are also novel subtypes.

Outbreak - the occurrence of an illness of public health importance, when the occurrence is in unusual numbers or under unusual circumstances.

Perinatal - the period before, during, and after the time of birth from the twenty-eighth (28th) week of gestation through the first seven (7) days after delivery.

Quarantine - the limitation of freedom of movement of well persons or animals that have been exposed to, or are suspected of having been exposed to, a communicable disease for a period of time equal to the longest usual incubation period of the disease in a manner that will prevent effective contact with those who are not exposed. Quarantine also shall mean the necessary restriction of the use of any premises suspected of contamination by communicable disease agents.

Restriction of movement - the limitation of freedom of movement of an infected person or animal, or a person or animal suspected of being infected, in the person's or animal's association with others not known to be immune to the communicable disease with which the person or animal is infected, or suspected of being infected.

Severe Acute Respiratory Syndrome or SARS - a contagious viral illness that spreads person-to-person by close proximity to an infected person. A suspect case may be identified by onset since February 1, 2003, of a temperature above 100.4 degrees Fahrenheit (100.4° F); one or more findings of respiratory illness including cough, shortness of breath, difficulty breathing, or hypoxia; and travel within ten (10) days of onset of symptoms to an area where there is current, documented community transmission of SARS or close contact within ten (10) days of onset of symptoms with a person known or suspected to have SARS. A probable case may be identified by the above findings plus radiographic evidence of pneumonia, respiratory distress syndrome, or autopsy findings consistent with pneumonia or respiratory distress syndrome without an identifiable cause.

Severe Maternal Morbidity – unexpected outcomes of labor and delivery that result in significant short-term consequences or long-term consequences to a woman’s health that include at least one of the following twenty-one specific morbidity indicators specified by the U.S. Centers for Disease Control and Prevention:

Acute myocardial infarction,

Acute renal failure,

Adult respiratory distress syndrome,

Amniotic fluid embolism,

Aneurysm,

Cardiac arrest/ventricular fibrillation,

Disseminated intravascular coagulation,

Eclampsia,

Heart failure/arrest during surgery or procedure,

Puerperal cerebrovascular disorders,

Pulmonary edema/acute heart failure,

Severe anesthesia complications,

Sepsis,

Shock,

Sickle cell disease with crisis,

Air and thrombotic embolism,

Blood transfusion,

Conversion of cardiac rhythm,

Hysterectomy,

Temporary tracheostomy, and

Ventilation.

Susceptible - a person or animal presumably not possessing resistance against a particular infectious agent.

Suspect - a person or animal whose medical history, symptoms, or laboratory findings suggest that the person or animal may have or may be developing some communicable disease.

Turtle - any animal of the order Testudinata (Chelonia), class Reptilia, having a carapace length of less than four inches (4"), including those commonly known as turtles, tortoises, and terrapins, except marine species (families Dermochildae and Cheloniidae).

Vancomycin-intermediate staphylococcus aureus (VISA) - a bacterium that is intermediate to vancomycin as per current CDC guidelines.

Vancomycin-resistant staphylococcus aureus (VRSA) - a bacterium that is resistant to vancomycin as per current CDC guidelines.

History

SOURCE: Commissioners’ Order 61-1117 (June 20, 1961), published as Health Regulations at §§ 8-5:101-205; as amended by § 7 of the Preventive Health Services Amendments Act of 1985, effective February 21, 1986 (D.C. Law 6-83; 32 DCR 7276, 7285 (December 13, 1985)); as amended by Final Rulemaking published at 42 DCR 6379, 6382 (November 17, 1995); as amended by Final Rulemaking published at 47 DCR 3493 (May 19, 2000); as amended by Final Rulemaking published at 50 DCR 6169 (August 1, 2003); as amended by Final Rulemaking published at 55 DCR 59979 (May 23, 2008); as amended by Final Rulemaking published at 56 DCR 848, 849 (January 23, 2009); as amended by Final Rulemaking published at 61 DCR 4939 (May 16, 2014); as amended by Final Rulemaking published at 63 DCR 15116 (December 9, 2016); as amended by Final Rulemaking published at 67 DCR 1951 (February 21, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 299

22-B3 TISSUE BANKS

22-B DCMR § 300 GENERAL PROVISIONS

300.1 This chapter shall provide minimum standards for the establishment, maintenance, and operation of tissue banks; and shall carry out the stated purposes of the D.C. Tissue Bank Act, as well as to meet the requirements of § 4(b) of the Act.

300.2 The provisions of this chapter shall apply to the establishment, maintenance, and operation of tissue banks.

300.3 In the absence of specific requirements in the Act and in this chapter, the management and operation of any tissue bank shall be in accordance with good medical and public health practice.

300.4 Each section and every part of each section of this chapter shall be independent of every other section or part of a section, and the finding or holding of any section or part of a section shall be void or ineffective for any cause shall not be deemed to affect any other section or part.

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is the District of Columbia Tissue Bank Act, D.C. Code, 2001 Ed. §§ 7 1541.01 to 7 1541.07; the District of Columbia Self-Government and Governmental Reorganization Act § 412, D.C. Code, 2001 Ed. § 1 204.04.
SOURCE: Commissioners’ Order 63-790 (March 26, 1963), 8 DCRR §§ 8-2:501 and 8-2:502 (1965).

22-B DCMR § 301 LICENSES

301.1 No person shall operate or hold himself or herself out as operating a tissue bank in the District after May 25, 1963, without being licensed, or designated by the licensee, as required by the Act and this chapter, unless the tissue bank is operated by, or in connection with, a federal or District agency.

301.2 Application for a license to operate a tissue bank shall be made to the Director on forms furnished by the Director for that purpose. Each application shall contain whatever other information concerning the operation of the bank as the Director may require, including but not limited to a statement of the general purposes and scope of the bank.

301.3 Each application for a license to operate a tissue bank shall be accompanied by payment of a fee of twenty-five dollars ($25).

301.4 Each application for a license to operate a tissue bank shall be signed and certified correct by the operator, unless the application is made by a person or persons licensed to operate a hospital, in which case it shall be signed and certified by the person licensed to operate the hospital.

301.5 Each tissue bank license shall specify the following information:

(a) The name of the licensee;

(b) The location of the bank; and

301.6 In any case in which a tissue bank is sponsored by and obtains a substantial portion of its financial support from a non-profit, charitable organization exempted from taxation under the provisions of §501 of the Internal Revenue Code of 1954, as amended, the name of the organization may, at the request of the applicant, be shown on the tissue bank license along with the name of the licensee.

301.7 Notwithstanding the provisions of § 301.1 of this section, the non-profit, charitable organization that substantially supports a tissue bank may indicate or advertise its sponsorship of the bank, using any style of name as the organization may elect.

301.8 Nothing in this section shall be construed as relieving the licensee from complying fully with all of the requirements of the Act and with this chapter.

301.9 Each tissue bank license shall be valid only for the licensee and the premises named in the license and only for the calendar year for which the license is issued.

301.10 The licensee shall frame the tissue bank license under clear glass or plastic, and post it in a conspicuous place on the licensed premises.

301.11 Whenever the Director finds that an applicant for a license does not meet the requirements of the Act or the provisions of this chapter, or that a licensee fails to comply with the Act or this chapter, the Director shall give written notice of the deficiency or failure to the applicant or licensee and shall require the applicant or licensee to show cause why a license should be issued or why his or her license should not be suspended or revoked.

301.12 Whenever the Director determines that the applicant does not meet the requirements of the Act or this chapter, or that a licensee fails to comply with the Act or this chapter, or that it would be in the best interests of the public health to deny, suspend, or revoke a license, the Director shall give written notice of that determination to the applicant or licensee by certified mail or personal service.

301.13 Any applicant or licensee may, within ten (10) days after receiving a notice as provided in § 301.12, request a hearing before the Director.

301.14 Not less than fifteen (15) days after receiving a request for a hearing, the Director shall fix a date and time for the hearing.

301.15 Any applicant for a license who is adversely affected by a determination made under the authority of this chapter may file an appeal in writing to the Board of Appeals and Review.

301.16 The appeal to the Board of Appeals and Review shall state the error alleged to be contained in any determination or refusal adversely affecting the applicant for a license or a licensee, and shall be filed within ten (10) days after receipt of the Director's determination.

History

SOURCE: Commissioners’ Order 63-790 (March 26, 1963), 8 DCRR §§ 8-2:504(a) - (g) (1965).

22-B DCMR § 302 OPERATION OF TISSUE BANKS

302.1 Each tissue bank shall be directed by an operator who shall be a physician with authority and responsibility for the direction of the bank.

302.2 The tissue bank operator shall maintain a roster of all persons authorized by him or her to have access to the bank, and shall establish specific rules for the operation of the bank and for governing the conduct of persons permitted access to the bank.

302.3 The roster and rules required in § 302.2 shall be made available to the Director upon request.

302.4 Whenever the licensee is a person licensed to operate a hospital, the licensee shall designate a physician who shall be the operator of the tissue bank.

302.5 In the case of any tissue bank exempted from licensing under the provisions of §4(e) of the Act, the individual directly in charge of the institution in which or in connection with which the tissue bank is operated shall designate a physician who shall be the operator of the bank.

302.6 The licensee shall notify the Director of any change of operator.

302.7 In the case of a tissue bank not required to be licensed under § 4(e) of the Act, the individual directly in charge of the institution in which or in connection with which the tissue bank is operated shall notify the Director of any change in the operator of the bank.

History

SOURCE: Commissioners’ Order 63-790 (March 26, 1963), 8 DCRR §§ 8-2:505(a) - (c), 8 DCRR (1965).

22-B DCMR § 303 RECORDS OF ACQUISITION AND WITHDRAWAL

303.1 No tissue may be placed in any tissue bank unless a proper record is made of its acquisition on a form that has been approved by the Director.

303.2 The record required in §303.1 shall consist of, but not be limited to, the following information:

(a) Name of donor;

(b) Place of death;

(d) Cause of death;

(e) Restrictions on the use of the tissue, if any, made by the donor or by the person having the right to the body;

(f) A complete description of the tissue, including categories of tissue and quantity of each category; and

(g) The signature of the physician who removed the tissue from the body of the deceased, and the signature of the operator.

303.3 No tissue may be placed in any tissue bank which has been acquired from another tissue bank, without being accompanied by a copy of the original record of acquisition and a detailed listing of the quantity and category of tissue.

303.4 No tissue may be withdrawn from a tissue bank unless a record of the withdrawal is made on a form approved by the Director.

303.5 The record of withdrawal required in §303.4 shall include, but not be limited to, the following information:

(a) A completed description of the tissue withdrawn, including categories of tissue and quantities of each category sent; and

(b) The purpose of withdrawal, that is, whether the tissue is to be used for human transplantation or for medico-surgical research.

303.6 Tissue shall be issued only to persons or institutions deemed qualified by the operator to use the tissue for the purposes set forth in the Act.

303.7 Whenever it becomes necessary to withdraw tissue from a tissue bank for any other purpose than for human transplantation or for medico-surgical research, a complete record of the withdrawal shall be made on a form approved by the Director.

303.8 The record of withdrawal required in §303.7 shall contain a complete description of the tissue withdrawn, the reasons for withdrawal, and the disposition made of the tissue.

History

SOURCE: Commissioners’ Order 63-790 (March 26, 1963), 8 DCRR §§ 8-2:506(a) - (c) (1965).

22-B DCMR § 304 PHYSICAL AND SANITARY REQUIREMENTS

304.1 The tissue bank operator shall at all times maintain sanitary conditions and sterile precautions appropriate to the procurement, banking, and issue of tissues, which, in the judgment of the Director, are consistent with accepted medical practices.

304.2 The location of the tissue bank shall be one that, in the judgment of the Director, will permit maintenance of the standard conditions and sterile precautions required in §304.1.

304.3 The facilities and other equipment provided for use by the bank shall be adequate for the purposes and scope of the bank as indicated in the application for license, and as approved by the Director.

History

SOURCE: Commissioners’ Order 63-790 (March 26, 1963), 8 DCRR §§ 8-2:507 and 8-2:508 (1965).

22-B DCMR § 305 INSPECTION

305.1 The Director shall make inspections of tissue banks and their records as may be required in the enforcement of the Act and this chapter.

305.2 The tissue bank operator shall cooperate in any inspection to the extent of providing the Director with the necessary assistance to make an inspection.

History

SOURCE: Commissioners’ Order 63-790 (March 26, 1963), 8 DCRR § 8-2:509 (1965).

22-B DCMR § 306 TRANSPORTATION OF TISSUE

306.1 Tissue may be transported to or from a tissue bank for any of the purposes of the Act or this chapter when accompanied by a signed copy of the applicable record required by § 303 of this chapter.

History

SOURCE: Commissioners’ Order 63-790 (March 26, 1963), 8 DCRR § 8-2:510 (1965).

22-B DCMR § 399 DEFINITIONS

399.1 The definitions contained in the Act are incorporated by reference in this chapter and made a part of this chapter.

399.2 In addition to the definitions contained in the Act, the words and phrases in this chapter shall have the meanings ascribed:

Act - the District of Columbia Tissue Bank Act, D.C. Code, 2001 Ed. §§ 7 1541.01 to 7 1541.07.

Department - the Department of Human Services of the District of Columbia.

Director - the Director of Human Services of the District of Columbia, or the Director's duly designated representative.

District - the territorial area known as the District of Columbia or the municipal government of the District of Columbia, as the context requires.

Operator - the licensee if the licensee is not a hospital; the physician designated by the licensee if the licensee is a hospital; or the physician designated to operate any tissue bank which, under the provisions of §4(e) of the Act, is not required to be licensed.

History

SOURCE: Commissioners’ Order 63-790 (March 26, 1963), 8 DCRR § 8-2:503 (1965).

22-B4 DRUG MANUFACTURE AND DISTRIBUTION

22-B DCMR § 400 GENERAL PROVISIONS

400.1 This chapter sets forth the procedures governing the licensure, registration and operation of drug manufacturers, distributors or wholesalers.

400.2 The rules in this chapter shall not apply to the distribution and sale of blood and blood products.

400.3 All in-state drug manufacturers, distributors, or wholesalers shall be licensed pursuant to § 401 of this chapter. All out-of-state drug manufacturers, distributors, or wholesalers shall be registered pursuant to § 404 of this chapter.

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is the District of Columbia Drug Manufacture and Distribution Licensure Act of 1990 §15, D.C. Code, 2001 Ed. § 48-701 to 48-715; and Mayor’s Order 92-45 (April 9, 1992).
SOURCE: Final Rulemaking published at 39 DCR 7729 (October 16, 1992).

22-B DCMR § 401 APPLICATION FOR IN-STATE LICENSURE

401.1 No person, with the exception of an out-of-state drug manufacturer, distributor, or wholesaler, duly registered under §§ 404 and 405, may engage in the manufacture, distribution, or wholesale of any drug until the application for licensure has been approved and a license issued by the Director.

401.2 Applications for licensure shall be made on a form prescribed by the Director and shall be accompanied by the required fee.

401.3 The application shall include the following information:

(a) The name and all trade or business names of the applicant and the address and telephone number of the place of business for which the applicant seeks a license;

(b) The name, address, and telephone number of contact personnel for all facilities used by the applicant for the storage, handling, and distribution of drugs;

(d) If the applicant is a corporation, the name and address of each officer or director of the corporation and each stockholder who owns ten percent (10%) or more of any one class of stock in the corporation or who owns ten percent (10%) or more of the total stock of the corporation, and the name of the state of incorporation if other than the District of Columbia;

(e) If the applicant is a partnership or joint venture, the name and address of each partner or joint venturer. If a partner or joint venturer is a corporation, any information required pursuant to paragraphs (c) and (l) of this section shall be produced by the partner or joint venturer;

(f) If the applicant is a sole proprietorship, the full name of the sole proprietor and the name of the business entity;

(g) A description of the manufacturing, wholesaling or distribution activity for which the applicant seeks a license;

(h) A list of all drugs that the applicant proposes to manufacture, distribute, or wholesale in the District of Columbia;

(i) Proof of current approval by the United States Food and Drug Administration for registration of producers of drugs and medical devices pursuant to § 360 of the Federal Food, Drug and Cosmetic Act, approved June 25, 1938 (21 U.S.C. §360);

(j) Proof of current registration with the Director and the United States Drug Enforcement Administration (DEA) if the applicant proposes to manufacture, distribute, or wholesale a controlled substance as defined in § 802 of the Drug Abuse Prevention and Control Act, approved October 27, 1970 (21 U.S.C. §802);

(k) A valid certificate of occupancy; and

(l) A certificate of good standing from the Director if the applicant is incorporated in the District of Columbia.

401.4 The Director shall consider the following factors in determining eligibility for licensure:

(a) Any conviction of the applicant under any federal, state or local laws relating to drug samples, wholesale or retail drug distribution, or distribution of controlled substances;

(b) Any felony convictions of the applicant under federal, state or local laws;

(c) The applicant’s past experience in the manufacture, distribution, or wholesale of drugs, including controlled substances;

(d) The furnishing by the applicant of false or fraudulent material in any application made in connection with drug manufacturing or distribution;

(e) Suspension or revocation by Federal, state, or local government of any license currently or previously held by the applicant for the manufacture or distribution of any drugs, including controlled substances;

(f) Compliance with licensing requirements under previously granted licenses, if any;

(g) Compliance with requirements to maintain and make available to District officials those records required under this chapter; and

(h) Any other factors or qualification the District considers relevant to and consistent with the public health and safety.

401.5 The Director shall require a separate license for each facility directly or indirectly owned or operated by the same business.

401.6 The Director shall have the right to deny a license to an applicant if it is determined that granting of such a license would not be consistent with the public health, safety and welfare.

401.7 The license must be posted in a conspicuous place in the facility to which it is issued.

History

SOURCE: Final Rulemaking published at 39 DCR 7729 (October 16, 1992).

22-B DCMR § 402 RENEWAL OF LICENSE

402.1 The Director shall mail a renewal notice to a licensee by first class mail to the licensee’s last known address on file with the Director at least forty-five (45) calendar days prior to the expiration of the license. The notice shall specify the expiration date.

402.2 The failure of a licensee to receive the renewal notice required by this section does not relieve the licensee of the responsibility of renewing the license by the expiration of the existing license.

402.3 If the Director does not receive the application for renewal of a license prior to the date of expiration on the license, the license shall lapse. The license may be reinstated within thirty (30) calendar days of its expiration, upon receipt of a completed renewal application.

402.4 The appropriate renewal fee shall accompany the application for renewal.

402.5 Any information the Director deems appropriate or necessary to renew the license since the initial application shall be mailed with the renewal notice.

History

SOURCE: Final Rulemaking published at 39 DCR 7729, 7731 (October 16, 1992).

22-B DCMR § 403 CONDITIONAL LICENSE

403.1 The Director may issue a license with specific conditions that are stated on the license.

403.2 The expiration license date, if any, of each condition shall be specified on the license.

403.3 The Director may revoke the license, if the Director determines that any of the conditions have been violated.

History

SOURCE: Final Rulemaking published at 39 DCR 7729, 7732 (October 16, 1992).

22-B DCMR § 404 APPLICATION FOR OUT-OF-STATE REGISTRATION

404.1 An out-of-state drug manufacturer, distributor, or wholesaler who conducts distribution activities within the District of Columbia shall be required to register with the Director.

404.2 No person required to be registered shall conduct distribution activities within the District of Columbia until the application for registration is issued and a Certificate of Registration is issued by the Director.

404.3 [REPEALED].

404.4 An applicant for an out-of-state registration shall submit the following:

(a) A completed application on the required form provided by the Director;

(b) The required registration fee;

(d) A copy of the most recent inspection report resulting from an inspection conducted by the regulatory or licensing agent of the state in which the principal place of business is located;

(e) Proof of current approval by the United States Food and Drug Administration for registration of producers of drugs and medical devices;

(f) Proof of current registration with the United States Drug Enforcement Administration for controlled substances, where applicable;

(g) The name and address of the Applicant’s designated registered agent in the District of Columbia;

(h) Proof of registration, and of good standing status, in the District of Columbia as a foreign filing entity as defined by Title 29 of the District of Columbia Official Code, if applicable; and

(i) Proof of “Clean Hands” as defined by the District of Columbia Tax and Revenue.

404.5 The Director shall require a separate registration for each facility directly or indirectly owned or operated by the same business.

404.6 The Director may require a registrant to submit documentation or written statements in support of an application. The Director may deny an application if the registrant fails to provide the requested information within fifteen (15) business days of receipt of the Director’s request.

History

SOURCE: Final Rulemaking published at 39 DCR 7729, 7732 (October 16, 1992); as amended by Final Rulemaking published at 63 DCR 8502 (June 17, 2016). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 404

22-B DCMR § 405 RENEWAL OF REGISTRATION FOR OUT-OF-STATE DRUG MANUFACTURERS, DISTRIBUTORS, REPACKAGERS, AND WHOLESALERS

405.1 The Director shall mail a renewal notice to an out-of-state registrant by first class mail to the registrant’s last known address on file with the Director at least forty-five (45) calendar days prior to the expiration of the registration.

405.2 The failure of a registrant to receive the renewal notice required by this section does not relieve the registrant of the responsibility of renewing the registration in a timely manner.

405.3 An applicant for renewal of an out- of -state registration shall submit the following:

A completed renewal application on the required form provided by the Director;

(b) The required renewal fee;

(d) A copy of the most recent inspection report resulting from an inspection conducted by the regulatory or licensing agent of the state in which the principal place of business is located;

(e) Proof of current approval by the United States Food and Drug Administration for registration of producers of drugs and medical devices;

(f) Proof of current registration with the United States Drug Enforcement Administration for controlled substances, where applicable;

(g) The name and address of the Applicant’s designated registered agent in the District of Columbia;

(h) Proof of registration, and of good standing status, in the District of Columbia as a foreign filing entity as defined by Title 29 of the District of Columbia Official Code, if applicable; and

(i) Proof of “Clean Hands” as defined by the District of Columbia Tax and Revenue.

405.4 A registration shall lapse if the application for renewal of the registration is not received prior to the date of expiration on the registration. The registration may be reinstated within thirty (30) calendar days of its expiration, upon receipt of a completed renewal application. If the registration lapses, the fee to reinstate the registration shall accompany the application for registration.

History

SOURCE: Final Rulemaking published at 39 DCR 7729, 7733 (October 16, 1992); as amended by Final Rulemaking published at 63 DCR 8502 (June 17, 2016). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 405

22-B DCMR § 406 EXEMPTIONS

406.1 The following shall be exempt from licensure and registration:

(a) Manufacturers’ representatives that distribute drug samples;

(b) Distributors’ representatives that distribute drug samples;

(c) Group purchasing organizations established to maintain and to operate for the purchase of drugs for distribution exclusively to its members;

(d) Intracompany distribution of products, namely to retail stores that are under common ownership or within the same corporate structure; and

(e) The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug for “emergency medical reasons” which includes transfers of prescription drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage.

History

SOURCE: Final Rulemaking published at 39 DCR 7729, 7733 (October 16, 1992).

22-B DCMR § 407 PERSONNEL

407.1 A pharmacist licensed in the District of Columbia or an individual approved by the Director as having scientific or technical training or experience to perform the duties required to ensure that the licensed activity is conducted in a manner that will protect the public health and safety shall supervise all personnel engaged in the manufacturing activities.

407.2 Each person employed in any drug wholesale distribution activity shall have education, training, and experience to ensure an acceptable level of proficiency to perform assigned functions and provide assurance that the drug product quality, safety and security will be maintained at all times.

407.3 Licensees shall establish and maintain a list of officers, directors, managers and other personnel in charge of manufacturing, wholesale drug distribution, storage, and handling. The list shall include a description of their duties and a summary of their qualifications.

History

SOURCE: Final Rulemaking published at 39 DCR 7729, 7734 (October 16, 1992).

22-B DCMR § 408 SECURITY

408.1 All facilities used for manufacturing and wholesale drug distribution shall be secure from unauthorized entry as follows:

(a) Access from outside the premises shall be kept to a minimum and be well controlled;

(b) The outside perimeter of the premises shall be well lighted; and

408.2 All facilities shall be equipped with an alarm system to detect entry after hours.

408.3 All facilities shall be equipped with a security system that will provide suitable protection against theft and diversion. When appropriate, the security system shall provide protection against theft or diversion that is facilitated or hidden by tampering with computers of electronic records.

History

SOURCE: Final Rulemaking published at 39 DCR 7729, 7734 (October 16, 1992).

22-B DCMR § 409 WRITTEN POLICIES AND PROCEDURES

409.1 Licensees shall establish, maintain, and adhere to written policies and procedures for the receipt, security, storage, inventory and distribution of drugs. Written policies shall include the following:

(a) Procedures for identifying, recording, and reporting losses and thefts;

(b) [Reserved]

(c) Procedures whereby the oldest approved stock of a drug product is distributed first. The procedure may permit deviation from this requirement, if such deviation is temporary and appropriate;

(d) Procedures to be followed for handling recalls and withdrawals of drugs. Such procedures shall ensure that all drugs included on the recall and/or withdrawal, are returned for proper disposition due to:

(1) An action initiated at the request of the Food and Drug Administration or other Federal, state, or local law enforcement or other government agency, including the Director;

(2) Any voluntary action by the manufacturer to remove defective or potentially defective drugs from the market; or

(3) Any action undertaken to promote public health and safety by replacing of existing merchandise with an improved product or new package design.

(e) Procedures to ensure that licensees prepare for, protect against, and handle any crisis that affects security or operation of any facility in the event of strike, fire, flood, or other natural disaster, or other situations of local, state or national emergency.

(f) Procedures to ensure that any outdated drugs shall be segregated from other drugs and either returned to the manufacturer or destroyed. This procedure shall provide for written documentation of the disposition of outdated drugs. This documentation shall be maintained for two (2) years after disposition of the outdated drugs.

History

SOURCE: Final Rulemaking published at 39 DCR 7729, 7734 (October 16, 1992).

22-B DCMR § 410 SALVAGING AND REPROCESSING

410.1 All facilities licensed pursuant to this chapter shall be in compliance with applicable provisions of Federal, state or local laws or regulations relating to drug product salvaging or reprocessing.

History

SOURCE: Final Rulemaking published at 39 DCR 7729, 7735 (October 16, 1992).

22-B DCMR § 411 EXAMINATION OF MATERIALS

411.1 Manufacturers, distributors and wholesalers upon receipt of each incoming shipping container shall carefully inspect all shipments of drugs to determine their identity and to prevent the acceptance of contaminated drugs unfit for distribution. This examination shall be adequate to reveal container damage that would suggest possible contamination or other damage to the contents.

411.2 Each outgoing shipment shall be carefully inspected for identity of the drug products and to ensure that there is no delivery of drugs that have been damaged in storage or held under improper conditions.

History

SOURCE: Final Rulemaking published at 39 DCR 7729, 7735 (October 16, 1992).

22-B DCMR § 412 LABELING, HANDLING, STORAGE, AND RECORDKEEPING STANDARDS

412.1 Drugs that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other drugs until they are destroyed or returned to their supplier.

412.2 Any drug whose immediate or sealed outer or sealed secondary containers have been opened or used shall be identified as such and shall be quarantined and physically separated from other drugs until they are either destroyed or returned to their supplier.

412.3 If the conditions under which a drug has been returned cast doubt on the drug’s safety, identity, strength, quality, or purity, then the drug shall be destroyed or returned to the supplier, unless examination, testing or other investigation proves that the drug meets appropriate standards of safety, identity, strength, quality, and purity. In determining whether the conditions under which a drug has been returned cast doubt on the drug’s safety, identity, strength, quality, or purity, the drug supplier shall consider, among other things, the conditions under which the drug has been held, stored, or shipped before or during its return and the condition of the drug and its container, carton, or labeling, as a result of storage or shipping.

412.4 All facilities at which drugs are stored, warehoused, handled, held, offered, marketed or displayed shall meet the following minimum requirements:

(a) Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;

(b) Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;

(c) Have a quarantine area for storage of drugs that are outdated, damaged, deteriorated, misbranded, adulterated, or that are in sealed, secondary containers that have been opened;

(d) Be maintained in a clean and orderly condition; and

(e) Be free from infestation by insects, rodents, birds, or vermin of any kind.

412.5 All drugs shall be stored at appropriate temperatures and under conditions in accordance with requirements, if any, in the labeling of such drugs, or according with the requirements in the current edition of an official compendium:

(a) If no storage requirements are established for a drug, the drug may be held at “controlled” room temperature, as defined in an official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected; and

(b) Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and/or logs shall be utilized to document proper storage of drugs.

412.6 Manufacturers, wholesalers, and distributors shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of drugs. These records shall include the following information:

(a) The source of the drugs, including the name and principal address of the seller or transferor, and the address of the location from which the drugs were shipped;

(b) The identity and quantity of the drugs received and distributed or disposed of; and

412.7 Inventories and records shall be made available for inspection and photocopying by the Director for a period of two (2) years following disposition of drugs.

412.8 Records described in this section that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for inspection during the retention period. Records kept at a central location apart from the inspection site and are not electronically retrievable shall be made available for inspection within two (2) business days of a request by the Director.

History

SOURCE: Final Rulemaking published at 39 DCR 7729, 7736 (October 16, 1992).

22-B DCMR § 413 INSPECTIONS

413.1 The Director shall conduct an on-site inspection of an applicant’s facility before a license is granted.

413.2 Applicants and licensees shall permit the Director or any authorized District official to enter and inspect their premises and delivery vehicles, and audit their records and operating procedures at any reasonable hour and in a reasonable manner.

413.3 Applicants and licensees shall permit the Director to have access to all records, policies and procedures, contracts, and any other information that the Director deems necessary to determine if the facility is in compliance with the Act, rules issued pursuant to the Act, or any other District law or Federal law applicable to the manufacture, distribution, or wholesale of drugs.

413.4 The Director shall send a written report of the findings of the inspection to the applicant or licensee no later than fifteen (15) working days after the conclusion of the inspection.

413.5 If the report states that there are deficiencies, the applicant or licensee shall correct them within the time period required by the Director.

413.6 The Director may request written proof of correction of all deficiencies and may conduct a follow-up inspection to determine correction of the deficiencies after the applicant or licensee notifies the Director that the deficiencies have been corrected.

413.7 The Director may deny or revoke a license if the deficiencies have not been corrected within the time period specified by the Director pursuant to § 414 of this chapter. The applicant may reapply for a license after the deficiencies are corrected by submitting a new application and fee in accordance with this chapter.

History

SOURCE: Final Rulemaking published at 39 DCR 7729, 7737 (October 16, 1992).

22-B DCMR § 414 SUSPENSION, DENIAL, REVOCATION OF LICENSE

414.1 The Director shall take action to deny, suspend, or revoke a license, or convert the license to a conditional license, subject to the right of a hearing as provided by this chapter.

414.2 Grounds for suspension, revocation, denial or refusal to renew a license include, but are not limited to, the following:

(a) Violation or noncompliance with the Act, rules issued pursuant to the Act, or any other applicable Federal or District law;

(b) Refusal to allow the Director or a duly authorized agent access to the facility for the purpose of determining compliance with the Act, or rules issued pursuant to the Act;

(c) Willful submission by the licensee of false or misleading information to the Director in connection with an application for licensure;

(d) Failure of the licensee to meet and maintain the standards required by the Act, or rules issued pursuant to the Act;

(e) Failure to comply with the terms of a plan to correct deficiencies submitted to the Director or other agreement with the Director; or

(f) Failure of the licensee to obey any lawful order of the Director issued pursuant to this chapter.

414.3 The Director shall revoke any license issued pursuant to the Act upon conviction of the licensee of a criminal violation of the Act, rules issued pursuant to the Act, or any applicable District or Federal law.

414.4 Once a license has been revoked or suspended, the licensee cannot distribute drugs in the District.

414.5 Upon service of the order of the Director suspending or revoking licensure, the licensee shall immediately deliver the certificate of licensure to the Director.

414.6 Upon suspension or revocation of a license, all controlled substances in the possession of the licensee shall be placed under seal.

414.7 No disposition may be made of controlled substances under seal unless the time for filing an appeal has elapsed or until all appellate remedies have been exhausted, unless a court orders the sale of perishable substances and the proceeds of the sale are deposited with the court.

414.8 The Director shall promptly notify the United States Drug Enforcement Administration of all orders suspending or revoking licensure and all forfeitures of controlled substances.

History

SOURCE: Final Rulemaking published at 39 DCR 7729, 7738 (October 16, 1992).

22-B DCMR § 415 WITHDRAWAL OF REGISTRATION

415.1 The Director may withdraw registration of a registrant who is not licensed or registered in the state in which they are physically located, or in good standing under Federal law or the laws of the state in which incorporated.

415.2 The Director shall give written notice to the applicant citing the basis for withdrawal. The effective date of withdrawal shall be ten (10) calendar days from the date of service of the notice, or immediately, in case of danger to the public health, safety or welfare.

415.3 The notice shall state that registration shall be automatically withdrawn unless, prior to the effective date, registrant submits official proof satisfactory to the Director of a license in good standing.

415.4 A registrant can reinstate registration by submitting official proof of compliance with Federal or state licensure or registration cited in the notice of withdrawal.

415.5 Once a registration has been withdrawn, a registrant cannot distribute drugs in the District.

History

SOURCE: Final Rulemaking published at 39 DCR 7729, 7739 (October 16, 1992).

22-B DCMR § 416 OPPORTUNITY FOR A HEARING

416.1 The Director shall take action to deny, suspend, or revoke a license, or convert the license to a conditional license pursuant to § 11 of the Act, D.C. Code, 2001 Ed. § 48-710.

416.2 Except for summary suspension undertaken pursuant to § 10 of the Act, D.C. Code, 2001 Ed. § 48-709, every applicant for or holder of a license or applicant for reinstatement after revocation shall be afforded notice and an opportunity to be heard prior to the action of the Director, the effect of which would be one of the following:

(a) To deny a license for good cause other than failure to meet the licensing requirements set forth in the Act and this chapter;

(b) To suspend a license;

(d) To refuse to reinstate a license;

(e) To convert the license to a conditional license;

(f) To refuse to issue a renewal license for any good cause other than failure to pay the prescribed fees;

(g) Impose a civil fine pursuant to the Department of Consumer and Regulatory Affairs Civil Infractions Act of 1985, D.C. Code, 2001 Ed. §§ 2-1801.01 to 2-1803.03; or

(h) Reinstatement of the license.

History

SOURCE: Final Rulemaking published at 39 DCR 7729, 7740 (October 16, 1992).

22-B DCMR § 417 NOTICE OF PROPOSED ACTION

417.1 When the Director proposes to deny a license for failure to meet the requirements of the Act or this chapter, the applicant shall be given written notice containing the following statements:

(a) That the applicant has failed to satisfy the Director as to the applicant’s qualifications;

(b) The respect in which the applicant has failed to satisfy the Director;

(c) That the denial will become final unless the applicant files a request for a hearing with the Director within fifteen (15) calendar days of the receipt of the notice; and

(d) A description of the rights of the applicant at a hearing as specified in § 423 of this chapter.

417.2 When the Director proposes to take any action of the type specified in § 416.2(a), (b), (c), (d), (e), or (f) of this chapter, the licensee shall be given a written notice containing the following statements:

(a) That the Director has sufficient evidence which, if not rebutted or explained, justifies the Director in taking the proposed action;

(b) That the Director may take the proposed action, unless within fifteen (15) calendar days of the receipt of the notice the respondent files with the Director a written request for a hearing or in the alternative submits documentary evidence for the Director’s consideration before the Director takes final action; and

History

SOURCE: Final Rulemaking published at 39 DCR 7729, 7740 (October 16, 1992).

22-B DCMR § 418 NOTICE OF HEARING

418.1 Any notice required by this chapter may be served either personally or by certified mail, return receipt requested, directed to the respondent at his or her last known address as shown by the records filed with the Director by the respondent.

418.2 If the notice is served personally, it shall be deemed to have been served at the time delivery is made to the respondent.

418.3 If the notice is served by certified mail, it shall be deemed to have been served on the date shown on the return receipt showing delivery or refusal of the respondent to receive notice.

418.4 In the event the respondent is no longer at the last known address as shown by the records filed with the Director and no forwarding address is available, the notice shall be deemed to have been served on the date the return receipt bearing such notification is received by the Director.

418.5 If a respondent scheduled for a hearing does not appear and no continuance has been or is granted, the Director may hear the evidence of those witnesses present, and the Director may proceed to consider the matter and render a decision on the basis of the evidence presented.

History

SOURCE: Final Rulemaking published at 39 DCR 7729, 7741 (October 16, 1992).

22-B DCMR § 419 PROCEDURE WHEN A RESPONDENT FAILS TO RESPOND TO A HEARING NOTICE

419.1 If the respondent does not respond to the hearing notice within the time specified, the Director may, without a hearing, take the action proposed in the notice. The Director shall, in writing, inform the respondent and the Corporation Counsel of his or her action.

History

SOURCE: Final Rulemaking published at 39 DCR 7729, 7742 (October 16, 1992).

22-B DCMR § 420 HEARINGS: SUMMARY SUSPENSION

420.1 A respondent who has been summarily suspended pursuant to § 10 of the Act, D.C. Code, 2001 Ed. § 48-709, shall be notified in writing of the action being taken and that the licensee is entitled to a hearing, upon written request within three (3) calendar days of the service of the notice.

420.2 The Director shall hold a hearing within three (3) calendar days of receipt of a timely request and shall issue a decision within three (3) calendar days of the hearing.

420.3 If a hearing is requested pursuant to this section, the request shall not serve to stay the issuance of an order suspending, revoking, or converting the license.

History

SOURCE: Final Rulemaking published at 39 DCR 7729, 7742 (October 16, 1992).

22-B DCMR § 421 HEARINGS: CEASE AND DESIST ORDERS

421.1 The Director may issue a cease and desist order when a hazardous condition exists that may endanger the health, safety, or welfare of the community.

421.2 The violator shall be notified in writing to cease operations immediately and that the violator is entitled to appeal the cease and desist order.

421.3 A person subject to a cease and desist order may request a hearing within seven (7) business days after service of the order but shall be required to comply with the order, pending appeal.

421.4 The Director shall hold a hearing within seven (7) calendar days of a receipt of a timely request and issue a decision within seven (7) calendar days after the hearing.

History

SOURCE: Final Rulemaking published at 39 DCR 7729, 7742 (October 16, 1992).

22-B DCMR § 422 EMBARGO

422.1 If the Director determines that a drug is adulterated or misbranded, the Director may order that the drug be removed from availability for distribution, sale, consumption, or use, or that the drug be destroyed or embargoed.

422.2 A person subject to an embargo shall be notified in writing of the action being taken and the basis of the action.

422.3 Whenever a drug is embargoed the Director shall order the drug be segregated and isolated from other drug products, affixed with a tag or other appropriate marking giving notice that the drug is, or is suspected of being, adulterated or misbranded.

422.4 The Director may continue to order the embargo of the drug until a sample has been analyzed by a qualified person designated by the Director.

422.5 If the Director determines that an embargoed drug is not adulterated or misbranded, he or she shall notify the person subject to the embargo that the tag or other marking may be removed.

422.6 If the Director determines that an embargoed drug is adulterated or misbranded the Director shall order that the drug be permanently removed from availability for distribution, sale, consumption, or use in the District of Columbia, or that the drug be destroyed.

422.7 It is unlawful for any person to remove or dispose of a drug that has been embargoed without permission from the Director.

History

SOURCE: Final Rulemaking published at 39 DCR 7729, 7742 (October 16, 1992).

22-B DCMR § 423 CONDUCT OF HEARINGS

423.1 All hearings before the Director shall be open to the public.

423.2 The Director, or his or her designee, shall hear the evidence and render a decision.

423.3 A respondent entitled to a hearing shall have the following rights:

(a) To be represented by counsel or other representative;

(b) To present all relevant evidence by means of witnesses, books, papers, documents and other relevant materials;

(d) To have subpoenas issued, upon written request to the Director, to compel the attendance of witnesses and the production of relevant books, papers, documents, and other relevant materials.

423.4 In conducting a hearing pursuant to this chapter, the Director is authorized to do the following:

(a) Administer oaths or affirmation to witnesses called to testify pursuant to D.C. Code, 2001 Ed. § 1-301.22;

(b) Subpoena respondents, witnesses, books, papers, documents and other materials pursuant to D.C. Code, 2001 Ed. § 1-301.21;

(d) Examine witnesses;

(e) Order a continuance;

(f) Enter into a consent agreement; and

(g) Render a decision.

423.5 The Director shall receive and consider any evidence or testimony; however, the Director may exclude irrelevant, immaterial, or unduly repetitious evidence or testimony.

423.6 In any proceeding resulting from the Director’s proposed action to deny licensure, the applicant shall have the burden of satisfying the Director of the applicant’s qualifications.

423.7 In any proceeding resulting from the Director's proposed action (a) to refuse to renew or reinstate a license; or (b) to suspend, revoke or convert the license to a conditional license, the Director shall have the burden of proving that the action should be taken.

423.8 A complete record shall be made of all evidence presented during the course of the hearing. Any party to the proceedings, or his or her attorney of record, shall be furnished with a copy of the record upon request and payment of a fee prescribed by the Director.

History

SOURCE: Final Rulemaking published at 39 DCR 7729, 7743 (October 16, 1992).

22-B DCMR § 424 DECISIONS

424.1 The decision of the Director shall include the following:

(a) Findings of fact;

(b) Conclusions of law; and

(c) A statement informing the respondent of the right to have the decision reviewed by the Board of Appeals and Review, and the time period within which the request for such a review must be filed.

424.2 The Director shall serve upon the respondent, or his or her attorney of record, a copy of the written decision, either by personal service or certified mail, return receipt requested. If served by certified mail, it shall be deemed served on the date contained on the return receipt for acceptance or refusal, or the date of the unsuccessful attempt by the United States Postal Service to make delivery.

History

SOURCE: Final Rulemaking published at 39 DCR 7729, 7744 (October 16, 1992).

22-B DCMR § 425 ADMINISTRATIVE AND JUDICIAL REVIEW

425.1 When a respondent fails, for good cause, to appear for a hearing which has been scheduled, the respondent may, within thirty (30) days from the date of the decision, apply to the Director to reopen the proceedings. The Director, upon finding the cause sufficient, may fix a time and place for the hearing and shall give notice to the parties.

425.2 The Director may reopen a proceeding for any cause deemed sufficient, provided that no appeal is pending or no decision has been issued regarding the case by the Board of Appeals and Review or any Federal or local court.

425.3 A respondent aggrieved by an adverse decision by the Director may seek a review of the decision by the Board of Appeals and Review according to its rules, as specified in Chapter 5 of Title 1 DCMR.

425.4 A respondent adversely affected by the decision of the Board of Appeals and Review may seek a review of the decision by the District of Columbia Court of Appeals according to the rules prescribed by the Court.

425.5 Within the time set by Court rule or order, the Director shall certify and file with the Clerk of the Court the record of the case as required by the Court.

History

SOURCE: Final Rulemaking published at 39 DCR 7729, 7745 (October 16, 1992).

22-B DCMR § 499 DEFINITIONS

499.1 When used in this chapter, the following words or phrases shall have the meanings ascribed:

Act - the District of Columbia Drug Manufacture and Distribution Licensure Act of 1990, D.C. Code, 2001 Ed. § 48-701 to 48-715.

Conditional License - a license issued pursuant to specific conditions.

Controlled Substance - a drug, substance, or immediate precursor, as defined under D.C. Code, 2001 Ed. § 48-902.02.

Department - the Department of Consumer and Regulatory Affairs.

Director - the Director of the Department of Consumer and Regulatory Affairs or a designee.

Distribute - to negotiate a sale or sell any drug for resale; or to act as a broker, agent, distributor, jobber, or wholesaler of any drug.

Drug - any substance as defined under D.C. Code, 2001 Ed. § 47-2885.02.

Manufacture - to prepare, produce, propagate, compound, convert, process, or package a drug, either directly or indirectly, by extraction from a substance of natural origin, or independently by means of chemical synthesis; any packaging or repackaging of the substance or drug; labeling or relabeling of any drug package or container to further distribution from the original place of manufacture to the person who makes final delivery, distribution, or sale to the ultimate consumer or user. Does not include the preparation or compounding of a drug by a pharmacist, practitioner, or any other authorized person who prepares or compounds a drug incidental to administering or dispensing a drug or conducting research, teaching, or chemical analysis on a drug in the course of professional practice.

Wholesaler - any person, including but not limited to, a manufacturer, repackager, own-label distributor, jobber, broker, agent, pharmacy, private label distributor, distributor warehouse, wholesale drug warehouse, independent wholesale drug trader, chain drug warehouse, retail pharmacy, or pharmacy that sells more than five percent (5%) of its drug inventory to a hospital or other pharmacy, which distributes a drug to a person other than a consumer or patient.

History

SOURCE: Final Rulemaking published at 39 DCR 7729, 7745 (October 16, 1992).

22-B5 SAFE DISPOSAL OF UNUSED PHARMACEUTICALS IN HEALTH CARE FACILITIES

22-B DCMR § 500 GENERAL PROVISIONS AND ENFORCEMENT

500.1 Effective January 1, 2011, a health care facility shall not dispose of any pharmaceutical product, used or unused, by flushing the product down a drain or by any other method that utilizes the public sewer system, except as authorized by this chapter.

500.2 Effective July 1, 2013, unless authorized by this chapter, a health care facility that is determined to have disposed of a pharmaceutical product by flushing the product down a drain or by any other method that utilizes the public sewer system, shall be:

Subject to a civil fine of up to one thousand dollars ($1,000) per occurrence; and

Required to submit to the Board of Pharmacy, or its designee, a mitigation

plan designed to prevent further such occurrences within thirty (30) days of receipt of a request for the mitigation plan.

The Director of the Department of Health (Director), or his or her agent, shall have the right to enter upon and into the premises of any health care facility:

At reasonable times;

After presenting proper identification; and

(c) For the purpose of making inspections to determine compliance with this chapter and the District of Columbia Unused Pharmaceutical Safe Disposal Act of 2009, effective March 5, 2010 (D.C. Law 18-112, D.C. Official Code §§ 48-851.01, et seq. (2012 Repl.)) (Act).

500.4 An inspection or investigation conducted pursuant to this chapter and the Act may include, but shall not be limited to:

Review of policies and procedures manuals;

Inspection of all locations within the health care facility where pharmaceuticals and pharmaceutical waste are stored; and

Review of all records, receipts, and other documentation pertaining to the health care facility’s pharmaceutical waste disposal.

500.5 Chapters 20 (Hospitals) and 32 (Nursing Facilities) of this subtitle shall supplement this chapter.

History

SOURCE: Final Rulemaking published at 60 DCR 9354 (June 21, 2013).

22-B DCMR § 501 EXEMPTED PHARMACEUTICAL PRODUCTS

501.1 When absent of any additional additives, the following pharmaceutical products may be disposed of by flushing the product down the drain or by another method that uses the sewer system:

(a) Sterile Water;

(b) Dextrose solutions such as five percent (5%) dextrose in water (D5W);

(d) Lactated Ringers;

(e) Potassium salts such as potassium chloride (KCl);

(f) Calcium salts such as calcium chloride (CaCl) and Calcium Gluconate; and

(g) Magnesium salts such as magnesium sulfate (MgSo4).

History

SOURCE: Final Rulemaking published at 60 DCR 9354 (June 21, 2013).

22-B DCMR § 502 DISPOSAL OF UNUSED PHARMACEUTICAL PRODUCTS

502.1 Pharmaceutical products may be disposed of through:

(a) A waste to energy program;

(b) A pharmaceutical waste container with appropriate procedures for disposal; or

Those pharmaceutical products which are defined as controlled substances under federal or District law shall be managed in accordance with federal and District laws and regulations.

Those pharmaceutical products which are defined as hazardous waste under federal or District law shall be managed in accordance with federal and District laws and regulations.

502.4 All antineoplastic and cytotoxic drugs shall be treated as hazardous waste and

managed and disposed of in accordance with the applicable federal and District laws and regulations.

502.5 A health care facility may choose to manage its pharmaceutical waste at a more stringent or higher level of waste management than that required under applicable District or federal laws and regulations.

502.6 All pharmaceutical waste shall be separated from active pharmaceutical stock and clearly labeled as “pharmaceutical waste.”

502.7 Pharmaceutical waste shall not be combined with other forms of waste unless the pharmaceutical waste is first denatured as recommended by both the FDA and DEA.

History

SOURCE: Final Rulemaking published at 60 DCR 9354 (June 21, 2013).

22-B DCMR § 503 RECORDKEEPING

The recordkeeping requirements of this section shall apply to all health care facilities, unless otherwise exempted by this chapter or the Director.

503.2 A healthcare facility shall maintain a complete and accurate record of its pharmaceutical waste disposal, for a period of three (3) years from the date of disposal.

503.3 A healthcare facility shall develop and maintain written policies and procedures for the management of its pharmaceutical waste.

(a) These policies and procedures shall include, at a minimum, the following:

Documentation that the program has been reviewed and updated as needed not less than every two (2) years;

(2) The position title(s) of the person(s) within the facility responsible for program implementation; and

(3) Policies and procedures designed to educate facility staff and volunteers, as part of an orientation process and continuing on an annual basis thereafter, regarding proper pharmaceutical waste disposal; and

(b) These policies and procedures may also include processes designed to minimize the creation of pharmaceutical waste, such as implementation of a pharmaceutical waste minimization program.

History

SOURCE: Final Rulemaking published at 60 DCR 9354 (June 21, 2013).

22-B DCMR § 599 DEFINITIONS

599.1 As used in this chapter the following terms shall have the meanings ascribed:

Act - District of Columbia Unused Pharmaceutical Safe Disposal Act of 2009, effective March 5, 2010 (D.C. Law 18-112, D.C. Official Code §§ 48-851.01, et seq. (2012 Repl.))

Board - District of Columbia Board of Pharmacy

Department - Department of Health

Director - Director of the Department

Hazardous pharmaceutical waste - a pharmaceutical product that is defined as hazardous waste under federal or District law.

Health care facility – a hospital, assisted living facility, nursing home, or institutional pharmacy.

Institutional pharmacy – that physical portion of a health care facility where drugs, devices, and other materials used in the diagnosis or treatment of injury, illness, and disease are dispensed, compounded, or distributed and pharmaceutical care is provided.

Pharmaceutical product – a drug or biologic for human use regulated by the federal Food and Drug Administration.

Pharmaceutical waste - a pharmaceutical product that is no longer suitable for its intended purpose or is otherwise being discarded, but does not include pharmaceuticals excreted from the body during normal physiological functions and medical procedures.

Pharmaceutical waste minimization program - a program used to identify pharmaceuticals that need to be discarded, to decrease pharmaceutical waste, and to implement more environmentally sustainable practices regarding pharmaceutical waste disposal.

History

SOURCE: Final Rulemaking published at 60 DCR 9354 (June 21, 2013).

22-B6 PROTECTION OF MINORS

22-B DCMR § 600 MINOR'S HEALTH CONSENT

600.1 Any person who is eighteen (18) years of age or older may consent to the provision of health services for himself or herself, or for his or her child or spouse.

600.2 Any minor who is seventeen (17) years of age or more may consent to voluntarily donate blood to a nonprofit organization, being regarded as having achieved his or her majority for the purposes of this section.

600.3 A minor parent may consent to the provisions of health services to his or her child.

600.4 Health services may be provided to a minor of any age without parental consent when, in the judgement of the treating physician, surgeon, or dentist, the delay that would result from attempting to obtain parental consent would substantially increase the risk to the minor's life, health, mental health, or welfare, or would unduly prolong suffering.

600.5 A health professional may render or attempt to render emergency service of first aid, medical, surgical, dental, or psychiatric treatment without compensation to any injured person or any person regardless of age who is in need of immediate health care when, in good faith, the professional believes that the giving of aid is the only alternative to probable death or serious physical or mental damage.

600.6 In an emergency where major surgery or any dangerous procedures will be performed, concurrence of another physician shall, if practical, be obtained.

600.7 A minor of any age may consent to health services which he or she requests for the prevention, diagnosis, or treatment of the following medical situations:

(a) Pregnancy or its lawful termination;

(b) Substance abuse, including drug and alcohol abuse; and

600.8 Self-consent of minors shall not apply to sterilization, such as tubal ligation or vasectomy.

600.9 [REPEALED]

600.10 (a) A minor who is sixteen ( l6) years of age or more and enrolled in a Medicaid or DC HealthCare Alliance health benefits plan may:

(l) Request their medical records from a health care provider without parental consent; and

(2) Make medical appointments and consent to the provision of eligible health services for themselves without parental consent; provided, that the minor is capable of meeting the informed consent standard.

(b) For the purposes of this subsection, the term:

(l) "Eligible health services" means primary care, dental, and vision health services, but shall not include specialist care, emergency care, surgery, or vaccinations; provided, that nothing in this definition shall be construed to limit or prevent a minor from seeking any health service that a minor is otherwise entitled to under any other provision in this chapter.

(2) "Informed consent standard" means the minor is able to comprehend the need for, the nature of, and any significant risks ordinarily inherent in the health services to be provided.

History

SOURCE: Regulation No. 74-22 (August 30, 1974), 21 DCR 477 (September 16, 1974), 6H DCRR § 2 (1982); as amended by § 2 of the Minors Health Consent Regulation, effective November 17, 1981 (D.C. Law 4-52; 28 DCR 4348 (October 9, 1981)); as amended by § 5 of the Preventive Health Services Amendments Act of 1985, effective February 21, 1986 (D.C. Law 6-83; 32 DCR 7276, 7282 (December 13, 1985)); as amended by Minor Consent for Vaccinations Amendment Act of 2020, effective March 16, 2021; (D.C. Law 23-193; 67 DCR 014774 (December 25, 2020)); as amended by the Consent for Vaccination of Minors Amendment Act of 2022, effective March 10, 2023 (D.C. Law 24-312; 70 DCR 000598 (January 20, 2023)); as amended by the Minor Access to Medical Records and Appointments Regulations Amendment Act of 2024, effective March 23, 2024 (D.C. Law 25-145; 71 DCR 003861 (April 5, 2024)). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 600

22-B DCMR § 601 FINANCIAL RESPONSIBILITY

601.1 A minor who consents to the provision of health services to himself or herself, or to the minor's child, under the terms of this chapter shall be liable for the payment of the services rendered pursuant to this chapter.

601.2 The spouse, parent, parents, or legal guardian shall not be liable for payment of services rendered, unless the spouse, parent, parents, or legal guardian have expressly agreed to pay for the care.

601.3 The minor consenting for health services shall assume financial responsibility for the cost of those services, except minors who are proven unable to pay and who receive the services in public institutions, or who qualify for medicaid or other subsidized forms of relief.

History

SOURCE: Regulation No. 74-22 (August 30, 1974), 21 DCR 477 (September 16, 1974), 6H DCRR § 4 (1982). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 601

22-B DCMR § 602 LIABILITY OF PROVIDER

602.1 No physician, surgeon, dentist, or health or mental care facility shall be compelled against his, her, or its best judgment to treat a minor on the minor's own consent.

602.2 A physician, surgeon, dentist, or health or mental care facility that refuses to treat a minor on the minor's own consent shall refer the minor to another facility.

602.3 If having acted in good faith, no physician, surgeon, dentist, or health or mental health care facility shall be held liable on the basis of a minor's misrepresentations.

602.4 Any minor who is examined, treated, hospitalized, or receives health services under this chapter may give legal consent, and no person who administers the health services shall be liable civilly or criminally for assault, battery, or assault and battery; or any other civil legal charge, except for negligence or intentional harm in the diagnosis and treatment rendered to the minor and for violations of the D.C. Mental Health Information Act of 1978.

602.5 Except as provided in the D.C. Mental Health Information Act of 1978, the health professional may, but shall not be obligated to, inform the parent, parents, or legal guardian of the minor of any treatment given or needed when, in the judgment of the health professional, the following situations exist:

(a) Severe complications are present or anticipated;

(b) Major surgery or prolonged hospitalization is needed;

(c) Failure to inform the parents or legal guardian would seriously jeopardize the safety and health of the minor patient; and

(d) To inform them would benefit the minor's physical and mental health and family harmony.

602.6 Except as provided in §602.7, such information about any treatment administered or needed shall be given to the minor's parent, parents, or legal guardian only when the minor consents or when, because of the minor's age or condition, the attending health professional can reasonably presume consent.

602.7 Information about any treatment needed by a minor who is found to be infected with a sexually transmitted disease and who has refused treatment shall be given to the minor's parent, parents, or legal guardian.

602.8 Except by specific legal requirements, no information in regard to sexually transmitted disease, drug substance abuse, pregnancy, and emotional illness shall be given by the health professional to another professional, school, law enforcement official, court authority, government agent, spouse, future spouse, employer, or any other person without consent of the minor, unless giving the information is necessary to the health of the minor and the public, and only when the minor's identity is kept confidential.

602.9 Notification of disclosure to the spouse, parent, parents, or legal guardian by the health professional shall not constitute libel or slander, a violation of the right of privacy, a violation of the rule of privileged communication, or any other legal basis of liability.

602.10 When a minor is found not suffering from a drug or substance abuse, including alcohol and nicotine, no information with respect to any appointment, examination, test, or other health procedure shall be given to the parent, parents, or legal guardian, if they have not been already informed as permitted in this section, without the consent of the minor.

History

SOURCE: Regulation No. 74-22 (August 30, 1974), 21 DCR 477 (September 16, 1974), 6H DCRR § 4 (1982); as amended by § 5 of the Preventive Health Services Amendments Act of 1985, effective February 21, 1986 (D.C. Law 6-83; 32 DCR 7276, 7283 (December 13, 1985)). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 602

22-B DCMR § 603 CONTRACEPTIVE INFORMATION, SERVICES, AND DEVICES FOR MINORS

603.1 Birth control information, services, and devices shall be provided by the health facilities operated by the District of Columbia, and may be provided by any qualified person or institution, without regard to the age or marital status of the patient or the consent of the patient's parent or guardian.

603.2 Prenatal and postnatal care, and necessary medical care for the babies, shall be provided by the health facilities operated by the District of Columbia, and may be provided by any qualified person or institution, without regard to the age or marital status of the patient or the consent of the parent or guardian of the minor mother.

603.3 The services provided by the District of Columbia enumerated in §§ 603.1 and 603.2 shall be provided at no cost to the patient unless voluntary payments or contributions are made.

603.4 No public benefit, grant, or stipend shall be conditioned upon the acceptance by any person of birth control information, services, and devices.

History

SOURCE: Regulation No. 71-27 §§ 1 - 4 (August 13, 1971), 18 DCR 154 (September 7, 1971). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 603

22-B DCMR § 604 RESERVED

22-B DCMR § 605 DAY NURSERIES

605.1 It shall be unlawful for any person, persons, corporation, or association to establish or maintain a day nursery, nursery school, boarding school, boarding house, foster family home, home, or other place within the District for the reception, board, or care of a child or children under fifteen (15) years of age, without first obtaining a permit from the Director to do so; and then only in accordance with the terms of the permit.

605.2 Application for a permit to establish a day nursery, nursery school, board school, boarding house, foster family home, home, or other place within the District for the reception, board, or care of a child or children under fifteen (15) years of age shall be made in writing upon a form prescribed by the Mayor.

605.3 The application for a permit shall give whatever detailed description of the day nursery, nursery school, boarding school, boarding house, foster family home, home, or other place as the Mayor may require.

605.4 The permit provided in this section may be revoked at any time by the Mayor, after a hearing, whenever the Mayor believes the health, comfort, or wellbeing of the inmates of the facility are in danger.

605.5 Permits shall be issued for a period not in excess of one (1) year, and shall expire one (1) year from the date of issuance.

605.6 Permits may be renewed for a period not to exceed one (1) year.

605.7 Each person holding a permit provided in this section shall at all times keep a register of the following information:

(a) The names and ages of all children admitted;

(b) The names and residence of the children's parents so far as known;

(d) The reason for a discharge.

605.8 Every register as required in §605.7 shall at all times be open for inspection by the Director or the Director's duly appointed representative.

605.9 The Director shall have the right to enter and inspect any facility as defined in this section at the times as may, in the Director's judgment, be necessary to secure the enforcement of the provisions of this chapter; Provided, that the provision of § 605.10 is complied with.

605.10 When not more than four (4) children are placed in foster care in a private family home by the Department of Public Welfare or by an agency licensed by the Mayor to place children in the District, the Director may accept a certification from the Department of Public Welfare or the agency, on a form furnished by the Department of Public Welfare or the agency, or on a form furnished by the Department, that the basic requirements for health protection have been met.

605.11 Any person who violates, or aids or abets in violating any of the provisions of this section shall be deemed guilty of a misdemeanor, and, upon conviction, shall be punished by a fine of not more than two hundred dollars ($200) for the first offense, and not more than five hundred dollars ($500) for a second and each subsequent offense.

History

SOURCE: 8 DCRR §§ D-620, D-630, and D-640 (1965); Regulation No. 71-27 §§ 1 - 4 (August 13, 1971), 18 DCR 154 (September 7, 1971). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 605

22-B DCMR § 610 STUDENT ACCESS TO TREATMENT

610.1 A student may possess and self-administer medication at a school in which the student is enrolled, at school-sponsored activities, and while on school-sponsored transportation, for the treatment of asthma, anaphylaxis, and diabetes, provided that:

(a) A responsible person has submitted a valid medication action plan to the school, as required by D.C. Official Code § 38-651.02;

(b) The student has a current certificate of health on file at the school, as required by D.C. Official Code § 38-602; and

610.2 An employee or agent of a school may administer medication to a student for the treatment of asthma, anaphylaxis, and diabetes provided that:

(a) The employee or agent has successfully completed training in the administration of the medication to be given to the student and remains current with that training by taking and passing refresher training;

(b) A responsible person has delivered the medication to be administered to the school;

(d) Except in emergency circumstances, a responsible person has administered the initial dose of a new medication; and

(e) The employee or agent properly disposes of sharps and medical waste by placing them in designated containers.

610.3 A school that has a self-administering student or an employee- or agent-assisted student who, as a course of treatment, uses sharps or creates medical waste, shall provide appropriately placed medical waste containers. Each container shall be secured with a lock to prevent access by unauthorized persons. The medical waste shall be disposed of properly and shall not be commingled with other waste.

History

SOURCE: Final Rulemaking published at 59 DCR 13687 (November 30, 2012).

22-B DCMR § 620 CONCUSSION PROTECTION

620.1 The provisions of this section shall apply to:

(a) Any athletic activity sponsored by a school;

(b) Any athletic activity sponsored by the Department of Parks and Recreation

(c) Any athletic activity sponsored by a private for-profit or nonprofit organization regardless of where that activity occurs in the District.

620.2 Each sponsor of athletic activity shall provide to the entity authorizing use of a recreation area for an athletic activity written verification that each coach, trainer, or Physical Education (PE) teacher for the athletic activity is in compliance with concussion protection training requirements of this section.

620.3 Each coach, athletic trainer, and PE teacher for an athletic activity shall take online concussion training and provide to her or his sponsoring organization a certificate of completion from either of the following online training resources:

Concussion in sports—v2.0

http://www.nfhslearn.com/electiveDetail.aspx?courseID=38000; or

CDC Concussion in sports—Heads Up

http://cdc.gov/concussion/headsup/training/.

620.4 The training and certificate of completion required by § 620.3 shall be completed by each coach, athletic trainer, and PE teacher before the athletic activity they are supervising begins practice.

620.5 Each coach and athletic trainer shall renew concussion training and provide the sponsoring organization with a certificate of completion every two years.

620.6 A school that offers an athletic activity shall provide training to school personnel to recognize the signs and symptoms of concussion and their manifestations in a school setting.

620.7 School personnel that interact with an athlete removed from athletic activity due to head injury shall receive information of the athlete’s injury and its specific symptom manifestations, including physical, cognitive, emotional, and sleep disturbance, and the checklist of signs and symptoms of concussion. The training and certification identified in § 620.3 shall satisfy the minimal training requirements of this subsection.

620.99 When used in this section, the following words and phrases shall have the meanings ascribed:

Athlete—a person who engages in an athletic activity who is eighteen (18) years of age or younger.

Athletic activity—a program or event, including practice and competition, organized as part of a school-sponsored, interscholastic-athletic program, an athletic program sponsored by the Department of Parks and Recreation, or an athletic program sponsored by a nonprofit or for-profit organization. This term includes participation in physical education classes that are part of a school curriculum.

Concussion—a traumatic injury to the brain that causes a change in a person’s mental status at the time of injury, such as feeling dazed, disoriented, or confused, which may involve a loss of consciousness, resulting from:

(a) A fall;

(b) A blow or jolt to the head or body;

(d) Acceleration and deceleration of the head.

Department—the Department of Health.

School—a public school operated under authority of the Mayor, a public charter school, a parochial school, or a private school.

History

SOURCE: Final Rulemaking published at 61 DCR 9593 (September 19, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 620

22-B DCMR § 699 DEFINITIONS

699.1 When used in this chapter, the following words and phrases shall have the meanings ascribed:

Administer—the direct application of medication to the human body whether by ingestion, inhalation, subcutaneous and intramuscular injection, or topical means.

Agent—a person not directly employed by the school who serves the student population of the school in some capacity, including a contractor of the school or a volunteer at the school.

Consent - informed consent, to give information, to make known, or to impart knowledge of a fact or circumstance of treatment or procedure.

Emancipated minor - a minor who is or has been married; or who is serving or has served in the armed forces; or who is employed and contributing more than half of his or her own support if residing with his or her parents; or who is residing apart from his or her parents and managing his or her own affairs; or who is making the major decisions affecting his or her own life.

Emergency circumstances—reasonably apparent circumstances that indicate that a delay in treatment would endanger the health or life of a student.

Employee—a person employed by the school to serve the student population of the school including, but not limited to, a teacher, maintenance staff person, or coach.

Foster family home - a family home maintained by an individual or individuals in which a child or children under fifteen (15) years of age is or are received for part or full-time board or care; Provided, that the child or children is or are not within the fourth (4th) degree related by blood or marriage to, nor adopted by, the individual or individuals, nor for whom the individual or individuals is or are the duly appointed guardian or guardians.

General supervision—the availability of a registered nurse or licensed practitioner to a school employee or agent for consultation in person or by electronic communication.

Health professional - state licensed physician, psychologist, dentist, osteopathic physician, nurse, and other licensed practitioner.

Health services - health services specified by the state, appropriately delivered by different health professions including examination, preventive and curative treatment, operation, hospitalization (admission or discharge), giving or receiving blood and blood derivatives, receiving organ transplantation, pledging donation of organs after death, the use of anesthetics, and receiving contraceptive advice and devices.

Licensed nurse—a registered nurse or licensed practical nurse.

Licensed practitioner—a licensed physician, or advanced practice registered nurse.

Medication—a prescription or non-prescription drug used to treat conditions and illnesses.

Medication action plan—a written medical treatment plan for an individual student signed by a licensed health care provider.

Minor - any person under the age of majority as defined by the District statute or under eighteen (18) years of age, whichever is lower.

Parent - either natural parent or legal guardian.

Prescription—a written order for a drug, medicinal chemical, or combination or mixture thereof, or for a medical device signed by a licensed health professional, or an order given orally by a licensed health professional to a pharmacist and immediately reduced to writing by the pharmacist specifying the address of the person for whom the drug or device is ordered and directions for use.

Responsible person—a student eighteen (18) years of age or older or the parent or legal guardian of a minor student.

School—a public school, public charter school, parochial school, or private school.

Sharp—a syringe, lancet, or other medical device intended to break the surface of the skin for the delivery of medication or for testing of blood or bodily fluids.

History

SOURCE: Regulation No. 74-22 (August 30, 1974), 21 DCR 477 (September 16, 1974), 6H DCRR § 1 (1982); as amended by Final Rulemaking published at 59 DCR 13687 (November 30, 2012).

22-B10 CONTROLLED SUBSTANCE REGISTRATION FOR MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS

22-B DCMR § 1000 COVERAGE

1000.1 The rules in this chapter contain the procedures governing the registration and regulation of manufacturers, distributors, and dispensers of controlled substances pursuant to Title III of the District of Columbia Uniform Controlled Substances Act of 1981 (D.C. Law 4-29, effective August 5, 1981, §§ 48-901.02 et seq.)(2001), hereinafter referred to as the "Act."

1000.2 To the extent consistent with the Act, regulations promulgated by the Federal Government pursuant to Title 21, Chapter II, of the Code of Federal Regulations (21 C.F.R. Part 1300 to End), and in effect as of the effective date of this chapter, shall be used as a guide in administering the Act.

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is Title III of the District of Columbia Uniform Controlled Substances Act of 1981, D.C. Code, 2001 Ed. §§ 48 903.01 to 48 903.09, Mayor’s Order 85-171 (October 18, 1985).
SOURCE: Final Rulemaking published at 33 DCR 1046 (February 21, 1986); as amended by Final Rulemaking published at 54 DCR 12298 (December 21, 2007).

22-B DCMR § 1001 SCHEDULES OF CONTROLLED SUBSTANCES

1001.1 The Department shall propose annually, the schedules of controlled substances consistent with the criteria for each schedule as specified under the Act.

1001.2 In proposing the schedules of controlled substances, the Department shall adopt the designations, reschedulings, additions and deletions as determined by federal law or regulation, unless otherwise contraindicated for the District of Columbia.

1001.3 The Department shall submit annual proposed schedules of controlled substances to the Mayor for Council approval.

1001.4 Pursuant to the District of Columbia Uniform Controlled Substances Act of 1981, D.C. Code, 2001 Ed. § 48 902.06, Sufentanil Citrate shall be added to the Schedule II list of controlled substances and shall be designated as "(R)."

History

SOURCE: Final Rulemaking published at 33 DCR 1046 (February 21, 1986).

22-B DCMR § 1002 PERSONS REQUIRED TO REGISTER

1002.1 Every person who manufactures, distributes, dispenses, or conducts research with any controlled substance, or who proposes to engage in the manufacture, distribution, dispensing, or conducting of research with any controlled substance within the District of Columbia shall obtain biennially and maintain current a registration issued by the Director in accordance with this chapter, unless exempted by federal law, or District of Columbia law or pursuant to §§ 1002.4 and 1002.5 of this chapter.

1002.2 Persons conducting manufacturing activities of controlled substances outside of the District of Columbia and doing business within the District of Columbia shall obtain biennially a registration in accordance with the rules of this subtitle, unless exempted by federal or District of Columbia law or pursuant to §§ 1002.4 and 1002.5 of this chapter.

1002.3 Out-of-state persons conducting distributing activities of controlled substances to persons within the District of Columbia shall obtain biennially a registration in accordance with the rules of this subtitle, unless exempted by federal or District of Columbia law or pursuant to §§ 1002.4 and 1002.5 of this chapter.

1002.4 Only persons actually engaged in the activities cited under §§1002.1 through 1002.3 are required to obtain a registration; related or affiliated persons who are not engaged in the activities cited in §§1002.1 through 1002.3 are not required to be registered. (For example, a stockholder or parent corporation of a corporation manufacturing controlled substances is not required to obtain a registration).

1002.5 Persons described in §302(c) of the Act need not register and may lawfully possess controlled substances under this chapter.

1002.6 Persons requesting waiver of the requirement for registration pursuant to § 302(d) of the Act shall make the request in writing to the Director.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1047 (February 21, 1986); as amended by Final Rulemaking published at 54 DCR 12298 (December 21, 2007).

22-B DCMR § 1003 REGISTRATION

1003.1 Unless otherwise exempted by federal law or this chapter, a person shall register with the Department and obtain and maintain a registration certificate before the person:

(a) Manufactures, distributes, or dispenses controlled substances in the District;

(b) Conducts research or instructional activities with controlled substances listed in Schedules II through V in the District;

(d) Conducts a chemical analysis with controlled substances listed in any schedule in the District; or

(e) Engages in any other activity for which registration is required.

1003.2 Beginning August 1, 2019, prior to applying for renewal of a controlled substance registration, a practitioner shall be registered with the District of Columbia Prescription Drug Monitoring Program (PDMP).

1003.3 The Department shall not renew a controlled substance registration for a practitioner that is not registered with the PDMP.

1003.4 For practitioners, a District of Columbia controlled substances registration issued pursuant to this chapter shall expire simultaneously with the expiration of the practitioner's District of Columbia health professional license, certification, or occupation registration.

1003.5 For non-practitioners, a District of Columbia controlled substance registration issued pursuant to this chapter shall expire at 12:00 midnight of December 31 of each even-numbered year.

1003.6 Applications to renew a registration must be filed in a timely manner, not less than sixty (60) days prior to the expiration of the registration.

1003.7 A registration certificate expires on the date shown on the certificate.

1003.8 The Director shall mail a renewal application or a notice to renew to a registrant not less than thirty (30) days before the expiration date shown on the certificate.

1003.9 If a person fails to apply for renewal of a registration before the expiration date of his or her registration, he or she shall thereafter apply for a new registration and the prior registration shall be deemed to have expired on the date specified on the registration.

1003.10 Any person who is required to be registered and who is not so registered may apply for registration at any time and may obtain an application form by writing to the Department of Health's Pharmaceutical Control Division, 717 14th Street, NW., 6th Floor, Washington, D.C. 20005.

1003.11 To apply for a controlled substances registration, an applicant shall:

(a) Submit a completed application to the Department on the required forms which shall be signed by the:

(1) Applicant, if an individual;

(2) General partner, if the applicant is a partnership; or

(3) Officer responsible for the applicant, if the applicant is a corporation or other entity; and

(b) Pay all applicable fees.

1003.12 Applications submitted for filing shall be dated upon receipt. Applications which are complete shall be accepted for filing. Applications failing to comply with the requirements set forth in this chapter and the Act shall not be accepted for filing.

1003.13 In the case of minor defects as to completeness, the Director may accept the application for filing with a request to the applicant for additional information.

1003.14 A defective application shall be returned to the applicant within ten (10) days following its receipt with a statement of the reason for not accepting the application for filing.

1003.15 A defective application may be corrected and resubmitted for filing at any time; the Director shall accept for review any application upon resubmission by the applicant.

1003.16 Accepting an application for filing does not preclude any subsequent request for additional information pursuant to this chapter and has no bearing on whether the application will be granted.

1003.17 If the information requested on the application is not applicable to the applicant, the applicant shall indicate such on the form.

1003.18 The Director may require an applicant to submit additional documentation pertinent to the registration or written statements in support of an application to:

(a) Clarify application information; or

(b) Determine if the applicant meets the requirements of this chapter.

1003.19 The Director may deny an application if the applicant fails to provide information within fifteen (15) days of receipt of the Director's request.

1003.20 An application shall be considered withdrawn if the following occurs:

(a) The applicant requests its return; or

(b) The applicant fails to respond to a registered or certified letter regarding the application within fifteen (15) days of its delivery to the applicant.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1047 (February 21, 1986); as amended by Final Rulemaking published at 54 DCR 12298 (December 21, 2007); as amended by Final Rulemaking published at 67 DCR 2798 (March 13, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1003

22-B DCMR § 1005 PERSONS EXEMPT FROM REGISTRATION FEE

1005.1 The Director shall exempt from payment of a fee for registration or re-registration, any official employee or agency of the District of Columbia who is authorized to do the following:

(a) To purchase controlled substances;

(b) To obtain the substances from official stocks;

(d) To conduct research, instructional activities, or chemical analysis with the substances, or any combination thereof, in the course of his or her official duties or employment.

History

SOURCE: Final Rulemaking published at 33 DCR 1046 (February 21, 1986).

22-B DCMR § 1006 SEPARATE REGISTRATION FOR INDEPENDENT ACTIVITIES

1006.1 The following groups of activities shall be deemed to be independent of each other:

(a) Manufacturing controlled substances;

(b) Distributing controlled substances;

(d) Conducting research with controlled substances listed in Schedules II through V;

(e) Conducting instructional activities with controlled substances listed in Schedules II through V;

(f) Conducting a narcotic treatment program using any narcotic drug listed in Schedules II, III, IV or V; Provided, that employees, agents, or affiliated practitioners in programs need not register separately. Each program site located away from the principal location and at which place narcotic drugs are stored or dispensed shall be registered separately and shall obtain narcotic drugs by use of the federal Drug Enforcement Administration order forms;

(g) Conducting research and instructional activities with controlled substances listed in Schedule I;

(h) Conducting chemical analysis with controlled substances listed in any Schedule;

(i) Importing controlled substances;

(j) Exporting controlled substance listed in Schedules I through IV; and

(k) Operating as a compounder as defined in §9900.

1006.2 Persons who engage in more than one (1) group of independent activities shall obtain a separate registration for each group of activities.

1006.3 Separate registration is not required for persons engaging in research with non-narcotic controlled substances in Schedules II through V where the registrant is already registered under this chapter in another capacity.

1006.4 Persons registered under federal law to conduct research with Schedule I substances may conduct research with Schedule I substances within the District of Columbia upon furnishing the Director evidence of that federal registration.

1006.5 Compliance by manufacturers and distributors with the provisions of the federal law respecting registration entitles them to be registered under this chapter.

1006.6 A person registered or authorized to conduct chemical analysis with controlled substances may do the following;

(a) Manufacture and import such substance for analytical or instructional purposes; or

(b) Distribute such substances to other persons registered or authorized to conduct chemical analysis or instructional activities or research with such substances.

History

SOURCE: Final Rulemaking published at 33 DCR 1046 (February 21, 1986).

22-B DCMR § 1007 SEPARATE REGISTRATION FOR SEPARATE LOCATIONS

1007.1 A separate registration is required for each principal place of business or professional practice where controlled substances are manufactured, distributed, or dispensed by a person.

1007.2 The following locations shall not be deemed to be places requiring separate registration:

(a) A warehouse where controlled substances are stored by or on behalf of a registered person, unless the substances are distributed directly from the warehouse to registered locations other than the registered location from which the substances were delivered or to persons not required to register by virtue of §302(c) of the Act;

(b) An office used by agents of a registrant where sales of controlled substances are solicited, made, or supervised but which neither contains such substances (other than substances for display purposes or lawful distribution as samples only) nor serves as a distribution point for filling sales orders; and

(c) An office used by a practitioner (who is registered at another location where controlled substances are prescribed but neither administered nor otherwise dispensed as a regular part of the professional practice of the practitioner at the office, and where no supplies of controlled substances are maintained.

History

SOURCE: Final Rulemaking published at 33 DCR 1046 (February 21, 1986).

22-B DCMR § 1008 EXEMPTION OF AGENTS AND EMPLOYEES: AFFILIATED PRACTITIONERS

1008.1 The following persons shall be exempt from registration:

(a) An agent or employee of a person who is registered to engage in any group of independent activities, provided the agent or employee is acting in the usual course of his or her business or employment;

(b) An individual practitioner, as defined in §142(20)(A) of the Act (other than an intern, resident, foreign trained physician or physician who is an agent or employee of the District of Columbia Government), who is an agent or employee of another practitioner registered to dispense controlled substances when acting in the usual course of his or her employment administering and dispensing (other than by issuance of prescription) controlled substances; but only to the extent that the individual practitioner is authorized or permitted to do so by the jurisdiction of the District of Columbia under the registration of the employee or principal practitioner. (For example, a pharmacist employed by a pharmacy need not be registered individually to fill a prescription for controlled substances if a pharmacy is so registered);

(c) An individual practitioner, who is an intern, resident, or foreign trained physician or a physician who is an agent or employee of the District of Columbia Government, when dispensing, administering and prescribing controlled substances under the registration of a hospital or other institution which is registered and by whom he or she is employed; Provided, that the following occurs:

(1) The dispensing, administering or prescribing is done in the usual course of his or her professional practice;

(2) The individual practitioner is authorized or permitted to do so in the District of Columbia;

(3) The hospital or other institution has verified that the individual practitioner is permitted to dispense, administer, or prescribe drugs within the District of Columbia;

(4) The individual practitioner is acting only within the scope of his or her employment in the hospital or institution;

(5) The hospital or other institution maintains a specific internal code number required by the Federal Drug Enforcement Administration for each intern resident or foreign trained physician so authorized; and

(6) A current list of internal codes and the corresponding individual practitioners is kept by the hospital or other institution and is made available at all times to other registrants, law enforcement agencies, and the Director upon request for the purpose of verifying the authority of the prescribing individual practitioner; and

(d) A local or federal law enforcement official, civil defense official or any other person with similar official responsibility as determined by the Director.

History

SOURCE: Final Rulemaking published at 33 DCR 1046 (February 21, 1986).

22-B DCMR § 1009 MODIFICATION, TRANSFER AND TERMINATION OF REGISTRATION

1009.1 Any registrant may apply to modify his or her registration to authorize the handling of additional controlled substances or to change his or her name or address, by submitting a letter of request to the Pharmaceutical and Medical Devices Control Division, Service Facility Regulation Administration, Department of Consumer and Regulatory Affairs, 614 H Street, N.W., Washington, D.C. 20001.

1009.2 The requesting material shall contain the registrant's name, address and registration number as printed on the certificate of registration, and the substances or schedules to be added to his or her registration or the new name or address and shall be signed by the registrant.

1009.3 If a modification of registration is approved, the Director shall issue a new certificate of registration to the registrant, who shall maintain it with the old certificate of registration until expiration.

1009.4 The registrant shall notify the Director within seven (7) days of any change of address. The address on file with the Department may be relied upon by the Department in issuing notices required under this chapter.

1009.5 The registration of any person shall terminate if and when the person dies, ceases legal existence, or discontinues business or professional practice.

1009.6 Any registrant who ceases legal existence or discontinues business or professional practice or who changes ownership of the business or professional practice, shall notify the Director within thirty (30) days of the fact in writing and surrender the current registration.

1009.7 Transfer or disposal or any controlled substances shall be the responsibility of the registrant or his or her legal representative.

1009.8 A new registration shall be required under the following circumstances:

(a) If any partners are added or deleted from the partnership;

(b) If there is a change in the president or chief executive officer of the corporation; or

1009.9 No registration or any authority conferred thereby shall be assigned or otherwise transferred except upon such conditions as the Director may specifically consent.

History

SOURCE: Final Rulemaking published at 33 DCR 1046 (February 21, 1986).

22-B DCMR § 1010 CERTIFICATE OF REGISTRATION

1010.1 The Director shall issue a Certificate of Registration or Reregistration only when the applicant has met all the requirements of the Act and these rules and the Director has determined pursuant to §303(a) of the Act that registration would not be inconsistent with the public interest.

1010.2 The Certificate of Registration shall contain the name, address, and registration number of the registrant, the activity authorized by the registration, the Schedules, as set forth in Title II of the Act, of the controlled substances which the registrant is authorized to handle, and the expiration date of the registration.

1010.3 The registrant shall prominently display the Certificate of Registration at the registered location.

History

SOURCE: Final Rulemaking published at 33 DCR 1046 (February 21, 1986).

22-B DCMR § 1011 PROCEDURAL RIGHTS INVOLVING SUSPENSION OR REVOCATION

1011.1 If it appears to the Director that an application for registration should be denied or that an existing registration should be suspended or revoked, the Director shall notify the applicant or registrant of the proposed denial, suspension, or revocation, briefly stating the reasons therefor and shall provide the applicant or registrant with an opportunity for a hearing in accordance with §305 of the Act and Chapter 11 of this subtitle.

History

SOURCE: Final Rulemaking published at 33 DCR 1046 (February 21, 1986).

22-B DCMR § 1012 SUSPENSION OR REVOCATION OF REGISTRATION

1012.1 The Director may suspend or revoke a registration for any reason stated in §304 of the Act.

1012.2 Upon service of the Order of the Director suspending or revoking registration, the registrant shall immediately deliver his or her Certificate of Registration to the Department.

1012.3 The Director may limit revocation or suspension of a registration to the particular controlled substance with respect to which grounds for revocation or suspension exist.

1012.4 If revocation or suspension is limited to a particular controlled substance or substances, the registrant shall be given a new Certificate of Registration for all substances not affected by the revocation or suspension.

1012.5 No fee shall be required to be paid for the new Certificate of Registration. The registrant shall deliver the old Certificate of Registration to the Department.

1012.6 If the Director suspends or revokes a registration, all controlled substances owned or possessed by the registrant at the time of suspension of the effective date of the revocation order shall be placed under seal.

1012.7 No disposition may be made of substances under seal until the time for taking an appeal has elapsed or until all appeals have been concluded unless a court order the sale of perishable substances and the deposit of the proceeds of the sale with the court.

1012.8 Upon a revocation order becoming final, all controlled substances shall be forfeited in accordance with the provisions of §502 of the Act.

1012.9 The Director shall promptly notify the Drug Enforcement Administration (hereinafter referred to as DEA) of all orders suspending or revoking registration and all forfeitures of controlled substances.

History

SOURCE: Final Rulemaking published at 33 DCR 1046 (February 21, 1986).

22-B DCMR § 1013 SUSPENSION OF REGISTRATION PENDING FINAL ORDER

1013.1 If the Director finds pursuant to §305(b) of the Act that there is an imminent danger to public health and safety, the Director may suspend any registration simultaneously with, or at any time subsequent to, the service upon the registrant of reasons therefor and a notice of hearing pursuant to §1101.

1013.2 In cases covered by §1013.1, the Director shall send the registrant the following:

(a) An order of immediate suspension which shall contain a statement of his or her findings regarding the danger to the public health or safety; and

(b) A notice of hearing on the suspension pursuant to §201.

1013.3 Upon service of the order of immediate suspension, the registrant shall at the time of service return his or her Certificate of Registration to the Department.

History

SOURCE: Final Rulemaking published at 33 DCR 1046 (February 21, 1986).

22-B DCMR § 1014 EXTENSION OF REGISTRATION

1014.1 In the event that an applicant for registration (who is doing business under a registration previously granted and not revoked or suspended) has applied for reregistration at least sixty (60) days before the date on which the existing registration is due to expire, and the Director has issued no order on the application on the date in which the existing registration of the applicant shall automatically be extended and continue in effect until the date on which the Director so issues his or her order.

1014.2 The Director may extend any other existing registration under the circumstances contemplated in this section even though the registrant failed to apply for reregistration at least sixty (60) days before expiration of the existing registration, with or without request by the registrant, if the Director finds that the extension is not inconsistent with the public health or safety.

History

SOURCE: Final Rulemaking published at 33 DCR 1046 (February 21, 1986).

22-B DCMR § 1015 ADDRESS FOR NOTICES

1015.1 Unless the Act or this chapter otherwise provide, all notice required under this chapter to be sent to the Department or Director shall be sent to the Department of Health, Pharmaceutical Control Division, 717 14th Street, NW, 6th Floor, Washington, DC 20005, or to its successor agency by certified mail, return receipt requested.

1015.2 Every applicant or registrant shall provide the Department with an address to which all communications from the Department to the applicant or registrant shall be sent. The address shall be an actual street address and shall include the city or town, state and zip code number.

1015.3 Furnishing of post office box numbers or other forms of address shall not constitute sufficient compliance with §1015.2.

1015.4 The address required by §1015.1 shall be provided by the applicant or registrant either as part of its application for registration or reregistration or by letter to the Department sent certified mail, return receipt requested.

History

SOURCE: Final Rulemaking published at 33 DCR 1046 (February 21, 1986); as amended by Final Rulemaking published at 54 DCR 12298 (December 21, 2007).

22-B DCMR § 1016 VIOLATIONS

1016.1 Activities performed relative to the handling, management and use of controlled substances in the District of Columbia shall be performed in accordance with any and all Federal and other District of Columbia laws, rules and regulations. Violation of the laws, rules and regulations shall constitute a violation of this chapter.

History

SOURCE: Final Rulemaking published at 33 DCR 1046 (February 21, 1986).

22-B DCMR § 1017 FAILURE TO COMPLY WITH RULES

1017.1 Failure of a registrant to comply with the rules as set forth in this chapter shall constitute a basis for revocation or suspension of the registrant's Certificate of Registration.

History

SOURCE: Final Rulemaking published at 33 DCR 1046 (February 21, 1986).

22-B DCMR § 1018 [RESERVED]

22-B DCMR § 1019 [RESERVED]

22-B DCMR § 1020 [RESERVED]

22-B DCMR § 1021 [RESERVED]

22-B DCMR § 1022 [RESERVED]

22-B DCMR § 1023 [RESERVED]

22-B DCMR § 1024 [RESERVED]

22-B DCMR § 1025 [RESERVED]

22-B DCMR § 1026 [RESERVED]

22-B DCMR § 1027 [RESERVED]

22-B DCMR § 1028 [RESERVED]

22-B DCMR § 1029 [RESERVED]

22-B DCMR § 1030 FEES

1030.1 The fees for a controlled substances registration shall be as follows:

(a) Initial registration - $130.00

(b) Biennial renewal - $130.00

(d) Duplicate certificate - $25.00

(e) Reinspection - $130.00

History

SOURCE: Final Rulemaking published at 43 DCR 3858 (July 19, 1996); as amended by Final Rulemaking published at 54 DCR 12298 (December 21, 2007).

22-B DCMR § 1099 DEFINITIONS

1099.1 When used in this chapter, the following words or phrases shall have the meanings ascribed:

Act - District of Columbia Uniform Controlled Substances Act of 1981, effective August 5, 1981, (D. C. Law 4-29; D.C. Official Code § 48-901)(2001).

Compounder - any person engaging in maintenance or detoxification treatment who also mixes, prepares, packages or changes the dosage form of a narcotic drug listed in Schedules II, III, IV or V for use in maintenance or detoxification treatment by another narcotic treatment program.

Controlled Premises - (1) places where original or other records or documents required under the Act are kept or request to be kept, and (2) places, establishments, etc., where persons registered under this Act or exempted from registration under the Act may lawfully hold, manufacture, distribute, dispense, conduct research with, or otherwise dispose of controlled substances.

Department - Department of Health

Detoxification Treatment - the dispensing for a period not in excess of twenty-one (21) days, of a narcotic drug or narcotic drugs in decreasing doses to an individual in order to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of a narcotic drug and as a method of bringing the individual to a narcotic drug-free state within such period of time.

Director - Director of the Department

Federal Act - means the Controlled Substance Act (84 Stat. 1242; 21 U.S.C. 801) or the Controlled Substance Import and Export Act (84 Stat. 1285; 21 U.S.C. 951).

Hearing Officer - either the Director or any person appointed by the Director.

Inspector - an employee of the Department authorized by the Director to mae inspections under the Act.

Maintenance Treatment - the dispensing for a period in excess of twenty-one (21) days, of a narcotic drug or narcotic drugs in the treatment of an individual for dependence upon heroin or other morphine-like drug.

Narcotic Treatment Program - a program for maintenance or detoxification treatment with narcotic drugs.

Practitioner - an individual licensed, registered, certified, or otherwise permitted by law to prescribe, dispense, and to administer drugs or medical devices, or to conduct research with respect thereto, within the course of such persons' professional practice or research.

Registrant - any person who is registered pursuant to §302 of the Act.

1099.2 The definitions contained in Title I, §102 of the Act, shall have the same meaning in this chapter.

History

SOURCE: Final Rulemaking published at 33 DCR 1046 (February 21, 1986); as amended by Final Rulemaking published at 54 DCR 12298 (December 21, 2007).

22-B11 HEARINGS

22-B DCMR § 1100 HEARING OFFICER

1100.1 Any hearing required by the Act or this chapter to be held by the Director may be conducted by the Director or a qualified hearing officer appointed by the Director.

1100.2 A hearing officer appointed by the Director shall have full authority to do the following:

(a) Conduct the hearings:

(b) Rule on all notices and other matters occurring during the hearing; and

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is the District of Columbia Uniform Controlled Substances Act of 1981 subch. V, D.C. Code, 2001 Ed. §§ 48-905.01 to 48-905.07; and Mayor’s Order 85-171 (October 18, 1985).
SOURCE: Final Rulemaking published at 33 DCR 1046, 1056 (February 21, 1986).

22-B DCMR § 1101 HEARINGS AND NOTICES

1101.1 Except for an emergency suspension undertaken pursuant to §305(b)(1) of the Act, D.C. Code, 2001 Ed. §48-903.05, the Director shall give an applicant or registrant written notice and an opportunity to be heard prior to taking any final action which would do any of the following;

(a) Deny an application for registration;

(b) Deny a renewal of registration;

(d) Revoke registration.

1101.2 The notice shall contain the following:

(a) A statement of the proposed action;

(b) A statement setting forth the reasons for the proposed action, including a specification of any specific act complained of;

(d) A statement that the applicant or registrant may secure a hearing before the Director or a hearing officer to contest the proposed action by depositing in the mail, within thirty (30) days of service of the notice, a certified letter addressed to the Director containing a request for a hearing or hand delivery same to the Office of the Director (receipt required for proof of delivery); and

(e) A statement that if the applicant or registrant does not request a hearing within thirty (30) days after service of the notice of the proposed action, the applicant or registrant shall be deemed to have conceded the validity of the reason or reasons stated in the notice, and the denial, suspension or revocation shall be final without a hearing.

1101.3 Notice in connection with hearings under this chapter shall be given and service effected in accordance with §305 of the Act, D.C. Code, 2001 Ed. §903.05.

1101.4 If the respondent does not mail a request for a hearing within the time and in the manner specified in §1101.2, the Director may, without a hearing, take the action contemplated in the notice.

1101.5 The Director shall notify the respondent in writing of action taken under §1101.2(e).

1101.6 If a hearing is timely requested pursuant to §1101.2, the Director shall notify the person of the date, time and location of the hearing and the name of the hearing officer. The hearing shall be convened within thirty (30) days of the filing of the respondent's response to the Director's proposed action.

1101.7 Unless otherwise authorized by the Director, any notice from and to the Director shall be sent by certified mail, return receipt requested, as provided in §305 of the Act.

1101.8 If an attorney enters his or her appearance for the respondent, any notice shall thereafter be served on the attorney, unless otherwise ordered by the Director or hearing officer.

1101.9 If the respondent is no longer at the last known address as shown on the records of the Department and no forwarding address is available, the notice shall be deemed to have been served on the date the return receipt bearing that notification is received by the Director.

1101.10 If the respondent shall believe the hearing officer selected to conduct the hearing is prejudiced against the respondent or his or her attorney, the respondent shall make a request in writing to the Director, at least ten (10) days prior to the date set for the hearing, to substitute another hearing officer. The request shall be accompanied by an affidavit signed by the respondent setting forth the facts upon which the claim of prejudice is predicated. Upon receipt of the request, the Director shall make a determination based upon sufficient evidence whether prejudice to the rights of the respondent exists and, if necessary, the Director may appoint a substitute hearing officer.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1056 (February 21, 1986).

22-B DCMR § 1102 SUMMARY SUSPENSION AND DENIAL OR RENEWAL

1102.1 A hearing shall be convened within five (5) days of the institution of proceedings in the following cases:

(a) Summary suspension; and

(b) Denial or renewal.

1102.2 A registrant who has been summarily suspended or denied renewal under §305 of the Act, D.C. Code, 2001 Ed. §48-903.05, shall be entitled upon written request to a postponement, for a reasonable period of time only, of the hearing scheduled pursuant to §1102.1 of these rules.

1102.3 Notice of hearing in summary suspension and non-renewal shall be made in accordance with §305 of the Act, D.C. Code, 2001 Ed. §48-903.05.

1102.4 Except as otherwise noted in this chapter, all procedures relating to hearings as set forth in this chapter shall apply to hearings in summary suspensions and denials of renewal.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1058 (February 21, 1986).

22-B DCMR § 1103 HEARING PROCEDURES

1103.1 Each hearing shall be open to the public.

1103.2 At each hearing, the hearing officer shall be present to hear the evidence.

1103.3 A person entitled to a hearing shall have the following rights:

(a) The right to be represented by counsel;

(b) The right to present all relevant evidence by means of witnesses, books, papers, and other documents;

(d) The right to have subpoenas, pursuant to §507 of the Act, D.C. Code, 2001 Ed. §48-905.07, issued to compel the attendance of witnesses and the production of relevant books, papers and other documents, upon written request for subpoenas to the hearing officer.

1103.4 The Hearing Officer shall have the following powers:

(a) To administer oaths or affirmations, either personally or through a designated agent, to witnesses called to testify;

(b) To subpoena respondents and other witnesses and relevant books, papers, and documents pursuant to §507 of the Act, D.C. Code, 2001 Ed. §48-905.07;

(d) To direct continuance of any case for good cause shown.

1103.5 If any person refuses to respond to a subpoena, refuses to take the oath or affirmation as a witness, refuses to be examined, or refuses to obey any lawful order of the hearing officer, the hearing officer may apply to the proper court for an order requiring compliance.

1103.6 The hearing officer shall follow the general rules of evidence applicable to administrative hearings under the District of Columbia Administrative Procedure Act, D.C. Code, 2001 Ed. §§2-501 to 2-510.

1103.7 The hearing officer shall exclude incompetent, irrelevant, immaterial, or unduly repetitious evidence or testimony.

1103.8 The hearing officer shall maintain order and shall not permit undue abuse or harassment of witnesses.

1103.9 The hearing officer may exclude testimony under the rules of privilege recognized by decisions of the courts of the District of Columbia or as provided by law, including, but not limited, to the following:

(a) Communication between attorney and client;

(b) Communication between physician and patient;

(c) Records and files of any official or agency of government which, by statute or otherwise, are recognized as confidential; and

(d) Privileged matter enumerated in §501(c) of the Act, D.C. Code, 2001 Ed. §48-905.01.

1103.10 All testimony shall be taken under oath.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1058 (February 21, 1986).

22-B DCMR § 1104 EXHIBITS AND OTHER DOCUMENTARY EVIDENCE

1104.1 When a written exhibit is offered in evidence, one (1) copy shall be furnished to each of the parties at the hearing unless the parties have been furnished previously with copies or the hearing officer directs otherwise.

1104.2 If the hearing officer has not fixed a time for the exchange of exhibits, the parties shall exchange copies of exhibits at the earliest practical time, preferably before the hearing or, at the latest, at the commencement of the hearing.

1104.3 The hearing officer may permit a party to withdraw original documents offered in evidence and substitute true copies.

1104.4 Documentary evidence may be received in the form of copies or excerpts if the original is not available.

1104.5 Upon request, parties shall be given an opportunity to compare the copy with the original when available.

1104.6 When relevant and material matter offered in evidence by any party is embraced in a book, paper, or document containing other matter not material or relevant, the party offering the same shall plainly designate the matter so offered. The immaterial and irrelevant parts shall be excluded and shall be segregated insofar as is practicable.

1104.7 If the hearing officer so directs, the relevant or material matter may be read into the record, or, if the hearing officer so directs, a true copy of the matter, in proper form, shall be received as an exhibit, and like copies shall be delivered by the party offering the same to opposing parties or to their attorneys appearing at the hearing, who shall be afforded an opportunity to examine the book, paper, or document, and to offer in evidence in like manner other portions thereof.

1104.8 If any portion of the record in any other proceeding, including a court proceeding, is offered in evidence, a true copy of that portion shall be presented for the record in the form of an exhibit unless one (1) of the following occurs:

(a) The party offering the same agrees unconditionally to supply the copies at a later time designated by the hearing officer; or

(b) The parties represented at the hearing stipulate upon the record that the relevant matter may be incorporated by reference; or

(c) The hearing officer directs the incorporation by reference or waives the requirement of presentation of documentary evidence with the consent of the parties.

1104.9 No document or other writing shall be accepted for the record after the close of the hearing, except in accordance with an order issued by the hearing officer.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1059 (February 21, 1986).

22-B DCMR § 1105 OFFICIAL NOTICE

1105.1 Without limiting the discretionary powers of the hearing officer to notice other matters or documents which are properly the subject of official notice, the following matters may be officially noticed in all proceedings under the provisions of this chapter:

(a) Matters which are subject to judicial notice in the courts of the District of Columbia;

(b) Matters of generally recognized technical or specialized facts within the knowledge and experience of the hearing officer; and

1105.2 All parties to a proceeding shall be notified either before or during the hearing, of any matters noticed, and they shall be afforded an opportunity to contest the material so noticed.

1105.3 Where the decision of the hearing officer rests on the official notice of a matter not appearing in the evidence in the record, any party shall, upon filing a motion within ten (10) days after thereof be afforded a reasonable opportunity to offer evidence to the contrary.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1060 (February 21, 1986).

22-B DCMR § 1106 DISPOSITION OF CASES

1106.1 If a respondent fails to appear at any scheduled hearing after proper service of notice, the hearing officer in the absence of a continuance or good cause being shown, may proceed with the hearing and make a decision in the absence of respondent.

1106.2 Unless otherwise provided by the Director, any contested case may be disposed of by stipulation, agreed settlement, consent order, or default as provided by §1106.1. Any disposition, other than a default, shall be signed by the Director or the Director's designated agent.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1061 (February 21, 1986).

22-B DCMR § 1107 TRANSCRIPTS

1107.1 Hearings shall be recorded either stenographically or electronically and shall be available for transcribing upon the request of any party.

1107.2 The costs of transcripts of the record shall be borne by the parties requesting the transcripts.

1107.3 Changes in the official transcript shall be made only when they involve errors affecting substance.

1107.4 A motion to correct a transcript shall be filed within ten (10) days of receipt of the transcript.

1107.5 If no objection to the motion is filed within ten (10) days, the transcript shall, upon the approval of the hearing officer, be changed.

1107.6 If an objection is received, the motion and objection shall be submitted to the person who transcribed the record together with a request for a comparison of the transcript with the record.

1107.7 After receipt of the report of the person who made the transcription, an order shall be entered by the hearing officer settling the record and ruling on the motion.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1061 (February 21, 1986).

22-B DCMR § 1108 BURDEN OF PROOF

1108.1 In any proceeding resulting from proposed action to deny an applicant registration, the burden of proof shall be upon the applicant to demonstrate his or her qualifications.

1108.2 In any proceeding resulting from a proposed action to deny renewal or to suspend or revoke registration, the burden shall be on the Department to show that the proposed action should be taken.

1108.3 Notwithstanding the ultimate burden of proof regarding registration, in any proceeding the burden of proof of any exemption or exception under the Act or any affirmative defense is upon the person claiming it.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1062 (February 21, 1986).

22-B DCMR § 1109 DECISIONS

1109.1 Within ten (10) days of the close of the hearing or as soon thereafter as it is practicable, the hearing officer shall notify the applicant or registrant of the proposed decision in the case. A copy of the notice shall be sent to the Director if the Director did not personally hear the case.

1109.2 The notice of the proposed decision shall contain the following:

(a) A statement of proposed findings of fact and conclusions of law;

(b) A statement that these findings and conclusions shall become final unless a motion for rehearing or reconsideration is received within ten (10) days of the service of the proposed decision; and

1109.3 The findings shall include specific findings on each relevant contested issue of fact. Proposed findings of fact shall, if set forth in statutory language, include a concise and explicit statement of the underlying fact supporting them.

1109.4 Findings of fact and conclusions of law shall be supported by and shall be in accordance with reliable, probative, and substantial evidence.

1109.5 Decisions made by a hearing examiner shall be made in consideration of the entire record of the proceeding, or upon such portion of the record of the proceeding as may be agreed upon by all the parties to the proceeding, and no evidence, information, or other knowledge, except that of which official notice is taken shall be considered.

1109.6 A proposed decision shall become final unless a motion for a rehearing or reconsideration is received from respondent within ten (10) days of service of the proposed decision on respondent or unless otherwise directed by the Director.

1109.7 At the expiration of the period for filing a motion for rehearing or reconsideration the Director may, on the Director's own motion or order, do any of the following:

(a) Issue a final decision and order; or

(b) Remand the matter for further proceedings.

1109.8 A final decision of the Director shall include findings of fact and conclusions of law in conformity with the District of Columbia Administrative Procedure Act, D.C. Code, 2001 Ed. §§2-501 to 2-510, and these rules.

1109.9 A copy of the decision or order shall be delivered or mailed by certified mail, return receipt requested, to each party and their attorney of record. Notice shall be effective as provided in §§1101.7 and 1101.8.

1109.10 The final decision shall contain a statement of respondent's appeal rights.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1062 (February 21, 1986).

22-B DCMR § 1110 MOTION FOR REHEARING OR RECONSIDERATION

1110.1 Motions for rehearing or reconsideration may be filed by respondent within ten (10) days of service of the proposed decision issued pursuant to §1109.1 of these rules.

1110.2 Motions for rehearing or reconsider shall be in writing and shall state with specificity the grounds upon which they are based.

1110.3 The hearing officer, if he or she was not the Director or authorized to make a final decision, shall forward a copy of respondent's motion for rehearing or reconsideration to the Director or person authorized to make a final decision, together with the hearing officer's recommendation.

1110.4 If the person who is to render a final decision in the matter did not personally hear the evidence, that person shall provide the respondent with an opportunity to present oral argument with respect to his or her motion and personally consider the portions of the record as may be designated by the party, before rendering a final decision adverse to respondent.

1110.5 A timely motion for rehearing or reconsideration is a prerequisite to an appeal under §1111 unless otherwise authorized by the Director.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1063 (February 21, 1986).

22-B DCMR § 1111 JUDICIAL REVIEW

1111.1 A person aggrieved by an adverse decision by the Director under this chapter may seek review in the District of Columbia Court of Appeals within fifteen (15) days of service of the decision of such other time as the court may prescribe for review of contested cases under §11 of the District of Columbia Administrative Procedure Act, D.C. Code, 2001 Ed. §2-510.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1063 (February 21, 1986).

22-B DCMR § 1199 DEFINITIONS

1199.1 The provisions of §1099 of chapter 10 of this title and the definitions set forth in that section shall apply to this chapter.

History

SOURCE: Final Rulemaking published at 33 DCR 1046 (February 21, 1986).

22-B12 CONTROLLED SUBSTANCES ACT RULES

22-B DCMR § 1200 PURPOSE

1200.1 This chapter shall comprise all the enumerated schedules of controlled substances under the District of Columbia Uniform Controlled Substances Act of 1981 (Act), effective August 5, 1981 (D.C. Law 4-29; D.C. Official Code § 48-902.01), and all final rulemakings made by the Mayor or designee that add, delete, or reschedule a controlled substance under the authority of Section 201 of the Act (D.C. Official Code § 48-902.01).

History

SOURCE: Final Rulemaking published at 39 DCR 1882 (March 20, 1992); as amended by Emergency and Proposed Rulemaking published at 47 DCR 7512 (September 15, 2000) [EXPIRED]; as amended by Final Rulemaking published at 48 DCR 914 (February 2, 2001); as amended by Emergency and Proposed Rulemaking published at 50 DCR 10421 (December 5, 2003) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 4080 (April 23, 2004); as amended by Final Rulemaking published at 61 DCR 10233 (October 3, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1200

22-B DCMR § 1201 SCHEDULE I ENUMERATED

1201.1 The controlled substances listed in this section are included in Schedule I of the Act unless removed therefrom pursuant to Section 201 of the Act:

Opiates: Unless specifically excepted or unless listed in another schedule, any of the following opiates including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of these isomers, esters, ethers, and salts is possible within the specific chemical designation:

1-Methyl-4-phenyl-4-propionoxypiperidine (MPPP);

1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine (PEPAP);

3-Methylfentanyl;

3-Methylthiofentanyl;

Acetyl-Alpha-Methylfentanyl;

Acetylmethadol;

Allylprodine;

Alphacetylmethadol except Levo-alphacetylmethadol

Alphameprodine;

Alphamethadol;

Alpha-Methylfentanyl;

Alpha-Methylthiofentanyl;

Benzethidine;

Betacetylmethadol;

Beta-hydroxyfentanyl;

Beta-hydroxy-3-Methylfentanyl;

Betameprodine;

Betamethadol;

Betaprodine;

Clonitazene;

Dextromoramide;

Diampromide;

Diethylthiambutene;

Difenoxin;

Dimenoxadol;

Dimepheptanol;

Dimethylthiambutene;

Dioxaphetyl butyrate;

(29) Dipipanone;

(30) Ethylmethylthiambutene;

(31) Etonitazene;

(32) Etoxeridine;

(33) Furethidine;

(34) Hydroxypethidine;

(35) Ketobemidone;

(36) Levomoramide;

(37) Levophenacylmorphan;

(38) Morpheridine;

(39) Noracymethadol;

(40) Norlevorphanol;

(41) Normethadone;

(42) Norpipanone;

(43) Para-fluorofentanyl;

(44) Phenadoxone;

(45) Phenampromide;

(46) Phenomorphan;

(47) Phenoperidine;

(48) Piritramide;

(49) Proheptazine;

(50) Properidine;

(51) Propiram;

(52) Racemoramide;

(53) Thiofentanyl;

(54) Thiophene;

(55) Tilidine; and

(56) Trimeperidine;

Opium Derivates: Unless specifically excepted or unless listed in another schedule, any of the following opium derivatives, its salts, isomers, and salts of isomers, whenever the existence of these salts, isomers, and salts of isomers is possible within the specific chemical designation:

Acetorphine;

Acetyldihydrocodeine;

Benzylmorphine;

Codeine methylbromide;

Codeine-N-Oxide;

Cyprenorphine;

Desomorphine;

Diacetylmorphine (heroin);

Dihydromorphine;

Drotebanol;

Etorphine (except hydrochloride salt);

Hydromorphinol;

Methyldesorphine;

Methyldihydromorphine;

Morphine methylbromide;

Morphine methylsulfonate;

Morphine-N-Oxide;

Myrophine;

Nicocodeine;

Nicomorphine;

Normorphine;

Pholcodine; and

Thebacon;

Hallucinogenic Substances: Unless specifically exempted or unless listed in another schedule, any material, compound, mixture, or preparation that contains any quantity of the following hallucinogenic substances, its salts, isomers, and salts of isomers, whenever the existence of these salts, isomers, and salts of isomers is possible within the specific chemical designation (for the purposes of this paragraph only, the term "isomer" includes the optical, position, and geometric isomers):

1-[1-(2-Thienyl)cyclohexyl]piperidine;

(2) 1- [1-(2-thienyl)cyclohexyl]pyrrolidine;

(3) 1-(1-Phenylcyclohexyl)-pyrrolidine,Pyrrolidine analog of phencyclidine, PCPy, PHP;

(4) (2C-C) 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine;

(5) (2C-D) 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine;

(6) (2C-E) 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine;

(7) (2C-H) 2-(2,5-Dimethoxyphenyl)ethanamine;

(8) (2C-I) 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine;

(9) (2C-N) 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine;

(10) (2C-P) 2-(2,5-Dimethoxy-4(n)-propylphenyl)ethanamine;

(11) (2C-T-2) 2-[4-(ethylthio)-2,5-dimethoxyphenyl)ethanamine;

(12) (2C-T-4)2-[4-(Isopropylthio)-2,5-dimethoxyphenyl] ethanamine;

(13) (2C-T-7) 2,5-Dimethoxy-4-(n)-propylthiophenethylamine);

(14) 2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25B-NBOMe);

(15) 2-(4-chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine 25C-NBOMe); and

(16) 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25I-NBOMe);

(17) 2,5-Dimethoxyamphetamine;

(18) 2,5-Dimethoxy-4-ethylamphetamine;

(19) 3,4-Methylenedioxymethamphetamine;

(20) 3,4-Methylenedioxyamphetamine;

(21) 3,4-Methylenedioxy-N-ethylamphetamine;

(22) 3,4,5-Trimethoxyamphetamine;

(23) 4-Bromo-2,5-dimethoxy-amphetamine;

(24) 4-Bromo-2,5-dimethoxyphenethylamine;

(25) 4-Methoxyamphetamine;

(26) 4-Methylaminorex;

(27) 4-Methyl-2,5-dimethoxyamphetamine;

(28) 5-flouro-UR-144 and XLR11[1-(5-Fluoro-pentyl)1Hindol-3-yl](2,2,3,3- tetramethylcyclopropyl)methanone;

5-Methoxy-3,4-methylenedioxyamphetamine;

(30) 5-Methoxy-N,N-diisopropyltryptamine (other name: 5-MeO-DIPT);

(31) 5-Methoxy-N,N-dimethyltryptamine;

(32) Bufotenine;

(33) Diethyltryptamine;

(34) Dimethyltryptamine;

(35) N-Ethyl-1-phenylcyclohexylamine;

(36) Ibogaine;

(37) Lysergic acid diethylamide;

(38) Mescaline;

(39) N-Ethyl-1-phenylcyclohexylamine;

(40) N-Ethyl-3-piperidyl benzilate;

(41) N-Methyl-3-piperidyl benzilate;

(42) Parahexyl--7374; some trade or other names: 3-Hexyl-1-hydroxy-7,8,9,10-tetrahydro-6,6,9-trimethyl-6Hdibenzo[b,d]pyran; Synhexyl;

(43) Peyote;

(44) Psilocybin;

(45) Psilocyn;

(46) Thiophene analog of phencyclidine;

(47) (2C-T) 2-(2,5-dimethoxy-4-(methylthio)phenyl)ethanamine; OR 4-methylthio-2,5-dimethoxyphenethylamine;

(48) 4- methylthio-2,5-dimethoxyphenethylamine;

(49) (2C-B-butterFLY) 2-(10-Bromo-2,3,4,7,8,9 hexahydropyrano[2,3-g]chromen-5-yl)ethanamine;

(50) (2C-B-FLY) 2-(8-bromo-2,3,6,7-tetrahydrofuro [2,3-f][1]benzofuran-4- yl)ethanamine;

(51) (2C-B-hemiFLY, 2CB-5- hemiFLY) 2-(7-Bromo-5-methoxy-2,3-dihydro-1-benzofuran-4- yl)ethanamine;

(52) (2C-B-FLY-NBOMe) N-(2-Methoxybenzyl)-1-(8-bromo-2,3,6,7- tetrahydrobenzo[1,2-b:4,5-b']difuran-4-yl)-2-aminoethane;

(53) (2C-B-NBOMe, 2,5B-NBOMe) 2-(4-bromo-2,5-dimethoxyphenyl)-N-[(2-methoxyphenyl)methyl]ethanamine; OR 2,5-Dimethoxy-4- bromo-N-(2-methoxybenzyl) phenethylamine

(54) 2CBCB-NBOMe N-(2-methoxybenzyl)-1-[(7R)-3-bromo-2,5-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methanamine;

(55) 2C-C-NBOMe, 2,5C-NBOMe 2-(4-chloro-2,5-dimethoxyphenyl)-N-[(2-methoxyphenyl)methyl]ethanamine; OR 2,5-Dimethoxy-4-chloro-N-(2-methoxybenzyl)phenethylamine;

(56) 2C-H-NBOMe, 2,5H-NBOMe 2-(2,5-dimethoxyphenyl)-N-[(2-methoxyphenyl)methyl]ethanamine;

(57) 2C-I-NBOH, 2,5I-NBOH N-(2-Hydroxybenzyl)-4-iodo-2,5-dimethoxyphenethylamine;

(58) 2C-I-NBOMe, 2,5INBOMe, 2,5I-NBOMe, 25I-NBOMe, NBOMe-2C-I, BOM-CI 2- 2-(4-iodo-2,5-dimethoxyphenyl)-N-[(2-methoxyphenyl)methyl]ethanamine; OR 2,5-Dimethoxy-4-iodo-N-(2-methoxybenzyl)phenethylamine;

(59) (2CBCB-NBOMe) N-(2-methoxybenzyl)-1-[(7R)-3-bromo-2,5- dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methanamine

(60) (2C-H-NBOMe, 2,5H-NBOMe) 2-(2,5-dimethoxyphenyl)-N-[(2-methoxyphenyl)methyl]ethanamine

(61) (2C-I-NBOH, 2,5I-NBOH) N-(2-Hydroxybenzyl)-4-iodo-2,5-dimethoxyphenethylamine;

(62) 2C-TFM-NBOMe) 2-(4-trifluoromethyl-2,5-dimethoxyphenyl)-N-[(2-ethoxyphenyl)methyl]ethanamine;

(63) (25I-NBF) 2-(4-iodo-2,5-dimethoxyphenyl)-N-[(2- fluorophenyl)methyl]ethanamine;

(64) (25I-NBMD, NBMD-2C-I, Cimbi-29) 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2,3ethylenedioxyphenyl)methyl]ethanamine;

(65) (3C-B-FLY) 2-(4-bromo-2,3,6,7-tetrahydrofurobensofuran-8-yl)-1- methyl-ethylamine;

(66) (4-CAB, AEPCA) 4-Chlorophenylisobutylamine; OR 1-(4-chlorophenyl)butan-2-amine; OR 4-chloro-α-ethylphenethylamine;

(67) (4-FA, PAL-303, Flux, Flits, R2D2) para-fluoroamphetamine; OR 4-fluoroamphetamine; OR (RS)-1-(4-Fluorophenyl)propan-2-amine;

(68) (5-APB) 5-(2-Aminopropyl)benzofuran;

(69) (5-APDB) 5-(2-Aminopropyl)-2,3-dihydrobenzofuran; 1-(2,3-dihydro-1-benzofuran-5-yl)propan-2-amine; 5-(2-Aminopropyl)-2,3-dihydrobenzofuran (3-Desoxy-MDA, EMA-4)

(70) (6-APB; Benzofury) 6-(2-aminopropyl)benzofuran; OR 1-benzofuran-6-ylpropan-2-amine;

(71) (6-APDB) 6-(2-Aminopropyl)-2,3,-dihydrobenzofuran;

(72) (APB) ((2-aminopropyl)benzofuran); OR [(2- aminopropyl)benzofuran]; OR (2-aminopropyl)benzofuran;

(73) (APDB) ((2-aminopropyl)-2,3-dihydrobenzofuran); OR [(2- aminopropyl)-2,3-dihydrobenzofuran]; OR (2-aminopropyl)- 2,3-dihydrobenzofuran;

(74) (bromo-dragonFLY) 1-(4-Bromofuro[2,3-f][1]benzofuran-8-yl)propan-2-amine; OR bromo-benzodifuranyl-isopropylamine;

(75) (DOB) 2,5-Dimethoxy-4-bromoamphetamine; OR 1-(4-Bromo-2,5- dimethoxyphenyl)-2-aminopropane;

(76) (DOC) 2,5-Dimethoxy-4-chloroamphetamine; OR 1-(4-chloro-2,5- dimethoxy-phenyl)propan-2-amine; OR 4-chloro-2,5- dimethoxyamphetamine;

(77) (DOI) 2,5-dimethoxy-4-iodoamphetamine; OR 1-(2,5-dimethoxy-4- iodophenyl)-propan-2-amine; OR 4-iodo-2,5- dimethoxyamphetamine;

(78) DOM, STP 4-methyl-2,5-dimethoxy-amphetamine; OR 4-methyl-2,5-dimethoxy-a-methylphenethylamine;

(79) (Fluoroamphetamine);

(80) MDA 3,4-methylenedioxy amphetamine;

(81) MDMA 3,4-methylenedioxymethamphetamine;

(82) MDE, MDEA3,4-methylenedioxy-N-ethylamphetamine; OR N-ethylalpha-methyl-3,4(methylenedioxy)phenethylamine;

(83) Mescaline 3,4,5-trimethoxyphenethylamine;

(84) (Mescaline-NBOMe) N-(2-Methoxybenzyl)-2-(3,4,5- trimethoxyphenyl)ethanamine; OR 3,4,5-trimethoxy-N-(2- methoxybenzyl)phenethylamine;

(85) (PMMA, 4-MMA) para-Methoxy-N-methylamphetamine; OR 4-methoxy-N- methylamphetamine; OR 1-(4-methoxyphenyl)-N-methyl- propan-2-amine;

(86) TMA, 3,4,5-trimethoxyamphetamine;

(87) 2,5-Dimethoxy-4-ethylamphetamine, (DOET, DOE);

(88) Eticyclidine (PCE, CI-400);

(89) N-Ethyl-mda; Eve (amphetamine); 3,4-Methylenedioxyethylamphetamine; 3,4-Methylenedioxy-N-ethylamphetamine;

(90) 4-Methylthioamphetamine (4-MTA);

(91) 2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2- methoxybenzyl)ethanamine, (2C-B-NBOMe);

(92) 4- Methyl- 2,5-dimethoxyphenethylamine, (2C-D);

(93) 2-(4-Methyl-2,5-dimethoxyphenyl)-N- (2-methoxybenzyl)ethanamine, (2C-D-NBOMe);

(94) 4-Ethyl- 2,5-dimethoxyphenethylamine, (2C-E);

(95) 2-5-Dimethoxy-4-iodo-N-(2-methoxybenzyl)ethanamine, (2C-I-NB0Me);

(96) 1-(Benzofuran-5-yl)-N-methylpropan-2-amine, (5-MAPB) (1-(benzofuran-5-yl)-N-methylpropan-2-amine);

(97) N-Methy-(6-bromo-3,4- methylenedioxypheny1)propan-2-amine, (6-Br-MDMA);

(98) 1-(6-chloro-1,3-benzodioxol-5-yl)-N-methylpropan-2-amine, 6-Chloro-MDMA (6-Cl-MDMA, 2-Cl-4,5-MDMA);

(99) (AB-FUBINACA) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide;

(100) (ADB-PINACA) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide;

(101) (ADBICA) N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indole-3-carboxamide;

(102) (APICA) N-(1-adamantyl)-1-pentylindole-3-carboxamide;

(103) (CUMYL-THPINACA) N-(2-Phenypropan-2-yl)-1-(tetrahydropyran 4- ylmethyl)-1H-indazole-3-carboxamide;

(104) (EAM-220O1); (5"-fluoro-JWH-210) (1-(5-Flouropentyl)-1H-indol-3-yl)(4-ethylnaphthalen-1-yl)methadone;

(105) (FUB-JWH-018) (1-(4-Fluorobenzyl)-1H-indol-3-yl)(naphthalene-1-yl)methadone;

(106) (FUB-PB-22); (UNII-DS46154N3F); (DS46154N3F) quinolin-8-yl 1-[(4-fluorophenyl)methyl]indole-3-carboxylate;

(107) (MDMB-CHMICA) N-(1-Methoxy-3,3-dimethyl-1-oxobutan-2yl)-1-(cyclohexylmethyl)-1H-indole-3-carboxamide;

(108) (MDMB-FUBINACA) N-(1-Methoxy-3,3-dimethyl-1-oxobutan-2-yl)-1(4-fluorobenzyl)-1H-indazole-3-carboxamide;

(109) (PX-2) N-(1-Amino-1-oxo-3-phenylpropan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide;

(110) (2-FMC) 1-(2-flourophenyl)-2-methylaminopropan-1-one;

(111) (2-MMC) 1-(2-methylphenyl)-2-methylaminopropan-1-one;

(112) (3,3-DMMC) 1-(3,4- dimethylphenyl)-2-methylaminopropan-1-one;

(113) (3-CMC) 1-(3-chlorophenyl)-2-methylaminopropan-1-one;

(114) (3-MeOMC) 1-(3-methoxyphenylaminopropan-1-one;

(115) (3-MMC) 1-(3-methylphenyl)-2-methylaminopropan-1-one;

(116) (4-BMC) 1-(4-bromophenyl)-2-methylaminopropan-1-one;

(117) (4-CMC) 1-(4-chlorophenyl)- 2-methylaminopropan-1-one;

(118) (4-MMC) 4-methyl methcathinone or 4-methyl ephedrone;

(119) (1-butyl-1H-indol-3-yl)(4-methylnaphthalen-1-yl)methanone;

(120) [1-[(1-methyl-2-piperidinyl)methyl]-1H-indol-3-yl]-1-naphthalenyl-methanone;

(121) 3–(4-methoxyphenyl)–2-methyl-1-[(2–(4-morpholinyl)ethyl)– 1H-indol-3-yl]-methanone;

(122) 2–(3-methoxyphenyl)–1–(1-pentyl-1H-indol-3-yl)-ethanone;

(123) (2-iodophenyl)[1-[(1-methyl-2-piperidinyl)methyl]-1H-indol- 3-yl]-methanone;

(124) [1-[(1-methyl-2-piperdinyl)methyl]-1H-indol-3- yl]tricycle[3.3.1.13,7]dec-1-yl-methanone;

(125) 1-naphthalenyl(1-propyl-1H-indol-3-yl)-methanone;

(126) 5-[3–(1-naphthoyl)–1H-indole-1-yl]pentanenitrile;

(127) 3–(1-naphthenylmethyl)–1-pentyl-1H-indole;

(128) (2-methyl-1-propyl-1H-indol-3-yl)–1-napthalenyl-methanone;

(129) 1-naphthalenyl[1–(4-penten-1-yl)–1H-indol-3-yl]-methanone;

(130) (4-bromonaphthalen-1-yl)(1-pentyl-1H-indol-3-yl)methanone;

(131) (4-fluoronaphthalen-1-yl)(1-pentyl-1H-indol-3-yl)methanone;

(132) (2-methyl-1-phenyl-1H-indol-3-yl)–1-naphthalenyl-methanone;

(133) 2–(2-chlorophenyl)–1–(1-pentyl-1H-indol-3-yl)-ethanone;

(134) 1–(5-chloropentyl)–1H-indol-3-yl- methanone;

(135) (adamantan-1-yl)(1-pentyl-1H-indol-3-yl)-methanone;

(136) (2-iodo-5-nitrophenyl)-[1–(1-methylpiperidin-2-ylmethyl)– 1H-indol-3-yl]-methanone;

(137) (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclo-propyl)methanone;

(138) 1–(5-fluoropentyl-1H-indol-3-yl)methanone;

(139) 1–(2-morpholinoethyl)–1H-indol-3-ylmethanone;

(140) 1-[(tetrahydro-2H-pyran-4-yl)methyl]-1H-indol-3-yl-(2,2,3,3-tetramethylcyclopropyl)methanone;

(141) 1-pentyl-N-tricyclo[3.3.1.13,7]dec-1-yl-1H-indole-3-carboxamide;

(142) 1-pentyl-N-tricyclo[3.3.1.13,7]dec-1-yl-1H-indazole-3-carboxamide;

(143) 1–(5-fluoropentyl)–N-tricyclo[3.3.1.13,7]dec-1-yl-1H-indole-3-carboxamide;

(144) 1–(5-chloropentyl)–1H-indol-3-ylmethanone;

(145) (1-isopentyl-1H-indol-3-yl)(naphthalen-1-yl)methanone;

(146) 1–(5-fluoropentyl-N-tricyclo[3.3.1.13,7]dec-1-yl-1H-indazole-3-carboxamide;

(147) (1-pentyl-1H-indol-3-yl)(4-propyl-1-naphthalenyl)-methanone;

(148) 1–(5-chloropentyl)–1H-indol-3-ylmethanone;

(149) (4-methyl-naphthalen-1-yl)[1–(pent-4-en-1-yl)–1H-indol-3-yl]methanone;

(150) (2-methoxy-1-naphthalenyl)(1-pentyl-1H-indol-3-yl)methanone;

(151) (3-methoxy-phenyl)(1-pentyl-1H-indol-3-yl)methanone;

(152) 1–(5-fluoropentyl)–1H-indol-3-yl- methanone;

(153) quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate;

(154) quinolin-8-yl 1–(5-fluoropentyl-1H-indole-3-carboxylate;

(155) 1–(cyclohexylmethyl)–8-quinolinyl-ester-1H-indole-3-carboxylic acid;

(156) N–(1-amino-3-methyl-1-oxobutan-2-yl)–1-pentyl-1H-indazole-3-carboxamide;

(157) 1–(5-fluoropentyl)–N–(naphthalene-1-yl)–1H-indole-3-carboxamide;

(158) N–(1-amino-3-methyl-1-oxobutan-2-yl)–1–(4-fluorobenzyl)–1H-indazole-3-carboxamide;

(159) N–(1-amino-3,3-dimethyl-1-oxobutan-2-yl)–1–(4-fluorobenzyl)–1H-indazole-3-carboxamide;

(160) N–(1-amino-3,3-dimethyl-1-oxobutan-2-yl)–1-pentyl-1H-indole-3-carboxamide;

(161) 2-iodophenyl)(1-pentyl-1H-indol-3-yl)methanone;

(162) [5–(2-methylphenyl)–1-pentyl-1H-pyrrol-3-yl]-1-naphthalenyl-methanone;

(163) 1-pentyl-N–(naphthalene-1-yl)–1H-indole-3-carboxamide;

(164) 1–(5-chloropentyl)–1H-indol-3-yl](4-methyl-1-naphthalenyl)-methanone;

(165) (4-methyl-naphthalen-1-yl)[2-methyl-1–(pent-4-en-1-yl)– 1H-indol-3-yl)]methanone;

(166) 1–(5-fluoropentyl)–1H-indol-3-ylmethanone;

(167) (2-ethylphenyl)(1–(5-fluoropentyl)–1H-indol-3-yl)methanone;

(168) 1–(5-chloropentyl)–1H-indol-3-ylmethanone;

(169) 1–(5-bromopentyl)–1H-indol-3-ylmethanone;

(170) (1–(5-fluoropentyl)–1H-indazol-3-yl)(naphthalene-1-yl)methanone;

(171) 1-[(1-methyl-2-piperidinyl)methyl]-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone;

(172) (1–(1-methylazepan-2-yl)–1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone;

(173) 4-hydroxy-3,3,4-trimethyl-1–(1-pentyl-1H-indol-3-yl)pentan-1-one;

(174) [1–(4-fluoropentyl)–1H-indol-3-yl]-1-naphthenyl-methanone;

(175) 2–(2-iodophenyl)–1–(1-pentyl-1H-indol-3-yl)ethanone;

(176) (1-hexyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone;

(177) (2,2,3,3-tetramethylcyclopropyl)[1–(4,4,4-trifluorobutyl)– 1H-indol-3-yl]methanone;

(178) 7-methoxy-1–(2-morpholinoethyl)–N–((1S,4R)–1,3,3-trimethylbicyclo[2.2.1]heptan-2-yl)–1H-indole-3-carboxamide;

(179) (4-fluorobenzyl)–1H-indole-3-quinolin-8-yl

Carboxylate;

(180) 1–(4-fluorobenzyl)–1H-indole-3-naphthalen-1-yl

Carboxylate;

(181) N–(1-amino-3,3-dimethyl-1-oxobutan-2-yl)–1-pentyl-1H-indazole-3-carboxamide;

(182) N–(1-amino-3,3-dimethyl-1-oxobutan-2-yl)–1–(5-fluoropentyl)–1H-indole-3-carboxamide;

(183) (1–(4-fluoropentyl)–1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone;

(184) 1-naphthalenyl(1-pentyl-1H-indazol-3-yl)methanone;

(185) N-naphthalenyl-1-pentyl-1H-indazole-3-carboxamide;

(186) N–(1-amino-3-methyl-1-oxobutan-2-yl)–1–(cyclohexylmethyl)–1H-indazole-3-carboxamide;

(187) naphthalene-1-yl(9-pentyl-9H-carbazol-3-yl)methanone;

(188) naphthalene-1-yl 1–(5-fluoropentyl)–1H-indole-3-carboxylate;

(189) methyl 3-methyl-2–(1-pentyl-1H-indazole-3-carboxamido;

(190) methyl 2–(1–5-fluoropentyl)–1H-indazole-3-caboxamido) methylbutanoate;

(191) N-benzyl-1-pentyl-1H-indole-3-carboxamide;

(192) N-benzyl-1–(5-fluoropentyl)–1H-indole-3-carboxamide;

(193) methyl 2–(1–(4-fluorobenzyl)–1H-indazole-3-carboxamido)–3-methylbutanoate;

(194) quinolin-8-yl 1-pentyl-1H-indazole-3-carboxylate;

(195) quinolin-8-yl 1–(5-fluoropentyl)–1H-indazole-3-carboxylate;

(196) naphthalene-2-yl 1–(2-fluorophenyl)–1H-indazole-3-carboxylate;

(197) N–(1-amino-3,3-dimethyl-1-oxobutan-2-yl)–1–(cyclohexylmethyl)–1H-indazole-3-carboxamide;

(198) (1–(4-flourobenzyl)–1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone;

(199) N–(1-amino-1-oxo—3-phenylpropan-2-yl)–1–(5-fluoropentyl)–1H-indole-3-carboxamide;

(200) N–(1-amino-1-oxo—3-phenylpropan-2-yl)–1–(5-fluoropentyl)–1H-indazole-3-carboxamide;

(201) methyl (1–(cyclohexylmethyl)–1H-indazole-3-carbonyl-L-valinate;

(202) N-[(1–(cyclohexylmethyl)–1H-indazole-3yl)carbonyl]- 3-methyl-L-valine, methyl ester;

(203) methyl 2–(1–(cyclohexylmethyl)–1H-indole-3-carboxamido)–3,3-dimethylbutanoate;

(204) (1–(5-fluoropentyl)–1H-benzo[d]imidazole-2-yl)(naphthalene-1-yl)methanone;

(205) (1–(4-fluorobenzyl)–1H-indol-3-yl)(napthalen-1-yl)methanone;

(206) methyl 2–(1–(4-fluorobenzyl)–1H-indazole-3-carboxamido)–3,3-dimethylbutanoate;

(207) quinolin-8-yl1–(4-fluorobenzyl)–1H-indazole-3-carboxylate;

(208) N–(adamantan-1-yl)–1–(4-fluorobenzyl)–1H-indazole-3-carboxamide;

(209) N–(1-amino-3-methyl-1-oxobutan-2-yl)–1–(5-fluoropentyl)–1H-indole-3-carboxamide;

(210) 2-[(1S,3R)–3-hydroxycyclohexyl]-5–(2-methylheptyl-2-yl)phenol;

(211) 3-hydroxy-2[3-methyl-6–(1-methylethyenyl)–2-cyclohexen-1-yl]-5-pentyl-2,5-cyclohexadiene-1,4-dione;

(212) 4-[4–(1,1-dimethylheptyl)–2,6-dimethoxyphenyl]-6,6-dimethyl-bicyclo[3.1.1]hept-2-ene-2-methanol;

(213) 1-naphthalenyl[4–(pentylox)–1-naphthalenyl]-methanone;

(214) 3–(2–(hydroxymethyl)–2,3-dihydro-1H-inden-4-yloxy)phenyl 4,4,4-trifluorobutane-1-sulfonate;

(215) N–(benzo[1,3]dioxol-5-ylmethyl)–7-methoxy-2-oxo-8-pentyloxy-1,2-dihydroquinoline-3-carboxamide;

(216) N-[3–(2-methoxyethyl)–4,5-dimethylthiazol-2-ylidene]-2,2,3,3-tetramethylcyclopropane-carboxamide;

(217) 5-chloro-3-ethyl-N-[4–(piperidin-1-yl)phenethyl)–1H-indole-2-carboximide;

(218) N-[4–(dimethylamino)phenethyl]-3-ethyl-5-fluoro-1H-indole-2-carboximide;

(219) N–(1-benzylpyrrolidin-3-yl)–5-chloro-3-ethyl-1H-indole-2-carboxamide;

(220) 5–(2-fluorophenyl)–1-pentyl-1H-pyrrol-3-ylmethanone;

(221) (3’-(aminocarbonyl)[1,1’-biphenyl]-3-yl)-cyclohexyl-carbamate;

(222) 5–(biphenyl-4-ylmethyl)–N,N-dimethyl-1H-tetrazole-1-carboxamide;

(223) 6-methyl-2–(p-tolylamino)–4H-benzo[d][1,3]oxazin-4-one;

(224) [1,1'-biphenyl]-3-yl-carbamic acid, cyclohexyl ester;

(225) 4-hydroxy-N–(4-hydroxyphenethyl)–3–(pentylamino)- benzamide; and

(226) 3’-carbamoyl-6-hydroxy-[1,1’-biphenyl]-3-ylcyclohexylcarbamate;

Depressants: Unless specifically excepted or unless listed in another schedule, any material, compound, or mixture, or preparation that contains any quantity of the following substances having a depressant effect on the central nervous system including its salts, isomers, and salts of isomers, whenever the existence of the salts, isomers, and salts of isomers is possible, within the specific chemical designation:

(1) Cyclobarbital; Hexemal; Cyclobarbitone;

(2) Etaqualone; Athinazone; Ethinazone; 3-(2-ethylphenyl)-2-

methylquinazolin-4-one;

(3) Gamma-Hydroxybutyric Acid [other names include GHB; gamma-hydroxybutyrate; 4-hyrdroxybutyrate; 4-hydroxybutanoic acid; socium oxybate; sodium xybutyrate];

(4) Mecloqualone; and

(5) Methaqualone;

Stimulants: Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation that contains any quantity of the following substances having a stimulant effect on the central nervous system, including its salts, isomers, and salts of isomers:

(1) Alpha-ethyltryptamine;

(2) Alpha-methyltryptamine;

(3) Aminorex;

(4) Brolamfetamine, bromo-DMA, 2,5-Dimethoxy-4-bromoamphetamine, Dimethoxybromoamphetamine (DOB);

(5) 1,4-dibenzylpiperazine;

(6) 1–(4-bromo-2,5-dimethoxybenzyl)-piperazine;

(7) 1–(4-fluorophenyl)-piperazine;

(8) 1–(2-methoxyphenyl)-piperazine;

(9) 1–(4-chlorophenyl)-piperazine;

(10) 1–(4-methoxyphenyl)-piperazine;

(11) 1–(3-methylbenzyl)piperazine;

(12) 1-benzyl-4-methylpiperazine;

(13) 8-methyl-8-azabicyclo[3.2.1]octan-3-yl 4-fluorobenzoate;

(14) methyl 3–(4-fluorophenyl)–8-methyl-8-azabicyclo[3.2.1]octane-2-carboxylate;

(15) Cathinone; Any compound (not being bupropion) structurally derived from 2-amino-1-phenyl-1-propanone by modification in any of the following ways:

(A) By substitution in the phenyl ring to any extent with alkyl, alkoxy, alkylenedioxy, haloalkyl or halide substituents, whether or not further substituted in the phenyl ring by one or more other univalent substituents;

(B) By substitution at the 3-position with an alkyl substituent; or

(C) By substitution at the nitrogen atom with alkyl or dialkyl groups, or by inclusion of the nitrogen atom in a cyclic structure;

(16) 2-diphenylmethylpyrrolidine, including 2-Benzylhydrylpyrrolidin, (S)-(-)-2-(diphenylmethyl)pyrrolidine, (S)-2-diphenylmethylpyrrolidine; (2S)-2-Benzylhydrylpyrrolidine; (2S) diphenylmethylpyrrolidine;

(17) Fenethylline;

(18) Mephedrone (4-methyl-N-methylcathinone), BZ-6378, 4-methylephedrone;

(19) Methcathinone, including 4-MEC 4-methyl-N-ethylcathinone, 4-methylethcathinone, para-methyl-N-ethylcathinone, para-methylethcathinone, 4-methyl-ethylcathinone;

(20) Methylenedioxypyrovalerone (MDPV);

(21) Methylone;

(22) N-Benzylpiperazine, (BZP) benzylpiperazine, N-benzylpiperazine;

(23) N-ethylamphetamine;

(24) N-Hydroxy-3, 4-methylenedioxyamphetamine;

(25) N, N-Dimethylamphetamine;

(26) 4-methyl-N-ethylcathinone (“4-MEC”);

(27) 4-methyl-alpha-pyrrolidinopropiophenone (“4-MePPP”);

(28) Alpha-pyrrolidinopentiophenone (“α-PVP”), (a-PVP, alpha-PVP), a-Pyrrolidinopentiophenone, 1-phenyl-2-(1 -pyrrolidinyl)-1-pentanone, alpha-pyrrolidinovalerophenone, a-pyrrolidinovalerophenone;

(29) 1-(1, 3-benzodioxol-5-yl)-2-(methylamino)butan-1-one (“butylone”);

(30) 2-(methylamino)-1-phenylpentan-1-one (“pentedrone”);

(31) 1-(1,3-benzodioxol-5-yl)-2-(methylamino)pentan-1-one (“pentylone”);

(32) 4-fluoro-N-methylcathinone (“4-FMC”), including 4-ethylmethcathinone, 4-ethyl-methcathinone, Flephedrone, 4-fluoromethcathinone;

(33) 3-fluoro-N-methylcathinone (“3-FMC”), 3-fluoromethcathinone;

(34) 1-(naphthalen-2-yl)-2-(pyrrolidin-1-yl)pentan-1-one (“naphyrone”);

(35) Alpha-pyrrolidinobutiophenone (“α-PBP”) (a-PBP, alpha-PBP) alpha-Pyrrolidinobutiophenone, a-Pyrrolidinobutiophenone, (RS)1-phenyl-2-(1-pyrrolidinyl)-1-pentanone;

(36) 2-DPMP, including desoxypipradrol, diphenylprolinol, 2-

Diphenylmethylpiperidine, 2-benzhydrylpiperidine;

(37) 2-FMC, 2-fluoromethcathinone;

(38) 3,4-DMMC, 3,4-dimethylmethcathinone;

(39) 4-MBC, Benzedrone, (±)-1-(4-methylphenyl)-2-(benzylamino)propan-1-one, 4-methyl-N-benzylcathinone,N-benzyl-4-methylcathinone, 1-(4 methylphenyl)-2-benzyla-minopropan-1-one;

(40) 4-MeMABP, 4-methylbuphedrone, (2-Methylamino-1-(4-methylphenyl)butan-1-one), 2-methylamino-1-(4-methylphenyl)butan-1-one;

(41) a-PPP, alpha-PPP, alpha-pyrrolidinopropiophenone, a-pyrrolidinopropiophenone;

(42) Buphedrone, a-methylamino-butyrophenone, 2-(methylamino)-1-phenylbutan-1-one, alpha-methylamino-butyrophenone;

(43) Butylone, bk-MBDB, beta-Keto-N-methylbenzodioxolylpropylamine, beta-Keto-N-methyl-3,4-benzodioxyolybutanamine;

(44) D2PM, diphenyl-2-pyrrolidinyl-methanol;

(45) Dimethocaine, (3-diethylamino-2,2-dimethylpropyl)-4-aminobenzoate;

(46) DMBDB, bk-DMBDB,dibutylone, 1-(Benzo[d][1,3]dioxol-5-yl)-2-(dimethylamino)butan-1-Dibutylone) one;

(47) DMEC, dimethylethcathinone;

(48) DMMC, dimethylmethcathinone;

(49) Ephedrone (sometimes used as another name for methcathinone)

2-(methylamino)-1-phenylpropan-1-one; OR 2-methylamino-1-phenylpropan-1-one;

(50) Ethcathinone, 2-ethylamino-1-phenyl-propan-1-one;

(51) Ethylethcathinone;

(52) Ethylmethcathinone;

(53) Ethylone 3,4-methylenedioxy-N-ethylcathinone; OR 3,4-methylenedioxyethylcathinone; OR 3,4-methylenedioxy-ethylcathinone; OR 3,4-methylenedioxyethcathinone;

(54) Eutylone beta-Keto-Ethylbenziodioxolylbutanamine;

(55) Fluorococaine;

(56) Fluoroethcathinone;

(57) Fluoroisocathinone;

(58) Fluoromethcathinone;

(59) HMMC 3-methoxymethcathinone;

(60) Isopentedrone;

(61) MaPPP, 4-MePPP, MPPP 4-methyl-alpha-pyrrolidinopropiophenone; OR 4-methyl-a-pyrrolidinopropiophenone; OR methylpyrrolidinopropiophenone; OR Methyl-pyrrolindinopropiophenone;

(62) MBP Methylbuphedrone;

(63) MBZP 1-methyl-4-benzylpiperazine;

(64) MDAI methylenedioxy-aminoindane; OR 5,6-methylenedioxy-2-aminoindane;

(65) MDAT 6,7-methylenedioxy-2-aminotetralin;

(66) MDDMA Dimethylone;

(67) MDMC Methylenedioxymethcathinone;

(68) MDPBP 3,4-methylenedioxy-alpha-pyrrolidinobutiophenone; OR 3,4-methylenedioxy-a-pyrrolidinobutiophenone;

(69) MDPPP 3,4-methylenedioxy-a-pyrrolidinopropiophenone; OR (RS)-1-(3,4-methylenedioxyphenyl)-2-(1-pyrrolidinyl)-1-propanone; OR 3,4-methylenedioxy-alpha-pyrrolidinopropiophenone;

(70) MDPV, MDPK 3,4-methylenedioxypyrovalerone; OR methylenedioxypyrovalerone;

(71) MEC Methylethcathinone;

(72) Mephedrone, 4-MMC 4-methylmethcathinone; OR 4-methylephedrone; OR (RS)-2-methylamino-1-(4-methylphenyl)propan-1-one;

(73) Metamfepramone, N,N-DMMC N,N-dimethylcathinone;

(74) Methedrone, Bk-PMMA, PMMC para-methoxymethcathinone; OR 4-methoxymethcathinone; OR methoxyphedrine; OR (RS)-1-(4-methoxyphenyl)-2-(methylamino)propan-1-one;

(75) Methylmethcathinone;

(76) Methylone, bk-MDMA, MDMC 3,4-methylenedioxy-N-methylcathinone; OR 3,4-methylenedioxymethcathinone; OR 3,4-methylenedioxymethylcathinone;

(77) MOMC Methoxymethcathinone;

(78) MOPPP 4-methoxy-alpha-pyrrolidinopropiophenone; OR 4-methoxy-a-pyrrolidinopropiophenone;

(79) MPBP 4-methyl-alpha-pyrrolidinobutyrophenone; OR 4-methyl-a-pyrrolidinobutryophenone; OR 4-methyl-alpha-pyrrolidinobutiophenone; OR 4-methyl-a-pyrrolidinobutiophenone;

(80) NRG-1, Naphyrone naphthylpyrovalerone;

(81) NRG-2;

(82) Pentedrone a-methylamino-Valerophenone; OR 2-(methylamino)-1-phenyl-1-pentanone; OR 2-methylamino-1-phenyl-1-pentanone;

(83) Pentylone beta-Keto-N-methylbenzodioxolylpentanamine; OR beta-keto-ethylbenzodioxolylpentanamine;

(84) 1-(2-Fluorophenyl)propan-2-amine, (2-FA);

(85) N-Methyl-1-(benzofuran-2-yl)propan-2- amine, (2-MAPB);

(86) 1-(3-Fluorophenyl)propan-2-amine, (3-FA), (RS)-1-(3-Fluorophenyl)propan-2-amine;

(87) (RS)-1-(3-fluorophenyl)-N-methylpropan-2-amine, (3-FMA);

(88) 1-(4-Chlorophenyl)propan-2-amine, para-Chloroamphetamine (PCA), 4-chloroamphetamine (4-CA);

(89) Levmetamfetamine or (-)-Methamphetamine; L-Methylamphetamine or (-)-Deoxyephedrine or R(-)-N-Methylamphetamine;

(90) 1–(3-fluorophenyl)–2–(methylamino)–1-propanone;

(91) 1–(4-fluorophenyl)–2–(methylamino)–1-propanone;

(92) 1–(4-methoxyphenyl)–2–(methylamino)–1-propanone;

(93) 2–(ethylamino)–1–(4-methoxyphenyl)–1-propanone;

(94) 1–(2-naphthalenyl)–2–(1-pyrrolidinyl)–1-pentanone;

(95) 1–(1,3-benzodioxol-5-yl)–2–(methylamino)–1-butanone;

(96) 1–(1,3-benzodioxol-5-yl)–2–(methylamino)–1-pentanone;

(97) 2–(ethylamino)–1-phenyl-1-propanone;

(98) 1-phenyl-2–(1-pyrrolidinyl)–1-propanone;

(99) 1–(4-methylphenyl)–2–(1-pyrrolidinyl)–1-propanone;

(100) 1–(4-methoxyphenyl)–2–(1-pyrrolidinyl)–1-propanone;

(101) 1–(1,3-benzodioxol-5-yl)–2–(1-pyrrolidinyl)–1-propanone;

(102) 1-phenyl-2–(1-pyrrolidinyl)–1-pentanone;

(103) 2-amino-1–(4-fluoro)–1-propanone;

(104) 2–(ethylamino)–1–(4-ethylphenyl)–1-propanone;

(105) 2–(dimethylamino)–1-phenyl-1-propanone;

(106) 1–(1,3-benzodioxol-5-yl)–2–(1-pyrrolidinyl)–1-butanone;

(107) 1–(methylphenyl)–2–(1-pyrrolidinyl)–1-hexanone;

(108) 1–(methylphenyl)–2–(1-pyrrolidinyl)–1-hexanone;

(109) 2–(methylamino)–1-phenyl-1-butanone;

(110) 2–(methylamino)–1-p-tolyl-1-butanone;

(111) 1–(4-methylphenyl)–2–(1-pyrrolidinyl)–1-butanone;

(112) 1–(3,4-dimethylphenyl)–2–(methylamino)–1-propanone;

(113) 1-phenyl-2–(1-pyrrolidinyl)–1-butanone;

(114) 1–(1,3-benzodioxol-5-yl)–2–(dimethylamino)–1-propanone;

(115) 1–(4-methylphenyl)–2–(benzylamino)–1-propanone;

(116) 1–(1-naphthy)–2–(1-pyrrolidinyl)–1-pentanone;

(117) 1–(1,3-benzodioxol-5-yl)–2–(benzylamino)–1-propanone;

(118) 1–(1,3-benzodioxol-5-yl)–2–(benzylamino)–1-butanone;

(119) 1–(1,3-benzodioxol)–2-[hydroxy(methyl)-amino]-1- propanone;

(120) 1–(1,3-benzodioxol-5-yl)–2–(dimethylamino)–1-butanone;

(121) 2–(ethyl(methyl)amino)–1-phenyl-butanone;

(122) 2–(ethyl(methyl)amino-1-phenyl-1-propanone;

(123) 2–(methylamino)–1-m-tolyl-1-propanone;

(124) 2–(pyrrolidin-1-yl)–1–(thiophen-2-yl)–1-pentanone;

(125) 1–(4-fluorophenyl)–2–(methylamino)–1-butanone;

(126) 1–(4-methoxyphenyl)–2–(pyrrolidin-1-yl)–1-butanone;

(127) 1–(4-ethylphenyl)–2–(pyrrolidin-1-yl)–1-butanone;

(128) 1–(4-methoxy-3-methylphenyl)–2–(methylamino)–1- propanone;

(129) 2–(ethylamino)–1–(3-methylphenyl)–1-propanone;

(130) 2-amino-(1H-indol-5-yl)propan-1-one;

(131) 1-phenyl-2–(piperidin-1-yl)butan-1-one;

(132) 2-methylamino-1–(2,4,5-trimethylphenyl)-propan-1-one);

(133) 1–(4-fluorophenyl)–2–(pyrrolidin-1-yl)pentan-1-one;

(134) 1–(benzo[d][1,3]dioxol-5-yl)–2–(dimethylamino)pentan-1-;

(135) 1–(2-fluorophenyl)–N-methyl-propan-2-amine;

(136) 1–(2-fluorophenyl)-propan-2-amine;

(137) 1–(3-fluorophenyl)- propan-2-amine;

(138) 1–(3-fluorophenyl)–N-methyl-propan-2-amine;

(139) N-ethyl-N-methyl-1-phenylpropan-2-amine;

(140) 1–(benzofuran-4-yl)propan-2-amine;

(141) 1–(2,3-dihydrobenzofuran-5-yl)proan-2-amine;

(142) 1–(2,3-dihydrobenzofuran-6-yl)proan-2-amine;

(143) N,N-dimethyl-1-phenylpropan-2-amine;

(144) 5,6,7,8-tetrahydrobenzo[1,3]-benzodioxol-7-amine;

(145) a-methyl-4–(methylthio)-benzene-ethanamine;

(146) 1–(4-chlorophenyl)-propan-2-amine;

(147) 1–(2,4,6-trimethoxyphenyl)-propan-2-amine;

(148) 1–(2,4,5-trimethoxyphenyl)-propan-2-amine;

(149) 1–(2,5-dimethylphenyl)-propan-2-amine;

(150) 1–(3,4-dimethylphenyl)-propan-2-amine;

(151) N–(1-phenylpropan-2-yl)propan-1-amine;

(152) 4–(2-aminopropyl)phenol;

(153) 3,4-methylenedioxy-N,N-dimethyl-amphetamine;

(154) N-ethyl-1–(4-methoxyphenyl)propan-2-amine;

(155) 6,7-dihydro-5H-inden[5,6-d][1,3]dioxol-6-amine;

(156) 5-methoxy-6-methyl-2,3-dihydro-1H-inden-2-amine;

(157) N-methyl-6,7-dihydro-5H-cyclopenta[1,3]-benzodioxol-6- amine;

(158) N-methyl-2,3-dihydro-1H-inden-2-amine;

(159) 2-[4–(2-fluoroethylthio)–2,5- dimethoxyphenyl]ethanamine;

(160) 8-bromo-2,3,6,7-tetrahydro-benzo[1,2-b;4,5-b’]difuran-4-ethanamine;

(161) 4-iodo-2,5-dimethoxy-N-[(2-methoxyphenyl)-methyl-benzene-ethamine;

(162) 2–(4-chloro-2,5-dimethoxyphenyl)–N–(2-methoxybenzyl)-ethanamine;

(163) 2–(2,5-dimethoxy-3,4-dimethylphenyl)-ethanamine;

(164) 2–(4-ethyl-2,5-dimethoxyphenyl)–N–(2-methoxybenzyl)-ethanamine;

(165) 2–(2,5-dimethoxy-3,4-dimethylphenyl)–N–(2- methoxybenzyl)-ethanamine;

(166) 2–(2,5-dimethoxyphenyl)–N–(2-methoxybenzyl)-ethanamine;

(167) 2–(2,5-dimethoxyphenyl-4-nitro)–N-[(2-methoxyphenyl)methyl]-ethanamine;

(168) 1–(4-iodo-2,5-dimethoxyphenyl)propan-2-amine;

(169) 1–(4-chloro-2,5-dimethoxyphenyl)propan-2-amine;

(170) 1–(4-bromo-2,3,6,7-terahydrofuro[2,3-f]benzofuran-8-yl)propan-2-amine;

(171) (2,5-dimethoxyphenyl)-propan-2-amine;

(172) 1-[4–(ethylthio)–2,5-dimethoxyphenyl)propan-2-amine;

(173) 1–(4-ethoxy-2,5-dimethoxyphenyl)propan-2-amine;

(174) 1-[2,5-dimethoxy-4–(propylthio)phenyl]propan-2-amine;

(175) 1–(4-ethyl-2,5-dimethoxyphenyl)propan-2-amine;

(176) N-benzyl-2-phenylethanamine;

(177) N,N-dimethyl-2-phenylethanamine;

(178) 6-chloro-aminotetralin;

(179) 2-phenethylamine;

(180) 2-phenyl-propan-1-amine;

(181) 1-methylamino-1–(3,4-methylendioxy-phenyl)propane;

(182) N-methyl-3-phenylbicyclo[2.2.1]heptan-2-amine;

(183) 1–(2-methoxyphenyl)–N-methylpropan-2-amine;

(184) 2–(4–(allyloxy)–3,5-dimethoxyphenyl)ethanamine;

(185) 4-methylhexan-2-amine;

(186) 4-methyl-5-phenyl-2-amino-oxazoline;

(187) (3-dimethylamino-2,2-dimethylpropyl)–4-aminobenzoate;

(188) 1–(4-fluorophenyl)–2–(methylamino)-propan-1-ol;

(189) 4-methyl-5-p-tolyl-4,5-dihydrooxazol-2-amine;

(190) 1-phenyl-2–(pyrrolidin-1-yl)propan-1-ol;

(191) 1–(3-methoxyphenyl)–N-propylcyclohexan-amine;

(192) 2–(ethylamino)–2–(3-methoxyphenyl)cyclohexanone;

(193) 1-phenylcyclohexan-amine;

(194) 1-[1–(benzothiophen-2-yl)cyclohexyl]piperidine;

(195) 1–(1-p-tolylcyclohexyl)-piperidine;

(196) 1–(4-methoxyphenyl)–N-propylcyclohexan-amine;

(197) 1-[1–(4-methoxyphenyl)cyclohexyl]-piperidine;

(198) 1-[1–(3-methoxyphenyl)cyclohexyl]-piperidine;

(199) 1-phenyl-N-propylcyclohexanamine;

(200) N–(2-methoxyethyl)–1-phenylcyclohexan-amine;

(201) N–(2-ethoxyethyl)–1-phenylcyclohexan-amine;

(202) N–(3-methoxypropyl)–1-phenylcyclohexan-amine;

(203) 3-[1–(piperidin-1-yl)cyclohexyl]-phenol;

(204) 2–(methoxyphenyl)–2–(methylamino)cyclohexanone;

(205) N-ethyl-1–(thiophen-2-yl)cyclohexanamine;

(206) (2–(2-chlorophenyl)–2–(ethylamino)-cyclohexanone);

(207) 2–(diphenylmethyl)-piperidine;

(208) 2-benzhydrylpyrrolidine;

(209) a,a-diphenyl-(pyrrolidin-2-yl)methanol;

(210) methyl 2–(3,4-dichlorophenyl)–2–(piperdin-2-yl)acetate;

(211) methyl 2–(3-chlorophenyl)–2–(piperidin-2-yl)acetate;

(212) methyl 2–(piperidin-2-yl)–2-p-tolylacetate; and

(213) ethyl 2-phenyl-2–(piperidin-2-yl)acetate;

Synthetic cannabinoids: Unless specifically exempted or unless listed in another schedule, any material, mixture, preparation, any compound structurally derived from, or that contains any quantity of the following synthetic substances, its salts, isomers, and salts of isomers, whenever the existence of these salts, isomers, and salts of isomers is possible within the specific chemical designation (for the purposes of this paragraph only, the term "isomer" includes the optical, position, and geometric isomers):

Classified Synthetic Cannabinoids:

Adamantoylindoles or adamantoylindazoles, including adamantyl carboxamide indoles and adamantyl carboxamide indazoles, or any compound structurally derived from 3-(1-adamantoyl) indole, 3-(1-adamantoyl)indazole, 3-(2-adamantoyl)indole, N-(1-adamantyl)-1H-indole-3-carboxamide, or N-(1-adamantyl)-1H-indazole-3-carboxamide by substitution at the nitrogen atom of the indole or indazole ring with alkyl, haloalkyl, alkenyl, cyanoalkyl, hydroxyalkyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl, 2-(4-morpholinyl)ethyl, or 1-(N-methyl-2-pyrrolidinyl)methyl, 1-(N-methyl-3-morpholinyl)methyl, or (tetrahydropyran-4-yl)methyl group, whether or not further substituted in the indole or indazole ring to any extent and whether or not substituted in the adamantyl ring to any extent, including the following: 2NE1, 5F-AKB-48, AB-001, APINACA and AKB-48, AM-1248, JWH-018 adamantyl carboxamide, STS-135;

Benzoylindoles - any compound structurally derived from a 3-(benzoyl)indole structure with substitution at the nitrogen atom of the indole ring with alkyl, haloalkyl, cyanoalkyl, hydroxyalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl, 2-(4-morpholinyl)ethyl, or 1-(N-methyl-2-pyrrolidinyl)methyl, 1-(N-methyl-3-morpholinyl)methyl, or (tetrahydropyran-4-yl)methyl group, whether or not further substituted in the indole ring to any extent and whether or not substituted in the phenyl ring to any extent, including the following: AM-630, AM-661, AM-679, AM-694, AM-1241, AM-2233, RCS-4 or SR-19, WIN 48,098 (Pravadoline);

Cyclohexylphenols - any compound structurally derived from 2-(3-hydroxycyclohexyl)phenol by substitution at the 5-position of the phenolic ring by alkyl, haloalkyl, cyanoalkyl, hydroxyalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl, 2-(4-morpholinyl)ethyl, or 1-(N-methyl-2-pyrrolidinyl)methyl, 1-(N-methyl-3-morpholinyl)methyl, or (tetrahydropyran-4-yl)methyl group, whether or not further substituted in the cyclohexyl ring to any extent, including, but not limited to, the following: CP 47,497, CP 47,497 C8 homologue, CP 55,490, CP 55,940, CP 56,667, cannabicyclohexanol;

Cyclopropanoylindoles – any compound structurally derived from 3-(cyclopropylmethanoyl)indole, 3-(cyclopropylmethanone)indole, 3-(cyclobutylmethanone)indole or 3-(cyclopentylmethanone)indole by substitution at the nitrogen atom of the indole ring, whether or not further substituted in the indole ring to any extent, whether or not substituted on the cyclopropyl, cyclobutyl, or cyclopentyl rings to any extent;

Naphthoylindoles – any compound structurally derived from 3-(1-naphthoyl)indole or 1H-indol-3-yl-(1-naphthyl)methane by substitution at the nitrogen atom of the indole ring by alkyl, haloalkyl, cyanoalkyl, hydroxyalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl, 2-(4-morpholinyl)ethyl group, 1-(N-methyl-2-pyrrolidinyl)methyl, 1-(N-methyl-3-morpholinyl)methyl, or (tetrahydropyran-4-yl)methyl group, whether or not further substituted in the naphthyl ring to any extent, including the following: AM-678, AM-1220, AM-1221, AM-1235, AM-2201, AM-2232, EAM-2201, JWH-004, JWH-007, JWH-009, JWH-011, JWH-015, JWH-016, JWH-018, JWH-019, JWH-020, JWH-022, JWH-046, JWH-047, JWH-048, JWH-049, JWH-050, JWH-070, JWH-071, JWH-072, JWH-073, JWH-076, JWH-079, JWH-080, JWH-081, JWH-082, JWH-094, JWH-096, JWH-098, JWH-116, JWH-120, JWH-122, JWH-148, JWH-149, JWH-164, JWH-166, JWH-180, JWH-181, JWH-182, JWH-189, JWH-193, JWH-198, JWH-200, JWH-210, JWH-211, JWH-212, JWH-213, JWH-234, JWH-235, JWH-236, JWH-239, JWH-240, JWH-241, JWH-242, JWH-258, JWH-262, JWH-386, JWH-387, JWH-394, JWH-395, JWH-397, JWH-398, JWH-399, JWH-400, JWH-412, JWH-413, JWH-414, JWH-415, JWH-424, MAM-2201, WIN 55,212;

Naphthoylnaphthalenes – any compound structurally derived from naphthalene-1-yl-(naphthalene-1-yl) methanone with substitutions on either of the naphthalene rings to any extent, including CB-13;

Naphthoylpyrroles - any compound structurally derived from 3-(1-naphthoyl)pyrrole by substitution at the nitrogen atom of the pyrrole ring by alkyl, haloalkyl, cyanoalkyl, hydroxyalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl, 2-(4-morpholinyl)ethyl, or 1-(N-methyl-2-pyrrolidinyl)methyl, 1-(N-methyl-3-morpholinyl)methyl, or (tetrahydropyran-4-yl)methyl group, whether or not further substituted in the pyrrole ring to any extent and whether or not substituted in the naphthyl ring to any extent, including the following: JWH-030, JWH-031, JWH-145, JWH-146, JWH-147, JWH-150, JWH-156, JWH-243, JWH-244, JWH-245, JWH-246, JWH-292, JWH-293, JWH-307, JWH-308, JWH-309, JWH-346, JWH-348, JWH-363, JWH-364, JWH-365, JWH-367, JWH-368, JWH-369, JWH-370, JWH-371, JWH-373, JWH-392;

Naphthylmethylindenes - any compound containing a naphthylideneindene structure or that is structurally derived from 1-(1-naphthylmethyl)indene with substitution at the 3-position of the indene ring by alkyl, haloalkyl, cyanoalkyl, hydroxyalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl, 2-(4-morpholinyl)ethyl, or 1-(N-methyl-2-pyrrolidinyl)methyl, 1-(N-methyl-3-morpholinyl)methyl, or (tetrahydropyran-4-yl)methyl group, whether or not further substituted in the indene ring to any extent and whether or not substituted in the naphthyl ring to any extent, including the following: JWH-171, JWH-176, JWH-220;

Naphthylmethylindoles – any compound structurally derived from an H-indol-3-yl-(1-naphthyl) methane by substitution at the nitrogen atom of the indole ring by alkyl, haloalkyl, cyanoalkyl, hydroxyalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl, 2-(4-morpholinyl)ethyl, or 1-(N-methyl-2-pyrrolidinyl)methyl, 1-(N-methyl-3-morpholinyl)methyl, or (tetrahydropyran-4-yl)methyl group, whether or not further substituted in the indole ring to any extent and whether or not substituted in the naphthyl ring to any extent, including the following: JWH-175, JWH-184, JWH-185, JWH-192, JWH-194, JWH-195, JWH-196, JWH-197, JWH-199;

Phenylacetylindoles - any compound structurally derived from 3-phenylacetylindole by substitution at the nitrogen atom of the indole ring with alkyl, haloalkyl, cyanoalkyl, hydroxyalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl, 2-(4-morpholinyl)ethyl, or 1-(N-methyl-2-pyrrolidinyl)methyl, 1-(N-methyl-3-morpholinyl)methyl, or (tetrahydropyran-4-yl)methyl group, whether or not further substituted in the indole ring to any extent and whether or not substituted in the phenyl ring to any extent, including the following: Cannabipiperidiethanone, JWH-167, JWH-201, JWH-202, JWH-203, JWH-204, JWH-205, JWH-206, JWH-207, JWH-208, JWH-209, JWH-237, JWH-248, JWH-249, JWH-250, JWH-251, JWH-253, JWH-302, JWH-303, JWH-304, JWH-305, JWH-306, JWH-311, JWH-312, JWH-313, JWH-314, JWH-315, JWH-316, RCS-8, or SR-18;

Quinolinylindolecarboxylates – any compound structurally derived from quinolin-8-yl-1H-indole-3-carboxylate by substitution at the nitrogen atom of the indole ring with alkyl, haloalkyl, benzyl, halobenzyl, alkenyl, haloalkenyl, alkoxy, cyanoalkyl, hydroxyalkyl, cycloalkylmethyl, cycloalkylethyl, (N-methylpiperidin-2-yl)alkyl, (4-tetrahydropyran)alkyl, or 2-(4-morpholinyl)alkyl, whether or not further substituted in the indole ring to any extent, whether or not substituted in the quinoline ring to any extent, including the following: BB-22, 5-Fluoro-PB-22, and PB-22;

Tetramethylcyclopropanoylindoles – any compound structurally derived from 3-tetramethylcyclopropanoylindole, 3-(1-tetramethylcyclopropyl)indole, 3-(2,2,3,3-tetramethylcyclopropyl)indole or 3-(2,2,3,3-tetramethylcyclopropylcarbonyl)indole with substitution at the nitrogen atom of the indole ring by an alkyl, haloalkyl, cyanoalkyl, hydroxyalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl, 2-(4-morpholinyl)ethyl, 1-(N-methyl-2-pyrrolidinyl)methyl, 1-(N-methyl-3-morpholinyl)methyl, or (tetrahydropyran-4-yl)methyl group whether or not further substituted in the indole ring to any extent and whether or not substituted in the tetramethylcyclopropanoyl ring to any extent, including the following: 5-bromo-UR-144, 5-chloro-UR-144, 5-fluoro-UR-144, A-796,260, A-834,735, AB-034, UR-144, and XLR11; and

Tetramethylcyclopropane-thiazole carboxamides – any compound structurally derived from 2,2,3,3-tetramethyl-N-(thiazol-2-ylidene)cyclopropanecarboxamide by substitution at the nitrogen atom of the thiazole ring by alkyl, haloalkyl, benzyl, halobenzyl, alkenyl, haloalkenyl, alkoxy, cyanoalkyl, hydroxyalkyl, cycloalkylmethyl, cycloalkylethyl, (N-methylpiperidin-2-yl)alkyl, (4-tetrahydropyran)alkyl, or 2-(4-morpholinyl)alkyl, whether or not further substituted in the thiazole ring to any extent, whether or not substituted in the tetramethylcyclopropyl ring to any extent, including A-836,339; and

Unclassified Synthetic Cannabinoids:

(A) AM-087 (6aR,10aR)-3-(2-methyl-6-bromohex-2-yl)- 6,6,9-trimethyl-6a,7,10,10a-tetrahydrobenzo[c]chromen-1-ol;

(B) AM-356 (methanandamide); (5Z,8Z,11Z,14Z)-N-[(1R)-2-hydroxy-1-methylethyl] icosa-5,8,11,14-tetraenamide; or arachidonyl-1'- hydroxy-2'-propylamide;

(C) (5Z,8Z,11Z,14Z)-N-[(1R)-2-hydroxy-1-methylethyl] icosa-5,8,11,14-tetraenamide; or arachidonyl-1'-hydroxy-2'-propylamide;

(D) AM-411(6aR,10aR)-3-(1-adamantyl)-6,6,9-trimethyl- 6a,7,10,10a-tetrahydrobenzo[c]chromen-1-ol;

(E) AM-855(4aR,12bR)-8-hexyl-2,5,5-trimethyl-1,4,4a,8, 9,10,11,12b-octahydronaphtho[3,2-c]isochromen-12-ol;

(F) AM-905(6aR,9R,10aR)-3-[(E)-hept-1-enyl]-9-

(hydroxymethyl)-6,6-dimethyl-6a,7,8,9,10,10a-hexahydrobenzo[c]chromen-1-ol;

(G) AM-906(6aR,9R,10aR)-3-[(Z)-hept-1-enyl]-9-

(hydroxymethyl)-6,6-dimethyl-6a,7,8,9,10,10a-hexahydrobenzo[c]chromen-1-ol;

(H) AM-2389(6aR,9R,10aR)-3-(1-hexyl-cyclobut-1-yl)-

6a,7,8,9,10,10a-hexahydro-6,6-dimethyl-6H-dibenzo[b,d]pyran-1,9 diol;

(I) BAY38-7271(-)-(R)-3-(2-Hydroxymethylindanyl-4-oxy) phenyl-4,4,4-trifluorobutyl-1-sulfonate;

(J) CP 50,556-1 (Levonantradol);

(K) 9-hydroxy-6-methyl-3-[5-phenylpentan-2-yl]oxy-5,6, 6a,7,8,9,10,10a-octahydrophenanthridin-1-yl]acetate; or [(6S,6aR,9R,10aR)-9-hydroxy-6-methyl-3-[(2R)-5- ph enylpentan-2-yl]oxy-5,6,6a,7,8,9,10,10a-;

(L) octahydrophenanthridin-1-yl] acetate; or [9-hydroxy-6-methyl-3-[5-phenylpentan-2-yl]oxy-5,6,6a,7,8,9,10, 10a-octahydrophenanthridin-1-yl]acetate;

(M) HU-210(6aR,10aR)-9-(hydroxymethyl)-6,6-dimethyl-

3-;

(N) (2-methyloctan-2-yl)-6a,7,10,10a-tetrahydrobenzo[c] chromen-1-ol; or [(6aR,10aR)-9-(hydroxymethyl) -6,6-dimethyl-3- (2-methyloctan-2-yl)-6a,7,10,10a- tetrahydrobenzo[c]chromen-1-ol; or 1,1-Dimethylheptyl- 11-hydroxytetrahydrocannabinol;

(O) HU-211 (Dexanabinol);

(P) (6aS,10aS)-9-(hydroxymethyl)-6,6-dimethyl-3- (2-methyloctan-2-yl)-6a,7,10,10a-tetrahydrobenzo[c]chromen-1-ol; or (6aS,10aS)-9-(hydroxymethyl) -6,6-dimethyl-3-(2-methyloctan-2-yl)-6a,7,10,10a-tetrahydrobenzo[c]chromen-1-ol;

(Q) HU-2433-dimethylheptyl-11- hydroxyhexahydrocannabinol;

(R) HU-308[(91R,2R,5R)-2-[2,6-dimethoxy-4- (2-methyloctan-2-yl)phenyl]-7,7-dimethyl-4-bicyclo[3.1.1]hept-3-enyl]methanol;

(S) HU-3313-hydroxy-2-[(1R,6R)-3-methyl-6- (1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-2,5-cyclohexadiene-1,4-dione;

(T) JTE-907N-(benzol[1,3]dioxol-5-ylmethyl) -7-methoxy-2-oxo-8-pentyloxy-1,2-dihydroquinoline-3-carboxamide;

(U) JWH-051((6aR,10aR)-6,6-dimethyl-3- (2-methyloctan-2-yl)-6a,7,10,10a-tetrahydrobenzo[c]chromen-9-yl)methanol;

(V) JWH-057(6aR,10aR)-3-(1,1-dimethylheptyl) -6a,7,10,10a-tetrahydro-6,6,9-trimethyl-6H-Dibenzo[b,d]pyran;

(W) JWH-133(6aR,10aR)-3-(1,1-Dimethylbutyl) -6a,7,10,10a-tetrahydro-6,6,9-trimethyl-6H-dibenzo[b,d]pyran;

(X) JWH-359 (6aR,10aR)- 1-methoxy- 6,6,9-trimethyl- 3-[(2R)-1,1,2-trimethylbutyl]- 6a,7,10,10a-tetrahydrobenzo[c]chromene;

(Y) URB-597[3-(3-carbamoylphenyl)phenyl] -N-cyclohexylcarbamate;

(Z) URB-602 [1,1'-Biphenyl]-3-yl-carbamic acid, cyclohexyl ester; or cyclohexyl [1,1'-biphenyl]-3-ylcarbamate;

(AA) URB-7546-methyl-2-[(4-methylphenyl)amino] -4H-3,1-benzoxazin-4-one;

(BB) URB-937 3'-carbamoyl-6-hydroxy-[1,1'-biphenyl]-3-yl cyclohexylcarbamate;

(CC) WIN 55,212-2(R)-(+)-[2,3-dihydro-5-methyl-3- (4-morpholinylmethyl)pyrrolo[1,2,3-de]-1,4-benzoxazin-6-yl]-1-napthalenylmethanone; or [2,3-Dihydro-5-methyl- 3-(4-morpholinylmethyl)pyrrolo[(1,2,3-de)-1,4-benzoxazin-6-yl]-1-napthalenylmethanone;

(DD) AM-2201 (1-(5-fluoropentyl)-3-(1-naphthoyl)indole);

(EE) AM-694 (1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole);

(FF) Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (“PB-22”; QUPIC);

(GG) Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (“5-fluoro-PB-22”; 5F-PB-22);

(HH) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (“AB-FUBINACA”);

(II) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (“ADB-PINACA”);

(JJ) THJ-2201 1-(5-fluoropentyl)-1H-indazol-3-1ylmethanone;

(KK) (N-(1-amino-3-methyl-1- oxobutan-2-yl)-1-(cyclohexylmethyl)- 1H-indazole-3-carboxamide (“AB-CHMINACA”);

(LL) (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) (“AB-PINACA“);

(MM) N-[(1S)-1-(aminocarbonyl)-2-methylpropyl]-1-(5-fluoropentyl)-1H-indazole-3-carboxamide, (5F-AB-PINACA);

(NN) N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indole-3-carboxamide, (5F-ADBICA or 5F-ADB-PICA);

(OO) (S)-methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate, (5F-AMB or 5F-MMB-PINACA or 5F-AMB-PINACA); and

(PP) N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide, N-(1-Adamantyl)-1-(5-fluoropenty1)-1 H- indazole-3-carboxarnide, (5F-APINACA or 5F-AKB48);

(g) Substituted tryptamines. This includes any compound, unless specifically excepted, specifically named in this schedule, or listed under a different schedule, structurally derived from 2-(1H-indol-3-yl) ethanamine (i.e., tryptamine) by mono- or di-substitution of the amine nitrogen with alkyl or alkenyl groups or by inclusion of the amino nitrogen atom in a cyclic structure regardless of whether the compound is further substituted at the alpha position with an alkyl group or further substituted on the indole ring to any extent with any alkyl, alkoxy, halo, hydroxyl, or acetoxy groups. Examples include the following:

(4-AcO-DET) 3-(2-Diethylaminoethyl)-1H-indol-4-yl acetate (DET);

(4-AcO-DMT, OAcetylpsilocin) 4-acetoxy-N,N-dimethyltryptamine;

(4-AcO-DPT) 4-acetoxy-N,N-dipropyltryptamine;

(4-HO-DiPT) 4-Hydroxy-di-isopropyl-tryptamine; OR 3-[2- (diisopropylamino)ethyl]-1H-indol-4-ol; OR 4-Hydroxy- N,N-diisopropyltryptamine;

(4-HO-MET) 4-hydroxy-N-methyl-N-ethyltryptamine;

(4-HO-MiPT) 3-(2-[Isopropyl(methyl)amino]ethyl)-1H-indol-4-ol;

(4-HO-MPMI) (R)-3-(N-methylpyrrolidin-2-ylmethyl)-4-hydoxyindole;

(4-HO-MPT) 3-{2-[methyl(propyl)amino]ethyl}-1H-indol-4-ol; OR 4- hydroxy-N-methyl-N-propyltryptamine;

(4-MeO-MiPT) 4-methoxy-N-methyl-N-isopropyltryptamine; OR 3-[2 (Isopropylmethylamino)ethyl]-4-methoxyindole;

4-methyl-aET 4-Methyl-α-ethyltryptamine; OR 1-ethyl-2-(4-methyl-1H- indol-3-yl)-ethylamine;

(5-MeO-AMT) 1-(5-methoxy-1H-indol-3-yl)propan-2-amine;

(5-MeO-DALT) N,N-diallyl-5-methoxytryptamine; OR N-allyl-N-[2-(5- methoxy-1H-indol-3-yl)ethyl]prop-2-en-1-amine;

(5-MeO-DET) N,N-Dethyl-5-Methoxytryptamine;

(5-MeO-DPT) N-[2-(5-methoxy-1H-indol-3-yl)ethyl]-N-propylpropan-1- amine;

(5-MeO-MiPT, Moxy, Moxie) N-[2-(5-methoxy-1H-indol-3-yl)ethyl]-N-methylpropan-2-amine;

(5-MeO-MPMI) (R)-3-(N-methylpyrrolidin-2-ylmethyl)-5-methoxyindole;

(DPT) N,N-Dipropyltryptamine; OR Dipropyltryptamine; OR 3-[2-(dipropylamino)ethyl]indole;

(Methyltryptamine, NMT) N-methyltryptamine; OR 2-(1H-Indol-3-yl)-N-methylethanamine; and

(MiPT) N-isopropyl-N-methyltryptamine;

(20) 2–(1H-indol-3-yl)–N-methyl-ethanamine;

(21) N–(2–(1H-indol-3-yl)ethyl-N-methylpropan-2-amine;

(22) N-[2–(1H-indol-3-yl)ethyl]-N-isopropylpropan-2-amine;

(23) N,N-dipropyl-1H-indole-3-ethanamine;

(24) 3-[2–(diethylamino)ethyl]-1H–4yl acetate;

(25) 3–(2-[isopropyl(methyl)amino]ethyl)–1H-indol-4-ol;

(26) 3-[2–(bis[1-methylethyl]amino)ethyl]-1H-indol-4-ol acetate;

(27) 3–(2-[isopropyl(methyl)amino]ethyl)–1H-indol-4-ol acetate;

(28) 3-[2–(dimethylamino)ethyl]-1H-indol-4-yl acetate;

(29) 4-hydroxy-N,N-diethyl-1H-indole-ethanamine;

(30) 4-methoxy-N,N-dimethyl-1H-indole-3-ethanamine;

(31) 3–(2–(diisopropylamino)ethyl)–1H-indol-4-ol;

(32) 3-[2–(ethyl[methyl]amino)ethyl]-1H-indol-4-yl acetate;

(33) 3–(2–(dipropylamino)ethyl)–1H-indol-4-ol;

(34) 3-[2–(dipropylamino)ethyl]-1H-indol-4-yl acetate;

(35) 4-acetoxy-N,N-di-2-propen-1-yl-1H-indole-3-ethanamine;

(36) 5-methoxy-N,N-di-2-propen-1-yl-1H-indole-3-ethanamine;

(37) 3–(2–(dimethylaminoethyl)–1H-indol-5-ol;

(38) 2–(5-methoxy-1H-indol-3-yl)–N,N-dimethylethanamine;

(39) N-[2–(5-methoxy-1H-indol-3-yl)ethyl]-N-methylpropyl;

(40) 1–(5-methoxy-1H-indol-3-yl)propan-2-amine;

(41) 3-[2–(dimethylamino)-ethyl]-1H-indol-5-yl acetate;

(42) N-[2–(5-methoxy-1H-indol-3-yl)ethyl]-N-propylpropan-1-amine;

(43) N,N-diethyl-2–(5-methoxy-1H-indol-3-yl)ethanamine; and

(44) N-ethyl-2–(5-methoxy-1H-indol-3-yl)–N-methyl-ethanamine;

(h) Unclassified novel psychoactive substances

(1) (2-AI, 2-aminoindane) 2,3-dihydro-1H-inden-2-amine;

(2) (2-FMA) 2-fluoromethamphetamine; OR (RS)-1-(2-fluorophenyl)-N-methylpropan-2-amine; N-Methyl-1-(3-fluorophenyl)propan-2- amine;

(3) (2-MeO-ketamine) methoxyketamine;

(4) (3-HO-PCE) 3-[1-(ethylamino) cyclohexyl]phenol;

(5) (3-HO-PCP) 3-hydroxyphencyclidine (3-MeO-PCE) 3-Methoxyeticyclidine;

(6) (3-MeO-PCP) 1-[1-(3-methoxyphenyl)cyclohexyl]-piperidine; OR 3-methoxyphencyclidine;

(7) (4-FMA) 4-fluoromethamphetamine; OR (RS)-1-(4-fluorophenyl)-N-methylpropan-2-amine; N-Methyl-1-(4-fluorophenyl)propan-2-amine;

(8) (4-MeO-PCP, methoxydine) 4-Methoxyphencyclidine; OR 1-[1-(4-methoxyphenyl)cyclohexyl]-piperidine;

(9) (5-IAI) 5-Iodo-2-aminoindane; OR 5-iodo-2,3-dihydro-1H-inden-2-amine;

(10) (5-ME) 5-methyl-ethylone;

(11) (BTCP) Benzothiophenylcyclohexylpiperidine;

(12) (DBP, DBZP) 1,4-Dibenzylpiperazine;

(13) (Ethyl-ketamine) 2-(2-chlorophenyl)-2-(ethylamino)cyclohexanone;

(14) (Fluoromethamphetamine);

(15) (Fluorophenylpiperazine; pFPP; 4-FPP; fluoperazine; flipiperazine) Para-fluorophenylpiperazine; OR 1-(4-fluorophenyl)piperazine;

(16) (Kratom) 7-hydroxymitragynine;

(17) (MCPP) 1-(3-Chlorophenyl)piperazine, OR Chlorophenylpiperazine, OR meta chlorophenylpiperazine; OR 1-(3-chlorophenyl)piperazine; OR 3-chlorophenylpiperazine;

(18) (Methiopropamine, MPA) 1-(thiophen-2-yl)-2-methylaminopropane; N-Methyl-1-(thiophen-2-yl)propan-2-amine;

(19) (Methoxetamine, MXE, 3 MeO-2-Oxo-PCE) (RS)2-(3-methoxyphenyl)-2-(ethylamino)cyclohexanone;

(20) (MPHP) Methyl-alpha-pyrrolidinohexiophenone; OR Methyl-pyrrolidino-hexanophenone;

(21) (O-desmethyltramadol, O-DT) 3-[2-(1-Amino-1-methylethyl)-1-hydroxycyclohexyl]phenol;

(22) (Phenazepam) 7-Bromo-5-(2-chlorophenyl)-1,3-dihydro-2H-1,4-benzodiazepin-2-one;

(23) (pMeOPP, MeOPP) 1-(4-Methoxyphenyl) piperazine;

(24) (pTFMPP) 1-[4-(trifluoromethylphenyl)] piperazine;

(25) (TFMPP) 3-trifluoromethylphenylpiperazine; OR 1-[3-(trifluoromethyl)phenyl]piperazine; OR 1-(3-trifluoromethylphenyl) piperazine; OR 1-(3-trifluoromethylphenyl)piperazine; OR 1-(3-[trifluoromethylphenyl])piperazine.

(26) (±)-2,5-Dimethoxy-alpha-methylphenethylamine, (DMA);

(27) 6,6,9-Trimethyl-3-(3-methyl-2-octanyl)-7,8,9,10-tetrahydro-6H-benzo[c]chromen-1-ol, (DMHP), Dimethylheptylpyran;

(28) 3-(2-(Dimethylamino)ethyl)indole, (DMT);

(29) P-methoxy-alpha-methylphenethylamine, (PMA);

(30) Methylenedioxyamphetamine, 3,4-methylenedioxy-amphetamine, MDA, tenamfetamine (INN), Sally, Sass, Sass-a-frass;

(31) Tenocyclidine (TCP);

(32) N-(1-Amino-3-methyl-1-oxobutan-2-y)- l -(5-fluoropenty1)-1H-indole-3-carboxamide, (5F-ABICA);

(33) [1-(2-morpholin-4-ylethyl)-1H-indol-3-yl]-(2,2,3,3-tetramethylcyclopropyl) methanone, (A-796,260);

(34) N-[(1S)-1-(Aminocarbonyl)-2-methylpropyl]-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide, (AB-CHMINACA);

(35) (4-F-a-PVP) 1-(4-fluorophenyl)-2-(1-pyrrolidinyl)pentan-1-one;

(36) (4-MeBP) 1-(4-Methylphenyl)-2-methylaminobutan-1-one;

(37) (4-MeO-a-PVP) 1-(4-methoxyphenyl)-2-(1-pyrrolidinyl)pentan-1-one;

(38) (NEB) 1-phenyl-2-ethylaminobutan-1-one;

(39) (a-PHP) 1-phenyl-2-(1-pyrrolidinyl)hexan-1-one;

(40) (a-PHPP) 1-phenyl-2-(1-pyrrolidinyl)heptan-1-one;

(41) (a-PVT) 1-(thiophen-2-yl)-2-(1-pyrrolidinyl)pentan-1-one;

(42) (NENK) 2-(2-chlorophenyl)-2-(ethylamino)cyclohexanone;

(43) (5-MeO-DMT) 5-methoxy-N,N-dimethyltryptamine;

(44) (AMT) alpha-methyltryptamine;

(45) (3,4-CTMP) methyl 2-(3,4-dichlorophenyl)-2-(piperdin-2-yl);

(46) (AH-7921) 3,4-dichloro-N-((1-(dimethylamino)cyclohexyl)methyl)benzamide;

(47) (4-ethyl-1-naphthalenyl)(1-pentyl-1H-indol-3-yl)methanone;

(48) 2–(2-methylphenyl)–1–(1-pentyl-1H-indol-3-yl)-ethanone;

(49) 1-[1–(2-cyclohexylethyl)–1H-indol-3-yl]-2–(2-methoxyphenyl)-

Ethanone;

(50) 1–(5-fluoropentyl)–1H-indol-3-ylmethanone;

(51) (2-methyl-1-[(1-methylpiperidin-2-yl)methyl]-6-nitro-1H-indol-3-yl)methanone; and

(52) (1-butyl-1H-indol-3-yl)(4-methoxyphenyl)-methanone.

(i) Synthetic compounds:

(1) MT-45 (1-Cyclohexyl-4-(1,2-diphenylethyl) piperazine;

(2) U-47700 (3,4-Dichloro-N-[(1R,2R)-2-(dimethylamino) cyclohexyl]-N-methylbenzamide; and

(3) W-1 4-chloro-N-[(2Z)-1-[2-(4-nitrophenyl)ethyl]piperidin-2-ylidene]benzene-1-sulfonamide.

History

SOURCE: Final Rulemaking published at 39 DCR 1882 (March 20, 1992); as amended by Final Rulemaking published at 41 DCR 7967 (December 16, 1994); as amended by the Uniform Controlled Substances Amendment Act of 1999, §2(a)(3), effective May 9, 2000 (D.C. Law 13-99; 47 DCR 791 (February 11, 2000)); as amended by Emergency and Proposed Rulemaking published at 47 DCR 7512 (September 15, 2000) [EXPIRED]; as amended by Final Rulemaking published at 48 DCR 914 (February 2, 2001); as amended by Emergency and Proposed Rulemaking published at 50 DCR 10421 (December 5, 2003) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 4080 (April 23, 2004); as amended by Final Rulemaking published at 61 DCR 10233 (October 3, 2014); as amended by Final Rulemaking published at 63 DCR 14819 (December 2, 2016); as amended by Final Rulemaking published at 65 DCR 0635 (January 26, 2018); as amended by Errata Notice published at 65 DCR 1721 (February 16, 2018). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1201

22-B DCMR § 1202 SCHEDULE II ENUMERATED

1202.1 The controlled substances listed in this section are included in Schedule II of the Act unless removed therefrom pursuant to Section 201 of the Act:

Unless specifically excepted or unless listed in another schedule, any of the following substances, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by combination of extraction and chemical synthesis;

Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate, excluding apomorphine, dextophan, nalbuphine, naltrexone, and their respective salts, but including the following:

Codeine;

Ethylmorphine;

Etorphine Hydrochloride;

Granulated opium;

Hydrocodone;

Tincture of opium;

Hydromorphone;

Metopon;

Morphine;

Opium extracts;

Opium fluid extracts;

Oripavine;

Oxycodone;

Oxymorphone;

Powdered opium;

Raw opium; and

Thebaine;

Opium: Any salt, compound, derivative, or preparation thereof that is chemically equivalent or identical with any of the substances referred to in subparagraph (1) of this paragraph, but not including the isoquinoline alkaloids of opium;

Opium poppy or poppy straw;

Coca leaves, except coca leaves or extracts of coca leaves from which cocaine, ecgonine, or derivatives of ecgonine or their salts have been removed; cocaine, its salts, optical and geometric isomers, salts of isomers; or any compound, mixture, or preparation that contains any substance referred to in this paragraph;

Concentrate of poppy straw (the crude extract of poppy straw in either liquid, solid, or powder form that contains the phenanthrene alkaloids of the opium poppy); and

Hashish;

Opiates: Unless specifically excepted or unless listed in another schedule, any of the following opiates, including their isomers, esters, ethers, salts, and salts of isomers, whenever the existence of these isomers, esters, ethers, and salts is possible within the specific chemical designation, dextrorphan excepted:

(1) 4-anilino-N-phenethyl-4-piperidine (ANPP);

(2) Alfentanil;

(3) Alphaprodine;

(4) Anileridine;

(5) Bezitramide;

(6) Bulk Dextropropoxyphene (non-dosage form);

(7) Carfentanil;

(8) Dihydrocodeine;

(9) Dihydroetorphine;

(10) Diphenoxylate;

(11) Fentanyl;

(12) Isomethadone;

(13) Levo-alphacetylmethadol [Some other names: levo-alpha- acetylmethadol, levomethadyl acetate, LAAM];

(14) Levomethorphan;

(15) Levorphanol;

(16) Metazocine;

(17) Methadone;

(18) Methadone-intermediate, 4-cyano-2-dimethylamino-4, 4-diphenyl butane;

(19) Moramide-intermediate, 2-methyl-3-morpholino-1, 1-diphenylpropane-carboxylic acid;

(20) Pethidine (meperidine);

(21) Pethidine-Intermediate-A, 4-cyano-1-methyl-4- phenylpiperidine; (Meperidine intermediate-A)

(22) Pethidine-Intermediate-B,ethyl-4-phenylpiperidine-4-carboxylate; (Meperidine intermediate-B);

(23) Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine- 4-carboxylic acid; (Meperidine intermediate-C)

(24) Phenazocine;

(25) Piminodine;

(26) Racemethorphan;

(27) Racemorphan;

(28) Remifentanil;

(29) Sufentanil;

(30) Tapentadol;

(31) (Acetylfentanyl) N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide

(32) (Butyrylfentanyl) N-(1-phenethylpiperidin-4-yl)-N-phenylbutyramide;

(33) (Fluorobutylfentanyl) N-(4-Fluorophenyl)-N-(1-phenethylpiperidin-4-yl)butyramide;

(34) (Hydroxythiofentanyl) N-( 1-(2-Hydroxy-2-(thiophen-2-yl)ethyl)piperidin-4-yl)-N-pheny1propanamide;

(35) (Isobutyrfentanyl) N-(1-Phenethylpiperidin-4-y1)-N-phenylisobutyramide;

(36) (Ocfentanil) N-(2-fluorophenyl)-2-methoxy-N-(1-phenethylpiperidin-4-yl)acetamide; N-(2-Fluorophenyl)-2-methoxy-N-(1-(2-phenylethyl)-4-piperidinyl)acetamide;

(37) 2–(1,3-dimethoxybuta-1,3-dien-2-yl)–3-ethyl-8-methoxy-1,2,3,4,6,7,12,12b-octahydroindolo[2,3-a]quin olizine;

(38) (2a,4aR,6aR,7R,9S,10aS10bR)-methyl-9-acetoxy-2–(furan-3- yl)–6a,10b-dimethyl-4,10-dioxododecahydro-1H- benzo[f]isochromene-7-carboxylate;

(39) 4,5-epoxy-17-methylmorphinan-3-ol;

(40) N-phenyl-N-[1–(2-phenethyl)–4-piperidinyl] acetamide;

(41) N–(1-benzylpiperidin-4-yl)–N–(x-fluorophenyl)-butanamide;

(42) 2-methyl-N-phenyl-N-[1–(1-phenylpropan-2-yl)piperidin-4- yl]propanamide;

(43) 1-cyclohexyl-4–(1,2-diphenylethyl)-piperazine;

(44) N-phenyl-N–(1–(2–(thiophen-2-yl)ethyl)piperidin-4-yl)acetamide;

(45) 4-chloro-N–(1-phenethylpiperidin-2-ylidene)benzenesulfonamide; and

(46) 4-chloro-N–(1–(4-nitrophenethyl)piperidin-2-ylidene)benzenesulfonamide;

Stimulants: Unless specifically excepted or unless listed in another schedule, any material compound, mixture, or preparation that contains any quantity of the following substances having a stimulant effect on the central nervous system:

(1) Amphetamines, its salts, optical isomers, and salts of its optical isomers;

(2) Biphetamine

(3) Eskatrol;

(4) (Ethylphenidate) ethyl 2-phenyl-2-(piperdin-2-yl)acetate;

(5) Lisdexamfetamine;

(6) Methylphenidate and its salts;

(7) Methamphetamine, its salts, isomers, and salts of isomers; and

(8) Phenmetrazine and its salts;

Immediate precursors: Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation that contains any

Amphetamine/methamphetamine immediate precursor: phenylacetone (other names: phenyl-2-propanone; P2P; benzyl methyl ketone; methyl benzyl ketone);

Immediate precursor to fentanyl: 4-anilino-N-phenethyl-4-piperidine (ANPP); and

Depressants: Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation that contains any quantity of the following substances having a depressant effect on the central nervous system, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:

Amobarbital;

Glutethimide.

Pentobarbital; and

Secobarbital; and

(f) Hallucinogenic substances:

Immediate precursors to phencyclidine (PCP):

1-phenylcyclohexylamine;

1-piperidinocyclohexanecarbonitrile (PCC); and

(2) Nabilone.

History

SOURCE: Final Rulemaking published at 39 DCR 1882, 1885 (March 20, 1992); as amended by Final Rulemaking published at 41 DCR 7967 (December 16, 1994); as amended by the Omnibus Narcotic and Abusive Drug Interdiction Amendment Act of 1990, effective June 13, 1990, § 2(b)(2) (D.C. Law 8-138; 37 DCR 2638 (April 27, 1990)); as amended by Emergency and Proposed Rulemaking published at 47 DCR 7512 (September 15, 2000) [EXPIRED]; as amended by Final Rulemaking published at 48 DCR 914 (February 2, 2001); as amended by Emergency and Proposed Rulemaking published at 50 DCR 10421 (December 5, 2003) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 4080 (April 23, 2004); as amended by Final Rulemaking published at 61 DCR 10233 (October 3, 2014); as amended by Final Rulemaking published at 63 DCR 14819 (December 2, 2016). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1202

22-B DCMR § 1203 SCHEDULE III ENUMERATED

1203.1 The controlled substances listed in this section are included in Schedule III of the Act unless removed therefrom pursuant to Section 201 of the Act:

Schedule III shall consist of the following controlled substances by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section:

The compounds, mixtures, or preparations in dosage unit form containing any stimulant substances listed in Schedule II which compounds, mixtures, or preparations were listed on August 25, 1971 as excepted compounds under Title 21 § 1308.32 of the Code of Federal Regulations (C.F.R.), and any other drug of the quantitative composition shown in that list for those drugs or which is the same except that it contains a lesser quantity of controlled substances;

(B) Benzphetamine;

Chlorphentermine;

(D) Clortermine;

(E) Mazindol; and

(F) Phendimetrazine;

Depressants: Unless listed in another schedule, any material compound, mixture, or preparation that contains any quantity of the following substances having a potential for abuse associated with depressant effect on the central nervous system:

Any compound, mixture, or preparation containing:

Amobarbital;

Aprobarbital;

Butabarbital;

Butabarbital (secbutabarbital);

Butalbital;

Butobarbital (butethal);

Secobarbital;

Pentobarbital; or any salt thereof and one (1) or more other active medicinal ingredients which are not listed in any schedule;

Perampanel;

Talbutal;

Thiamylal;

Thiopental; and

Vinbarbital;

Any suppository dosage form containing:

Amobarbital;

Aprobarbital;

Butabarbital;

Butabarbital (secbutabarbital);

Butalbital;

Butobarbital (butethal);

Pentobarbital; or any salt of any of these drugs and approved by the Food and Drug Administration for marketing only as a suppository;

Secobarbital; and

Vinbarbital; and

Any substance that contains any quantity of a derivative of barbituric acid, or any salt of a derivative of barbituric acid:

(i) Chlorhexadol;

(ii) Embutramide;

(iii) Any drug product containing gamma-hydroxybutric acid including its salts, isomers, and salts of isomers.

(iv) Ketamine;

(v) Lysergic acid;

(vi) Lysergic acid amide;

(vii) Methyprylon;

(viii) Sulfondiethylmethane;

(ix) Sulfonethylmethane;

Sulfonmethane; and

Tiletamine & Zolazepam Combination Product;

Nalorphine;

Narcotic drugs. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing any of the following narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid, in limited quantities as set forth below:

Not more than one and eight-tenths (1.8) grams of codeine per one hundred (100) milliliters or not more than ninety (90) milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium;

Not more than one and eight-tenths (1.8) grams of codeine per one hundred (100) milliliters or not more than ninety (90) milligrams dosage unit, with one (1) or more active non-narcotic ingredients in recognized therapeutic amounts;

Not more than three hundred (300) milligrams of dihydrocodeinone per one hundred (100) milliliters or not more than fifteen (15) milligrams per dosage unit, with a 4-fold or greater quantity of an isoquinoline alkaloid of opium;

Not more than three hundred (300) milligrams dihydrocodeine per one hundred (100) milliliters or not more than fifteen (15) milligrams per dosage unit with one (1) or more active, non-narcotic ingredients in recognized therapeutic amounts;

Not more than one and eight-tenths (1.8) grams of dihydrocodeine per milliliters or not more than ninety (90) milligrams per dosage unit, with one (1) or more active, non-narcotic ingredients in recognized therapeutic amounts;

(F) Codeine and isoquinoline alkaloid ninety (90) milligrams per dosage unit;

(G) Codeine combination product ninety (90) milligrams per dosage unit;

(H) Dihydrocodeine combination product ninety (90) milligrams per dosage unit;

Ethylmorphine combination product fifteen (15) milligrams per dosage unit;

(J) Hydrocodone and isoquinoline alkaloid less than fifteen (15) milligrams per dosage unit;

(K) Hydrocodone combination product less than fifteen (15) milligrams per dosage unit;

(L) Not more than three hundred (300) milligrams of ethylmorphine per one hundred (100) milliliters or not more than fifteen (15) milligrams per dosage unit, with one (1) or more ingredients in recognized therapeutic amounts;

(M) Not more than five hundred (500) milligrams of opium per one hundred (100) milliliters or per one hundred (100) grams or not more than twenty-five (25) milligrams per dosage unit, with one (1) or more active, non-narcotic ingredients in recognized therapeutic amounts;

(N) Opium combination product twenty-five (25) milligrams per dosage unit;

Not more than fifty (50) milligrams of morphine per one hundred (100) milliliters or per one hundred (100) grams with one (1) or more active, non-narcotic ingredients in recognized therapeutic amounts; and

Any material, compound, mixture, or preparation containing Buprenorphine or its salts;

Anabolic Steroids: Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing any quantity of the following substances, drug, or hormonal substance, chemically and pharmacologically related to testosterone (other than estrogens, progesterons, and corticosteroids) that promotes muscle growth and includes:

Boldenone (17beta-hydroxyandrost-1,4- diene-3-one);

Chlortestosterone (4-chlortestosterone);

Clostebol(4-chloro-17beta-hydroxyandrost- 4-en-3-one);

Dehydrochloromethyltestosterone (4-chloro-17beta-hydroxy-17alpha-methylandrost-1,4-dien-3-one);

Delta1-dihydrotestosterone (17beta-hydroxy-5alpha androst-1-en-3-one);

Drostanolone(17beta-hydroxy-2alpha-methyl- 5alphaandrostan-3-one);

Ethylestrenol(17alpha-ethyl-17beta-hydroxyestr- 4-ene);

Fluoxymesterone (9-fluoro-17alpha-methy 11beta,17beta- dihydroxyandrost-4-en-3-one);

Formebulone (formebolone);(2-formyl-17alpha- methyl11alpha,17beta-dihydroxyandrost-1,4-dien-3-one);

(J) Furazabol(17alpha-methyl- 17betahydroxyandrostano [2,3-c]-furazan);

(K) Mesterolone; (1alpha-methyl-17beta-hydroxy- 5alphaandrostan-3-one);

(L) Methandienone(17alpha-methyl- 17betahydroxyandrost- 1,4-diene-3-one);

(M) Methandriol (17alpha-methyl-3beta, 17betadihydroxyandrost-5-ene) (a.k.a. Methandrostenolone);

(N) Methenolone (1-methyl-17beta-hydroxy- 5alpha-androst1-en-3-one);

(O) Methyltestosterone (17alpha-methyl- 17betahydroxyandrost- 4-en-3-one);

(P) Mibolerone (7alpha,17alpha-dimethyl- 17betahydroxyestr- 4-en-3-one);

Nandrolone (17beta-hydroxyestr-4-en-3-one);

Norethandrolone (17alpha-ethyl-17beta-hydroxyestr - 4en-3-one);

Oxandrolone (17alpha-methyl-17beta-hydroxy-

2-oxa5alpha-androstan-3-one);

Oxymesterone (17alpha-methyl-4, 17betadihydroxyandrost-4-en-3-one);

Oxymetholone (17alpha-methyl-2- hydroxymethylene17beta-hydroxy-5alpha-androstan-3-one);

Stanolone;

Stanozolol (17alpha-methyl-17beta-hydroxy-5alpha

androst-2-eno[3,2-c]-pyrazole);

Testolactone (13-hydroxy-3-oxo- 13,17-secoandrosta 1,4-dien-17-oic acid lactone);

Testosterone (17beta-hydroxyandrost-4-en-3-one);

Trenbolone (17beta-hydroxyestr-4,9,11-trien-3- one);

(AA) 13β-ethyl-17β-hydroxygon-4-en-3-one;

(BB) 17α-methyl-3α,17β-dihydroxy-5a-androstane;

(CC) 17α-methyl-3β,17β-dihydroxy-5a-androstane;

(DD) 17α-methyl-3β,17β-dihydroxyandrost-4-ene;

(EE) 17α-methyl-4-hydroxynandrolone (17α-methyl-4- hydroxy-17β-hydroxyestr-4-en-3-one);

(FF) 17α-methyl-Δ1-dihydrotestosterone (17β-hydroxy-17α-methyl-5α-androst-1-en-3-one) (a.k.a. '17-α-methyl-1-testosterone');

(GG) 19-nor-4,9(10)-androstadienedione (estra-4,9(10)-diene-3,17-dione);

(HH) 19-nor-4-androstenediol (3α, 17β-dihydroxyestr- 4-ene);

(II ) 19-nor-4-androstenediol (3β, 17β-dihydroxyestr- 4-ene);

(JJ) 19-nor-4-androstenedione (estr-4-en-3,17-dione);

(KK) 19-nor-5-androstenediol (3α, 17β-dihydroxyestr- 5-ene);

(LL) 19-nor-5-androstenediol (3β, 17β-dihydroxyestr- 5-ene);

(MM) 19-nor-5-androstenedione (estr-5-en-3,17-dione);

(NN) 1-androstenediol (3α,17β-dihydroxy-5α-androst- 1-ene);

(OO) 1-androstenediol (3β,17β-dihydroxy-5α-androst- 1-ene);

(PP) 1-androstenedione ([5α]-androst-1-en-3,17-dione);

(QQ) 3α,17β-dihydroxy-5a-androstane;

(RR) 3β,17-dihydroxy-5a-androstane;

(SS) 4-androstenediol (3β,17β-dihydroxy-androst-4-ene);

(TT) 4-androstenedione (androst-4-en-3,17-dione);

(UU) 4-dihydrotestosterone (17β-hydroxy-androstan- 3-one);

(VV) 4-hydroxy-19-nortestosterone (4,17β-dihydroxy- estr-4-en-3-one);

(WW) 4-hydroxytestosterone (4,17β-dihydroxy-androst- 4-en-3-one);

(XX) 5-androstenediol (3β,17β-dihydroxy-androst-5-ene);

(YY) 5-androstenedione (androst-5-en-3,17-dione);

(ZZ) Androstanedione 5α-androstan-3,17-dione;

(AAA) Bolasterone (7α,17α-dimethyl-17β-hydroxyandrost-4-en-3-one);

(BBB) Boldione (androsta-1,4-diene-3,17-dione);

(CCC) Calusterone (7β,17α-dimethyl-17β-hydroxyandrost-4-en-3-one);

(DDD) Desoxymethyltestosterone (17α-methyl-5α- androst-2-en-17β-ol) (a.k.a. 'madol');

(EEE) Furazabol (17α-methyl-17β-hydroxyandrostano[2,3-c]-furazan);

(FFF) Mestanolone (17α-methyl-17β-hydroxy- 5-androstan-3-one);

(GGG) Methasterone (2α,17α-dimethyl-5α-androstan- 17β-ol-3-one);

(HHH) Methyldienolone (17α-methyl-17β-hydroxyestra-4,9(10)-dien-3-one);

(III) Methyltrienolone (17α-methyl-17β-hydroxyestra-4,9,11-trien-3-one);

(JJJ) Norbolethone (13β, 17α-diethyl-17β-hydroxygon- 4-en-3-one);

(KKK) Norclostebol (4-chloro-17β-hydroxyestr- 4-en-3-one);

(LLL) Normethandrolone (17α-methyl-17β-hydroxyestr- 4-en-3-one);

(MMM) Prostanozol (17β-hydroxy-5α-androstano[3,2-c]pyrazole);

(NNN) Stenbolone (17β-hydroxy-2-methyl-[5α]-androst-1-en-3-one);

(OOO) Tetrahydrogestrinone (13β, 17α-diethyl-17β-hydroxygon- 4,9,11-trien-3-one)

(PPP) Δ1-dihydrotestosterone (a.k.a.'1-testosterone') (17β-hydroxy-5α-androst-1-en-3-one); and

(QQQ) Any salts, ester or isomer of a drug or substance described or listed in this paragraph, if that salt, ester, or isomer promotes muscle growth. Except the term does not include an anabolic steroid that is expressly intended for administration through implants to cattle or other nonhuman species and that has been approved by the Secretary of Health and Human Services for such administration. If any person prescribes, dispenses or distributes that steroid for human use the person shall be considered to have prescribed, dispensed or distributed an anabolic steroid within the meaning of this paragraph.,

(6) Hallucinogenic substances;

(7) Dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule in a U.S. Food and Drug Administration approved drug product. [Some other names for dronabinol: 6aR-trans)-6a,7,8,10a-tetrahydro- 6,6,9- trimethyl-3-pentyl-6H-dibenzo [b,d]pyran-1-o1] or (-)-delta-9-(trans)-tetrahydrocannabinol]; and

(8) Cannabis.

(b) The Mayor may except by rule any compound, mixture, or preparation containing any stimulant or depressant substance listed in paragraphs (1) and (2) of subsection (a) of this section from the application of all or any part of this chapter if the compound, mixture, or preparation contains one (1) or more active medicinal ingredients not having a stimulant or depressant effect on the central nervous system, and if the admixtures are included therein in combinations, quantity, proportion, or concentration that vitiates the potential for abuse of the substances that have a stimulant or depressant effect on the central nervous system.

History

SOURCE: Final Rulemaking published at 39 DCR 1882, 1888 (March 20, 1992); as amended by Final Rulemaking published at 41 DCR 7967 (December 16, 1994); Emergency and Proposed Rulemaking published at 47 DCR 7512 (September 15, 2000) [EXPIRED]; as amended by Final Rulemaking published at 48 DCR 914 (February 2, 2001); as amended by Emergency and Proposed Rulemaking published at 50 DCR 10421 (December 5, 2003) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 4080 (April 23, 2004); as amended by Final Rulemaking published at 61 DCR 10233 (October 3, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1203

22-B DCMR § 1204 SCHEDULE IV ENUMERATED

1204.1 The controlled substances listed in this section are included in Schedule IV of the Act unless removed therefrom pursuant to Section 201 of the Act. Schedule IV shall consist of the following controlled substances:

(a) Depressants: Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation that contains any quantity of the following substances, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:

(1) Alfaxalone;

(2) Alprazolam;

(3) Barbital;

(4) Bromazepam;

(5) Camazepam;

(6) Chloral betaine;

(7) Chloral hydrate;

(8) Chlordiazepoxide;

(9) Clobazam;

(10) Clonazepam;

(11) Clorazepate;

(12) Clotiazepam;

(13) Cloxazolam;

(14) Delorazepam;

(15) Diazepam;

(16) Dichloralphenazone;

(17) Estazolam;

(18) Ethyl loflazepate;

(19) Ethchlorvynol;

(20) Ethinamate;

(21) Fludiazepam;

(22) Flunitrazepam;

(23) Flurazepam;

(24) Fospropofol;

(25) Halazepam;

(26) Haloxazolam;

(27) Ketazolam;

(28) Loprazolam;

(29) Lorazepam;

(30) Lormetazepam;

(31) Mebutamate;

(32) Medazepam;

(33) Meprobamate;

(34) Methohexital;

(35) Methylphenobarbital (mephobarbital);

(36) Midazolam;

(37) Nimetazepam;

(38) Nitrazepam;

(39) Nordiazepam;

(40) Oxazepam;

(41) Oxazolam;

(42) Paraldehyde;

(43) Petrichloral;

(44) Phenobarbital;

(45) Pinazepam;

(46) Prazepam;

(47) Quazepam;

(48) Temazepam;

(49) Tetrazepam; and

(50) Triazolam;

(b) Fenfluramine: Any material, compound, mixture, or preparation that contains any quantity of the following substances, including its salts, isomers, (whether optical, position, or geometric), and salts of such isomers, whenever the existence of the salts, isomers, and salts of isomers is possible: Fenfluramine;

(c) Stimulants: Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation that contains any quantity of the following substances having a stimulant effect on the central nervous system, including its salts, isomers (whether optical, position, or geometric), and salts of such isomers whenever the existence of the salts, isomers and salts of isomers is possible within the specific chemical designation:

(1) Cathine;

(2) Clortermine;

(3) Dexfenfluramine;

(4) Diethylpropion;

(5) Fencamfamin;

(6) Fenproporex;

(7) Lorcaserin;

(8) Mazindol;

(9) Mefenorex;

(10) Modafinil;

(11) Pemoline (including organometallic complexes and chelates thereof);

(12) Phentermine;

(13) Pipradrol;

(14) Sibutramine; and

(15) SPA;

(d) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture or preparation that contains any quantity of the following substances, including its salts:

(1) Butorphanol;

(2) Dextropropoxyphene (Alpha-(+)-4-demethylamino-1), 2-diphenyl-1-3-methyl-2-propionoxybutane; and

(3) Pentazocine;

(e) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing limited quantities of any of the following narcotic drugs, or any salts thereof of not more than one (1) milligram of difenoxin and not less than twenty-five (25) micrograms of atropine sulfate per dosage unit;

(f) Carisoprodol;

(g) Zaleplon;

(h) Zolpidem;

(i) Zopiclone;

(j) Suvorexant;

(k) Tramadol;

(l) Brotizolam; 3-(2- bromophenyl)-4-[(3- chlorophenyl)methylideneamino]-1H-1,2,4-triazole-5-thione;

(m) Vinylbital; (Vinylbitone; Vinylbitalum;);

(n) Mesocarb;

(o) Dezocine;

(p) Allobarbital; Allobarbitone;

(q) (Phenazepam) 7-bromo-5-(2-chlorophenyl)-1,3,dihydro-2H-1,4-benzodiazepin-2-one;

(r) 4–(2-chlorophenyl)–2-ethyl-9-methyl-6H-thieno-[3,2- f][1,2,4]triazolo[4,3-a][1,4]diazepine(#) 7-bromo-5–(2-chlorophenyl)–1H-benzo[e][1,4]diazepin-2(3H)-one(#) 8-bromo-1-methyl-6-phenyl-4H-[1,2,4]triazolo[4,3a][1,4]benzodiazepine;

(s) 3-methyl-6-[3–(trifluoromethyl)phenyl][1,2,4]triazol[4,3-b]pyridazine; and

(t) 6–(5-chloro-2-pyridyl)–6,7-dihydro-7-oxo-5H-pyrrolo[3,4- b]pyrazin-5-yl 4-methylpiperazine-1-carboxylate.

History

SOURCE: Final Rulemaking published at 39 DCR 1882, 1888 (March 20, 1992); as amended by Emergency and Proposed Rulemaking published at 47 DCR 7512 (September 15, 2000) [EXPIRED]; as amended by Final Rulemaking published at 48 DCR 914 (February 2, 2001); as amended by Emergency and Proposed Rulemaking published at 50 DCR 10421 (December 5, 2003) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 4080 (April 23, 2004); as amended by Final Rulemaking published at 61 DCR 10233 (October 3, 2014); as amended by Final Rulemaking published at 63 DCR 14819 (December 2, 2016). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1204

22-B DCMR § 1205 SCHEDULE V ENUMERATED

1205.1 The following controlled substances listed below are included in Schedule V of the Act unless removed therefrom pursuant to Section 201 of the Act:

Narcotic drugs containing non-narcotic active medicinal ingredients: Any compound, mixture, or preparation containing limited quantities of any of the following narcotic drugs, or salts thereof, that also contains one (1) or more non-narcotic active medicinal ingredients in sufficient proportion to confer upon the compound, mixture, or preparation valuable medicinal quantities other than those possessed by the narcotic drug alone:

Not more than two hundred (200) milligrams of codeine per one hundred (100) milliliters or per one hundred (100) grams;

(2) Not more than one hundred (100) milligrams of dihydrocodeine per one hundred (100) milliliters or per one hundred (100) grams;

(3) Not more than one hundred (100) milligrams of ethylmorphine per one hundred (100) milliliters or per one hundred (100) grams;

(4) Not more than two and five-tenths (2.5) milligrams of diphenoxylate and not less than twenty-five (25) micrograms of atropine sulfate per dosage unit;

(5) Not more than one hundred (100) milligrams of opium per one hundred (100) milliliters or per one hundred (100) grams;

(6) Not more than one half-tenth (0.5) milligrams of Difenoxin and not less than twenty-five (25) micrograms of atropine sulfate per dosage unit;

(b) [REPEALED];

Pyrovalerone; and

(d) Depressants. Unless specifically exempted or excluded or unless listed in another schedule, any material, compound, mixture, or preparation that contains any quantity of the following substances having a depressant effect on the central nervous system, including its salts:

Ezogabine [N-[2-amino-4-(4-fluorobenzylamino)-phenyl]- carbamic acid ethyl ester];

Lacosamide [(R)-2-acetoamido-N-benzyl-3-methoxy- propionamide]; and

Pregabalin [(S)-3-(aminomethyl)-5-methylhexanoic acid].

History

SOURCE: Final Rulemaking published at 39 DCR 1882, 1892 (March 20, 1992); as amended by Emergency and Proposed Rulemaking published at 47 DCR 7512 (September 15, 2000) [EXPIRED]; as amended by Final Rulemaking published at 48 DCR 914 (February 2, 2001); as amended by Emergency and Proposed Rulemaking published at 50 DCR 10421 (December 5, 2003) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 4080 (April 23, 2004); as amended by Final Rulemaking published at 61 DCR 10233 (October 3, 2014); as amended by Final Rulemaking published at 65 DCR 0635 (January 26, 2018); as amended by Errata Notice published at 65 DCR 1721 (February 16, 2018); as amended by Final Rulemaking published at 66 DCR 2327 (February 22, 2019); as amended by Final Rulemaking published at 67 DCR 14204 (December 4, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1205

22-B13 PRESCRIPTIONS AND DISTRIBUTION

22-B DCMR § 1300 GENERAL PROVISIONS

1300.1 This chapter shall apply to all categories of prescriptions drugs.

1300.2 Unless otherwise prohibited in this chapter or by District or federal law, a pharmacist may accept as valid for dispensing, a written prescription, an oral prescription, a telephone facsimile prescription, or an electronic prescription, issued by a practitioner who holds a valid license issued by the District of Columbia, or other U.S. state, to prescribe drugs or medical devices.

1300.3 A prescription shall only be issued by a practitioner who holds a valid license issued by the District of Columbia, or other U.S. state, to prescribe drugs or medical devices. If the prescription is for a controlled substance, the practitioner must also have a valid federal Drug Enforcement Agency (DEA) registration number and if applicable, a valid District of Columbia controlled substance registration or be exempt from registration pursuant to § 302 of the District of Columbia Uniform Controlled Substances Act of 1981, effective August 5, 1981, (D.C. Law 4-29, D.C. Official Code § 48-901.01).

1300.4 A prescription issued by an individual practitioner may be communicated to a pharmacist by an employee or agent of the individual practitioner only pursuant to the directions and order of the practitioner, and in conformance with the applicable federal and District of Columbia laws and regulations, and this chapter.

1300.5 A prescription shall only be filled by a licensed pharmacist or individual practitioner legally authorized to dispense a prescription.

1300.6 Pharmacists shall exercise sound professional judgment with respect to the accuracy and authenticity of any prescription they dispense. If the pharmacist questions the accuracy or authenticity of prescription, he or she shall verify the order with the practitioner prior to dispensing.

1300.7 Prior to dispensing a prescription, pharmacists shall determine, in the exercise of sound professional judgment, that the prescription is a valid prescription. A pharmacist shall not dispense a prescription if the pharmacist knows that the prescription was issued without a valid patient-practitioner relationship.

1300.8 An internet based or telephone consultation or questionnaire evaluation is not adequate to establish a valid patient-practitioner relationship except as follows:

(a) In the event of a documented medical emergency;

(b) In an on-call or cross-coverage arrangement; or

(c) Where patient care is rendered in consultation with another practitioner who has an ongoing relationship with the patient and who has agreed to supervise the patient's treatment, including the use of any prescribed medications.

1300.9 Nothing in this chapter shall be construed as authorizing or permitting any person to do any act which such person is not authorized or permitted to do under other Federal laws or obligations under international treaties, conventions or protocols, or under the law of the State in which he or she desires to do such act nor shall compliance with such parts be construed as compliance with other Federal or State laws unless expressly provided in such other laws.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1064 (February 21, 1986); as amended by Final Rulemaking published at 53 DCR 10055 (December 22, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1300

22-B DCMR § 1301 WRITTEN PRESCRIPTION ORDERS

1301.1 In addition to conforming to all applicable federal and District requirements, a written prescription drug order shall contain the following:

(a) The printed or typed full name, address, and telephone number of the practitioner;

(b) The original, legal signature of the practitioner, in ink;

(d) The full name of the patient;

(e) The name, strength and quantity of the drug prescribed, directions for use, and number of refills, when applicable; and

(f) Be written in ink, indelible pencil or typewriter.

1301.2 In addition to the requirements of § 1301.1, a prescription drug order for a controlled substance shall also include the following:

(a) The patient's address;

(b) The practitioner's Federal Drug Enforcement Administration (DEA) registration number;

(d) Be signed by the practitioner in the same manner as the practitioner would sign a check or legal document (for example: "J.H. Smith" or "John H. Smith").

1301.3 Any person who is exempted from registration under federal or District of Columbia statute shall include on all prescriptions for controlled substances issued by him or her the registration number of the hospital or other institution and the special internal code number assigned to him or her by the hospital or other institution as provided in the Act or this chapter, in lieu of the registration number of the practitioner required by this chapter.

1301.4 An official exempted from registration under federal or District of Columbia statute shall include on all prescriptions issued by that individual, his or her branch of service or agency (e.g., "U.S. Army" or "Public Health Service") and the individual's service identification number, in lieu of the registration number of the practitioner required by this chapter.

1301.5 The service identification number for a Public Health Service employee is his or her social security identification number or, if applicable, his or her National Provider Identifier (NPI) number. Each prescription shall have the name of the individual stamped or printed on it, as well as the signature of the individual.

1301.6 The dispensing pharmacist shall document the following information on each prescription order that has been dispensed:

(a) The name or initials of the pharmacist who performed the final verification; and

(b) Any change or alteration made to the prescription dispensed based on contact with the practitioner to show a clear audit trail. This shall include but not be limited to, a change in quantity, directions, or number of refills.

1301.7 Authorization obtained from the practitioner to substitute a drug, shall be documented on the prescription order, except in the case of an institutional pharmacy which maintains readily retrievable, written, documented policies authorizing such substitution.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1064 (February 21, 1986); as amended by Final Rulemaking published at 53 DCR 10055 (December 22, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1301

22-B DCMR § 1302 ORAL PRESCRIPTION ORDERS

1302.1 A pharmacist shall not dispense an oral prescription drug order for a controlled substance listed in Schedule II except as provided in § 1306.5 of this chapter.

1302.2 An oral prescription drug order from a practitioner or a practitioner's designated agent shall:

(a) Only be received by a pharmacist; and

(b) Be immediately reduced to writing.

1302.3 In addition to conforming to all applicable federal and District requirements, an oral prescription drug order shall contain the following:

(a) The full name, address, and telephone number of the practitioner;

(b) The date of issuance;

(d) The name, strength, and quantity of the drug, directions for use, and number of refills, when applicable; and

(e) The name of the practitioner's designated agent authorized to orally communicate the prescription to the pharmacist.

1302.4 In addition to the requirements of § 1302.3, a prescription for a controlled substance, when authorized by law for dispensing, shall also include the following:

(a) The practitioner's federal Drug Enforcement Administration (DEA) registration number; and

(b) The practitioner's District of Columbia Controlled Substances registration number, if applicable.

1302.5 The dispensing pharmacist shall document the following information on the written record of each prescription order that has been dispensed:

(a) The name or initials of the pharmacist who performed the final verification; and

(b) Any change or alteration made to the prescription dispensed based on contact with the practitioner to show a clear audit trail. This shall include, but not be limited to, a change in quantity, directions, or number of refills.

1302.6 Authorization obtained from the practitioner to substitute a drug, shall be documented on the prescription order, except in the case of an institutional pharmacy which maintains readily retrievable, written, documented policies authorizing such substitution.

1302.7 For any person who is exempted from registration under federal or District of Columbia statute, the pharmacist shall include on all prescriptions for controlled substances issued by the exempted practitioner the registration number of the hospital or other institution and the special internal code number assigned to him or her by the hospital or other institution as provided in the Act, in lieu of the registration number of the practitioner required by this chapter.

1302.8 For an official who is exempted from registration under federal or District of Columbia statute, the pharmacist shall include on all prescriptions issued by that individual, his or her branch of service or agency (e.g., "U.S. Army" or "Public Health Service") and the individual's service identification number, in lieu of the registration number of the practitioner required by this chapter.

1302.9 For any Public Health Service employee that is exempted from registration under federal or District of Columbia statute, the pharmacist shall include the individual's social security identification number or, if applicable, his or her National Provider Identifier (NPI) number, office, title, and business address on the prescription.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1065 (February 21, 1986); as amended by Final Rulemaking published at 53 DCR 10055 (December 22, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1302

22-B DCMR § 1303 TELEPHONE FACSIMILE PRESCRIPTION ORDERS

1303.1 A practitioner shall not transmit a prescription via telephone facsimile if in doing so it would interfere with a patient's freedom to choose a pharmacy, or without a patient's consent.

1303.2 A pharmacist shall not dispense a telephone facsimile prescription drug order for a controlled substance listed in Schedule II, except as permitted under § 1306 of this chapter.

1303.3 A telephone facsimile prescription shall be transmitted only by a practitioner or a practitioner's designated agent directly from the practitioner's office or a health care facility to the pharmacy with no intervening person having access to the prescription drug order.

1303.4 To maintain the confidentiality of patient records:

(a) The pharmacy and the practitioner shall both have adequate security and system safeguards designed to prevent and detect unauthorized access, modification, or manipulation of patient records and telephone facsimile transmissions; and

(b) The pharmacy shall implement and maintain procedures, system controls and other efforts to ensure compliance with the Health Insurance Portability and Accountability Act ("HIPAA"), federal and District laws regarding the confidentiality and protection of patient information.

1303.5 The pharmacy shall implement and maintain procedures to verify the authenticity of the telephone facsimile transmission and its source of origin which may include:

(a) Maintenance of a practitioner's telephone facsimile number reference;

(b) Verification of the telephone number of the originating telephone facsimile equipment; and

(c) Telephone verification with the practitioner's office that the prescription as transmitted via telephone facsimile contains the same exact information it contained when originated by the practitioner and contains no alterations by any intervening parties.

1303.6 In addition to conforming to all applicable federal and District requirements, a telephone facsimile prescription drug order shall contain the following at the time it is transmitted:

(a) A prescription bearing the following information:

(1) The printed or typed full name, address, telephone number and facsimile number of the practitioner;

(2) The signature of the practitioner;

(3) The date of issuance;

(4) The full name and address of the patient;

(5) The name and dosage of the drug, directions for use, quantity dispensed, and number of refills, when applicable; and

(6) A statement which indicates that the prescription was transmitted via telephone facsimile;

(b) Along with the prescription, the following information shall be transmitted:

(1) The name, address, and facsimile number of the pharmacy to which the prescription was transmitted;

(2) The date the prescription was transmitted via facsimile to the pharmacy, if the date is different from the date of issuance of the prescription;

(3) If transmitted by a designated agent, the full name of the designated agent; and

(4) A clearly legible statement that:

(A) The telephone facsimile transmission is intended only for the recipient to which it was addressed and contains information that is confidential;

(B) The recipient is prohibited from distribution or dissemination of the information contained in the transmission unless permitted by federal or District law; and

(C) If the recipient is not the intended recipient or the authorized agent of the intended recipient, the recipient should immediately notify the sender by telephone and return the original message to the sender.

1303.7 In addition to the requirements of § 1303.6, a prescription for a controlled substance, when authorized by law for dispensing, shall also include the following:

(a) The practitioner's federal Drug Enforcement Administration (DEA) registration number;

(b) The practitioner's District of Columbia Controlled Substances registration number, if applicable;

(c) Be signed by the practitioner in the same manner as the practitioner would sign a check or legal document (for example: "J.H. Smith" or "John H. Smith"); and

(d) Any other requirements under District or federal law.

1303.8 Any person who is exempted from registration under federal or District of Columbia statute shall include on all prescriptions for controlled substances issued by him or her the registration number of the hospital or other institution and the special internal code number assigned to him or her by the hospital or other institution as provided in the Act or this chapter, in lieu of the registration number of the practitioner required by this chapter.

1303.9 An official exempted from registration under federal or District of Columbia statue shall include on all prescriptions issued by that individual, his or her branch of service or agency (e.g., "U.S. Army" or "Public Health Service") and the individual's service identification number, in lieu of the registration number of the practitioner required by this chapter.

1303.10 The service identification number for a Public Health Service employee is his or her social security identification number or, if applicable, his or her National Provider Identifier (NPI) number. Each prescription shall have the name of the officer stamped or printed on it, as well as the signature of the officer.

1303.11 The dispensing pharmacist shall document the following information on each facsimile prescription order that has been dispensed:

(a) The name or initials of the pharmacist who performed the final verification; and

1303.12 Authorization obtained from the practitioner to substitute a drug, shall be documented on the prescription order, except in the case of an institutional pharmacy which maintains readily retrievable, written, documented policies authorizing such substitution.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1066 (February 21, 1986); as amended by Final Rulemaking published at 53 DCR 10055 (December 22, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1303

22-B DCMR § 1304 ELECTRONIC PRESCRIPTION ORDERS

1304.1 A practitioner shall not electronically transmit a prescription if in doing so it would interfere with a patient's freedom to choose a pharmacy, or without a patient's consent.

1304.2 A pharmacist shall not dispense an electronic prescription for a controlled substance listed in any schedule, unless otherwise authorized or permitted by federal law or regulations.

1304.3 An electronic prescription may be transmitted only by a practitioner or a practitioner's designated agent:

(a) Directly to a pharmacy through a secure computer to computer transmission;

(b) Directly to a pharmacy through a secure computer to facsimile transmission; or

(c) Processed by a commercial intermediary that is duly authorized to operate in the District of Columbia, if applicable, and which ensures the confidentiality and security of the transmission process.

1304.4 The original electronic transmission shall be readily retrievable through the pharmacy computer system and shall be immediately reduced to hardcopy and filed in accordance with District of Columbia regulations.

1304.5 To maintain the confidentiality of patient records:

(a) The pharmacy computer system and the practitioner shall both have adequate security and system safeguards designed to prevent and detect unauthorized access, modification, or manipulation of patient records and electronic transmissions; and

(b) The Director of Pharmacy or Pharmacist in Charge shall implement and maintain procedures, system controls, and other efforts to ensure compliance with HIPAA, federal and District laws concerning the confidentiality and protection of patient information.

1304.6 The Director of Pharmacy or Pharmacist in Charge shall create and maintain a an ongoing security program and procedures which are capable of identifying misuse or unauthorized use of electronic signatures;

1304.7 The Director of Pharmacy or Pharmacist in Charge shall implement and maintain procedures, computer system controls, and other efforts, including contractual arrangements with commercial intermediaries, to:

(a) Verify the authenticity of the electronic transmission and its source of origin;

(b) Ensure that the electronic transmission contains the same exact information it contained when originated by the practitioner;

(d) Prevent unauthorized access and changes to electronically transmitted prescriptions; and

(e) Other efforts which, in the professional judgment of the pharmacist, may be necessary to ensure the validity of the transmission.

1304.8 In addition to conforming to all applicable federal and District requirements, an electronic prescription order shall conform to federally recognized national transmission standards and contain the following information at the time it is transmitted:

(a) A prescription bearing the following information:

(1) The full name, address, and telephone number of the practitioner;

(2) The electronic signature of the practitioner;

(3) The date of issuance;

(4) The full name and address of the patient; and

(5) The name and dosage of the drug, directions for use, quantity dispensed, and number of refills, when applicable.

(b) Along with the prescription, the following information shall be transmitted:

(1) The National Council on Prescription Drug Programs (NCPDP) pharmacy number of the pharmacy to which the prescription was transmitted;

(2) The date the prescription was transmitted to the pharmacy, if the date is different from the date of issuance of the prescription; and

(3) If transmitted by the prescriber's designated agent, the full name of the designated agent.

1304.9 The dispensing pharmacist shall document the following information on each electronic prescription order that has been dispensed:

(a) The name or initials of the pharmacist who performed the final verification; and

1304.10 Authorization obtained from the practitioner to substitute a drug, shall be documented on the prescription order, except in the case of an institutional pharmacy which maintains readily retrievable, written, documented policies authorizing such substitution.

1304.11 Electronic transmission technology shall not be used to circumvent or violate any provision of District or federal laws or regulations.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1067 (February 21, 1986); as amended by Final Rulemaking published at 53 DCR 10055 (December 22, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1304

22-B DCMR § 1305 ISSUANCE OF CONTROLLED SUBSTANCE PRESCRIPTIONS

1305.1 The prescribing practitioner and the pharmacist shall be jointly responsible for compliance with this chapter in prescribing and dispensing a controlled substance.

1305.2 A prescription for a controlled substance shall be issued or dispensed only for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice.

1305.3 A prescription for a controlled substance shall be issued for treatment of individual patients. A prescription for a controlled substance shall not be issued to an individual practitioner for general dispensing purposes.

1305.4 A prescription for a controlled substance listed in any schedule shall be used for the purpose of continuing the patient's dependency only when its issuance is pursuant to authorized clinical treatment in a narcotic treatment rehabilitation program.

1305.5 Any person issuing a prescription and any person knowingly filling a prescription which is not in conformity with this chapter shall be subject to the penalties provided for violations of the Act and this chapter.

1305.6 An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of the Act, and a person knowingly filling such a prescription, and the person issuing it, shall both be subject to the penalties provided for violations of the provisions of law relating to controlled substances.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1067 (February 21, 1986); as amended by Final Rulemaking published at 53 DCR 10055 (December 22, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1305

22-B DCMR § 1306 PRESCRIPTIONS FOR CONTROLLED SUBSTANCES LISTED IN SCHEDULE II

1306.1 Except as otherwise authorized in this section, a controlled substance listed in Schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, shall only be dispensed pursuant to a valid written prescription signed by the prescribing practitioner, unless otherwise authorized by federal law.

1306.2 A prescription for a controlled substance listed in Schedule II shall not be filled if submitted more than thirty (30) days after the date on which the prescription is written; except as follows:

A pharmacist may fill a prescription for a controlled substance listed in Schedule II that was submitted to the pharmacy more than thirty (30) days after the date on which it was written, if it is clear on the face of the prescription that the individual practitioner issued multiple prescriptions authorizing the patient to receive a total of up to a ninety (90)-day supply of the Schedule II controlled substance and:

(i) Each separate prescription was issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice;

(ii) The individual practitioner provided written instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill each prescription; and

(iii) The prescription is presented to the pharmacy for filling not more than ninety (90) days after the date on which the prescription was written.

1306.3 A prescription for a controlled substance listed in Schedule II shall not be refilled and shall be cancelled out by a line drawn through the entire prescription order, with the date dispensed and initials of the person that dispensed the drug.

1306.4 A prescription for a Schedule II controlled substance may be transmitted by the practitioner or the practitioner's agent to a pharmacy via telephone facsimile equipment, provided that the original written, signed prescription is presented to the pharmacist for review prior to issuance of the controlled substance to the patient or the patient's representative. The original prescription shall be maintained in accordance with the requirements of this chapter and as required under federal and District law.

1306.5 In emergency situations, as defined under § 1306.6 of this chapter, a pharmacist may dispense Schedule II drugs upon the oral prescription of a practitioner. The pharmacist shall comply with the following requirements as set forth in 21 C.F.R. § 1306.11(d) and failure to do so may result in suspension or revocation of a pharmacy registration:

(a) The quantity prescribed and dispensed is limited to no more than a seven (7) day supply to treat the patient during the emergency period (dispensing beyond the emergency period shall be pursuant to a written prescription signed by the prescribing individual practitioner);

(b) The prescription shall be immediately reduced to writing by the pharmacist and shall contain all information required by District and federal law;

(c) If the prescribing practitioner is not known to the pharmacist, the pharmacist shall make a reasonable effort to determine that the oral authorization came from a registered practitioner, which may include a call back to the prescribing practitioner using the practitioner's phone number as listed in the telephone directory or other good faith efforts to insure the practitioner's identity; and

(d) Within seven (7) days after authorizing an emergency oral prescription, the practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of § 1301 of this chapter, the prescription shall:

(1) Have written on its face "Authorization for Emergency Dispensing," and the date of the oral order; and

(2) The written prescription shall be delivered to the pharmacist in person or by mail, but if delivered by mail, it must be postmarked within the seven (7) day period. Upon receipt, the dispensing pharmacist shall attach the written prescription to the oral emergency prescription which was previously reduced to writing. The pharmacist shall notify, in writing, the Director if the prescribing individual practitioner fails to deliver a written prescription to him or her. Failure of the pharmacist to notify the Director shall void the authority conferred by this section to dispense without a written prescription of a prescribing practitioner.

1306.6 As used in this section "emergency situation" means those situations in which the prescribing practitioner determines the following:

(a) That immediate administration of the controlled substance is necessary, for proper treatment of the intended ultimate user;

(b) That no appropriate alternative treatment is available, including administration of a drug which is not a controlled substance under Schedule II; and

(c) That it is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person dispensing the substance, prior to the dispensing.

1306.7 A prescription for a Schedule II controlled substance to be compounded for direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion may be transmitted by the practitioner or the practitioner's agent to the institutional or home health care pharmacy by telephone facsimile. The telephone facsimile shall serve as the original written prescription and shall be maintained in accordance with the requirements of this Title and federal and District law.

1306.8 A prescription for a Schedule II controlled substance for a resident of a Long Term Care Facility may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by telephone facsimile. The telephone facsimile shall serve as the original written prescription and shall be maintained in accordance with the requirements of this Title and federal and District law.

1306.9 A prescription for a Schedule II controlled substance for a patient enrolled in a hospice care program certified or paid for by Medicare under Title XVIII or a hospice program which is licensed by the District may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by telephone facsimile. The practitioner or the practitioner's agent shall note on the prescription that the patient is a hospice patient. The telephone facsimile shall serve as the original written prescription and shall be maintained in accordance with the requirement of this Title and federal and District law.

1306.10 An individual practitioner may administer or dispense directly to a patient a Schedule II controlled substance in the course of his or her professional practice without a prescription, subject to the conditions set forth in 21 C.F.R. § 1306.07.

1306.11 An institutional practitioner may administer or dispense directly, (but not prescribe) a controlled substance listed in Schedule II only pursuant to:

(a) A valid written prescription signed by the prescribing individual practitioner; or

(b) An order for medication made by an individual practitioner which is dispensed for immediate administration to the patient, subject to § 21 C.F.R. 1306.07.

History

SOURCE: Notice of Final Rulemaking published at 53 DCR 10055 (December 22, 2006); as amended by Final Rulemaking published at 57 DCR 1240 (February 5, 2010).

22-B DCMR § 1307 PARTIAL FILLING OF PRESCRIPTIONS LISTED IN SCHEDULE II

1307.1 The partial filling of a prescription for a controlled substance listed in Schedule II is permissable, if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription and he or she makes a notation of the quantity supplied on the face of the written prescription (or written record of the emergency oral prescription).

1307.2 The remaining portion of the prescription may be filled within seventy-two (72) hours of the partial filling; however, if the remaining portion is not or cannot be filled within the seventy-two (72) hour period, the pharmacist shall so notify the prescribing individual practitioner. No further quantity may be supplied beyond seventy-two (72) hours without a new prescription.

1307.3 A Prescription for Schedule II controlled substance for a patient in a Long Term Care Facility (LTCF) or for a patient with a medical diagnosis documenting a terminal illness may be filled in partial quantities to include individual dosage units and in accordance with federal law. If there is any question whether a patient may be classified as having a terminal illness, the pharmacist must contact the practitioner prior to partially filling the prescription. The pharmacist shall also observe the following:

(a) Both the pharmacist and the prescribing practitioner have a corresponding responsibility to assure that the controlled substance is for a terminally ill patient;

(b) The pharmacist must record on the prescription whether the patient is "terminally ill" or an "LTCF patient";

(c) A prescription that is partially filled and does not contain the notation "terminally ill" or "LTCF patient" shall be deemed to have been filled in violation of the federal and District law;

(d) For each partial filling, the dispensing pharmacist shall record on the back of the prescription (or on another appropriate record, uniformly maintained, and readily retrievable) the date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist;

(e) The total quantity of Schedule II controlled substances dispensed in all partial fillings must not exceed the total quantity prescribed; and

(f) Schedule II prescriptions for patients in a LTCF or patients with a medical diagnosis documenting a terminal illness shall be valid for a period not to exceed sixty (60) days from the issue date unless sooner terminated by the discontinuance of medication.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1067 (February 21, 1986); as amended by Final Rulemaking published at 53 DCR 10055 (December 22, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1307

22-B DCMR § 1308 LABELING OF SUBSTANCES LISTED IN SCHEDULE II

1308.1 The pharmacist filling a written or emergency oral prescription for a controlled substance listed in Schedule II shall affix to the package a label meeting the requirements set forth in § 1912.2 of this title.

1308.2 The label of a drug listed in Schedules II, III, IV, and V shall, when dispensed to or for a patient, contain a clear, concise warning that it is a crime to transfer the drug to any person other than the patient. When the size of the label space requires a reduction in type, the reduction shall be made to a size no smaller than necessary and in no event to a size smaller than necessary and in no event to a size smaller than six (6) point type.

1308.3 The requirements of § 1308.1 do not apply when a controlled substance listed in Schedule II is prescribed for administration to an ultimate user who is institutionalized, if the following limitations are observed:

(a) Not more than a seven (7) day supply of the controlled substance listed in Schedule II is dispensed at one time;

(b) The controlled substance listed in Schedule II is not listed in the possession of the ultimate user before the administration;

(c) The institution maintains appropriate safeguards and records regarding the proper administration, control dispensing, and storage of the controlled substance listed in Schedule II; and

(d) The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product, and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription or required by law.

1308.4 When dispensed to or for a patient, the label of a drug listed in Schedules II, III, IV, or V shall contain a clear and concise warning that it is a crime to transfer the drug to any person other than the patient.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1070 (February 21, 1986); as amended by Final Rulemaking published at 56 DCR 4742 (June 19, 2009). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1308

22-B DCMR § 1309 PRESCRIPTIONS FOR CONTROLLED SUBSTANCES LISTED IN SCHEDULES III, IV AND V

1309.1 Unless otherwise permitted under federal law, a pharmacist shall dispense directly a controlled substance listed in Schedule III, IV or V, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act only pursuant to:

(a) A valid written prescription signed by the prescribing practitioner;

(b) A telephone facsimile of a written prescription, signed by the prescribing practitioner, transmitted by the practitioner or the practitioner's designated agent to the pharmacy; or

(c) An oral prescription of a practitioner immediately reduced to writing by the pharmacist containing all information required under § 1302 of this chapter.

1309.2 An individual practitioner may administer or dispense directly to a patient a Schedule III, IV or V controlled substance in the course of his or her professional practice without a prescription, subject to the conditions set forth in 21 C.F.R. § 1306.07.

1309.3 An institutional practitioner may administer or dispense directly, but not prescribe, a controlled substance listed in Schedule III, IV, or V only pursuant to:

(a) A valid written prescription signed by an individual practitioner;

(b) A telephone facsimile of a written prescription or order for medication transmitted by the individual practitioner or the practitioner's designated agent to the institutional practitioner or pharmacist;

(c) An oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist containing all information required under § 1302 of this chapter; or

(d) An order for medication made by an individual practitioner which is dispensed for immediate administration to the patient, subject to § 21 C.F.R. 1306.07.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1067 (February 21, 1986); as amended by Final Rulemaking published at 53 DCR 10055 (December 22, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1309

22-B DCMR § 1310 REFILLING OF PRESCRIPTIONS LISTED IN SCHEDULES III, IV OR V

1310.1 A prescription for a controlled substance listed in Schedule III, IV, or V may not be filled or refilled more than six (6) months after the date on which the prescription was issued.

1310.2 A prescription authorized to be refilled may not be refilled more than five (5) times.

1310.3 Each refilling of a prescription shall be entered on the back of the prescription, or on another appropriate, uniformly maintained, readily retrievable record such as a patient profile. The following information must be retrievable by the prescription number:

(a) The name of the controlled substance, or the name and manufacturer of the drug if it is a substitute or generic drug for the drug actually prescribed or filled initially;

(b) The strength and dosage form of the controlled substance;

(d) The identity or initials of the dispensing pharmacist for each refill; and

(e) The total number of refills for that prescription.

1310.4 Each refilling of a prescription shall state the amount dispensed.

1310.5 If the pharmacist merely initials and dates the back of the prescription, he or she shall be deemed to have dispensed a refill for the full face amount of the prescription.

1310.6 The prescribing practitioner may authorize additional refills of a Schedule III, IV or V prescription controlled substance on the original prescription or through an oral refill authorization transmitted to the pharmacist provided that the following conditions are met:

(a) The total quantity authorized, including the amount of the original prescription, does not exceed five (5) refills or extend beyond six (6) months from the date of issue of the original prescription;

(b) The pharmacist obtaining the oral authorization shall record the date, quantity of refill, and number of additional refills authorized, on the reverse of the original prescription and initial the prescription documenting that he or she received the authorization from the prescribing practitioner who issued the original prescription; and

(c) The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial filling of the original prescription.

1310.7 Additional quantities of prescription controlled substances listed in Schedule III, IV or V, beyond the five (5) refill, six (6) month limitation, shall only be authorized by a prescribing practitioner through the issuance of a new and separate prescription.

1310.8 As an alternative to the procedures provided under § 1310.3 of this chapter, an automated data processing system may be used for the storage and retrieval of refill information for prescription drug orders for controlled substances in Schedule III, IV, or V, subject to the conditions outlined under 21 C.F.R. § 1306.22(b).

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1071 (February 21, 1986); as amended by Final Rulemaking published at 53 DCR 10055 (December 22, 2006); as amended by Final Rulemaking published at 56 DCR 4742 (June 19, 2009). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1310

22-B DCMR § 1311 PARTIAL FILLING OF PRESCRIPTIONS LISTED IN SCHEDULES III, IV OR V

1311.1 The partial filling of a prescription for a controlled substance listed in Schedules III, IV or V is permissible within six (6) months after date thereof provided that the following occurs:

(a) The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed; and

(b) Each partial filling is recorded in the same manner as a refilling.

1311.2 The remaining portion of a partially filled prescription may be filled within seventy-two (72) hours of the first partial filling; however, if the remaining portion is not or cannot be filled within the seventy-two (72) hour period, the pharmacist shall so notify the prescribing individual practitioner. No further quantity may be supplied beyond seventy-two (72) hours without a new prescription.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1067 (February 21, 1986). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1311

22-B DCMR § 1312 LABELING OF SUBSTANCES LISTED IN SCHEDULES III, IV OR V

1312.1 The pharmacist filling a prescription for a controlled dangerous substance listed in Schedule III, IV or V shall affix to the package a label meeting the requirements set forth in § 1912.2 of this title.

1312.2 The requirements of § 1312.1, do not apply when a controlled substance listed in Schedule III or IV is prescribed for administration to an ultimate user who is institutionalized; provided, that the following occurs:

(a) Not more than a thirty (30) day supply of one hundred (100) dosage units, whichever is less, of the controlled substance listed in Schedule II, IV or V is dispensed at one time;

(b) The controlled substance listed in Schedule III, IV or V is not in the possession of the ultimate user before administration;

(c) The institution maintains appropriate safeguards and records the proper administration, control, dispensing, and storage of the controlled substance listed in Schedule III, IV or V; and

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1071 (February 21, 1986); as amended by Final Rulemaking published at 56 DCR 4742 (June 19, 2009). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1312

22-B DCMR § 1313 FILING OF PRESCRIPTION ORDERS

1313.1 Prescription orders for controlled substances in Schedules I and II shall be maintained in a file separate from all other records of the pharmacy.

1313.2 Prescription orders for controlled substances in Schedules III, IV and V shall be maintained either in a separate prescription file or in such form that they are readily retrievable from the other prescription records of the pharmacy. They will be deemed readily retrievable if, at the time they are initially filed, the face of the prescription is marked in red ink in the lower right corner with the letter "C" no less than one-inch high and filed in the usual consecutively numbered prescription file for non-controlled substances.

1313.3 All prescription orders shall be in compliance with requirements under this section, the Act and 21 C.F.R. Part 1306, where applicable.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1067 (February 21, 1986). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1313

22-B DCMR § 1314 DISPENSING WITHOUT A PRESCRIPTION

1314.1 A controlled substance listed in Schedule II, III, IV or V which is not a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, may be dispensed by a pharmacist without a prescription to a purchaser at retail; provided, that the following occurs:

(a) The dispensing is made only by a pharmacist (as defined in 21 C.F.R. §1406.02(d)), and not by a non-pharmacist employee even if under the supervision of a pharmacist (although after the pharmacist has fulfilled his or her professional and legal responsibilities set forth in this section, the actual cash, credit transaction, or delivery, may be completed by a non-pharmacist);

(b) Not more than 240 cc. (8 ounces) of any controlled substance containing opium, nor more than 120 cc. (4 ounces) of any other controlled substance, nor more than forty-eight (48) dosage units of any controlled substance containing opium, nor more than twenty-four (24) dosage units of any other controlled substance may be dispensed at retail to the same purchaser in any given forty-eight (48) hour period; except pursuant to a written or oral prescription of a duly licensed practitioner in possession of a Federal Controlled Substances Registration number;

(d) The pharmacist requires every purchaser of a controlled substance under this section not known to him or her to furnish suitable identification (including proof of age where appropriate);

(e) A bound record book for dispensing of controlled substances under this section is maintained by the pharmacist, which book shall contain the name and address of the purchaser, the name and quantity of controlled substance purchased, the date of each purchase, and the name or initials of the pharmacist who dispensed the substance to the purchaser (the book shall be maintained in accordance with the record-keeping requirement of 21 C.F.R. § 1404.04); and

(f) A prescription is not required for distribution or dispensing of the substance pursuant to any other federal or District of Columbia laws or regulations, or this chapter.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1067 (February 21, 1986). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1314

22-B DCMR § 1315 DELIVERY OF PRESCRIPTION MEDICATION BY MAIL OR CARRIER

1315.1 This section shall apply to a pharmacy's delivery of filled prescriptions for individual patients by United States Postal Service, common carrier, employee or courier service to an address within the District of Columbia. Where a delivery is to an address outside of the District of Columbia, the pharmacy shall be governed by the laws of the state to which the prescription is being delivered.

1315.2 A licensed pharmacist shall supervise the dispensing of prescription drugs or devices by mail, common carrier, employee or courier service.

1315.3 The prescription shall contain all requirements specified for prescriptions as listed within this chapter and shall be packaged and sent in conformance with the applicable federal laws and regulations of the U.S. Department of Justice, Drug Enforcement Administration 21 C.F.R. §§ 1300 et seq., and the U.S. Postal Service 18 U.S.C. § 1716.

1315.4 A pharmacy may deliver the following by employee or courier, but shall not dispense the following by mail or common carrier:

(a) Antibiotics that have been reconstituted;

(b) Prescription drugs generally recognized to be subject to significant deterioration due to heat, cold, fermentation, or prolonged agitation unless it can be documented that the drug was shipped according to industry recognized shipping standards; or

1315.5 A Prescription drug or device shall be shipped by U.S. Postal Service, common carrier, employee, or courier service unless the purchaser agrees in advance to another means of delivery that does not violate the provisions of this chapter.

1315.6 Prescription drugs and medical devices dispensed by any method shall be packaged and sent in conformance with the applicable federal and District laws and regulations and standards pertaining to temperature, light, and humidity and in containers that are resistant to breaking, denting, and tampering.

1315.7 A prescription medication may be delivered to:

The patient for whom the prescription is prescribed;

Wherever the patient is located;

An agent authorized by the patient; or

The residence of the patient, regardless of whether the patient is present at the residence at the time of delivery.

1315.8 If a patient authorizes delivery of a prescription medication or device to an agent at a location other than the pharmacy or the patient’s residence, the pharmacy shall document in a readily retrievable record:

The patient’s authorization;

The identity of the agent to whom the medication is sent; and

The date, time; and location where the medication was sent.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1071 (February 21, 1986); as amended by Final Rulemaking published at 53 DCR 10055 (December 22, 2006); as amended by Final Rulemaking published at 56 DCR 4742 (June 19, 2009). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1315

22-B DCMR § 1316 TRANSFER BETWEEN PHARMACIES OF PRESCRIPTION INFORMATION FOR REFILL PURPOSES

1316.1 The transfer of original prescription information for a controlled substance listed in Schedules III, IV, or V for the purpose of refill dispensing is permissible, subject to the requirements of § 1316.3 of this chapter, between pharmacies on a one-time basis only. However, pharmacies utilizing a linked pharmacy system may transfer up to the maximum number of refills permitted by law.

1316.2 The transfer of original prescription information for a non-controlled substance for the purpose of refill dispensing is permissible subject to the requirements of § 1316.3 of this chapter.

1316.3 Any authorized transfer of original prescription information between non-linked pharmacy systems for the purpose of refill dispensing shall be subject to the following requirements:

(a) The transfer shall be communicated directly between two licensed Pharmacists;

(b) The transferring pharmacist shall record on the invalidated prescription, in hardcopy or electronically, the following information:

(1) The words "VOID" and "TRANSFER";

(2) The name, address, and telephone number of the pharmacy to which it was transferred;

(3) The name of the pharmacist receiving the prescription information;

(4) For controlled substances, the DEA registration number of the prescriber and of the pharmacy to which the prescription is being transferred and the District of Columbia Controlled Substances registration number, if applicable, of the prescriber and of the pharmacy to which the prescription is being transferred; and

(5) The date of the transfer and the name of the pharmacist transferring the information;

(1) Write the word "TRANSFER" on the face of the transferred prescription;

(2) All information required to be on a prescription pursuant to 21 C.F.R. § 1306.05 and this chapter;

(3) Date of issuance of original prescription;

(4) Original number of refills authorized on original prescription;

(5) Date of original dispensing;

(6) Number of valid refills remaining;

(7) The transferring pharmacy's name, address, and telephone number;

(8) Name of pharmacist who transferred the prescription; and

(9) For controlled substances, the DEA registration number of the prescriber and the pharmacy from which the prescription was transferred, and the District of Columbia Controlled Substances registration number, if applicable, of the prescriber and of the pharmacy from which the prescription information was transferred;

1316.4 Direct pharmacist to pharmacist communication is not required between pharmacies utilizing a linked pharmacy system to transfer prescription drug orders or information for dispensing purposes. However, the common electronic file shall contain a complete record of each prescription drug order and refill dispensed, and a hard copy record of each prescription drug order accessed for purposes of refilling shall be generated and maintained at the pharmacy refilling the prescription drug order.

1316.5 The original and transferred prescription(s) shall be maintained for a period of two (2) years from the date of initial filling in accordance with District of Columbia regulations.

1316.6 Pharmacies electronically accessing the same prescription record shall satisfy all information requirements as required of a manual prescription transferral.

1316.7 A pharmacist at the transferring pharmacy may not refill a prescription that has been transferred to another pharmacy.

1316.8 The use of unified prescription records by more than one pharmacy through a computerized prescription database does not constitute a permanent transfer of a prescription order.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1067 (February 21, 1986); as amended by Final Rulemaking published at 53 DCR 10055 (December 22, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1316

22-B DCMR § 1317 ADMINISTERING OR DISPENSING OF CONTROLLED SUBSTANCES

1317.1 The administering or dispensing directly (but not prescribing) of controlled substances listed in any schedule to a controlled substance dependent person for the purpose of detoxification or for continuing his or her dependence upon these drugs in the course of conducting an authorized clinical investigation in the development of a narcotic addict rehabilitation program shall be permissible; provided, that the following conditions are met:

(a) Approval is obtained before the initiation of this program by submission of a "Notice of Claimed Investigation Exemption for a New Drug" to the Food and Drug Administration [which will be reviewed concurrently by FDA for scientific merit and by the Pharmaceutical Control Division, for drug control requirements]; and

(b) That the clinical investigation thereafter accords with this approval, as required by the Federal Act and Federal regulations.

1317.2 Any practitioner who violates any of the provisions of the federal law or regulations shall be in violation of this chapter.

1317.3 Nothing in this chapter shall prohibit a physician who is not specifically registered to conduct a narcotic treatment program from administering (but not prescribing) controlled substances to a person for the purpose of relieving acute withdrawal symptoms when necessary while arrangements are being made for referral for treatment. Not more than one (1) day's medication may be administered to the person or issued for the person's use at one time. The emergency treatment may be carried out for not more than three (3) days and may not be renewed or extended.

1317.4 The rules of this chapter are not intended to impose any limitations on a physician or authorized hospital staff to administer or dispense controlled substances in a hospital to maintain or detoxify a person as an incidental adjunct to medical or surgical treatment of conditions other than addiction, or to administer or dispense controlled substances to persons with intractable pain in which no relief or cure is possible or none has been found after reasonable efforts.

History

SOURCE: Final Rulemaking published at 53 DCR 10055 (December 22, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1317

22-B DCMR § 1318 [RESERVED]

History

SOURCE: Final Rulemaking published at 53 DCR 10055 (December 22, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1318

22-B DCMR § 1319 [RESERVED]

History

SOURCE: Final Rulemaking published at 53 DCR 10055 (December 22, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1319

22-B DCMR § 1320 DISTRIBUTION BY A DISPENSER TO ANOTHER PRACTITIONER OR A REVERSE DISTRIBUTOR

1320.1 A practitioner who is authorized to dispense a controlled substance may distribute (without being registered to distribute) a quantity of the substance to:

(a) A reverse distributor who is registered to receive controlled substances under federal and District law; or

(b) Another practitioner for the purpose of general dispensing by the practitioner to his or her patients, provided that the following conditions are satisfied:

(1) The practitioner to whom the controlled substance is to be distributed is registered appropriately to dispense that controlled substance;

(2) The distribution is recorded by the distributing practitioner and by the receiving practitioner in accordance with 21 C.F.R. § 1304.22(c);

(3) If the substance is listed in Schedule I or II, an order form shall be used as required by 21 C.F.R. § 1305; and

(4) The total number of dosage units of all controlled substances distributed by the practitioner pursuant to this section, during the twelve (12) month period in which the practitioner is registered to dispense, does not exceed five percent (5%) of the total number of dosage units of all controlled substances distributed and dispensed by the practitioner during the twelve (12) month period.

1320.2 If at any time during the twelve (12) month period during which the practitioner is registered to dispense, the practitioner has reason to believe that the total number of dosage units of all controlled substances which will be distributed by him or her to another practitioner pursuant to this section will exceed five percent (5%) of the total number of dosage units of all controlled substances distributed and dispensed by him or her during the twelve (12) month period, the practitioner shall obtain a registration to distribute controlled substances.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1071 (February 21, 1986); as amended by Final Rulemaking published at 56 DCR 4742 (June 19, 2009). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1320

22-B DCMR § 1321 DISTRIBUTION TO SUPPLIER

1321.1 A person lawfully in possession of a controlled substance listed in any schedule may distribute (without being registered to distribute) that substance, to the person from whom he or she obtained it or to the manufacturer of the substance, or, if designated, to the manufacturer's registered agent for accepting returns, provided that a written record is maintained containing the following:

(a) The date of the transaction;

(b) The name, form, and quantity of the substance;

The name, address, and controlled substance registration number(s), if any, of the person making the distribution; and

The name, address, and controlled substance registration number(s), if known, of the supplier or manufacturer.

1321.2 An order form shall be used in the manner prescribed in 21 C.F.R. § 1305, and shall be maintained as the written record for a controlled substance listed in Schedule I or II which is returned. Any person not required to register pursuant to Sections 302(c) or 1007(b)(1) of the Federal Act 21 U.S.C. § 822(c) or 957(b)(1) shall be exempt from maintaining the records required by this section.

1321.3 Distributions referred to in this section may be made through a freight forwarding facility operated by the person to whom the controlled substance is being returned provided that prior arrangement has been made for the return and the person making the distribution delivers the controlled substance directly to an agent or employee of the person to whom the controlled substance is being returned.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1071 (February 21, 1986); as amended by Final Rulemaking published at 56 DCR 4742 (June 19, 2009). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1321

22-B DCMR § 1322 DISTRIBUTION UPON DISCONTINUANCE OR TRANSFER OF BUSINESS

1322.1 A registrant desiring to discontinue business activities altogether or with respect to controlled substances (without transferring such business activities to another person) shall:

Return for cancellation his or her District of Columbia certificate of registration to the Director;

Return for cancellation his or her federal registration certificate and any unexecuted order forms in his or her possession to the DEA; and

Dispose of any controlled substances in his or her possession in accordance with 21 C.F.R. § 1307.21.

1322.2 A registrant desiring to discontinue business activities altogether or with respect to controlled substances (by transferring those business activities to another person) shall submit in person or by registered or certified mail, return receipt requested, to the Director, at least fourteen (14) days before the date of the proposed transfer (unless the director waives this time limitation in individual instances) the following information:

The name, address, controlled substance registration number(s), and authorized business activity of the registrant discontinuing the business (registrant-transferor);

The name, address, controlled substance registration number(s), and authorized business activity of the person acquiring the business (registrant-transferee);

(c) Whether the business activities will be continued at the location registered by the person discontinuing the business, or moved to another location (if the latter, the address of the new location shall be listed); and

(d) The date on which the transfer of controlled substances will occur.

1322.3 Unless the registrant-transferor is informed by the Director, before the date on which the transfer was stated to occur, that the transfer shall not be permitted to occur, the registrant-transferor may distribute (without being registered to distribute) controlled substances in his or her possession to the registrant-transferee in accordance with the following:

(a) On the date of transfer of the controlled substances, a complete inventory of all controlled substances being transferred shall be taken in accordance with 21 C.F.R. § 1304.11. This inventory shall serve as the final inventory of the registrant-transferor and the initial inventory of the registrant-transferee, and a copy of the inventory shall be included in the records of each person. It shall not be necessary to file a copy of the inventory with the Director unless requested by the Director. Transfers of any substances listed in Schedule I or II shall require the use of order forms in accordance with 21 C.F.R. § 1305;

(b) On the date of transfer of the controlled substances, all records required to be kept by the registrant-transferor with reference to the controlled substances being transferred, under 21 C.F.R. § 1304, shall be transferred to the registrant-transferee. Responsibility for the accuracy of the records prior to the date of transfer shall remain with the transferor. Responsibility for the custody and maintenance of the records after the date of the transfer shall be upon the transferee; and

(c) In the case of registrants required to make reports pursuant to 21 C.F.R. § 1304, a report marked “Final” shall be prepared and submitted by the registrant-transferor showing the disposition of all the controlled substances for which a report is required; no additional report will be required from him or her, if no further transactions involving controlled substances are consummated by him or her. The initial report of the registrant-transferee shall account for transactions beginning with the day next succeeding the date of discontinuance or transfer of business by the transferor-registrant and the substances transferred to him or her shall be reported as recipients in his or her initial report.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1071 (February 21, 1986); as amended by Final Rulemaking published at 56 DCR 4742 (June 19, 2009). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1322

22-B DCMR § 1323 MANUFACTURE AND DISTRIBUTION OF CONTROLLED SUBSTANCE SOLUTIONS AND COMPOUNDS BY A PHARMACIST

1323.1 A pharmacist may manufacture (without being registered to manufacture) an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in a proportion that shall not exceed twenty (20%) of the complete solution, compound, or mixture.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1071 (February 21, 1986); as amended by Final Rulemaking published at 53 DCR 10055 (December 22, 2006); as amended by Final Rulemaking published at 56 DCR 4742 (June 19, 2009). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1323

22-B DCMR § 1324 PROCEDURE FOR DISPOSING OF LEGALLY OBTAINED CONTROLLED SUBSTANCES

1324.1 Any registrant in possession of legally obtained controlled substances and desiring or required to dispose of any of these substances shall contact Drug Enforcement Administration, Regional Office, for instructions and to request the necessary form (DEA-41).

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1077 (February 21, 1986). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1324

22-B DCMR § 1325 ISSUANCE OF NON-CONTROLLED SUBSTANCES

1325.1 A pharmacist shall dispense a non-controlled substance, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, or medical device pursuant to a valid written, oral, facsimile, or electronic prescription issued in compliance with this chapter by a licensed practitioner authorized to prescribe the substance or medical device.

1325.2 A prescription issued by a prescribing practitioner may be communicated to a pharmacist by an employee or agent of the individual practitioner only pursuant to the directions and order of the practitioner, and in conformance with applicable federal and District of Columbia laws and regulations and this chapter.

1325.3 A prescription order shall be issued or dispensed only for a legitimate medical purpose by a prescribing practitioner acting in the usual course of his or her professional practice.

1325.4 The prescribing practitioner and the pharmacist shall be jointly responsible for compliance with this chapter in prescribing and dispensing a prescribed substance or medical device.

1325.5 Any person issuing a prescription and any person knowingly filling a prescription which is not in conformity with this chapter shall be subject to the penalties provided for violations of the Act and this chapter.

1325.6 Non-controlled substance prescriptions shall have a label affixed to the package meeting the requirements as set forth in Chapter 19 of this title.

1325.7 The label required in § 1325.6 does not apply to a prescription for a non-controlled substance that is prescribed for administration to a patient who is institutionalized if the following limitations are observed:

(a) Not more than a thirty (30) day supply or one hundred (100) dosage units, whichever is less, of the prescription is dispensed at one time;

(b) The prescription controlled substance is not in the possession of the patient prior to administration;

(c) The institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing, and storage of the prescription substance; and

(d) The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product, and the patient, and sets forth the directions for use and cautionary statements, if any, contained in the prescription or required by law.

1325.8 A prescription for a non-controlled substance shall not be filled if presented for dispensing more than one (1) year after the date on which the prescription was issued.

1325.9 The total amount dispensed under one prescription order for a non-controlled substance, including refills, shall be limited to a one (1) year supply, not to exceed other applicable federal or District laws.

1325.10 Each refilling of a prescription shall be entered on the back of the prescription, or on another appropriate, uniformly maintained, readily retrievable record such as a medication record. The following information must be retrievable by the prescription number:

The name of the drug or the name and manufacturer of the substituted drug if different than the originally prescribed or filled drug;

(b) The dosage form of the drug dispensed;

(d) The identity or initials of the dispensing pharmacist for each refill; and

(e) The total number of refills for that prescription.

1325.11 If the pharmacist merely initials and dates the back of a prescription or in the electronic record, he or she shall be deemed to have dispensed a refill for the full face amount of the prescription.

1325.12 The prescribing practitioner may authorize additional refills of a non-controlled substance on the original prescription through an oral refill authorization transmitted to the pharmacist provided that the following conditions are met:

(a) The total quantity authorized, including the amount of the original prescription, does not extend beyond one year from the date of issuance of the original prescription;

(c) The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial filling of the original prescription.

1325.13 Additional quantities of prescription non-controlled substances beyond the one year limitation, shall only be authorized by a prescribing practitioner through the issuance of a new and separate prescription.

1325.14 As an alternative to the procedures provided under § 1325.10 of this chapter, an automated data processing system may be used for the storage and retrieval of refill information for prescription drug orders and prescription records.

1325.15 The partial filling of a prescription for a non-controlled substance is permissible, if the pharmacist is unable to supply the full quantity called for in the prescription, and he or she makes a notation of the quantity supplied on the face of the written or facsimile prescription (or written record of the oral prescription), provided that:

(a) Each partial filling is recorded in the same manner as a refilling;

(b) The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed; and

A pharmacist shall notify the prescribing physician if:

The pharmacist is unable to dispense the remaining portion of a partially filled prescription for a prescription non-controlled substance within a reasonable period of time;

The inability to do so lies with the pharmacy; and

In the professional judgment of the pharmacist the delay may jeopardize or alter the drug therapy of the patient.

History

SOURCE: Final Rulemaking published at 56 DCR 4742 (June 19, 2009). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1325

22-B DCMR § 1326 GENERIC SUBSTITUTION

1326.1 A pharmacist may dispense a generically equivalent drug product if:

The generic product costs the patient less than the prescribed drug product;

The patient does not refuse the substitution; and

The prescribing practitioner does not indicate on the written, facsimile, or electronic prescription form that the specific prescribed brand is to be dispensed by marking “DISPENSE AS WRITTEN,” “BRAND NECESSARY,” “NO SUBSTITUTION,” or other similar language.

1326.2 If a prescription is transmitted orally, the prescribing practitioner or the practitioner’s authorized agent shall prohibit substitution by specifying “BRAND NECESSARY,” “NO SUBSTITUTION,” or other similar language.

1326.3 The formulary of drug products for the District of Columbia shall be the chemical and generic drugs contained in the publication, “Approved Drug Products with Therapeutic Equivalence Evaluations (also known as the Orange Book)”, and its monthly updates. This drug formulary is incorporated by reference as a part of this chapter.

1326.4 A copy of the publication, “Approved Drug Products with Therapeutic Equivalence Evaluations,” may be obtained from the Superintendent of Documents, Government Printing Office of the United States, Washington, DC 20402. The electronic version may be accessed on line at http://www.fda.gov/cder/ob/default.htm This URL is subject to change.

History

SOURCE: Final Rulemaking published at 56 DCR 4742 (June 19, 2009). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1326

22-B DCMR § 1327 SUBSTITUTION OF DOSAGE FORMS

1327.1 A pharmacist may dispense a dosage form of a drug product different from that prescribed, such as a tablet instead of a capsule or liquid instead of tablets, provided that:

The pharmacist notifies the patient of the dosage form substitution prior to filling the prescription;

The pharmacist documents the substitution on the prescription record;

The pharmacist notifies the practitioner of the dosage form substitution prior to dispensing or as soon as is reasonably possible thereafter; and

The dosage form dispensed contains the identical amount of the active ingredients as the dosage prescribed for the patients, is not an enteric-coated or time release product; and does not alter desired clinical outcomes.

1327.2 The notification required in § 1327.1(c) shall not apply to those circumstances where the dosage form substitution is made in order to comply with the prescriber’s intent, (i.e., physician prescribed tablets but the medication only comes in capsules.)

1327.3 Substitution of dosage form shall not include the substitution of a product that has been compounded by the pharmacist unless the pharmacist contacts the practitioner prior to dispensing and obtains permission to dispense the compounded product.

History

SOURCE: Final Rulemaking published at 56 DCR 4742 (June 19, 2009). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1327

22-B DCMR § 1328 THERAPEUTIC INTERCHANGE

1328.1 This section shall not apply to generic drug substitutions. For generic drug substitutions, see the requirements of § 1326 of this chapter.

As used in this section, “therapeutic interchange” means the dispensing of chemically different drugs that are considered to be therapeutically equivalent.

1328.3 A therapeutic interchange shall not be made without the prior approval of the prescribing practitioner.

1328.4 The approval required pursuant to § 1328.3 may be in the form of a readily retrievable, written, documented policy maintained by the pharmacy which clearly indicates that the provider has intended to approve the therapeutic interchange.

1328.5 The patient shall be notified of the therapeutic interchange prior to, or upon delivery, of the dispensed prescription to the patient. The notification shall include:

A description of the change;

The reason for the change; and

Contact information indicating who the patient may contact with questions concerning the change.

History

SOURCE: Final Rulemaking published at 56 DCR 4742 (June 19, 2009). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1328

22-B DCMR § 1329 RETURN OF PRESCRIPTION DRUGS

1329.1 In the interest of the public health of the District of Columbia and the possible adverse effects which the resale of drugs may have upon the health of the public, it shall be unlawful for any licensed pharmacist to accept any unused prescription or drug, in whole or part, after it has been dispensed or sold, for the purpose of re-dispensing or resale to any person.

History

SOURCE: Final Rulemaking published at 56 DCR 4742 (June 19, 2009). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1329

22-B DCMR § 1330 [REPEALED]

History

SOURCE: Final Rulemaking published at 36 DCR 8154 (December 1, 1989); as amended by Final Rulemaking published at 53 DCR 10055 (December 22, 2006); as amended by Final Rulemaking published at 56 DCR 4742 (June 19, 2009). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1330

22-B DCMR § 1331 [REPEALED]

History

SOURCE: Final Rulemaking published at 42 DCR 5016 (September 1, 1995); as amended by Final Rulemaking published at 56 DCR 4742 (June 19, 2009). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1331

22-B DCMR § 1332 DRUG MANUFACTURERS AND DISTRIBUTORS FEES

1332.1 The licensure fees for drug manufacturers and distributors located within the District of Columbia are as follows:

(a) Annual fee $200.00*

(b) Late fee 100.00

(d) License validation 20.00

1332.2 The registration fees for drug manufacturers and distributors located outside the boundaries of the District of Columbia are as follows:

(a) Annual fee $100.00*

(b) Late fee 50.00

*These fees are mandated by the Omnibus Budget Support Act of 1994, § 501(b), effective June 14, 1994 (D.C. Law 10-128).

History

SOURCE: Final Rulemaking published at 42 DCR 5016, 5017 (September 1, 1995); as amended by Final Rulemaking published at 53 DCR 10055 (December 22, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1332

22-B DCMR § 1333 PRESCRIPTION REQUIREMENTS FOR MEDICAID COVERED SERVICES

1333.1 Effective April 1, 2008, a written prescription for any drug, including over-the-counter drugs, for a Medicaid fee for service beneficiary shall only be written on tamper resistant prescription pads meeting at least one of the following characteristics:

(a) The prescription pad contains one or more industry-recognized features designed to prevent unauthorized copying of a completed or blank prescription form;

(b) The prescription pad contains one or more industry-recognized features designed to prevent erasure or modification of information written on the prescription by the prescriber; or

(c) The prescription pad contains one or more industry-recognized features designed to prevent the use of counterfeit prescription forms.

1333.2 Beginning April 1, 2009, a written prescription for any drug, including over-the-counter drugs, for a Medicaid beneficiary shall only be written on tamper resistant prescription pads meeting all of the following characteristics:

(a) The prescription pad contains one or more industry-recognized features designed to prevent unauthorized copying of a completed or blank prescription form;

(b) The prescription pad contains one or more industry-recognized features designed to prevent erasure or modification of information written on the prescription by the prescriber; and

(c) The prescription pad contains one or more industry-recognized features designed to prevent the use of counterfeit prescription forms.

1333.3 The requirements of this section shall apply whether Medicaid is the primary or secondary payor of the prescription being filled.

1333.4 Prescription orders transmitted to a pharmacy via telephone, telephone facsimile, or electronic prescription order are exempt from the tamper resistant requirements set forth in §§ 1331.1 and 1333.2 of this chapter.

1333.5 The tamper resistant requirements in § 1333.1 of this chapter do not apply to refill prescriptions of an original written prescription that was presented to a pharmacy before April 1, 2008.

1333.6 The exceptions set forth under Section 1927(k)(3) of the Social Security Act (42 U.S.C. § 1396r-8(k)(3)) concerning nursing facilities, hospitals, and other institutional and clinical settings, shall also be an exception to the requirements of this section.

1333.7 In the event a prescription is not submitted on a tamper resistant prescription form meeting the requirements set forth in §§ 1331.1 and 1333.2, a pharmacy may fill the prescription in full as written on an emergency basis as long as the pharmacy receives a verbal, telephone facsimile, electronic, or compliant written prescription within seventy-two (72) hours after the date on which the prescription was filled.

1333.8 Effective April 1, 2008, the Medical Assistance Administration (MAA) shall only reimburse providers for covered Medicaid outpatient drugs when the written, non-electronic, prescription is executed on a tamper resistant pad meeting the requirements of this section.

History

SOURCE: Final Rulemaking published at 55 DCR 3284 (March 28, 2008). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1333

22-B DCMR § 1399 DEFINITIONS

1399.1 As used in this chapter, the following words and phrases shall have the meanings ascribed:

Act - District of Columbia Uniform Controlled Substances Act of 1981, effective August 5, 1981 (D.C. Law 4-29; D.C. Official Code § 48-901.01).

Administer - the direct application of a drug to the body of a patient or research subject by injection, inhalation, ingestion, or any other means.

Adulterated drug or medical device - as defined in § 501 of the Federal Food, Drug and Cosmetic Act, (Pub. L. 96-354, 21 U.S.C. § 351), as amended.

Automated data processing system - a system utilizing computer software and hardware for the purpose of recordkeeping.

Automated medication system - A robotic, computerized, or mechanical device and its components that distributes medications in a licensed health care facility, or prepares medications for final dispensing by a licensed pharmacist to a patient or a patient's agent, and maintains related transaction information.

Board - The District of Columbia Board of Pharmacy established by the District of Columbia Health Occupations Revision of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code § 3-1201.01.)

Centralized automated medication system - An automated medication system located in a pharmacy from which medication is distributed or prepared for final dispensing by a licensed pharmacist for a specific patient.

Common carrier - An organization that transports persons or goods according to defined routes and schedules and offers its services to the general public such as FedEx and UPS.

Community/Retail pharmacy - a pharmacy that provides services to the public or general community on an outpatient bases, whether at retail, through third party payment, or other measure of no or minimum cost to the consumer.

Compounding - the preparation or mixing, of a drug or device as the result of a practitioner's prescription drug order or for the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or dispensing. Compounding also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.

Computer generated facsimile - a computer to facsimile transmission sent by a computer that has a facsimile modem through which documents can be sent.

Controlled premises - (1) places where original or other records or documents required under the Act are kept or requested to be kept, and (2) places or establishments, where persons registered under the Act or exempted from registration under the Act may lawfully hold, manufacture, distribute, dispense, conduct research with, or otherwise dispose of controlled substances.

Controlled substances - those drug items or chemicals regulated under the Federal Controlled Substances Act of 1970, (Pub. L. 91-513, 21 U.S.C. §§ 801 et seq.), as amended; and the District of Columbia Uniform Controlled Substances Act of 1981, effective August 5, 1981 (D.C. Law 4-29, D.C. Official Code §§ 48-901 et seq.) as amended.

Courier - An individual or entity that is hired to take parcels directly from one place to another.

DEA - The United States Drug Enforcement Administration.

Decentralized automated medication system— An automated medication system that is located outside of the pharmacy in a health care facility with an on-site pharmacy and in which medication is stored in a manner that may be, but need not be, patient specific.

Department - The District of Columbia Department of Health.

Director - The Director of the District of Columbia Department of Health.

Dispense - the interpretation, evaluation, and implementation of a prescription drug order, including the preparation and delivery of a drug or medical device to a patient or patient's agent.

Dispensing pharmacist - A pharmacist who, in the process of dispensing a prescription medication after the complete preparation of the prescription medication and before delivery of the prescription medication to a patient or patient's agent, verifies, checks, and initials the medication record.

Distribute - the actual, constructive, or attempted transfer from one person to another, other than by administering or dispensing, of a drug or medical device whether or not there is an agency relationship.

Drug -

(a) Any substance recognized as a drug, medicine, or medicinal chemical in the official United States Pharmacopoeia, official National Formulary, official Homeopathic Pharmacopoeia, or official Veterinary Medicine Compendium or other official drug compendium or any supplement to any of them;

(b) Any substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animal;

(c) Any chemical substance (other than food) intended to affect the structure or any function of the body of man or other animal; and

(d) Any substance intended for use as a component of any items specified in subparagraph (a), (b), or (c) of this paragraph, but not including medical devices or their components, parts, or accessories.

Electronic - relating to technology having electrical, digital, magnetic, wireless, optical, electromagnetic, or similar capabilities.

Electronic prescription - a prescription drug order which is transmitted by an electronic device to the receiver (pharmacy), or which is transmitted computer to computer between a practitioner's office and a pharmacy, and which contains an electronic signature. An electronic prescription includes computer generated facsimile prescription drug orders but does not include telephone facsimile prescription drug orders.

Electronic record - a record created, generated, sent, communicated, received, or stored by electronic means.

Electronic signature - a confidential, unique, personalized electronic security code, key, number or other identifier attached to or logically associated with a record that is used for secure electronic data transmissions which identifies and authenticates the signatory and is executed or adopted by the signatory with the intent to sign the record.

Generically equivalent drugs - drugs that are:

(a) Pharmaceutical equivalents in that they contain identical amounts of the same active drug ingredients in the same dosage form and meet compendial or other applicable standards of identity strength, quality, and purity;

(b) Bioequivalents in that they do not present a known or potential bioequivalence problem or if they do present such a known or potential problem they are shown to meet an appropriate bioequivalence standard; and

(c) Adequately labeled and are manufactured under conditions which, at a minimum, comply with FDA Current Good Manufacturing Practice Regulations.

HIPAA - The Federal Health Insurance Portability and Accountability Act of 1996.

Individual Practitioner - an individual who is licensed or registered in the District of Columbia to prescribe a prescription drug or medical device in the course of his or her professional practice, including a physician, dentist, veterinarian, podiatrist, optometrist, or advanced practice nurse. It does not include a pharmacist, pharmacy, or an institutional practitioner.

Institutional practitioner - an intern, resident physician, fellow, or person in an equivalent professional position who:

(a) Is not yet licensed under District of Columbia law to administer, dispense, or prescribe controlled substances;

(b) Is enrolled in a bona fide professional training program in a base hospital or institutional training facility registered by the Federal Drug Enforcement Administration and District of Columbia; and

(c) Is authorized by the base hospital or institutional training facility to administer, dispense, or prescribe controlled substances.

Linked pharmacy system - pharmacies within the same retail name chain utilizing a Common electronic file or database to transfer prescription drug orders or information for dispensing purposes between or among pharmacies within the same retail chain which also participates in the same common prescription file.

Mayor - the Mayor of the District of Columbia or the Mayor's designated agent.

Medical device - an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is:

(a) Recognized in the official National Formulary, the official United States Pharmacopoeia, or any supplement thereto;

(b) Intended for use in the diagnosis of disease or any other condition, or in the cure, mitigation, treatment, or prevention disease in man or other animal; or

(c) Intended to affect the structure of any function of the body of man or other animal, and which does achieve any of its principal intended purposes through chemical action within or on the body of man or other animal, and which does not depend upon being metabolized for the achievement of any of its principal intended purposes.

Misbranded drug or medical device - as defined in Section 501 of the Federal Food, Drug and Cosmetic Act, (Pub. L. 96-354, 21 U.S.C. § 352), as amended.

Narcotic Drug - any of the following whether produced directly or indirectly by extraction from substances of vegetable origin or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis:

(a) Opium, opiates, derivatives of opium and opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers and salts is possible within the specific chemical designation. Such term does not include the isoquinoline alkaloids of opium;

(b) Poppy straw and concentrate of poppy straw;

(c) Coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine and derivatives of ecgonine or their salts have been removed;

(d) Cocaine, its salts, optical and geometric isomers, and salts of isomers;

(e) Ecgonine, its derivatives, their salts, isomers and salts of isomers; or

(f) Any compound, mixture, or preparation which contains any quantity of these substances.

Narcotic treatment program - a program engaged in maintenance or detoxification treatment with narcotic drugs.

Non-Prescription drug - A drug which may be sold without a prescription and which is labeled for use by the consumer in accordance with the requirements of the laws and rules of the District of Columbia and the federal government and includes both the classifications over-the-counter drugs and restricted drugs.

Original prescription - the original written prescription drug order; the original oral drug order that has been reduced to writing by the pharmacist; the original telephone facsimile prescription, or the original electronic prescription.

Over-the-counter drug - drugs which may be sold without a prescription and which are packaged for use by the consumer and labeled in accordance with the requirements of the laws and regulations of the District of Columbia and the federal government.

Patient - practitioner relationship - means that at a minimum the practitioner has met face to face with the patient, has obtained a patient history, and conducted a physical examination or evaluation adequate to establish a diagnosis, identify underlying conditions and contraindications to the treatment recommended.

Pharmacist - a person who is licensed in the District of Columbia to engage in the practice of pharmacy.

Pharmacy - any establishment or institution, or any part thereof, where the practice of pharmacy is conducted; drugs are compounded or dispensed, offered for sale, given away, or displayed for sale at retail; or prescriptions are compounded or dispensed.

Practice of pharmacy - the interpretation and evaluation of prescription orders; the compounding, dispensing, and labeling of drugs and devices, and the maintenance of proper records therefore; the responsibility of advising, where regulated or otherwise necessary, of therapeutic values and content, hazards, and use of drugs and devices; and the offering of performance of those acts, services, operations, and transactions necessary in the conduct, operation, management, and control of a pharmacy.

Prescriber - the practitioner who issues a prescription.

Prescription - any order for a drug, medicinal chemical, or combination or mixtures thereof, or for a medically prescribed medical device, in writing, dated and signed by an authorized health professional or given orally to a pharmacist by an authorized health professional or the person's authorized agent and immediately reduced to writing by the pharmacist or pharmacy intern, specifying the address of the person for whom the drug or device is ordered and directions for use to be placed on the label.

Prescription drug - any of the following:

(a) A drug which is required under federal law to be labeled with either of the following statements prior to being dispensed or delivered:

(1) "Caution: Federal law prohibits dispensing without prescription"; or

(2) "Caution: Federal law restricts this drug to use by, or on the other of, a licensed veterinarian.

(b) A drug which is required by any applicable federal, or District of Columbia law or regulation to be dispensed pursuant only to a prescription drug order or is restricted to use by practitioners only; or

Proprietor of a pharmacy - a person designated as proprietor in an application for a pharmacy license. The proprietor may be an individual a corporation, a partnership, or an unincorporated association, and shall at all times own a controlling interest in the pharmacy.

Provider pharmacy - the community pharmacy or the institutional pharmacy providing remote pharmacy services.

Registrant - a person who is registered under the District of Columbia Uniformed Controlled Substances Act of 1981, effective August 5, 1981 (D. C. Law 4-29; D.C. Official Code § 48-901.01).

Remote automated medication system - an automated medication system that is located in a health care facility that does not have an on-site pharmacy and in which medication is stored in a manner that may be, but need not be, patient specific.

Remote pharmacy services - the provision of pharmacy services, including the storage and dispensing of prescription drugs, in a facility that is not at the same location as the provider pharmacy.

Remote site - a facility not located at the same location as the pharmacy at which remote pharmacy services are provided using an automated medication dispensing system.

Restricted drug— A drug for which a prescription is not required that pursuant to District of Columbia or federal law or regulation must be stored behind the pharmacy counter and which shall not be directly accessible to the public.

Reverse distributor - a duly authorized party who receives drugs, including controlled substances, acquired from another duly authorized party for the purpose of:

(a) returning unwanted, unusable, or outdated controlled substances to the manufacturer or the manufacturer's agent; or

(b) where necessary, processing such substances or arranging for processing such substances for disposal.

Starter dose - a dose of medication removed from a remote or decentralized automated medication system within the first 24 hours after it is ordered.

Security procedure - a procedure employed for the purpose of verifying that an electronic signature, record, or performance is that of a specific person or for detecting changes or errors in the information in an electronic record. The term includes a procedure that requires the use of algorithms or other codes, identifying words or numbers, encryption, or callback or other acknowledgment procedures.

Telepharmacy system - a system that monitors the dispensing of prescription drugs and provides for related drug use review and patient counseling services by an electronic method which shall include the use of the following types of technology:

(a) audio and video;

(b) still image capture; and

Telephone Facsimile prescription - a prescription drug order which is transmitted by Telephone electronic device which sends an exact image to the receiver (pharmacy).

Therapeutic interchange - The dispensing of chemically different drugs that are considered to be therapeutically equivalent.

Therapeutically equivalent drugs - Drug products that are chemically dissimilar but produce essentially the same therapeutic outcome and have similar toxicity profiles. Usually these drugs are within the same pharmacologic class. They frequently differ in chemistry, mechanism of action, and pharmacokinetic properties, and may possess different adverse reaction, toxicity, and drug interaction profiles.

History

SOURCE: Final Rulemaking published at 53 DCR 10055 (December 22, 2006); as amended by Final Rulemaking published at 56 DCR 4742 (June 19, 2009). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1399

22-B15 INSPECTIONS

22-B DCMR § 1500 AUTHORITY TO MAKE INSPECTIONS

1500.1 In carrying out its functions under the Act, the Chief Pharmaceutical Control Officer and his or her designee, is authorized in accordance with §§302(f) and 505 of the Act to enter controlled premises and conduct administrative and non-administrative inspections thereof, for the purpose of doing the following:

(a) Inspecting, copying, and verifying the correctness of records, reports, or other documents required to be kept or made under the Act and this chapter including, but not limited to, inventory and other records required to be kept pursuant to this chapter, prescription and distribution records required to be kept pursuant to this chapter, shipping records identifying the name of each carrier used and the date and quantity of each shipment, and storage records identifying the name of each warehouse used and the date and quantity of each storage;

(b) Inspecting within reasonable limits and in a reasonable manner all pertinent equipment, finished and unfinished controlled substances and other substances or materials, containers, and labeling found at the controlled premises relating to the Act;

(d) Collecting samples of controlled substances or precursors (in the event any samples are collected during an inspection, the inspector shall issue a receipt for such samples to the owner, operator, or agent in charge of the premises);

(e) Checking records and information on distribution of controlled substances by the registrant as they relate to total distribution of the registrant (i.e., has the distribution in controlled substances increased markedly within the past year, and if so why); and

(f) Except as provided by the Act, all other things therein (including records, files, papers, processes, controls and facilities) appropriate for verification of the records, reports, documents referred to in this section or otherwise bearing on the provisions of the Act cited in this section and this chapter.

1500.2 If an administrative inspection warrant is required for inspection pursuant to §505 of the Act (D.C. Code, 2001 Ed. §48-905.05), the Chief shall be responsible for seeking the warrant.

1500.3 The Chief may, without a warrant, inspect books and records pursuant to an administrative subpoena issued in accordance with §507 of the Act (D.C. Code, 2001 Ed. §48-905.07) and in situations described in §505(a)(4) of the Act D.C. Code, 2001 Ed. §48-905.05(a)(4).

1500.4 An inspection authorized by this section shall not extend to financial data, sales data, other than shipment data, or pricing data unless the owner, operator, or agent in charge of the controlled premises consents in writing.

1500.5 Refusal by the registrant or owner, operator, agent or other person in charge of the controlled premises to allow an inspection shall constitute a basis for suspension or revocation of registration in the following circumstances:

(a) When inspection is authorized pursuant to an administrative inspection warrant issued pursuant to §505(b) of the Act (D.C. Code, 2001 Ed. §48-905.05(b)); and

(b) When inspection is authorized pursuant to this chapter and §505(a)(4)(B), (C), (D) or (E) of the Act (D.C. Code, 2001 Ed. §48-905.05(a)(4) (B), (C), (D) or (E)).

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is Title III of the District of Columbia Uniform Controlled Substances Act of 1981, D.C. Code, 2001 Ed. §§48-903.01 to 48-903.09; Mayor’s Order 85-171 (October 18, 1985).
SOURCE: Final Rulemaking published at 33 DCR 1046, 1077 (February 21, 1986).

22-B DCMR § 1501 INSPECTIONS

1501.1 An inspection shall be carried out by an inspector from the Department's Service Facility Regulation Administration, Pharmaceutical and Medical Devices Control Division or other employee authorized by the Act or the Director.

1501.2 The inspector prior to entry shall do the following:

(a) State the purpose of his or her inspection to the owner, operator, agent or other person in charge of the premises to be inspected; and

(b) Present appropriate credentials to the owner, operator, agent or other person in charge for making the inspection.

1501.3 Appropriate credentials for the making of the inspection shall include, but are not limited to, the following:

(a) Duly issued identification card, badge, etc., of the Department for the inspector;

(b) Notice of inspection issued by the Service Facility Regulation Administration, Pharmaceutical and Medical Devices Control Division containing the following:

(1) The name and title of the owner, operator, agent or other person in charge of the premises;

(2) The controlled premises name;

(3) The controlled premises address to be inspected;

(4) The date of the inspection;

(5) The findings from the inspection; and

(6) The signature of the inspector.

1501.4 Any person to whom a registration or exemption has been issued shall retain copies of Inspection Reports and Violation Notices issued by the Service Facility Regulation Administration, Pharmaceutical and Medical Devices Control Division or designees, and shall maintain the reports or notices on the registered premises in a manner so as to make them available upon request of the Director or inspector for a period of at least two (2) years.

1501.5 It shall be the duty of the Chief Pharmaceutical Control Officer or his or her designee to investigate a complaint of a violation of any provisions of the Act or this chapter.

1501.6 No person shall hinder, obstruct, or in any way interfere with the Chief Pharmaceutical Control Officer or his or her designee in the performance of official duty in carrying out the provisions of the Act or this chapter or any other applicable law or regulations.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1079 (February 21, 1986).

22-B DCMR § 1502 RECORDS AND REPORTS

1502.1 Every registrant shall keep records, maintain inventories and file reports in conformance with the requirements of federal law including the requirements prescribed under 21 C.F.R. Part 1304.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1080 (February 21, 1986).

22-B DCMR § 1503 ACCOUNTABILITY AUDITS

1503.1 Accountability audits in pharmacies shall be accomplished through a review of invoices, prescription file, other records required by federal and District of Columbia laws and regulations, and this chapter.

1503.2 Accountability audits of medical, dental, and veterinary practitioners shall be accomplished through a review of records required to be kept by federal and District of Columbia laws and regulations, and this chapter.

1503.3 Accountability audits of manufacturers and distributors (including wholesalers) shall be accomplished through a review of invoices received and distributed and other records required by federal and District of Columbia laws and regulations, and this chapter.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1080 (February 21, 1986).

22-B DCMR § 1504 ORDER FORMS

1504.1 Controlled Substances in Schedule I or II shall be distributed by a registrant to another registrant only pursuant to an order form. Compliance with the provisions of federal law and regulations respecting order forms shall be deemed compliance with this chapter.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1080 (February 21, 1986).

22-B DCMR § 1505 RETENTION OF RECORDS

1505.1 All records required by this chapter shall be retained for a period of at least two (2) years.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1081 (February 21, 1986).

22-B DCMR § 1599 DEFINITIONS

1599.1 The provisions of §1099 of Chapter 10 of this subtitle and the definitions set forth in that section shall apply to this chapter.

History

SOURCE: Final Rulemaking published at 33 DCR 1046, 1081 (February 21, 1986).

22-B16 PROVISION OF RESPITE CARE FOR MENTALLY RETARDED PERSONS

22-B DCMR § 1600 GENERAL PROVISIONS

1600.1 Respite care shall provide support services to mentally retarded persons in order to give a primary caregiver temporary overnight relief from the daily responsibilities of caring for each mentally retarded individual who lives in his or her home.

1600.2 Respite care shall be offered to do the following:

(a) To restore or maintain the primary caregivers’ physical and emotional well being;

(b) To prevent commitment of mentally retarded individuals;

(d) To assist primary caregivers in times of emergency.

1600.3 Periods of respite care may be as brief as an overnight stay, several days, or several weeks subject to the limitations in § 1600.4.

1600.4 No mentally retarded person shall receive more than forty-two (42) days of respite in any twelve (12) month period unless it is determined that more than forty-two (42) days is required, and specific authorization by the Court after a hearing is obtained as set forth in D.C. Code, 2001 Ed. §§ 7-1304.01 to 7-1304.13.

1600.5 Emergency respite services shall be short term; authorized for no more than seven (7) successive days.

1600.6 Emergency respite care shall be terminated after the seven (7) days with appropriate planning for longer periods of respite, or when permanent residential planning is finalized.

1600.7 Respite care shall be provided in any of the following types of facilities:

(a) A licensed group home for mentally retarded persons;

(b) A licensed or approved specialized foster home;

(d) A certified intermediate care facility for the mentally retarded;

(e) A licensed nursing home; or

(f) A licensed hospital.

1600.8 Respite care shall be provided by the Department of Human Services and coordinated by the Mental Retardation/Developmental Disabilities Administration (MR/DDA), hereafter referred to as the Administration.

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is the Mentally Retarded Citizens Constitutional Rights and Dignity Act of 1978 § 314, D.C. Code, 2001 Ed. §7-1303.14; and Mayor’s Reorganization Plan No. 2 of 1979, 3 D.C. Code, 2001 Ed. at 338.
SOURCE: Final Rulemaking published at 34 DCR 3319 (May 22, 1987).

22-B DCMR § 1601 APPLICATION PROCESS

1601.1 Respite care shall be requested at least thirty (30) days in advance of any anticipated need for respite care services.

1601.2 A primary caregiver of a mentally retarded person who is a citizen of the District of Columbia may make application for respite services.

1601.3 Each applicant seeking respite care shall make application on forms obtained from the Administration and shall provide any additional information requested including, but not limited to, the following:

(a) Eligibility;

(b) Appropriateness or need for respite care;

(d) Length of stay.

History

SOURCE: Final Rulemaking published at 34 DCR 3319, 3321 (May 22, 1987).

22-B DCMR § 1602 NOTIFICATION TO APPLICANT

1602.1 The Administration shall give each applicant oral and written notice of its determination under § 1601.3, within fifteen (15) days of receipt of the completed application, including any additional information requested.

1602.2 If the applicant’s request for respite care is approved, the oral and written notice to him or her shall state the following:

(a) The date scheduled for the provision of respite care services;

(b) The name, address and telephone number of the facility that shall provide the services;

(d) The amount of fee to be paid.

1602.3 If the applicant’s request for respite care is denied, the oral and written notification to the applicant shall explain the basis for the denial or refer the applicant to an appropriate agency or resource for alternate services.

History

SOURCE: Final Rulemaking published at 34 DCR 3319, 3321 (May 22, 1987).

22-B DCMR § 1603 PLACEMENT PROCESS

1603.1 The Administration shall make referrals to appropriate facilities in order to identify a facility that will accept the mentally retarded person who is in need of respite care services.

1603.2 Prior to the placement of the mentally retarded person into a respite care arrangement, the Administration staff shall meet with the mentally retarded person, his or her primary caregiver, and the proposed provider of the respite care in order to do the following:

(a) To make final arrangements for the placement; and

(b) To make the arrangements for the return of the mentally retarded person to his or her home.

1603.3 Placement of mentally retarded persons in respite care shall be made in the least restrictive environment.

1603.4 Each provider of respite care shall be required to sign a contractual agreement established by the Administration which specifies the services to be rendered.

History

SOURCE: Final Rulemaking published at 34 DCR 3319, 3322 (May 22, 1987).

22-B DCMR § 1604 EMERGENCY RESPITE

1604.1 When the primary caregiver believes that an emergency exists which jeopardizes the residential placement temporarily, they may request emergency respite care.

1604.2 The Administration shall assess each request for emergency respite and make a determination as to whether an emergency exists.

1604.3 If no emergency exists, the applicant will be referred to the appropriate agency or resource.

1604.4 When it is determined that an emergency exists, the Administration shall take whatever action is necessary commensurate with the nature of the emergency.

1604.5 In the event that the nature of the emergency warrants the immediate relocation of the mentally retarded person for purposes of respite, the Administration shall identify an appropriate respite facility and make arrangements to effect the emergency respite placement of the mentally retarded person.

1604.6 The Administration shall require, to the extent possible, the same information included in § 1601.3 for making informed decisions.

History

SOURCE: Final Rulemaking published at 34 DCR 3319, 3322 (May 22, 1987).

22-B DCMR § 1699 DEFINITIONS

1699.1 For the purpose of this chapter, the following definitions shall apply unless otherwise provided:

Applicant - a parent, guardian or family member for the mentally retarded person.

Community Residence Facility - a facility that provides a sheltered living environment for individuals aged eighteen (18) or older (except that, in the case of group homes for mentally retarded persons, no minimum age shall apply) who desire or need such an environment because of their physical, mental, familial, social, or other circumstances, and who are not in the custody of the Department of Corrections of the District of Columbia.

Emergency - an unforseen circumstance that includes, but is not limited to:

(a) A temporary lack of supervision for the mentally retarded person due to the illness or hospitalization of the primary caregiver; or

(b) A temporary loss of the mentally retarded person’s home as a result of fire or other emergency.

Group Home for Mentally Retarded Persons - a community residence facility that provides a home-like environment for at least four (4) but no more than eight (8) related or unrelated mentally retarded individuals who require specialized living arrangements, and maintains the necessary staff, programs, support services, and equipment for their care and habilitation.

Hospital - a facility that provides twenty-four (24) hour inpatient care including diagnostic, therapeutic, and other health related services, for a variety of physical or mental conditions, and may in addition provide outpatient services, particularly emergency care.

Intermediate Care Facility for the Mentally Retarded - a protective residential setting with on-going evaluation and planning, twenty-four (24) hour supervision, coordination, and integration of health and rehabilitation services by a team of professionals under the supervision of Qualified Mental Retardation Professional (QMRP) to help each resident to function at an optimal level; the facility or home will be certified for participation in the Federal Medicaid Program.

Least Restrictive Environment - a living arrangement which least inhibits an individual’s independence and right to liberty.

Mentally Retarded - a significantly sub-average general intellectual level determined in accordance with standard measurements as recorded in the Manual of Terminology and Classification in Mental Retardation, 1973, American Association on Mental Deficiency, existing concurrently with impairment in adaptive behavior, which originates during the development period.

Nursing Home - a twenty-four (24) hour inpatient facility, or distinct part-thereof, primarily engaged in providing professional nursing services, health-related services, and other supportive service needed by the patient resident.

Primary Caregiver - parents, guardian, family member or specialized foster parents who customarily care for the mentally retarded person.

Provider - a public or private agency which provides respite care services under a contractual agreement with the Administration.

Respite Care - temporary overnight care provided to a mentally retarded person in a hospital or facility, upon application of a primary caregiver, for the temporary relief of the parent, guardian or family member, who normally provides for the care of the person.

Specialized Foster Home - a structured living environment combined with the companionship, guidance, support and the personal attention of a family setting for mentally retarded persons.

History

SOURCE: Final Rulemaking published at 34 DCR 3319, 3323 (May 22, 1987).

22-B18 PRESCRIPTION DRUG MARKETING COSTS

22-B DCMR § 1800 MANNER OF REPORTING AND FILING FEE

1800.1 Beginning July 1, 2007, each manufacturer or labeler of prescription drugs, directly or indirectly distributed for dispensation in the District, that employs, directs or utilizes marketing representatives in the District shall file the annual report required by section 302 of the Act ("annual report") in the form and manner provided by the Director.

1800.2 The annual report shall be filed with the Department by July 1st of each year and shall contain, for the previous calendar year, all of the information required by the Act and be accompanied by payment of the required filing fee.

1800.3 Manufacturers and labelers shall use the date of the activity to assign a reporting period and where the activity spans between more than one reporting period the cost shall be prorated by each applicable reporting period.

1800.4 Manufacturer and labeler grant amounts shall be reported for the period in which the money is provided and are not required to be allocated over the life of the grant.

1800.5 For purposes of the annual report due July 1, 2007 only, manufacturers and labelers shall report the required information by quarters. If any or all of the data for the first three quarters of 2006 is not available, then the manufacturers and labelers may substitute an explanation of why the data is not available for the data itself.

1800.6 In conjunction with filing the required annual report, each manufacturer or labeler shall pay to the Department the required filing fee of five thousand ($5,000), by mailing a check, made out to "D.C. Treasurer," to District of Columbia Department of Health, Chief Financial Officer, 825 North Capitol Street, N.E., Room 5100,Washington, D.C. 20002.

1800.7 The Department may reduce the amount of the filing fee through rulemaking if the Department finds that its administrative costs are less than anticipated.

History

SOURCE: Notice of Final Rulemaking published at 54 DCR 5287 (May 25, 2007); as amended by Fiscal Year 2011 Budget Support Act of 2010, effective September 24, 2010 (D.C. Law 18-223), published at 57 DCR 6242, 6361 (July 23, 2010).

22-B DCMR § 1801 CONTENT OF ANNUAL REPORT

1801.1 The annual report shall include the following information as it pertains to prescription drug marketing costs and activities expended by the manufacturer or labeler in the District in a form that provides the value, nature, purpose, and recipient of the expense:

(a) All expenses associated with advertising, marketing, and direct promotion of prescription drugs through radio, television, magazines, newspapers, direct mail, and telephone communications as they pertain to District residents;

(b) With regard to all persons and entities licensed to provide health care in the District, including health care professionals and persons employed by them in the District, carriers licensed under Title 31 of the D.C. Official Code (Insurance and Securities), health plans and benefits managers, pharmacies, hospitals, nursing facilities, clinics, and other entities licensed to provide health care in the District, the following information:

(1) All expenses associated with educational or informational programs, materials, and seminars, and remuneration for promoting or participating in educational or informational sessions, regardless of whether the manufacturer or labeler provides the educational or informational sessions or materials. This includes but is not limited to:

(i) Support for independent or continuing medical education programs (IME or CME) to the extent of participation by such persons and entities, including payments to medical education companies;

(ii) Printing costs of patient education materials and disease management materials distributed to such persons and entities. Design and other production costs also must be reported for materials designed specifically for District users;

(iii) Payment of consulting fees and expenses directly or indirectly to such persons and entities, subject to exceptions in § 1801.2 of this chapter;

(iv) Payments made directly or indirectly to such persons and entities for participation in speakers' bureaus and honoraria or other payments for time while speaking at or attending meetings, lectures or conferences;

(v) Payments made directly or indirectly to such persons or entities for writing articles or publications;

(vi) Charitable grants, either directly or earmarked, to such persons and entities, even if unrestricted; and

(vii) Payments made directly or indirectly to such persons or entities in connection with market research surveys or other activities undertaken in support of developing advertising and/or marketing strategies.

(2) All expenses associated with food, entertainment, gifts valued at more than $25, and anything provided to a health care professional for less than market value;

(3) All expenses associated with trips and travel; and

(4) All expenses associated with product samples, except for samples that will be distributed free of charge to patients; and

(c) The aggregate cost of, including all forms of payment to, all employees or contractors of the manufacturer or labeler who directly or indirectly engage in the advertising or promotional activities listed in paragraphs (a) and (b), limited to that portion of payment to the employees or contractors that pertains to activities within the District or to recipients of the advertising or promotional activities who are residents of or are employed in the District.

1801.2 The following expenses are not subject to the reporting requirements of this chapter:

(a) Marketing expenses of twenty-five dollars ($25) or less per day and per health care provider or entity;

(b) Reasonable compensation and reimbursement for expenses in connection with a bona fide clinical trial of a new vaccine, therapy, treatment, or indication;

(c) Scholarships and reimbursement of expenses for attending a significant educational, scientific or policy-making conference or seminar of a national, regional, or specialty medical or other professional association if the recipient of the scholarship is chosen by the association sponsoring the conference or seminar; and

(d) Expenses associated with advertising and promotional activities purchased for a regional or national market that includes advertising in the District if the portion of the costs pertaining to or directed at the District or cannot be reasonably allocated, distinguished, determined or otherwise separated out.

Beginning with the July 2012 filing, for the 2011 reporting period, payments made to health care practitioners for participation in market research shall not be subject to the reporting requirements of the Act and this chapter if the following conditions are met:

(a) The market research is conducted by an independent survey research organization;

(b) The pharmaceutical client does not know the identity of the practitioners who participate in the research; and

1801.4 All costs reported in the annual report must be determined using Generally Accepted Accounting Principles (GAAP).

Each manufacturer or labeler subject to the provisions of the Act shall, as part of its annual report:

Report the name and contact information of the individual responsible for the company’s compliance with the provisions of this chapter, and accuracy of the annual report;

(b) Identify by name and position title the individual submitting the report; and

(c) Submit separately in conjunction with the filing of the report under § 1802.1, a wet signature certification that states that “under penalty of law the information contained in the report is to the best of my knowledge after due diligence to inquire about the truthfulness and accuracy of the report, accurate” and an acknowledgment that providing false information or omitting required information on the report is unlawful.

1801.6 The individual identified in § 1801.5(a) of this chapter shall be a member of senior management or senior level company official within the manufacturer’s or labeler’s company or corporate structure.

History

SOURCE: Notice of Final Rulemaking published at 54 DCR 5287 (May 25, 2007); as amended by Notice of Final Rulemaking published at 59 DCR 535 (January 27, 2012).

22-B DCMR § 1802 SUBMISSION OF ANNUAL REPORT

1802.1 Each manufacturer or labeler subject to reporting under the Act, shall submit the required annual report to the Department in an electronic format that is satisfactory to the Director.

1802.2 For each gift which was provided during the reporting period, that meets the requirements for mandated reporting, the manufacturer or labeler shall provide the following information:

(a) Name of manufacturer or labeler;

(b) Date of payment or gift;

(d) Type of recipient (e.g., clinic, doctor, hospital, pharmacist, university, other prescriber, benefits manager, health plan, nursing facility, psychiatric hospital, other healthcare provider);

(e) Credentials of recipient, if applicable (e.g., APRN, DDS, MD, DO, DPM, DVM);

(f) Nature of payment (e.g., book, cash or check, donation, food, grant, lodging, transportation, samples);

(g) Primary purpose of payment (e.g., consulting, professional education, charitable grant, speaker fee or payment); and

(h) Monetary value of payment.

1802.3 For each advertising, marketing, or direct promotion activity which occurred during the reporting period, that meets the requirements for mandated reporting, the manufacturer or labeler shall provide the following information:

(a) Name of manufacturer or labeler;

(b) Date(s) of activity;

(c) Type of activity (e.g., advertising, marketing, direct promotion, market research survey, patient education including materials such as disease management information; materials/consulting to promote new uses of drugs);

(d) Medium (e.g., radio, television, magazines, newspapers, direct mail, telephone);

(e) Name of medium, if applicable (e.g., television or radio station, newspaper, magazine);

(f) Product marketed (e.g., name of drug, general brand/company awareness);

(g) Target audience (e.g., general public, prescribers); and

(h) Cost of activity.

1802.4 For all employees and/or contractors of the manufacturer or labelers that that meets the requirements for mandated reporting, the manufacturer or labeler shall provide the aggregate costs, including all forms of payment, for these services as determined using GAAP.

History

SOURCE: Notice of Final Rulemaking published at 54 DCR 5287 (May 25, 2007).

22-B DCMR § 1803 CONFIDENTIALITY AND PUBLIC INFORMATION

1803.1 Notwithstanding any provision of law to the contrary, information submitted to the Department pursuant to this title shall be confidential and not a public record.

1803.2 A manufacturer or labeler subject to reporting under the Act, as part of its annual report, may identify any information that it claims is a trade secret and if so identified, shall certify in writing the reasons for its claim that the information is a trade secret.

1803.3 Data compiled in aggregate form by the Department for purposes of the reporting required by the Act is a public record as long as it does not reveal trade information that is protected by District, state, or federal law.

1803.4 The Director shall designate a person to review the reports required in § 1805 of this chapter before publication of the reports to ensure against disclosure of a trade secret of any manufacturer or labeler that has filed a report in compliance with the Act and this chapter. As part of such determination, such person may contact the manufacturer or labeler.

History

SOURCE: Notice of Final Rulemaking published at 54 DCR 5287 (May 25, 2007).

22-B DCMR § 1804 ENFORCEMENT AND FINE

1804.1 These rules may be enforced in a civil action brought by the Office of the Attorney General for the District of Columbia.

1804.2 Failure to timely file a complete annual report in accordance with the Act and the provisions of this chapter constitutes a civil violation.

1804.3 Each submission of false information or omission of required information on the annual report shall constitute a separate civil violation.

1804.4 A fine of one thousand dollars ($1,000), plus costs and attorney's fees, may be adjudged for each civil violation.

1804.5 When a manufacturer or labeler fails to timely file a complete annual report in accordance with the Act and provisions of this chapter, the District's costs for enforcement shall include all costs expended by the Director and/or the Attorney General during the course of the investigation of noncompliance, subsequent enforcement and resolution of the enforcement action, including staff time, equipment use, hearing records, expert assistance, and such other items as the Department determines to be a cost of the action which shall be calculated at the higher of the actual costs or $1000 per day for each day that the complete and accurate report was due but not filed.

History

SOURCE: Notice of Final Rulemaking published at 54 DCR 5287 (May 25, 2007).

22-B DCMR § 1805 DEPARTMENT REPORTS

1805.1 Beginning November 30, 2007, the Department shall provide an annual report, providing information in aggregate form, on prescription drug marketing expenses, to the Council and the Attorney General by November 30th of each year.

1805.2 Beginning January 1, 2008, and every two (2) years thereafter, the Department shall provide a report to the Council and the Attorney General, providing information in aggregate form, containing an analysis of the data submitted to the Department, including the scope of prescription drug marketing activities and expenses and their effect on cost, utilization, and delivery of health care services, and any recommendations with regard to marketing activities of prescription drug manufacturers and labelers.

History

SOURCE: Notice of Final Rulemaking published at 54 DCR 5287 (May 25, 2007).

22-B DCMR § 1899 DEFINITIONS

1899.1 As used in this Chapter the following terms shall have the meanings ascribed:

Act - AccessRx Act of 2004, effective May 18, 2004 (D.C. Law 15-164; D.C. Official Code § 48-831.01 et seq.)

Affiliate - any individuals, partnerships, corporations, joint ventures, companies, firms, contractors or other legal entities, if directly or indirectly, either one owns, controls or can control the other, or a third party owns, controls or can control both.

Council - Council of the District of Columbia

Department - Department of Health

Director - Director of the Department

Attorney General - Attorney General for the District of Columbia, formerly known as the Corporation Counsel.

GAAP - Generally Accepted Accounting Principles. A widely accepted set of rules, conventions, standards, and procedures for reporting financial information.

Independent survey research organization- a survey research organization, marketing research organization, or similar entity that is not owned or affiliated, directly or indirectly, with a pharmaceutical company, manufacturer, or labeler, and which does not share employees or independent contractors with a pharmaceutical company, manufacturer, or labeler.

Labeler - An entity or person that receives prescription drugs from a manufacturer or wholesaler and repackages those drugs for later retail sale and that has a labeler code from the federal Food and Drug Administration under 21 C.F.R. § 207.20.

Manufacturer - a manufacturer of prescription drugs and includes subsidiary or affiliate of a manufacturer.

Marketing Representative - an individual who is employed by or is under contract to represent a manufacturer or labeler and engages in the marketing of prescription drugs in the District to any person or entity licensed to provide health care in the District.

Trade secret - information, including a formula, pattern, compilation, program, device, method, technique, or process, that:

(A) Derives actual or potential independent economic value, from not being generally known to, and not being readily ascertainable by, proper means by another who can obtain economic value from its disclosure or use; and

(B) Is the subject of reasonable efforts to maintain its secrecy.

Wet signature - means a physically generated signature of a person that can be compared to other physically generated signatures of the person for verification of authenticity.

History

SOURCE: Notice of Final Rulemaking published at 54 DCR 5287 (May 25, 2007); as amended by Notice of Final Rulemaking published at 59 DCR 535, 536 (January 27, 2012).

22-B19 PHARMACIES

22-B DCMR § 1900 GENERAL PROVISIONS

1900.1 It shall be unlawful for any person to operate, maintain, open, or establish a pharmacy within the District of Columbia without a valid license or registration from the Mayor.

1900.2 It shall be unlawful for an establishment or institution, or any part thereof, that does not provide services of the practice of pharmacy, as defined within, to use or have upon it, or displayed within it, or affixed to, or used in connection with it, a sign bearing the word or words "pharmacy," or "apothecary," "drug store," "druggist," or any word or words of similar or like import which would tend to indicate that the practice of pharmacy is being conducted in the establishment or institution.

1900.3 No drugs shall be permitted within a pharmacy until a license is obtained from the Director.

1900.4 A pharmacy shall maintain written policies and procedures regarding appropriate cleanliness and hygiene practices and ensure that its employees comply with the established policies and procedures.

1900.5 A pharmacy shall:

(a) Review its written policies and procedures, as necessary but at least biennially,

(b) Revise them as necessary, and

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980 § 19(a)(3), D.C. Code, 2001 Ed. § 47-2885.18(a)(3), as amended by the District of Columbia Health Occupations Revisions Act of 1985, D.C. Code, 2001 Ed. §§ 3-1201.01 to 3-1213.01.
SOURCE: Final Rulemaking published at 38 DCR 6734 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008).

22-B DCMR § 1901 GENERAL OPERATING STANDARDS

1901.1 A pharmacy shall be operated only by pharmacist holding a valid license in the District of Columbia to practice pharmacy or, if a non-resident pharmacy, a valid license in the state in which the pharmacy is physically located.

1901.2 A licensed pharmacist shall be on duty at all times that a pharmacy is open for business. Where only one pharmacist is on duty, the pharmacy shall be closed for business during the pharmacist's meal period and breaks.

1901.3 The following items shall be posted conspicuously in the vicinity of the pharmacy practice area:

(a) Certificate of Occupancy Permit (where applicable);

(b) Pharmacy license;

(d) Professional licenses of pharmacists on duty;

(e) Certificates of registration of pharmacy interns; and

(f) The hours that the pharmacy is open for business.

1901.4 A pharmacy shall stock, maintain, sell, compound, dispense, and distribute only FDA registered drugs, medical devices, and chemicals for compounding.

1901.5 A pharmacy shall sell, dispense, or otherwise distribute only drugs and medical devices that are safe for their intended purposes, and that are neither misbranded nor adulterated.

1901.6 Drugs and medical devices with expired dating, or that are otherwise misbranded or adulterated, shall not be stored with currently dated products or those that are safe for their intended purposes, but shall be separated from active stock and so identified.

1901.7 A pharmacy shall only obtain a drug or medical device from a pharmacy, manufacturer, distributor, or wholesaler that is registered or exempted from registration in the District of Columbia pursuant to § 302 (c) of the Uniform Controlled Substances Act or, if a non-resident pharmacy, be registered or exempted from registration by the federal government or the state in which the pharmacy, manufacturer, distributor, or wholesaler is located.

Burglaries, thefts, suspected diversions, significant losses of drug inventory or the inability to account for such inventory, and damage to a pharmacy or its inventory by fire, flood, or other causes shall be reported by the licensee or agent of the licensee to the Director within forty-eight (48) hours after discovery.

1901.9 Neither drugs nor other merchandise shall be dispensed, sold, held for sale, or given away in any pharmacy damaged by fire, flood, or other causes until the Director or designee has determined that the merchandise is not adulterated or otherwise unfit for sale, use, or consumption. Damaged premises shall be inspected by the Director or designee to determine their continued suitability for pharmacy operations.

1901.10 Chapter 65 (Pharmacists) of Title 17 DCMR and Chapter 13 of Title 22 DCMR supplement this chapter.

History

SOURCE: Final Rulemaking published at 38 DCR 6734 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008); as amended by Notice of Final Rulemaking published at 57 DCR 10518 (November 12, 2010).

22-B DCMR § 1902 NEW LICENSURE OF PHARMACIES

1902.1 Licenses shall be issued for the following categories of pharmacies as defined in this chapter, except for non-resident pharmacies, which shall be required to register with the Department:

(a) Retail pharmacy/community pharmacy;

(b) Nuclear pharmacy;

(d) Special or limited use pharmacy; and

(e) Non-resident pharmacy.

1902.2 A retail chain pharmacy with locations both in and outside of the District of Columbia shall obtain:

(a) A license for each location within the District of Columbia; and

(b) A registration pursuant to § 1903 for each location outside the District of Columbia which dispenses, distributes, ships, mails, or delivers, in any manner, prescription drugs or prescription medical devices directly or indirectly to a patient in the District of Columbia.

1902.3 The Director shall not license or register a pharmacy, person, or entity, which serves as a storefront, broker, agent, dealer, or in any way exists to facilitate the dispensing, shipping, mailing, delivery, or distribution of prescription drugs or devices from Canada, or any other jurisdiction outside of the United States, to District of Columbia residents.

1902.4 Except as otherwise provided in this chapter, an applicant for a new license to operate a pharmacy shall furnish proof satisfactory to the Director of the following:

That a valid certificate of occupancy, where required by the Department of

Consumer and Regulatory Affairs, has been issued for the premises where the pharmacy will be located;

If the pharmacy is owned by a corporation, that the corporation is in good

standing with the District of Columbia, or the state of incorporation if the pharmacy is incorporated in a state other than the District of Columbia;

That each person listed on the application (individuals, partners, or officers of the corporation) has not been convicted of a felony involving drugs;

Whether the pharmacy intends to engage in the compounding of sterile

pharmaceuticals; and

Other information as may be necessary to properly evaluate the applicant and the application.

1902.5 It shall be unlawful for any person to furnish false or fraudulent information on an application for a license or registration.

1902.6 The application for a pharmacy license shall be made on a form to be prescribed by the Director and shall include the required fee. No license fee shall be required for the operation of a pharmacy by the United States government or by the District of Columbia government.

1902.7 The application for a pharmacy license shall include the name and license number of the licensed pharmacist who shall be responsible for ensuring that the pharmacy complies with all applicable laws and regulations pertaining to the operation of the respective pharmacy and practice of pharmacy. The pharmacist shall be known as:

(a) The "pharmacist-in-charge" for a retail/community pharmacy, special or limited use pharmacy, or non-resident pharmacy;

(b) The "Director of Pharmacy" for an institutional pharmacy; and

1902.8 The proprietor of a pharmacy, or other appropriate individual, shall notify the Director within thirty (30) days after a change in the pharmacist-in-charge, Director of Pharmacy, or Responsible Nuclear Pharmacist.

1902.9 Prior to issuing a license, the Director shall make an inspection of a pharmacy to determine compliance with the Act and this chapter.

1902.10 The Director shall send a written report of the findings of the inspection to the licensee no later than fifteen (15) days after the conclusion of the inspection.

1902.11 The Director shall issue a license to a pharmacy that the Director determines is in compliance with the Act and this chapter.

1902.12 The Director shall indicate on the face of the license:

(a) The pharmacy classification for which the license is issued; and

(b) Any restrictions on the license for special or limited use pharmacies.

1902.13 A license is valid only for the proprietor, the premises, and the pharmacy name designated on the license and the location for which it is issued.

1902.14 A pharmacy license is not transferable.

1902.15 The pharmacy license shall be issued in the name of the proprietor whether or not the proprietor of a pharmacy is a pharmacist.

1902.16 A license is the property of the District of Columbia government and shall be returned to the Director immediately upon the occurrence of any of the following events:

(a) Suspension or revocation of the license;

(b) Refusal or failure to renew the license;

(d) Change in proprietorship of the pharmacy;

(e) Death of the proprietor;

(f) Failure of the pharmacy to open for business within thirty (30) days after the license has been issued, except that the Director may grant an extension at his or her discretion for good cause shown;

(g) Failure of the pharmacy to operate for any reason for more than ninety (90) consecutive days after it has opened for business; or

(h) Closure of the pharmacy.

1902.17 The term of a license issued or renewed pursuant to this chapter is two (2) years and shall expire on May 31 of each odd numbered year regardless of the issuance date unless the Director changes the renewal system pursuant to § 1902.18.

1902.18 The Director may change the renewal system to another system for the administrative convenience of the Director.

1902.19 If the Director changes the renewal system pursuant to § 1902.18 of this chapter, the term of a license that is in effect on the date of the Director's determination may be extended up to two (2) years in order to permit an orderly transition.

History

SOURCE: Final Rulemaking published at 38 DCR 6734 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008); as amended by Final Rulemaking published at 69 DCR 002763 (April 1, 2022). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1902

22-B DCMR § 1903 REGISTRATION OF NONRESIDENT PHARMACIES

1903.1 The purpose of these rules is to provide standards for the operation of nonresident pharmacies, which dispense or distribute prescription drugs or medical devices, directly or indirectly such as through the use of an agent or intermediary, to persons located within the District of Columbia. The Department has determined that these rules are necessary to protect the health and welfare of the citizens of the District of Columbia.

1903.2 Nonresident pharmacies which dispense, distribute, ship, mail, or deliver in any manner, prescription drugs or medical devices into the District of Columbia, directly or indirectly, shall, in addition to complying with all applicable federal laws, be registered by the Department and comply with the pharmacy and drug laws and regulations of the District of Columbia, unless and unto the extent that compliance would violate the pharmacy or drug laws or regulations in the state in which the nonresident pharmacy is located.

1903.3 No person or entity required to be registered shall ship, mail, or deliver in any manner, prescription drugs or medical devices into the District of Columbia, directly or indirectly, until a Certificate of Registration is issued by the Department.

1903.4 A nonresident pharmacy shall:

(a) Register with the Department on a form provided by the Department and pay the required fee (no registration fee shall be required for the registration of a nonresident pharmacy operated by the United States government or any other state government); and

(b) Biennially renew the registration and pay the required fee.

1903.5 The term of a registration issued or renewed pursuant to this chapter is two (2) years, or the balance of the registration period, whichever is shorter, and shall expire on May 31 of each odd numbered year regardless of the issuance date unless the Director changes the renewal system pursuant to § 1903.6.

1903.6 The Director may change the renewal system to another system for the administrative convenience of the Director.

1903.7 If the Director changes the renewal system pursuant to § 1903.6 of this chapter, the term of a registration that is in effect on the date of the Director's determination may be extended up to two (2) years in order to permit an orderly transition.

1903.8 As part of the application for registration or renewal of registration, a nonresident pharmacy shall:

Submit evidence to the Department that the nonresident pharmacy holds a

pharmacy license, registration, or permit, in good standing, issued by the state in which the pharmacy is located;

Submit evidence to the Department that the nonresident pharmacy holds a

valid DEA registration number, if the pharmacy dispenses prescription-controlled substances listed in any Schedule into the District of Columbia;

Submit evidence that the pharmacist in charge holds a valid license in good standing in the state in which the nonresident pharmacy is located;

(d) Provide the name, address, and title of its:

(1) Owner or proprietor;

(2) Pharmacist-in-charge, along with his or her license number and state of licensure;

(3) Principal corporate officers;

(4) Pharmacists who are dispensing prescription drugs or medical devices to citizens of the District of Columbia, along with their license numbers and state of licensure; and

(5) Resident agent located within the District of Columbia designated to accept service of process;

(e) Submit a copy of the most recent inspection report resulting from an inspection conducted by the regulatory or licensing agent of the state in which the nonresident pharmacy is located, or the federal agency that inspected;

Indicate whether the nonresident pharmacy is currently engaged in the compounding of sterile pharmaceuticals or intends to engage in the compounding of sterile pharmaceuticals after approval of a registration;

Submit an affidavit by the pharmacist-in-charge certifying that the pharmacist-in-charge has read and understands the pharmacy and drug laws and regulations of the District of Columbia, and that the pharmacist-in-charge has made the pharmacy and drug laws and regulations of the District of Columbia available to all pharmacists working in the nonresident pharmacy;

Provide evidence of the nonresident pharmacy’s ability to provide to the

Department a record of a prescription order dispensed to a resident of the District of Columbia not later than three (3) business days after the time the Department requests the record;

Provide all website address(es) and domain registration(s) to the Department, if applicable; and

If the nonresident pharmacy is solely internet-based or operates primarily as an internet-based pharmacy, the pharmacy shall also:

Submit proof acceptable to the Department of certification by the Verified Internet Pharmacy Practice Sites Program (VIPPS) of the National Association of Boards of Pharmacy, or other national certification program for internet pharmacies acceptable to the Department, for each website and domain registration; and

Submit proof of registration in good standing in the District of Columbia as a foreign corporation.

1903.9 The Director shall deny an application for registration if the applicant fails to provide the required information or documentation.

1903.10 A nonresident pharmacy shall report a change in the name or address of the resident agent in writing to the Department within thirty (30) days after the change.

1903.11 A nonresident pharmacy shall report a change in the pharmacist-in-charge, or corporate officers within thirty (30) days after the change.

1903.12 A nonresident pharmacy which changes proprietorship or ownership, its name, or location shall notify the Department within ten (10) days after the change and apply for a new registration.

1903.13 A nonresident pharmacy shall notify the Department within ten (10) days after closing.

1903.14 A nonresident pharmacy shall, during its regular hours of operation, but not less than six (6) days per week, and a minimum of forty (40) hours per week, provide toll-free telephone communication consultation between patients in the District of Columbia and a licensed pharmacist at the pharmacy who has access to the patient's prescription records. This toll-free number shall be disclosed on a label affixed to each container of drugs or medical device dispensed to patients in the District of Columbia.

1903.15 A nonresident pharmacy shall immediately communicate to a patient or prescribing practitioner any expected delay in delivering the prescribed drug or device which might jeopardize or alter the drug therapy of the patient.

1903.16 A nonresident pharmacy shall maintain, at all times:

(a) A license, registration, or permit in good standing issued in the state in which it is located;

(b) Its records of prescription drugs and devices dispensed to patients in the District of Columbia so that the records are readily retrievable, in hardcopy or electronically, for a period of five (5) years from the date of first dispensing. Records which are more than two (2) years old may be stored offsite as long as they can be retrieved within three (3) business days of a request;

(c) Compliance with the laws and regulations regarding confidentiality of prescription records in the state in which it is located, and if there are no such laws in that state, then the pharmacy shall comply with the confidentiality laws and regulations of the District of Columbia;

(d) Compliance with all requests for information made by the Department pursuant to this section; and

(e) If the pharmacy is internet-based or primarily internet-based:

(1) Certification by the Verified Internet Pharmacy Practice Sites Program (VIPPS) of the National Association of Boards of Pharmacy, or other national certification program for internet pharmacies acceptable to the Department, for each website and domain registration; and

(2) Registration in good standing in the District of Columbia as a foreign corporation.

1903.17 By applying for and being granted registration as a nonresident pharmacy in the District of Columbia, a nonresident pharmacy shall be deemed to have given its consent to provide to the Department, not later than three (3) business days after the time the Department requests the record:

(a) All Information and records concerning a prescription drug or medical device order dispensed to a resident of the District of Columbia;

(b) Any inspection reports, warning notices, notice of deficiency reports, disciplinary actions or any other related reports from the state in which it is located concerning the operation of the nonresident pharmacy for review of compliance with state and federal drug laws; and

1903.18 If a nonresident pharmacy fails to comply with any provision of § 1903.17 the Department may summarily suspend the registration. The Department may lift a summary suspension imposed under this section if the Department determines that the nonresident pharmacy has provided the requested information or records.

1903.19 In addition to any other appropriate remedies or actions, the Director shall withdraw the registration of a registrant that:

(a) Loses licensure in good standing in the state in which it is located;

(b) Loses registration in good standing in the District of Columbia as a foreign corporation; or

1903.20 When withdrawing a registration pursuant to § 1903.19 of this chapter, the Director shall give written notice to the registrant citing the basis for withdrawal. The effective date of withdrawal shall be thirty (30) calendar days from the date of service of the notice, or immediately, in the case of danger to the public health, safety, or welfare.

1903.21 The notice required in § 1903.20 of this chapter shall state that the registration shall be automatically withdrawn unless, prior to the effective date, the registrant submits proof satisfactory to the Director that the registrant has the licensure or registration required pursuant to § 1903.16.

1903.22 In the case of a withdrawal that is effective immediately, the registrant may seek reinstatement of the registration by submitting proof satisfactory to the Director that the registrant no longer poses a danger to the public health, safety, or welfare.

1903.23 In addition to any other appropriate remedies or actions, the Director may fine, suspend, or withdraw the registration of a registrant that violates the pharmacy or drug laws or regulations of the state in which it is located, the District of Columbia, or the United States; or causes harm or injury to a person in the District of Columbia.

1903.24 A registrant shall be afforded notice and, upon written request received by the Director within thirty (30) days of the receipt of the notice, an opportunity to be heard prior to the Director taking action pursuant to § 1903.19 against the registrant.

1903.25 Once a registration has been withdrawn, a registrant shall not ship, mail, or deliver in any manner, prescription drugs or medical devices into the District of Columbia, whether directly or indirectly.

1903.26 Upon receipt of a complaint against the nonresident pharmacy, the Department shall forward the complaint to the state where the nonresident pharmacy is located.

1903.27 The Department will extend reciprocal cooperation to any state that licenses or registers nonresident pharmacies for the purpose of investigating complaints against pharmacies located in the District of Columbia or the sharing of information and investigative reports, as long as the other state will extend the same reciprocal cooperation to the Department.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6735 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008); as amended by Final Rulemaking published at 69 DCR 002763 (April 1, 2022). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1903

22-B DCMR § 1904 RENEWAL OF PHARMACY LICENSE

1904.1 The Director shall mail a renewal notice to a licensee by first class mail to the licensee's last known address on file with the Director at least sixty (60) days prior to the expiration of the license.

1904.2 The failure of a licensee to receive the renewal notice required by this section does not relieve the licensee of the responsibility of renewing the license by the expiration of the existing license.

1904.3 A licensee applying for renewal of a license shall submit the application for renewal not less than thirty (30) days prior to its expiration, to avoid lapse.

1904.4 A licensee applying for a renewal of a license shall disclose whether the licensee is currently engaged in the compounding of sterile pharmaceuticals or intends to engage in the compounding of sterile pharmaceuticals after approval of a licensee.

1904.5 If the Director does not receive the application for renewal of a license at least thirty (30) days prior to the expiration date, the license shall lapse on the expiration date. The licensee may be reinstated within thirty (30) days of expiration upon receipt of a completed renewal application and the payment of a late fee.

1904.6 Upon receipt of the required late fee and final processing of the renewal application, the licensee shall be deemed to have possessed a valid license during the period between the expiration of the license and the reinstatement date.

1904.7 Reinstatement of a license that has been expired for over thirty (30) days shall be at the discretion of the Director. Otherwise, a licensee that fails to submit the completed renewal application or required late fee within thirty (30) days after the expiration of the applicant's license shall be required to apply for new licensure pursuant to § 1902 of this chapter.

1904.8 Prior to the renewal of a license, the Director shall make an inspection of a pharmacy to determine compliance with the Act and this chapter.

1904.9 The Director shall send a written report of the findings of the inspection to the licensee no later that fifteen (15) days after the conclusion of the inspection.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6736 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008); as amended by Final Rulemaking published at 69 DCR 002763 (April 1, 2022). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1904

22-B DCMR § 1905 CHANGE IN PHARMACY NAME, PROPRIETORSHIP, OR LOCATION

1905.1 A proprietor desiring to change the name of a pharmacy shall apply to the Director on a form prescribed by the Director and pay the required fee.

1905.2 A proprietor desiring to change the location of a pharmacy within the District shall apply for a new license in accordance with the requirements set forth in § 1902 of this Chapter.

1905.3 If the change of name or location is approved, the Director shall issue a new license indicating the new name or location. The licensee is not permitted to use the new name or location until it has received official notification from the Director of approval of the change.

1905.4 A proprietor desiring to change the proprietorship of a pharmacy shall notify the Director at least sixty (60) days prior to the date of the change. The prospective proprietor shall apply for a new license in accordance with § 1902 of this chapter.

1905.5 When a pharmacy changes proprietorship, the license shall become void and shall be surrendered promptly to the Director, and a license shall be obtained by the new proprietor whether or not there is any change in the name of the pharmacy.

1905.6 The Director may issue a license to a new proprietor of a pre-existing licensed pharmacy without a pre-licensure inspection as required by § 1902.9 of this chapter, provided the new proprietor certifies in the application for a new license that the pharmacy will not undergo substantial physical or operational changes in the first year of licensure.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6737 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008).

22-B DCMR § 1906 CLOSING A PHARMACY

1906.1 Whenever a pharmacy plans to discontinue operation, the proprietor shall, in addition to the requirements of this section, comply with the provisions of § 1323 of this Title, and notify the Director of the closing of the pharmacy not later than fifteen (15) days prior to the anticipated date of closing. The notice shall be submitted to the Director in writing and shall contain the following information:

(a) The date the pharmacy will close;

(b) The names, addresses, and telephone numbers of the persons who shall have custody of the prescription files, the bulk compounding records, the repackaging records, all drugs including the controlled substances, and inventory records of the pharmacy to be closed; and

(c) The names, addresses, DEA registration numbers, and District registration numbers of any persons who will acquire any of the drugs and controlled substances from the pharmacy to be closed, if known at the time the notification is filed.

1906.2 A pharmacy that dispenses prescription drugs shall, at least fifteen (15) days prior to the closing date of the pharmacy, post a closing notice sign in a conspicuous place in the front of the prescription department and at all public entrance doors to the pharmacy. The closing notice sign shall contain the following information:

(a) The date of closing; and

(b) The name, address, and telephone number of the pharmacy acquiring the prescription drug orders, refill information, and patient medication records of the pharmacy.

1906.3 On the date of closing, the pharmacy shall, in addition to complying with all other District and federal requirements:

(a) Transfer the prescription drug files, refill information, and patient medication records to a licensed pharmacy within a reasonable distance of the closing pharmacy. The pharmacy shall be the same pharmacy which was identified in the closing notice sign; and

(b) Remove all signs and symbols indicating the presence of a pharmacy, or any representation that would tend to mislead the public that pharmacy is located at the address.

1906.4 Not later than fifteen (15) days after the pharmacy has closed, the proprietor shall submit to the Director the following:

(a) The pharmacy license;

(b) The District of Columbia certificate of registration; and

(1) The actual date of closing;

(2) Confirmation that all drugs have been transferred to an authorized person or persons, or destroyed. If the drugs were transferred, the names and addresses of the persons to whom they were transferred;

(3) If controlled substances were transferred, a list of the names, addresses, DEA registration numbers, and District registration numbers of the persons to whom the substances were transferred, the substances transferred, the amount of each substance transferred, the date on which the transfer took place, and a copy of DEA form 222 for the transfer of Schedule II controlled substances;

(4) Confirmation that the DEA registration and all unused DEA 222 forms (order forms) were returned to the DEA;

(5) Confirmation that all pharmacy labels with addresses and blank prescription pads with addresses which were in the possession of the pharmacy were destroyed;

(6) If controlled substances were transferred, confirmation that an inventory has been conducted; and

(7) Confirmation that all signs and symbols indicating the presence of the pharmacy have been removed.

1906.5 If a pharmacy is closed suddenly due to fire, destruction, natural disaster, death, property seizure, eviction, bankruptcy, or other emergency circumstances the pharmacy shall notify the Director immediately or as far in advance of the closing as allowed by the circumstances.

1906.6 The pharmacist-in-charge and the proprietor of the pharmacy shall be jointly responsible for ensuring the pharmacy's compliance with the provisions of this section.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6738 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008).

22-B DCMR § 1907 PHYSICAL STANDARDS

1907.1 The physical standards contained in this section shall apply to all pharmacies, unless otherwise exempted by this chapter or the Director.

1907.2 A pharmacy shall meet the applicable requirements of the District of Columbia zoning, building, fire, plumbing, and electrical codes.

1907.3 A pharmacy shall not be permitted to operate in either a temporary or trailer-type facility, except by special or limited use license as approved by the Director.

1907.4 The prescription drug compounding and dispensing area shall:

Be a minimum of one hundred fifty (150) square feet in area, except that a pharmacy licensed prior to the effective date of these rules may be of a lesser square footage as approved by the Director;

Satisfy compounding space requirements as follows:

For the compounding of non-sterile and sterile pharmaceuticals, have a minimum of ten (10) square feet of counter space for the pharmacist-in-charge, with additional space for each additional pharmacist on duty, to compound and dispense drugs safely and efficiently, except that a pharmacy licensed prior to the effective date of this chapter may be of lesser square footage of counter space as approved by the Director;

Beginning six (6) months after the effective date of these regulations, for the compounding of non-sterile pharmaceuticals, satisfy all other compounding space requirements established in the current published edition of USP General Chapter 795, 800; and

Beginning six (6) months after the effective date of these regulations, for the compounding of sterile pharmaceuticals, satisfy all compounding space requirements as established in the current published edition of USP General Chapter 797, 800;

Contain an area which is suitable for confidential patient counseling, if the pharmacy serves the public;

Be separated from other areas by a barrier which renders the area inaccessible to unauthorized persons;

(e) Provide an unobstructed view of the pharmacist on duty;

(f) Be properly lighted and ventilated;

(g) Have a sink and goose-neck faucet within the dispensing and compounding area for the immediate access and use of all pharmacy personnel, maintained in a sanitary condition, which shall provide hot running water no less than one hundred and ten degrees Fahrenheit (110° F) (forty-three and one-third degrees Celsius (43.3° C)), cold running water, and shall include:

(1) Soap or detergent from a dispenser; and

(2) Air-driers or single-use non shedding towels;

(h) Maintain the temperature of the pharmacy within a range compatible with the proper storage of drugs;

Have refrigeration facilities exclusively for the storage of drugs requiring cold storage with a thermometer controlling the interior temperature to keep it maintained between thirty-six degrees Fahrenheit (36°F) and forty-six degrees Fahrenheit (46°F); and

Beginning six (6) months after the effective date of these regulations, comply with all other requirements of the current published editions of USP General Chapters 795, 797, and 800 relevant to the type of compounding being undertaken.

1907.5 All areas where drugs and medical devices are stored, shall be dry, well lighted, well ventilated, maintained at a temperature safe for the storage of drugs as specified by the United States Pharmacopoeia/National Formulary (USP/NF) or the United States Food and Drug Administration (USFDA) and maintained in a clean and orderly condition.

1907.6 Storage areas shall be maintained at temperatures which will ensure the integrity of the drugs prior to their dispensing as stipulated by the United States Pharmacopoeia/National Formulary (USP/NF) and/or the manufacturer's or distributor's labeling unless otherwise indicated by the Bureau of Food, Drug & Radiation Protection, Pharmaceutical Control Division.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6739 (November 8, 1991); as amended by Final Rulemaking published at 55 DCR 270 (January 11, 2008); as amended by Final Rulemaking published at 64 DCR 8588 (September 1, 2017); as amended by Final Rulemaking published at 69 DCR 002763 (April 1, 2022). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1907

22-B DCMR § 1908 SANITATION STANDARDS

1908.1 The sanitary standards contained in this section shall apply to all pharmacies and drug and medical device storage areas, unless otherwise exempted by this chapter or the Director.

1908.2 A pharmacy and all areas under the control of the pharmacy, including storage areas and restrooms, shall be maintained in a clean and sanitary condition free of infestation by rodents, birds, insects, and other vermin.

1908.3 All pharmacy and storage areas shall be dry and well ventilated.

1908.4 All pharmacy equipment shall be kept clean and in good operating condition.

1908.5 Trash shall be kept in opaque trash bags and covered waste receptacles.

1908.6 Trash, sewage, and other refuse shall be removed from a pharmacy in a timely and sanitary manner.

1908.7 Restroom facilities shall be located in an area reasonably accessible to pharmacy personnel and supplied with a hand washing sink, soap or detergent, toilet paper, and air driers or single-service towels.

1908.8 The pharmacy's plumbing facilities shall be kept in good repair.

1908.9 Animals shall not be permitted in the pharmacy or areas immediately adjacent to and under the control of the pharmacy except for guide dogs accompanying disabled persons.

1908.10 All persons working in a pharmacy in any capacity shall follow hygienic work practices, including the washing of hands thoroughly as often as is necessary to remove soil and contamination.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6740 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008).

22-B DCMR § 1909 REQUIRED EQUIPMENT AND REFERENCES

1909.1 The equipment and references requirements of this section shall apply to all pharmacies, unless otherwise exempted by this chapter or the Director.

1909.2 The pharmacist-in-charge shall be responsible for maintaining the following:

(a) Current dispensing information reference source consistent with the scope of pharmacy practice at the location of the permitted pharmacy;

(b) A set of prescription balances, sensitive to 15 milligrams, and weights or an electronic scale if the pharmacy engages in dispensing activities that require the weighing of components;

(c) Other equipment, supplies, and references consistent with the pharmacy's scope of practice and with the public safety; and

(d) All other items required by federal and District of Columbia laws and regulations.

1909.3 A pharmacy may apply to the Director for a waiver of any of the equipment required under § 1909.2 where the equipment would be inapplicable to the services provided by the pharmacy.

1909.4 A pharmacy shall be equipped to provide emergency information about reactions to poisons from a current source.

1909.5 In addition to the requirements set forth under § 1909.2, a nuclear pharmacy shall maintain the following items, in hard copy or electronic format, in its reference library:

(a) A reference on the safe handling of radioactive materials;

(b) A minimum of three texts dealing with nuclear medicine science;

(d) Code of Federal Regulations, Title 49, Parts 106-199, with recent amendments.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6741 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008).

22-B DCMR § 1910 SECURITY AND SAFEGUARDS AGAINST DRUG DIVERSION

1910.1 The security and safeguards requirements of this section shall apply to all pharmacies, unless otherwise exempted by this chapter or the Director.

1910.2 A pharmacy shall have a security alarm system which:

(a) Detects unauthorized entry into the premises;

(b) Provides zone protection for the drug storage, compounding, and dispensing areas;

(c) Beginning six (6) months after the effective date of these regulations, includes a video surveillance system meeting the requirements set forth in § 1910.3 of this chapter;

(d) Has an auxiliary source of power; and

(e) Is in good repair and operating order at all times.

1910.3 Beginning six (6) months after the effective date of these regulations, all

pharmacies shall be required to operate and maintain in good working order

a video surveillance system on the premises in compliance with the following:

The video surveillance system shall be continuously operated twenty-four (24) hours, seven (7) days a week and shall display an accurate date and time stamp on all video recordings;

The video surveillance system shall store without recording over, at a minimum, the current day and previous thirty (30) days of video surveillance recording;

The video surveillance system shall record all pharmacy-related operations, including drug storage, dispensing, compounding, and patient consultations areas, but may exclude private patient areas and areas used for administering medications or immunizations;

The video surveillance system shall record all automated dispensing machines (ADM) utilized in institutional pharmacies, but may exclude private patient areas;

The video surveillance recordings for the current day and previous thirty (30) days shall be viewable upon request by a Department investigator or inspector;

The video surveillance system shall be capable of producing, at a minimum, a digital storage device of the current day and previous thirty (30) days of recording in a standard format that is viewable on any Windows PC and that includes any required device or software necessary for viewing;

The video surveillance recording shall be provided to the Department within seventy-two (72) hours of a request by a Department investigator or inspector; and

The video surveillance system shall be maintained in good working order at all times and tested monthly for proper retrieval functionality. The pharmacy shall retain all documentation regarding the testing of its video surveillance system, and present that documentation upon request to a Department inspector or investigator. The pharmacy shall report any malfunctioning or inoperability of the system to the Department within seventy-two (72) hours of discovering the issue.

1910.4 The prescription drug compounding and dispensing area and the drug storage area shall be separately enclosed and secured in such a manner as to prevent diversion and authorized access.

1910.5 Any controlled substance stored outside of the prescription drug compounding and dispensing area shall be kept in a locked storage area.

1910.6 If only a designated area of an establishment is used as a pharmacy, the pharmacy area shall be securely enclosed and capable of being locked and equipped with an alarm system and inaccessible from the rest of the establishment.

1910.7 Each pharmacist, while on duty, shall be responsible for the security of the pharmacy, including provisions for effective control against theft or diversion of drugs or devices.

1910.8 A pharmacy shall be secured by either a physical barrier with a suitable lock, or by an electronic barrier to detect entry, and protected by an alarm at all times while a pharmacist is not on duty.

1910.9 Access to the prescription drug compounding, dispensing, and storage areas shall be restricted to:

(a) Pharmacists employed by the pharmacy;

(b) Ancillary persons who require entry for the purpose of discharging a job related duty in the presence of a pharmacist; and

1910.10 The following drugs, medical devices, and medical supplies shall not be kept or displayed in an area that is accessible to the public:

(a) Prescription or legend drugs and medical devices;

(b) Devices that may be used in the administration of controlled substances;

(d) Over-the-counter medicines that have been identified by the Food and Drug Administration or the Director as having a potential for misuse or abuse.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6742 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008); as amended by Final Rulemaking published at 69 DCR 002763 (April 1, 2022). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1910

22-B DCMR § 1911 PACKAGING AND HANDLING OF DRUGS AND MEDICAL DEVICES

1911.1 The packaging and handling requirements of this section shall apply to all pharmacies, unless otherwise exempted by this chapter or the Director.

1911.2 A pharmacy shall dispense drugs or medical devices in new and clean containers or in the manufacturer's original container or package.

1911.3 A pharmacy shall dispense drugs in child-resistant containers unless there is written documentation that the patient has requested otherwise, pursuant to the Federal Poison Prevention Act of 1970, 16 C.F.R. Part 1700.

1911.4 A pharmacy shall not reuse a manufacturer's bottle or container.

1911.5 A pharmacy shall not reuse a bottle or container that has held toxic, adulterated, or misbranded substances.

1911.6 A pharmacy shall obtain drugs only from suppliers licensed or registered as required by federal and District law.

1911.7 A pharmacy shall obtain only drugs that are in the original manufacturer's or distributor's container.

1911.8 A pharmacist shall direct and supervise the compounding, repackaging, or prepackaging of drugs and make the final verification of the prepackaged product and document the verification.

1911.9 A pharmacy shall keep a log of drugs that have been compounded, repackaged, or prepackaged under a pharmacist's supervision. The log must contain the following information:

(a) The name of the drug;

(b) The name of the manufacturer or distributor;

(d) The strength of the drug;

(e) The expiration date;

(f) The date of prepackaging or repackaging;

(g) The quantity of drugs prepared; and

(h) The name or initials of the pharmacist supervising the packaging.

1911.10 A pharmacy shall keep the log required under § 1911.09 of this chapter for five (5) years from the date of packaging. Records that are more than two (2) years old may be stored offsite as long as they can be retrieved within three (3) business days of a request.

1911.11 All drugs and medical devices held by a pharmacy shall be stored:

(a) In a proper and safe manner;

(b) In an appropriate container or package that provides for protection of the product;

(d) As required by the manufacturer, this chapter, and other applicable federal and District of Columbia laws or regulations.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6743 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008).

22-B DCMR § 1912 LABELING OF DISPENSED DRUGS

1912.1 The labeling requirements of this section shall apply to all pharmacies, unless otherwise exempted by this chapter or the Director.

1912.2 A container in which a prescription drug or device is sold or dispensed must bear a label containing the following information:

(a) The name, address, and telephone number of the pharmacy;

(b) The name of the patient, or if the ultimate user is an animal, the name of the owner, the first name of the animal, and the species of the animal;

(d) The date of filling;

(e) The generic, chemical, or brand name of the drug unless omission is specifically requested by the prescriber in writing pursuant to the District of Columbia Prescription Drug Price Information Act, (D.C. Law 1-81, D.C. Code §§ 48-801 et al);

(f) The strength, dosage, and quantity of the drug dispensed;

(g) The directions for use and cautionary statements, if any, contained in the prescription or required by law;

(h) The serial number of the prescription or prescription number; and

(i) The expiration date of the product according to the manufacturer or one (1) year from the date the drug or medical device is dispensed, whichever comes first, subject to the discretion of the pharmacist to select an earlier date on which the life of a compounded drug product may expire.

1912.3 If a prescription order is for a controlled substance, the label shall also include a clear, concise warning that it is a crime to transfer the drug to any person other than the patient.

1912.4 A pharmacy shall be responsible for labeling each prepackaged or repackaged container with the following information:

(a) The name of the drug;

(b) The name of the manufacturer if the drug is generic;

(d) The manufacturer or distributor's control or lot number; and

(e) The expiration date of the product according to the manufacturer or on one (1) year from the date the drug or medical device is prepackaged, whichever comes first, subject to the discretion of the pharmacist to select an earlier date on which the life of a compounded drug product may expire.

1912.5 When the size of the label required pursuant to this section requires a reduction in type, the reduction shall not be made to a size smaller than is necessary and under no circumstances shall the size be less than six (6) point type.

1912.6 Once opened, a multi-dose container shall be labeled with the expiration date of the product according to the manufacturer or on one (1) year from the date the drug or medical device is prepackaged, whichever comes first, subject to the discretion of the pharmacist to select an earlier date on which the life of a compounded drug product may expire.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6744 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008).

22-B DCMR § 1913 RECORDKEEPING

1913.1 The recordkeeping requirements of this section shall apply to all pharmacies, unless otherwise exempted by this chapter or the Director.

1913.2 A pharmacy shall maintain on a current basis a complete and accurate record of all prescription drugs and devices received, sold, compounded, dispensed, or otherwise disposed of by the pharmacy for a period of five (5) years.

1913.3 For purposes of this section, the requirement may be met by maintaining the most recent two years of records on site and the remaining three years of records off site as long as the records can be retrieved within three (3) business days of a request.

1913.4 A pharmacy shall keep a chronological record, for a period of five (5) years from the date of first dispensing, of each prescription that is filled or refilled including the following information:

(a) The name and address of the patient;

(b) The name and address of the prescriber and date prescribed;

(c) The name, strength, dosage form, and quantity of the drug prescribed, and quantity dispensed if different from the quantity prescribed;

(d) The name and manufacturer of the drug if it is a substitute or generic drug for the drug actually prescribed or filled initially;

(e) Directions for use;

(f) The date the prescription was compounded, dispensed, or refilled;

(g) The name or initials of the pharmacist responsible for final verification of the prescription order;

(h) The prescriber's Drug Enforcement Administration (DEA) number and District of Columbia Controlled Substances number when required by law or regulation;

(i) The expiration date of the drug dispensed;

(j) Any change or alteration made to the prescription dispensed based on contact with the practitioner to show a clear audit trail. This shall include, a change in quantity, directions, number of refills, or authorization to substitute a drug; and

(k) Any other information required by District of Columbia or federal law or regulations.

1913.5 The pharmacist performing the final verification of a prescription shall be identified on the prescription record by name or initial, and shall be fully responsible for the accuracy of the processing, compounding, and dispensing of the prescription order.

1913.6 A pharmacy shall put in place systems to assign a secure identification code to each pharmacist for use on verification records, or require manual signatures of pharmacists performing final verifications to ensure that only the actual verifying pharmacist can place his or her name or initials on the verification records.

1913.7 All prescriptions orders shall be maintained for a period of five (5) years from the date of first dispensing.

1913.8 Prescription orders for controlled substances in Schedules I and II shall be maintained in a file separate from all other records of the pharmacy.

1913.9 Prescription orders for controlled substance in Schedules III, IV, and V shall be maintained either in a separate prescription file or in such form that they are readily retrievable from the other prescription records of the pharmacy. They will be deemed readily retrievable if, at the time they are initially filed, the face of the prescription is marked in red ink in the lower right corner with the letter "C" no less than one-inch high and filed in the usual consecutively numbered prescription file for non-controlled substances. However, if a pharmacy employs an electronic recordkeeping system for prescriptions which permits identification by prescription number and retrieval of original documents by prescriber's name, patient's name, drug dispensed, and date filled, then the requirement to mark the hard copy prescription with a red "C" is waived.

1913.9 All prescription orders shall be in compliance with requirements under this section, the Act and Title 21, C.F.R. Part 1306, where applicable.

1913.10 There shall be maintained in each pharmacy a bound volume, which shall be available for inspection by the Director, in which shall be recorded information required by federal or District of Columbia law or regulation concerning each sale of:

(a) Over-the-counter (OTC) Schedule V controlled substances;

(b) Hypodermic syringes, needles, or other medical devices which may be used in the administration of controlled substances;

(c) Gelatin capsules and glassine envelopes in quantities sufficient to indicate an intention to use such substances for the illegal distribution or dispensing of any controlled substance; and

(d) Diluents or adulterants, such as lactose or quinine, in quantities sufficient to indicate an intention to use such substances for the illegal distribution or dispensing of any controlled substance.

1913.11 A pharmacy shall maintain a patient record system in an automated data processing system or manual record system which shall provide for the immediate retrieval of patient information during the pharmacy's normal operating hours which may include:

(a) Full name of the patient for whom the drug is intended;

(b) Street address and telephone number of the patient;

(d) Patient's gender, height and weight;

(e) A list of all prescription drug orders obtained by the patient at the pharmacy maintaining the patient record during the (5) years immediately preceding the most recent entry showing the name of the drug, prescription number, name and strength of the drug, the quantity and date received, and the name of the practitioner;

(f) The pharmacist comments relevant to the individual's drug therapy, including any other information peculiar to the specific patient or drug;

(g) Patient allergies, drug reactions, current medications and relevant prior medications including non-prescription medications and relevant devices, or medication conditions which are communicated by the patient or the patient's agent; and

(h) Any other information which the pharmacist, in his or her professional judgment, deems appropriate.

1913.12 A patient record shall be maintained for a period of not less than five (5) years from the date of the last entry in the profile record. This record may be a hard copy or a computerized form.

1913.13 Prescription records, patient records, and any other individually identifiable health care information shall be maintained, used, and disclosed only in a manner that protects the integrity and confidentiality of the information, and that is in compliance with the requirements of HIPPA, and all applicable federal and District of Columbia laws and regulations.

1913.14 Authorized agents of the Director shall have immediate and unimpeded access to all pharmacy patient records and the pharmacist-in-charge shall be responsible for informing their superiors.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6745 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008).

22-B DCMR § 1914 COMPUTERIZED RECORDKEEPING

1914.1 A pharmacy may use an automated data processing system to meet the recordkeeping requirements under § 1913 of this Title if the system meets the requirements of this section.

1914.2 The automated data processing system shall have:

(a) Adequate security and systems safeguards designed to prevent and detect unauthorized access, modification, or manipulation of patient records. A pharmacy shall document any alterations in the prescription drug order, occurring after the prescription has been dispensed, and identify the pharmacist responsible for the alteration;

(b) The capability of producing:

(1) Readable required documentation and information on all original and refilled prescriptions through on-line retrieval, or, from the cathode ray tube (CRT), microfiche, microfilm, printout, or other method acceptable to the Board of Pharmacy; and

(2) A refill-by-refill audit trail for any specified strength and dosage form of any drug. The audit trail shall be by printout, and include the name of the prescribing practitioner, name and location of the patient, quantity dispensed on each refill, dispensing date of each refill, name or identification code of the pharmacist performing the final verification, and unique identifier of the prescription drug order.

(d) Adequate safeguards to ensure security and confidentiality of patient records pursuant to the applicable federal and District of Columbia laws and regulations.

1914.3 A pharmacist shall be responsible for the completeness and accuracy of the information he or she enters into the automated data processing system.

1914.4 All entries made into the automated data processing system shall include the initials or identification code of the dispensing pharmacist responsible for the transaction giving rise to the entry.

1914.5 The pharmacist-in-charge shall maintain a record keeping system in which each pharmacist involved in dispensing shall sign a statement each day attesting to the fact that the prescription information entered into the computer that day has been reviewed and is correct as shown. The log book or file shall be maintained at the pharmacy for a period of five (5) years from the date of dispensing. Records which are more than two (2) years old may be stored offsite as long as they can be retrieved within three (3) business days of a request.

1914.6 Any facility maintaining centralized prescription records shall be capable of sending a requested printout to the Pharmacy within seventy-two (72) hours.

1914.7 The pharmacist-in-charge, Director of Pharmacy, or Responsible Nuclear Pharmacist, as applicable, shall develop and implement a policy and procedure manual for the operational aspects of the automated data processing system which shall:

(a) Identify the required output documentation stored and provided by the system;

(b) Identify the procedures for when the system is not operational;

(d) Outline the audit procedures;

(e) Identify personnel responsibilities; and

(f) Provide a quality assurance mechanism for data entry validation.

1914.8 A pharmacy shall maintain sufficient patient data and prescription drug order data, in hard copy format, to permit reconstruction of the data and proper dispensing of prescription orders, within two (2) hours of an unscheduled system interruption or malfunction of the automated data processing system.

1914.9 A pharmacy shall have an auxiliary system or procedures in place to ensure that all refills are authorized and that the maximum number of refills is not exceeded, if the automated data processing system is inoperative for any reason. In the event the actual number of remaining authorized refills cannot be determined and the pharmacist is unable to contact the prescribing provider for a new prescription, the pharmacist may use his or her professional judgment to dispense not more than a seven (7) day supply to cover or prevent a medical emergency.

1914.10 The auxiliary system set forth in § 1914.9 shall be capable of meeting the requirements of this chapter and functioning in the place of the automated data processing system until the automated data processing system is again operational.

1914.11 All prescription drug order information shall be entered into the automated data processing system not more than ninety-six (96) hours after the automated data processing system is again operational.

1914.12 A pharmacy shall implement routine backup file and file maintenance procedures to prevent loss of patient data.

1914.13 A pharmacy shall notify the Board of Pharmacy of a permanent loss of prescription drug order information or patient information due to a system failure, not more than twenty-four hours (24) after the discovery.

1914.14 A pharmacy shall be responsible for continuity in the maintenance of prescription records if the relationship with its data processing services supplier terminates.

1914.15 A pharmacy using an automated data processing system shall comply with all applicable federal and District of Columbia laws and regulations.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6746 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008).

22-B DCMR § 1915 AUTOMATED MEDICATION DISPENSING SYSTEMS

1915.1 An automated medication dispensing system may be utilized in a licensed pharmacy or health care facility if the requirements of this section are being met.

1915.2 An automated medication dispensing system shall be used only in settings where there is an established program of pharmaceutical care that ensures prescription orders are reviewed by a pharmacist in accordance with established policies and procedures and good pharmacy practice.

1915.3 The recordkeeping requirements of this section may be met by maintaining the most recent two years of records on site and the remaining three years of records off site as long as the records can be retrieved within three (3) business days of a request.

1915.4 A pharmacy shall provide the Director written notice of the installation of an automated medication dispensing system prior to utilizing an automated medication dispensing system. The notice shall include:

(a) The name and address of the pharmacy;

(b) The location of the automated equipment;

(d) The type of system, manufacturer's name, make, and model.

1915.5 An automated medication dispensing system shall have adequate security and procedures to:

(a) Prevent unauthorized access;

(b) Comply with federal and District of Columbia laws and regulations; and

1915.6 An automated medication dispensing system shall electronically record all transactions involving drugs stored in, removed, or dispensed from the system.

1915.7 The pharmacy, or provider pharmacy providing remote pharmacy services, shall:

(a) Maintain records regarding the automated medication dispensing system in a readily retrievable manner for at least five (5) years. The records shall include:

(1) Maintenance records and service logs;

(2) System failure reports;

(3) Accuracy audits and system performance audits;

(4) Copies of reports and analyses generated as part of the quality assurance program;

(5) Reports or databases related to level of access and changes in the level of access to the system; and

(6) Training records including the training content, date, and identity of those attending the training program.

(b) Maintain dispensing records for all prescription drugs or devices dispensed or distributed from the automated medication system for a period of five (5) years and shall include:

(1) Identity of the system accessed;

(2) Identification of the individual accessing the system;

(3) Date of transaction;

(4) Name, strength, dosage form, and quantity of drug accessed; and

(5) Name of the patient for whom the drug was accessed.

(c) Maintain stocking and removal records of all drugs stored in and removed from the system for a period of five (5) years, which shall include identification of the person stocking or removing drugs from the system and identification of the pharmacist who verified that the system was accurately filled;

(d) Maintain records, including records of drugs discarded through the use of a reverse distributor, of all drugs discarded as waste for a period of five (5) years, which shall include identification of the person discarding the drugs and the identification of the pharmacist who verified that the drugs were properly discarded in accordance with federal and District law and regulations;

(e) Ensure that the automated medication dispensing system maintains the integrity of the information in the system and protects patient confidentiality;

(f) Ensure that a comprehensive program of quality assurance for the automated medication dispensing system is in place;

(g) Ensure that the system complies with this chapter;

(h) Maintain policies and procedures related to:

(1) The operation of the system;

(2) Training of personnel using the system; and

(3) Operations during system down time;

(i) Establish a process to:

(1) Ensure the security of the system;

(2) Account for medication added to and removed from the system; and

(3) Minimize the potential for misidentification of medications, dosages, and dosage forms by those accessing the automated medication system; and

(j) Ensure that authorized individuals working with the automated medication dispensing system receive initial and annual training regarding:

(1) The capabilities and limitations of the system;

(2) The operation of the system; and

(3) Procedures for system downtime.

1915.8 The records which are required to be maintained pursuant to § 1915.7 shall be stored on site where the automated medication dispensing system is located.

1915.9 The Director of Pharmacy or pharmacist-in-charge shall:

(a) Control access to the automated medication dispensing system;

(b) Designate in writing the individuals who are authorized to access the system;

(d) Develop policies and procedures regarding the automated medication system; and

(e) Be responsible for all pharmacy operations involving the automated medication dispensing system.

1915.10 Access to the automated medication dispensing system shall be limited to individuals that have completed documented training concerning the automated pharmacy system and who are one of the following:

(a) Licensed pharmacist;

(b) Qualified pharmacy personnel under a licensed pharmacist's supervision; or

1915.11 Where a centralized automated medication dispensing system is being used, a licensed pharmacist shall perform a final check of each medication that is removed from the system prior to distribution or dispensing, unless:

(a) A licensed pharmacist utilizing a centralized automated medication dispensing system distributes patient specific medications within the licensed health care facility and the medication is distributed for subsequent administration by a health care professional permitted by law to administer medication; or

(b) A licensed pharmacist performs a daily quality assurance check of the integrity of the system that includes random sampling of the output.

1915.12 Where a decentralized automated medication dispensing system is being used:

(a) A licensed pharmacist shall perform a review of each order for medication before the medication is removed from the system, except if the order is for a starter dose; and

(b) A licensed pharmacist shall perform a review of each order for a starter dose within twenty-four (24) hours of removal of the starter does from the remote or decentralized automated medication system, if the patient is still under the care of the facility when the review is to be performed.

1915.13 Only a licensed pharmacist may fill an automated medication dispensing system, unless otherwise specifically permitted by this section.

1915.14 Automated medication dispensing systems that possess sufficient safeguards to ensure accuracy of the replenishment may be filled by:

(a) Authorized personnel pursuant to § 1915.9(b), supervised by a licensed pharmacist with a pharmacist performing the final verification; or

(b) Health care professionals licensed under the Act, and authorized to access an automated medication dispensing system due to the health care professionals' privileges to administer medication.

1915.15 Only a licensed pharmacist may return medication to the automated medication dispensing system, unless otherwise specifically permitted by this section.

1915.16 Automated medication dispensing systems that possess sufficient safeguards to ensure accuracy of the replenishment may allow for medication to be returned to those systems by:

(a) Authorized personnel pursuant to § 1915.9(b), supervised by a licensed pharmacist; or

(b) Health care professionals licensed under the Act, and authorized to access an automated medication dispensing system due to the health care professionals' privileges to administer medication.

1915.17 Medication which is returned to an automated medication dispensing system may be used for subsequent administration provided that:

(a) The drugs are in sealed, tamper evident packaging which has not been opened;

(b) The medication is in an unadulterated form;

(c) If in a unit of use package, the medication is in the intact package that the medication was in when initially removed from the system;

(d) The return of medication is documented within the system or in other records maintained by a licensed pharmacist; and

(e) The return of medication is conducted in accordance with written procedures.

1915.18 Drugs for use in an automated medication dispensing system shall be packaged in the original manufacturer's container or be prepackaged and labeled in compliance with the requirements of this chapter, and applicable federal and District laws and regulations.

1915.19 Controlled dangerous substances shall only be dispensed and distributed in accordance with applicable federal and District of Columbia laws and regulations.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6748 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008).

22-B DCMR § 1916 REMOTE AUTOMATED PHARMACY SERVICES

1916.1 The purpose of this section is to provide standards for the provision of remote pharmacy services by a provider pharmacy in a facility that is not at the same location as the provider pharmacy through an automated pharmacy system.

1916.2 A provider pharmacy may provide remote pharmacy services directly or through the use of a Board-approved subcontractor using an automated pharmacy system to a health care facility or other appropriate facility located in the District of Columbia if:

(a) The provider pharmacy submits an application to the Director for permission to provide remote pharmacy services using an automated medication dispensing system. The application shall include:

(1) The name, address, and license number of the provider pharmacy;

(2) The name and address of the facility where the remote pharmacy services will be provided;

(3) The name and address of the subcontractor who will provide after-hours remote pharmacy services, if applicable;

(4) An affidavit with the notarized signatures of the pharmacist-in-charge, and the medical director or the person responsible for the on-site operation of the facility affirming that the provider pharmacy and the facility have entered into a written agreement outlining the responsibilities of each party in complying with this chapter and the applicable federal and District laws and regulations; and

(5) Documentation that the automated medication dispensing system is located where medications are administered by authorized health care professions.

(b) The Director approves the application. Upon approval of the application, the provider pharmacy will be sent a certificate which must be displayed at the remote site.

1916.3 A provider pharmacy may only utilize a subcontractor for the provision of after-hours and weekend remote pharmacy services, or in the case of an emergency situation caused by forces majeure, i.e. acts of God.

1916.4 A provider pharmacy shall notify the Director in writing within ten (10) days of a change of location, discontinuance of service, or closure of a remote site or remote pharmacy service.

1916.5 The pharmacist-in-charge of the provider pharmacy is responsible for all pharmacy operations involving the automated pharmacy system located at the remote site including supervision of the automated pharmacy system and compliance with this section.

1916.6 The following duties shall be performed only by a licensed pharmacist at the provider pharmacy:

(a) Receiving an oral, facsimile, or electronic prescription drug order;

(b) Interpreting the prescription drug order;

(d) Selecting the drug product;

(e) Interpreting the patient's medication records and conducting a drug regimen review;

(f) Authorizing the telepharmacy system to print a prescription label at the remote site; and

(g) Performing the final check of the dispensed prescription to ensure that the prescription drug order has been dispensed accurately as prescribed. The final check shall be accomplished through a visual check using electronic methods.

1916.7 Patient counseling of an inpatient of a health care facility may be performed by either a pharmacist or a licensed health care professional authorized to administer drugs.

1916.8 Drugs shall only be dispensed at a remote site through an automated prescription medication dispensing system if:

(a) An original prescription drug order has been received, or reviewed electronically, by a pharmacist at the provider pharmacy;

(b) A pharmacist at the provider pharmacy has approved the release of the initial dose of a prescription drug order; and

(c) A pharmacist at the provider pharmacy has conducted a drug regimen review prior to releasing a prescription drug order to the automated pharmacy system.

1916.9 Non-sterile drugs which require reconstitution through the addition of a specified amount of water may be dispensed by the remote site only if a registered pharmacy technician or an authorized licensed healthcare provider reconstitutes the product.

1916.10 Subsequent doses from an approved prescription drug order may be removed from the automated medication system by, authorized personnel, after the initial approval. Any change made in the prescription drug order shall require a new approval by a pharmacist to release the drug.

1916.11 A provider pharmacy shall only store drugs at a remote site within an automated medication dispensing system that is locked by key or combination so as to prevent access by unauthorized personnel.

1916.12 A pharmacist from the provider pharmacy shall be accessible at all times to respond to a patient's or other health professional's questions and needs pertaining to drugs dispensed through an automated medication dispensing system at a remote site. The access may be by telephone or through a twenty-four (24) hour pager service.

1916.13 The provider pharmacy shall be responsible for ensuring that the requirements set forth under §§ 1914 and 1915 of this Title are met, and for maintaining all required records.

1916.14 The pharmacist-in-charge of the provider pharmacy shall be responsible for ensuring that the remote site and automated medication dispensing system comply with all applicable federal and District laws and regulations.

1916.15 Nothing in this section shall be construed to permit a pharmacy, or provider pharmacy, located within the District of Columbia to provide remote pharmacy services to a facility or individual located outside of the District of Columbia without legal authorization under the laws of the recipient state or jurisdiction.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6750 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008).

22-B DCMR § 1917 TELEPHARMACY SERVICES

1917.1 The purpose of this section is to provide standards for the provision of remote pharmacy services by a provider pharmacy in a facility that is not at the same location as the provider pharmacy through a telepharmacy system.

1917.2 Telepharmacy systems may only be used in institutional settings.

1917.3 A provider pharmacy may provide remote pharmacy services directly, or through the use of a Director-approved subcontractor, using a telepharmacy system to a health care facility or other appropriate facility located in the District of Columbia if:

(a) The provider pharmacy submits an application to the Director for permission to provide remote pharmacy services using a telepharmacy system. The application shall include:

(1) The name, address, and license number of the provider pharmacy;

(2) The name and address of the facility where the remote pharmacy services will be provided;

(3) The name and address of the subcontractor who will provide after-hours remote pharmacy services; and

(4) An affidavit with the notarized signatures of the pharmacist-in-charge or Director or Pharmacy, and the medical director or the person responsible for the on-site operation of the facility affirming that the provider pharmacy and the facility have entered into a written agreement outlining the responsibilities of each party in complying with this chapter and the applicable federal and District laws and regulations.

(b) The Director approves the application. Upon approval of the application, the provider pharmacy will be sent a certificate which must be displayed at the remote site.

1917.4 A provider pharmacy may only utilize a subcontractor for the provision of after-hours and weekend remote pharmacy services; or as emergency staffing where the President of the United States or the Mayor has declared a disaster or bio-terrorism related event in the District of Columbia.

1917.5 A provider pharmacy and the facility shall notify the Director in writing within ten (10) days of a change of location, discontinuance of service, or closure of a remote site or remote pharmacy service.

1917.6 The pharmacist-in-charge or director of pharmacy, of the provider pharmacy is responsible for all pharmacy operations involving the telepharmacy system located at the remote site including supervision of the telepharmacy system and compliance with this section.

1917.7 The following duties shall be performed only by a licensed pharmacist at the provider pharmacy:

(a) Receiving an oral prescription drug order;

(b) Interpreting the prescription drug order;

(d) Interpreting the patient's medication records and conducting a drug regimen review;

(e) Authorizing the telepharmacy system to print a prescription label at the remote site;

(f) Performing the final check of the dispensed prescription to ensure that the prescription drug order has been dispensed accurately as prescribed. The final check shall be accomplished through a visual check using electronic methods; and

(g) Counseling the patient. This counseling may be performed using electronic methods such as telephone, email, video conferencing, and webcam.

1917.8 Nonsterile drugs which require reconstitution through the addition of a specified amount of water may be dispensed by the remote site only if a registered pharmacy technician or an authorized licensed healthcare provider reconstitutes the product.

1917.9 Drugs shall only be dispensed at a remote site through a telepharmacy system if:

(a) An original prescription drug order has been received, or reviewed electronically, by a pharmacist at the provider pharmacy;

(b) A pharmacist at the provider pharmacy has approved the release of the initial dose of a prescription drug order;

(c) A pharmacist at the provider pharmacy has conducted a drug regimen review prior to releasing a prescription drug order to the telepharmacy system; and

(d) A pharmacist is able to electronically supervise the telepharmacy system and the dispensing of the prescription drug order.

1917.10 Drugs may be dispensed by the provider pharmacy through a telepharmacy system at a remote site only in unit-of-use or unit dose containers that are:

(a) Prepackaged in suitable containers at the provider pharmacy and appropriately labeled as required under this Title; or

(b) In original manufacturer's or distributor's containers.

1917.11 A provider pharmacy shall only store drugs at a remote site within an area that is locked by key or combination so as to prevent access by unauthorized personnel.

1917.12 A pharmacist from the provider pharmacy shall be accessible at all times to respond to a patient's or other health professional's questions and needs pertaining to drugs dispensed through a telepharmacy system at a remote site. The access may be by telephone or through a twenty-four (24) hour pager service.

1917.13 The provider pharmacy shall be responsible for ensuring that the requirements set forth under §§ 1913 and 1914 of this Title are met and for maintaining all required records.

1917.14 The pharmacist-in-charge or Director of Pharmacy of the provider pharmacy shall be responsible for ensuring that the remote site and telepharmacy system comply with all applicable federal and District laws and regulations.

1917.15 Nothing in this section shall be construed to permit a pharmacy, or provider pharmacy, located within the District of Columbia to provide remote pharmacy services to a facility or individual located outside of the District of Columbia without legal authorization under the laws of the recipient state or jurisdiction.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008).

22-B DCMR § 1918 PROSPECTIVE DRUG REGIMEN REVIEW

1918.1 For purposes of promoting therapeutic appropriateness, a pharmacist shall, prior to or at the time of dispensing a prescription drug order, review the patient's medication record and each prescription drug order presented for dispensing. The review shall include screening for the following, if available:

(a) Over-utilization or under-utilization;

(b) Therapeutic duplication;

(d) Drug-drug interactions;

(e) Incorrect drug dosage or duration of drug treatment;

(f) Drug-allergy interactions;

(g) Reasonable dose and route of administration;

(h) Clinical abuse/misuse;

(i) Proprietary or over-the-counter drugs;

(j) Natural or herbal products; and

(k) Homeopathic products.

1918.2 Upon identifying any of the above, the pharmacist shall take appropriate steps to avoid or resolve any problem or potential problem including consultation with the practitioner. The pharmacist shall document such occurrences.

1918.3 The pharmacy must maintain the patient profile in a readily retrievable manner meeting the requirements of § 1913.11 of this Chapter.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6751 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008).

22-B DCMR § 1919 PATIENT COUNSELING

1919.1 Following review of a patient's medical record and prior to dispensing a drug or medical device, a pharmacist shall make a verbal offer to counsel, or his designee shall notify the patient or the patient's agent of the opportunity to receive an oral consultation from the pharmacist:

(a) Whenever a prescription drug or device has not previously been dispensed to a patient;

(b) Whenever a prescription drug or device has not previously been dispensed to a patient in the same dosage form, strength, or with the same written directions;

(d) Whenever the pharmacist deems it warranted in the exercise of his or her professional judgment.

1919.2 The pharmacy shall post a sign in a conspicuous manner informing patients of their right to receive an oral consultation from the pharmacist regarding their prescriptions.

1919.3 The consultation shall be face to face, whenever practicable, or by telephone and shall include appropriate elements of patient counseling which may include the following:

(a) The name and description of the drug or device;

(b) The dosage form, dosage, route of administration, and duration of drug therapy;

(d) Special directions and precautions for preparation, administration, and use by the patient;

(e) Common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;

(f) Techniques for self-monitoring of drug therapy;

(g) Proper storage;

(h) Prescription refill information;

(i) Action to be taken in the event of a missed dose; and

(j) Pharmacist comments relevant to the individual's drug therapy, including any other information peculiar to the specific patient, drug, or device.

1919.4 The consultation shall be reinforced with the provision of written information which may include:

(a) Information leaflets:

(b) Pictogram labels; or

1919.5 When the patient or patient's agent is not present, as in the case of prescription deliveries, the pharmacist shall ensure that the patient receives written notice:

(a) Of his or her right to request consultation; and

(b) A telephone number from which the patient may obtain oral consultation from a pharmacist who has ready access to the patient's record.

1919.6 Only a pharmacist may counsel a patient or the patient's agent and answer questions concerning prescription drugs or devices.

1919.7 A pharmacist shall assess to the best of his or her ability that the patient or agent understands the counseling information provided.

1919.8 A pharmacist shall not be required to counsel a patient or caregiver when the patient or caregiver refuses consultation. The pharmacist shall document such refusal for consultation.

1919.9 A pharmacist shall not be required to counsel an inpatient of a health care facility, where other licensed health care professionals are authorized to administer drugs, except upon request.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6752 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008).

22-B DCMR § 1920 PHARMACIST-IN-CHARGE

1920.1 A retail/community pharmacy, special or limited use pharmacy, or non-resident pharmacy shall be managed by a pharmacist (hereafter referred to as "Pharmacist-in-charge"). The pharmacist-in-charge shall be licensed to practice pharmacy in the District of Columbia, except that the pharmacist-in-charge of a non-resident pharmacy shall be licensed in the state in which the pharmacy is located.

1920.2 A pharmacist may not serve as a pharmacist-in-charge unless he is physically present in the pharmacy a sufficient amount of time to provide supervision and control. A pharmacist may not serve as a pharmacist-in-charge for more than one (1) pharmacy at a time except upon obtaining written permission from the Director.

1920.3 In addition to any other responsibilities set forth under this Title, the pharmacist-in-charge or proprietor of a pharmacy shall have the following responsibilities:

(a) Ensuring that quality assurance programs are in place for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems. Quality assurance programs shall be designed to prevent and detect drug diversion;

(b) Developing or adopting, implementing, and maintaining a training manual and program for the training of all individuals employed in the pharmacy who are legally authorized to assist in the practice of pharmacy. The pharmacist-in-charge shall be responsible for supervising the training program;

(c) Developing or ensuring the establishment of policies and procedures for the procurement, storage, security, and disposition of drugs and devices;

(d) Developing or ensuring the establishment of policies and procedures for the provision of pharmacy services;

(e) Ensuring that the automated pharmacy system is in good working order and accurately dispenses the correct strength, dosage form, and quantity of the drug prescribed while maintaining appropriate recordkeeping and security safeguards;

(f) Implementing an ongoing quality assurance program that monitors performance of the automated pharmacy system, which is evidenced by written policies and procedures;

(g) Ensuring that all pharmacists employed at the pharmacy are currently licensed in the District of Columbia, or if it is a non-resident pharmacy, in the state in which the pharmacy is located;

(h) Ensuring that all pharmacy interns employed at the pharmacy are currently registered in the District of Columbia;

(i) Ensuring the making or filing any reports required by federal or District of Columbia laws or regulations, which shall include but not be limited to, notifying the Director of the occurrence of any of the following:

(1) Permanent closing;

(2) Change of proprietorship, management, location, or pharmacist-in-charge;

(3) Any theft or loss of prescription drugs or medical devices;

(4) Conviction of any employee of any federal, state, or District of Columbia drug laws;

(5) Disasters, accidents, or any theft, destruction, or loss of records required to be maintained by federal or District of Columbia law or regulation;

(6) Occurrences of significant adverse drug reactions;

(7) Illegal use or disclosure of protected patient health information;

(j) Developing or ensuring the establishment of policies and procedures for preventing the illegal use or disclosure of protected health information, or verifying the existences thereof and ensuring that all employees of the pharmacy read, sign, and comply with the established polices and procedures; and

(k) Developing or ensuring the establishment of a procedure for proper management of drug recalls which may include, where appropriate, contacting patients to whom the recalled drug product(s) have been dispensed.

1920.4 The pharmacist-in-charge may be assisted by a sufficient number of pharmacists, pharmacy interns, and pharmacy technicians as may be required to competently and safely provide pharmacy services.

1920.5 The pharmacist-in-charge or proprietor of a pharmacy shall assure the development and implementation of written policies and procedures to specify the duties to be performed by pharmacy interns and pharmacy technicians. The duties and responsibilities of these personnel shall be consistent with their training and experience. These policies and procedures shall, at a minimum:

(a) Specify that pharmacy interns and pharmacy technicians are to be personally and directly supervised by a pharmacist stationed within the same work area who has the ability to control and who is responsible for the activities of the pharmacy interns and pharmacy technicians; and

(b) Specify that pharmacy interns and pharmacy technicians shall not be assigned duties that may be performed only by a pharmacist, which shall include but not be limited to:

(1) Drug utilization review;

(2) Clinical conflict resolution;

(3) Prescriber contact concerning prescription drug order clarification;

(4) Patient counseling on prescription, over-the-counter, and herbal products;

(5) Dispensing process validation;

(6) Receiving new oral prescription drug orders, or refill authorizations;

(7) Prescription transfers; and

(8) Independent compounding.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6752 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008).

22-B DCMR § 1921 INSTITUTIONAL PHARMACIES

1921.1 An institutional pharmacy shall be managed by a pharmacist (hereafter referred to as "Director of Pharmacy ") who is licensed to practice pharmacy in the District of Columbia.

1921.2 The Director of Pharmacy shall be a full-time employee of the institutional facility in which the institutional pharmacy is located, except that the Director of Pharmacy may be a part-time employee when the pharmacy department or service is not located on site and a formal agreement exists for the provision of pharmaceutical services to the institution.

1921.3 The recordkeeping requirements of this section may be met by maintaining the most recent two years of records on site and the remaining three years of records off site as long as the records can be retrieved within three (3) business days of a request.

1921.4 The Director of Pharmacy shall be responsible for, at a minimum, the following:

Developing or ensuring that the institutional pharmacy meets all requirements set forth under applicable federal and District of Columbia laws and regulations;

Developing or adopting, and maintaining, and making available written policies and procedures that delineate the operation and activities of the provision of pharmacy services for the institution that ensure compliance with all applicable federal and District of Columbia laws and regulations;

Ensuring that the pharmacy maintains and makes available a sufficient inventory of antidotes and other emergency drugs, both in the pharmacy and in patient care areas, as well as current antidote information, telephone numbers of regional poison control centers, and other emergency assistance organizations, and other materials and information as may be deemed necessary by the appropriate committee of the institutional facility, if any;

Ensuring the provision of the appropriate level of pharmaceutical care services to patients of the institutional facility;

Ensuring that drugs and devices are prepared for distribution safely, and accurately as prescribed;

Ensuring a sufficient supply of drugs and devices to meet the needs of the patients of the institutional facility, and other appropriate equipment for the preparation thereof;

Developing or ensuring the establishment of a system for the compounding, sterility assurance, quality assurance, and quality control of sterile pharmaceuticals compounded within the institutional pharmacy;

Developing or ensuring the establishment of a system to assure that all pharmacy personnel responsible for compounding or for supervising the compounding of sterile pharmaceuticals within the pharmacy receive appropriate education and training and competency evaluation;

Ensuring the provision of written guidelines and approval of the procedures to assure that all pharmaceutical requirements are met when any part of preparing, sterilizing, and labeling of sterile pharmaceuticals is not performed under direct pharmacy supervision;

Developing or ensuring the establishment of a system for bulk compounding or batch preparation of drugs;

Ensuring that the pharmacy maintains records of all transactions of the institutional pharmacy as may be required by applicable federal or District of Columbia law or regulations, and as may be necessary to maintain accurate control over and accountability for all pharmaceutical materials;

Ensuring that the records in a data processing system are maintained in compliance with federal and District of Columbia laws and regulations;

Ensuring the automated medication dispensing system is operated and maintained in compliance with federal and District of Columbia laws and regulations;

Maintaining and making available metric-apothecaries weight and measure conversion tables and charts to applicable personnel;

Maintaining and making available current reference materials on toxicology, pharmacology, bacteriology, sterilization, and disinfection;

Preparation and sterilization of parenteral medications compounded within the institutional facility;

Ensuring the education and training of nursing personnel concerning incompatibility and provision of proper incompatibility information when the admixture of parenteral products is not accomplished within the institutional pharmacy;

Developing or ensuring the establishment and implementation of policies and procedures to ensure that discontinued and outdated drugs, and containers with worn, illegible, or missing labels are returned to the pharmacy for proper disposition, or that the Director of Pharmacy, or his or designees, make proper disposition of such drugs at the storage site;

Developing or ensuring the establishment of and implementation of a recall procedure to assure the medical staff and the pharmacy staff that all drugs included on the recall are returned to the pharmacy for proper disposition;

Ensuring documentation of suspected and reported adverse drug reactions to the prescriber;

(u) Ensuring the making and maintaining of reports of suspected reactions to the FDA, to the manufacturer, and to the United States Pharmacopeia, and reporting of drug product defects accordingly;

(v) Developing or ensuring the establishment of procedures for an ongoing quality assurance program of pharmaceutical services that include a mechanism for reviewing and evaluating drug related patient care, as well as an appropriate response to findings;

(w) Notifying the Director of the occurrence of any of the following:

(1) Permanent closing of the pharmacy;

(2) Change of proprietorship, management, location, or pharmacist-in-charge of the pharmacy;

(3) Any theft or loss of prescription drugs or medical devices from the pharmacy;

(4) Conviction of any employee of the pharmacy of any federal, state, or District of Columbia drug laws;

(5) Disasters or accidents resulting in damage to the pharmacy facility, or

inventory;

(6) Any theft, destruction, or loss of records required to be maintained by

federal or District of Columbia law or regulation;

(7) Occurrences of significant adverse drug reactions; or

(8) Illegal use or disclosure of protected patient health information; and

(x) Ensuring the making or filing of any reports required by federal or District of Columbia laws or regulations.

1921.5 The Director of Pharmacy shall maintain the following records for a period of five (5) years:

Physician's orders;

Proofs of use of Schedule II controlled substances and any other drugs requested or required;

Reports of suspected adverse drug reactions;

Drug distribution records from night cabinets, automated medication dispensing systems, emergency kits, and similar systems;

Inventories of the pharmacy;

Inventories of controlled substances;

Alcohol and flammable reports; and

Any other records and reports as may be required by federal or District of Columbia law and regulations.

1921.6 In the event of an adverse drug reaction, an entry reflecting the reaction shall be made on the patient's pharmacy record.

1921.7 The Director of Pharmacy, at least once a month, shall inspect the pharmacy and all areas of the institution where drugs are stored or maintained, and make appropriate written records and notations of those inspections. An inspection shall verify that:

Licensed pharmacists are responsible for all drugs dispensed and all prescription orders are checked by licensed pharmacists prior to leaving the pharmacy;

(b) Ancillary pharmacy personnel are properly directed and supervised;

(d) Outdated drugs are retired from stock in the institutional pharmacy or the facility it serves;

(e) Controlled substances which have been distributed are properly and adequately documented and recorded by pharmacy personnel;

(f) Emergency medication kits are adequate and in proper supply both within the pharmacy and at outside storage locations; and

(g) Security and storage standards are met.

1921.8 The Director of Pharmacy shall be assisted by a sufficient number of additional licensed pharmacists as may be required to operate the institutional pharmacy competently, safely, and adequately to meet the needs of the patients of the facility.

1921.9 Trained technical and administrative personnel may be employed in a support capacity in institutional pharmacies, provided that the support activities are performed under the supervision of a pharmacist.

1921.10 Areas occupied by an institutional pharmacy shall be capable of being locked by key or combination to prevent access by unauthorized personnel.

1921.11 An institutional pharmacy, or any part thereof, shall be locked in the absences of personal and direct supervision by authorized personnel.

1921.12 The Director of Pharmacy shall designate in writing, by title and specific area, those persons who have access to particular areas within the pharmacy during non-business hours of the pharmacy.

1921.13 Authorized persons may have access to designated areas in the institutional pharmacy, and may remove drugs in compliance with the institution's established policies and procedures.

1921.14 Personnel authorized to have access to designated areas in the institutional pharmacy, shall receive thorough education and training in the proper methods of access, removal of drugs, and records and procedures required, prior to being permitted access to those areas of the pharmacy.

1921.15 The Director of Pharmacy or his or her designee shall administer the education and training required by § 1921.14 of this chapter.

1921.16 Removal of any drug from the pharmacy by an authorized person shall be recorded on a suitable form showing the patient's name, identification number, room number, name of the drug, strength, amount, date, time and the signature of the authorized person. The form shall be left with the container from which the drug was removed.

1921.17 During the times that an institutional pharmacy may be unattended by a licensed pharmacist, arrangements shall be made in advance by the Director of Pharmacy for provision of drugs to the licensed medical staff and other authorized personnel of the institutional facility by use of night cabinets, automated medication dispensing systems, telepharmacy systems, or by similar means, and in emergency circumstances, by access to a designated area of the pharmacy by persons authorized to handle, manage, or administer medication. A pharmacist shall be "on call" during all absences.

1921.18 If night cabinets are used, the following procedures shall be used:

(a) In the absence of a licensed pharmacist, drugs shall be stored in a locked cabinet or other enclosure constructed and located outside of the pharmacy area, to which only specifically authorized personnel may obtain access by key or combination, and which is sufficiently secure to deny access to unauthorized persons by force or otherwise;

(b) The Director of Pharmacy, in conjunction with the appropriate committee of the institutional facility, shall develop inventory listings of those drugs to be included in night cabinets and shall ensure that:

All drugs available in the cabinet or similar container are properly stored and labeled; and

Only prepackaged drugs are available, in amounts sufficient for immediate therapeutic requirements;

Whenever access to the cabinet occurs, written practitioners' orders and proofs-of-use are provided to the pharmacist by the start of the business the following business day;

All drugs therein are inventoried no less than once per week;

A complete audit of all activity concerning the cabinet is conducted no less than once per month; and

Written polices and procedures are established to implement the requirements of this subsection.

1921.19 Whenever any drug is not available from floor supplies, night cabinets, automated medication dispensing systems, telepharmacy systems, or by similar means, and the drug is required to treat the immediate needs of a patient whose health would otherwise be jeopardized, the drug may be obtained from the pharmacy in accordance with the following requirements:

(a) One (1) supervisory registered professional nurse, and only one (1), in any given eight (8) hour shift is responsible for obtaining drugs from the pharmacy. The responsible nurse shall be designated in writing by the appropriate committee of the institutional facility. The responsible nurse may, in times of emergency, delegate this duty to another licensed registered nurse;

The responsible nurse shall, prior to being permitted to obtain access to the pharmacy, receive thorough education and training in the proper methods of access, removal of drugs, and records and procedures; and

The Director of Pharmacy or his or her designee shall administer the education and training required in subsection (b) of this section.

1921.20 Removal of any drug from the pharmacy by an authorized nurse shall be recorded on a suitable form showing the patient's name, room number, name of the drug, strength, amount, date, time and the signature of the nurse. The form shall be left with the container from which the drug was removed.

1921.21 Investigational drugs shall be stored in and dispensed from the pharmacy only by a pharmacist. All information with respect to investigational drugs shall be maintained in the pharmacy.

1921.22 For an institutional facility that does not have an institutional pharmacy, drugs may be provided for use by authorized personnel by emergency kits located at the facility, provided the following requirements are met:

The pharmacist-in-charge at the provider pharmacy shall determine, in consultation with the medical and nursing staff of the facility, which drugs and what quantity of those drugs should be included in the emergency kit and prepare the kit for use only by those persons licensed or authorized to administer drugs;

The emergency kit shall contain the drugs required to meet the immediate therapeutic needs of patients and which are not available from any other authorized source in sufficient time to prevent risk of harm to patients by delay resulting from obtaining such drugs from such other sources;

The emergency kit shall be sealed with a tamper evident seal, and stored in a secured area to prevent unauthorized access by force or otherwise, and to ensure a proper environment for preservation of the drugs inside the kit;

The exterior of the emergency kit shall be labeled so as to clearly indicate that it is an emergency drug kit and that it is for use in emergencies only. The label shall contain a listing of the drugs contained in the kit, including the name, strength, quantity, and expiration date of the contents, and the name, address, and telephone number of the pharmacy who prepared the kit;

All drugs contained in an emergency kit shall be labeled with the necessary information required by the medical staff of the institutional facility to prevent misunderstanding or risk of harm to the patients;

Drugs shall be removed from emergency kits only pursuant to a valid written or verbal order by an authorized prescriber;

Whenever an emergency kit is opened, the provider pharmacist shall be notified and the pharmacist shall restock and reseal the kit as soon as possible, but not more than seventy-two (72) hours after notification. In the event the kit is opened in an unauthorized manner, the pharmacist and other appropriate personnel of the facility shall be notified;

The expiration date of an emergency kit shall be the earliest date of expiration of any drug supplied in the kit. Upon the occurrence of the expiration date, the provider pharmacist shall replace the expired drug; and

The provider pharmacist shall, in conjunction with the medical staff of the institutional facility, develop and implement written policies and procedures to ensure compliance with the provisions of this subsection, and other applicable federal and District of Columbia laws and regulations.

1921.23 Drugs shall be dispensed from the institutional pharmacy only pursuant to the valid prescription order of an authorized practitioner.

1921.24 The Director of Pharmacy shall maintain a listing, including signatures, of those practitioners who are authorized to issue orders to the institutional pharmacy.

1921.25 Drugs brought into an institutional facility by a patient shall not be administered unless they can be identified by the pharmacist and the quantity and quality of the drug assured.

1921.26 The Director of Pharmacy shall develop or ensure the establishment and implementation of policies and procedures to ensure that if drugs brought into an institutional facility by a patient are not to be administered, that they are properly returned to an adult member of the patient's immediate family.

1921.27 Prescription drug orders for use by inpatients of the facility shall contain the following information:

(a) Patient name, identification number, and room number;

(b) Drug name;

(d) Directions for use and route of administration;

(e) Date and physician's signature, or signature of his or her authorized representative; and

(f) The words "Patient May Use Own Medications" when the prescription drug order is being written for drugs brought into the institution by the patient pursuant to § 1921.25.

1921.28 Prescription drug orders for use by outpatients shall, in addition to the information items required by § 1921.27, contain the patient's address, the facility's address, and DEA registration number, if applicable.

1921.29 Drugs dispensed for use by inpatients of an institutional facility, whereby the drug is not in the possession of the ultimate user prior to administration, shall be dispensed in appropriate containers and adequately labeled to meet the following requirements:

(a) The label of a single-unit package of an individual-dose or unit-dose system of packaging of drugs shall include:

The generic, chemical, or brand name of the drug;

The route of administration, if other than oral;

The strength and volume, where appropriate,

The control number or lot number, and expiration date;

Identification of the repackager by name or by license number and shall be clearly distinguishable from the rest of the label; and

Special storage conditions, if required.

(b) When a multiple-dose drug distribution system (i.e. blister cards) is utilized, including dispensing of single unit packages, the drugs shall be dispensed in a container to which is affixed a label containing the following information:

(1) Identification of the dispensing pharmacy;

(2) The patient's name;

(3) The date of dispensing;

(4) The generic, chemical, or brand name of the drug dispensed; and

(5) The drug strength.

1921.30 All drugs dispensed to inpatients for self administration, and all drugs dispensed to ambulatory or outpatients, shall contain a label affixed to the container indicating:

(a) The name and address of the pharmacy dispensing the drug;

(b) The name of the patient for whom the drug is prescribed; or, if the patient is an animal, the name of the owner, name of the animal, and the species of the animal;

(d) Such directions as may be stated on the prescription drug order;

(e) The date of dispensing;

(f) Any cautions which may be required by federal or District of Columbia law,

(g) The serial number or prescription number of the prescription drug order;

(h) The name or initials of the dispensing pharmacist;

(i) The generic, chemical, or brand name of the drug dispensed;

(j) The strength, dosage, and quantity of the drug dispensed;

(k) The name of the manufacturer or distributor of the drug; and

(l) The expiration date.

1921.31 Beginning six (6) months after the effective date of these regulations, pharmacies engaged in the practice of compounding and dispensing of any drugs shall comply with the standards set forth in the current published edition of USP General Chapters 795, 797, and 800 relevant to the type of compounding and dispensing undertaken.

1921.32 [REPEALED]

1921.33 In addition to existing labeling requirements, parenteral product labels shall include:

Telephone number of the pharmacy;

Name and concentrations of all ingredients contained in the parenteral product, including primary solution;

(d) A label for all cytotoxic agents which shall state: "Chemotherapy - Dispose of Properly".

1921.34 Pharmacies engaged in the practice of compounding and dispensing of parenteral solutions shall have on the premises, or readily accessible, a patient record for each patient being treated with parenteral therapy. In addition to existing recordkeeping requirements, the following records shall be maintained in the pharmacy:

(a) Records of the furnishing of all prescriptions and medical supplies;

(b) Progress notes documenting contact with the patient or physician relative to parenteral therapy; and

1921.35 [REPEALED]

1921.36 The Director of pharmacy shall ensure that all pharmacists engaging in compounding parenteral solutions have training or have demonstrated previous training in the safe handling and compounding of parenteral solutions, including cytotoxic agents.

1921.37 Beginning six (6) months after the effective date of these regulations, pharmacies providing parenteral services shall have written policies and procedures for the disposal of infectious materials, materials containing cytotoxic residues, and all preparations and waste that may be produced or used in compounding or the final product. The procedures shall include cleanup of spills and shall conform with applicable District of Columbia and federal law and regulations as well as the current published editions of USP General Chapters 795, 797, and 800 as applicable.

1921.38 The pharmacist or their designated individual is responsible for developing and maintaining a quality assurance program that insures a clean and sanitary environment for the preparation of sterile products and ensures that the parenteral products that are produced are sterile. The pharmacist or their designated individual is required to develop and implement a training program to be completed by all sterile compounders under their supervision concerning the implementation of the quality assurance program. Documentation of these activities, including, but not limited to, a written training program and tests used to demonstrate familiarity of the quality assurance program requirements, shall be available to the Director.

1921.39 [REPEALED]

1921.40 [REPEALED]

1921.41 [REPEALED]

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6753 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008); as amended by Notice of Final Rulemaking published at 57 DCR 10518 (November 12, 2010); as amended by Final Rulemaking published at 69 DCR 002763 (April 1, 2022). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1921

22-B DCMR § 1922 NUCLEAR PHARMACIES

1922.1 A pharmacy, institution, or other establishment that provides radiopharmaceutical services shall obtain from the Director a nuclear pharmacy license. The license to operate a nuclear pharmacy shall be conditioned upon approval of the United States Nuclear Regulatory Commission (NRC) where applicable.

1922.2 A license to operate a pharmacy providing radiopharmaceutical services shall only be issued to a qualified nuclear pharmacist as defined in § 1922.3.

1922.3 A qualified nuclear pharmacist shall:

(a) Be a currently licensed pharmacist in the District of Columbia;

(b) Have met the Nuclear Regulatory Commission standards of training for medically used or radioactive by-product material; and

(c) Be currently certified as a nuclear pharmacist by a certification board recognized by the Board; or in lieu of certification:

Submit proof acceptable to the Board that the individual has completed a minimum of two hundred (200) contact hours of didactic instruction in nuclear pharmacy and the safe handling and the use of radioactive material from a program recognized by the Board; and

Submit proof acceptable to the Board that the individual has completed a minimum of five hundred (500) hours of supervised clinical nuclear pharmacy training under the supervision of a qualified nuclear pharmacist in a nuclear pharmacy providing nuclear pharmacy services or in a structured clinical nuclear pharmacy training program in an approved school of pharmacy.

1922.4 A qualified nuclear pharmacist shall be responsible for all operations of the nuclear pharmacy and shall be in personal attendance at all times that the nuclear pharmacy is open for business.

1922.5 A nuclear pharmacy shall be managed by a nuclear pharmacist (hereafter referred to "Responsible Nuclear Pharmacist ") who is licensed to practice pharmacy in the District of Columbia. A nuclear pharmacist shall not be the Responsible Nuclear Pharmacist for more than one nuclear pharmacy at a time.

1922.6 The Responsible Nuclear Pharmacist shall be assisted by a sufficient number of additional authorized nuclear pharmacists as may be required to operate the pharmacy competently, safely, and adequately to meet the needs of the patients of the pharmacy.

1922.7 All personnel performing tasks in the preparation and distribution of radioactive drugs shall be under the direct supervision of a qualified nuclear pharmacist.

1922.8 The Responsible Nuclear Pharmacist shall designate in advance, one or more other licensed pharmacists to have access to the licensed area in emergency situations when a qualified nuclear pharmacist is not present. These pharmacists may obtain single doses of radiopharmaceuticals for the immediate emergency and shall document such withdrawals in the control system.

1922.9 The Responsible Nuclear Pharmacist shall be responsible for, at a minimum, the following:

(a) Ensuring that radiopharmaceuticals are dispensed and delivered safely and accurately as prescribed;

(b) Developing a system to ensure that all personnel responsible for compounding or supervising the compounding of radiopharmaceuticals within the pharmacy receive appropriate education and training and competency evaluation;

(c) Establishing policies for procurement of drugs and devices and storage of all pharmaceutical materials including radiopharmaceuticals, components, used in the compounding of radiopharmaceuticals, and drug delivery practices;

(d) Developing a system for the disposal and distribution of drugs from the pharmacy;

(e) Developing a system for the compounding, sterility assurance, and quality control of sterile radiopharmaceuticals;

(f) Maintaining records of all transactions of the pharmacy necessary to maintain accurate control over and accountability for all pharmaceutical materials including radiopharmaceuticals, required by applicable federal and District of Columbia laws and regulations;

(g) Developing a system to ensure maintenance of effective controls against the theft or diversion of prescription drugs, and prescription records;

(h) Ensuring that the pharmacy has a system to dispose of radioactive and cytotoxic waste in a manner so as not to endanger the public health;

(i) Developing and implementing written policies and procedures to ensure compliance with the applicable provisions of federal and District of Columbia laws and regulations;

(j) Notifying the Director of the occurrence of any of the following:

(1) Permanent closing of the pharmacy;

(2) Change of proprietorship, management, location, or pharmacist-in-charge of the pharmacy;

(3) Any theft or loss of prescription drugs or medical devices from the pharmacy;

(4) Conviction of any employee of the pharmacy of any federal, state, or District of Columbia drug laws;

(5) Disasters or accidents resulting in damage to the pharmacy facility, or

inventory;

(6) Any theft, destruction, or loss of records required to be maintained by

federal or District of Columbia law or regulation;

(7) Occurrences of significant adverse drug reactions; or

(8) Illegal use or disclosure of protected patient health information; and

(k) Ensuring the making or filing of any reports required by federal or District of Columbia laws or regulations.

1922.10 Nuclear pharmacies shall have adequate space and equipment, commensurate with the scope of services required and provided, meeting minimal space requirements established for all pharmacies in the District or as otherwise defined by the Director.

1922.11 The Nuclear Pharmacy area shall be secured from unauthorized personnel.

1922.12 In a nuclear pharmacy providing ordinary pharmacy services in addition to radiopharmaceutical services, the nuclear pharmacy area shall be separate from the pharmacy areas for non-radioactive drugs and shall be secured from unauthorized personnel.

1922.13 All pharmacies handling radiopharmaceuticals shall provide a radioactive storage and product decay area, occupying at least twenty-five (25) square feet of space, separate from and exclusive of the hot laboratory, compounding, dispensing, quality assurance and office areas.

1922.14 Nuclear pharmacies shall maintain records of acquisition, inventory, and disposition of all radioactive drugs and other radioactive materials in accordance with all applicable federal and District of Columbia laws and regulations.

1922.15 A nuclear pharmacy shall have the equipment and reference material required under § 1909 of this Title as well as all other applicable federal and District of Columbia laws and regulations.

1922.16 Radiopharmaceuticals shall be dispensed only upon a prescription drug order from a practitioner authorized to possess, use, and administer radiopharmaceuticals.

1922.17 A nuclear pharmacy shall dispense only radiopharmaceuticals which comply with acceptable standards of radiopharmaceutical quality assurance.

1922.18 The immediate outside container (shield) of a radioactive drug to be dispensed shall bear the following information:

(a) The name and address of the nuclear pharmacy;

(b) The name of the prescriber (authorized user);

(d) The serial number, lot number, or prescription number assigned to the radiopharmaceutical order;

(e) The standard radiation symbol;

(f) The name of the diagnostic procedure;

(g) The words "Caution: Radioactive Material";

(h) The name of the radionuclide and chemical form;

(i) The amount of radioactivity and the calibration date and time;

(j) The expiration date and time;

(k) In the case of a diagnostic radiopharmaceutical, the patient's name or the words "Per Physician's Order";

(l) In the case of a therapeutic radiopharmaceutical, the patient's name;

(m) The activity and date and time of assay;

(n) The volume, if in liquid form; and

(o) The requested activity and the calibrated activity.

1922.19 The immediate inner container shall be labeled with:

(a) The standard radiation symbol;

(b) The words "Caution-Radioactive Material"; and

1922.20 Orders for radiopharmaceuticals, whether written or verbal, shall include at least the following information:

(a) The name of the institution or facility and the name of the person transmitting the order;

(b) The date that the radiopharmaceutical will be needed and the calibration time;

(d) The dose or activity of the radiopharmaceutical at the time of calibration; and

(e) In the case of a therapeutic radiopharmaceutical or a radiopharmaceutical blood product, the name of the patient shall be obtained prior to dispensing.

1922.21 The amount of radioactivity shall be determined by radiometric methods for each individual dose immediately prior to dispensing.

1922.22 Beginning six (6) months after the effective date of these regulations, a nuclear pharmacy shall comply with applicable laws and regulations of District of Columbia and federal agencies, including the laws and regulations governing any non-radioactive drugs, and any medical devices that may be dispensed, and all other requirements set forth in the current published editions of USP General Chapters 795, 797, 800 and 825 relevant to the type of compounding being undertaken.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6761 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008); as amended by Notice of Final Rulemaking published at 57 DCR 10518, 10519 (November 12, 2010); as amended by Final Rulemaking published at 69 DCR 002763 (April 1, 2022). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1922

22-B DCMR § 1923 PHARMACY FEES

1923.1 The fees related to pharmacies are as follows:

(a) Biennial License Fee: $900.00

(b) Late Fee: $125.00

(d) Duplicate certificate: $35.00

(e) License validation: $35.00

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6763 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008); as amended by Fiscal Year 2011 Budget Support Act of 2010, effective September 24, 2010 (D.C. Law 18-223), published at 57 DCR 6242, 6357 (July 23, 2010).

22-B DCMR § 1924 RESERVED

22-B DCMR § 1925 INSPECTION AND INVESTIGATION

1925.1 The Director, or his agent, shall have the right to enter upon and into the premises of any licensee, registrant, applicant for a license or registration, pharmacy or other location where prescription drugs or devices are stored, or reasonably believed to be stored:

(a) At reasonable times,

(b) After presenting proper identification; and

(c) For the purpose of making compliance inspections or conducting complaint investigations concerning the laws and regulations applicable to the practice of pharmacy, operation of pharmacies, and handling of controlled and prescription drugs.

1925.2 An inspection or investigation conducted under this Title may include:

(a) The examination of the pharmacy records, including prescriptions, invoices, and inventory records;

(b) The obtaining of prescriptions, information, and samples pertaining to drugs dispensed;

(c) The examination of any drugs, medical devices, or any other pharmaceutical products or medicinal chemicals that are in the pharmacy; and

(d) The review of any records and publications that are required by any applicable District of Columbia or federal laws or regulations to be kept in a pharmacy.

The Director may delegate to staff of the Department the authority to conduct inspections of pharmacy operations covered by this chapter. Inspections shall be conducted upon the issuance of a new license and at least annually thereafter. Inspections may be conducted more frequently as often as the Director deems necessary or useful.

1925.4 The Director shall delegate staff to investigate complaints of violations of the Act, this chapter, and all other applicable laws and regulations regarding the practice of pharmacy and the operation of a pharmacy.

1925.5 The Director may delegate to staff of the Department the authority to conduct compliance inspections, audits, and other inspections required under the Act to ensure accountability for all controlled substances and to ensure compliance with laws regulating the practice of pharmacy and the distribution of prescription drugs and devices in the District and all other applicable laws and regulations regarding the practice of pharmacy and the operation of a pharmacy.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6766 (November 8, 1991); as amended by Final Rulemaking published at 55 DCR 270 (January 11, 2008); as amended by Final Rulemaking published at 57 DCR 5741 (July 2, 2010).

22-B DCMR § 1926 TAKING OF SAMPLES

1926.1 Whenever the Director or other authorized agent of the Department has reason to believe that a drug or medical device is maintained or dispensed in violation of these rules or other District or federal laws or regulations, he or she may take a sample of that item or items pursuant to this section.

1926.2 In addition to sample taking authorized pursuant to § 1926.1 of this chapter, the Director or authorized agent may take a reasonable number of samples as a part of the regular pharmacy inspection process to check for compliance with the Act, this chapter, and other laws or regulations applicable to the practice of pharmacy.

1926.3 The Director or authorized agent may affix to a product, device, or drug a tag or other appropriate marking giving notice that the sample product has been marked for inspection.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6767 (November 8, 1991).

22-B DCMR § 1927 OPPORTUNITY FOR A HEARING

1927.1 The Director shall take action to deny, suspend, or revoke a pharmacy license pursuant to § 11 of the Act, D.C. Code, 2001 Ed. § 47-2885.10.

1927.2 Except for a summary suspension undertaken pursuant to § 11(b) of the Act, D.C. Code, 2001 Ed. § 47-2885.10(b), every applicant for or holder of a license or applicant for reinstatement after revocation shall be afforded notice and an opportunity to be heard prior to the action of the Director, the effect of which would be one of the following:

(a) To deny a license for cause other than failure to qualify;

(b) To suspend a license;

(d) To refuse to reinstate a license;

(e) To refuse to issue a renewal license for any cause other than failure to pay the prescribed fees; or

(f) Impose a civil fine pursuant to the Department of Consumer and Regulatory Affairs Civil Infractions act of 1985, D.C. Code, 2001 Ed. §§ 2-1801.01 to 2-1803.03.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6767 (November 8, 1991).

22-B DCMR § 1928 NOTICE OF CONTEMPLATED ACTION

1928.1 When the Director contemplates denying a license for failure to qualify, he or she shall give the applicant written notice containing the following statements:

(a) That the applicant has failed to satisfy the Director as to the applicant’s qualifications;

(b) The respect in which the applicant has failed to satisfy the Director;

(c) That the denial will become final unless the respondent files a request for a hearing with the Director within fifteen (15) days of the receipt of the notice; and

(d) A description of the rights of the respondent at a hearing as specified in § 1932.3.

1928.2 When the Director contemplates taking any action of the type specified in § 1927.2(b), (c), (d), or (e) of this chapter, he or she shall give the licensee a written notice containing the following statements:

(a) That the Director has sufficient evidence which, if not rebutted or explained, justifies the Director in taking the contemplated action;

(b) That the Director may take the proposed action, unless within fifteen (15) days of the receipt of the notice the respondent files with the Director a written request for a hearing or in the alternative submits documentary evidence for the Director’s consideration before the Director takes final action; and

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6768 (November 8, 1991).

22-B DCMR § 1929 NOTICE OF HEARING

1929.1 Any notice required by this chapter may be served either personally or by certified mail, return receipt requested, directed to the respondent at his or her last known address as shown by the records of the Department of Consumer and Regulatory Affairs.

1929.2 If notice is served personally, it shall be deemed to have been served at the time delivery is made to the respondent.

1929.3 If notice is served by certified mail, it shall be deemed to have been served on the date shown on the return receipt showing delivery or refusal of the respondent to receive notice.

1929.4 In the event the respondent is no longer at the last known address as shown by the records of the Department of Consumer and Regulatory Affairs and no forwarding address is available, the notice shall be deemed to have been served on the date the return receipt bearing such notification is received by the Director.

1929.5 If a respondent scheduled for a hearing does not appear and no continuance has been or is granted, the Director may hear the evidence of those witnesses present, and the Director may proceed to consider the matter and render a decision on the basis of the evidence presented.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6768 (November 8, 1991).

22-B DCMR § 1930 PROCEDURE WHEN A RESPONDENT FAILS TO RESPOND TO A HEARING NOTICE

1930.1 If the respondent does not respond to the hearing notice within the time specified, the Director may, without a hearing, take the action contemplated in the notice. The Director shall, in writing, inform the respondent, the Corporation Counsel, and the Board of his or her action.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6769 (November 8, 1991).

22-B DCMR § 1931 HEARINGS-SUMMARY SUSPENSION AND DENIAL OF RENEWAL

1931.1 A hearing shall be convened within five (5) days of the institution of proceedings in the following cases:

(a) Summary suspension; and

(b) Denial of renewal.

1931.2 A respondent who has been summarily suspended pursuant to § 11(b) of the Act, D.C. Code, 2001 Ed. § 47-2885.10(b), or notified of intent to deny renewal, shall be entitled, upon written request, to a hearing, or to a postponement, for a reasonable time only, of the hearing scheduled pursuant to this section.

1931.3 If a hearing is requested pursuant to this section, the request shall not serve to stay the issuance of an order suspending or denying the license.

1931.4 Except as otherwise noted in this chapter, all procedures relating to hearings as set forth within this chapter shall apply to hearings on summary suspensions and denials of renewal.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6769 (November 8, 1991).

22-B DCMR § 1932 CONDUCT OF HEARINGS

1932.1 All hearings before the Director shall be open to the public.

1932.2 The Director, or his or her designee, shall hear the evidence and render a decision.

1932.3 A respondent entitled to a hearing shall have the following rights:

(a) To be represented by counsel or other representative;

(b) To present all relevant evidence by means of witnesses, books, papers, and documents;

(d) To have subpoenas issued, upon written request to the Director, to compel the attendance of witnesses and the production of relevant books, papers and documents.

1932.4 In conducting a hearing pursuant to this chapter, the Director is authorized to do the following:

(a) Administer oaths or affirmation to witnesses called to testify pursuant to D.C. Code, 2001 Ed. § 1-301.22;

(b) Subpoena respondents, witnesses, books, papers, and documents pursuant to D.C. Code, 2001 Ed. § 1-301.21;

(d) Examine witnesses;

(e) Order a continuance; and

(f) Enter into a consent agreement.

1932.5 The Director shall receive and consider any evidence or testimony; however, the Director may exclude irrelevant, immaterial, or unduly repetitious evidence or testimony.

1932.6 In any proceeding resulting from the Director’s contemplated action to deny licensure, the applicant shall have the burden of satisfying the Director of the applicant’s qualifications.

1932.7 In any proceeding resulting from the Director’s contemplated action to refuse to renew, to suspend, or to revoke a license, or to refuse to restore a license, the Department shall have the burden of proving that the action should be taken.

1932.8 A complete record shall be made of all evidence presented during the course of a hearing. Any party to the proceedings shall be furnished with a copy of the record upon request and payment of a fee prescribed by the Director.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6770 (November 8, 1991).

22-B DCMR § 1933 DECISIONS

1933.1 The decision of the Director shall include the following:

(a) Findings of fact;

(b) Conclusions of law; and

(c) A statement informing the respondent concerning his or her right to have the decision reviewed by the Board of Appeals and Review, and the time period within which the request for such a review must be filed.

1933.2 Within seven (7) days after the decision issued, the Director shall serve upon the respondent, or his or her attorney of record, a copy of the written decision, either by personal service or certified mail, return receipt requested. If served by certified mail, it shall be deemed served on the date contained on the return receipt for acceptance or refusal, or the date of the unsuccessful attempt of the postal service to make delivery.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6771 (November 8, 1991).

22-B DCMR § 1934 ADMINISTRATIVE AND JUDICIAL REVIEW

1934.1 When a respondent fails, for good cause, to appear for a hearing which has been scheduled, the respondent may, within thirty (30) days from the date of the decision, apply to the Director to reopen the proceedings. The Director, upon finding the cause sufficient, may fix a time and place for the hearing and shall give notice to the parties.

1934.2 The Director may reopen a proceeding for any cause he or she deems sufficient, provided that no appeal is pending or no decision has been issued regarding the case by the Board of Appeals and Review or a court.

1934.3 A respondent aggrieved by an adverse decision by the Director may seek a review of the decision by the Board of Appeals and Review according to its rules, 1 DCMR Chapter 5.

1934.4 A respondent adversely affected by the decision of the Board of Appeals and Review may seek a review of the decision by the District of Columbia Court of Appeals according to the rules prescribed by the Court.

1934.5 Within the time set by Court rule or order, the Director shall certify and file with the Clerk of the Court the record of the case as required by the Court.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6772 (November 8, 1991).

22-B DCMR § 1999 DEFINITIONS

1999.1 When used in this chapter, the following words and phrases shall have the meanings ascribed:

Act - the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, D.C. Code, 2001 Ed. §§ 47-2885.01 to 47-2885.23, as amended.

Administer - the direct application of a drug to the body of a patient or research subject by injection, inhalation, ingestion, or any other means.

Adulterated drug or device - the meaning as defined in § 501 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 351, as amended.

Adulterated drug or medical device - as defined in § 501 of the Federal Food, Drug and Cosmetic Act, (Pub. L. 96-354, 21 USC § 351) as amended.

Applicant - a person, partnership, or corporation applying for a license to practice pharmacy under this chapter.

Automated data processing system - a system utilizing computer software and hardware for the purpose of recordkeeping.

Automated medication dispensing system - a robotic, computerized, or mechanical device and its components that distributes or dispenses medications in a licensed health care facility, or prepares medications for final dispensing by a licensed pharmacist to a patient or a patient's agent, and maintains related transaction information.

Centralized automated medication system - an automated medication system located in a pharmacy from which medication is distributed or prepared for final dispensing by a licensed pharmacist for a specific patient.

Community/Retail pharmacy - a pharmacy as defined under HORA that provides pharmacy services to the public or general community on an outpatient basis, whether at retail, through third party payment, or other measure of no or minimum cost to the consumer.

Compounding - the preparation, mixing, assembling, packaging, or labeling of a drug or device as the result of a practitioner's prescription drug order or for the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or dispensing. Compounding also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns.

Computer - programmable electronic device capable of multi-functions, including, but not limited to, storage, retrieval, and processing information.

Controlled substances - those drug items or chemicals regulated under the Federal Controlled Substances Act of 1970, approved October 27, 1970 (Pub.L. 91-513, 21 USC § 801 et seq.) as amended; and the District of Columbia Uniform Controlled Substances Act of 1981, effective August 5, 1981 (D.C. Law 4-29, D.C. Official Code § 48-901 et seq.) as amended.

CRT - cathode ray tube used to impose visual information on a screen.

Decentralized automated medication system - an automated medication system that is located outside of the pharmacy in a health care facility with an on-site pharmacy and in which medication is stored in a manner that may be, but need not be, patient specific.

Department - The District of Columbia Department of Health.

Director - The Director of the District of Columbia Department of Health.

Director of Pharmacy - the licensed pharmacist in an institutional facility who is in direct charge of, and has overall responsibility for the operation and management of pharmacy services of that institution.

Dispense - the interpretation, evaluation, and implementation of a prescription drug order, including the preparation and delivery of a drug or medical device to a patient or patient's agent.

Downtime - that period of time when a computer is inoperable.

Drug - means:

(a) any substance recognized as a drug, medicine, or medicinal chemical in the official United States Pharmacopoeia, official National Formulary, official Homeopathic Pharmacopoeia, or official Veterinary Medicine Compendium or other official drug compendium or any supplement to any of them;

(b) any substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animal;

(c) any chemical substance (other than food) intended to affect the structure or any function of the body of man or other animal; and

(d) any substance intended for use as a component of any items specified in subparagraph (a), (b), or (c) of this paragraph, but does not include medical devices or their components, parts, or accessories.

Expired drug or medical device - expiration of the date required by the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 352, to be placed on the label of the original container by the manufacturer, packer, or distributor for which the product may be placed on the market for use or consumption.

Final Verification - The review of the final prescription prior to delivery to a patient to ensure that the ordered medication or medical device is properly prepared and placed in a suitable container with appropriate labeling

Hardware - the fixed component parts of a computer.

HIPAA - The Federal Health Insurance Portability and Accountability Act of 1996, approved August 21, 1996 (42 U.S.C. §§ 1320d-1320d-8).

Homeopathic Drug - A substance that has known "homeopathic provings" and/or known effects which mimic the symptoms, syndromes or conditions which it is administered to treat, and is manufactured according to the specifications of the Homeopathic Pharmacopoeia of the United States (HPUS). Official homeopathic drugs are those that have been monographed and accepted for inclusion in the HPUS.

HORA - Health Occupation Revision Act of 1985 ("Act"), effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq.).

Inspection - a periodic on site review of places at which prescription drugs or devices may be produced, sold, or stored to determine compliance with applicable federal and District laws and regulations, including pre-licensure inspections performed to ensure a facility complies with applicable District law and regulations prior to receiving a license to operate in the District.

Investigation - the process of gathering and recording essential facts and observations with respect to the events and circumstances related to complaints, reported information, including interviews, reviewing records, and physical inspections to determine whether there is a violation of any applicable laws or regulations.

Institutional Facility - means any organization whose primary purpose is to provide a physical environment for patients to obtain health care services, including a(n):

(1) Hospital;

(2) Convalescent home;

(3) Nursing home;

(4) Extended care facility;

(5) Mental health facility;

(6) Rehabilitation center;

(7) Psychiatric center;

(8) Developmental disability center;

(9) Drug abuse treatment center;

(10) Family planning clinic;

(11) Penal institution;

(12) Hospice;

(13) Public health facility;

(14) Athletic facility.

Institutional pharmacy - means that physical portion of an institutional facility where drugs, devices, and other materials used in the diagnosis and treatment of injury, illness, and disease are dispensed, compounded, distributed and pharmaceutical care is provided.

Labeler - an entity or person that receives prescription drugs from a manufacturer or wholesaler and repackages those drugs for later retail sale and that has a labeler code from the federal Food and Drug Administration under 21 C.F.R. § 207.20.

Labeling - the process of affixing a label to any drug container, but does not include the labeling by a manufacturer, packer, or distributor of an over-the- counter drug, packaged legend drug, or medical device.

Mayor - the Mayor of the District of Columbia or the Mayor's designated agent.

Medical device - an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is:

(a) recognized in the official National Formulary, the official United States Pharmacopoeia, or any supplement thereto;

(b) intended for use in the diagnosis of disease or any other condition, or in the cure, mitigation, treatment, or prevention disease in a human or other animal; or

(c) intended to affect the structure of any function of the body of man or other animal, and which does achieve any of its principal intended purposes through chemical action within or on the body of a human or other animal, and which does not depend upon being metabolized for the achievement of any of its principal intended purposes.

Misbranded drug or medical device - as defined in section 501 of the Federal Food, Drug and Cosmetic Act, (Pub. L. 96-354, 21 USC § 352) as amended

Nonresident pharmacy - A pharmacy, including an internet-based pharmacy, located outside the District of Columbia which ships, mails, or delivers, in any manner, prescription drugs or prescription medical devices into the District of Columbia, whether directly or through an intermediary, pursuant to a valid prescription.

Nuclear pharmacy - a pharmacy as defined under HORA that provides those pharmacy services that are engaged in the production, distribution, and dispensing of radiopharmaceuticals.

Over-the-counter drug (Proprietary) - drugs which may be sold without a prescription and which are prepackaged for use by the consumer and labeled in accordance with the requirements of the laws and regulations of the District of Columbia and the federal government.

Person - any individual, partnership, association, corporation, company, joint stock association, or any organized group of persons whether incorporated or not, or any trustee, receiver, or assignee thereof.

Pharmaceutical Care - the provision of drug therapy and other patient care services intended to achieve outcomes related to the cure or prevention of a disease, elimination or reduction of a patient's symptoms, or arresting or slowing of a disease process.

Pharmacist - a person who is licensed to engage in the practice of pharmacy in the jurisdiction in which he or she is practicing.

Pharmacist-in-charge - a licensed pharmacist who accepts responsibility for the operation of a pharmacy and who is personally in full and actual charge of the pharmacy and pharmacy personnel.

Pharmacy intern - any person who is registered in the District of Columbia to engage in the practice of pharmacy under the direct supervision of a pharmacist.

Pharmacy technician - an individual employed by a pharmacy who possesses appropriate education, training, and experience to assist in the practice of pharmacy, under the direct supervision of a pharmacist, by assisting in the technical services of preparing pharmaceuticals for final dispensing by a pharmacist.

Prescriber - a practitioner who is authorized by law to issue a prescription.

Prescription (Legend) - any order for a drug, medicinal chemical, or combination or mixtures thereof, or for a medically prescribed medical device, in writing, dated and signed by an authorized health professional or given orally to a pharmacist by an authorized health professional or the person's authorized agent and immediately reduced to writing by the pharmacist or pharmacy intern, specifying the address of the person for whom the drug or device is ordered and directions for use to be placed on the label.

Prescription drug - means any of the following:

(a) A drug which under federal law is required to be labeled with either of the following statements prior to being dispensed or delivered:

(1) "Caution: Federal law prohibits dispensing without prescription"; or

(2) "Caution: Federal law restricts this drug to use by, or on the order of, a licensed veterinarian.

(b) A drug which is required by any applicable federal, or District of Columbia law or regulation to be dispensed pursuant only to a prescription drug order; or

Printout - a hard copy produced by a computer that is readable without the aid of any special device.

Provider pharmacy - The community/retail pharmacy or the institutional pharmacy providing remote pharmacy services.

Qualified nuclear pharmacist - a licensed pharmacist, who is certified as a nuclear pharmacy by a certification board recognized by the Board and who has met the standards of training for NRC for medically used and radioactive by-product materials, and any other standards required by the Board or any applicable federal or District of Columbia laws or regulations.

Radiopharmaceuticals - radioactive drugs and chemicals within the classification of legend drugs as defined under the Federal Food, Drug, and Cosmetic Act, approved June 25, 1938 (21 USC §§ 301 et seq.).

Radiopharmaceutical quality assurance - means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine its suitability for use on humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

Remote pharmacy services - The provision of pharmacy services, including the storage and dispensing of prescription drugs, in a facility that is not at the same location as the provider pharmacy.

Remote site - a facility not located at the same location as the pharmacy at which remote pharmacy services are provided using an automated medication dispensing system.

Respondent - a person, partnership, or corporation to whom the Director sends a notice of anticipated action against the license or application therefor.

Software - computer programs, procedures, and storage of required information data.

Special or limited use pharmacy - a pharmacy as defined under HORA that provides pharmacy services that are primarily for a special purpose or are limited by the type of drugs dispensed, such as sterile parenteral solutions.

Starter dose - a dose of medication removed from a remote or decentralized automated medication system within the first 24 hours after it is ordered.

Still image capture - A specific image captured electronically from a video or other image capture device.

Stop date - in institutional settings, the length of time to administer a medication as indicated by the prescribing practitioner, or established institutional policy on length of administration of drugs by category in the absence of the prescriber’s notation.

Store and forward - A video or still image record which is saved electronically for future review.

Systems back-up - (auxiliary record maintenance) hard copy, disk, tape, or equivalent used if the computer system becomes inoperative.

Telepharmacy - The practice of pharmacy through the use of a telepharmacy system.

Telepharmacy system - A system that monitors the dispensing of prescription drugs and provides for related drug use review and patient counseling services by an electronic method which shall include the use of the following types of technology:

(a) Audio and video;

(b) Still image capture; and

USP General Chapter – Standard developed by United States Pharmacopoeia/National Formulary (USP/NF).

USP – United States Pharmacopoeia, may also be referred to as United States Pharmacopoeia/National Formulary (USP/NF). USP/NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). The USP-NF is copyrighted by The United States Pharmacopeial Convention and therefore is not republished here. However, a copy of the text may be obtained at https://www.uspnf.com/purchase-usp-nf.

History

SOURCE: Final Rulemaking published at 38 DCR 6734, 6761 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008); as amended by Notice of Final Rulemaking published at 57 DCR 10518, 10519 (November 12, 2010); as amended by Final Rulemaking published at 69 DCR 002763 (April 1, 2022). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 1999

22-B20 HOSPITALS

22-B DCMR § 2000 GENERAL PROVISIONS

2000.1 This chapter shall provide minimum standards for the establishment and maintenance of hospitals in order to protect the public interest by promoting the health, welfare, and safety of individuals in hospitals.

2000.2 In the absence of requirements in this chapter or in other applicable regulations, the management and operation of each hospital shall be in accordance with applicable Medicare Certificate of Participation requirements, and in the absence of other standards, in accordance with the Joint Commission standards, if applicable, and good medical, nursing and public health practices.

2000.3 If a hospital delivers services through a contract with a business that is licensed only by another jurisdiction, the hospital shall be responsible for the delivery of services in compliance with the laws of the District of Columbia.

2000.4 The Director of the Department of Health shall make the final determination as to whether any building, or part of a building, or any group of buildings constitutes a hospital.

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is the Reorganization Plan No. 5 of 1952, 1 D.C. Code, 2001 Ed. at 115; Reorganization Plan No. 3 of 1967, 1 D.C. Code, 2001 Ed. at 125, District of Columbia Self-Government and Governmental Reorganization Act § 412, D.C. Code, 2001 Ed. § 1 204.04; the Health-Care and Community Residence Facility, Hospice and Home Care Licensure Act of 1983 § 5(a), D.C. Code, 2001 Ed. § 44-504; and the Omnibus Budget Support Act of 1994 § 501(b), D.C. Law 10-128, 41 DCR 2110 (April 22, 1994).
SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2001 STANDARDS OF COMPLIANCE

2001.1 The provisions of this chapter set forth the minimal requirements for the establishment, maintenance, and operation of hospitals.

2001.2 Wherever in this chapter or in other applicable standards the performance requirements are not specified, the Director may formulate and publish standards which, if followed, shall constitute substantial compliance with the requirements of this chapter.

2001.3 The standards formulated and published by the Director pursuant to § 2001.2 shall be made available to the public, and shall be maintained on file in the Director's office for inspection during regular business hours.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2002 LICENSE REQUIREMENTS

2002.1 Except as otherwise expressly provided for in this chapter, no person shall operate or hold himself or herself out as operating a hospital in the District of Columbia, whether public or private, for profit or not for profit, without being licensed as required by § 3 of the Health-Care and Community Residence Facility, Hospice and Home Care Licensure Act of 1983, effective February 24, 1984, D.C. Law 5-48, D.C. Official Code § 44-501 et seq. (2005 Repl.) (hereinafter, the Act).

2002.2 A facility shall submit an application for initial licensure to the Director no later than ninety (90) days prior to the stated date of operation. The license fee shall accompany the application. The application for a hospital license shall state each service for which the applicant undertakes to furnish hospital care and the number of beds allocated to each service; and shall furnish other information as may be required.

2002.3 In addition to the requirements of § 2002.2, an applicant for licensure shall also provide the following:

(a) Hospital location;

(b) Previous owner, license number, Medicare and Medicaid numbers;

(d) Type of current certification(s);

(e) Accreditation status;

(f) Bed capacity;

(g) Offsite location(s);

(h) Services to be provided;

(i) Staffing;

(j) Description of facility;

(k) Proposed use of idle space;

(l) Hospital Administrator/Chief Executive Officer;

(m) Person in charge in absence of administrator;

(n) Nurse administrator:

(o) Name of Medical Director and Director of Nursing;

(p) Applicant (owner);

(q) Type of organization;

(r) Interested parties;

(s) Other providers owned by the applicant;

(t) Subsidiary/parent information;

(u) Chain organization (organization structure);

(v) Background information (affiliations, adverse actions, etc);

(w) Owner of building/land;

(x) Type of organization;

(y) Name of the lease holder if the hospital has a lease agreement for hospital space;

(z) Name of management company;

(aa) Contact person; and

(bb) Designee for acceptance of service.

2002.4 A facility making application for initial licensure shall have obtained a Certificate of Occupancy and a Certificate of Need and shall list approvals on the application.

2002.5 A facility shall submit an application for license renewal to the Director no later than sixty (60) days before the expiration date of the current license. The facility shall submit the license fee with the application.

2002.6 The Director may impose a late application filing fee, in addition to the license fee, for a facility that fails to submit a license renewal application within the time prescribed.

2002.7 The Director may conduct background checks on the applicant or licensee to determine his or her suitability or capability to operate or to continue operating a health care facility. Background checks shall consist of, but not be limited to, the following:

(a) Contacts with the police to ascertain criminal convictions;

(b) Verification of licensure status;

(d) Verification of residency status;

(e) Verification of solvency; and

(f) Contacts with District and other state officials to determine outstanding warrants, complaints, criminal convictions, and records of malpractice actions.

2002.8 The licensee of a health care facility shall inform the Director of a change in operation within thirty (30) days after the change. Change of operation means any alteration in function, program, or services that is substantially different from that reported on the hospital's most recent license application.

2002.9 Each license in the licensee's possession shall be the property of the District Government and shall be returned to the Director immediately upon any of the following events:

(a) Suspension or revocation of the license;

(b) Refusal to renew the license;

(d) Voluntary discontinuance of the operation by the licensee.

2002.10 The Director shall issue each license in the name of the owner and operator only for the premises and person or persons named as applicants in the application and the license shall not be valid for use by any other person or persons or at any place other than that designated in the license. Any transfer as to person or place without the approval of the Director shall cause the immediate forfeiture of the license.

2002.11 Each hospital license shall specify the following:

(a) The name of the person to whom the license is issued;

(b) The name and location of the hospital;

(d) The expiration date; and

(e) Any special limitations imposed by the Director.

2002.12 The Director shall classify each license as follows:

(a) General hospitals; or

(b) Special hospitals.

2002.13 The Director shall classify each facility license as regular, provisional or restricted.

2002.14 The D.C. Fire and Emergency Medical Services shall conduct inspections of a facility to determine compliance with fire safety requirements.

2002.15 The D.C. Fire and Emergency Medical Services shall submit to the Director the findings from inspections with a determination regarding licensure of a facility. The Director shall incorporate the determination in the licensure recommendation.

2002.16 The D.C. Fire and Emergency Medical Services shall take action as deemed necessary against a facility for noncompliance with regulations under its jurisdiction.

2002.17 Each facility shall meet the minimum requirements for insurance as appropriate for the number and types of beds in the facility and the number and types of services available as determined by the Director.

2002.18 Each facility shall comply with all Certificate of Need requirements. The Director may subject a facility to an adverse action based on failure to comply.

2002.19 The license shall be posted in a conspicuous place at all times.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2003 CERTIFICATES REQUIRED

2003.1 No license to operate a hospital shall be issued by the Director until the certifications required under this section have been issued.

2003.2 Upon satisfactory proof being submitted, the Director shall certify that the services that are, or are proposed to be, furnished on the premises are, or will be, primarily to provide the following facilities and services by or under the supervision of a physician or provider eligible to admit, or by an oral surgeon where a physician is available at all times on call:

(a) Diagnostic facilities and services and therapeutic facilities and services for surgical or medical diagnosis, treatment, and care of injured, disabled, or sick persons; or

(b) Obstetric facilities and services for the care of maternity patients and newborn infants.

2003.3 Upon proof satisfactory to them, and after examination of the premises, the Director of the Department of Consumer and Regulatory Affairs, and the Fire Chief shall certify that the premises that are proposed to be used for that purpose are, in their judgment, suitable for that purpose.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2004 INITIAL LICENSURE

2004.1 Prior to initial licensure of a facility, the Director shall conduct an on-site inspection to determine compliance with the applicable statutes and rules governing the facility.

2004.2 The Director shall send a written report of the findings to the facility no later than fifteen (15) days from the conclusion of the inspection.

2004.3 A facility with deficiencies shall correct them within thirty (30) days upon receipt of the written report prior to the issuance of a license. The facility may submit written proof of correction of deficiencies where appropriate.

2004.4 The Director may conduct a follow-up inspection to determine correction of deficiencies cited within ten (10) days following the thirty (30) day correction period or upon notification from the facility that the deficiencies have been corrected.

2004.5 The Director may deny the application for licensure or issue a restricted or provisional license to a facility that has not corrected deficiencies. The facility shall reapply for licensure when deficiencies are corrected, or for a more limited license, if appropriate.

2004.6 The Director shall issue a provisional license, not to exceed ninety (90) days, to a facility initially approved.

2004.7 The Director shall conduct an unannounced on-site inspection of the facility within ninety (90) days of operation to assess the facility's continued compliance with the statutes and rules governing the facility. The Director shall issue a regular license not to exceed one (1) year to a facility that is in full or substantial compliance.

2004.8 The Director shall renew a provisional license for a facility not in substantial compliance with the applicable statutes and rules of this chapter. Facilities taking ameliorative action to correct violations, but without deficiencies that pose a serious and imminent danger to the public's health, safety and welfare, may apply for renewal.

2004.9 The facility shall correct the deficiencies within sixty (60) days and the Director may require the facility to submit a plan of correction.

2004.10 The Director shall conduct an on-site inspection after sixty (60) days to determine correction. The Director shall issue a regular license, not to exceed one (1) year, to the facility if found in substantial compliance.

2004.11 The Director shall not renew a provisional license or grant a regular license to a facility not in substantial compliance, not taking ameliorative action, or with violations that pose a serious and imminent danger to the public's health, safety and welfare.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2005 LICENSE RENEWAL

2005.1 The Director shall conduct an on-site inspection of a facility to determine compliance with the statutes and rules governing the facility prior to the expiration of the license. Unless otherwise notified, inspections shall be unannounced.

2005.2 The Director shall send a written report of the findings to the facility no later than fifteen (15) days from the conclusion of the inspection.

2005.3 Consistent with applicable statutes and the rules governing the facility, the Director shall take adverse action, provided in sections 2009 - 2011 of this chapter, against a facility found to have life threatening deficiencies, or a continuing pattern of deficiencies which pose a serious threat to the public's health and safety.

2005.4 The Director may require the facility to submit a written, signed and dated plan of correction to abate deficiencies cited no later than ten (10) business days following the receipt of the written report of findings.

2005.5 The Director shall issue a renewal license for a period not to exceed one (1) year to a facility with no deficiencies or with minor deficiencies that can be corrected within thirty (30) days.

2005.6 The Director shall issue a provisional license not to exceed ninety (90) days to a facility that is not in substantial compliance with the applicable statutes and rules of this chapter, but does not have deficiencies that are life threatening or that endanger the public's health and safety.

2005.7 The Director shall issue a regular license not to exceed one (1) year to a facility issued a provisional license pursuant to § 2004.6 that is in full or substantial compliance after ninety (90) days, based on a follow-up inspection.

2005.8 The Director shall renew the provisional license for a facility initially issued a license pursuant to § 2004.7 that is not in substantial compliance after ninety (90) days, but is making significant progress toward correction of deficiencies cited.

2005.9 The Director may prohibit a facility from accepting new patients and providing a service by issuing a restricted license when he or she finds that the facility has violations of a serious nature, and no substantial corrective action has been taken.

2005.10 Consistent with the applicable statutes and rules governing the facility, the Director shall take adverse action against a facility that is not making substantial progress after issuance of the first provisional license, or its renewal, or a restricted license.

2005.11 The Director shall automatically suspend or convert to a provisional or restricted status the license of a facility that loses its federal certification until a determination is made regarding its continued operation and license status.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2006 REMOVAL PERMITS

2006.1 No hospital or part of a hospital shall move from the premises for which a license has been issued to any other premises without first having obtained from the Director a permit to move to the premises not covered by the license issued to the hospital.

2006.2 The removal permit shall indicate on its face the special conditions governing the moving of the hospital or part of the hospital as the Director may find to be in the interest of the public health.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2007 COMPLAINT INVESTIGATIONS

2007.1 The Director may receive any and all complaints alleging violations of the requirements contained in the applicable laws and regulations, and may conduct unannounced investigations to determine the validity of the complaints.

2007.2 The facility shall permit the Director entry to investigate complaints. The Director shall conduct complaint investigations during time periods and staff shifts consistent with the allegations in the complaint when considered appropriate.

2007.3 The Director may require the facility to respond to the written report of findings with a written plan of correction no later than ten (10) days after the receipt of the report.

2007.4 The Director shall communicate the findings of the complaint investigation directly to the facility and the complainant, if the complainant is identified to the Director, at the conclusion of the investigation.

2007.5 The Director shall investigate complaint allegations of a life threatening nature or those that represent immediate danger within two (2) business days of receipt of the complaint by the Department. All other complaints shall be investigated by the Director no later than thirty (30) days from receipt or the complaint or as considered appropriate.

2007.6 The Director shall immediately suspend or revoke a license or issue a provisional or restricted license in accordance with the applicable statutes and the rules of this chapter if a facility is found to have life threatening deficiencies or deficiencies which seriously endanger the public's health and safety.

2007.7 The Director shall require a facility which is found in violation of the applicable statutes and the rules of this chapter, but whose deficiencies are not life threatening or seriously endangering to the public's health, safety and welfare, to correct the deficiencies within thirty (30) days from receipt of the complaint investigation report.

2007.8 The Director shall issue a provisional or a restricted license, as appropriate, to a facility that has not corrected deficiencies within thirty (30) days.

2007.9 If appropriate, the Director shall issue a restricted license to a facility which is found to have life threatening deficiencies or deficiencies which seriously endanger the public's health and safety. If not appropriate, the Director shall suspend or revoke the facility's license consistent with the applicable statutes and this chapter.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2008 VARIANCES

2008.1 The Director may grant a variance from any of the requirements of the applicable statutes and the rules of this chapter, if the applicant can show undue hardship and the variance can satisfy the following conditions:

(a) It is not inconsistent with other statutory provisions;

(b) It is not deleterious to the public health and safety; and

2008.2 A facility requesting a variance shall submit in writing to the Director the following:

(a) The regulatory requirement(s) for which a variance from strict compliance is being requested;

(b) Specific justification as to why the facility cannot meet the requirement(s); and

(c) Alternative measures provided to ensure quality care and services consistent with the applicable statutes and this chapter.

2008.3 The Director shall grant a variance only to the extent necessary to ameliorate an undue hardship and only when compensating factors are present to give adequate protection to the public health without impairing the intent and purpose of this chapter.

2008.4 If the Director believes that the conditions in § 2008.1 are not met, the Director shall issue a written proposed denial together with advice to the applicant as to his or her right to a hearing on the matter which shall be conducted by the Office of Administrative Hearings in accordance with § 2013.

2008.5 The Director shall maintain a record, to which the public shall have access through the Freedom of Information Act, of all variances granted. The record shall contain a complete written explanation of the basis for each variance.

2008.6 If a variance is requested from standards established pursuant to § 5(a) (3) of the Act, the Director shall provide an opportunity to comment before a decision is made.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2009 CIVIL PENALTIES

2009.1 Violation of any provision of this chapter may be subject to penalties in accordance with § 10 of the Act.

2009.2 In accordance with § 10(e) of the Act, civil fines, penalties, and related costs may be imposed against a hospital for the violation of any provision of this chapter. Adjudication, enforcement and applicable fines, penalties and costs shall be those established by or pursuant to Chapter 18 of Title 2 of the D.C. Official Code.

2009.3 In accordance with § 10(f)(1) of the Act, any person who commits a violation of any provision of this chapter that results in demonstrable harm to a patient, resident, or client of a facility or agency, shall be subject to a fine for each offense not to exceed $ 10,000. For each violation, each day of violation shall constitute a separate offense, and the penalties prescribed shall apply to each separate offense. The total fine for a series of related offenses shall not exceed $ 100,000. Procedures for adjudication of violations under this subsection shall be those established pursuant to Chapter 18 of Title 2.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2010 DENIAL, SUSPENSION, AND REVOCATION OF A HEALTH CARE FACILITY LICENSE

2010.1 The Director may refuse to issue or renew or may revoke, or may suspend a license issued pursuant to this chapter for one or more of the reasons listed in § 5(a)(2)(F) of the Act.

2010.2 Except for a conversion or summary suspension undertaken pursuant to §6(d)(1) of the Act, every applicant for or holder of a license, or applicant for reinstatement after revocation, shall be afforded notice and an opportunity to be heard prior to the action of the Director, if the effect of the Director's action would be one of the following:

(a) To deny a license for cause which raised an issue of fact;

(b) To suspend a license;

(d) To refuse to restore a license;

(e) To issue a limited renewal license; or

(f) To refuse to issue a renewal license for any cause other than failure to pay the prescribed fees.

2010.3 When the Director contemplates taking any action of the type specified in 2010.2 of this chapter, the Director shall give to the applicant, or to another designee chosen by the applicant, a written notice containing the following statements:

(a) In the case of a license denial, that the applicant has failed to satisfy the Director as to the applicant's qualifications;

(b) The respect in which the applicant has failed to satisfy the Director; and

(c) That the denial shall become final unless the applicant files a request for a hearing with the Director within fifteen (15) days of receipt of the notice.

(d) That the Director has sufficient evidence (setting forth the nature of the evidence), which if not rebutted or explained, justifies taking the proposed action; and

(e) That the Director shall take the proposed action unless within fifteen (15) days of the receipt of the notice the facility files with the Office of Administrative Hearings a written request for a hearing or in the alternative submits documentary evidence for the court's consideration before final action is taken.

2010.4 If the facility does not respond to the notice within the time specified, the Director may, without a hearing, take the action contemplated in the notice. The applicant or licensee shall be informed in writing of the action taken.

2010.5 If the applicant or licensee chooses to submit to the Office of Administrative Hearings documentary evidence but does not request a hearing, the Director may submit a written response to the Office of Administrative Hearings within fifteen (15) days of the receipt of the documentary evidence by the Office of Administrative Hearings or otherwise within a time period allotted by the Office of Administrative Hearings.

2010.6 Grounds for suspension, revocation or refusal to issue or renew a license shall include the following:

(a) Failure to meet or maintain the standards required by this chapter;

(b) Willful submission of false or misleading information to the Director in connection with an application for licensure or related to licensing procedures;

(c) Violation of this chapter, or other laws and regulations of the District of Columbia or the United States relating to the operation of a hospital and which are applicable to hospitals operating in the District of Columbia;

(d) Failure to allow inspections pursuant to this chapter;

(e) Failure to obey any lawful order of the Director, pursuant to the rules of this chapter;

(f) Conviction of a member of the governing body, a Director, Administrator, the Chief Executive Officer, department head, or other key staff member of a felony involving the management or operation of a hospital, or which is directly related to the integrity of the facility or the public health or safety; or

(g) Any act which constitutes a threat to the public's health or safety.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2011 SUMMARY SUSPENSION AND LICENSURE CONVERSION, HEARINGS

2011.1 Notwithstanding any other provision of this chapter, the Director, pursuant to § 6(d)(l) of the Act, and under conditions described in that section may do the following:

(a) Convert the facility's license to a provisional or restricted; or

(b) Summarily suspend the facility's license.

2011.2. The Director may summarily suspend the license of any hospital or convert its license to a provisional or restricted license if the Director determines that existing deficiencies constitute an immediate or serious and continuing danger to the health, safety or welfare of its patients.

2011.3 Upon summarily suspending a license pursuant to §§ 2011.2, the Director shall immediately give the hospital written notice of the action, including a copy of the order of suspension, a statement of the grounds for the action and notification that the hospital may, within seven (7) business days from the day written notice is received, file with the Office of Administrative Hearings a written request for an expedited hearing with respect to the action.

2011.4 The Office of Administrative Hearings shall convene a hearing within three (3) business days following receipt of the facility's timely request for a hearing to review the reasonableness of the suspension.

2011.5 If a summary suspension is requested, the request for hearing shall not serve to stay the order suspending the license.

2011.6. Except as otherwise noted in this chapter all procedures relating to hearings as set forth in this chapter shall apply to hearings in summary suspensions.

2011.7 Conversions of licenses to restricted or provisional licenses shall be in accordance with § 7 of the Act.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2012 SERVICE OF NOTICE

2012.1 Any notice required by this chapter may be served either personally or by certified mail, return receipt requested, directed to the applicant or licensee at the last known address as shown by the records of the Department.

2012.2 If notice is served personally, it shall be considered by the Director to have been served at the time when delivery is made to the applicant or licensee.

2012.3 If notice is served by certified mail, it shall be considered by the Director to have been served on the date written or stamped upon the return receipt showing delivery of the notice to the applicant or licensee, or refusal of the applicant or licensee to receive the notice.

2012.4 In the event that the applicant or licensee is no longer at the last known address as shown by the records of the Department and no forwarding address is available, the notice shall be considered by the Director to have been served on the date the return receipt bearing the notification is received by him or her.

2012.5 If an applicant or licensee scheduled for a hearing does not appear and no continuance has been or is granted, the Director may take the contemplated action without a hearing.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2013 CONDUCT OF HEARINGS

2013.1 Every hearing before the Office of Administrative Hearings shall be open to the public and shall be in accordance with its rules of procedure and this chapter.

2013.2 An applicant or licensee entitled to a hearing shall have the following rights:

(a) To be represented by counsel;

(b) To present testimony;

(d) To examine all opposing witnesses on any matter relevant to the issues; and

(e) To have subpoenas issued to compel the attendance of witnesses and the production of relevant books, papers, and documents upon making written request therefore to the Office of Administrative Hearings.

2013.3 In any proceeding resulting from the Director's contemplated action to deny new licensure, the applicant shall have the burden of proving his or her qualification for licensure.

2013.4 In any proceeding resulting from the Director's contemplated action to refuse to renew, to revoke, or to suspend a license, the Department shall have the burden of proving that such action should be taken, or in the case of a summary suspension, that the action was valid.

2013.5 In all hearings, a complete record shall be made of all evidence presented during the course of a hearing. Any party to the proceedings desiring it shall be furnished with a copy of the record, upon payment of the fee prescribed by the Office of Administrative Hearings.

2013.6 Final decisions shall be rendered, petitions for reconsiderations taken and appeals filed in accordance with the rules of the Office of Administrative Hearings.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2014 GOVERNING BODY AND ADMINISTRATION

2014.1 Each hospital shall have a governing body which shall have the authority and responsibility for the direction and policy of the hospital.

2014.2 The governing body's responsibilities shall include:

(a) Monitoring policies to assure appropriate administration and management of the facility;

(b) Maintaining the hospital's compliance with all applicable state and federal statutes, relevant state and federal rules and regulations, the hospital's policies and procedures as well as the hospital's plans of correction;

(c) Ensuring the quality of all services, care and treatment provided to patients whether those services, care or treatment are furnished by hospital staff or through contract with the hospital;

(d) Designating an administrator who is responsible for the day-to-day management of the hospital and defining the administrator's duties and responsibilities;

(e) Notifying the Department in writing within thirty (30) working days when a vacancy in the administrator position occurs, including who will be responsible for the position until another administrator is appointed;

(f) Notifying the Department in writing within thirty (30) working days when the administrator vacancy is filled indicating effective date and name of person appointed administrator;

(g) Appointment and reappointment of medical staff members who are credentialed in accordance with the District of Columbia Health Occupations Revision Act of 1985 (D.C. Law 6-99) and delineating their clinical privileges, according to the procedures for credentials review established by the medical staff and approved by the governing authority;

(h) In collaboration with the medical staff, establishing criteria for membership on the medical staff or clinical privileges;

(i) Rendering within a fixed period of time the final decision regarding medical staff recommendations for denial of staff appointments and reappointments, as well as for the denial, limitation, suspension or revocation of privileges. There shall be a mechanism provided in the medical staff bylaws, rules and regulations for review of decisions, including the right to be heard when requested by the practitioner;

(j) Ensuring the medical staff is accountable to the governing body for the quality of medical care and treatment;

(k) Ensuring a medical staff and a utilization review process is formed and operated for the purpose of reviewing the medical and hospital care provided and the use of hospital resources to assist individual physicians, administrators and nurses in maintaining and providing a high standard of medical and hospital care and efficient use of the hospital;

(l) At least once each year, reviewing reports and recommendations regarding all Quality Assurance/Performance Improvement activities and the Medical Staff and Utilization Review process. Reports shall be utilized to implement programs and policies to maintain and improve the quality of patient care and treatment;

(m) Establishing a means for liaison and communication between the governing authority, the medical staff and administration and promoting effective communication and coordination of services among the various hospital departments, administration and the medical staff;

(n) Requiring the medical staff to be organized with a chief of staff, president, or chairperson and approving the organization, bylaws, rules and regulations, and policies and procedures of the medical staff and the departments in the hospital;

(o) Establishing visitation policies which are in the best interest of patients, including, but not limited to, protection from communicable diseases, protection from exposure to deleterious substances and hazardous equipment and assurance of health and safety of patients; and

(p) In addition to the requirements of section 2032.1(d), establishing a written infection control program which includes a description of risks, strategies to address the risks, a statement of goals, a system to evaluate the program and applicable policies and procedures.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2015 ADMINISTRATOR

2015.1 The administrator shall be responsible for planning, organizing, and directing the day to day operation of the hospital. The administrator shall report and be directly responsible to the governing body in all matters related to the maintenance, operation, and management of the hospital.

2015.2 The Administrator shall be present forty (40) hours per week during regular business hours, and shall be responsible for the operation of the facility twenty-four (24) hours per day, seven (7) days per week.

2015.3 The administrator's responsibilities include:

(a) Making sure there is adequate attention to the management of the hospital twenty-four (24) hours of day;

(b) Providing for the protection of patients' health, safety, and well-being;

(d) Designating a substitute, who shall be responsible and accountable for management of the facility, to act in the absence of the administrator;

(e) Developing and implementing procedures on collecting and reporting information on abuse, neglect and exploitation;

(f) Ensuring that investigations of suspected abuse, neglect or exploitation are completed and that steps are taken to protect patients;

(g) Developing and implementing procedures for the collection of data on and reporting of adverse events and unusual incidents, which may also be known as or include, sentinel events and near misses. Procedures must also include the implementation of corrective actions.

(h) Ensuring that bodies are held in the morgue no longer than thirty (30) days and that the hospital complies with the following:

(1) Reporting requirements provided by the Vital Records Act of 1981 (D.C. Law 4-34), and

(2) Notification and reporting requirements in the the Establishment of the Office of the Chief Medical Examiner Act of 2000 (D.C. Law 13-172); and

(i) Developing and implementing policies to ensure adequate and appropriate monitoring of infants and children when they are placed in patient care units without adult patients

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2016 GENERAL STAFF REQUIREMENTS

2016.1 Each hospital shall maintain a sufficient number of staff with the qualifications, training and skills necessary to meet patient needs. The hospital shall be staffed twenty-four (24) hours per day.

2016.2 Each hospital shall ensure and maintain evidence of, for employees and contract staff, current active licensure, registration, certification or other credentials in accordance with applicable District of Columbia law, prior to staff assuming job responsibilities and shall have procedures for verifying that the current status is maintained.

2016.3 Whenever a licensed health-care professional is terminated as a result of a job-related incident, the hospital shall refer a report of the incident to the appropriate professional health-care board which shall review the report in accordance with the District of Columbia Health Occupations Revision Act of 1985 (D.C. Law 6-99).

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2017 HEALTH SCREENINGS AND EXAMINATIONS

2017.1 A hospital’s policies and procedures for health screening and examinations to prevent the transmission of communicable diseases must comply with the Americans with Disabilities Act (ADA) and the Genetic Information Nondiscrimination Act (GINA).

2017.2 Each person, other than a physician, involved in the performance of duties involving direct patient care shall have an occupational health screening by a physician or other qualified health professional after receiving a conditional offer for employment or within thirty (30) calendar days after commencing employment, and at least once every two (2) years thereafter. Each physician shall have an occupational health screening performed by another physician or other qualified health care professional after receiving a conditional offer for employment, at a time before commencing employment, and once every two (2) years thereafter.

2017.3 Occupational health screenings may include:

(a) A limited medical history (excluding family medical history);

(b) A physical examination;

(c) An intradermal tuberculin test, a U.S. Food and Drug Administration (FDA) approved blood test for tuberculin, or a written report of an intradermal or blood test or x-ray made by a qualified person within twelve (12) months before the date of the examination; and

(d) Any other laboratory work performed as part of an occupational health screening.

2017.4 An intradermal tuberculin test and any subsequent tests performed as part of an occupational health screening shall be performed in accordance with Section 2017.5.

2017.5 Preventative measures, screening, testing, and frequency of screening and testing for tuberculosis performed as part of an occupational health screening shall be in accordance with standards and guidelines of the Centers for Disease Control and Prevention (CDC).

2017.6 A report, signed by an examining physician or other qualified health professional, shall be made of each occupational health screening.

2017.7 The report of each occupational health screening shall be kept on file in the hospital, stored separately from the employee’s personnel file, and shall be open to inspection by the Department.

2017.8 In lieu of the intradermal tuberculin test required by this subsection, the examining physician may accept a written report of the test or x-ray made by a qualified person within twelve (12) months prior to the date of the examination.

2017.9 Each person who is involved in direct patient care and who has been absent from duty because of an illness required to be reported to the Department shall, prior to returning to duty, obtain certification from a physician or other qualified health professional, as provided for in the hospital’s policies, that they may return to duty without apparent danger of transmitting the cause of the illness to any patient.

2017.10 A copy of each certification required by § 2017.9 shall be kept on file, stored separately from the employee’s personnel file, and made available for examination by the Department.

2017.11 Hospital work shall be deemed to be an occupation the duties of which are such that the activity of each individual performing the work is likely to be dangerous to the lives or health of other persons, within the meaning of § 213 of Chapter 2 of this title relating to the reporting and control of communicable diseases.

2017.12 Immunization against communicable disease shall be required of all employees and all other persons who routinely come in contact with patients or patient areas. Immunizations shall be in accordance with current standards and guidelines developed by the CDC.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008); as amended by Final Rulemaking published at 71 DCR 006175 (May 17, 2024). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 2017

22-B DCMR § 2018 STAFF TRAINING

2018.1 Each hospital shall ensure that staff receive training in order to perform assigned job responsibilities.

2018.2 Each hospital shall provide and maintain evidence of an orientation program for all new staff and, as needed, for existing staff who are given new assignments. The orientation program shall include an explanation of:

(a) Job duties and responsibilities;

(b) Hospital's sanitation and infection control programs;

(d) Patient rights;

(e) Patient care policies and procedures relevant to the job;

(f) Personnel policies and procedures;

(g) Emergency procedures;

(h) The Disaster preparedness plan; and

(i) Reporting requirements for abuse, neglect or exploitation.

2018.3 Each hospital shall provide and maintain evidence of ongoing/continuous in-services or continuing education for staff. A record shall be maintained including dates, topics and participants.

2018.4 Each hospital shall maintain a current employment record for each staff person. The record shall contain, at a minimum, information on orientation, in-services, credentialing, health history screening and background check information, including information verifying compliance with the Health-Care Facility Unlicensed Personnel Criminal Background Check Act of 1998 (D.C. Law 12-238, as amended; D.C. Official Code § 44-551 et seq.).

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2019 MEDICAL STAFF

2019.1. Each hospital shall have a medical staff that shall be responsible for carrying out the provisions of the bylaws, consistent with rules and regulations, and shall recommend to the governing body bylaws, or amendments to the bylaws, as they deem appropriate to the operation of the particular hospital. The medical staff shall be organized in a manner and shall function in a manner consistent with the size, needs and resources of the hospital and of the medical staff.

2019.2 The clinical staff of each medical service, surgical service, obstetric service, pediatric service, psychiatric service, radiology service, and anesthesiological service shall be organized under the directorship of an internist, surgeon, obstetrician, pediatrician, psychiatrist, radiologist, and anesthesiologist respectively, each of whom shall be responsible for the policies, procedures, and supervision of the medical work in his or her respective service. Likewise, any medical service shall be organized under the directorship of a licensed professional who is a medical specialist in that medical service.

2019.3 The medical staff shall be responsible to the governing authority for the quality of medical care and treatment provided in the hospital and shall:

(a) Participate in a Quality Assurance/Performance Improvement program to determine the status of patient care and treatment;

(b) Abide by hospital and medical staff policies;

(d) Recommend criteria and procedures for appointment and reappointment to the medical staff and for delineating clinical privileging to facilitate the provision of quality patient care and treatment.

2019.4 Each licensee shall require all employees, contract workers, and volunteers working in the hospital to familiarize themselves with the provisions of this chapter as appropriate to the functions they perform and with all other regulations applicable to their duties.

2019.5 Each hospital shall provide a medical staff that shall be adequate for the diagnostic facilities and services, therapeutic facilities and services, and rehabilitation facilities and services which the hospital undertakes to provide.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2020 AVAILABILITY OF PHYSICIANS

2020.1 Each general hospital shall have a physician available on the premises at all times.

2020.2 Each special hospital shall at all times have a physician available on the premises or available on call; Provided, that when the Director, after consultation with the chief of the involved service, finds that the condition of the patients in the hospital requires the presence of a physician on the premises at all times, the Director shall impose the requirement.

2020.3 Each patient shall be under the care of a physician, regardless of whether the patient is also under the care of an allied health professional practitioner authorized to practice in the District.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2021 NURSING STAFF

2021.1 Each hospital shall provide a nursing staff that is adequate for the diagnostic facilities and services, therapeutic facilities and services, and rehabilitation facilities and services that the hospital undertakes to provide.

2021.2 The Department of Nursing Service shall be under the direction of a registered nurse qualified by education, experience, and demonstrated ability for the position of Director of Nursing Service.

2021.3 The Director of Nursing Service shall participate in the establishment of policies and procedures for the conduct of nursing service.

2021.4 The Director of Nursing shall be a full-time employee during regular business hours, and shall be responsible for the operation of the nursing service twenty-four (24) hours per day, seven (7) days per week.

2021.5 A well-organized departmental plan of administrative authority, with delineation of responsibilities and duties of each category of nursing shall be required both in relation to patient care and to the educational responsibilities of the nursing service.

2021.6 An Assistant to the Director of Nursing shall be provided for the evening and night tours of duty.

2021.7 Supervisory and staff personnel shall be provided for each department of patient care unit to ensure the immediate availability of a professional nurse for bedside care of all patients at all times.

2021.8 Qualified personnel shall be provided in sufficient numbers to provide nursing care not requiring the services of a licensed registered nurse.

2021.9 Nursing personnel for the surgical operating suite, maternity and newborn service, outpatient service, and other services of the hospital shall be provided in keeping with their size and degree of activity.

2021.10 All nursing personnel shall be qualified by education, experience, and demonstrated ability for the positions to which they are assigned.

2021.11 Private duty nurses and licensed practical nurses and nursing assistants shall be under the supervision and direction of a registered nurse at all times.

2021.12 Nursing care procedures and care plans (which may be interdisciplinary care plans), written in conformance with hospital policy, shall be provided for patients, either on an individual or patient care unit basis follow the policy

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2022 PATIENT RIGHTS

2022.1 Each hospital shall protect and promote each patient's rights. This includes the establishment and implementation of written policies and procedures, which include, but are not limited to, the following rights. Each patient or designee, when appropriate, shall have the right to:

(a) Respectful and safe care given by competent personnel;

(b) Be informed of patient rights during the admission process;

(d) Participate in the development and implementation of a plan of care and any changes;

(e) Make informed decisions regarding care and to receive information necessary to make decisions;

(f) Refuse treatment and to be informed of the medical consequences of refusing treatment;

(g) Formulate advance directives and have the hospital comply with the directives unless the hospital notifies the patient of the inability to do so;

(h) Personal privacy and confidentiality of medical records;

(i) Be free from abuse, neglect, and exploitation;

(j) Access information contained in his/her medical record within a reasonable time frame when requested, subject to limited circumstances where the attending physician determines it would be harmful to disclose the information to the patient for therapeutic reasons;

(k) Be free from chemical and physical restraints that are not medically necessary;

(l) Receive hospital services without discrimination based upon race, color, religion, gender, national origin, or payer. Hospitals are not required to provide uncompensated or free care and treatment unless otherwise required by law; and

(m) Voice complaints and file grievances without discrimination or reprisal and have those complaints and grievances addressed.

2022.2 Each hospital shall establish and implement a process to provide patients and/or their designee appropriate education to assist in understanding the identified condition and the necessary care and treatment.

2022.3 Each hospital shall document its assessment of each patient's ability to understand the scope and nature of the diagnosis and treatment needed.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2023 GRIEVANCES

2023.1 Each hospital shall establish and implement a written process that promptly addresses grievances filed by patients or their representatives. The process includes, but is not limited to:

(a) A procedure for submission of grievances which is made available to patients or representatives;

(b) Time frames and procedures for review of grievances and provision of a response; and

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2024 PATIENT CARE AND TREATMENT

2024.1 Except in the case of emergency, no medication or treatment other than dental shall be given to any patient without an order of a physician or other qualified health professional. A physician order shall include physician approved protocols.

2024.2 No dental medication or treatment shall be given to any patient without an order of a dentist, physician, or other qualified health professional, except in an emergency.

2024.3 The physician's, dentist's, or other qualified health professional's order shall be recorded at the time it is made and shall be signed by the physician, dentist, or other qualified health professional as soon as practicable.

2024.4 Each hospital shall provide the necessary care and treatment to meet the needs of patients. Care and treatment provided shall meet prevailing professional standards and scope of practice requirements. Each hospital shall establish and implement written policies and procedures that encompass care and treatment provided to patients.

2024.5 A plan of care shall be established, implemented and kept current to meet the identified needs for each inpatient. The plan of care shall be interdisciplinary when appropriate to meet individual needs of patients.

2024.6 When the hospital is responsible for the administration of medication, medication shall be administered by a qualified health professional for whom medication administration is included within the scope of practice. The hospital shall ensure that medication is properly administered in accordance with prevailing professional standards.

2024.7 The hospital shall allow patients to self-administer medications, with or without supervision, when assessment determines that self-medication is appropriate and that the patient is capable of doing so.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2025 ERRORS IN PROVISION AND ADMINISTRATION OF MEDICATIONS

2025.1 Each hospital shall establish and implement policies and procedures for reporting any errors in administration or provision of prescribed medications. Errors shall be reported to the prescriber in a timely manner upon discovery and a written report of the error prepared.

2025.2 Documentation of medication errors shall be maintained by each hospital and made available for review by the Department.

2025.3 Each hospital shall establish and implement policies and procedures for reporting any adverse reaction to a medication in a timely manner upon discovery to the prescriber and for documenting the event in the patient's medical record.

2025.4 Each hospital shall establish and implement procedures on the handling of drugs to ensure that patients receive medications as prescribed by a medical practitioner. At a minimum, the following shall be evident:

(a) An accounting during each shift at each nursing unit of all controlled substances that have been dispensed as multiple-dose floor stock and individual patient prescriptions; and

(b) Authorized personnel designated by hospital policy in accordance with applicable law are allowed access to medications, including controlled substances.

2025.5 Each hospital shall maintain records in sufficient detail to assure that patients receive the medications prescribed by a medical practitioner and maintain records to protect medications against theft and loss.

2025.6 Each hospital shall develop and maintain for each inpatient an individual medication administration record that includes, but is not limited to:

(a) The identification of the patient;

(b) The name of the medication given;

(d) Identification of the person who administered or provided the medication and any refusal by the patient; and

(e) The patient's medication allergies and sensitivities.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2026 SEPARATE PATIENT CARE

2026.1 Each hospital regularly providing care for obstetric conditions, pediatric conditions, and psychiatric conditions shall have one (1) or more physically and functionally separate care units for each category of conditions for which care is regularly provided.

2026.2 A newborn infant shall not be placed in the same room with any child or any adult except in a maternity nursing unit with mothers for whom there is no apparent danger of transmitting a communicable disease.

2026.3 Infants and children shall not be placed in patient rooms with adult patients other than with parents or legal guardians.

2026.4 Patients with suspected or diagnosed contagious conditions shall be isolated from those not having the suspected or diagnosed condition except in an emergency and on a temporary basis.

2026.5 The maternity and newborn care unit shall be separate from other patient care units and shall be used only for the care of maternity patients and newborn infants; provided, that when there are no other beds available, noninfectious gynecological patients may be cared for on a temporary basis in a maternity and newborn patient care unit.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2027 RESTRAINT OR SECLUSION OF PATIENTS

2027.1 Every general hospital, special hospital for adults with one hundred (100) or more beds, and every special hospital that maintains a psychiatric service for adults shall provide one (1) or more security rooms.

2027.2 All other special hospitals shall maintain a seclusion room and provide an attendant to be with the patient constantly where needed prior to removal to a psychiatric service.

2027.3 No patient shall be placed in mechanical restraint or other seclusion, unless ordered by a physician or other qualified health professional, and unless a nurse or attendant is continuously on duty in charge of and responsible for the patient.

2027.4 No restraint shall be applied unless it is designed and applied so that the person responsible can readily remove the restraints in case of an emergency.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2028 PATIENT NUTRITION

2028.1 Each hospital shall provide for the daily nutritional needs of all patients, including the provision of any diets ordered by a medical practitioner.

2028.2 A current diet manual acceptable to dietary, nursing and medical staff shall be maintained and available for reference.

2028.3 Education on matters of diet and nutrition shall be available to patients when appropriate.

2028.4 Assessments of the nutritional status of patients shall be conducted by an appropriate professional licensed to conduct nutritional assessments in accordance with the District of Columbia Health Occupations Revision Act of 1985, D.C. Law 6-99.

2028.5 Each hospital shall document on-going nutritional assessments for patients who require and receive supplemental nutrition. Nutritional assessments shall include weighing, laboratory testing and other appropriate indicators.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2029 DISCHARGE PLANNING

2029.1 Each hospital shall provide discharge planning to patients. The discharge planning program includes, but is not limited to:

(a) A system for timely evaluation of any discharge planning needs of patients;

(b) Identification of staff responsible for the program;

(c) Development of a discharge plan, including medication review, with the patient or representative when need is identified;

(d) Medication review with the patient or representative;

(e) Maintenance of a complete and accurate list of community-based services, resources and facilities to which patients can be referred; and

(f) Arrangement for the initial implementation of a discharge plan including transfer of necessary medical information.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2030 RECORD KEEPING REQUIREMENTS

2030.1 Each hospital shall maintain records and reports in a manner to ensure accuracy and easy retrieval.

2030.2 A medical record shall be maintained for every patient, including newborn infants, admitted for care in the hospital or treated in the emergency or outpatient service. Medical records may be created and maintained in written or electronic form, or a combination of both, provided that a complete record is accessible at all times. Medical records shall contain sufficient information to clearly identify the patient, to justify the diagnosis and treatment and to document the results accurately.

2030.3 Each medical record shall contain, when applicable, the following information:

(a) Identification data;

(b) Chief complaint;

(d) History and physical examination;

(e) Admitting diagnosis;

(f) All pathology/laboratory and radiology reports;

(g) Properly executed informed consent forms;

(h) Consultation reports;

(i) Medical practitioner orders;

(j) Documentation of all care and treatment, medical and surgical;

(k) Tissue report;

(l) Progress notes of all disciplines;

(m) Discharge summary and final diagnosis;

(n) Autopsy findings; and

(o) Advanced directives, if available.

2030.4 Medical records shall contain entries which are dated, legible and indelibly verified. The author of each entry shall be identified and authentic. Authentication shall include signature, written initials, or computer entry.

2030.5 Telephone or verbal orders of authorized individuals are accepted and transcribed by qualified personnel who are identified by title or category in the medical staff bylaws or rules and regulations. Telephone or verbal orders shall be authenticated as soon as is practical by the medical practitioner who is responsible for ordering, providing or evaluating the service furnished.

2030.6 The hospital shall monitor and require medical records be completed within thirty (30) days of discharge of the patient.

2030.7 The medical record of each patient shall be maintained and preserved, in original, microfilm, electronic or other similar form, for a period of at least ten (10) years following discharge or in the case of minors, the records shall be kept until three years after the age of majority has been attained. In cases in which a hospital ceases operation, all medical records of patients shall be transferred as directed by the patient or authorized representative to the hospital or other health care facility or health care service to which the patient is transferred. All other medical records that have not reached the required time for destruction shall be stored to assure confidentiality and the Department shall be notified of the address where stored.

2030.8 Medical records shall be kept confidential, available only for use by authorized persons or as otherwise permitted by law. Records shall be available for examination by authorized representatives of the Department.

2030.9 Patient information and/or records will be released only with consent of the patient or designee or as permitted by law. When a patient is transferred to another health care facility or service, appropriate information for continuity of care shall be sent to the receiving health care facility or service.

2030.10 In addition to patient medical records, each hospital shall maintain, when applicable, the following:

(a) A permanent patient index that includes, but is not limited to:

(1) Name and identification numbers of each patient;

(2) Dates of admission and discharge;

(3) Name of admitting physician; and

(4) Disposition or place to which patient was discharged/transferred.

(b) Administrative records and reports including governing authority and departmental meeting minutes, staff orientation and in-service records and staff schedules as worked for a minimum of three years, unless longer is required by law.

2030.11 In order to ensure the patient's right of confidentiality, medical records are destroyed or disposed of by shredding, incineration, electronic deletion, or another equally effective protective measure.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2031 PHYSICAL PLANT STANDARDS

2031.1 All hospitals shall be designed, constructed and maintained in a manner that is safe, clean, and functional for the type of care and treatment to be provided. The physical plant standards for facilities, which include support services, care and treatment areas, construction standards and building systems are set forth below.

2031.2 The hospital may share the following support service areas among detached structures, care and treatment areas, or with other licensed health care facilities.

(a) Dietary: If food preparation is provided on site, the hospital shall dedicate space and equipment for the preparation of meals. Food service physical environment and equipment shall comply with Title 25 of the District of Columbia Municipal Regulations (the Food Code) except when used only for training or activity purposes.

(b) Laundry: If the hospital provides laundry services, the services may be provided by contract or on-site by the hospital.

(1) Contract: If contractual services are used, the hospital shall have areas for soiled linen awaiting pickup and separate areas for storage and distribution of clean linen.

(2) On-site: If on-site services are provided, the hospital shall have areas dedicated to laundry.

(A) If personal laundry areas are provided, the areas shall be equipped with a washer and dryer for use by patients. In new construction, the hospital shall provide a conveniently located sink for soaking and hand-washing of laundry.

(B) Hospital laundry area for hospital processed bulk laundry shall be divided into separate soiled (sort and wash areas) and clean (drying, folding, and mending areas) rooms. In new facilities a separate soaking and hand-washing sink and housekeeping room shall be provided in the laundry area.

(i) Imaging rooms shall accommodate the operational and shielding requirements of the equipment installed and the condition of the patient and shall provide clear floor area adequate for the safety of staff and patients.

(ii) Laboratory areas shall provide for sample collection and protection, analyzing, testing and storage. The hospital shall handle all potentially contagious and hazardous samples in a manner as to minimize transmission of infectious diseases.

(d) Waste processing: The hospital shall provide areas to collect, contain , process, and dispose of medical and general waste produced within the hospital in such a manner as to prevent the attraction of rodents, flies and all other insects and vermin, and to minimize the transmission of infectious diseases.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2032 MEDICAL SERVICES

2032.1 In the absence of applicable requirements in this chapter, the following services shall be operated in accordance with the indicated provisions of the Medicare/Medicaid participation requirements:

(a) Pharmaceutical services, Title 42 of the Code of Federal Regulations (hereinafter "C.F.R.") § 482.25;

(b) Radiological services, 42 C.F.R. § 482.26;

(d) Infection control services, 42 C.F.R. § 482.42;

(e) Surgical services, 42 C.F.R. § 482.51;

(f) Anesthesia services, 42 C.F.R. § 482.52;

(g) Outpatient services, 42 C.F.R. § 482.54;

(h) Emergency services, 42 C.F.R. § 482.55; and

(i) Rehabilitation services, 42 C.F.R. § 482.56.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2033 CARE AND TREATMENT AREAS

2033.1 The hospital shall not share the following care and treatment areas among detached structures or with other facilities operated by another licensee:

(a) Staff Areas: Facilities that provide nursing services shall provide the following support areas for each distinct group of care and treatment patient rooms.

(1) Control Point: The hospital shall have an area or areas for charting, and patient records, and call and alarm annunciation systems.

(2) Medication Station: The hospital shall have a medication station for storage and distribution of drugs and routine medications. Distribution may be done from a medicine preparation room or unit, from a self-contained medicine- dispensing unit, or by another system. If used, a medicine preparation room or unit shall be under visual control of nursing staff and shall contain a work counter, sink, refrigerator, and double-locked storage for controlled substances.

(3) Utility Areas: The hospital shall have a work area where clean materials are assembled. The work area shall contain a work counter, a hand-washing fixture, and storage facilities for clean and sterile supplies. If the area is used only for storage and holding as part of a system for distribution of clean and sterile supply materials, the work counter and hand-washing fixtures may be omitted. A hospital shall have separate work rooms or holding rooms for soiled materials. A work room for soiled materials shall contain a fixture for disposing wastes and a hand-washing sink.

(b) Equipment and Supplies: The hospital shall have services and space to distribute, maintain, clean and sanitize durable medical instruments, equipment, and supplies required for the care and treatment performed in the hospital.

(1) Durable Medical: The hospital shall ensure that the durable medical equipment is tested and calibrated in accordance with the manufacturer's recommendations.

(2) Sterile Processing: The hospital shall have areas for decontamination and sterilizing of durable medical instruments and equipment.

(A) The hospital shall provide separate central sterile processing and waste processing areas.

(B) In new construction and where provided, central processing areas shall have separate soiled (sorting and decontamination) and clean (sterilizing and processing) rooms. The hospital shall have hand-washing sinks in both clean and soiled rooms.

(C) Equipment Storage: The hospital shall have space to store equipment, stretchers, wheelchairs, supplies, and linen out of the path of normal traffic.

(c) Surgery: A hospital providing surgical services shall have at least one operating or procedure room and the following support areas. In new construction and hospitals with more than two operating rooms, the following support areas and central processing areas shall be located in restricted access areas:

(1) Preoperative Patient Area: Preoperative patient area(s) shall have sufficient space and equipment to accommodate both ambulatory and non-ambulatory patients. These areas shall be under the direct visual control of the nursing staff.

(2) Recovery Area: Recovery area(s) shall contain a medication station, hand-washing sink, charting area, provisions for bedpan cleaning; and equipment and supply storage space.

(3) Dressing Area: A hospital providing outpatient surgery shall have patient dressing and toilet rooms separate from staff gowning areas.

(4) Housekeeping Room: The hospital shall have soiled utility and housekeeping areas exclusively for the surgical suite.

(d) Emergency Care: A hospital providing emergency services shall have at least one procedure or treatment room for emergency services. To support the provision of emergency care, the hospital shall have the following:

(1) Entrance: A well marked, illuminated covered entrance at grade level for emergency vehicle and pedestrian access;

(2) Waiting Area: Patient and visitor waiting area(s) that are in direct observation of the reception, triage, or control station, with access to a public phone and drinking fountain;

(3) Storage: Storage areas for general medical/surgical emergency supplies, medications and equipment under staff control and out of the path of normal traffic; and

(4) Toilet Room: A patient toilet room with hand-washing sink convenient to the procedure or treatment room(s).

(e) Rehabilitation: A hospital providing rehabilitation services in a distinct unit shall have at least one treatment room or cubicle, an area for specialized treatment and care, hand-washing sink(s), storage for equipment and supplies, call system, medication storage and distribution, and areas to allow for patient toileting, dressing, and consultation.

(f) Obstetrics: A hospital providing obstetric services in a distinct unit shall have at least one patient room, nursery with work area, space and equipment to allow for care and treatment of both mother and infant, hand-washing sink, storage for equipment and supplies, call and alarm annunciation systems, medication storage and distribution, and convenient accommodations for patient toileting, dressing, and consultation.

(g) Psychiatric or Mental Health: A hospital providing psychiatric or mental health services in a distinct unit shall provide space and equipment that allows for patient and staff safety. The hospital shall provide at least one observation room, separate quiet and noisy activity areas, dining areas, private and group areas for specialized treatment and care, a hand-washing sink, storage for equipment and supplies, security systems, and an area for medication storage and distribution. Patient toileting, dressing, holding, and consultation rooms shall have durable finishes. In rooms where care and treatment is provided to patients exhibiting violent, aggressive or suicidal behavior, the rooms shall have:

(1) Tamper-resistant air distribution devices, lighting fixtures, sprinkler heads, and safety devices;

(2) Ventilation, exhaust, heating and cooling components that are inaccessible to patients;

(3) Bedroom, toilet, and bathing room doors that are not lockable or capable of being obstructed from within; and

(4) Electrical outlets protected by ground fault interrupting devices.

(h) In-patient Hospice Care: A hospital providing in-patient hospice services in a distinct unit shall have private patient bedrooms, over-night and dining accommodations for family members, private family visiting areas, areas that allow for toileting, bathing, dressing and hand-washing, storage for equipment and supplies, call system, medication storage and distribution.

(1) Alzheimer's, Dementia, and Related Conditions: A hospital providing in-patient services for Alzheimer's, dementia, and related conditions in a distinct unit shall have personalized patient bedrooms, activity areas, separate dining areas, features that support patient orientation to their surroundings, areas for specialized treatment and care, hand-washing sinks, secured storage for equipment and supplies, call and security systems, and an area for medication storage and distribution.

(i) Outpatient Areas: Areas for the care and treatment of patients not residing in the hospital shall comply with the following:

(1) Areas shall not interfere with inpatients being served;

(2) Furniture and equipment shall meet care and treatment needs of outpatients;

(3) Toilets, which are easily accessible from all program areas shall be provided; and

(4) Sufficient inside and outside space to accommodate the full range of program activities and services shall be provided.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2034 CONSTRUCTION STANDARDS

2034.1 All hospitals shall be designed, constructed, and maintained in a manner that is safe, clean, and functional for the type of care and treatment to be provided. The standards for the facilities are set forth below.

2034.2 New construction shall comply with the following codes and guidelines to provide a safe and accessible environment that is conducive to the care and treatment to be provided:

(a) The BOCA (Building Officials and Code Administrators) National Building Code;

(b) Life Safety Code (National Fire Protection Association 101);

(d) Guidelines for Design and construction of Hospitals and Health Care Facilities;

(e) National Electrical Code; and

(f) Uniform Federal Accessibility Standards.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2035 ENVIRONMENT

2035.1 All facilities shall comply with the following applicable codes and standards to provide a safe environment:

(a) Life Safety Code (National Fire Protection Association 101); and

(b) The Food Code, Title 25 of the District of Columbia Municipal Regulations

2035.2 Existing and new facilities shall comply with the physical plant standards contained in § 2031 of this chapter. The hospital shall maintain all building materials and structural components so that total loads imposed do not stress materials and components more than one and one-half times the working stresses allowed in the building code for new buildings of similar structure, purpose, or location.

2035.3 Interpretations: All dimension, sizes, and quantities; noted herein will be determined by rounding fractions to the nearest whole number.

2035.4 Floor area is the space with ceilings at least seven feet in height and does not include areas such as enclosed storage, toilets, and bathing rooms, corridors and halls. The space beyond the first two feet of vestibules and alcoves less than five feet in width will not be included in the required floor area. In rooms with sloped ceilings, at least half of the ceiling shall be at least seven feet in height with areas less than five feet in height not included in the required floor area.

2035.5 Dining Areas: If provided, dining areas for patients shall have an outside wall with windows for natural light and ventilation. In addition:

(a) Dining areas shall be furnished with tables and chairs that accommodate or conform to patient needs.

(b) Dining areas shall have a floor area of fifteen (15) square feet per patient in existing facilities and twenty (20) square feet per patient in new construction.

(c) Dining areas shall allow for group dining at the same time in either separate dining areas or a single dining area, or dining in two (2) shifts, or dining during open dining hours.

(d) Dining areas shall not be used for sleeping, offices or corridors.

2035.6 Activity Areas: If provided, activity areas shall have space for patient socialization and leisure time activities. In addition:

(a) Activity areas shall have furnishings to accommodate group and individual activities.

(b) Activity areas shall have a floor area of at least fifteen (15) square feet per patient residing in bedrooms and may be combined with dining areas.

(d) The hospital shall make activity areas available to all patients.

2035.7 Bathing Rooms: A hospital shall provide a bathing room consisting of a tub and/or shower adjacent to each bedroom or provide a central bathing room on each floor with patient rooms. Tubs and showers regardless of location shall be equipped with hand grips or other assistive devices as needed or desired by the bathing patient.

(a) In new construction a central bathing room shall open off the corridor and contain a toilet and sink or have an adjoining toilet room, and not open directly in food preparation or dining area.

(b) Bathing Fixtures: Existing and new facilities shall have at least one bathing fixture per twenty (20) licensed beds. New construction shall have at least one bathing fixture per twelve (12) licensed beds.

2035.8 Toilet Rooms: The hospital shall provide toilet rooms with hand-washing sinks for patient use.

(a) Existing facilities shall have a toilet and sink adjoining each bedroom or shared toilet rooms may provide one fixture per four licensed beds.

(b) New construction and new facilities shall have a toilet and sink fixture provided adjoining each patient room.

2035.9 Patient Rooms: The hospital shall provide patient rooms which allow for sleeping, afford privacy, provide access to furniture and belongings, and accommodate inpatient care and treatment.

2035.10 Patient Rooms:

(a) Shall not be located in any garage, storage area, shed or similar detached buildings;

(b) Shall not be accessed through a bathroom, food preparation area, laundry or another bedroom;

(c) Shall be located on an outside wall with a window with a minimum glass size of 8 square feet per patient. The window shall provide an unobstructed view of at least ten (10) feet;

(d) Shall contain at least twenty-five (25) cubic feet of storage volume per patient in dressers, closets or wardrobes; and

(e) If they have multiple beds, shall allow for an accessible arrangement of furniture, which provides a minimum of three (3) feet between beds.

2035.11 Existing or New Facility: Patient rooms in existing and new facilities shall have at least the following floor areas:

(a) Floor areas for single patient rooms shall be one hundred (100) square feet.

(b) Floor areas for multiple bed patient rooms shall be eighty (80) square feet per bed with maximum of four (4) beds.

2035.12 New Construction: Patient rooms in new construction shall have at least the following floor areas.

(a) Floor areas for single patient rooms shall be one hundred and twenty (120) square feet.

(b) Floor areas for multiple bed patient rooms shall be one hundred (100) square feet per bed with a maximum of two (2) beds.

2035.13 Isolation Rooms: The number and type of isolation rooms in a hospital shall be determined by the hospital and based upon an infection control risk assessment. In addition:

(a) Facilities shall make provisions for isolating patients with infectious diseases.

(b) A hospital shall have a minimum of one isolation room with an adjoining toilet room.

(c) In new construction, facilities shall equip isolation rooms with hand-washing and gown changing facilities at the entrance of the room.

2035.14 Observation Areas: If the hospital provides medical observation, extended recovery or behavior intervention methods, the hospital shall provide one or more appropriately equipped rooms for patients needing close supervision. Each room shall:

(a) Have appropriate temperature control, ventilation and lighting;

(b) Be void of unsafe wall or ceiling fixtures and sharp edges;

(c) Have a way to observe the patient, such as an observation window or if necessary, flat wall mirrors so that all areas of the room are observable by staff from outside of the room;

(d) Have a way to assure that the door cannot be held closed by the patient in the room which could deny staff immediate access to the room; and

(e) Be equipped to minimize the potential of the patient's escape, injury, suicide or hiding of restricted substances.

2035.15 Critical Care Rooms: If monitored complex nursing care is provided, the hospital shall provide one or more rooms for patients needing the care. Each room shall be appropriately located and equipped to promote staff observation of patients. Rooms with a single occupant shall have a minimum floor area of no less than one hundred and thirty (130) square feet. Multiple bed locations shall contain at least one hundred and ten (110) square feet per bed with a minimum of four (4) feet between beds. The room shall include provision for life support, medical gas, sleeping, and convenient bathing and toileting facilities.

2035.16 Bassinets: Each bassinet shall have a minimum floor area of forty (40) square feet with at least three (3) feet between bassinets.

2035.17 Cubicles: Patient care and treatment cubicles shall have a minimum floor area of sixty (60) square feet with at least three (3) feet between bedsides and adjacent side walls.

2035.18 Examination Rooms: Each examination room shall have a minimum floor area of eighty (80) square feet and a minimum of three (3) feet clear dimension around three (3) sides of the examination table or chair.

2035.19 Treatment Rooms: Treatment room for procedures performed under topical, local, or regional anesthesia without pre-operative sedation shall have a minimum floor area of one hundred and twenty (120) square feet and a minimum of ten (10) feet clear dimension.

2035.20 Procedure Rooms: Procedure rooms for invasive and minor surgical procedures performed in conjunction with oral, parenteral, or intravenous sedation or under analgesic or dissociative drugs shall have a minimum floor area of two hundred (200) square feet and a minimum of fourteen (14) feet clear dimension.

2035.21 Operating Rooms: Operating rooms for major surgical procedures that require general or regional block anesthesia and support of vital bodily functions shall have a minimum floor area of three hundred (300) square feet and a minimum of sixteen (16) feet clear dimension.

2035.22 Corridors: The hospital corridors shall be wide enough to allow passage and be equipped as needed by the patient with safety and assistive devices to minimize injury. All stairways and ramps shall have handrails.

2035.23 Doors: The hospital doors shall be wide enough to allow passage and be equipped for privacy, safety, and with assistive devices to minimize patient injury.

2035.24 All patient room, toilet, and bathing room doors shall provide privacy yet not create seclusion or prohibit staff access for routine or emergency care.

(a) In new construction all toilet and bathing rooms used by patients with less than fifty (50) square feet of clear floor area shall not have doors that solely swing inward.

(b) Doors may prevent escape and create seclusion where therapeutically required, such as emergency protective custody, detoxification and psychiatric locations.

2035.25 Outdoor Areas: Any outdoor area for patient usage provided by the hospital shall be equipped and situated to allow for patient safety and abilities.

2035.26 Hand-washing Sinks: The hospital shall provide a hand-washing sink equipped with towels and a soap dispenser in all examination, treatment, isolation and procedure rooms and which shall also be available for every four care and treatment cubicle locations. Two scrub sinks shall be available near the entrance of each operating room.

2035.27 Privacy: In multiple bed patient rooms, visual privacy, and window curtains shall be provided for each patient. In new facilities and new construction the curtain layout shall totally surround each care and treatment location which will not restrict access to the entrance to the room, lavatory, toilet, or enclosed storage facilities.

2035.28 Finishes: A hospital shall provide the following special room finishes:

(a) Washable room finishes should be provided in procedure rooms, existing isolation rooms, sterile processing rooms, workroom, laundry, and food-preparation areas shall have smooth, non- adsorptive, surfaces which are not physically affected by routine housekeeping cleaning solutions and methods. Acoustic lay-in ceilings, if used, shall be non-perforated.

(b) Scrubbable room finishes provided in operating rooms and new isolation rooms shall have smooth, non-adsorptive, non-perforated surfaces that are not physically affected by harsh germicidal cleaning solutions and methods.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2036 BUILDING SYSTEMS

2036.1 Hospitals shall have building systems that are designed, installed and operated in such a manner as to provide for the safety, comfort, and well being of the patient.

2036.2 Water and Sewer Systems: The hospital shall have and maintain an accessible, adequate, safe and potable supply of water. Where an authorized public water supply of satisfactory quantity, quality, and pressure is available, the hospital shall be connected to it and its supply used exclusively.

2036.3 The collection, treatment, storage, and distribution potable water system of a hospital shall be constructed, maintained, and operated in accordance with all provisions of the Safe Drinking Water Act, approved December 16, 1974 (88 Stat. 1660; 42 U.S.C.S. §§ 300f et seq.).

2036.4 The water distribution system shall be protected with anti-siphon devices, and air-gaps to prevent potable water system and equipment contamination.

2036.5 Continuously circulated filtered and treated water systems shall be provided as required for the care and treatment equipment used in the hospital.

2036.6 The hospital shall maintain a sanitary and functioning sewage system.

2036.7 Hot Water System: The hot water system shall have the capacity to provide continuous hot water at temperatures as required by these regulations.

2036.8 Heating and Cooling Systems: The hospital shall provide a heating and air conditioning system for the comfort of the patient and capable of maintaining the temperature in patient care and treatment areas as follows:

2036.9 In existing and new facilities the systems shall be capable of producing a temperature of at least seventy degrees Fahrenheit (70°F) during heating conditions and a temperature that does not exceed eighty-five degrees Fahrenheit (85°F) during cooling conditions.

2036.10 In new construction the systems shall be capable of producing a temperature of at least seventy-five degrees Fahrenheit (75°F) during heating conditions and a temperature that does not exceed eighty degrees Fahrenheit (80°F) during cooling conditions.

2036.11 In new construction and new facilities, central air distribution and return systems shall have the following percent dust spot rated filters:

(a) General areas: thirty (30) +%; and

(b) Care, treatment, and treatment processing areas: ninety (90) +%.

2036.12 Surgical areas shall have heating and cooling systems that are capable of producing room temperatures at a range between sixty-eight (68°F) and seventy-three degrees Fahrenheit (73°F) and humidity at a range between thirty (30) and sixty percent (60%) relative humidity.

2036.13 Airflow shall move from clean to soiled locations. In new construction, air movement shall be designed to reduce the potential of contamination of clean areas.

2036.14 Floors in operating rooms, procedure rooms and other locations subject to wet cleaning methods or body fluids shall not have openings to the heating and cooling system.

2036.15 Ventilation System: All hospitals shall provide exhaust and clean air to prevent the concentrations of contaminants which impair health or cause discomfort to patients and employees.

(a) Existing facilities shall have adequate ventilation.

(b) New construction and new facilities shall provide a mechanical exhaust ventilation system for windowless toilets, baths, laundry rooms, housekeeping rooms, kitchens and similar rooms at ten air changes per hour.

(c) New construction shall provide mechanical ventilation system(s) capable of providing air changes per hour (hereafter "ACH") as follows:

(A) Care and treatment areas: five (5) ACH;

(B) Procedure and airborne isolation areas: fifteen (15) ACH; and

(d) Hospitals shall provide an emergency backup ventilation system for all patient rooms without operable windows.

2036.16 Electrical System: The hospital shall have an electrical system that has sufficient capacity to maintain the care and treatment services that are provided and that properly grounds care and treatment areas.

(a) New construction and new facilities shall have ground fault circuit interrupters protected outlets in wet areas and within six (6) feet of sinks.

(b) All facilities shall provide the minimum average illumination levels as follows:

(1) General purpose areas: five (5) foot candles;

(2) General corridors: ten (10) foot candles;

(3) Personal care and dining areas: twenty (20) foot candles;

(4) Reading and activity areas: thirty (30) foot candles;

(5) Food preparation areas: forty (40) foot candles;

(6) Hazardous work surfaces: fifty (50) foot candles;

(7) Care and treatment locations: seventy (70) foot candles;

(8) Examination task lighting: one hundred (100) foot candles;

(9) Procedure task lighting: two hundred (200) foot candles;

(10) Surgery task lighting: one thousand (1000) foot candles; and

(11) Reduced night lighting in patient rooms and corridors.

2036.17 Essential Power System: Facilities shall have an emergency power generator for all care and treatment locations which involve general anesthetics or electrical life support equipment, and in emergency procedure and treatment rooms.

(a) Existing and new facilities shall maintain emergency power for essential care and treatment equipment and lighting, medical gas systems, and nurse call systems.

(b) New construction shall maintain emergency power for essential care and treatment equipment and lighting, medical gas systems, ventilation and heating systems, and nurse call systems.

(c) Facilities with electrical life support equipment shall maintain essential power systems with an on-site fuel source. The minimum fuel source capacity shall allow for non-interrupted system operation.

2036.18 Call Systems: Call systems shall be operable from patient beds (except at psychiatric or mental hospital beds), procedure and operating rooms, and recovery bed and toilet locations. The system shall transmit a receivable (visual, audible, tactile, or other) signal to on-duty staff which readily notifies and directs the staff to the location where the call was activated.

In addition:

(a) In new construction the call system shall have a dedicated emergency call device which allows activation by a patient from treatment rooms and cubicles, and toilet and bathing fixtures.

(b) In locations where patients are unable to activate the call, a dedicated staff assist or code call device shall promptly summon other staff for assistance.

2036.19 Medical Gas System: The hospital shall safely provide medical gas and vacuum by means of portable equipment or building systems as required by patient receiving care and treatment. In addition:

(a) The installation, testing, and certification of nonflammable medical gas, clinical vacuum, and air systems shall comply with the requirements of the Life Safety Code (National Fire Protection Association 101).

(b) The hospital shall identify portable and system components, and periodically test and approve all medical gas piping, alarms, valves, and equipment for patient care and treatment. The hospital shall document such approvals for review and reference.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2037 HOUSEKEEPING AND MAINTENANCE

2037.1 Each hospital shall provide a safe, clean and comfortable environment for patients.

2037.2 Housekeeping and Maintenance: The hospital shall provide the necessary housekeeping and maintenance to protect the health and safety of patients.

In addition:

(a) The hospital's buildings and grounds shall be kept clean, safe and in good repair.

(b) All garbage and rubbish shall be disposed of in such a manner as to prevent the attraction of rodents, flies and all other insects and vermin. Garbage shall be disposed of in such a manner as to minimize the transmission of infectious diseases and minimize odor.

(c) The hospital shall provide and maintain adequate lighting, environmental temperatures and sound levels in all areas that are conducive to the care and treatment provided.

(d) The hospital shall maintain and equip the premises to prevent the entrance, harborage or breeding of rodents, flies and all other insects and vermin.

2037.3 Equipment, Fixtures and Furnishings: The hospital shall provide and maintain all equipment, fixtures and furnishings clean, safe and in good repair. In addition:

(a) Common areas and patient areas shall be furnished with beds, chairs, sofas, tables and storage that is comfortable and reflective of patient needs.

(b) The hospital shall provide equipment adequate to meet the care and treatment needs of patients.

(c) The hospital shall establish and implement a process designed for routine and preventative maintenance of equipment and furnishings to ensure that the equipment and furnishings are safe and function to meet the intended use.

2037.4 Linens: The hospital shall provide each patient with an adequate supply of clean bed, bath and other linens necessary for care and treatment. Linens shall be in good repair. In addition:

(a) The hospital shall establish and implement procedures for the storage and handling of soiled and clean linens.

(b) When the hospital provides laundry services, water temperatures to laundry equipment shall exceed one hundred and sixty degrees Fahrenheit (160°F) or the laundry may be appropriately sanitized or disinfected by another acceptable method in accordance with manufacturer's instructions.

2037.5 The hospital shall develop and implement policies and procedures to ensure that any facility-owned pet does not negatively affect patients. The policies and procedures shall include:

(a) An annual examination by a licensed veterinarian;

(b) Vaccinations as recommended by the licensed veterinarian that include, at a minimum, current vaccination for rabies for dogs, cats and ferrets;

(d) Responsibility for care and supervision of the pet by facility staff.

2037.6 Environmental Safety: The hospital shall be responsible for maintaining the environment in a manner that minimizes accidents. In addition:

(a) The hospital shall maintain the environment to protect the health and safety of patients by keeping surfaces smooth and free of sharp edges, mold or dirt; keeping floors free of objects and slippery or uneven surfaces and keeping the environment free of other which may pose a potential risk.

(b) The hospital shall maintain all doors, stairways, passageways, aisles, or other means of exit in a manner that provides safe and adequate access for care and treatment.

(c) The hospital shall provide water for bathing and hand-washing at safe and comfortable temperatures to protect patients from potential for burns or scalds.

2037.7 The hospital shall establish and implement policies and procedures to monitor and maintain water temperatures that accommodate patient preferences, but not to exceed the following temperatures:

(a) Water temperature at patient hand-washing fixtures shall not exceed one hundred and twenty degrees Fahrenheit (120°F).

(b) Water temperatures at patient bathing and therapy fixtures shall not exceed one hundred and ten degrees Fahrenheit (110°F).

2037.8 The hospital shall establish and implement policies and procedures to ensure hazardous/poisonous materials are properly handled and stored to prevent accidental ingestion, inhalation, or consumption of the hazardous/poisonous materials by patients.

2037.9 The hospital shall restrict access to mechanical equipment which may pose a danger to patients.

2037.10 Disaster Preparedness and Management: The hospital shall establish and implement procedures to ensure that patient care and treatment, safety and well-being are maintained during and following instances of natural disasters, disease outbreaks, or other similar situations, including:

(a) The hospital shall establish plans to move patients to points of safety or provide other means of protection in case of fire, tornado, or other natural disasters or the threat of ingestion, absorption, or inhalation of hazardous materials;

(b) The hospital shall ensure that food, water, medicine, and medical supplies, and other necessary items for care and treatment are available and obtainable from alternate sources;

(c) The hospital shall ensure that plans are in place to move and house patients in points of safety when the building or a portion of the building is damaged to the point it is uninhabitable. The damage may be due to fire, tornadoes or other disasters; and

(d) The hospital shall ensure that plans are in place to provide for the comfort, safety and well-being of patients in the event of electrical or gas outage, heating, cooling or sewage systems failure, or loss or contamination of water supply.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B DCMR § 2038 MRSA INFECTION PREVENTION

2038.1 Each hospital shall have written infection prevention and control policies and procedures.

2038.2 Each hospital shall identify MRSA colonized patients in an intensive care unit or other at-risk unit.

2038.3 Each patient colonized or infected with MRSA shall be isolated in an appropriate manner consistent with guidelines for best practices. A patient in a long-term care facility who is infected or colonized shall be permitted to participate in group activities provided that any draining wounds are covered, bodily fluids are contained, and the patient is observed to have proper hygiene practices.

2038.4 Each hospital shall adhere to hand hygiene best practices to ensure, through education and monitoring, that healthcare personnel properly cleanse hands between patient care activities.

2038.5 Each hospital shall monitor trends in the incidence of MRSA in the hospital over time and enhance infection control interventions if rates do not decrease.

2038.6 Each hospital shall maintain a mechanism for identifying a MRSA patient who is readmitted to the hospital (i.e. flagging).

2038.7 Each hospital shall have a worker education requirement regarding modes of transmission, use of personal protective equipment, disinfection policies and procedures, and other preventive measures in accordance with current CDC guidelines on the use of “Standard Precautions” and “Transmission-Based Precautions”.

2038.99 When used in this section, the following terms shall have the meanings ascribed:

Colonized - having a bacterial organism present on or in the body that is not causing illness.

Long-term care facility - a component of a hospital intended for the treatment of patients who require extended stays in a hospital setting to complete their treatment.

Methicillin-resistant staphylococcus aureus (MRSA) - a bacterium that is resistant to antibiotics known as beta-lactams. These antibiotics include methicillin, amoxicillin, oxacillin, and penicillin.

History

SOURCE: Notice of Final Rulemaking published at 56 DCR 848 (January 23, 2009).

22-B DCMR § 2039 TESTING FOR SYNTHETIC CANNABINOID SURVEILLANCE

2039.1 When a patient presents to a hospital with a reported or witnessed use of a synthetic cannabinoid and with signs and symptoms of overdose for which the treating clinician would otherwise order a standard urine drug screen, the hospital shall require the treating clinician to order a urine sample to be taken from the patient at or near the time of arrival at the emergency room.

2039.2 When a patient presents to a hospital with a reported or witnessed use of a synthetic cannabinoid and with signs and symptoms of overdose for which the treating clinician would otherwise order a standard urine drug screen, the hospital may require the treating clinician to order a blood sample taken from the patient at or near the time of arrival at the emergency room.

2039.3 The hospital shall label each urine sample or blood sample collected pursuant to Subsection 2039.1 or 2039.2 with the following patient identifying information:

(a) Name;

(b) Date of birth;

(d) Hospital name or hospital number; and

(e) Medical record number.

2039.4 The hospital shall complete a Public Health Sample Submission Form created by the Office of the Chief Medical Officer for each urine sample or blood sample collected pursuant to Subsection 2039.1 or 2039.2.

2039.5 The hospital shall keep the Public Health Sample Submission Form with the urine sample or blood sample collected pursuant to Subsection 2039.1 or 2039.2.

2039.6 The hospital shall store each urine sample or blood sample arising from Subsection 2039.1 or 2039.2 according to protocols provided to the hospitals by the Department.

2039.7 The hospital shall make each urine sample or blood sample collected pursuant to Subsection 2039.1 or 2039.2 available for pickup by an employee or authorized agent of the District who presents proper credentials or authorization from an appropriate District of Columbia official.

2039.8 The hospital providing the patient’s urine sample or blood sample arising from Subsection 2039.1 or 2039.2 shall have no responsibility for testing the sample or for advising the patient of the results of the test of the sample that was provided to the District.

2039.9 The hospital providing the patient’s urine sample or blood sample may request from the District the test results for a patient treated by the hospital.

2039.10 Nothing in this rule restricts the ability of the hospital to conduct other testing on the patient.

2039.11 These rules will expire on March 31, 2016.

History

SOURCE: Final Rulemaking published at 63 DCR 3741 (March 11, 2016)[EXPIRING March 31, 2016]. District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 2039

22-B DCMR § 2099 DEFINITIONS

2099.1 When used in this chapter, the following terms and phrases shall have the meanings ascribed:

Abuse - any knowing, reckless, or intentional act or omission by a provider that causes or is likely to cause or contribute to, or which caused or is likely to have caused or contributed to, injury, death, or financial exploitation of a patient.

Act - the Health -Care and Community Residence Facility, Hospice and Home Care Licensure Act of 1983, D.C. Law 5-48 (D.C. Official Code § 44-501 et seq.).

Administrator - the person who is responsible for day-to-day operation of the facility to include the Medical Director.

Anesthesiologist - a licensed physician who is certified by the American Board of Anesthesiology or who has training and experience in the field of anesthesiology, substantially equivalent to that required for certification.

Communicable disease - Communicable disease - any disease denominated a communicable disease, including without limitation any illness due to an infectious agent or its toxic product, which is transmitted directly or indirectly to a well person from an infected person, animal, or ectoparasite; or any illness due to an infectious agent or its toxic product which is transmitted through the agency of an intermediate host, vector, or by exposure within the immediate environment. Communicable disease also shall mean any disease occurring as an outbreak of illness or toxic conditions, regardless of etiology in an institution or other identifiable group of people.

Conversion - the act of limiting a license to either a restricted or provisional status.

District or D.C - the District of Columbia.

Dentist - any licensed person who is authorized to practice dentistry in accordance with the District of Columbia Health Occupations Revision Act of 1985, D.C. Law 6-99.

Department - the District of Columbia Department of Health.

Director - the Director of the Department of Health.

Emergency room - any area in the hospital set up for the reception and treatment of persons in need of emergency medical care.

Hospital - a facility that provides twenty-four 24-hour inpatient care, including diagnostic, therapeutic, elective surgery, and other health-related services, for a variety of physical or mental conditions, and may in addition provide outpatient services, particularly emergency care.

Hospital, general - a hospital that has the facilities and provides the services that are necessary for the general medical and surgical care of patients, including the provision of emergency care by an Emergency Department.

Hospital, private - a hospital not operated by an agency of the United States of the District of Columbia.

Hospital, special - a hospital that:

(a) Defines a program of specialized services, such as obstetrics, mental health, orthopedy, long term acute care, rehabilitative services or pediatric services;

(b) Admits only patients with medical or surgical needs within the defined program; and

Idle space - Hospital area that is not used for patient services or any activity related to patient services and is either (1) inactive, (2) under renovation or (3) inactive in anticipation of renovation..

Infant - a young person between the ages of thirty (30) days and one (1) year.

Infectious disease - a disease caused by an communicable agent.

Internist - a licensed physician who is certified by the American Board of Internal Medicine or who has training and experience in internal medicine substantially equivalent to that required for that certification.

Joint Commission - an independent, not-for-profit organization that evaluates and accredits health-care facilities in the United States.

Laboratory - any area in the hospital set up for chemical, bacteriological, and histopathological examinations.

Medical record - a hospital record of a patient that provides identifying information about the patient and information about his or her medical condition, progress, and treatment.

Near miss - any process variation that did not affect an outcome but for which a recurrence carries a significant chance of a serious adverse outcome

Newborn - any newly delivered infant who is up to twenty-nine days old.

Nurse - a person who is licensed and currently registered to practice nursing in accordance with the District of Columbia Health Occupations Revision Act of 1985, D.C. Law 6-99.

Nurse, private duty - a licensed professional or practical nurse who is engaged directly by the patient or his or her representative for the purpose of rendering nursing care to that patient.

Nursery - a room in a newborn patient care unit used as a patient room for newborn infants.

Obstetrician - a licensed physician who is certified in obstetrics by the American Board of Obstetrics and Gynecology, or who has training and experience in obstetrics substantially equivalent to that required for that certification.

Oral surgeon - a dentist who is a diplomat of the American Board of Oral Surgery, or a member of the American Society of Oral Surgery, or who has training and experience substantially equivalent to that required to be a diplomat or member.

Patient - a person who has been admitted to a hospital for the diagnosis, treatment, or care of physical or mental conditions.

Patient room - a room set aside for the accommodation, care, and treatment of a patient or patients.

Pediatrician - a licensed physician who is certified by the American Board of Pediatrics, or who has training and experience in pediatrics substantially equivalent to that required for that certification.

Person - any individual, firm, partnership, corporation, company, or association; and including any administrators, guardians, trustees, directors, and agents.

Public Hospital - a hospital owned and operated by the government.

Physician - a person currently licensed pursuant to the Health Occupations Revision Act of 1985, effective March 25, 1986, D.C. Law 6-99, D.C. Official Code Section 3-1201.01 et seq., to practice medicine and surgery, or a person licensed in another jurisdiction whose application for a license or registration is pending in the District.

Provisional License- a license issued to a facility which is not in substantial compliance with all applicable laws and regulations, but which is taking ameliorative action in accordance with a mutually agreed upon timetable to achieve compliance

Psychiatrist - a licensed physician who is certified in psychiatry by the American Board of Neurology and Psychiatry, or who has substantial training and experience in psychiatry equivalent to that required for that certification.

Qualified Health Professional - a person licensed pursuant to the Health Occupations Revision Act of 1985, effective March 25, 1986, D.C. Law 6-99, D.C. Official Code Section 3-1201.01 et seq., to practice a health occupation in the District, and who is authorized under the terms of that Act to perform the activity referred to in the particular regulation.

Regular license- a license which is issued for one year to a facility which is in compliance with all applicable laws and regulations.

Restricted license- a license which permits operation of a facility but prohibits the facility from accepting new residents and patients or from delivering services that it would otherwise be authorized to deliver, or both.

Sentinel event - an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof.

Substantial Compliance- meeting the majority of rules without jeopardizing health and safety.

Surgeon - a physician who is certified by the American Board of Surgery or who has training and experience in surgery substantially equivalent to that required for that certification.

History

SOURCE: Notice of Final Rulemaking published at 55 DCR 8813 (August 15, 2008).

22-B21 NEONATAL SCREENING SERVICES

22-B DCMR § 2100 NEWBORN HEARING SCREENING

2100.1 Each institution shall establish a Newborn Hearing Screening Service according to the following requirements:

(a) Each institution shall designate a person to be responsible for the newborn hearing screening service in that institution.

(b) An audiologist, otolaryngologist, or other qualified person, including a neonatal nurse or a hospital technician, shall oversee each newborn hearing screening service. The person assigned to oversee the newborn hearing screening service may be full or part time, on or off site, an employee of the hospital, or under contract or other arrangement that allows him or her to oversee the newborn hearing screening service. This person shall advise the institution about all aspects of the newborn hearing screening service, including screening, and recommendations for follow-up testing and treatment.

(c) Each institution shall provide hearing screening services pursuant to this section, unless any of the following occurs:

(1) The procedure is contrary to the parents’ religious beliefs;

(2) The parents withhold consent to perform the screening; or

(3) The institution transfers the newborn to another institution for treatment before hearing screening can be completed, provided that the transferring institution informs the Perinatal and Infant Health Bureau of the Department, or its successor, within twenty-four (24) hours.

(d) Newborn hearing screening may be performed by any of the following:

(1) An audiologist;

(2) An otolaryngologist;

(3) A neonatal nurse appropriately trained to perform hearing screening and under supervision by an audiologist or otolaryngologist;

(4) A hospital technician appropriately trained to perform hearing screening and under supervision by an audiologist or otolaryngologist; or

(5) A hospital volunteer appropriately trained to perform hearing screening and under supervision by an audiologist or otolaryngologist.

2100.2 Before discharging the newborn, each institution shall do the following:

(a) Provide the newborn’s parents with oral information and written materials that describe the benefits and purpose of hearing screening, the procedures used for hearing screening, and the consequences of hearing loss;

(b) Provide the newborn’s parents with oral and written information about whether it performed a hearing screening on the newborn;

(c) After performing the hearing screening, provide the newborn’s parents, the newborn’s primary care provider, if known, and the Perinatal and Infant Health Bureau of the Department, or its successor, with oral and written results of the hearing screening; and

(d) After performing the hearing screening, recommend to the newborn’s parents and the newborn’s primary care provider, if known, appropriate follow-up testing and treatment that may be necessary.

2100.3 If the parents do not understand English well enough to comprehend the information, the institution shall provide the information required by § 2100.2 in the parents’ native language.

2100.4 For newborns that require additional procedures to complete the screening after being discharged from the institution, the institution shall provide the newborn’s parents and the newborn’s primary care provider, if known, with written notice about the availability and importance of additional screening procedures.

2100.5 An institution that completes a newborn hearing screening and finds that the newborn did not pass the screening shall provide the newborn’s parents, the Department, and the newborn’s primary care provider, if known, with written results of the screening, recommended diagnostic procedures, and resources available for newborns with hearing impairment.

History

SOURCE: Final Rulemaking published at 56 DCR 7631 (September 25, 2009).

22-B DCMR § 2101 METABOLIC DISORDERS

2101.1 Each institution shall make available blood tests to screen each newborn delivered or cared for at the institution for the following metabolic disorders:

(a) 2,4-Dienoyl-CoA reductase deficiency;

(b) 2-Methylbutyl-CoA dehydrogenase deficiency;

(d) 3-Methylglutaconyl-Coa hydratase deficiency;

(e) 3-OH 3-CH3 glutaric aciduria (HMG);

(f) 5-Oxoprolinuria (pyroglutamic aciduria);

(g) Argininemia;

(h) Argininosuccinic acidemia (ASA);

(i) Beta-ketothiolase deficiency (BKT);

(j) Biotinidase deficiency (BIOT);

(k) Carbamoylphosphate synthetase deficiency (CPS def.);

(l) Carnitine uptake defect (CUD);

(m) Citrullinemia (CITR);

(n) Congenital adrenal hyperplasia (CAH);

(o) Cystic fibrosis (CF);

(p) Galactosemia (GALT;

(q) Glucose-6-Phosphate Dehydrogenase Deficiency (G6PD);

(r) Glutaric acidemia type I (GA I);

(s) Hemoglobinopathy;

(t) Homocystinuria (HCY);

(u) Hyperammonemia, hyperornithinemia, homocitrullinemia syndrome (HHH)

(v) Hyperornithine with gyral atrophy;

(w) Hypothyroidism;

(x) Isobutyryl-CoA dehydrogenase deficiency;

(y) Isovaleric acidemia (IVA);

(z) Long-chain L-3-OH acyl-CoA dehydrogenase deficiency (LCHADD);

(aa) Malonic aciduria;

(bb) Maple Syrup Urine Disease (MSUD);

(cc) Medium chain acyl-CoA dehydrogenase deficiency (MCAD);

(dd) Methylmalonic acidemia (Cbl A, B);

(ee) Multiple acyl-CoA dehydrogenase deficiency (MADD);

(ff) Multiple carboxylase deficiency (MCD);

(gg) Neonatal carnitine palmitoyl transferase deficiency- type II (CPT-II);

(hh) Phenylketonuria (PKU);

(ii) Propionic acidemia (PROP);

(jj) Short chain acyl-CoA dehydrogenase deficiency (SCAD);

(kk) Short chain hydroxy acyl-CoA dehydrogenase deficiency (SCHAD);

(ll) Trifunctional protein deficiency (TFP);

(mm) Tyrosinemia type I (TYR I);

(nn) Very long-chain acyl-CoA dehydrogenase deficiency (VLCAD);

(oo) Severe Combined Immunodeficiency (SCID)

(pp) Pompe Disease (also called glycogen storage disease type II or acid maltase deficiency);

(qq) X-Linked Adrenoleukodystrophy (X-ALD);

(rr) Mucopolysaccharidosis Type 1 (MPS1); and

(ss) Spinal Muscular Atrophy (SMA).

2101.2 Each institution shall inform the parent or parents of the availability and purpose of the tests for the conditions set forth in Subsection 2201.1 and shall document in the newborn’s health record that the parent or parents were properly informed and understood the purpose of the tests.

2101.3 Each institution shall provide the parent or parents a reasonable opportunity to object to performance of the tests and shall document in the newborn’s health record whether the parent or parents consented or withheld consent to have the testing done.

2101.4 Each institution that has obtained parental consent to have the newborn tested shall take from the newborn a blood sample of sufficient quantity to enable a laboratory designated by the Mayor to analyze the sample for the tests identified in Subsection 2201.1, unless an identical test has been performed. Each institution shall send the sample to the designated laboratory.

2101.5 A newborn’s parent is indigent for the purpose of § 9 of the District of Columbia Newborn Screening Requirement Act of 1979, effective April 29, 1980 (D.C. Law 3-65; D.C. Official Code § 7-838), if the parent does not have coverage by Medicaid or third party medical or health insurance coverage and has total pre-tax household income, including child support payments, alimony, rent payments received, and any other income received on a regular basis, equal to or less than three hundred per cent (300%) of the federal poverty level.

2101.6 A newborn’s parent shall document income to satisfy the requirements of § 2101.5 as follows:

(a) For a person whose source of income is earned income, one of the following:

(1) Originals or copies of all earnings statements received within the previous thirty (30) days;

(2) A copy of the first two (2) pages of a District of Columbia tax return for the most recent tax year;

(3) A copy of the first page of a Federal tax return for the most recent tax year; or

(4) For a newly employed parent, a copy of an offer of employment that states the amount of salary to be paid.

(b) For a parent whose source of income includes unearned income, one of the following:

(1) A copy of a Social Security or worker’s compensation benefit statement;

(2) Proof of child support or alimony received; or

(3) A copy of a Federal tax return for the most recent tax year, including all schedules and attachments.

2101.7 A newborn is a resident of the District of Columbia for the purpose of § 9 of the District of Columbia Newborn Screening Requirement Act of 1979, effective April 29, 1980 (D.C. Law 3-65; D.C. Official Code § 7-838), if the newborn’s mother is a resident of the District of Columbia on the date on which the newborn was born.

2101.8 The mother of a newborn shall document residency to satisfy the requirements of § 2101.7 by providing one of the following:

(a) A valid motor vehicle operator’s permit issued by the District;

(b) A non-driver’s identification card issued by the District;

(d) A copy of a lease or a rent receipt for real property located in the District;

(e) A utility bill for real property located in the District; or

(f) A copy of the most recent Federal income tax return or Earned Income Credit Form.

History

SOURCE: Final Rulemaking published at 56 DCR 7631 (September 25, 2009); as amended by Final Rulemaking published at 60 DCR 3581 (March 15, 2013); as amended by Final Rulemaking published at 64 DCR 13489 (December 29, 2017); as amended by Final Rulemaking published at 70 DCR 000413 (January 13, 2023). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 2101

22-B DCMR § 2199 DEFINITIONS

2199.1 When used in this chapter, the following terms and phrases shall have the meanings ascribed:

2,4-Dienoyl-CoA reductase deficiency—an autosomal recessive genetic disorder characterized by a deficiency of 2,4 Dienoyl CoA Reductase necessary for the degradation of unsaturated fatty acids with an even number of double bonds. Symptoms include sepsis, hypotonia, decreased feeding, and intermittent vomiting. Low carnitine levels can be detected and respiratory acidosis may occur.

2-Methylbutryl-CoA dehydrogenase deficiency—an autosomal recessive genetic disorder resulting from a defect in the metabolism of the branched chain amino acid isoleucine. Symptoms include poor feeding, lethargy, hypoglycemia, and metabolic acidosis. Symptomatic patients display developmental delay, seizure disorders, and progressive muscle weakness in infancy and childhood.

3-Methylcrotonyl-CoA carboxylase deficiency (3MCC)—a progressive autosomal recessive genetic disorder characterized by failure to thrive, hypotonia, muscle atrophy, seizures, mental retardation, and dermatological changes.

3-Methylglutaconyl-CoA hydratase deficiency—an autosomal recessive genetic disorder involving an enzyme in the metabolism of the amino acid leucine. Symptoms appear in a wide range of clinical severity and may include acute life-threatening cardiopulmonary symptoms soon after birth, psychomotor retardation, hypotonia, failure to thrive, microcephaly, seizures, and spasticity. Some patients may have acute episodes of vomiting, metabolic acidosis, and lethargy progressing to coma.

3-OH 3-CH3 glutaric aciduria or 3-hydroxy-3-methylglutaryl-CoA lyase deficiency (HMG)—an autosomal recessive disorder. Symptoms may include metabolic acidosis, hypoglycemia, sensitivity to dietary leucine, carnitine deficiency, hepatomegaly, fever, somnolence, and coma. If this disorder is untreated, it is likely to result in death during childhood.

5-Oxoprolinuria (pyroglutamic aciduria)—a group of autosomal recessive genetic conditions including glutathione synthetase deficiency, glutamylcysteine synthetase deficiency and 5-oxoprolinase deficiency caused by a deficiency of one (1) of three (3) enzymes in the gama glutamyl cycle and characterized by metabolic acidosis, hemolytic anemia, electrolyte imbalance, and jaundice.

Argininemia—an autosomal recessive genetic condition that presents from two (2) months to four (4) years of age. Symptoms include progressive spastic paraplegia, failure to thrive, delayed milestones, hyperactivity, and irritability, with episodic vomiting, hyperammonemia, seizures, microcephaly, and cerebral atrophy resulting in mental retardation.

Argininosuccinic acidemia (ASA)— an autosomal recessive disorder of the urea cycle. Symptoms are hyperammonemia accompanied by lack of appetite, vomiting, listlessness, seizures, and coma. Onset is usually at birth, but symptoms may not be noticeable for days or weeks. The build up in ASA, if too high, ultimately causes a build up in ammonia. Build up of ammonia is toxic and can cause brain damage. ASA is also characterized by excessive urinary excretion of argininosuccinic acid, epilepsy, ataxia, mental retardation, liver disease, and friable, tufted hair.

Audiologist—a person who meets the education and experience requirements for a Certificate of Clinical Competence in the area of audiology granted by the American Speech and Hearing Association or who meets the educational requirements for certification and is in the process of accumulating the supervised experience required for certification.

Beta-ketothiolase deficiency (BKT)—an autosomal recessive disorder characterized by recurrent severe metabolic acidosis. Symptoms include increased plasma glycine level, metabolic acidosis, episodic ketosis, vomiting, dehydration, coma, and cardiomyopathy, with on average onset of five (5) to twenty-four (24) months.

Biotinidase deficiency (BIOT)—an autosomal recessive disorder characterized by a lack of the enzyme biotinidase that can lead to seizures, developmental delay, eczema, and hearing loss that are treated with free biotin. Symptoms include hypotonia, ataxia, alopecia, seborrheic dermatitis, and optic nerve atrophy. Metabolic acidosis can result in coma and death.

Carbamoylphosphate synthetase deficiency (CPS def.)—an autosomal recessive genetic condition that presents within seventy-two (72) hours with symptoms of lethargy, vomiting, hypothermia, respiratory alkalosis, and seizures progressing to coma. Survivors of the newborn period have recurrent episodes of hyperammonemia associated with viral infections or increased dietary protein intake. Some patients have a later onset with less severe symptoms.

Carnitine uptake defect (CUD)—a class of autosomal recessive disorders characterized by hypoketotic hypoglycemia, seizures, vomiting, lethargy progressing to coma, cardiomyopathy, and hepatomegaly. This disorder includes carnitine palmitoyl transferase deficiency type I and carnitine acylcarnitine translocase deficiency.

Citrullinemia (CITR)—an autosomal recessive genetic disorder characterized by a deficiency of argininosuccinic acid synthetase, hyperammonemia accompanied by lack of appetite, vomiting, listlessness, seizures, and coma. Onset is usually at birth, but symptoms may not be noticeable for days or weeks. When left untreated, brain damage, coma, and death will occur.

Congenital adrenal hyperplasia (CAH)— a set of inherited disorders that occurs in both males and females as a result of the excess production of male hormones and an underproduction of the enzyme 21-hydroxylase. Symptoms include severe acne, excess facial or body hair, early development of pubic hair, receding scalp hairline, menstrual disturbances in females, and infertility in males and females in its mild form and ambiguous genitalia in newborn girls and salt and hormonal imbalances in girls and boys in more severe forms. If not treated, CAH can cause heart failure and death within a few days from birth. CAH can not be cured, however, it can be effectively treated.

Cystic fibrosis (CF)—an autosomal recessive disorder characterized by progressive chronic damage to the respiratory system, chronic digestive system problems, and can affect other organs. CF affects mucus-producing glands producing thick mucus that can obstruct air passages in the lungs, affects sweat and salivary glands, and blocks enzymes secreted by the pancreatic duct. Cystic Fibrosis can cause lung disease, failure to grow, clubbed fingers and toes, muscular weakness, and visual impairment.

Department—the District of Columbia Department of Health.

Director—the Director of the District of Columbia Department of Health.

Galactosemia—a condition involving the inability to convert galactose to glucose.

Glucose-6-phosphate dehydrogenase deficiency (G6PD)—a condition resulting in anemia or jaundice that is made worse by certain medications and some foods.

Glutaric acidemia type I (GA-I)—an autosomal recessive enzyme deficiency genetic disorder characterized by hypoglycemia, dystonia, and dyskinesia. After a period of apparently normal development, the disorder may appear suddenly and present as vomiting, metabolic acidosis, hypotonia, and central nervous system degeneration. It is not yet known how or why Glutaric Acid causes brain damage, yet damage occurs when a crisis causes an acidic environment in the blood created by excess protein byproducts. Crises can be provoked by common childhood illnesses such as colds, flu, ear infections, stomach virus, fever, etc.

Hearing impairment—a dysfunction of the auditory system, of any type or degree, sufficient to interfere with the acquisition and development of speech and language skills, with or without the use of sound amplification.

Hearing screening—an objective physiological measure of hearing sensitivity used to determine the likelihood of hearing loss.

Hemoglobinopathy—a class of disorders caused by the presence of abnormal hemoglobin production in the blood, due to genetic variations that can result in production of hemoglobin with different structures or thalassemias and reduction in the amount of normal hemoglobin produced. This term includes the following hemoglobin variants: HbS, HbC, HbE, HbD, and alpha/beta thalassemias.

Homocystinuria—a condition resulting from one of several genetically determined errors of methionine metabolism.

Hyperammonemia, hyperornithinemia, homocitrullinemia syndrome (HHH)—an autosomal recessive genetic disorder that may present at birth or in later childhood. Newborns on high protein formulas or foods may vomit with feeding, refuse to eat, become lethargic, or develop hyperammonemic coma. Patients gravitate to diets low in milk and meat during childhood.

Hyperornithine with gyrate deficiency—an autosomal recessive genetic disorder characterized by slow progressive vision loss leading to blindness. Myopia and decreased night vision appear as early symptoms in the patient’s teens and early twenties.

Hypothyroidism—those clinical conditions that result from abnormally low circulating levels of thyroid hormone.

Institution—a hospital or maternity center.

Isobutyryl-CoA dehydrogenase deficiency—an autosomal recessive genetic disorder involving the inability to metabolize valine with a highly variable presentation.

Isovaleric acidemia (IVA)—an autosomal recessive genetic disorder caused by a defect in the breakdown of the molecule isovaleryl-CoA that presents in acute or intermittent episodes. IVA can present as an acute episode of illness during the first few weeks of a newborn’s life, or it may present chronically with intermittent episodes of illness throughout life. Both forms of IVA are caused by the same biochemical defect. Infants who survive an acute neonatal episode will go on to exhibit the chronic intermittent form. Symptoms of acute IVA are attacks of vomiting, lack of appetite, and listlessness; lethargy, neuromuscular irritability, and hypothermia are other characteristics. Episodes can be triggered by upper respiratory infections or by excessive consumption of high-protein foods. Early detection through newborn screening and good treatment of IVA generally leads to normal development. Permanent neurologic damage can occur if an acute episode is not prevented or is misdiagnosed.

Long-chain L-3-OH acyl-CoA dehydrogenase deficiency (LCHADD)—an autosomal recessive genetic disorder characterized by failure to oxidize fatty acids due to a missing or malfunctioning enzyme. Symptoms include hypoglycemia, lethargy, failure to thrive, cardiomyopathy and developmental delay. Early identification and treatment can prevent life-threatening episodes.

Malonic aciduria—an autosomal recessive genetic disorder caused by a deficiency of malonyl-CoA decarboxylase (MCD) with a variable presentation ranging from acute neonatal onset to later in childhood. Symptoms include developmental delay, seizures, hypotonia, diarrhea, vomiting, metabolic acidosis, hypoglycemia, and ketosis.

Maple syrup urine disease (MSUD)—a condition resulting from the impairment of branched chain alpha-ketoacid dehydrogenase.

Maternity center—a facility or other place, other than a hospital or the mother’s home, that provides antepartal, intrapartal, and postpartal care for both mother and newborn infant during and after normal, uncomplicated pregnancy.

Medium chain acyl-CoA dehydrogenase deficiency (MCADD)—an autosomal recessive genetic disorder characterized by inability to convert fat to energy. Fasting is not tolerated well in people with MCADD. Symptoms generally begin in infancy or early childhood, however, there are some with no apparent symptoms at birth. Low blood sugar, seizures, brain damage, cardiac arrest and serious illness can occur very quickly in children who are not feeding well. Some experience recurrent episodes of metabolic acidosis, hypoglycemia, lethargy, and coma. If not detected and treated appropriately, MCADD can result in intellectual and developmental disability and death. Those treated are expected to have normal life expectancy.

Metabolic disorder—a disorder that results in a defect in the function of a specific enzyme or protein.

Methylmalonic acidemia—one (1) of two (2) variations of an autosomal recessive genetic disorder caused by an enzymatic defect in the oxidation of amino acids characterized by lethargy, failure to thrive, vomiting, dehydration, respiratory distress, hypotonia, and hepatomegaly. Acute episodes may include drowsiness, coma, and seizures, with subsequent developmental delays. This disorder includes methylmalonic acidemia CblA, methylmalonic acidemia CblB, and methylmalonic acidemia mutase deficiency.

Multiple acyl-CoA dehydrogenase deficiency (MADD)—an autosomal recessive genetic disorder, also known as glutaric acidemia type II, with three (3) different clinical presentations. Symptoms include hypotonia, hepatomegaly, severe nonketotic hypoglycemia, metabolic acidosis, and variable body odor of sweaty feet.

Multiple carboxylase deficiency (MCD)—an autosomal recessive genetic disorder characterized by a biotin deficiency. Symptoms include seizures, developmental delay, eczema, and hearing loss. Other symptoms are immune system impairment, skin rashes, hair loss, and intellectual and developmental disability that are treatable with oral biotin supplements.

Neonatal carnitine palmitoyl transferase deficiency-type II (CPT-II)—an autosomal recessive genetic disorder of mitochondrial fatty acid oxidation that presents in three (3) forms. The classic form has adult onset of exercise-induced muscle weakness, often with rhabdomyolysis and myoglobinuria that may be associated with renal failure. A second form that is often fatal between three (3) and eighteen (18) months of age has symptoms of hepatomegaly, non-ketotic hypoglycemia, cardiomyopathy, hypotonia, and muscle weakness. A severe form presents in newborns with non-ketotic hypoglycemia, cardiomyopathy, hypotonia, muscle weakness, and renal dysgenesis in some patients.

Newborn—an infant under four (4) weeks of age.

Phenylketonuria (PKU)—the metabolic disease of the newborn in which metabolites of phenylalanine appear in the urine.

Propionic acidemia (PROP)—an autosomal recessive genetic disorder characterized by protein intolerance, vomiting, failure to thrive, lethargy, and profound metabolic acidosis. If not treated early, brain damage, coma, seizures and death can occur.

Severe Combined Immunodeficiency (SCID) -- a primary immunodeficiency disease that affects infants lacking T lymphocytes, the white blood cells that help resist infections. Babies with this disease are born healthy and identified only after they begin to suffer from severe infections. SCID affects a minimum of one in 100,000 newborns.

Short chain acyl-CoA dehydrogenase deficiency (SCAD)—an autosomal recessive genetic disorder of fatty acid beta oxidation with a usual clinical onset between the second month and second year of life, with some presenting within a few days of birth and some in adulthood. Symptoms include hypotonia, progressive muscle weakness, developmental delay, and seizures. Symptoms worsen with seemingly innocuous illness that may lead to lethargy, coma apnea, cardiopulmonary arrest, or sudden unexplained death.

Short chain hydroxy acyl-CoA dehydrogenase deficiency (SCHAD)—an autosomal recessive genetic disorder of mitochondrial fatty acid beta oxidation for which a complete spectrum of presentation has not been defined. Most patients have hypoglycemia as the major symptom along with seizures, neurologic sequala or death as the outcome. Several present in the first days or months of life with hypoglycemic seizures secondary to hyperinsulinism. Some patients present after one (1) year with acute onset of vomiting, lethargy, and hyponatremic seizures.

Trifunctional protein deficiency (TFP)—an autosomal recessive mitochondrial fatty acid oxidation genetic disorder characterized by an inability to break down long-chain fatty acids into an energy source. Metabolic crises can occur when fasting, as well as hypoglycemia, lethargy, hypotonia, myopathy, failure to thrive, cardiomyopathy, and neuropathy. Severe untreated cases may present as SIDS.

Tyrosinemia type I (TYRO-I)—an autosomal recessive genetic disorder that causes severe liver disease in infancy. Affected persons develop cirrhosis of the liver and eventually require liver transplantation. The most sever form causes symptoms within the first months of life. These infants experience poor weight gain, enlarged liver and spleen, swelling of the legs, increased tendency of bleeding. Even with therapy death frequently occurs within six (6) to nine (9) months of life for those with the severe form. Children with a less severe form also suffer from enlargement of the liver, spleen, poor weight gain, vomiting, and diarrhea.

Very long-chain acyl-CoA dehydrogenase deficiency (VLCAD)—an autosomal recessive genetic disorder in which the body cannot oxidize fatty acids because of a missing or mal-functioning enzyme. Symptoms include hypoketotic hypoglycemia, hepatocellular disease, and cardiomyopathy. Fatal infantile encephalopathy may be the only indication of the condition.

History

SOURCE: Final Rulemaking published at 56 DCR 7631 (September 25, 2009); as amended by Final Rulemaking published at 60 DCR 3581 (March 15, 2013).

22-B24 [REPEALED]

22-B DCMR § 2400 [REPEALED]

History

SOURCE: 30 DCRR § 2.1 (1972); as amended by Final Rulemaking published at 52 DCR 8922 (October 7, 2005). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 2400

22-B DCMR § 2401 [REPEALED]

History

SOURCE: 30 DCRR § 2.2 (1972); as amended by Final Rulemaking published at 52 DCR 8922 (October 7, 2005). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 2401

22-B DCMR § 2402 [REPEALED]

History

SOURCE: 30 DCRR § 3.1 (1972); as amended by Final Rulemaking published at 52 DCR 8922 (October 7, 2005). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 2402

22-B DCMR § 2403 [REPEALED]

History

SOURCE: 30 DCRR § 3.2 (1972); as amended by Final Rulemaking published at 52 DCR 8922 (October 7, 2005). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 2403

22-B DCMR § 2404 [REPEALED]

History

SOURCE: 30 DCRR § 3.3 (1972); as amended by Final Rulemaking published at 52 DCR 8922 (October 7, 2005). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 2404

22-B DCMR § 2405 [REPEALED]

History

SOURCE: 30 DCRR § 3.4 (1972); as amended by Final Rulemaking published at 52 DCR 8922 (October 7, 2005). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 2405

22-B DCMR § 2406 [REPEALED]

History

SOURCE: 30 DCRR § 3.5 (1972); as amended by Final Rulemaking published at 52 DCR 8922 (October 7, 2005). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 2406

22-B DCMR § 2407 [REPEALED]

History

SOURCE: 30 DCRR § 3.6 (1972); as amended by Final Rulemaking published at 52 DCR 8922 (October 7, 2005). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 2407

22-B DCMR § 2408 [REPEALED]

History

SOURCE: 30 DCRR § 4.1 (1972); as amended by Final Rulemaking published at 52 DCR 8922 (October 7, 2005). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 2408

22-B DCMR § 2409 [REPEALED]

History

SOURCE: 30 DCRR § 4.2 (1972); as amended by Final Rulemaking published at 42 DCR 4085 (August 4, 1995); as amended by Final Rulemaking published at 52 DCR 8922 (October 7, 2005). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 2409

22-B DCMR § 2410 [REPEALED]

History

SOURCE: 30 DCRR § 4.3 (1972); as amended by Final Rulemaking published at 31 DCR 1885 (April 20, 1984); as amended by Final Rulemaking published at 42 DCR 4085 (August 4, 1995). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 2410

22-B DCMR § 2411 [REPEALED]

History

SOURCE: Final Rulemaking published at 35 DCR 9052 (December 30, 1988); as amended by Final Rulemaking published at 52 DCR 8922 (October 7, 2005). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 2411

22-B25 HEALTH PROFESSIONAL REPORTING REQUIREMENTS

22-B DCMR § 2500 GENERAL PROVISIONS

2500.1 This chapter requires any health professional, and any employer of a health professional, in the District of Columbia to timely report certain actions taken by or against the health professional to the board, commission or authority (“authority”) responsible for licensing, registering, or certifying the health professional.

2500.2 These reporting requirements will ensure that the appropriate authority is notified when a health professional has certain actions taken against him or her as a result of his or her actions. The appropriate authority is authorized to take necessary action to ensure the health professional does not engage in unsafe practices which may endanger members of the public.

2500.3 Failure to comply with the reporting requirements in this chapter may lead to disciplinary actions as outlined below.

History

SOURCE: Final Rulemaking published at 68 DCR 011097 (October 22, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 2500

22-B DCMR § 2501 REPORTING REQUIREMENTS FOR HEALTH PROFESSIONALS

2501.1 Health professionals are required to submit a report to the board, commission or authority responsible for licensing, registering or certifying the heath professional within ten (10) business days of any of the following occurrences:

(a) The health professional obtains knowledge that a health care licensing authority of another state has taken disciplinary action against him or her; or

(b) The health care professional has been:

(i) Named in a malpractice suit and received notice of a judgment against him or her in that suit; or

(ii) Convicted of a crime; or

(iii) A party to a settlement, whether or not confidential, stemming from a malpractice claim to be paid by the health professional, an insurer, or other entity on behalf of the health professional; or

(i) For reasons related to the health professional’s clinical practice or employment standards:

a. Reduced, suspended, revoked, not renewed the health professional’s employment or staff membership; or

b. Involuntarily terminated or restricted the health professional’s employment or staff membership; or

(ii) Asked the health professional to resign because his or her conduct has been determined to violate D.C. Official Code § 3-1205.14 including professional incompetence; or

(d) The health professional has voluntarily resigned or been asked by his or her employer to resign, while being investigated by the employer for conduct in violation of D.C. Official Code § 3-1205.14, including professional incompetence.

History

SOURCE: Final Rulemaking published at 68 DCR 011097 (October 22, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 2501

22-B DCMR § 2502 REPORTING REQUIREMENTS FOR EMPLOYERS

2502.1 An employer of a licensed, certified or registered health professional shall submit a report notifying the board, commission or authority within ten (10) business days after taking any of the following actions:

For reasons related to the health professional’s clinical practice or employment standards:

Reduced, suspended, revoked or not renewed the health professional’s clinical privileges; or

Involuntarily terminated or restricted the health professional’s employment or staff membership; or

Asked the health professional to resign because his or her conduct has been determined to have committed a violation of D.C. Official Code § 3-1205.14, including professional incompetence; or

The health professional has voluntarily resigned, or been asked by the employer to resign, while being investigated by the employer for conduct in violation of D.C. Official Code § 3-1205.14, including professional incompetence.

2502.2 If the employer has temporarily suspended or required the relinquishment of privileges of a health professional while he or she enters and successfully completes a prescribed program of education or rehabilitation, no report needs to be made. However, if there is no reasonable expectation that the health professional will enter and successfully complete a prescribed program of education or rehabilitation, the employer shall submit a report immediately in accordance with Section 2503.

History

SOURCE: Final Rulemaking published at 68 DCR 011097 (October 22, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 2502

22-B DCMR § 2503 REPORTS

2503.1 Health professionals and employers are required to submit a report to the appropriate board, commission, or authority within ten (10) business days of any of the occurrences specified in §§ 2501 or 2502.

2503.2 Reports shall be submitted by registered or certified mail, return receipt requested, or by courier service, commercial carrier, personal service, or via e-mail to a secure e-mail address(es) identified by the Department.

2503.3 Reports shall include all relevant information including any investigative reports, witness statements, medical records and correspondence.

2503.4 Records reported and obtained as a result of this requirement shall remain confidential and not be disclosed except as otherwise authorized or required by law. Submission of records does not constitute a waiver of confidentiality.

2503.5 For any report submitted pursuant to the entry of a confidential settlement, the health professional shall not include any details required by the settlement to be kept confidential.

History

SOURCE: Final Rulemaking published at 68 DCR 011097 (October 22, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 2503

22-B DCMR § 2504 IMMUNITY

2504.1 The employer, or employee of the employer, who acting in good faith makes a report pursuant to this chapter, shall have immunity from administrative, civil, or criminal liability that might otherwise be incurred or imposed with respect to making the report. The same immunity shall extend to participation in any administrative or judicial proceeding involving the report.

2504.2 In all administrative, civil, or criminal proceedings resulting from the report, there shall be a rebuttable presumption that the maker of the report acted in good faith.

History

SOURCE: Final Rulemaking published at 68 DCR 011097 (October 22, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 2504

22-B DCMR § 2505 ENFORCEMENT

2505.1 Failure of either the employer or the health professional to submit a required report in accordance with this chapter to notify the proper authorities of actions identified in this chapter may result in the imposition of fines.

2505.2 The Director or the appropriate board, commission or authority may issue a Notice of Infraction (NOI) to the employer or health professional imposing a civil fine whenever the Director or board, commission or authority has reasonable grounds to believe the employer or health professional is in violation of a requirement of this title.

2505.3 An NOI shall be in writing in a form prescribed by the Director and shall include:

(a) The name of the health provider or employer (“respondent”);

(b) A citation or reference to the provision of this title that the respondent has violated;

(d) The amount of the civil fine applicable to the infraction;

(e) A statement that:

(1) The fine must be paid within fifteen (15) calendar days of the date that the NOI has been served on the respondent;

(2) The respondent has the right to request a hearing before the Office of Administrative Hearings (“OAH”); and

(3) If the respondent fails to pay the fine or request a hearing within fifteen (15) calendar days of the date the NOI is served on the respondent, a penalty equal to the amount of the fine may be imposed; and

Any other information the Director may require.

2505.4 Each NOI shall be served and filed in the manner prescribed by 16 DCMR § 3102.

2505.5 In response to an NOI, a respondent shall file a written answer with OAH within fifteen (15) calendar days of the date the NOI is served on the respondent. The answer shall:

(a) Admit the infraction and pay the fine;

(b) Admit the infraction with an explanation, and provide any supporting documentation; or

2505.6 If a respondent admits an infraction in the NOI, the respondent shall include payment of the fine with the answer. If respondent pays the stated fine but fails to indicate a specific answer, the respondent shall be deemed to have admitted the infraction.

2505.7 If a respondent submits a written answer to OAH but does not pay the stated fine and fails to state an answer as required by § 2505.4, the respondent shall be deemed to have denied the infraction.

2505.8 If the respondent admits an infraction with an explanation, the respondent shall state in the written answer whether the respondent requests a hearing on the papers or an in-person hearing. The OAH may hold an in-person hearing in its sole discretion.

2505.9 If a respondent denies an infraction, OAH may schedule an in-person hearing in accordance with its rules.

2505.10 If a respondent does not answer the NOI within fifteen (15) calendar days:

(a) OAH shall issue a default order; and

(b) A civil penalty equal to double the amount of the fine imposed by the NOI shall be imposed by OAH in the default order.

2505.11 If a respondent fails to answer an NOI in a timely manner, the respondent shall not have a right to a hearing on the NOI, unless the respondent shows good cause for the failure to answer the NOI in a timely manner.

2505.12 If a respondent challenges an NOI as defective on its face, an administrative law judge (“ALJ”) within OAH may review the NOI prior to a hearing and, if the ALJ determines that the NOI is defective on its face, dismiss the NOI. If the ALJ does not dismiss the NOI, the respondent shall be deemed to have denied the infraction and the OAH shall schedule a hearing. The respondent's evidence presented in support of the denial may include evidence on whether the NOI is defective.

2505.13 In a proceeding challenging the imposition of a fine for failure to comply with these reporting requirements, the employer or the health professional has the burden of proving that the report was sent in accordance with the requirements of this chapter if the board, commission or authority states that it did not receive the report.

2505.14 A civil penalty, including a fine, may be downwardly modified by OAH if:

(a) The downward modification is not inconsistent with the provision of this title or other applicable law that is the basis for the penalty;

(b) The Director is provided with an opportunity to present to OAH its opinion on a proposed downward modification or fine reduction; and

2505.15 The schedule of fines for failure to submit a required report is:

For the first violation: $ 2,500;

For the second violation: $ 5,000;

For the third and subsequent violations: $ 10,000.

History

SOURCE: Final Rulemaking published at 68 DCR 011097 (October 22, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 2505

22-B DCMR § 2599 DEFINITIONS

2599.1 As used in this chapter, the following terms have the meaning ascribed:

Board - the Board of Audiology and Speech-Language Pathology, the Board of Chiropractic, the Board of Dentistry, the Board of Dietetics and Nutrition, the Board of Marriage and Family Therapy, the Board of Medicine, the Board of Nursing, the Board of Long-Term Care Administration, the Board of Occupational Therapy, the Board of Optometry, the Board of Pharmacy, the Board of Physical Therapy, the Board of Podiatry, the Board of Professional Counseling, the Board of Psychology, the Board of Respiratory Care, the Board of Social Work, or the Board of Veterinary Medicine, all as established by the Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq.) as amended.

Department – the Department of Health or DC Health.

Director – the Director of the District of Columbia Department of Health.

Employer – any entity, including a facility, agency, assisted living residence, private office, health care provider, or group home in the District of Columbia that employs health care professionals or utilizes the services of a health professional who is contracted with a third party or is self-employed, including those engaged in the practice of pharmacy. This definition does not include the private person who, for his or her own health needs, has contracted directly with a health professional.

Health professional – a person licensed, registered, certified, or permitted to practice a health occupation regulated by a licensing board, commission or authority in the District of Columbia.

Professional incompetence – a health professional’s unfitness to continue in the health professional’s profession, or to provide one or more services ordinarily provided as part of the profession, as demonstrated by:

A lack of knowledge, skill or judgment; or

Disregard for the welfare of a patient or client.

History

SOURCE: Final Rulemaking published at 68 DCR 011097 (October 22, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 2599

22-B26 MATERNITY CENTERS

22-B DCMR § 2600 GENERAL PROVISIONS

2600.1 This chapter, and Chapter 31 of Title 22 of the D.C. Municipal Regulations, shall apply to the establishment and maintenance of maternity centers in order to protect the public interest by promoting the health, welfare, and safety of individuals in maternity centers.

2600.2 The Director shall make the final determination as to whether any building, or part of a building, or a group of buildings, constitutes a maternity center.

2600.3 Each section, subsection and paragraph of this chapter shall be independent of every other section, subsection and paragraph, and the finding or holding of any section, subsection and paragraph to be void or ineffective for any cause shall not be deemed to affect the validity of any other section, subsection and paragraph.

2600.4 Words used in this chapter shall have their usual meaning unless the context or a definition clearly indicates a different meaning.

2600.5 Words used in this chapter in the present tense include the future, words in the singular number include the plural number, words in the plural number include the singular number, and words in the masculine include the feminine.

2600.6 Whenever any office or department of the District government, other than the Director, is referred to in this chapter, the term shall include the authorized agent of the office or department.

2600.7 Data relating to a maternity center, obtained as a result of the application of the provisions of this chapter, shall not be disclosed publicly in a manner that identifies the maternity center except in or following a public hearing, or except as necessary in case of a public health emergency.

2600.8 Each maternity center shall, in addition to the other requirements of this chapter, comply with the requirements of sections 2100 and 2101 regarding newborn hearing screening and newborn testing for metabolic disorders.

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is the Health-Care and Community Residence Facility, Hospice and Home Care Licensure Act of 1983 § 5, D.C. Code §44-504; Reorganization Plan No. 4 of 1996, 3 D.C. Code, 2001 Ed. at 413; and Mayor’s Order 98-137 (August 20, 1998).
SOURCE: Notice of Final Rulemaking published at 46 DCR 2779 (March 19, 1999); as amended by Corrected Notice of Final Rulemaking published at 46 DCR 3970 (April 30, 1999); as amended by Notice of Final Rulemaking published at 49 DCR 4859 (April 12, 2002); as amended by Corrected Notice of Final Rulemaking published at 49 DCR 6130 (July 5, 2002); as amended by Notice of Final Rulemaking published at 52 DCR 9852 (November 4, 2005); as amended by Final Rulemaking published at 56 DCR 7631 (September 25, 2009).

22-B DCMR § 2601 STANDARDS OF COMPLIANCE

2601.1 The Director may formulate and publish additional standards pursuant to the D.C. Administrative Procedure Act which, if followed, shall constitute prima facie evidence of compliance with the requirements of this chapter.

2601.2 Standards formulated and adopted by the Director pursuant to this chapter and the D.C. Administrative Procedure Act shall be made available to the public, and shall be maintained on file in the Director's office for inspection during regular business hours.

2601.3 The Director shall accept other means of compliance with this chapter if, after demonstration by the proponent of any method, process, means, or thing, it is determined that the method, process, means, or thing can, or is likely to, perform in the manner indicated or required, such that the total services and facilities of the maternity center will assure that the public health purpose will be achieved on a continuing basis.

2601.4 Demonstration by a proponent may include, but need not be limited to, approvals or acceptances by nationally recognized testing laboratories, reports of compliance with nationally accepted standards, or reports of investigations by universities or governmental agencies, and shall be in sufficient detail and magnitude that the Director may assure himself or herself that the public health purpose can and will be achieved under normal operating conditions on a continuing basis.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 2779, 2780 (March 19, 1999); as amended by Corrected Notice of Final Rulemaking published at 46 DCR 3970, 3971 (April 30, 1999).

22-B DCMR § 2602 LICENSE REQUIREMENTS

2602.1 No person shall operate or hold himself or herself out as operating a maternity center in the District without being licensed as required by the Act, except that any person operating a maternity center within the District on the date of adoption of these rules shall ensure compliance with these rules and obtain a license pursuant to this chapter within six (6) months of the date the rules were adopted.

2602.2 Each person who proposes to operate a maternity center in the District shall apply for a maternity center operator's license on a form prescribed by the Director.

2602.3 At the time of application, the applicant shall specify each category of birth conditions for which care will be offered. At the request of the Director, the applicant shall provide any other information relative to the operation of the maternity center.

2602.4 The initial application for a maternity center license, and applications for subsequent renewal, shall be accompanied by a license fee of three hundred ($ 300) dollars.

2602.5 The application for a maternity center license shall be submitted at least ninety (90) days before the prospective effective date of the license. Renewal applications shall be submitted at least (60) days prior to the expiration of the current license.

2602.6 Each applicant for a maternity center license shall, as a condition precedent to the issuance of the license, submit evidence satisfactory to the Director showing sufficient insurance coverage for the following:

(a) Hazard (fire, extended coverage, and vandalism);

(b) Consequential (indirect) loss from operation breakdowns;

(d) Legal risk (liability), provided that such coverage includes malpractice insurance of at least one hundred thousand dollars ($ 100,000), and comprehensive general coverage of at least three hundred thousand dollars ($ 300,000), per incident. Such coverage shall include coverage of all personnel, consultants or volunteers delivering direct patient care.

2602.7 No license to operate a maternity center shall be issued by the Director until the applicant has demonstrated that he or she is a resident of the District, or if the applicant is not a resident of the District, until the applicant, as a condition of the license, appoints or employs an agent who is a resident of the District, and notifies the Director of the appointment or employment.

2602.8 Each nonresident licensee shall maintain a resident agent and shall notify the Director, within five (5) business days, of any change in the appointment or employment of his or her resident agent.

2602.9 No license to operate a maternity center shall be issued by the Director until the certifications required under this chapter have been issued.

2602.10 Each maternity center shall be accredited by the Commission for the Accreditation of Birth Centers.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 2779 (March 19, 1999); as amended by Corrected Notice of Final Rulemaking published at 46 DCR 3970 (April 30, 1999).

22-B DCMR § 2603 CERTIFICATIONS REQUIRED

2603.1 Upon receipt of satisfactory proof from the applicant, the Director shall certify that the following services shall be provided at the maternity center by or under the supervision of a certified nurse-midwife, provided a physician, as described in §2614, is available on call at all times:

(a) Diagnostic services for screening and referral for care of at-risk maternity patients and newborn infants; and

(b) Midwifery services for the care of maternity patients and newborn infants.

2603.2 The Director, Department of Consumer and Regulatory Affairs ("DCRA"), or a designee, and the Chief, District of Columbia Fire Department ("Fire Department"), or a designee, shall inspect any physical facility to be used as a maternity center to determine whether the facility is appropriate for the proposed use, and if appropriate, issue to the applicant and the Director certification of the appropriate use. The Director shall not issue a license to operate a maternity center until the Director receives the certification of appropriateness from the Fire Department and DCRA.

2603.3 The Director may waive the on-site inspection if the Director determines that the maternity center to be located in the District is headquartered and licensed outside the District, and in the opinion of the Director, licensure by another jurisdiction constitutes sufficient evidence that the maternity center is in substantial compliance with District of Columbia law.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 2779 (March 19, 1999); as amended by Corrected Notice of Final Rulemaking published at 46 DCR 3970 (April 30, 1999).

22-B DCMR § 2604 ISSUANCE OF LICENSES

2604.1 The Director may issue a regular, provisional, or restricted license to operate a maternity center.

2604.2 Each maternity center license shall specify the following:

(a) The name of the person or organization to whom the license is issued;

(b) The name and location of the maternity center;

(c) The total rated bed capacity of beds and number of bassinets provided solely for maternity patients and newborn infants;

(d) The expiration date;

(e) The categories of care which the maternity center may furnish; and

(f) Any special limitations imposed by the Director.

2604.3 Licenses shall be classified as follows:

(a) Regular - for facilities that comply satisfactorily with the provisions of law and regulations; the Director shall issue a regular license to the maternity center if the facility complies satisfactorily with the provisions of this chapter.

(b) Provisional - for a maternity center that does not comply fully with the provisions of law and the regulations, where the non-compliance is not sufficiently serious in the judgment of the Director as to justify denial of a license for the operation of the center, and the center is taking appropriate corrective action as required by the Director. The maternity center may be permitted to operate under such conditions as the Director may specify for a period not to exceed 90 days under a provisional license.

(c) Restricted license - for a maternity center that does not comply fully with the provisions of law and the regulations, where the non-compliance is sufficiently serious in the judgment of the Director as to prohibit the maternity center from accepting new patients or to restrict the services offered by the center, for a period not to exceed ninety (90) days, when appropriate corrective action is not forthcoming from the center.

2604.4 Each maternity center license shall be valid only for the licensee and premises named in the license.

2604.5 The licensee shall frame the license under clear glass or plastic, and shall post it in conspicuous place in the main lobby or administrative office of the maternity center.

2604.6 Prior to the initial issuance of a license, and before license renewal, the Director or a designee shall conduct an on-site inspection of the applicant's maternity center to ensure compliance with the Act and the rules of this chapter.

2604.7 The Director or his or her designee may enter, announced or unannounced, a maternity center applying for licensure pursuant to this chapter during normal operating hours for the purpose of compliance with the Act or this chapter. The official conducting the inspection shall make every effort not to disrupt the normal operations of the maternity center.

2604.8 After initial licensure, the Director, in lieu of an on-site inspection, may accept accreditation by a private accrediting body, federal certification for participation in a health-insurance or medical assistance program as evidence of, and in lieu of inspecting for, compliance with any or all of the provisions of this chapter that incorporate or are substantially similar to applicable standards or conditions of participation established by that body or the federal government. Acceptance of private accreditation shall be contingent on the maternity center:

(a) Notifying the Director of all survey and resurvey dates no later than five (5) days after it receives notice of these dates;

(b) Permitting authorized government officials to accompany the survey team; and

(c) Submitting to the Director a copy of the certificate of accreditation, all survey findings, recommendations and reports, plans of correction, interim self-survey reports, notice of noncompliance, progress reports on correction of noncompliances, preliminary decisions to deny or limit accreditation, and all other similar documents relevant to the accreditation process, no later than five (5) days after their receipt by the maternity center or agency or submission to the accrediting body.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 2779 (March 19, 1999); as amended by Corrected Notice of Final Rulemaking published at 46 DCR 3970 (April 30, 1999).

22-B DCMR § 2605 CHANGE OF NAME, LOCATION OR OWNERSHIP

2605.1 A licensed maternity center or part of a licensed maternity center shall not be relocated from the premises designated in the maternity center's license unless the licensee requests in writing approval from the Director at least thirty (30) days prior to the relocation, and obtains from the Director written permission to relocate.

2605.2 The relocation permit shall indicate on its face the special conditions governing the relocation of the maternity center or part of the maternity center as the Director may find to be in the interest of the public health.

2605.3 A licensee shall notify the Director of any change in ownership or name of the maternity center at least thirty (30) days prior to the change. If there is a change in the legal or beneficial ownership of ten (10) percent or more of the stock of a corporation that owns or operates a maternity center, the Director may, in his or her discretion, require reinspection or relicensure. In the event of a name change only, the licensee shall provide that information and such documents and records as needed to register the name change.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 2779 (March 19, 1999); as amended by Corrected Notice of Final Rulemaking published at 46 DCR 3970 (April 30, 1999).

22-B DCMR § 2606 TERMINATION OF LICENSES

2606.1 Each maternity center license, unless sooner terminated, suspended, or revoked, shall be issued only for one (1) calendar year from the date of issuance, and shall be subject to annual renewal. A provisional or restricted license shall be renewed no more than once.

2606.2 A licensed maternity center may continue to operate after the expiration of its license if a licensee applies for a renewal license at least ninety (90) days prior to the expiration of the licensee's current license. The licensee may continue to operate the maternity center until the Director notifies the licensee that the application for a renewal license is denied, at which time the center shall immediately cease operations.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 2779 (March 19, 1999); as amended by Corrected Notice of Final Rulemaking published at 46 DCR 3970 (April 30, 1999).

22-B DCMR § 2607 DENIAL, SUSPENSION, REVOCATION OR CONVERSION OF LICENSE

2607.1 The denial, suspension, revocation or conversion of a maternity center license shall be governed by this section and 22 DCMR §§ 3107 and 3108.

2607.2 The Director may refuse to issue or renew, suspend, or revoke the license of a maternity center that is in violation of any provision of the Act, rule adopted pursuant to the Act, or other provision of District of Columbia or federal law, or whose governing body, chief executive officer, administration, or director has made a material misrepresentation of fact to a government official with respect to the center's compliance with any provision of the Act, rule adopted pursuant to the Act, or other provision of District of Columbia or federal law.

2607.3 If the Director determines that a maternity center operator has failed to comply with the provisions of this chapter, the Act or any District or federal law or regulation, the Director shall notify the licensee, in writing, of the failure to comply and require the licensee to show cause within five (5) days of the receipt of notice from the Director why the license should not be suspended or revoked.

2607.4 If the licensee does not respond to the show cause request, or if the licensee fails to show cause why the license should not be suspended or revoked to the Director's satisfaction, the Director shall suspend or revoke the license as appropriate to protect the public health, safety or welfare.

2607.5 If a maternity center loses its accreditation, it shall provide written notice thereof to the Director within five (5) calendar days of notification of such loss. Upon receipt of the written notice, the Director shall immediately:

(a) Convert the maternity center's license to a provisional or restricted license; or

(b) Suspend the center's license based upon a finding that loss of accreditation was prompted by existing deficiencies that pose an immediate and continuing danger to the health, safety or welfare of the center's patients.

2607.6 Upon suspension or conversion of a license pursuant to this section, the Director shall immediately give the maternity center written notice of the action, including a copy of the order of suspension or conversion, the grounds for the action, and notification that the center may file a written request for an expedited preliminary review hearing within seven (7) days of receipt of the notice, excluding Saturdays, Sundays, and holidays.

2607.7 If the center fails to timely communicate a request for an expedited preliminary review hearing, the order of suspension or conversion shall remain in effect until terminated by the Director or a final hearing is held before the Director or his or her designee within thirty (30) days of the date the order was entered.

2607.8 Upon receipt of a timely request for an expedited preliminary review hearing, the Director shall, within three business days, provide a hearing to review the reasonableness of the suspension or conversion. The Director shall have the burden of establishing a prima facie case of immediate or serious and continuing endangerment to the health, safety or welfare of persons utilizing the facilities and/ or services of the center. The order of suspension or conversion shall be either affirmed or vacated at the hearing.

2607.9 If, after an expedited preliminary review hearing, the order of suspension or conversion is affirmed, it shall remain in effect for no longer than thirty (30) days from the date affirmed, unless extended by the Director, during which time a final hearing shall be held to consider the appropriateness of revocation or continuing restrictions on licensure.

2607.10 A final hearing on the suspension or conversion of a maternity center's license shall be held before the Director within thirty (30) days of the affirmation of the proposed order of suspension after an expedited preliminary review hearing, or within thirty (30) days of the date suspension or conversion was ordered if no expedited hearing was held. At the final hearing, the Director shall consider the appropriateness of revocation or continuing restrictions on licensure and shall have the burden of proving the conditions justifying revocation or continuing restrictions.

2607.11 Prior to expiration of a suspension or conversion order, an extension may be granted by the Director for a period not to exceed an additional thirty (30) calendar days upon agreement of all parties or for good cause shown.

2607.12 A licensed maternity center may continue to operate after its license has been suspended or revoked if the licensee's appeal of the suspension or revocation is pending. The licensee may continue to operate the maternity center until the Director notifies the licensee that the appeal of the suspension or revocation is denied.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 2779 (March 19, 1999); as amended by Corrected Notice of Final Rulemaking published at 46 DCR 3970 (April 30, 1999).

22-B DCMR § 2608 CENTER DESIGN, CONSTRUCTION AND SAFETY

2608.1 Each maternity center's design, construction and safety shall meet the building code, zoning regulations, and regulations regarding access for the handicapped of the District of Columbia, and the fire safety requirements as stated in the 1997 edition of the Life Safety Code of the National Fire Protection Association, NFPA 101, as interpreted and enforced by the Fire Chief.

2608.2 Each maternity center shall be designed, constructed, maintained and operated to minimize the possibility of a fire or other life threatening emergency to the personnel and patients. The protection of personnel and patients from fire or other life-threatening emergency shall be assured by careful development of operating and maintenance procedures in compliance with this section.

2608.3 New and existing buildings to be occupied by a maternity center may be of any recognized construction type except wood frame, providing that fire and safety requirements are adhered to. Any building three or more stories in height shall be of at least one hour fire resistive construction, or it shall be equipped with a sprinkler system. Every building over eight (8) stories or seventy-five (75) feet in height shall be equipped with a sprinkler system. If the maternity center is housed in another multi-use building, the fire regulations which govern it shall apply to that part of the building which houses the maternity center.

2608.4 There shall be a minimum of two exits from every level including the floor levels below the street. Additional exits may be necessary, based on the size of the center and the travel distance from the exits. Fire escapes exterior to the building are not considered exits.

2608.5 Hallways and doorways providing ingress and egress to the maternity center and birth rooms shall be adequate to accommodate an ambulance stretcher or wheelchair. Other doorways shall be a minimum of three (3) feet in width. Adequacy of these structures shall be demonstrated as part of the fire inspection procedure by means of a trial run implementation of a transfer procedure.

2608.6 Every stairway, elevator shaft, light and ventilation shaft, chute, and other opening between floors shall be enclosed or protected to prevent the spread of fire or smoke from one floor to another for a minimum of twenty (20) minutes.

2608.7 Any area used for general storage and the boiler or furnace room shall be separated by fire resistant construction and meet all requirements of §§ F-305.3 and 308.1, respectively, of the Fire Prevention Code. If any oxygen or compressed gases are stored or used, up to two thousand (2,000) cubic feet may be stored in one room, or approximately ten (10) average oxygen bottles, and such storage and use of oxygen cylinders shall be in compliance with § 2401.1 of the Fire Prevention Code.

2608.8 Each maternity center shall contain devices for detection, alarm and suppression of a fire as required by Chapter 5 of the Fire Prevention Code, and shall also contain devices for the detection and alarm of carbon monoxide. Detection and alarm devices may be combined in one device. Suppression of the fire may be manual by fire extinguishers or automatic by a sprinkler system. If fire extinguishers are used, there shall be at least one 2AIOABC extinguisher on each floor, with a travel distance of no more than one hundred (100) feet to any one extinguisher from any place on that floor.

2608.9 Each maternity center shall provide continuous illumination in the areas of egress during occupancy, and an auxiliary source of power for illumination in the birth room in the event of a power failure in accordance with § F-604.1 of the Fire Prevention Code.

2608.10 Each maternity center shall make available to its personnel a written copy of a plan for evacuation in the event of fire which has been reviewed and approved by the D.C. Fire Department. All personnel shall be instructed and kept informed of their responsibilities under the plan. A minimum of four fire drills at regular intervals shall be supervised and conducted for personnel annually.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 2779 (March 19, 1999); as amended by Corrected Notice of Final Rulemaking published at 46 DCR 3970 (April 30, 1999).

22-B DCMR § 2609 FACILITIES AND EQUIPMENT

2609.1 Each maternity center shall be configured to have, at a minimum, a reception and waiting area, a kitchen, bath facilities, birth rooms, examination rooms, a secure record storage area, and utility and laundry facilities. Each maternity center shall also be equipped with a heating, ventilation and air conditioning system in good working order. Each maternity center shall be illuminated by normal household lighting in common areas, adequate examination lights in the birth rooms, and provisions for automatic emergency lighting during a power failure.

2609.2 The reception or waiting area shall be adequate to meet the needs of patients and their families for space and comfort.

2609.3 The kitchen shall include a refrigerator, range, sink, storage cabinets, disposable dishware and eating utensils, and counter space for the convenience of patient's families to prepare snacks.

2609.4 Birth rooms shall be located so as to provide unimpeded rapid access to an exit of the building where emergency transportation vehicles may be accommodated. Each birth room shall be a minimum of 120 square feet, and designed to accommodate:

(a) A bed large enough to safely accommodate mother and baby;

(b) At least three persons, other than the mother and baby;

(d) A bassinet;

(e) A designated space for birth room supplies; and

(f) A sink with hot and cold running water in or adjacent to the room.

2609.5 Permanent toilet facilities equipped with grab bars shall be provided in each room where labor is permitted. Separate toilet facilities shall be provided for patient's family and personnel of the maternity center.

2609.6 Bath or shower facilities, with grab bars, shall be provided to each laboring mother within the patient's room or immediately adjacent thereto.

2609.7 Utility and storage facilities shall be provided for washing, sterilizing, storage, and other handling of equipment, linens, and medical supplies. Clean linen, sterile supplies, and equipment shall be separated from those that are soiled and/or contaminated.

2609.8 Offices for the provision of antepartum and well-woman care shall be distinctly separate from the birth areas.

2609.9 Areas for record storage, administrative staff, and minor laboratory tests shall be provided in space separate and distinct from public areas.

2609.10 Furnishings shall be constructed of materials that are fire retardant (or are made so) and can be easily cleaned with appropriate antiseptic solutions.

2609.11 Each maternity center shall be equipped with a washer and dryer maintained in good working order.

2609.12 Each maternity center shall be equipped with the following items that shall be maintained in working order in an area convenient for emergency application, and a record of periodic maintenance checks documenting functional competency and availability for each item kept on the premises of the maternity center:

(a) Portable infant equipment for transfer which shall provide for at least heat regulation, oxygen administration, and infant resuscitation;

(b) Warming devices shall be available so that adequate heat regulation of each newborn infant can be achieved;

(d) Oxygen for emergency use which shall be stored according to directions on the tank and consistent with § F-2401.0 of the Fire Prevention Code;

(e) Diagnostic equipment, including a microscope, a sphygmomanometer, adult, fetal and infant auscultation equipment, infant and adult airways; and

(f) Sterilization equipment.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 2779 (March 19, 1999); as amended by Corrected Notice of Final Rulemaking published at 46 DCR 3970 (April 30, 1999).

22-B DCMR § 2610 VARIANCES

2610.1 A maternity center required to perform an act by the provisions of this chapter shall be granted a variance under this section by the Director excusing the performance, either in whole or in part, upon a finding by the Director that the full performance of the act would result in exceptional or undue hardship by reason of excessive structural or mechanical difficulty, or impracticability, from bringing the maternity center affected into full compliance with all requirements of this chapter.

2610.2 A maternity center requesting a variance shall submit in writing to the Director the following:

(a) The regulatory requirement(s) for which a variance from strict compliance is being requested;

(b) Specific justification as to why the maternity center cannot meet the requirement(s); and

2610.3 The Director may grant a variance from any of the requirements of the Act and rules of this chapter, if the variance can satisfy the following conditions, and when compensating factors are present to give adequate protection to the public health without impairing the intent and purpose of the Act or rules of this chapter:

(a) The applicant can show undue hardship by reason of excessive structural or mechanical difficulty or impracticality;

(b) It is consistent with other provisions of the Act;

(d) It would not have the effect of permitting a violation of other laws or regulations of the District of Columbia.

2610.4 The Director shall grant a variance only to the extent necessary to ameliorate an undue hardship.

2610.5 If the Director determines that the conditions in § 2610.3 are not met, the Director shall issue a written proposed denial together with advice to the applicant as to his or her right to a hearing on the matter which shall be conducted by the Director in accordance with this chapter.

2610.6 The Director shall maintain a record, open to inspection by the public, of all variances granted. The record shall contain a complete written explanation of the basis for each variance.

2610.7 The Director shall not be authorized to delegate any authority granted to him or her in this section.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 2779 (March 19, 1999); as amended by Corrected Notice of Final Rulemaking published at 46 DCR 3970 (April 30, 1999).

22-B DCMR § 2611 NONCONFORMING FIXTURES, APPURTENANCES, MATERIAL, AND METHODS

2611.1 Any person desiring to install or use a fixture, appurtenance, material, or method of a type not conforming with the requirements of, nor expressly prohibited by this chapter shall, prior to the installation or use, submit to the Director proof by recognized authority as the Director may require, to permit the Director to determine whether a fixture, appurtenance, material, or method is of a design or quality, or both, that appears to the Director as suitable, safe, and sanitary for the use for which it is intended. In the event the Director determines that a fixture, appurtenance, material, or method appears suitable, safe, and sanitary for the use for which it is intended, the Director may then permit its installation or use; provided, that the manner of installation or use is otherwise in accordance with applicable regulations.

2611.2 The Director may approve the installation or use in a maternity center of fixtures, appurtenances, materials, and methods of a type not conforming with the requirements of, nor expressly prohibited by, this chapter after the Director determines that a fixture, appurtenance, material, or method is of a design or quality, or both, that appears to him or her as suitable, safe, and sanitary for the use for which it is intended.

2611.3 The Director shall maintain a record of approvals or denials to use nonconforming items which shall be available to the public and, from time to time, shall recommend amendment of this chapter so as to either authorize or prohibit the installation or use of nonconforming fixtures, appurtenances, materials, and methods.

2611.4 Each installation or use approved under this section shall be subject to periodic inspection by the Director, and any fixture, appurtenance, material, or method shall, upon order, be discontinued or removed, if the inspection indicates to the Director that it is unsuitable, unsafe, unsanitary, or contrary to other applicable laws or regulations.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 2779 (March 19, 1999); as amended by Corrected Notice of Final Rulemaking published at 46 DCR 3970 (April 30, 1999).

22-B DCMR § 2612 ENVIRONMENTAL SERVICES AND INFECTION CONTROL

2612.1 In order to prevent against and provide for the control of infection, each maternity center shall be equipped with the following:

(a) Handwashing sinks in or adjacent to the birth rooms;

(b) Separate toilet facilities for patients and their families and maternity center personnel;

(c) Laundry facilities that are segregated as follows: an enclosed holding area with a handwashing sink to store soiled laundry, and a workroom with a handwashing sink to store and to hold clean laundry;

(d) A janitor's closet and a sink for maintenance use separate from laundry and toilet facilities;

(e) An enclosed area for the storage of clean supplies and equipment; and

(f) Sterilization equipment to sterilize all surgical instruments used in patient care.

2612.2 If a dishwasher is used, it shall have a sanitation cycle.

2612.3 There shall be a defined means of discarding waste products and materials, including medical waste. Soiled linen shall be laundered with a final rinse cycle of at least 160 degrees F, or an approved commercial laundry may be used.

2612.4 Materials that cannot be properly sterilized for re-use shall be disposed of after a single use.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 2779 (March 19, 1999); as amended by Corrected Notice of Final Rulemaking published at 46 DCR 3970 (April 30, 1999).

22-B DCMR § 2613 OWNERSHIP AND RESPONSIBILITY

2613.1 Each maternity center, whether organized as for profit or nonprofit, as a sole proprietorship, partnership, or corporation, shall identify the individuals or entity with authority and responsibility for overall policy and fiscal management of the maternity center and the services according to the stated purposes.

2613.2 The responsible individual or entity appointed by the maternity center shall develop and maintain a written organizational plan and be responsible for the appointment of a certified nurse-midwife as Director of the maternity center and a qualified physician as Director of Medical Affairs.

2613.3 The names of individuals who comprise the governing entity of each maternity center and an organizational chart shall be posted in an area available to each patient.

2613.4 The Director of the maternity center shall be responsible to the governing entity for the operation and maintenance of the center.

2613.5 The Director of Medical Affairs shall be a board certified or board eligible obstetrician/gynecologist with full obstetrical privileges at a nearby hospital. The Director of Medical Affairs shall be responsible for advising and consulting with the staff of the maternity center on all matters related to medical management of pregnancy, birth, postpartum, newborn and gynecologic health care, and established practice guidelines, including approval of policies, procedures and protocols for midwifery management of care.

2613.6 If nurse midwifery services are provided by the maternity center, a certified nurse midwife shall be appointed Director of Midwifery Services. The Director of the maternity center may serve in this capacity.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 2779 (March 19, 1999); as amended by Corrected Notice of Final Rulemaking published at 46 DCR 3970 (April 30, 1999).

22-B DCMR § 2614 OPERATING PROCEDURES

2614.1 Every maternity center, regardless of size, shall have written Practice Guidelines establishing procedures for both normal and emergency care. These guidelines shall be consistent with the Practice Guidelines of the American College of Nurse-Midwives and District of Columbia laws and regulations relating to midwifery practices, and shall indicate the areas of responsibility of medical, nurse-midwifery and nursing personnel and the extent to which the responsibility of physicians can be delegated. These Practice Guidelines shall be available to all members of the center and shall be reviewed annually.

2614.2 There shall be written Practice Guidelines that establish standards for the services provided by the maternity center. Practice Guidelines shall be developed by and approved by the governing entity, reviewed at least annually, revised as necessary, dated to indicate the time of last review, signed by the Director of Medical Affairs and the Director of the maternity center, and enforced by the Director of the center.

2614.3 The Practice Guidelines shall describe the scope and conduct of maternity care provided in the center. Practice Guidelines shall relate to at least the following:

(a) Organizational structure, which delineates lines of authority, communications, and Practice Guidelines for admission and discharge responsibilities to patients; and

(b) Screening criteria and procedure for identifying:

(1) Low-risk maternity patients who shall be eligible for all services offered by the maternity center;

(2) Individuals who shall be ineligible for delivery services at the center;

(c) Plans and procedures for consultation, back-up services, transport of a newborn infant or patient to a hospital where appropriate care is available;

(d) Routine and emergency care of the patient, fetus and/or newborn infant, discharge planning, and post-partum follow-up until completion of care at the maternity center or transfer to other levels of care;

(e) Confidentiality of records;

(f) Role of medical, nursing and midwifery staff;

(g) Maintenance of required records, reports and statistical information;

(h) Infection control, including housekeeping, cleaning, sterilization, sanitation, storage of equipment and supplies, and health of personnel;

(i) Pertinent safety practices, including fire drills;

(j) The adoption, revision and implementation of Practice Guidelines;

(k) Regulation of persons visiting the maternity center;

(l) Roles and functions of maternity center personnel;

(m) Requirements for labor and birth room services and equipment;

(n) Quality assurance plan, with system for program review and evaluation, follow-up for correction of deficiencies, for improvement in services and functions;

(o) Written personnel staffing plan;

(p) Initiation of cardiopulmonary resuscitation;

(q) Administration of medications;

(r) Receiving, transcribing, safeguarding and management of narcotics and anesthetic agents;

(s) Prophylactic treatment of the eyes of newborn infants; and

(t) Footprinting of newborn infants and fingerprinting of the infants' mothers; and

(u) Security measures.

2614.4 The Practice Guidelines for maternity center intrapartum care shall be developed jointly by the Director of the center, Director of Medical Affairs, and Director of Midwifery Services of the maternity center and include but not be limited to procedures for:

(a) Intrapartum admission;

(b) Intrapartum management/risk assessment;

(d) Birth/Delivery procedure;

(e) Episiotomy/Laceration repair;

(f) Emergency events:

(1) Medical emergency procedures;

(2) Emergency equipment;

(3) Resuscitation of newborn infants;

(4) Hemorrhage;

(5) Prolapsed cord; and

(6) CPR Review;

(g) Birth Certificate.

2614.5 A certified nurse-midwife, or a physician with special training in obstetrics, shall attend each patient in labor from the time of admission, during labor, during birth and through the immediate postpartum period. Such attendance may be delegated only to another certified nurse-midwife or physician.

2614.6 At least two attendants must be present at every birth, one of whom is a physician or certified nurse-midwife. Both attendants shall be currently certified in adult CPR equivalent to the American Heart Association Class C basic life support, and neonatal CPR equivalent to the American Academy of Pediatrics/American Heart Association.

2614.7 Qualified personnel, to include at a minimum a licensed nurse-midwife and/or a Board certified physician on the premises or on call, shall be on duty at all times when patients are admitted.

2614.8 The Director of the Maternity Center shall develop and adopt rules and procedures, subject to the approval of the governing entity, which shall include:

(a) Program for ensuring compliance by center personnel, including orientation, in-service education, and attendance at outside programs;

(b) Standard Practice Guidelines for providing safe and appropriate plans of care to meet the needs of each patient, her family and her newborn infant in keeping with current professional standards for uncomplicated pregnancy, intrapartal care, and postpartal and newborn care; and

(c) Delivery Practice Guidelines shall be consistent with the current professional standards of the National Association of Childbearing Centers, the Commission for the Accreditation of Birth Centers and the American College of Nurse Midwives.

2614.9 Each maternity center shall have a written quality assurance plan program designed to objectively and systematically monitor and evaluate the quality and appropriateness of services provided by the maternity center.

2614.10 The quality assurance plan shall describe the organization, objectives, scope and mechanism for overseeing the effectiveness of monitoring, evaluation and problem solving activities of the maternity center. The plan shall be evaluated at least annually and revised as necessary. Findings, conclusions, recommendations, actions taken and results of actions taken shall be documented and available for inspection by licensing and accrediting agencies.

2614.11 Each maternity center shall have a written practice agreement with at least one board-certified or board eligible obstetrician/gynecologist and a board certified or board eligible pediatrician or neonatologist for the provision of 24-hour consultation, referral and transfer to an appropriate hospital facility for obstetric or newborn care under their direction.

2614.12 Each maternity center shall have written policies for the management of emergencies including, but not limited to, the following:

(a) Written procedures that clearly specify consultation and referral policies, notification of the receiving hospital, Practice Guidelines for when to initiate emergency procedures, and updating and transfer of the patient's medical report;

(b) A written transfer agreement with a hospital that provides for the transfer of patients to that hospital when they are no longer considered "low risk." The hospital must be accredited by the Joint Commission on Accreditation of Health Care Organizations and be capable of providing the following:

(1) Management of all obstetrical complications;

(2) Provision of a neonatal support system with facilities for high-risk newborn care or the capability for newborn stabilization and prearranged transport to a neonatal intensive care nursery elsewhere; and

(3) Prior written agreement with the hospital to allow for prompt admission.

2614.13 Each maternity center shall provide for adequate emergency transportation services which shall include the following:

(a) A written agreement between the maternity center and a transport service that can provide vehicles with equipment necessary to meet the needs of obstetric and newborn infant patients;

(b) Arrangements with a transport service to provide personnel with training in obstetrical and newborn infant emergency care; and

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 2779 (March 19, 1999); as amended by Corrected Notice of Final Rulemaking published at 46 DCR 3970 (April 30, 1999).

22-B DCMR § 2615 PERSONNEL

2615.1 An individual personnel record shall be maintained for each person employed by the maternity center and shall include, but not be limited to, the following:

(a) A current job description for each person which is reviewed and revised as needed;

(b) Evidence of a pre-employment examination, which shall include the results of a rubella antibody titer, a tuberculin skin test, and if indicated, a chest x-ray;

(c) Evidence of the education, training and experience of the individual, and/or a copy of the current appropriate license, registration or certification credentials;

(d) Written personnel policies distributed to personnel;

(e) Evidence indicating the person was oriented to their specific job description, center personnel policies, philosophy, and emergency procedures during the first week of employment; and

(f) Work schedules, time-worked schedules, on-call schedules, payroll, and disciplinary records.

2615.2 All personnel records shall be maintained during the course of a person's employment with the maternity center and for three (3) years following the person's separation from the center.

2615.3 There shall be sufficient, qualified personnel available to perform the services offered by the maternity center. In evaluating the numbers and qualifications of staff, the Director of the maternity center shall consider, at a minimum, the following criteria:

(a) The number and type of patients of the center;

(b) The type of services provided by the center;

(d) Any specific requirements of these rules;

(e) Professional credentials; and

(f) Professional licensure requirements of the District of Columbia.

2615.4 All personnel and any consultants or volunteers providing services under the auspices of the maternity center who are required by the District of Columbia to be licensed, registered or certified shall have valid licenses, registrations or certificates, copies of which licenses, registrations or certificates shall be on file with the maternity center.

2615.5 Professional staff shall be responsible for training and supervision of all non-professional staff, unlicensed staff and volunteers.

2615.6 All personnel must have a pre-employment physical examination, including tuberculin testing, and demonstrate evidence of immunity to rubella or a rubella vaccination prior to employment.

2615.7 The Director of the maternity center is responsible for assuring that all personnel are free of communicable diseases.

2615.8 All personnel who provide direct patient care services shall have an annual physical examination, and a record thereof maintained in the individual's personnel file.

2615.9 All maternity center personnel who are exposed to blood shall demonstrate evidence of full immunization against hepatitis B or documentation of refusal.

2615.10 Maternity center personnel shall have annual training that meets OSHA regulations and any other applicable infection control guidelines.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 2779 (March 19, 1999); as amended by Corrected Notice of Final Rulemaking published at 46 DCR 3970 (April 30, 1999).

22-B DCMR § 2616 PATIENT RIGHTS AND RESPONSIBILITIES

2616.1 Each maternity center shall admit for labor and delivery only low risk individuals. A low risk individual is one who:

(a) Has been determined to be in general good health;

(b) Meets the reasonable and generally accepted criteria of good maternal and fetal health;

(d) Has no major medical or mental health problems;

(e) Has had no significant obstetrical complications which are likely to recur; and

(f) Is anticipated to have an uncomplicated course of pregnancy and labor, including a normal spontaneous vaginal birth without the use of general or conductive anesthesia.

2616.2 Each maternity center shall fully inform each patient of the risks and benefits of using the center and shall obtain the written, informed consent of each patient intending to use the maternity center for labor and delivery.

2616.3 Each consent form shall include, but not be limited to the center's services, transfer policy, newborn infant screening procedures, eye prophylaxis of the newborn infant and any other District of Columbia requirements.

2616.4 Each maternity center shall provide for patients and their families an orientation program that shall include, but not be limited to, the following:

(a) The philosophy and goals of the center;

(b) The services that are available in the center, and if the center makes referrals, services that may be made available by referral, consultation, or contract, including child birth education, EPSDT, well-child care, sibling classes, genetic services, breast feeding education and counseling, WIC services, nutritional counseling, parenting support, drop-in support, social work and legal assistance, and laboratory/X-ray/sonography;

(d) A tour of the maternity center; and

(e) Verbal and written information on the benefits and risks of using the services available at the center.

2616.5 Each maternity center shall develop written policies for visits by family and other support persons.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 2779 (March 19, 1999); as amended by Corrected Notice of Final Rulemaking published at 46 DCR 3970 (April 30, 1999).

22-B DCMR § 2617 PATIENT EVALUATION AND PREPARATION

2617.1 Every patient admitted to the maternity center in labor shall undergo an evaluation consisting of an updated history, updated physical examination, and laboratory testing. This may be performed by a certified nurse-midwife, physician, or a registered nurse.

2617.2 Maternity center personnel shall ensure that a copy of the ambulatory care prenatal record is filed in the patient's chart. This record shall be reviewed by the Director of Medical Services and notations shall be documented concerning parity, estimated date of delivery, and other pertinent medical and obstetric data. Blood group, Rh type, serologic tests for syphilis, rubella titer, and any other important laboratory information shall also be recorded.

2617.3 The interval history documentation in the medical record shall include the time of onset of contractions, the status of the membranes, and the presence of any significant bleeding. Additional information having a bearing on the laboring mother's health shall also be recorded.

2617.4 Admitting personnel shall record whether the patient attended childbirth education classes, and her plans for breast or bottle feeding.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 2779 (March 19, 1999); as amended by Corrected Notice of Final Rulemaking published at 46 DCR 3970 (April 30, 1999).

22-B DCMR § 2618 MATERNITY SERVICES

2618.1 Each maternity center shall provide antepartum and postpartum care to women eligible for labor and delivery in the center if a plan of care is developed.

2618.2 Every patient admitted for labor and delivery shall have received a well-designed program of antepartum care. Antepartum care may be defined as a planned program of medical evaluation and management, as well as observation and education of the pregnant woman directed toward making pregnancy, labor, delivery, postpartum and the interconceptional period a safe and satisfying family experience. A well-designed antepartum program shall provide the opportunity for instruction of the patient and her partner toward appropriate care for the patient and the newborn infant.

2618.3 Each maternity center shall ensure that each patient's antepartum care record is available in the center at the time of admission for labor and delivery. Each record shall be updated at the time of discharge from the center to include pertinent data of maternity center care for subsequent management of the patient.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 2779 (March 19, 1999); as amended by Corrected Notice of Final Rulemaking published at 46 DCR 3970 (April 30, 1999).

22-B DCMR § 2619 DISCHARGE PLANNING AND POSTPARTUM CARE

2619.1 Each patient shall receive counseling, including but not limited to, normal newborn infant behavior, normal newborn care, and accident prevention prior to discharge from the maternity center.

2619.2 Discharge will be in accordance with the discharge policy of the maternity center.

2619.3 Each maternity center shall conduct, on the day of discharge, an examination of all newborn infants discharged from the maternity center and the examination shall include but not be limited to:

(a) Complete physical examination, including vital signs;

(b) Recording of discharge:

(1) Weight;

(2) Height; and

(3) Head circumference;

(1) Blood groups;

(2) Coombs, type and Rh only on Rh negative and O+ mothers;

(3) Hb and Hct;

(d) Performing metabolic screening in accordance with District of Columbia laws regarding time of evaluation, to include:

(1) PKU - 72 hours;

(2) Thyroid;

(3) MS - LTD;

(4) Hemocystinuria;

(5) Galactosemia;

(6) Sickle hemoglobinopathy; and

(7) Other, e.g., glucose testing for size/dates discrepancy;

(e) Indicate whether the following medications were administered or prescribed:

(1) Aqua Mephyton - 1mg 1M; and

(2) Ophthalmic prophylaxis for ophthalmonia neonatorum;

(f) Ensure newborn infant is feeding properly; and

(g) Complete documentation that the discharging professional has discussed all deviations from normal discovered during discharge examination with a physician consultant before discharge.

2619.4 If any procedures and/or testing, including newborn screening, are not performed for any reason, release forms must be signed by the parent or legal guardian.

2619.5 Each abnormal test shall be reported to the pediatrician/physician.

2619.6 Each maternity center shall designate a qualified person to visit the home of the patient on the first day following discharge to provide:

(a) Patient teaching to include care of mother and infant; and

(b) Review results of discharge examination of mother and newborn infant.

2619.7 Each maternity center shall designate a qualified person to visit the client on the third or fourth day following discharge to do the following:

(a) Review procedures implemented during the first visit;

(b) Collect a blood sample for newborn screening; and

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 2779 (March 19, 1999); as amended by Corrected Notice of Final Rulemaking published at 46 DCR 3970 (April 30, 1999).

22-B DCMR § 2620 ADMINISTRATION OF MEDICATIONS

2620.1 Each maternity center shall develop a written plan for pain control that utilizes primarily close human support, psychological analgesia, hydrotherapy and adequate preparation for the birth experience.

2620.2 If a professional determination is made by the physician or certified nurse midwife that the best interest of the patient would be served by the implementation/use of an analgesic/anesthetic, systemic analgesia may be administered. General and regional anesthesia shall not be used in a maternity center. Local anesthesia for episiotomy and repair may be performed according to procedures outlined in the maternity center's Practice Guidelines.

2620.3 Personnel of each maternity center, in cooperation with a licensed consultant pharmacist, the nursing staff and as necessary, representatives of other disciplines, shall develop written Practice Guidelines governing the safe administration and control of drugs and other medications. Such guidelines shall comply with 22 DCMR Chapters 5 and 10, and be annually reviewed and revised as necessary.

2620.4 The Practice Guidelines governing drugs and medications shall provide for legal authorization, storage, administration and record keeping, including but not limited to the following:

(a) Medications shall be ordered by a certified-nurse midwife or physician or other member of the staff who is licensed to write such orders;

(b) Medication orders shall be recorded in the patient's chart and signed by the ordering person with his/her whole signature;

(c) Medications shall be administered by a physician, nurse midwife, registered nurse or licensed practical nurse, and in accordance with the approved practice guidelines;

(d) Each maternity center shall have on file a current copy of Drug Enforcement Administration Certificates for all maternity center personnel authorized to prescribe and/or dispense controlled substances;

(e) Controlled substances shall be stored in a locked cabinet;

(f) Medications requiring refrigeration shall be kept in a pharmaceutical refrigerator or in a separate locked compartment within a refrigerator. All refrigeration shall have thermometers that are easily readable, in proper working condition, and accurate within a range of plus or minus two (2) degrees;

(g) Medications labeled for "external use" or "poison" shall be kept separate from other medications in a locked cabinet;

(h) All drugs shall be labeled adequately, including the expiration date; and

(i) Each maternity center shall maintain in good repair and operating order a security system designed to detect illegal entry into the drug storage area.

2620.5 Each maternity center shall maintain an adequate system for accounting for controlled substances. Each person licensed to distribute, administer or dispense controlled substances shall be required to keep records and maintain inventories in conformance with the record keeping and inventory requirements of federal and District of Columbia law.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 2779 (March 19, 1999); as amended by Corrected Notice of Final Rulemaking published at 46 DCR 3970 (April 30, 1999).

22-B DCMR § 2621 MEDICAL RECORDS AND REPORTING

2621.1 Each maternity center shall maintain a medical record system and Practice Guidelines that a provide for identification, security, confidentiality, control, retrieval and preservation of patient care data and information.

2621.2 Each maternity center shall keep in one centralized location medical records indicating all the services rendered to maternity center patients.

2621.3 Each patient shall have a single integrated medical record. Each entry into a patient's record shall be dated and signed by the center personnel making the entry, indicating name and title. Each page of each patient's record shall have two unique forms of identification. The record with respect to each patient shall be accurate and complete. Patients shall have access to their own records.

2621.4 Each maternity center shall record the following information with respect to each newborn infant:

(a) All information required by the State Center for Health Statistics of the District of Columbia;

(b) The condition of the newborn infant at birth, including the Apgar Score at one minute and five minutes, time of sustained respiration, details of physical abnormalities and pathological states;

(d) Verification of eye prophylaxis or parental objection;

(e) Newborn screening as mandated by District of Columbia law or evidence of parental objection;

(f) Treatments, medications and any special procedures or problems utilized or encountered; and

(g) Condition at discharge or transfer.

2621.5 Each maternity center shall keep each patient's and newborn infant's entire record until the infant reaches the age of majority plus three (3) years.

2621.6 Medical records shall be stored in such a manner as to provide protection from loss, damage or unauthorized access.

2621.7 A written authorization for release of medical record information outside the maternity center must be signed by the patient prior to the release of any medical record information. In the event of a request for a newborn infant's medical record information, authorization must be signed by the legal parent or guardian except that, if a newborn infant has reached 18 years of age or is otherwise legally emancipated, he or she shall be capable of granting such authorization.

2621.8 The maternity center shall collect and make available to the State Center for Health Statistics, licensing authorities and other appropriate authorities the following data on an annual basis:

(a) Number of births by categories: birth weight, gestational age, maternal age, maternal parity, race, number of prenatal visits and when prenatal care was started;

(b) Antepartum, intrapartum and postpartum transfer rates and indications for transfer listed for each transfer;

(d) Neonatal hospital admissions listed individually;

(e) Stillbirths listed individually;

(f) Hospitals which have refused transfers, listed individually with the reason for refusal;

(g) Maternal mortality and morbidity and diagnosis; and

(h) Perinatal mortality and morbidity and diagnosis.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 2779 (March 19, 1999); as amended by Corrected Notice of Final Rulemaking published at 46 DCR 3970 (April 30, 1999).

22-B DCMR § 2622 HEARINGS AND APPEALS

2622.1 Whenever these rules grant a hearing to an applicant or licensee adversely affected by an initial determination under this chapter, the hearing shall be conducted in accordance with 22 DCMR §§ 3110 through 3112.

2622.2 Whenever these rules grant to an applicant or licensee adversely affected by a final determination under this chapter, this appeal shall be filed in writing with the Board of Appeals and Review pursuant to 22 DCMR § 3113.

2622.3 Each appeal shall be filed within the period specified in the final determination notice, but in no case more than thirty (30) days after the date of service of the notice, except where a request for a variance has been submitted to the Director in accordance with the provisions of this chapter. The appeal shall be filed within ten (10) days after the date of the service of the notice of the final determination on the request for the variance.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 2779 (March 19, 1999); as amended by Corrected Notice of Final Rulemaking published at 46 DCR 3970 (April 30, 1999).

22-B DCMR § 2699 DEFINITIONS

2699.1 When used in this chapter, the following terms and phrases shall have the meanings ascribed:

Act - The Health-Care and Community Residence Facility, Hospice and Home Care Licensure Act of 1983, D.C. Code, 2001 Ed. §§44-501 to 44-554.

Center - A maternity center as defined below.

Communicable disease - any disease as defined in 22 DCMR §299.

D.C. or District - the District of Columbia.

Department - the Department of Health of the District of Columbia.

Director - the Director of the D.C. Department of Health.

Hospital - any building or part of a building, or group of buildings, in which there are facilities, services, or ancillary services provided for the housing of two (2) or more persons not related by blood or marriage within the third (3rd) degree of consanguinity to the owner, operator, or manager of the building, part of the building, or group of buildings, for the diagnosis, treatment, or care of physical or mental conditions for a period of more than twenty-four (24) consecutive hours; or for maternity care involving labor and delivery for any period of time.

Infant - a person under the age of one (1) year.

Infant, newborn - any newly delivered infant.

Laboratory - any area in the maternity center or hospital set up for chemical, bacteriological, and histopathological examinations.

Maternity care - medical and/or nursing care of women for pregnancy, delivery, or the puerperal state, or for any condition intimately related to the pregnancy, delivery, or puerperal state.

Maternity center - a facility or other place, other than a hospital or the mother's home, that provides antepartal, intrapartal, and postpartal care for both mother and newborn infant during and after normal, uncomplicated pregnancy.

Maternity and newborn service - that part of the hospital in which, as a regular practice, pregnant women are delivered of babies, pregnant or puerperal women receive care, and in which newborn infants receive care.

Medical record - a maternity center or hospital record of a patient that provides identifying information about the patient and information about his or her medical condition, progress, and treatment.

Midwifery services - techniques and practices provided by a nurse-midwife to women in childbirth.

Newborn care - medical and/or nursing care of newborn infants.

Nurse - any person engaged in providing nursing care, and includes professional and non-professional nursing personnel.

Nurse-midwife - an advanced practice registered nurse educated in midwifery and certified by the American College of Nurse-Midwives.

Nurse, registered - a person who is licensed and currently registered by the Board of Nursing of the District to practice professional nursing in the District; or a person licensed to practice in another jurisdiction whose application for registration is pending in the District.

Obstetrician - a physician who is certified in obstetrics by the American Board of Obstetrics and Gynecology, or who has training and experience in obstetrics substantially equivalent to that required for certification.

Obstetrics - the provision of medical care and services to women during and after pregnancy.

Patient - a person who has been admitted to a maternity center or hospital for the diagnosis, treatment, or care of physical or mental conditions.

Pediatrician - a physician who is certified by the American Board of Pediatrics, or who has training and experience in pediatrics substantially equivalent to that required for that certification.

Person - any individual, firm, partnership, corporation, company, organization or association; including executors, administrators, guardians, trustees, directors, and agents.

Pharmacist - a person who is authorized to practice pharmacy by the Board of Pharmacy of the District of Columbia.

Physician - a person licensed or registered by the Board of Medicine of the District to practice medicine and surgery, or a person licensed in another jurisdiction whose application for a license or registration is pending in the District.

Rated bed capacity - the number of beds, exclusive of bassinets for newborn infants, normally available for the full-time care of patients when the minimum number of square feet of floor space per bed and other standards specified in this chapter are applied.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 2779 (March 19, 1999); as amended by Corrected Notice of Final Rulemaking published at 46 DCR 3970 (April 30, 1999).

22-B27 ADULT TRAUMA CARE

22-B DCMR § 2700 GENERAL PROVISIONS

2700.1 The Director, Department of Health, shall designate Level I and Level II hospitals for adult trauma care facilities as the inclusive trauma system in the District of Columbia, provided a facility complies with the provisions of this chapter.

2700.2 The provisions of this chapter shall be used by the District of Columbia for the purposes of assessing the suitability of hospitals for receipt of certain trauma patients in the District of Columbia's Emergency Medical Services System (EMS).

2700.3 An inclusive trauma care system is a system that is fully integrated into the EMS and is designated to meet the needs of all injured patients requiring care in an acute care facility, regardless of severity of injury, geographic location, or population density.

2700.4 An inclusive trauma care system shall have the following components:

(a) Medical direction;

(b) Prevention;

(d) Training;

(e) Triage;

(f) Prehospital care;

(g) Transportation;

(h) Hospital care;

(i) Public education;

(j) Rehabilitation; and

(k) Research.

2700.5 An inclusive trauma care system shall also include the following:

(a) System management;

(b) Prehospital provider;

(d) Rehabilitation/reconstructive services.

2700.6 The designation of an adult trauma care facility as Level I or Level II guarantees the immediate availability and dedication of specialized surgeons, anesthesiologists, physician specialists, nurses, and resuscitation life-support equipment at the facility on a twenty-four (24) hour a day basis.

2700.7 Level I facilities shall have the capability to provide total care for every aspect of an injury, and shall ensure prompt transfer between facilities during all phases of acute and rehabilitative care.

2700.8 A Level I trauma facility shall be an institution which, in addition to meeting the Level II guidelines, shall deploy and coordinate resources for the special types of care required for the major and multiple trauma victim and have a continued commitment to training and research as minimal characteristics of the hospital's commitment to trauma care.

2700.9 Level II facilities may have the capability to provide total care for every aspect of an injury and may ensure prompt transfer between facilities during all phases of acute and rehabilitative care.

2700.10 For optimal care of the severely injured, Level I and Level II facilities shall meet the following requirements:

(a) Skilled surgeons and other members of the trauma team shall be immediately available;

(b) When an arriving patient meets the hospital-specific guidelines defining a major resuscitation, the attending surgeon shall be present in the emergency department:

(1) Upon arrival of the patient, when there is advance notification from the field; or

(2) Within fifteen (15) minutes of activating the trauma team, when there is no advance notification;

(c) Compliance with the requirements of subsections (a) and (b) at a rate of eighty percent (80%) or greater shall be documented; and

(d) The following minimum criteria shall be used to define a major resuscitation:

(1) Confirmed blood pressure less than ninety (90) millimeters of mercury (mmHg) at any time in adults;

(2) Respiratory compromise, airway obstruction, or intubation;

(3) Transfer patients from other hospitals receiving blood to maintain vital signs;

(4) Gunshot wounds to the abdomen, neck, or chest;

(5) Glasgow Coma Scale (GCS) less than eight (<8) with mechanism attributed to trauma; and

(6) Emergency physician's discretion.

2700.11 All major trauma patients shall be admitted to an adult trauma care facility.

2700.12 Each Level I facility shall conduct research at the clinical or basic sciences level, and shall be responsible for disseminating new information.

2700.13 A designated person in each Level I and Level II facility shall be responsible for multi-disciplinary and interdepartmental coordination of trauma care.

2700.14 Each facility shall be in compliance with all applicable local laws and regulations.

2700.15 The management and operation of any adult trauma care facility shall be in accordance with good medical and public health practices.

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is the Health-Care and Community Residence Facility, Hospice and Home Care Licensure Act of 1983 §§2(b) and 5, D.C. Code, 2001 Ed. §§44-501 and 44-504; Reorganization Plan No. 4 of 1996, 3 D.C. Code, 2001 Ed. at 413; and Mayor’s Order 98-137 (August 20, 1998).
SOURCE: Notice of Final Rulemaking published at 46 DCR 8741 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3915 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7260 (July 23, 2004).

22-B DCMR § 2701 INJURY PREVENTION AND CONTROL

2701.1 Each adult trauma care facility shall implement injury prevention and control programs to accomplish injury prevention.

2701.2 Institutional involvement in injury prevention programs shall be based upon the resources of staff, time, and funds available.

2701.3 Injury prevention may be categorized in terms of primary, secondary, or tertiary implementation. Primary prevention refers to the elimination of the trauma incident. Secondary prevention refers to reducing the severity of injuries during the incident through the use of safety restraints and helmets. Tertiary prevention includes all efforts following the trauma incident that optimize outcome, thereby preventing complications, long-term disability, or death.

2701.4 Adult trauma care facilities shall develop an injury prevention program. In developing the program, the facility shall:

(a) Gather and analyze data;

(b) Select a target population and its injuries;

(d) Identify, select, and obtain commitments from public and private institutions to implement the plan;

(e) Develop protocols and materials;

(f) Orient and train organizations and individuals;

(g) Provide monitoring and support; and

(h) Evaluate and revise as necessary.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8741 (October 29, 1999).

22-B DCMR § 2702 HOSPITAL ORGANIZATION - TRAUMA SERVICES

2702.1 The staff credentialing committee of an adult trauma care facility shall specifically delineate all privileges of members of the staff providing trauma services.

2702.2 Each trauma team shall be organized and directed by a general surgeon with expertise in and commitment to the care of the injured. All patients with multiple system or major injuries shall be evaluated by the trauma services team.

2702.3 Each trauma team shall be available in-house twenty-four (24) hours per day with attending coverage as specified in this chapter.

2702.4 The team leader during the resuscitation efforts shall be an emergency department physician, until the arrival of a trauma surgeon who shall then act as the team leader.

2702.5 Each facility shall provide a team approach for responding to the needs of and giving optimal care to patients with multiple-system injuries. Each team leader shall be a qualified surgeon contributing specific care in the area of his or her specialty, and shall continually oversee and coordinate the operation of the team and care of its patients throughout their hospital stay.

2702.6 The team leader shall be able to interpret and reconcile the recommendations of team members and consultants from a number of specialties and accept the responsibility for transmitting those recommendations to the hospital staff.

2702.7 Each adult trauma care facility shall appoint a Trauma Service Director, who shall be a board certified surgeon with demonstrated special competence in trauma care.

2702.8 The Trauma Service Director shall have oversight authority for the care of each trauma patient and administrative authority for the hospital's trauma program.

2702.9 The Trauma Service Director shall be responsible for recommending appointment to and removal from the trauma service, along with the medical staff credentialing committee, and in consultation with the appropriate service chief.

2702.10 The Trauma Service Director shall meet each of the specific qualifications for surgeons, including personal involvement in the care of the injured, education in trauma care, involvement in professional trauma organizations, and board certification.

2702.11 In adult trauma care facilities, the Trauma Service Director shall have active involvement or participation as an instructor in the American College of Surgeons Advanced Trauma Life Support (ATLS) courses, participation in other Continuing Medical Education (CME) courses, and the provision of instruction to other health care personnel.

2702.12 The Trauma Service Director shall have the appropriate specific responsibilities of evaluating newly appointed members of the trauma service and overseeing ongoing education for new and existing attending surgeons and physicians as appropriate.

2702.13 The Trauma Service Director, or his or her designee, shall participate in the development of trauma-care systems at the community, state, or national levels.

2702.14 The Trauma Service Director in Level I facilities shall be responsible for encouraging the staff to undertake clinical and basic research, with publication of their results.

2702.15 The Trauma Service Director shall make presentations on trauma care to medical staff and other health care organizations providing trauma care.

2702.16 The Trauma Service Director shall be responsible for quality improvement in each adult trauma care facility.

2702.17 Each adult trauma care facility shall have designated specialists available twenty-four (24) hours per day for the care of major trauma patients.

2702.18 Each adult trauma care facility shall be staffed by surgeons who are board certified in a surgical specialty recognized by the American Board of Medical Specialties.

2702.19 Each trauma surgeon in an adult trauma care facility shall have an interest in and a commitment to trauma care, demonstrated by participation in the organization of trauma protocols, trauma teams, trauma call rosters, and trauma rounds.

2702.20 General surgeons on the trauma team in adult trauma care facilities shall successfully complete the "American College of Surgeons Advanced Trauma Life Support Course."

2702.21 Each surgeon member of the trauma team shall participate in a minimum of sixteen (16) hours of trauma related Continuing Medical Education (CME) courses per year. At least fifty percent (50%) of this CME shall be extramural, and both Category I and II CME may be counted toward satisfying this requirement.

2702.22 A physician's participation in regional groups, such as state and regional trauma committees, and membership in regional organizations, shall constitute significant involvement in and commitment to trauma-related matters.

2702.23 In each adult trauma care facility, the emergency physician shall be a member of the trauma team who participates in the care of the patient, and in all audits and critiques necessary for excellence in trauma care.

2702.24 Emergency physicians shall be involved with surgeons in the development of trauma care systems as part of the overall development of emergency medical systems in the community. In addition, they shall be active in organizations contributing to the benefit of injured patients.

2702.25 An anesthesiologist shall have the overall responsibility for preoperative airway control of the patient during resuscitation, and act as postoperative consultant in cardiorespiratory support and pain control. Anesthesiologists on the trauma team shall be appropriately certified, have the necessary educational background in care of the trauma patient, and engage in trauma quality improvement and in investigative, teaching, and community activities.

2702.26 The emergency physician and anesthesiologist on the trauma team shall be board certified in their specialty as recognized by the American Board of Medical Specialties.

2702.27 In each adult trauma care facility, the following medical specialists shall be available for consultation in the care of patients with multiple injuries:

(a) Cardiologist;

(b) Pulmonary medicine;

(d) Nephrologists; and

(e) Dialysis team.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8741 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3915 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7260 (July 23, 2004).

22-B DCMR § 2703 TRAUMA COORDINATOR

2703.1 Each adult trauma care facility shall have a trauma coordinator who is fundamental to the institution's trauma program development, implementation, and evaluation. Working in conjunction with the Trauma Service Director, the trauma coordinator shall be responsible for the organization of services and systems necessary for a multidisciplinary approach throughout the continuum of trauma care. The trauma coordinator is supervised by the Trauma Service Director.

2703.2 The trauma coordinator shall have an active role in the following:

(a) Participating in clinical activities, including:

(1) Developing clinical protocols;

(2) Monitoring patient care; and

(3) Assisting staff in problem solving;

(b) Ensuring continuing education for staff, including:

(1) Assisting in professional staff development activities;

(2) Conducting case reviews;

(3) Arranging continuing education for trauma care staff;

(4) Developing and implementing a community trauma education program; and

(5) Establishing trauma prevention programs;

(1) Developing protocol design; and

(2) Performing data collection and analysis, and distribution of findings;

(d) Assisting in developing a quality assurance program, including the development of audit filters and case reviews;

(e) Performing administrative duties, including organization management, budget preparation and staff accountability;

(f) Assisting in maintaining a trauma registry, performing data collection, coding, including external causes of injury, e-coding and scoring, and developing processes for validation of data and submitting the data to the citywide trauma registry maintained by the District of Columbia Department of Health; and

(g) Serving as a consultant and liaison to medical staff, prehospital EMS agencies, patients' families and the community at large.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8741 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3915 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7260 (July 23, 2004).

22-B DCMR § 2704 HOSPITAL DEPARTMENTS, DIVISIONS, SERVICES, SECTIONS

2704.1 Each adult trauma care facility shall have departments, divisions, services, or sections with designated chiefs and shall be staffed by qualified specialists in the following areas:

(a) General Surgery;

(b) Neurologic Surgery;

(d) Emergency Services; and

(e) Anesthesia.

2704.2 In each adult trauma care facility, a clearly identifiable neurosurgeon shall be promptly available when a patient needs to be seen. Immediate care necessitates a reliable on-call schedule with a specific protocol for back-up coverage.

2704.3 The requirement set forth in § 2704.2 may be fulfilled by an in-house neurosurgeon or other surgeon who has special competence in the care of patients with neurotrauma, as judged by the chief of neurosurgery, and who is capable of undertaking measures for the stabilization and treatment of neurotrauma patients.

2704.4 In each adult trauma care facility, the following minimum personnel and equipment required for the treatment of severe neurological trauma shall be on call and promptly available for the treatment of trauma patients at all times:

(a) Specifically named general surgeon;

(b) Specifically named neurosurgeon;

(c) Emergency department staffed twenty-four (24) hours a day by a physician who has successfully completed training in Advanced Trauma Life Support (ATLS) or who has demonstrated his or her level of expertise as determined by the Trauma Service Director;

(d) Twenty-four (24) hour availability of an operating room capable of the rapid acceptance of patients for craniotomy or spinal surgery;

(e) Twenty-four (24) hour availability of a computerized tomographic (CT) scanner and technician;

(f) Intensive care unit (ICU) with appropriate equipment and staffing, including capabilities for monitoring intracranial pressure (ICP); and

(g) A clearly defined bypass plan in the event of unavailability of the neurosurgeon or other essential resources.

2704.5 The care of neurological trauma may also include a readily available magnetic resonance imaging (MRI) scanner.

2704.6 An orthopedic surgeon shall be available at all times for the optimal management of the trauma patient. The orthopedic surgeon shall be a member of the trauma team.

2704.7 An orthopedic surgeon shall have immediate and ongoing participation in the care of patients with musculoskeletal injuries, and shall interact with the rest of the trauma team regarding the patient's care.

2704.8 An orthopedic surgeon shall be promptly available to participate in the initial evaluation of the trauma patient in the emergency department. The orthopedic surgeon shall evaluate the neurovascular status and structural integrity of the extremities and axial skeleton.

2704.9 The minimum qualifications of an orthopedic surgeon on-call shall include board certification or eligibility for board certification during the first five (5) years after residency, documentation of a minimum of sixteen (16) hours of Category I or II CME per year in skeletal traumatology, and participation in the facility's trauma service educational and quality improvement activities.

2704.10 An orthopedic surgeon shall have demonstrated skill in:

(a) The management of open wounds;

(b) Recognition and treatment of compartment syndrome;

(d) Internal fixation of femoral fractures.

2704.11 Each adult trauma care facility shall provide, for optimal musculoskeletal management, an adequate extended team composed of orthopedic assistants, nurses, physician assistants, and others who can assist with casts and traction, and can provide evaluation and care of patients both in the emergency room and on the acute care units.

2704.12 Operating room nurses and technologists shall be experienced in the use and care of fracture-fixation instruments and devices, as well as be able to provide appropriate assistance during skeletal surgery. Appropriately trained X-ray technologists must be available in the operating room to assist with fluoroscopic procedures and to provide prompt radiographs when needed.

2704.13 Each adult trauma care facility shall maintain essential equipment for optimal fracture treatment, including:

(a) A complete stock of plaster, fiberglass cast, and splint material with adequate padding;

(b) Equipment for skeletal traction of spine and extremities;

(d) A pulse-lavage unit with appropriate protective shields, including waterproof gowns and drapes;

(e) Tissue pressure measurement equipment;

(f) An image-intensifier fluoroscope;

(g) A fracture table, compatible with the fluoroscope, that permits supine and lateral decubitus positions, with attachments for procedures on femur, tibia, upper extremity, and pelvis;

(h) A radiolucent operating table for intraoperative fluoroscopy of pelvis, extremities, and spine;

(i) Intramedullary nailing instruments and implants for femur, tibia, and humerus; interlocking nail equipment for the femur and tibia, and nails that can be used without reaming the medullary canal shall also be available;

(j) Standard sets of instruments, including power drills, reamers, and wire drivers for fracture fixation of small and large bones, with assorted plates and screws, including fixation devices for the proximal and distal femur, with sideplate length sufficient for extensive shaft comminution and multiple levels of injury;

(k) Instruments and implants for reducing and stabilizing spinal injuries and for decompressing the spinal canal if necessary; and

(l) Equipment and supplies for microvascular and microneural surgery.

2704.14 Each adult trauma care facility shall maintain an adequate number of orthopedists committed to trauma care. Orthopedists assigned to provide scheduled coverage for trauma patients shall qualify for membership on the trauma service team and shall participate in service activities, especially those related to quality improvement and to the development of institutional protocols for systematic evaluation and management of common injuries.

2704.15 In Level I facilities, orthopedic members of the trauma service are responsible for teaching and research appropriately related to musculoskeletal injuries and for providing readily available consultation to physicians in the surrounding community.

2704.16 In each adult trauma care facility, a general orthopedist shall provide primary care for musculoskeletal injuries. When orthopedic trauma specialists are not immediately available, the initial orthopedic care may be provided by another member of the staff, who shall then transfer that patient to the specialist. Interhospital transfer shall be required in appropriate cases.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8741 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3915 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7260 (July 23, 2004).

22-B DCMR § 2705 CLINICAL CAPABILITIES (HOSPITAL PERSONNEL)

2705.1 Each adult trauma care facility shall have the following specialties available in-house twenty-four (24) hours per day:

(a) General Surgery;

(b) Emergency Medicine; and

2705.2 The patient evaluation and treatment team shall consist of a team of surgeons that will include, at a minimum, a post-graduate resident in at least the fourth (4th) year of training.

2705.3 The attending surgeon shall participate in each major therapeutic decision and be present at each operative procedure. The hospital's trauma performance improvement program shall monitor compliance with the requirements of this section.

2705.4 An attending neurosurgeon shall be available and dedicated to that hospital's trauma service. This requirement may be satisfied by an in-house neurosurgery resident or physician who has special competence, as judged by the chief of neurosurgery, in the care of patients with neurological trauma, and who is capable of initiating measures directed toward stabilizing the patient and initiating diagnostic procedures.

2705.5 The requirement to provide emergency medical services may be fulfilled by an emergency medicine chief resident capable of assessing emergency situations in trauma patients and providing any indicated treatment. When senior residents are used to fulfill availability requirements, the staff specialist on-call shall be advised and be available for consultations.

2705.6 In Level I facilities, the requirement to provide anesthesiology services may be satisfied by anesthesiology chief residents or a certified nurse anesthetist (CRNA) capable of assessing emergency situations in trauma patients and providing any indicated treatment, including surgical anesthesia. Whenever a Level I facility uses an anesthesiology resident or a certified nurse anesthetist (CRNA) to satisfy this requirement, the facility shall notify the staff anesthesiologist on-call, who shall be promptly available.

2705.7 In Level II facilities, the requirement to provide anesthesiology services is satisfied when the staff anesthesiologist is in the hospital at the time of, or shortly after, the patient's arrival. Before the staff anesthesiologist arrives, an anesthesiology chief resident or certified nurse anesthetist (CRNA) capable of assessing emergency situations in trauma patients and of initiating and providing any indicated treatment shall be available.

2705.8 Each Level I facility shall have personnel on-call and promptly available with competence to assess and/or perform procedures in the following areas:

(a) Cardiac Surgery;

(b) Cardiology;

(d) Infectious Disease;

(e) Internal Medicine;

(f) Microvascular Surgery (replant/flaps);

(g) Obstetrics-Gynecologic Surgery;

(h) Ophthalmic Surgery;

(i) Oral/Maxillofacial Surgery;

(j) Orthopedic Surgery;

(k) Plastic Surgery;

(l) Pulmonary Medicine;

(m) Radiology;

(n) Thoracic Surgery; and

(o) Urologic Surgery;

2705.9 Each Level II facility shall have personnel on-call and available with the competence to perform procedures in the following areas:

(a) Cardiology;

(b) Internal Medicine;

(d) Ophthalmic Surgery;

(e) Oral/Maxillofacial Surgery;

(f) Orthopedic Surgery;

(g) Plastic Surgery;

(h) Pulmonary Medicine;

(i) Thoracic Surgery;

(j) Urologic Surgery; and

(k) Radiology.

2705.10 Each Level II facility may have personnel on-call and available with competence to perform procedures in the following areas:

(a) Cardiac Surgery;

(b) Hand Surgery;

(d) Microvascular Surgery (replant/flaps).

2705.11 In non-surgical specialty cases, the patient's primary care physician shall be notified at an appropriate time.

2705.12 Thoracic surgery may be performed by a general trauma surgeon with privileges to provide thoracic surgical care to patients with thoracic injuries.

2705.13 Transplant specialists shall be provided as follows:

(a) Level I facilities may have transplant specialists on-staff and available to respond for consultation; if no transplant specialists are on-staff, a Level I facility shall have a written transfer agreement with another facility for needed transplant service;

(b) Level II facilities shall have a written transfer agreement with another facility for needed transplant service, and transfer shall take place if transplant personnel or resources are not available at the Level II facility.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8741 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3915 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7260 (July 23, 2004).

22-B DCMR § 2706 FACILITY RESOURCES AND CAPABILITIES

2706.1 Emergency department personnel in each adult trauma care facility shall consist of at least the following:

(a) A designated physician director of the emergency department;

(b) Physicians with special competence in the care of the critically injured, who are designated members of the trauma team and are physically present in the emergency department and sufficient in number to provide coverage twenty-four (24) hours per day; and

(c) Nursing personnel with special capability in trauma care who provide continual monitoring of the trauma patient from hospital arrival to disposition in the Intensive Care Unit (ICU), Operating Room (OR), or patient care unit.

2706.2 The requirement for an emergency medicine physician may be satisfied by emergency medicine senior residents capable of assessing emergency situations in trauma patients and providing any indicated treatment. When senior residents are used to satisfy this requirement, the facility shall advise the staff specialist on-call who shall be promptly available. Institutions that have emergency medicine residency training programs shall provide supervision twenty-four (24) hours per day by an in-house attending emergency physician.

2706.3 A facility shall have a team available for twenty-four (24) hours per day in-house coverage in the emergency department. The team shall provide the initial management of the major trauma patient and shall consist of at least the following personnel:

(a) An emergency department attending physician with knowledge of trauma care who is Advanced Trauma Life Support (ATLS) Certified or has demonstrated an appropriate level of expertise as determined by the Trauma Service Director, but not less than sixteen (16) hours trauma- related CME, clinical involvement, and special interest in trauma;

(b) Surgical residents who shall be in at least the fourth (4th) year of post-graduate specialty training;

(c) An anesthesiologist; however, the initial response may be by a anesthesiology chief resident or a critical care nurse anesthetist with trauma proficiency, and the attending anesthesiologist shall be promptly available;

(d) A minimum of two (2) nurses familiar with emergency and critical care, qualified to function as members of the trauma team by specific criteria defining orientation and practice requirements; at least one (1) nurse shall have specialized knowledge of trauma care; and

(e) Registered nurses, licensed practical nurses, and nurse aides in sufficient number to provide appropriate coverage.

2706.4 The in-house team shall be on group call pagers to meet each patient with maximum readiness upon arrival. If the in-house team is not on group call pagers, a paging system shall function to mobilize the team within a maximum of two (2) minutes.

2706.5 The annual team responses for an adult Level I trauma center shall be at least twelve hundred (1200) patients, or a minimum of two hundred and forty (240) patients with an Injury Severity Score greater than fifteen (>15), or an average of more than thirty five (35) patients with an Injury Severity Score greater than fifteen (15) for all trauma panel surgeons.

2706.6 Repealed.

2706.7 Each adult trauma care facility shall have mobile X-ray capability with twenty-four (24) hours per day coverage by in-house technicians.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8741 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3915 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7260 (July 23, 2004).

22-B DCMR § 2707 TRAUMA RESUSCITATION AREA

2707.1 The emergency department of each adult trauma care facility shall have a large space designated and dedicated as the trauma resuscitation area. The space shall be large enough to allow assembly of the full trauma team plus necessary equipment including ventilators and a portable X-ray machine.

2707.2 Equipment may include ultrasound. Equipment or procedure trays to perform invasive treatments shall be available as follows:

(a) Airway control and ventilation equipment;

(b) Pulse oximetry;

(d) Electrocardiograph-oscilloscope-defibrillator;

(e) Internal paddles;

(f) Central venous pressure (CVP) monitoring equipment;

(g) Standard intravenous (IV) fluids and administration sets;

(h) Large-bore intravenous catheters;

(i) Sterile surgical sets for airway control, cricothyrotomy, thoracostomy, venous cutdown, central line insertion, thoracotomy, and peritoneal lavage;

(j) Arterial catheters;

(k) Drugs necessary for emergency care;

(l) X- ray availability twenty-four (24) hours per day;

(m) Cervical traction devices;

(n) Broselow tape;

(o) Thermal control equipment for the patient, fluids, and blood;

(p) Rapid infuser system;

(q) Qualitative end-tidal Carbon Dioxide (CO2) determination; and

(r) Communication with Emergency Medical Services (EMS) vehicles.

2707.3 The trauma resuscitation area shall contain adequate telephones, telephone lines, and intercoms.

2707.4 In Level I facilities, dedicated phone lines shall be used between the resuscitation area and the blood bank and operating room. Large wallboards shall display team members' names and roles, as well as key hospital phone numbers and on-call personnel.

2707.5 Each adult trauma care facility shall have the following communication capabilities:

(a) Pre-hospital to hospital link for direct medical command and early hospital notification;

(b) Trauma team alert and activation;

(d) Trauma team and intrafacility personnel communication; and

(e) Interfacility communication.

2707.6 In each adult trauma care facility, the resuscitation trauma team shall consist of at least the following personnel:

(a) Surgeon (trauma team leader);

(b) Emergency physician;

(d) Nurses;

(e) Respiratory therapist;

(f) Radiologic technologist;

(g) Blood bank or laboratory personnel;

(h) Operating room staff;

(i) Critical care nurse;

(j) Security officer;

(k) Surgical and emergency residents;

(l) Chaplain; and

(m) Social worker.

2707.7 Each individual trauma team member shall assist in the assessment of the patient with simultaneous life support, diagnosis of injuries, acquisition of laboratory specimens, initial radiographic survey, and communication and mobilization of all necessary hospital resources.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8741 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3915 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7260 (July 23, 2004).

22-B DCMR § 2708 OPERATING SUITE

2708.1 Operating suites in each adult trauma care facility shall be staffed and equipped to handle each patient brought into the emergency department in need of immediate surgical intervention.

2708.2 Operating suites shall be immediately available twenty-four (24) hours per day. Operating suites in Level I facilities shall be staffed in-house. Operating suites in Level II facilities may be staffed in-house.

2708.3 Each operating suite in Level and Level II facilities shall have equipment suitable for use in adults, including:

(a) Thermal control equipment for patients, blood, and fluids;

(b) X-ray capability, including C-arm image intensifier available twenty-four (24) hours per day;

(d) Craniotomy instruments;

(e) Equipment appropriate for fixation of long-bone and pelvic fractures;

(f) Bronchoscope; and

(g) Rapid Infuser system.

2708.4 Each operating suite in a Level I facility shall have the following capability and equipment, in addition to the requirements set out in § 2708.3:

(a) Cardiopulmonary bypass; and

(b) Operating room microscope.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8741 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3915 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7260 (July 23, 2004).

22-B DCMR § 2709 POSTANESTHETIC RECOVERY ROOM (PAR)

2709.1 In each adult trauma care facility, the postanesthetic recovery room (PAR), which may be the Surgical Intensive Care Unit, shall be staffed and equipped as follows:

(a) Registered nurses and other essential personnel twenty-four (24) hours per day;

(b) Equipment for the continuous monitoring of temperature, hemodynamics, and gas exchange;

(d) Pulse oximetry;

(e) Reserved; and

(f) Thermal control.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8741 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3915 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7260 (July 23, 2004).

22-B DCMR § 2710 INTENSIVE CARE UNITS (ICU) FOR TRAUMA PATIENTS

2710.1 A hospital designated as a Level I trauma center shall have a surgically directed and staffed Intensive Care Unit (ICU).

2710.2 In each adult trauma care facility, there shall be designated a surgical director or surgical co-director for the ICU.

2710.3 The trauma service that assumes initial responsibility for the care of an injured patient shall maintain that responsibility as long as the patient remains critically ill. The surgeon in charge shall remain in that role even if the patient requires admission to an intensive care unit (ICU).

2710.4 Medical and surgical specialists shall be consulted as needed to provide specific expertise in the care of the patient in the ICU. The Surgical Intensive Care Unit (SICU) service physician must be in-house twenty-four (24) hours per day for Level I facilities.

2710.5 The surgeon team leader in an adult trauma care facility shall have obtained critical care training during residency or fellowship and must have expertise in the perioperative and postinjury care of the critically injured patient. The surgeon team leader shall possess a Certificate of Added Qualifications in Surgical Critical Care from the American Board of Surgery, or have documented active participation during the preceding twelve (12) months in ICU administration and quality improvement activities and direct involvement in the ICU care of trauma patients.

2710.6 Each ICU shall have a physician with privileges in critical care and approved by the Surgical Critical Care Service Director on duty in the ICU twenty-four (24) hours a day or immediately available in the hospital.

2710.7 The clinical nurse manager for an ICU shall be responsible for those aspects of administration that pertain to nursing in the unit and for quality improvement in nursing. He or she shall hold certification as a Critical Care Nurse (CCRN) or have evidence of equivalent critical care training.

2710.8 Each nurse assigned to trauma patients shall be a registered nurse, and shall hold certification as a CCRN or have evidence of equivalent critical care training from the American Association of Critical Care Nurses. Before assuming responsibility for patients in the ICU, each nurse shall be oriented to the care of the critically ill trauma patient. Each nurse shall complete at least eight (8) hours of Continuing Medical Education (CME) each year.

2710.9 The course work for nurses identified in §§ 2710.7 and 2710.8 shall cover mechanisms of injury in traumatized individuals, fluid and electrolyte balance, pressure monitoring, ventilator management, and infection control. It shall also provide an overview of aspects of the operative treatment of specific injuries.

2710.10 ICU nursing staff shall be maintained at a level that insures a nurse-patient ratio of one to two (1:2) on each shift and shall be increased above this as dictated by patient acuity.

2710.11 Each ICU shall have support personnel available as follows:

(a) Respiratory therapists;

(b) Physical therapists;

(d) Social workers;

(e) Interpreters;

(f) In-house radiology technologist;

(g) In-house acute hemodialysis;

(h) In-house Computerized Tomographic (CT) technician; and

(i) Angiographer, sonographer, magnetic resonance imaging (MRI) technician.

2710.12 Equipment in the ICU shall include, at a minimum, the following:

(a) Cardiopulmonary resuscitation cart;

(b) Electrocardiograph machine;

(d) Sets of instruments for the following procedures:

(1) Tracheostomy;

(2) Thoracostomy;

(3) Venous cut-down;

(4) Central venous puncture;

(5) Tracheal intubation;

(6) Intracranial monitoring equipment; and

(7) Pulmonary artery monitoring equipment.

2710.13 Each adult trauma care facility shall provide an ICU physician on duty twenty-four (24) hours per day. This coverage may be provided by the patient's primary physician or by a physician who is credentialed in critical care by the hospital. This coverage for emergencies is not intended to replace the primary surgeon in caring for the patient in the ICU; it is to ensure that the patient's immediate needs will be met while the primary surgeon is being contacted.

2710.14 Each adult trauma care facility ICU shall provide or have immediately available the following equipment:

(a) Scale;

(b) Volume - cycled and pressure - cycled ventilators;

(d) Vascular and intracranial pressure monitors;

(e) Pulse or venous oximeters;

(f) Infusion devices;

(g) Thermodilution cardiac output computers;

(h) Blood warmers;

(i) Equipment for rapid warming and cooling off of patients;

(j) Orthopedic traction devices;

(k) Beds designed for care of patients with spinal cord injuries and for patients at high risk for decubitus ulcers;

(l) Sets for arterial cannulation and peritoneal lavage; and

(m) Adjustable chairs for mobilization of patients.

2710.15 Each ICU in an adult trauma care facility shall be concentrated in a single unit or in contiguous units. Trauma ICU beds on floors different from the operating rooms must have ready access to a nearby elevator that is immediately available for emergency transport. The elevator facilities shall be adequate to ensure immediate transport of the patient and all needed ancillary equipment between the operating rooms and the ICU, and shall be situated to facilitate the transport of the critically ill patient to special procedure departments.

2710.16 All ICU beds shall have bedside monitoring capabilities for central venous, pulmonary arterial, systemic arterial, and intracranial pressure monitoring. All beds shall have piped-in air and oxygen and adequate space for a mechanical ventilator, and at least every other bed shall have a sink. At least one bed shall have the space and water drainage capabilities adequate to support a bedside hemodialysis unit. All beds shall have lighting adequate for performance of minor operative procedures such as chest-tube insertion and central venous puncture.

2710.17 Sleeping quarters for the physician who is immediately responsible for the patients in the trauma ICU shall be located near or within the unit. A quiet room nearby, separate from the unit, shall be available for discussions with family members. Space also shall be available near the ICU for educational activities for physicians, nurses, and support personnel.

2710.18 Each adult trauma care facility shall have access to clinical diagnostic services for blood gases measurements, hematocrit levels, serum potassium values, and chest X-rays within thirty (30) minutes of a request. This capability shall be continuously monitored by the quality improvement program.

2710.19 Each Level I facility shall investigate the pathophysiology and treatment of the critically injured patient.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8741 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3915 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7260 (July 23, 2004).

22-B DCMR § 2711 ACUTE HEMODIALYSIS CAPABILITY

2711.1 A Level I facility shall have in-house hemodialysis services which shall be available within one hundred and twenty (120) minutes of the request, twenty-four (24) hours per day.

2711.2 A Level II facility may provide in-house hemodialysis services which may be available within one hundred and twenty (120) minutes of the request twenty-four (24) hours per day.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8741 (October 29, 1999).

22-B DCMR § 2712 BURN CENTER

2712.1 Each adult trauma care facility shall have, or shall have access to, a Burn Center directed by a licensed, board certified general or plastic surgeon on the active medical staff who has at least two (2) years of experience in the management of burn patients in a Burn Center.

2712.2 The Burn Center shall be staffed by physician and nursing personnel who are trained in burn care and equipped for the care of the extensively burned patient.

2712.3 A burn service shall be formally established by the medical staff of the facility, and members of the burn service shall be properly credentialed by the facility. The chief of the burn service shall serve as the Medical Director of the Burn Center.

2712.4 The burn service Medical Director shall have the appropriate authority and responsibility to direct and coordinate all medical services for patients admitted to the Burn Center. The Medical Director shall be responsible for regular communications with physicians and other authorities regarding referred patients and for appropriate Burn Center management functions, including quality improvement, liaison with other burn centers, internal and external educational programs, and coordination with regional and state EMS programs. The burn service Medical Director shall participate actively in the care of at least fifty (50) acute burn patients a year.

2712.5 The Burn Center shall admit an average over any three (3) year period of one hundred (100) or more patients annually with acute burn injures, and shall maintain an average daily census of three (3) or more patients with acute burn injuries.

2712.6 The Burn Center shall have one (1) registered nurse who is administratively responsible for and has a full-time commitment to the Burn Center. This individual shall have at least two (2) years of intensive care or equivalent experience on a burn unit and at least six (6) months of management experience.

2712.7 The Burn Center shall have the following support personnel:

(a) Social Worker;

(b) Dietitian;

(d) Psychologists;

(e) Clergy; and

(f) Physical and occupational therapists.

2712.8 The Burn Center shall have the capability of delivering all therapy required, including rehabilitation, and shall also engage in teaching, training of personnel, and burn research.

2712.9 Each adult trauma care facility may have written transfer agreements with a nearby Burn Center or hospital with a burn service unit.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8741 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3915 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7260 (July 23, 2004).

22-B DCMR § 2713 ACUTE SPINAL CORD/HEAD INJURY MANAGEMENT CAPABILITY

2713.1 Each adult trauma care facility shall use a team approach to the initial and continued management of an acute spinal cord or head injury, as follows:

(a) In circumstances where a designated spinal cord injury rehabilitation center exists in the region, early transfer to that facility shall be considered for selected patients; transfer agreements shall be in effect with a designated spinal cord injury rehabilitation center; and

(b) In circumstances where a head injury center exists in the region, transfer to the facility shall be considered for selected patients; transfer agreement shall be in effect with a head injury center.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8741 (October 29, 1999).

22-B DCMR § 2714 SPECIAL RADIOLOGICAL CAPABILITIES

2714.1 In Level I facilities, special radiological capabilities shall be available twenty-four (24) hours per day and shall consist of at least the following:

(a) In-house radiology technician;

(b) Angiography;

(d) Nuclear scanning;

(e) Computerized tomography;

(f) In-house Computerized Tomography (CT) technician; and

(g) Magnetic Resonance Imaging (MRI).

2714.2 In Level II facilities, special radiological capabilities shall be available twenty-four (24) hours per day and shall consist of at least the following:

(a) In-house radiology technician;

(b) Angiography;

(d) Computerized tomography.

2714.3 In Level II facilities, special radiological capabilities may also include:

(a) Nuclear scanning;

(b) In-house Computerized Tomography (CT) technician; and

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8741 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3915 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7260 (July 23, 2004).

22-B DCMR § 2715 CLINICAL LABORATORY SERVICE

2715.1 Clinical laboratory services in adult trauma facilities shall be available twenty-four (24) hours per day for the following:

(a) Standard analyses of blood, urine, and other body fluids;

(b) Blood typing and cross-matching;

(d) Comprehensive blood bank or access to a community central blood bank and adequate storage facilities;

(e) Blood gases and potential of Hydrogen (pH) determinations;

(f) Microbiology.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8741 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3915 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7260 (July 23, 2004).

22-B DCMR § 2716 REHABILITATION MEDICINE

2716.1 Each adult trauma care facility shall have a physician-directed rehabilitation service program staffed by personnel trained in rehabilitation care and equipped properly for the care of the critically injured patient. This shall include the following:

(a) Physical therapy;

(b) Occupational therapy;

(d) Social service.

2716.2 Adult trauma care facilities shall have transfer agreements with approved rehabilitation facilities for long-term care.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8741 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3915 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7260 (July 23, 2004).

22-B DCMR § 2717 PROGRAMS FOR PERFORMANCE IMPROVEMENT

2717.1 In adult trauma facilities, programs for performance improvement shall have the following elements:

(a) Trauma registry;

(b) Special audit for all trauma deaths;

(d) Multidisciplinary trauma conference;

(e) Medical nursing audit, utilization review, tissue review;

(f) Review of prehospital trauma care;

(g) Review of times and reasons for transfer of injured patients;

(h) Times of and reasons for trauma-related bypass documentation; and

(i) Quality improvement personnel specifically dedicated to the trauma service program.

2717.2 Performance improvement programs in each adult trauma care facility shall be met by establishing the following:

(a) A hospital organizational structure that facilitates the process of quality improvement by providing the responsible surgeon with authority to change policies, procedures, and protocols that address the care of the injured trauma patient;

(b) The development of standards of quality care;

(1) Defining the population of trauma patients to whom the standards are applied;

(2) Defining adverse outcomes or deviations from quality (for example, death or complications from injury or treatment);

(3) Defining quality indicators or audit filters that examine the process of care; and

(4) Developing a systematic process for collection, evaluation, and analysis of data that describe or define the process of care and outcome;

(d) A process of peer review to evaluate specific cases or problems identified by the monitoring process. This requires:

(1) Documentation of the process and outcome of peer review; and

(2) Tabulation of the judgments from peer reviews to provide a basis for trend analysis and to assess the effect of any corrective action;

(e) A process for implementing corrective action to address problems or deficiencies identified by either the monitoring process or the peer review process; and

(f) A process for reevaluating and documenting the effect of the corrective action taken.

2717.3 A performance improvement program shall consist of the following components:

(a) Standards and organization:

(1) Define the population to be monitored;

(2) Develop standards of care;

(3) Establish credentialing standards for practitioners;

(4) Provide administrative support for the process; and

(5) Designate a responsible surgeon and provide him or her with the appropriate authority to enact the process;

(b) Data collection:

(1) Establish a process for data collection;

(2) Establish quality indicators (audit filters) for the continuous or periodic evaluation of specific aspects of care;

(3) Define adverse outcomes according to an explicit list of well-defined complications; and

(4) Monitor the incidence of adverse outcomes on a regular basis and to compare to regional and national norms;

(1) Establish a systematic peer-review process using multiple disciplines for the continuous or periodic evaluation of tended data, sentinel events, or specific cases; and

(2) Provide written documentation of identified problems and opportunities to correct the problem and improve care;

(d) Corrective action:

(1) Define corrective actions needed to address problems identified in the analysis;

(2) Implement corrective action;

(3) Assess the effect of the corrective action; and

(4) Periodically reassess or monitor the effectiveness of the action to document improvements and define future objectives.

2717.4 In each adult trauma care facility, the governing body of a hospital has the ultimate authority and responsibility to provide for the delivery of quality patient care.

2717.5 Each adult trauma care facility shall have a designated clinician with authority, responsibility, and accountability for the assessment and improvement of quality of care.

2717.6 In each adult trauma care facility, the Trauma Service Director shall be responsible for performance improvement.

2717.7 Repealed.

2717.8 In each adult trauma care facility, standards of quality care shall emphasize the outcome of care and the process by which it is rendered. To ensure quality care, trauma facilities and trauma systems shall have the following attributes of care:

(a) Systematic actions designed to improve the health of the patient;

(b) Be rendered in a timely fashion, relative to the severity of the illness;

(d) Be rendered to a completely informed patient so that the patient can be knowledgeable, cooperative, and participate in health care decisions;

(e) Be based on sound scientific principles and standards;

(f) Be rendered with sensitivity and concern for the patient and his or her family;

(g) Be rendered with a cost-efficient use of available technology; and

(h) Be accurately documented in the patient's medical record.

2717.9 Elements critical to the consistent delivery of quality care in adult trauma facilities include:

(a) Delineation of privileges to limit trauma care duties to those with demonstrated skills, commitment, and experience;

(b) Reevaluation of privileges and reappointment to the trauma team shall be based on the following criteria:

(1) Maintenance of good standing in the primary specialty;

(2) Evidence of continuing education in trauma care;

(3) Documented attendance at a multidisciplinary conference where either morbidity or mortality comprises more than fifty percent (50%) of the subject matter, and hospital peer review conferences that deal with care of injured patients; and

(4) Satisfactory performance in managing trauma patients based on performance assessment and outcome analysis;

(d) A surveillance program, including at a minimum all trauma patients who:

(1) Are admitted to the hospital for more than two (2) days;

(2) Are admitted to an intensive care unit or operating room;

(3) Are transferred into or out of the hospital; and

(4) Die as a result of trauma injuries;

(e) Autopsy information, including complete anatomical diagnosis of injury to assess quality of care. A postmortem examination shall be sought in all trauma-related deaths.

2717.10 Continuous audits, periodic focused audits, specific case review, and trend analysis shall be available to evaluate the process of care in order to review outcome. Deaths and major complications shall have specific case review. Complications may be monitored by trend analysis, which requires determining the incidence of the complication over a given interval (for example, monthly or quarterly) and following the incidence over subsequent intervals. Changes in trends or unexpected variations should provoke a focused audit of the patient developing the complication.

2717.11 The requirements of § 2717.10 shall be carried out as follows:

(a) Audit filters shall be used to examine the timeliness, appropriateness, and effectiveness of care rendered to an individual patient, and the value of continuous or periodic use of these filters in the quality improvement program shall be reviewed regularly by individual trauma facilities. Minimum filters to be applied include the following:

(1) Selected complications, monitored as either trends or sentinel events. Trauma Service Directors shall select those complications for audit and review those complications that are frequent or severe in their cohort of trauma patients; and

(2) All trauma deaths.

(b) A focused audit shall be used periodically to examine the process of care;

(c) The Trauma Score/Injury Severity Score (TRISS) method shall be used to estimate the likelihood of patient survival based on a regression equation and shall take into account:

(1) Patient age;

(2) The severity of anatomical injury as measured by the Injury Severity Score (ISS);

(3) The physiological status of the patient on admission based on the Revised Trauma Score (RTS); and

(4) The type of injury (blunt or penetrating);

(d) An internal review shall be conducted to identify patients to receive an in-depth peer review and audit. In-depth review of the charts of nonsurvivors who were expected to survive is mandatory;

(e) External comparison, to relate trauma center performance to an external reference, shall be performed, and shall include summing the individual calculated probabilities of survival for any cohort of patient to provide the number of expected survivors for the cohort;

(f) A multidisciplinary trauma peer-review committee shall meet regularly. The committee shall be chaired by the Trauma Service Director and have representation from all of the major services that treat trauma patients. The task of the committee is to conduct critical reviews, evaluate, and discuss the quality of care in cases of adverse outcome (complications and deaths), particularly focusing on those deaths of persons statistically expected to survive, which were identified using outcome norms; and

(g) Following identification and documentation of a specific problem in patient care or system performance by the peer-review process, corrective action shall be taken through one of the following mechanisms:

(1) Change of existing policies and procedures that govern or define the standard of care;

(2) Professional education: cases shall be selected for discussion at the trauma service morbidity/mortality review conference; deficits in knowledge shall be addressed through education of the whole group of trauma care providers or of specific trauma care providers;

(3) Physician counseling: review of a special case or cases shall be made by the Trauma Services Director with the individual physician; the process of evaluation and counseling shall be carefully documented; and

(4) Credentialing process: information from quality improvement activities shall be considered at the time of credentialing and in the delineation of privileges; serious deficits may result in the limitation of privileges or the failure to be reappointed in the discretion of the Director of Trauma Services.

2717.12 In addition to the requirements set out in § 2717.1 (a), adult trauma care facilities shall have a Trauma Registry that provides accurate data describing patient injury severity, process of care, and outcomes.

2717.13 An adult trauma care facility shall satisfy the requirements of § 2717.11(g) by establishing a multidisciplinary review committee that shall require a quorum of a majority of the members at each meeting. The multidisciplinary review committee shall consist of the following members:

(a) Chairperson - Trauma Service Director;

(b) Trauma nurse coordinator;

(d) A representative of the orthopedic surgery department;

(e) A representative of the emergency medicine department;

(f) A representative of the anesthesiology department;

(g) A staff pathologist;

(h) A staff radiologist; and

(i) A representative from rehabilitation medicine.

2717.14 The goals of a multi-disciplinary review committee shall be as follows:

(a) Review selective deaths;

(b) Review complications;

(d) Review organizational issues on a regular basis and in a systematic fashion.

2717.15 The objectives of this multi-disciplinary peer review committee shall be as follows:

(a) To identify and resolve problems or specific issues; and

(b) To identify new policies or protocols and have the representatives from the various departments listed in § 2717.13 transmit the information back to their respective departments.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8741 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3915 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7260 (July 23, 2004).

22-B DCMR § 2718 TRANSFER AGREEMENTS

2718.1 Level I facilities shall have transfer agreements with other facilities whereby the Level I facility serves as a receiving facility.

2718.2 Level II facilities shall have transfer agreements whereby the Level II facility serves as both a transferring and receiving facility.

2718.3 When interhospital transfer is in the patient's best interest, the treating physician shall ensure that the patient is optimally stabilized within the capabilities of the transferring institution. The facility shall stabilize each injury or physiologic derangement, such as respiratory distress or shock, before the transfer. The urgent needs of the patient who requires advance level trauma care shall supersede the requirement that patients be cared for within a specific provider network.

2718.4 Transferring physician responsibilities shall include:

(a) Identifying the patient needing transfer;

(b) Initiating the transfer process by direct contact with the receiving surgeon or physician;

(d) Determining the appropriate mode of transportation in consultation with the receiving surgeon or physician; and

(e) Transferring all records, results, and X-rays to the receiving facility.

2718.5 Receiving physician responsibilities shall include:

(a) Ensuring resources are available at the receiving facility;

(b) Providing advice or consultation regarding specifics of the transfer or additional evaluation or resuscitation prior to transport;

(d) Identifying a process for transportation, allowing feedback from the receiving physician to the transport team directly or to the medical direction of the transport team.

2718.6 Patient transport management shall consist of the following care:

(a) Qualified personnel and equipment shall be available during transport to meet anticipated contingencies;

(b) Sufficient supplies shall accompany the patient during transport, such as intravenous (IV) fluids, blood and medications as appropriate;

(d) Vital functions shall be supported; for example, hemodynamics, ventilation, central nervous system, and spinal protection;

(e) Records shall be kept during transport; and

(f) Communication shall be kept with on-line medical direction during transport.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8741 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3915 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7260 (July 23, 2004).

22-B DCMR § 2719 RESERVED

22-B DCMR § 2720 CONTINUING EDUCATION

2720.1 Each adult trauma facility shall provide a formal program for Continuing Medical Education (CME) specifically addressing adult trauma care and for the following personnel:

(a) General surgery residency program participants;

(b) Advanced Trauma Life Support (ATLS) providers;

(1) Staff or community physicians CME;

(2) Nurses;

(3) Allied health personnel; and

(4) Prehospital personnel.

2720.2 The Trauma Service Director shall demonstrate educational involvement in trauma by active participation as an instructor for the American College of Surgeons (ACS) of an ATLS course.

2720.3 General surgeons on the trauma team shall successfully complete the ACS ATLS Course.

2720.4 All members of the trauma team shall have at least sixteen (16) hours of trauma-related CME training annually. Fifty percent (50%) of these hours during any three (3) -year period shall be obtained outside the surgeon's own institution.

2720.5 Emergency physicians on the trauma team shall have at least sixteen (16) hours of trauma-related CME training each year. Trauma CME credit may be earned by attending regional or national meetings concerning trauma-related issues and from in-house conferences, such as grand rounds and multidisciplinary conferences. Fifty percent (50%) of these hours during any three (3) year period shall be obtained outside the physician's own institution.

2720.6 Neurosurgical members of the trauma team at Level and II facilities shall have at least sixteen (16) hours of trauma-related CME. Fifty percent (50%) of these hours during any three (3) year period shall be obtained outside the surgeon's own institution.

2720.7 Orthopedic surgical members of the trauma team at Level I and II facilities shall have at least sixteen (16) hours of trauma-related CME annually. Fifty percent (50%) of these hours during any three (3) year period shall be obtained outside the surgeon's own institution.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8741 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3915 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7260 (July 23, 2004).

22-B DCMR § 2721 OUTREACH PROGRAM

2721.1 Each adult trauma care facility shall be available for telephone and on-site consultations with physicians in the community and surrounding area regarding the care and treatment of trauma patients.

2721.2 Each Level I facility shall conduct at least twelve (12) education or outreach presentations over a three (3) year period.

2721.3 Each Level II facility may conduct at least twelve (12) education or outreach presentations over a three (3) year period.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8741 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3915 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7260 (July 23, 2004).

22-B DCMR § 2722 TRAUMA EDUCATION

2722.1 Level I facilities shall undertake the following public education activities:

(a) Perform epidemiology research to include:

(1) Conducting studies in injury control;

(2) Collaborating with other institutions in epidemiological research;

(3) Monitoring the progress of prevention programs; and

(4) Consulting with qualified researchers on evaluation measures;

(b) Conduct trauma injury surveillance including:

(1) Conducting special emergency department and field collection projects;

(2) Maintaining an expanded trauma registry data; and

(1) Designating a trauma prevention coordinator;

(2) Conducting outreach activities and program development;

(3) Providing information resources and submission of results to the District of Columbia Department of Health; and

(4) Collaborating with existing national, regional, and state programs.

2722.2 Level II facilities shall conduct the following prevention and public education activities:

(a) Maintain injury surveillance and trauma registry data;

(b) Establish an injury prevention program, including:

(1) Designating a trauma prevention coordinator;

(2) Conducting outreach activities and program development;

(3) Providing Information resources; and

(4) Collaborating with existing national, regional and state program.

2722.3 Level II facilities may conduct:

(a) Epidemiology research, including but not limited to:

(1) Conducting studies in injury control;

(2) Collaborating with other institutions in research;

(3) Monitoring progress of prevention programs; and

(4) Consulting with qualified researchers on research evaluation measures;

(b) Injury surveillance, to include:

(1) Special emergency department and field collection project; and

(2) Expanded trauma registry data.

2722.4 In Level I facilities the requirements of § 2722.1(a)(4) shall be met in consultation with an epidemiologist or biostatistician.

2722.5 In Level I facilities, the requirements of § 2722.1(b)(1) shall be met by performing special data collection projects as needed.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8741 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3915 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7260 (July 23, 2004).

22-B DCMR § 2723 TRAUMA RESEARCH PROGRAM

2723.1 Level I facilities shall have a trauma research program designed to produce new knowledge applicable to the care of injured trauma patients. This research may be conducted utilizing traditional laboratory and clinical research, reviews of clinical series, and epidemiologic or other studies.

2723.2 A trauma research program shall have an organizational structure that fosters and monitors consistent publication of articles focused on trauma related issues in peer-reviewed journals.

2723.3 A Level I facility shall periodically present research results at local, regional, and national society meetings and conduct ongoing studies approved by local human and animal research review boards. Each Level I facility shall demonstrate research productivity to include at least ten (10) peer-reviewed publications over a three (3) year period. These publications may pertain to any aspect of the trauma program.

2723.4 In Level I facilities, the trauma research program shall have an organized program with a designated director. The research group shall meet on a regular basis and there shall be evidence of productivity identified as proposal review by the Institutional Review Board, presentations at local/regional/national meetings, and publications in peer-reviewed journals.

2723.5 Level II facilities may have a trauma research program.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8741 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3915 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7260 (July 23, 2004).

22-B DCMR § 2724 DISASTER PLAN

2724.1 Each adult trauma care facility shall develop a disaster plan.

2724.2 Each adult trauma care facility shall have a plan that differentiates between multiple casualty situations, in which five to forty (5 to 40) victims are involved, and disasters leading to mass casualties. A treatment plan shall be in place to deal with multiple casualties as opposed to a widespread disaster where all hospitals in the area may be involved.

2724.3 To develop a successful facility disaster plan, a facility shall:

(a) Document the potential disasters for the region;

(b) Develop a flexible protocol for response to each of these disasters by an organized, logical, and realistic plan in accordance with existing local EMS systems;

(d) Practice, evaluate, and update the disaster response plan on a regular basis; and

(e) Educate the public about proper responses to disasters.

2724.4 Each adult trauma care facility shall participate in a local and regional disaster plan by ensuring that its activities and resources for responding to the trauma needs of the community are incorporated into the plan.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8741 (October 29, 1999).

22-B DCMR § 2725 ORGAN PROCUREMENT ACTIVITY

2725.1 Each adult trauma care facility shall have an Organ Donation and Transplantation Program.

2725.2 Each adult trauma care facility shall develop policies and procedures for ensuring access to information on the option to donate organs.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8741 (October 29, 1999).

22-B DCMR § 2799 DEFINITIONS

2799.1 For the purposes of this chapter, the following words and phrases shall have the meaning described:

Audit Filters - clinical indicators used to examine the process of care and to identify potential patient-care problems.

Burn Service - the patient care team based in a hospital, and designed to treat patients with diverse degrees of burns.

Certificate of Added Qualifications in Surgical Critical Care - recognition of specialized education in surgical critical care by the American Board of Surgery.

Emergency Medical System or EMS - the arrangement of personnel, facilities, and equipment for the effective and coordinated delivery of emergency care required to prevent and manage incidents that occur from a medical emergency or from an accident, natural disaster, or similar situation.

Glasgow Coma Scale - scoring system that defines eye, motor and verbal responses in the patient with injury to the brain.

Immediately available - implies the physical presence of the health professional in a stated location at the time of need by the trauma patient.

Injury - the result of an act that damages, harms, or hurts; unintentional or intentional damage to the body resulting from acute exposure to mechanical, thermal, electrical, or chemical energy or from the absence of such essentials as heat or oxygen.

Injury Severity Score - the sum of the squares of the Abbreviated Injury Scale Scores of the three most severely injured body regions.

Major trauma patient - a patient at risk of dying from traumatic injuries.

Prehospital provider - individual who is trained to provide emergency medical services and is certified as such by the local authorities in accordance with the current national standard. Includes First Responders, Emergency Medical Technician/Basic (EMT/B) and advanced life support providers (EMT/Paramedics).

Promptly available - implies the physical presence of the health professional in a stated location within a short period of time, with the time period for actual appearance to be determined by the Trauma Service Director, and continuously monitored by the performance improvement program.

Revised Trauma Score - a prehospital/emergency center scoring system in which numerical values are assigned to differing levels of Glasgow Coma Scale, systolic blood pressure, and respiratory rate.

Trauma Patient - a patient suffering injuries as a result of physical trauma.

Trauma Registry - database to provide information for analysis and evaluation of the quality of patient care, including epidemiologic and demographic characteristics of trauma patients.

Trauma Score/Injury Severity Score (TRISS) - the likelihood of patient survival based on a regression equation that includes patient age, injury severity score, revised trauma score, and the type of injury (blunt or penetrating).

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8741 (October 29, 1999).

22-B28 PEDIATRIC TRAUMA CARE

22-B DCMR § 2800 GENERAL PROVISIONS

2800.1 The Director, Department of Health, shall designate Level I and Level II hospitals for pediatric trauma care services as the inclusive trauma system in the District of Columbia, provided a facility complies with the provisions of this chapter.

2800.2 The provisions of this chapter shall be used by the District of Columbia for the purposes of assessing the suitability of hospitals for receipt of certain pediatric trauma patients in the District of Columbia's Emergency Medical Services System (EMS).

2800.3 An inclusive trauma care system is a system that is fully integrated into the EMS system and is designated to meet the needs of all injured patients requiring care in an acute care facility, regardless of severity of injury, Geographic location, or population density.

2800.4 An inclusive trauma care system shall have the following components:

(a) Medical direction;

(b) Prevention;

(d) Training;

(e) Triage;

(f) Prehospital care;

(g) Transportation;

(h) Hospital care;

(i) Public education;

(j) Rehabilitation; and

(k) Research.

2800.5 An inclusive trauma care system shall be composed of the following:

(a) System management;

(b) Prehospital providers;

(d) Rehabilitation/reconstructive services.

2800.6 The designation of a pediatric trauma center as Level I and Level II guarantees the immediate availability and dedication of specialized surgeons, anesthesiologists, physician specialists, nurses, and resuscitation life-support equipment at the facilities on a twenty-four (24) hour-a day basis.

2800.7 Level I facilities shall have the capability to provide total care for every aspect of an injury, and shall ensure prompt transfer between facilities during all phases of acute and rehabilitative care.

2800.8 A Level I pediatric trauma center shall be an institution which, in addition to meeting the Level II guidelines, shall deploy and coordinate resources for the special types of care required for the major and multiple pediatric trauma victim and have a continued commitment to training and research as minimal characteristics of the hospital's commitment to pediatric trauma care.

2800.9 Level II facilities may have the capability to provide total care for every aspect of an injury and may ensure prompt transfer between facilities during all phases of acute and rehabilitative care.

2800.10 For optimal care of the severely injured, Level I and Level II facilities shall meet the following requirements:

(a) Skilled surgeons and other members of the trauma team shall be immediately available;

(b) When an arriving patient meets the hospital-specific guidelines defining a major resuscitation, the attending surgeon shall be present in the emergency department:

(1) Upon arrival of the patient, when there is advance notification from the field; or

(2) Within fifteen (15) minutes of activating the trauma team, when there is no advance notification;

(c) Compliance with the requirements of subsections (a) and (b) at a rate of eighty percent (80%) or greater shall be documented; and

(d) The following minimum criteria shall be used to define a major resuscitation:

(1) Hypotension: infant less than sixty (60) Systolic Blood Pressure (SBP), child less than seventy (70) SBP, and adolescent less than eighty (80) SBP;

(2) Glasgow Coma Scale less than eight (8) with hemodynamic instability;

(3) Penetrating injury with hemodynamic instability;

(4) Transfusion: interhospital transfer;

(5) Burns more than fifty percent (50%) of body surface;

(6) Vascular, thoracic, abdominal management;

(7) Hemodynamics Instability: infant less than sixty (60) SBP, child less than seventy (70) SBP, adolescent less than eighty (80) SBP, Oxygen saturation less than ninety-three percent (93%), and capillary refill more than four (4) seconds; and

(8) Discretion of Surgical Coordinator or Emergency Department (ED) attending physician.

2800.11 All major pediatric trauma patients shall be admitted to a pediatric trauma center.

2800.12 Each Level I facility shall conduct research at the clinical or basic sciences level, and shall be responsible for disseminating new information.

2800.13 A designated person in each Level I and Level II facility shall be responsible for multi-disciplinary and interdepartmental coordination of trauma care.

2800.14 Each facility shall be in compliance with all applicable local laws and regulations.

2800.15 The management and operation of any pediatric trauma care facility shall be in accordance with good medical and public health practices.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8779 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3933 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7277 (July 23, 2004).

22-B DCMR § 2801 INJURY PREVENTION AND CONTROL

2801.1 Each pediatric trauma care facility shall implement injury prevention and control programs to accomplish injury prevention.

2801.2 Institutional involvement in injury prevention programs shall be based upon the resources of staff, time, and funds available.

2801.3 Injury prevention may be categorized in terms of primary, secondary, or tertiary implementation. Primary prevention refers to the elimination of the trauma incident. Secondary prevention refers to reducing the severity of injuries during the incident through the use of safety restraints and helmets. Tertiary prevention includes all efforts following the trauma incident that optimize outcome, thereby preventing complications, long-term disability, or death.

2801.4 Pediatric trauma care facilities shall develop an injury prevention program. In developing the program, the facility shall:

(a) Gather and analyze data;

(b) Select a target population and its injuries;

(d) Identify, select, and obtain commitments from public and private institutions to implement the program;

(e) Develop protocols and materials;

(f) Orient and train organizations and individuals;

(h) Provide monitoring and support; and

(i) Evaluate and revise as necessary.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8779 (October 29, 1999).

22-B DCMR § 2802 HOSPITAL ORGANIZATION - PEDIATRIC TRAUMA SERVICES

2802.1 The staff credentialing committee of a pediatric trauma care facility shall specifically delineate all privileges of members of the staff providing Pediatric Trauma Services.

2802.2 Each pediatric trauma resuscitation team shall be organized and directed by a general surgeon with expertise in and commitment to the care of the injured. All pediatric patients with multiple system or major injury shall be evaluated by the trauma services team.

2802.3 Each pediatric trauma team shall be available in-house twenty-four (24) hours per day with attending coverage as specified in this chapter.

2802.4 The team leader during the resuscitation efforts shall be an emergency department physician until the arrival of a surgeon who shall then act as the team leader.

2802.5 Each facility shall provide a team approach for responding to the needs of and giving optimal care to pediatric patients with multiple-system injuries. Each team leader shall be a qualified surgeon contributing specific care in the area of his or her specialty, and shall continually oversee and coordinate the operation of the team and care of its patients throughout their hospital stay.

2802.6 The team leader shall be able to interpret and reconcile the recommendations of team members and consultants from a number of specialties and accept the responsibility for transmitting those recommendations to the hospital staff.

2802.7 Each pediatric trauma care facility shall appoint a Trauma Service Director who shall be a board certified surgeon with demonstrated special competence in pediatric trauma care.

2802.8 The Trauma Service Director shall have oversight authority for the care of each trauma patient and administrative authority for the hospital's trauma program.

2802.9 The Trauma Service Director shall be responsible for recommending appointment to and removal from the trauma service, along with the medical staff credentialing committee, and in consultation with the appropriate service chief.

2802.10 The Trauma Service Director shall meet each of the specific qualifications for surgeons, including personal involvement in the care of the injured, education in trauma care, involvement in professional trauma organizations and board certification.

2802.11 In pediatric trauma care facilities, the Trauma Service Director shall have active involvement or participation as an instructor in the American College of Surgeons PALS (Pediatric Advanced Life Support) courses, participation in other CME (Continuing Medical Education) courses, and the provision of instruction to other health care personnel.

2802.12 The Trauma Service Director shall have the appropriate specific responsibilities of evaluating newly appointed members of the trauma service and overseeing ongoing education for new and existing attending surgeons and physicians as appropriate.

2802.13 The Trauma Service Director, or his or her designee, shall participate in the development of pediatric trauma-care systems at the community, state, or national levels.

2802.14 The Trauma Service Director in Level I facilities shall be responsible for encouraging the staff to undertake clinical and basic research, with publication of their results.

2802.15 The Trauma Service Director shall make presentations on trauma care to medical staff and other health care organizations providing trauma care.

2802.16 The Trauma Service Director shall be responsible for quality improvement in each pediatric trauma care facility.

2802.17 Each pediatric trauma care facility shall have designated specialists available twenty-four (24) hours per day for the care of major trauma patients.

2802.18 Each pediatric trauma care facility shall be staffed by surgeons who are board certified in a surgical specialty recognized by the American Board of Medical Specialties.

2802.19 Each trauma surgeon in a pediatric trauma care facility shall have an interest in and a commitment to trauma care, demonstrated by participation in the organization of trauma protocols, trauma teams, trauma call rosters, and trauma rounds.

2802.20 General surgeons on the trauma team in pediatric trauma care facilities shall successfully complete the American College of Surgeons Advanced Trauma Life Support (ATLS) Course.

2802.21 Each surgeon member of the trauma team shall participate in a minimum of sixteen (16) hours of trauma-related continuing medical education (CME) courses per year. At least fifty percent (50%) of this CME shall be extramural and both category I and category II CME may count toward satisfying that requirement.

2802.22 A physician's participation in regional groups, such as state and regional trauma committees, and membership in regional organizations, shall constitute significant involvement in and commitment to trauma-related matters.

2802.23 In each pediatric trauma care facility, the emergency physician shall be a member of the trauma team who participates in the care of the patient and in all audits and critiques necessary for excellence in trauma care.

2802.24 Emergency physicians shall be involved with surgeons in the development of trauma care systems as part of the overall development of emergency medical systems in the community. In addition, they shall be active in organizations contributing to the benefit of injured patients.

2802.25 An anesthesiologist shall have the overall responsibility for preoperative airway control of the patient during resuscitation, and act as postoperative consultant in cardiorespiratory support and pain control. An anesthesiologist on the trauma team shall satisfy the following requirements:

(a) Be appropriately certified;

(b) Have the necessary educational background in care of the trauma patient;

(d) Engage in investigative, teaching, and community activities.

2802.26 The emergency physician and anesthesiologist on the trauma team shall be board certified in their respective specialties as recognized by the American Board of Medical Specialties.

2802.27 In each pediatric trauma care facility; the following medical specialists shall be available for consultation in the area of patients with multiple injuries:

(a) Cardiologist;

(b) Pulmonary medicine;

(d) Nephrologist; and

(e) Dialysis team.

(f) Repealed.

(g) Repealed.

(h) Repealed.

(i) Repealed.

(j) Repealed.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8779 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3933 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7277 (July 23, 2004).

22-B DCMR § 2803 TRAUMA COORDINATOR

2803.1 Each pediatric trauma care facility shall have a trauma coordinator who is fundamental to the institution's trauma program development, implementation, and evaluation. Working in conjunction with the Trauma Service Director, the trauma coordinator shall be responsible for the organization of services and systems necessary for a multidisciplinary approach throughout the continuum of trauma care. The trauma coordinator is supervised by the Trauma Service Director.

2803.2 The trauma coordinator shall have an active role in the following:

(a) Participating in clinical activities, including:

(1) Developing clinical protocols;

(2) Monitoring patient care; and

(3) Assisting staff in problem solving;

(b) Ensuring continuing education for staff, including:

(1) Assisting in professional staff development activities;

(2) Conducting case reviews;

(3) Arranging continuing education for trauma care staff;

(4) Developing and implementing a community trauma education program; and

(5) Establishing trauma prevention programs;

(1) Developing Protocol design; and

(2) Performing data collection and analysis, and distribution of findings;

(d) Assisting in developing a quality assurance program, including the development of audit filters and case reviews;

(e) Performing administrative duties, including organization management, budget preparation and staff accountability;

(f) Assisting in maintaining a trauma registry, performing data collection, coding including external causes of injury, e-coding and scoring, and developing processes for validating data and submitting the data to the citywide trauma registry maintained by the District of Columbia Department of Health; and

(g) Serving as a consultant and liaison to medical staff, prehospital EMS agencies, patients' families and the community at large.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8779 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3933 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7277 (July 23, 2004).

22-B DCMR § 2804 HOSPITAL DEPARTMENTS, DIVISIONS, SERVICES, SECTIONS

2804.1 Each pediatric trauma care facility shall have departments, divisions, services, or sections with designated chiefs and shall be staffed by qualified pediatric specialists in the following areas:

(a) General Surgery;

(b) Neurologic Surgery;

(d) Emergency Services; and

(e) Anesthesia.

(f) Repealed.

(g) Repealed.

(h) Repealed.

(i) Repealed.

(j) Repealed.

2804.2 In each pediatric trauma care facility; a clearly identifiable neurosurgeon shall be promptly available when a patient needs to be seen. Immediate care necessitates a reliable on-call schedule with a specific protocol for back-up coverage.

2804.3 The requirement set forth in § 2804.2 may be fulfilled by an in-house neurosurgeon or other surgeon who has special competence in the care of patients with neurotrauma, as judged by the chief of neurosurgery, and who is capable of undertaking measures for the stabilization and treatment of neurotrauma patients.

2804.4 In each pediatric trauma care facility, the following minimum personnel and equipment required for the treatment of severe neurological trauma shall be on call and promptly available for the treatment of trauma patients at all times:

(a) Specifically named surgeon;

(b) Specifically named neurosurgeon;

(c) Emergency department staffed twenty-four (24) hours per day by a physician who has successfully completed training in Advanced Trauma Life Support (ATLS) or who has demonstrated his or her level of expertise as determined by the Trauma Service Director;

(d) Twenty-four (24) hour availability of an operating room capable of the rapid acceptance of patients for craniotomy or spinal surgery;

(e) Twenty-four (24) hour availability of a computerized tomographic (CT) scanner and technician;

(f) Intensive care unit (ICU) with appropriate equipment and staffing, including capabilities for monitoring intracranial pressure (ICP); and

(g) A clearly defined bypass plan in the event of unavailability of the neurosurgeon or other essential resources.

2804.5 The care of neurological trauma may also include readily available magnetic resonance imaging (MRI) scanner.

2804.6 An orthopedic surgeon shall be available at all times for the optimal management of the trauma patient. The orthopedic surgeon shall be a member of the trauma team.

2804.7 An orthopedic surgeon shall have immediate and ongoing participation in the care of patients with musculoskeletal injuries, and shall interact with the rest of the trauma team regarding patient care.

2804.8 An orthopedic surgeon shall be promptly available to participate in the initial evaluation of the trauma patient in the emergency department. The orthopedic surgeon shall evaluate the neurovascular status and structural integrity of the extremities and axial skeleton.

2804.9 The minimum qualifications of an orthopedic surgeon on-call shall include the following:

(a) Board certification (or eligibility during the first five (5) years after residency);

(b) Not less than sixteen (16) documented hours of Category I or II Continuing Medical Education (CME) per year in skeletal traumatology; and

2804.10 Orthopedic surgeon shall have demonstrated skill in:

(a) The management of open wounds;

(b) Recognition and treatment of compartment syndrome;

(d) Internal fixation of femoral fractures.

2804.11 Each pediatric trauma care facility shall provide, for optimal musculoskeletal management, an adequate extended team composed of orthopedic assistants, nurses, physician assistants, and others who can assist with casts and traction, and can provide evaluation and care of patients both in the emergency room and on the acute care units.

2804.12 Operating room nurses and technologists shall be experienced in the use and care of fracture-fixation instruments and devices, as well as able to provide appropriate assistance during skeletal surgery. Appropriately trained X-ray technologists must be available in the operating room to assist with fluoroscopic procedures and to provide prompt radiographs when needed.

2804.13 Each pediatric trauma care facility shall maintain essential equipment for optimal fracture treatment, including:

(a) A complete stock of plaster, fiberglass cast, and splint material with adequate padding;

(b) Equipment for skeletal traction of spine and extremities;

(d) A pulse-lavage unit with appropriate protective shields, including waterproof gowns and drapes;

(e) Tissue pressure measurement equipment;

(f) An image-intensifier fluoroscope;

(g) A fracture table, compatible with the fluoroscope, that permits supine and lateral decubitus positions, with attachments for procedures on femur, tibia, upper extremity, and pelvis;

(h) A radiolucent operating table for intraoperative fluoroscopy of pelvis, extremities, and spine;

(i) Intramedullary nailing instruments and implants for femur, tibia, and humerus; interlocking nail equipment is essential for the femur and tibia, and nails that can be used without reaming the medullary canal shall also be available;

(k) Instruments and implants for reducing and stabilizing spinal injuries and for decompressing the spinal canal if necessary; and

(l) Equipment and supplies for microvascular and microneural surgery.

2804.14 Each pediatric trauma care facility shall maintain an adequate number of orthopedists committed to trauma care. Orthopedists assigned to provide scheduled coverage for trauma patients shall qualify for membership on the trauma service team and shall participate in service activities, especially those related to quality improvement and so the development of institutional protocols for systematic evaluation and management of common injuries.

2804.15 In Level I facilities, orthopedic members of the trauma service are responsible for teaching and research appropriately related to musculoskeletal injuries and for providing readily available consultation to physicians in the surrounding community.

2804.16 In each pediatric trauma care facility, a general orthopedist shall provide primary care for musculoskeletal injuries. When orthopedic trauma specialists are not immediately available, the initial orthopedic care may be provided by another member of the staff, who will then transfer that patient to the specialist. Interhospital transfer shall be required in appropriate cases.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8779 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3933 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7277 (July 23, 2004).

22-B DCMR § 2805 CLINICAL CAPABILITIES (HOSPITAL PERSONNEL)

2805.1 Each pediatric trauma care facility shall have the following surgical specialties available in-house twenty-four (24) hours each day:

(a) General Surgery;

(b) Repealed.

(d) Emergency Medicine;

(e) Anesthesiology; and

(f) Repealed.

2805.2 The evaluation and treatment of a patient may be started by a team of surgeons that includes, at a minimum, a post-graduate resident in at least the fourth (4th) year of training.

2805.3 The attending surgeon shall participate in each major therapeutic decision and be present at each operative procedure. Compliance with these criteria and their appropriateness shall be monitored by the hospital's trauma performance improvement program.

2805.4 An attending neurosurgeon shall be available and dedicated to that hospital's trauma service. This requirement may be satisfied by an in-house neurosurgery resident or physician who has special competence, as judged by the chief of neurosurgery, in the care of patients with neurological trauma, and who is capable of initiating measures to stabilize the patient and initiate diagnostic procedures.

2805.5 Each Level I facility shall have personnel on-call and promptly available with competence to access or perform procedures in the following areas:

(a) Cardiac Surgery;

(b) Cardiology;

(d) Infectious Disease;

(e) Microvascular Surgery (replant/flaps);

(f) Ophthalmic Surgery;

(g) Oral/Maxillofacial Surgery;

(h) Orthopedic Surgery;

(i) Internal Medicine;

(j) Plastic Surgery;

(k) Pulmonary Medicine;

(l) Radiology;

(m) Urologic Surgery;

(n) Obstetrics-Gynecologic Surgery; and

(o) Thoracic Surgery.

2805.6 Each Level II facility shall have personnel on-call and available with the competence to perform procedures in the following areas:

(a) Cardiology;

(b) Internal medicine;

(d) Ophthalmic surgery;

(e) Oral/maxillofacial surgery;

(f) Orthopedic surgery;

(g) Plastic surgery;

(h) Pulmonary medicine;

(i) Thoracic surgery;

(j) Urologic surgery; and

(k) Radiology.

2805.7 Each Level II facility may have personnel on-call and available with competence to perform procedures in the following areas:

(a) Cardiac surgery;

(b) Hand surgery;

(d) Microvascular surgery (replant/flaps).

2805.8 In non-surgical specialty cases the patient's primary care physician shall be notified at an appropriate time.

2805.9 Thoracic surgery may be performed by a general trauma surgeon with privileges to provide thoracic surgical care to patients with thoracic injuries.

2805.10 Transplant specialists shall be provided as follows:

2805.11 The requirement to provide emergency medical services may be satisfied by an emergency medicine chief resident capable of assessing emergency situations in trauma patients and providing any indicated treatment. When senior residents are used to satisfy availability requirements, the staff specialist on-call shall be advised and be available for consultations.

2805.12 The requirement to provide anesthesiology services may be satisfied in a Level I facility by an anesthesiology chief resident or a certified nurse anesthetist (CRNA) capable of assessing emergency situations in trauma patients, and providing any indicated treatment, including surgical anesthesia. When an anesthesiology resident or a CRNA is used to satisfy availability requirements the staff anesthesiologist on-call shall be advised and be promptly available.

2805.13 The requirement to provide anesthesiology services is satisfied in a Level II facility when the staff anesthesiologist will be in the hospital at the time of, or shortly after, the patient's arrival. Before the staff anesthesiologist arrives, an Anesthesiology chief resident or a CRNA capable of assessing emergency situations in trauma patients and of initiating and providing any indicated treatment shall be available.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8779 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3933 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7277 (July 23, 2004).

22-B DCMR § 2806 FACILITY RESOURCES AND CAPABILITIES

2806.1 In each pediatric trauma facility, emergency department personnel shall consist of at least the following:

(a) A designated physician director of the emergency department;

(b) A physician with special competence in care of the critically injured who is a designated member of the trauma team and is physically present in the emergency department twenty-four (24) hours per day; and

(c) Nursing personnel with special capability in trauma care who provide continual monitoring of the trauma patient from hospital arrival to disposition in the pediatric intensive care unit (PICU), operating room (OR), or patient care unit.

2806.2 The requirement for an emergency medicine physician may be satisfied by an emergency medicine senior resident capable of assessing emergency situations in trauma patients and providing any indicated treatment. When a senior resident is used to satisfy this requirement the staff specialist on-call will be advised and will be promptly available. Supervision shall be provided by an in-house attending emergency physician twenty-four (24) hours per day in an institution where there is an emergency medicine residency training program.

2806.3 A team available for twenty-four (24) hours per day in-house coverage in the emergency department and who provides the initial management of the major pediatric trauma patient shall consist of at least the following personnel:

(a) An emergency department attending physician with knowledge of trauma care who is Advanced Trauma Life Support (ATLS) Certified and may be Pediatric Advanced Life Support (PALS) Certified, or who has demonstrated an appropriate level of expertise as determined by the Trauma Service Director. An appropriate level of expertise is demonstrated with not less than sixteen (16) hours trauma-related Continuing Medical Education (CME), board certification, clinical involvement, and special interest in trauma.

(b) Surgical residents, as follows:

(1) In Level I facilities, each surgical resident shall be in at least his or her fourth (4th) year of post-graduate specialty training; and

(2) In Level II facilities, each surgical resident shall be at least in his or her third (3rd) year of post-graduate specialty training;

(c) An anesthesiologist who shall be promptly available when the initial response by an anesthesiology chief resident or a critical care nurse anesthetist;

(d) A minimum of two (2) nurses familiar with emergency and critical care, qualified to function as members of the trauma team by specific criteria defining orientation and practice requirements; one (1) nurse shall have specialized knowledge of trauma care; and

(e) Registered nurses, licensed practical nurses, and nurses aides in sufficient number to provide appropriate coverage.

2806.4 The in-house team shall be on group call pagers to meet each patient with maximum readiness upon arrival. If the in-house team is not on group call pagers, a paging system shall function to mobilize the team within a maximum of two (2) minutes.

2806.5 The annual team responses for a pediatric Level I trauma center shall be at least twelve hundred (1200) patients, or a minimum of two hundred and forty (240) patients with an Injury Severity Score of greater than fifteen (15), or more than thirty five (35) patients with an Injury Severity Score of greater than fifteen (15) on average for all trauma panel surgeons.

2806.6 Repealed.

2806.7 Each pediatric trauma care facility shall have mobile X-ray capability with twenty-four (24) hours per day coverage by in-house technicians.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8779 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3933 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7277 (July 23, 2004).

22-B DCMR § 2807 PEDIATRIC TRAUMA RESUSCITATION AREA

2807.1 In each pediatric trauma care facility, the emergency department shall have a large space designated and dedicated as the trauma resuscitation area. The space shall be large enough to allow assembly of the full trauma team plus necessary equipment including ventilators and/or portable X-ray machine.

2807.2 Equipment may include ultrasound. Equipment or procedure trays to perform invasive treatments shall be available as follows:

(a) Airway control and ventilation equipment;

(b) Pulse oximetry;

(d) Electrocardiograph-oscilloscope-defibrillator;

(e) Internal paddles;

(f) Central venous pressure (CVP) monitoring equipment;

(g) Standard intravenous (IV) fluids and administration sets;

(h) Large-bore intravenous catheters;

(i) Sterile surgical sets airway control/cricothyrotomy, thoracostomy, venous cutdown, central line insertion, thoracotomy, peritoneal lavage;

(j) Arterial catheters;

(k) Drugs necessary for emergency care;

(l) X-ray availability twenty-four (24) hours per day;

(m) Cervical traction devices;

(n) Broselow tape;

(o) Thermal control equipment for patient, fluids, and blood;

(p) Rapid infuser system;

(q) Qualitative end-tidal Carbon Dioxide (CO2) determination; and

(r) Communication with Emergency Medical Service (EMS) vehicles.

2807.3 The pediatric trauma resuscitation area shall contain adequate telephones, telephone lines, and intercoms.

2807.4 In Level I facilities, dedicated phone lines shall be used between the resuscitation area and the blood bank and/or operating room. Large wallboards shall display team members' names and roles, as well as key hospital phone numbers and on-call personnel.

2807.5 Each adult trauma care facility, shall have the following communication capabilities:

(a) Prehospital to hospital link for direct medical command and carly hospital notification;

(b) Trauma team alert and activation;

(d) Trauma team and intrafacility personnel communication; and

(e) Interfacility communication.

2807.6 In each pediatric trauma care facility, the pediatric resuscitation area trauma team shall consist of at least the following personnel:

(a) Surgeon (Trauma team leader);

(b) Emergency physician;

(d) Nurses;

(e) Respiratory therapist;

(f) Radiologic technologist;

(g) Blood bank or laboratory personnel;

(h) Operating room staff;

(i) Surgical and emergency residents;

(j) Critical care nurse;

(k) Security officer;

(l) Chaplain; and

(m) Social worker.

2807.7 Each individual trauma team member shall assist on the assessment of the patient with simultaneous life support, diagnosis of injuries, acquisition of laboratory specimens, initial radiographic survey, and communication and mobilization of any and all necessary hospital resources.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8779 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3933 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7277 (July 23, 2004).

22-B DCMR § 2808 PEDIATRIC OPERATING SUITE

2808.1 Operating suites in each pediatric trauma care facility shall be staffed and equipped to handle each pediatric patient brought into the emergency department in need of immediate surgical intervention.

2808.2 Operating suites in Level I facilities shall be adequately staffed in-house and immediately available twenty-four (24) hours per day. Operating suites in Level II facilities may be adequately staffed in-house and immediately available twenty-four (24) hours per day.

2808.3 Each operating suite in Level I and Level II facilities shall have equipment suitable for use with children, including:

(a) Thermal control equipment for patients, blood, and fluids;

(b) X-ray capability, including C-arm image intensifier available twenty-four (24) hours per day;

(d) Craniotomy instruments;

(e) Equipment appropriate for fixation of long-bone and pelvic fractures. Rapid infuser system; and

(f) Rapid infuser system.

2808.4 Each operating suite in Level I facilities shall have the following capability and equipment, in addition to the requirements set out in § 2808.3:

(a) Cardiopulmonary bypass capability; and

(b) Operating microscope.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8779 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3933 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7277 (July 23, 2004).

22-B DCMR § 2809 POSTANESTHETIC RECOVERY ROOM (PAR)

2809.1 In each pediatric trauma care facility, the postanesthetic recovery room (PAR), which may be the Surgical Pediatric Intensive Care Unit (PICU), shall be staffed and equipped as follows:

(a) Registered nurses and other essential personnel twenty-four (24) hours per day;

(b) Equipment for the continuous monitoring of temperature, hemodynamics, and gas exchange;

(d) Pulse oximetry; and

(e) Thermal control.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8779 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3933 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7277 (July 23, 2004).

22-B DCMR § 2810 PEDIATRIC INTENSIVE CARE UNITS (PICU) FOR TRAUMA PATIENTS

2810.1 A hospital shall have a surgically-directed and staffed Pediatric Intensive Care Unit (PICU) in order to be designated as a Level I trauma center.

2810.2 Each pediatric trauma care facility shall designate a surgical director or surgical co-director for the PICU.

2810.3 The pediatric trauma service that assumes initial responsibility for the care of an injured patient shall maintain that responsibility as long as the patient remains critically ill. The surgeon in charge shall remain in that role even if the patient requires admission to a pediatric intensive care unit (PICU).

2810.4 Medical and surgical specialists shall be consulted as needed to provide specific expertise in the care of the patient in the PICU. The surgical PICU service physician shall be in-house twenty-four (24) hours per day in Level I facilities.

2810.5 The surgeon team leader in a pediatric trauma care facility shall have obtained critical care training during residency or fellowship and must have expertise in the perioperative and postinjury care of the critically injured patient. The surgeon team leader shall possess a Certificate of Added Qualifications in Surgical Critical Care from the American Board of Surgery, or have documented active participation during the preceding twelve (12) months in PICU administration and quality improvement activities, and direct involvement in the PICU care of trauma patients.

2810.6 Each PICU shall have a physician with privileges in critical care and approved by the Surgical Critical care service Director on duty in the PICU twenty-four (24) hours a day or immediately available in the hospital.

2810.7 The clinical nurse manager for a PICU shall be responsible for those aspects of administration that pertain to nursing in the unit and for quality improvement in nursing. He or she shall hold certification as a Critical Care Nurse (CCRN) or have evidence of equivalent critical care training.

2810.8 Each nurse assigned to trauma patients shall be a registered nurse, and shall hold certification as a CCRN or have evidence of equivalent critical care training from the American Association of Critical Care Nurses. Before assuming responsibility for patients in the PICU, each nurse shall be oriented to the care of the critically ill trauma patient. Each nurse shall complete at least eight (8) hours of Continuing Medical Education each year.

2810.9 The course work for nurses identified in §§ 2810.7 and 2810.8 shall cover mechanisms of injury in traumatized individuals, fluid and electrolyte balance, pressure monitoring, ventilator management, and infection control. It shall also provide an overview of aspects of operative treatment of specific injuries.

2810.10 PICU nursing staff shall be maintained at a level that insures a nurse patient ratio of one to two (1:2) on each shift and shall be increased above this as dictated by patient acuity.

2810.11 Each PICU shall have support personnel available as follows:

(a) Respiratory therapists;

(b) Physical therapists;

(d) Social workers;

(e) Interpreters;

(f) In-house radiology technologist;

(g) In-house acute hemodialysis;

(h) In-house computerized tomographic (CT) technician; and

(i) Angiographer, sonographer, magnetic resonance imaging (MRI) technician.

2810.12 Equipment in the PICU shall include, but not be limited to, the following:

(a) Cardiopulmonary resuscitation cart;

(b) Electrocardiograph machine;

(d) Sets of instruments for the following procedures:

(1) Tracheostomy;

(2) Thoracostomy;

(3) Venous cut-down;

(4) Central venous puncture;

(5) Tracheal intubation;

(6) Intracranial monitoring equipment; and

(7) Pulmonary artery monitoring equipment.

2810.13 Each pediatric trauma care facility shall provide a PICU physician on duty twenty-four (24) hours per day. This coverage may be provided by the patient's primary physician or by a physician who is credentialed in critical care by the hospital. This coverage for emergencies is not intended to replace the primary surgeon in caring for the patient in the PICU; it is to ensure that the patient's immediate needs will be met while the primary surgeon is being contacted.

2810.14 Each pediatric trauma care facility ICU shall provide or have immediately available the following equipment:

(a) Scale;

(b) Volume - cycled and pressure - cycled ventilators;

(d) Vascular and intracranial pressure monitors;

(e) Pulse or venous oximeters;

(f) Infusion devices;

(g) Thermodilution cardiac output computers;

(h) Blood warmers;

(i) Equipment for rapid warming and cooling off of patients;

(j) Orthopedic traction devices;

(k) Beds designed for care of patient with spinal cord injuries and for patients at high risk for decubitus ulcers;

(l) Sets for arterial cannulation and peritoneal lavage;

(m) Adjustable chairs for mobilization of patients; and

(n) Repealed.

2810.15 Each PICU in a pediatric trauma care facility shall be concentrated in a single unit or in contiguous units. Trauma PICU beds on floors different from the operating rooms must have ready access to a nearby elevator that is immediately available for emergency transport. The elevator facilities shall be adequate to ensure immediate transport of the patient and all needed ancillary equipment between the operating rooms and the PICU, and shall be situated to facilitate the transport of the critically ill patient to special procedure departments.

2810.16 All PICU beds shall have bedside monitoring capabilities for central venous, pulmonary arterial, systemic arterial, and intracranial pressure monitoring. All beds shall have piped-in air and oxygen and adequate space for a mechanical ventilator, and at least every other bed shall have a sink. At least one bed shall have the space and water drainage capabilities adequate to support a bedside hemodialysis unit. All beds shall have lighting adequate for performance of minor operative procedures such as chest-tube insertion and central venous puncture.

2810.17 Sleeping quarters for the physician who is immediately responsible for the patients in the trauma PICU shall be located near or within the unit. A quiet room nearby, but separate from the unit, shall be available for discussions with family members. Space also shall be available near the PICU for educational activities for physicians, nurses, and support personnel.

2810.18 Each pediatric trauma care facility shall have access to clinical diagnostic services for essential laboratory evaluations and diagnostics such as blood gases measurement, hematoerit levels, serum potassium values, and chest X-rays within thirty (30) minutes of a request. This capability shall be continuously monitored by the quality improvement program.

2810.19 Each Level I facility shall investigate the pathophysiology and treatment of the critically injured pediatric patient.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8779 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3933 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7277 (July 23, 2004).

22-B DCMR § 2811 ACUTE PEDIATRIC HEMODIALYSIS CAPABILITY

2811.1 A Level I facility shall have in-house hemodialysis services which shall be available within one hundred and twenty (120) minutes of the request, twenty-four (24) hours per day.

2811.2 A Level II facility may provide in-house hemodialysis services which may be available within one hundred and twenty (120) minutes of the request twenty-four (24) hours per day.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8779 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3933 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7277 (July 23, 2004).

22-B DCMR § 2812 PEDIATRIC BURN CENTER

2812.1 Each pediatric trauma care facility shall have, or shall have access to, a Burn Center directed by a licensed, board certified general or plastic surgeon on the active medical staff who has at least two (2) years of experience in management of burn pediatric patients in a Burn Center.

2812.2 The Burn Center shall be staffed by physician and nursing personnel who are trained in burn care and equipped for the care of the extensively burned patient.

2812.3 A burn service shall be formally established by the medical staff of the institution, and members of the burn service shall be properly credentialed by the facility. The chief of the burn service shall serve as the Medical Director of the burn center.

2812.4 The burn service Medical Director shall have the appropriate authority and responsibility to direct and coordinate all medical services for patients admitted to the Burn Center. The Medical Director shall be responsible for regular communications with physicians and other authorities regarding referred patients and for appropriate burn center management functions, including quality improvement, (liaison with other burn centers), internal and external educational programs, and coordination with regional and state EMS programs. The burn center Medical Director and each staff surgeon shall participate actively in the care of at least fifty (50) acute burn patients a year.

2812.5 The Burn Center shall admit an average over any three (3) year period of one hundred (100) or more patients with acute burn injuries annually and shall maintain an average daily census of three (3) or more patients with acute burn injuries.

2812.6 The Burn Center shall have one (1) registered nurse who is administratively responsible for and has a full-time commitment to the burn center. This individual shall have two (2) years of intensive care or equivalent experience on a burn unit and at least six (6) months of management experience.

2812.7 The Burn Center shall have the following support personnel:

(a) Social worker;

(b) Dietitian;

(d) Physical and occupational therapists;

(e) Psychologists;

(f) Clergy; and

(g) Repealed.

2812.8 The Burn Center shall have the capability of delivering all therapy required, including rehabilitation, and shall also engage in teaching, training of personnel, and burn research.

2812.9 Each pediatric trauma care facility may have written transfer agreements with a nearby Burn Center or hospital with a burn service unit.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8779 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3933 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7277 (July 23, 2004).

22-B DCMR § 2813 ACUTE SPINAL CORD/HEAD INJURY MANAGEMENT CAPABILITY

2813.1 Each pediatric trauma care facility, shall use a team approach to the initial and continued management of the acute spinal cord and head injury, as follows:

(b) In circumstances where a head injury center exists in the region, transfer to the facility shall be considered for selected patients; transfer agreements shall be in effect with a head injury center.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8779 (October 29, 1999).

22-B DCMR § 2814 SPECIAL PEDIATRIC RADIOLOGICAL CAPABILITIES

2814.1 In Level I facilities, special radiological capabilities shall be available twenty-four (24) hours per day and shall consist of at least the following:

(a) In-house radiology technician;

(b) Angiography;

(d) Nuclear scanning;

(e) Computerized tomography;

(f) In-house computerized tomograph (CT) technician; and

(g) Magnetic resonance imaging (MRI).

2814.2 In Level II facilities, special radiological capabilities shall be available twenty-four (24) hours per day and shall consist of at least the following:

(a) In-house radiology technician;

(b) Angiography;

(d) Computerized tomography; and

(e) Repealed.

2814.3 Special radiological capabilities in Level II facilities may also include:

(a) Nuclear scanning;

(b) In-house computerized tomographic (CT) technician; and

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8779 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3933 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7277 (July 23, 2004).

22-B DCMR § 2815 CLINICAL LABORATORY SERVICE

2815.1 Clinical laboratory services in pediatric trauma care facilities shall be available twenty-four (24) hours per day for the following:

(a) Standard analyses of blood, urine, and other body fluids;

(b) Blood typing and cross-matching;

(d) Comprehensive blood bank or access to a community central blood bank and adequate storage facilities;

(e) Blood gases and potential of Hydrogen (pH) determinations;

(f) Microbiology; and

(g) Repealed.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8779 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3933 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7277 (July 23, 2004).

22-B DCMR § 2816 REHABILITATION MEDICINE

2816.1 Each pediatric trauma care facility shall have a physician-directed rehabilitation service program staffed by personnel trained in rehabilitation care and equipped properly for the care of the critically injured patient, including, at a minimum, the following:

(a) Physical therapy;

(b) Occupational therapy;

(d) Social service.

2816.2 Pediatric trauma care facilities may have transfer agreements with a rehabilitation service for long term care.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8779 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3933 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7277 (July 23, 2004).

22-B DCMR § 2817 PROGRAMS FOR PERFORMANCE IMPROVEMENT

2817.1 Programs for performance improvement in a pediatric trauma facility shall have the following elements:

(a) Trauma registry;

(b) Special audit for all trauma deaths;

(d) Multidisciplinary trauma conference;

(e) Medical nursing audit, utilization review, tissue review;

(f) Review of prehospital trauma care;

(g) Review of times and reasons for transfer of injured patients;

(h) Times of and reasons for trauma-related bypass documentation; and

(i) Quality improvement personnel specifically dedicated to the trauma service program.

2817.2 Quality improvement programs in each pediatric trauma care facility shall be met by establishing the following:

(b) The development of standards of quality care;

(1) Defining the population of trauma patients to whom the standards are applied;

(2) Defining adverse outcomes or deviations from quality (for example, death or complications from injury or treatment);

(3) Defining quality indicators or audit filters that examine the process of care; and

(4) Developing a systematic process for collection, evaluation, and analysis of data that describe or define the process of care and outcome;

(d) A process of peer review to evaluate specific cases or problems identified by the monitoring process. This requires:

(1) Documentation of the process and outcome of peer review; and

(2) Tabulation of the judgments from peer review to provide a basis for trend analysis and to assess the effect of any corrective action;

(e) A process for implementing corrective action to address problems or deficiencies identified by either the monitoring process or the peer-review process; and

(f) A process for reevaluating and documenting the effect of the corrective action taken.

2817.3 A performance improvement program shall consist of the following components:

(a) Standards and organization.

(1) Define the population to be monitored;

(2) Develop standards of care;

(3) Establish credentialing standards for practitioners;

(4) Provide administrative support for the process; and

(5) Designate a responsible surgeon and provide him or her with the appropriate authority to enact the process;

(b) Data collection:

(1) Establish a process for data collection;

(2) Establish quality indicators (audit filters) for the continuous or periodic evaluation of specific aspects of care;

(3) Define adverse outcomes according to an explicit list of well-defined complications; and

(4) Monitor the incidence of adverse outcomes on a regular basis and to compare to regional and national norms;

(1) Establish a systematic peer-review process using multiple disciplines for the continuous or periodic evaluation of tended data, sentinel events, or specific cases; and

(2) Provide written documentation of identified problems and opportunities to correct the problem and improve care;

(d) Corrective action:

(1) Define corrective actions needed to address problems identified in the analysis;

(2) Implement corrective action;

(3) Assess the effect of the corrective action; and

(4) Periodically reassess or monitor the effectiveness of the action to document improvements and define future objectives.

2817.4 In each pediatric trauma care facility, the governing body of a hospital has the ultimate authority and responsibility to provide for the delivery of quality patient care.

2817.5 Each pediatric trauma care facility shall have a designated clinician with authority, responsibility, and accountability for the assessment and improvement of quality of care.

2817.6 In Level I and Level II facilities, the Trauma Service Director shall be responsible for performance improvement.

2817.7 Repealed.

2817.8 In each pediatric trauma care facility, standards of quality care shall emphasize the outcome of care and the process by which it is rendered. To ensure quality care, trauma facilities and trauma systems shall deliver services that shall be:

(a) Composed of systematic actions designed to improve the health of the patient;

(b) Rendered in a timely fashion, relative to the severity of the illness;

(d) Provided to a completely informed patient so that the patient can be knowledgeable, cooperative, and participate in health care decisions;

(e) Based on sound scientific principles and standards;

(f) Provided with sensitivity and concern for the patient and his or her family;

(g) Rendered with a cost-efficient use of available technology; and

(h) Accurately documented in the patient's medical record.

2817.9 Elements critical to the consistent delivery of quality care in pediatric trauma facilities include:

(a) Delineation of privileges to limit trauma care duties to those with demonstrated skills, commitment, and experience;

(b) Reevaluation of privileges and reappointment to the trauma team shall be based on the following criteria:

(1) Maintenance of good standing in the primary specialty;

(2) Evidence of continuing education in trauma care;

(4) Satisfactory performance in managing trauma patients based on performance assessment and outcome analysis;

(d) A surveillance program, including at a minimum all trauma patients who:

(1) Are admitted to the hospital for more than two (2) days;

(2) Are admitted to an pediatric intensive care unit or operating room;

(3) Are transferred into or out of the hospital; and

(4) Die as a result of trauma injuries;

(e) Autopsy information, including complete anatomical diagnosis of injury to assess quality of care. A postmortem examination shall be performed in all trauma-related deaths.

2817.10 Continuous audits, periodic focused audits, specific case review, and trend analysis shall be available to evaluate the process of care in order to review outcome. Deaths and major complications shall have specific case review. Complications may be monitored by trend analysis, which requires determining the incidence of the complication over a given interval (for example, monthly or quarterly) and following the incidence over subsequent intervals. Changes in trends or unexpected variations should provoke a focused audit of the patient developing the complication.

2817.11 The requirements of § 2817.10 shall be carried out as follows:

(a) Audit filters shall be used to examine the timeliness, appropriateness, and effectiveness of care rendered to an individual patient. The value of continuous or periodic use of these filters in the quality improvement program shall be reviewed regularly by individual trauma facilities. Minimum filters to be applied include the following:

(1) Repealed.

(2) Repealed.

(3) Repealed.

(4) Repealed.

(5) Repealed.

(6) Repealed.

(7) Repealed.

(8) Repealed.

(9) Repealed.

(10) Repealed.

(11) Selected complications, monitored as either trends or sentinel events. Trauma Service Directors shall select those complications for audit and review those complications that are frequent or severe in their cohort of trauma patients; and

(12) All trauma deaths;

(b) A focused audit shall be used periodically to examine the process of care.

(1) Repealed.

(2) Repealed.

(3) Repealed.

(4) Repealed.

(5) Repealed.

(c) The Trauma Score/Injury Severity Score (TRISS) method shall be used to estimate the likelihood of patient survival based on a regression equation that takes into account:

(1) Patient age;

(2) The severity of anatomical injury as measured by the Injury Severity Score (ISS);

(3) The physiological status of the patient on admission based on the Revised Trauma Score (RTS); and

(4) The type of injury (blunt or penetrating);

(d) An internal review shall be conducted to identify patients to receive an in-depth peer review and audit. The in-depth review shall include charts of nonsurvivors who were expected to survive;

(f) A multidisciplinary trauma peer-review committee shall meet regularly. The committee shall be chaired by the Trauma Service Director and have representation from all of the major services that treat trauma patients. The task of the committee is to conduct critical reviews, evaluate, and discuss the quality of care in cases of adverse outcome (complications and deaths), particularly focusing on those deaths statistically expected to survive, which were identified using outcome norms; and

(1) Change of existing policies and procedures that govern or define the standard of care;

(2) Professional education: cases may be selected for discussion at the trauma service morbidity/mortality review conference; deficits in knowledge can be addressed through education of the whole group of providers or of specific providers;

(3) Physician counseling: review of a special case or cases is made by the Trauma Services Director with the individual physician; the process of evaluation and counseling shall be carefully documented; and

(4) Credentialing process: information from quality improvement activities shall considered at the time of credentialing and in the delineation of privileges; serious deficits may result in the limitation of privileges or the failure to be reappointed in the discretion of the Trauma Services Director.

2817.12 In addition to the requirements set out in § 2817.1 (a), pediatric trauma care facilities shall have a Trauma Registry that provides accurate data describing patient injury severity, process of care, and outcomes.

2817.13 To satisfy the requirements of §2817.11(g) a pediatric trauma facility shall establish a multidisciplinary review committee, which shall have a quorum of a majority of the members at each meeting. The multidisciplinary review committee shall consist of the following members:

(a) Chairperson - Trauma Service Director;

(b) Trauma nurse coordinator;

(d) A representative from orthopedic surgery;

(e) A representative from emergency medicine;

(f) A representative from anesthesiology;

(g) A staff pathologist;

(h) A staff radiologist; and

(i) A representative from rehabilitation medicine.

2817.14 The goals of a multi-disciplinary review committee shall be as follows:

(a) Review selective deaths;

(b) Review complications;

(d) Review organizational issues regularly and systematically.

2817.15 The objectives of this multi-disciplinary peer review committee shall be as follows:

(a) To identify and resolve problems or specific issues that need to be rectified; and

(b) Trigger new policies or protocols and have the representatives from the various departments listed in § 2817.13 transmit this information back to their respective departments.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8779 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3933 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7277 (July 23, 2004).

22-B DCMR § 2818 TRANSFER AGREEMENTS

2818.1 Level I facilities shall have transfer agreements with other hospitals acting as receiving facilities.

2818.2 Level II facilities shall have transfer agreements as transferring and receiving facilities.

2818.3 Once it is apparent that interhospital transfer is in the patient's best interest, the treating physician shall ensure that the patient is optimally stabilized within the capabilities of the transferring institution. Measures shall be taken to stabilize each injury or physiologic derangement, such as respiratory distress or shock, before the transfer. The urgent needs of the patient who requires advance level trauma care shall supersede the requirement that patients be cared within a specific provider network.

2818.4 Transferring physician responsibilities shall include:

(a) Identifying the patient needing transfer;

(b) Initiating the transfer process by direct contact with the receiving surgeon or physician;

(d) Determining the appropriate mode of transportation in consultation with the receiving surgeon or physician; and

(e) Transferring all records, results, and x-rays to the receiving facility.

2818.5 Receiving physician responsibilities shall include:

(a) Ensuring resources are available at the receiving facility;

(b) Providing advice or consultation regarding specifics of the transfer or additional evaluation or resuscitation prior to transport;

(d) Identifying a process for transportation, allowing feedback from the receiving physician to the transport team directly or to the medical direction of the transport team.

2818.6 Management during transport of patient:

(a) Qualified personnel and equipment shall be available during transport to meet anticipated contingencies;

(b) Sufficient supplies shall accompany the patient during transport, such as intravenous (IV) fluids, blood, and appropriate medications;

(d) Vital functions shall be supported; for example, hemodynamics, ventilation, central nervous system, and spinal protection;

(e) Records shall be kept during transport; and

(f) Communication shall be kept with on-line medical direction during transport.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8779 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3933 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7277 (July 23, 2004).

22-B DCMR § 2819 RESERVED

22-B DCMR § 2820 CONTINUING EDUCATION

2820.1 A formal program for Continuing Medical Education (CME) specifically addressing pediatric trauma care shall be provided by the hospital for the following personnel:

(a) General surgery residency program participants;

(b) Advanced Trauma Life Support (ATLS) providers;

(1) Staff or community physicians CME;

(2) Nurses;

(3) Allied health personnel; and

(4) Prehospital personnel.

2820.2 The Trauma Service Director shall demonstrate educational involvement in trauma by active participation as an instructor for the American College of Surgeons (ACS) of an ATLS course.

2820.3 General surgeons on the trauma team shall successfully complete the ACS ATLS Course.

2820.4 All members of the trauma team shall have at least sixteen (16) hours of trauma-related CME training annually. Fifty percent (50%) of these hours during any three (3) -year period shall be obtained outside the surgeon's own institution.

2820.5 Emergency physicians on the trauma team shall have at least sixteen (16) hours of trauma-related CME training each year. Trauma CME credit may be earned by attending regional or national meetings concerning trauma-related issues and from in-house conferences, such as grand rounds and multidisciplinary conferences. Fifty percent (50%) of these hours during any three (3) year period shall be obtained outside the physician's own institution.

2820.6 Neurosurgical members of the trauma team at Level and II facilities shall have at least sixteen (16) hours of trauma-related CME. Fifty percent (50%) of these hours during any three (3) year period shall be obtained outside the surgeon's own institution.

2820.7 Orthopedic surgical members of the trauma team at Level I and II facilities shall have at least sixteen (16) hours of trauma-related CME annually. Fifty percent (50%) of these hours during any three (3) year period shall be obtained outside the surgeon's own institution.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8779 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3933 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7277 (July 23, 2004).

22-B DCMR § 2821 OUTREACH PROGRAM

2821.1 Each pediatric trauma care facility shall be available for telephone and on-site consultations with physicians in the community and surrounding area regarding the care and treatment of trauma patients.

2821.2 Each Level I facility shall conduct at least twelve (12) education or outreach presentations over a three (3) year period.

2821.3 Each Level II facility may conduct at least twelve (12) education or outreach presentations over a three (3) year period.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8779 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3933 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7277 (July 23, 2004).

22-B DCMR § 2822 PEDIATRIC TRAUMA EDUCATION

2822.1 Level I facilities shall undertake the following public education activities:

(a) Perform epidemiology research to include:

(1) Conducting studies in injury control;

(2) Collaborating with other institutions in epidemiological research;

(3) Monitoring the progress of prevention programs; and

(4) Consulting with qualified researchers on evaluation measures.

(b) Conduct trauma injury surveillance including:

(1) Conducting special emergency department and field collection projects;

(2) Maintaining an expanded trauma registry data; and

(1) Designating a trauma prevention coordinator);

(2) Conducting outreach activities and program development;

(3) Providing information resources and submission of results to the District of Columbia Department of Health; and

(4) Collaborating with existing national, regional, and state programs.

2822.2 Level II facilities shall conduct the following prevention and public education activities:

(a) Maintain injury surveillance and trauma registry data;

(b) Establish an injury prevention program, including:

(1) Designating a trauma prevention coordinator;

(2) Conducting outreach activities and program development;

(3) Providing information resources; and

(4) Collaborating with existing national, regional and state programs.

2822.3 Level II facilities may conduct:

(a) Epidemiology research, including but not limited to:

(1) Conducting studies in injury control;

(2) Collaborating with other institutions in research;

(3) Monitoring progress of prevention programs; and

(4) Consulting with qualified researchers on research evaluation measures;

(b) Injury Surveillance to include:

(1) Special emergency department and field collection project; and

(2) Expanded trauma registry data.

2822.4 In Level I facilities, the requirements of § 2822.1 (a)(4) shall be met by making an epidemiologist or biostatistician available.

2822.5 In Level I facilities requirements of § 2822.1 (b)(1) shall be met by including the capability of doing special data collection projects as needed.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8779 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3933 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7277 (July 23, 2004).

22-B DCMR § 2823 TRAUMA RESEARCH PROGRAM

2823.1 Level I facilities shall have a trauma research program designed to produce new knowledge applicable to the care of injured trauma patients. This research may be conducted in a number of ways, including traditional laboratory and clinical research, reviews of clinical series, and epidemiological or other studies.

2823.2 A trauma research program shall have an organizational structure that fosters and monitors consistent publication of articles focused on trauma related issues in peerreviewed journals.

2823.3 A Level I facility shall periodically present research results at local, regional, and national society meetings and conduct ongoing studies approved by local human and animal research review boards. Each Level I facility shall demonstrate research productivity to include at least ten (10) peer-reviewed publications over a three (3) year period. These publications may pertain to any aspect of the trauma program.

2823.4 In Level I facilities, the trauma research program shall have an organized program with a designated director. The research group shall meet on a regular basis and there shall be evidence of productivity identified as proposal review by the Institutional Review Board, presentations at local/regional/national meetings, and publications in peerre-viewed journals.

2823.5 Level II facilities may have a trauma research program.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8779 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3933 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7277 (July 23, 2004).

22-B DCMR § 2824 DISASTER PLAN

2824.1 Each pediatric trauma care facility shall develop a disaster plan.

2824.2 Each pediatric trauma care facility shall have a plan that differentiates between multiple casualty situations, in which five to forty (5 to 40) victims are involved, and disasters leading to mass casualties. A treatment plan shall be in place to deal with multiple casualties as opposed to a widespread disaster where all hospitals in the area may be involved

2824.3 To develop a successful facility disaster plan, a facility shall:

(a) Document the potential disasters for the region;

(b) Develop a flexible protocol for response to each of these disasters by an organized, logical, and realistic plan in accordance with existing local EMS systems;

(d) Practice, evaluate, and update the disaster response plan on a regular basis; and

(e) Educate the public about proper responses to disasters.

2824.4 Each pediatric trauma care facility shall participate in a local and regional disaster plan by ensuring that its activities and resources for responding to the trauma needs of the community are incorporated into the plan.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8779 (October 29, 1999).

22-B DCMR § 2825 ORGAN PROCUREMENT ACTIVITY

2825.1 Each pediatric trauma care facility shall have an Organ Donation and Transplantation Program.

2825.2 Each pediatric trauma care facility shall develop policies and procedures for ensuring access to information on the option to donate organs.

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8779 (October 29, 1999).

22-B DCMR § 2899 DEFINITIONS

2899.1 For the purposes of this chapter, the following words and phrases shall have the meaning described:

Audit Filters - clinical indicators used to examine the process of care and to identify potential patient-care problems.

Burn Service - the patient care team based in a hospital, and designed to treat patients with diverse degrees of burns.

Certificate of Added Qualifications in Surgical Critical Care - recognition of specialized education in surgical critical care by the American Board of Surgery.

Emergency Medical System EMS - the arrangement of personnel, facilities, and equipment for the effective and coordinated delivery of emergency care required to prevent and manage incidents that occur from a medical emergency or from an accident, natural disaster, or similar situation.

Glasgow Coma Scale - scoring system that defines eye, motor and verbal responses in the patient with injury to the brain.

Immediately available - implies the physical presence of the health professional in a stated location at the time of need by the trauma patient.

Injury Severity Score - the sum of the squares of the Abbreviated Injury Scale Scores of the three most severely injured body regions.

Revised Trauma Score - a prehospital/emergency center scoring system in which numerical values are assigned to differing levels of Glasgow Coma Scale, systolic blood pressure, and respiratory rate.

Trauma patient - a patient suffering injuries as a result of physical trauma.

Trauma Registry - database to provide information for analysis and evaluation of the quality of patient care, including epidemiological and demographic characteristics of trauma patients.

Trauma Score/Injury Severity Score or TRISS - the likelihood of patient survival based on a regression equation that includes patient age, injury severity score, revised trauma score, and the type of injury (blunt or penetrating).

History

SOURCE: Notice of Final Rulemaking published at 46 DCR 8779 (October 29, 1999); as amended by Notice of Emergency and Proposed Rulemaking published at 51 DCR 3933 (April 16, 2004) [EXPIRED]; as amended by Final Rulemaking published at 51 DCR 7277 (July 23, 2004).

22-B29 PUBLIC HEALTH LABORATORY

22-B DCMR § 2900 PUBLIC HEALTH LABORATORY FEES

2900.1 The following fees shall be for the services and supplies provided by the District of Columbia Public Health Laboratory and shall have discounted fees for bulk services:

Test Service Category

Fee

Immunology

Syphilis EIA

$ 3.00

Syphilis RPR

3.00

Syphilis FTA

10.00

HIV serum

10.00

HIV serum western blot

34.00

Ora-sure HIV

6.00

Ora-sure western blot

35.00

Herpes-1

9.00

Herpes-2

9.00

Hepatitis B panel (not including confirmation)

28.00

Surface antigen

13.00

Surface antigen confirmation

20.00

Surface antibody

8.00

Core antibody

13.00

Hepatitis A lgM

13.00

Hepatitis A total

13.00

Hepatitis C lgG

14.00

Rabies (nonpriority)

100.00

Rabies (priority)

Hematology

Complete blood count (CBC)

4.00

Microscopic Differential (Diff)

4.00

Urinalysis

4.00

Complete urinalysis (microscopic indicated)

5.00

Sedimentation rate

4.00

Clinical chemistry

SMAC 7

8.00

SMAC 12

12.00

SMAC 20

20.00

Liver profile

7.00

Electrolyte profile

6.00

Lipid profile

20.00

Coronary profile

10.00

Clinical Microbiology

STD Smear culture identification

30.00

STD Culture confirmation (DNA)

30.00

STD Drug Susceptibility testing

30.00

Chlamydia swab (DNA)

20.00

Gonorrhea swab (DNA)

20.00

Gonorrhea culture (JEMBEC)

20.00

Environmental Surveillance

Blood lead screening

11.00

Lead in dust

11.00

Environmental Microbiology

Food culture and identification

60.00

Bacterial drinking water analysis

30.00

Cryptosporidium

20.00

Giardia lamblia

60.00

The foregoing testing services are eligible for bulk discounts provided that the specimens submitted for testing and for which a bulk discount is requested are for the same test. A twenty per cent (20%) bulk discount shall apply for tests of a minimum of one hundred and one (101) up to five hundred (500) specimens. A thirty per cent (30%) discount shall apply for tests of a minimum of five hundred and one (501) and up to one thousand (1000) specimens. A thirty-five per cent (35%) discount shall apply for a minimum of one thousand and one (1001) specimens.

The following additional tests, which are not eligible for bulk discounts, can be provided through the Public Health Laboratory from other providers:

Other testing services

CD4/CD8 ratio (HIV)

$ 200.00

Epstein-Barr virus

150.00

HIV viral load progressive

450.00

HIV viral load ultra

500.00

Test Service Category

Fee

Diagnostic Immunology

Toxoplasma Gondii (Toxo)

$ 11.00

Rubeola

14.00

Rubeola IgM

28.00

Rubella

14.00

Rubella IgM

28.00

Varicella

13.00

Mumps

18.00

Clinical Chemistry

Serum pregnancy

7.00

Urinalysis

Urine pregnancy

7.00

Substance Abuse Panel

Amphetamines

Barbiturates

Cocaine

Methadone

Opiates

PCP

THC

8.00

Public Health Laboratory forms

Laboratory request forms per 100

50.00

HIV laboratory request forms per 100

30.00

Premarital blue cards (DHR 366) each

10.00

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 3693 (April 19, 2002); as amended by Notice of Final Rulemaking published at 50 DCR 995 (January 31, 2003).

22-B30 CENTRAL REFERRAL BUREAU; HEALTH CARE FEES

22-B DCMR § 3000 [RESERVED]

EDITOR’S NOTE: The Notice of Final Rulemaking published at 39 DCR 5098 (July 10, 1992) deleted former §§3000 - 3017, which regulated Health Care and Community Residence Facilities. Accordingly, this chapter has been renamed “Central Referral Bureau; Health Care Fees” to more accurately reflect its current, remaining subject matter.

The previously-cited Notice also replaced former Chapter 31 of this title in its entirety. Please refer to current Chapter 31 for provisions regulating the licensure of Health Care and Community Residence Facilities.

22-B DCMR § 3001 [RESERVED]

22-B DCMR § 3002 [RESERVED]

22-B DCMR § 3003 [RESERVED]

22-B DCMR § 3004 [RESERVED]

22-B DCMR § 3005 [RESERVED]

22-B DCMR § 3006 [RESERVED]

22-B DCMR § 3007 [RESERVED]

22-B DCMR § 3008 [RESERVED]

22-B DCMR § 3009 [RESERVED]

22-B DCMR § 3010 [RESERVED]

22-B DCMR § 3011 [RESERVED]

22-B DCMR § 3012 [RESERVED]

22-B DCMR § 3013 [RESERVED]

22-B DCMR § 3014 [RESERVED]

22-B DCMR § 3015 [RESERVED]

22-B DCMR § 3016 [RESERVED]

22-B DCMR § 3017 [RESERVED]

22-B DCMR § 3018 NEIGHBORHOOD HEALTH CLINIC FEES

3018.1 The following fees shall be for the services provided by the Neighborhood Health Centers, and shall have the sliding fee scale, set forth at §3018.2, for patients who are not covered by Medicaid, Medicare, or any other third party insurance and whose annual gross family incomes fall within the ranges of the sliding scale. These rates shall not apply to those persons who are receiving assistance under title VII of the D.C. Public Assistance Act of 1982, D.C. Code, 2001 Ed. §§4-207.01 to 4-207.04, and who do not receive assistance under Medicaid:

Service Category

Fee

Acrylic or Plastic Restoration

Acrylic or plastic restoration, Class III

$ 16.00

Acrylic or plastic restoration, Class V

12.00

Esthetic restoration, including angle

20.00

Alveoloplasty (surgical preparation of ridge for dentures)

Alveolectomy with extraction

$ 55.00

Alveolectomy without extraction

75.00

Cardiology

Follow-up visit

25.00

Initial visit

75.00

Crowns - Single Restoration Only

Acrylic jacket

72.00

Dowel crown

120.00

Gold full cast

94.00

Stainless steel crown

31.00

Temporary crown

17.00

Veneer crown

94.00

Dental - Diagnostic

Full mouth x-ray series

22.00

Occlusal x-ray

8.00

Periapical x-ray, one film

4.00

Periapical x-ray, two films

7.00

Periapical x-ray, three films

8.00

Endodontics

Pulp capping

8.00

Pulpotomy

16.00

Root Canal

One Canal; excludes final restoration

75.00

Two Canals; excludes final restoration

96.00

Three Canals; excludes final restoration

116.00

Family Planning

Follow-up visit

40.00

General Medicine

Follow-up /return/acute care visit

40.00

Initial visit (comprehensive medical evaluation

75.00

including complete history, review of medical

records, complete physical examination,

laboratory testing and appropriate prescriptions)

Nursing Home Visit

32.25

Obstetrics/Gynecology

Acute care visit

$ 40.00

Follow-up visit

40.00

Initial visit

60.00

Oral Surgery

Complicated extraction

Extraction of tooth, erupted

30.00

Extraction of tooth, soft tissue impaction

45.00

Extraction of tooth, partial bony impaction

59.00

Extraction of tooth, complete bony impaction

65.00

Root tips

25.00

Simple extraction (per tooth)

11.50

Surgical exposure of bony impaction

45.00

Other Restorative Services

10.00

Orthodontics

Appliances to control harmful habits

75.00

Pediatrics

Acute care visit

40.00

Adolescent or athletic exam

50.00

Follow-up visit

40.00

Periapical Services

Apicoectomy

52.00

Periapical curettage

34.00

Periodontics

Adjunctive services

Deep scaling

25.00/quad

Advanced periodontitis

Vincents treatment

50.00

Nonsurgical services

Subgingival curettage, root

50.00/quad

Surgical services

Gingivectomy or gingivoplasy

100.00/quad

Podiatry

Follow-up visit

20.00

Initial visit/comprehensive

40.00

Postpartum OB

Follow-up visit

40.00

Acute

40.00

Prenatal OB

Follow-up/Returns

$ 40.00

Acute

40.00

Preventive

Dental Prophylaxis

Prophylaxis, mouth exam, fluoride application,

bitewings, oral hygiene instruction

25.00

Prophylaxis, under age 15

7.00

Prophylaxis, age 15 and over

10.00

Florida treatment

8.00

Space maintainers

Fixed, band type

75.00

Lingual archwire

75.00

Space maintainer, removable

59.00

Prostodontics

Additional clasps for partial dentures

25.00

Adjustment denture

10.00

Complex denture repair

35.00

Full denture1

100.00

Partial denture1

150.00

Simple denture repair

12.00

1 This fee represents the maximum charge for this service regardless of the number of treatment sessions required to complete dentures plus two (2) visits for adjustments.

Prosthodontics, Fixed

Amalgam build-up

35.00

Reduction of Dislocation

60.00

Restorative

Amalgam restoration (including polishing)

Amalgam restorative pit, one surface

6.00

Amalgam restoration, two pits

9.00

Amalgam one surface, deciduous

10.00

Amalgam two surfaces, deciduous

14.00

Amalgam three surfaces

21.00

Amalgam four surfaces

27.00

Amalgam one surface, permanent

10.00

Amalgam two surfaces, permanent

14.00

Amalgam three surfaces, permanent

21.00

Amalgam four surfaces, permanent

$ 27.00

Pin reinforced

6.00

Specialized Clinics

Physician services - comprehensive

50.00

(comprehensive medical evaluation, diagnosis

and treatment for allergic, ophthalmologic

and dermatologic complaints)

Physician services - Limited

25.00

(Re-evaluation and treatment for a special

complaint as defined above)

Services performed by ancillary professionals

20.00

not under the supervision of the physician

such as nutritional and social work counseling services

Specialized Services

Allergy F-U

40.00

Chest F-U

40.00

Dermatology F-U

40.00

Hearing F-U

40.00

Occ. Therapy F-U

40.00

Ophthalmo F-U

40.00

Psych. F-U

40.00

Phys. Therapy F-U

40.00

Speech F-U

40.00

Surgical Incision

Curettage of fistulous tract

15.00

Incision/Drainage abscess intraoral

25.00

Incision/Drainage, extraoral

65.00

3018.2 The sliding fee schedule applicable to self-pay patients for the services described in §3018.1 and certain other services provided by the Department of Human Services shall be as follows:

Department of Human Services Sliding Fee Schedule

22-B DCMR § 3019 HOME CARE SERVICES BUREAU FEES

3019.1 Fees for the health care services provided by the Home Care Services Bureau are as follows:

Service Category

Fee/Visit

Health Aides

$ 54.50

Nurses

62.00

Physical Therapists

58.00

Physicians

135.00

Podiatrists

71.00

Social Workers

71.50

3019.2 The fees set forth in §3019.1 shall be billed as follows: to Medicaid / Medicare and third-party insurers for full reimbursement; and to self-pay patients, on the basis of income, according to the sliding fee schedule used by the Department of Human Services for other fees, set forth at §3018.2. The above rates will not apply to those persons who are receiving assistance under title VII of the District of Columbia Public Assistance Act of 1982, D.C. Code, 2001 Ed. §§4-207.01 to 4-207.04, and who do not receive assistance under Medicaid.

History

SOURCE: Final Rulemaking published at 31 DCR 6493 (December 21, 1984); as amended by Final Rulemaking published at 32 DCR 6565 (November 15, 1985). EDITOR’S NOTE: Title VII of the District of Columbia Public Assistance Act of 1982, D.C. Code, 2001 Ed. §§4-207.01 to 4-207.04, referenced in §3019.2, was repealed by D.C. Law 10-253 §502(f).

22-B DCMR § 3020 CENTRAL REFERRAL BUREAU

3020.1 The Mayor shall establish a Central Referral Bureau which shall have the functions provided in this section.

3020.2 The Central Referral Bureau shall keep and make available to the public an accurate and current listing of all licensed skilled care, intermediate care, and community residence facilities in the District, indexed according to their classification, location, size, admission restrictions, the ratings assigned them by the Central Referral Bureau, and their most recent occupancy reports.

3020.3 The Central Referral Bureau shall develop, in cooperation with District medical associations, nurses’ associations, pharmaceutical associations, associations of nursing home directors and community residence facility residence directors, mental health associations, associations for retarded persons, senior citizens’ associations, and any other interested community associations, criteria and a monitoring system for rating licensed facilities based on the excellence with which they perform their recognized functions.

3020.4 The Central Referral Bureau shall not be responsible for any assessments that are normally the responsibility of District licensing authorities.

3020.5 The Central Referral Bureau shall keep on file for public inspection the following records concerning each licensed facility:

(a) For community residence facilities only, the community residence facility’s program statement required under §3413 of chapter 34;

(b) The facility’s current charges;

(d) The facility’s current occupancy level reports;

(e) The Central Referral Bureau’s rating of the facility according to the Bureau’s criteria and the basis upon which the rating is made; and

(f) A written summary of any complaints made about the facility to the Central Referral Bureau together with the results of any investigations of the complaints and any responses from a facility concerning the complaints.

3020.6 The Central Referral Bureau shall recommend placements in community residence facilities for the following:

(a) All persons seeking such living arrangements who are receiving a supplement to their Supplementary Security Income from the District;

(b) All persons who are receiving general public assistance from the District;

(c) All persons who are on convalescent leave from Saint Elizabeth’s Hospital, if their hospitalization was paid for in part by the District; and

(d) Any other persons to whom the District is responsible for the cost of their care and maintenance.

3020.7 Recommended placements shall be based on an evaluation of the applicant’s physical, mental, and social needs made by a team of physicians, nurses, social workers, and other professional and paraprofessional personnel made available to the Central Referral Bureau for that purpose.

3020.8 The Central Referral Bureau shall be responsible for certifying that a person is eligible for the supplementation of his or her Supplementary Security Income by the District government.

3020.9 The Central Referral Bureau shall recommend placements in specific skilled care, intermediate care, or community residence facilities for any other person seeking such living arrangements at the request of the prospective resident or his or her next of kin, doctor, or sponsor.

3020.10 Placement recommendations shall be based on evaluations of the prospective resident’s physical, mental, and social needs as determined by the prospective resident’s own physician or the professionals made available to the Central Referral Bureau by the District government.

3020.11 For persons having no access to private or institutional social service assistance in actual placement in the facility, the Central Referral Bureau shall arrange assistance.

3020.12 The Central Referral Bureau shall charge a fee for its service that takes into account the income and resources of the prospective resident.

3020.13 The Central Referral Bureau shall advise the public, through the mass media and other reasonable means, of its functions.

3020.14 The Central Referral Bureau shall receive complaints from residents, prospective residents, next of kin, sponsors of residents (if any), and other interested persons about skilled, intermediate, or community residence facilities and, after an initial screening of the complaint, shall refer those complaints to the proper District official.

3020.15 The Central Referral Bureau’s conclusion as to the validity of any complaints shall be made known in writing to the residence director of the facility involved, if any, and the appropriate District licensing authority.

3020.16 The Central Referral Bureau shall reassess the placement of each resident of a community residence facility who is described in §3020.6 periodically as it deems necessary, but in no case less often than once every two (2) years, for the purpose of determining whether the community residence facility in which the resident resides is able to meet his or her physical, mental, and social needs within the limits of its license.

3020.17 The reassessment by the Central Referral Bureau shall be based on the following:

(a) Records required to be kept by the facility under §§3410 through 3412 and §3440 of this title when applicable;

(b) Any additional information solicited or received by the Central Referral Bureau from the resident, his or her sponsor (if any), personal physician, and the residence director; and

(c) Any reevaluation of the resident’s physical, social, and mental needs made by professionals available to the Central Referral Bureau that the Bureau may request to be made.

3020.18 The Central Referral Bureau shall be responsible for the development of training programs as deemed necessary for the administrators, residence directors, and other community residence facility staff in order to provide pertinent information concerning the following:

(a) Nutrition;

(b) Aspects of mental health, mental retardation, and aging;

(d) Social and recreational programming; and

(e) Administration and financial management.

3020.19 Nothing in this section shall preclude an institution or a social service agency from maintaining its own placement and monitoring arrangements with community residence facilities.

History

AUTHORITY: The authority for this section is Reorganization Plan No. 3 of 1967 §402, 1 D.C. Code, 2001 Ed. at 125.
SOURCE: Community Residence Facilities Licensure Act of 1977 §401, D.C. Law 2-35, 24 DCR 1458, 1516 (August 19, 1977).

22-B DCMR § 3021 CRIPPLED CHILDREN’S CLINICAL SERVICES FEES

3021.1 The following rates shall be for clinical services provided under the Crippled Children’s Program:

Description of Service

Compre-hensive*

Intermediate Follow-up / Consultation

Limited*

Brief*

Screening*

Other

Pediatrics

$ 90.00

$ 55.00

$ 38.00

$20.00

None

Orthopedics

90.00

55.00

38.00

20.00

None

Neurology

90.00

55.00

38.00

20.00

None

Cardiology

90.00

55.00

38.00

20.00

None

Neurogenic Bladder

90.00

55.00

38.00

20.00

None

Ophthalmology

90.00

55.00

38.00

20.00

None

Plastic Cleft Palate

90.00

55.00

38.00

20.00

None

Developmental Evaluations

90.00

55.00

38.00

20.00

None

Psychological Services

90.00

None

60.00

40.00

None

Audiology Services

90.00

None

50.00

20.00

$ 15.00

Speech Pathology

90.00

None

50.00

20.00

15.00

Physical Therapy

90.00

None

38.00

20.00

15.00

Occupational Therapy

90.00

None

38.00

20.00

15.00

Social Services

50.00

25.00

None

Hearing Aid Evaluation

$ 60.00

Hearing Aid Issuance

Monaural

450.00

Binaural

900.00

Per visit

** Not applicable

3021.2 Fees for crippled children’s clinical services shall be billed to Medicaid and third-party insurers for full reimbursement, and self-pay patients, on the basis of income according to the sliding fee schedule under §3018.

History

AUTHORITY: The authority for this section is the Fees for Clinical Services and Asbestos Abatement Act of 1984, D.C. Code, 2001 Ed. §44-731.
SOURCE: Final Rulemaking published at 32 DCR 3835 (July 5, 1985).

22-B DCMR § 3022 THE ADULT DAY TREATMENT PROGRAM FEES

3022.1 The fee for the Adult Day Treatment Program shall be sixty-eight dollars ($68.00) per day. This fee shall become effective on October 1, 1985.

3022.2 The fee cited in §3022.1 shall be billed to Medicaid/Medicare and third-party insurers. Self-pay patients who qualify on the basis of income shall pay a percentage of that fee according to the sliding fee scale under §3018, not to exceed ten and one-half percent (10.5%) of the gross family income on an annual basis. This rate shall not apply to those persons who are receiving assistance under title VII of the District of Columbia Public Assistance Act of 1982, D.C. Code, 2001 Ed. §§4-207.01 to 4-207.04, and who do not receive assistance under Medicaid.

History

AUTHORITY: The authority for this section is the Fees for Clinical Services and Asbestos Abatement Act of 1984, D.C. Code, 2001 Ed. §44-731.
SOURCE: Final Rulemaking published at 32 DCR 5109 (September 6, 1985). EDITOR’S NOTE: Title VII of the District of Columbia Public Assistance Act of 1982, D.C. Code, 2001 Ed. §§4-207.01 to 4-207.04, referenced in §3022.2, was repealed by D.C. Law 10-253 §502(f).

22-B DCMR § 3023 REIMBURSEMENT FOR SERVICES TO PERSONS ELIGIBLE FOR D.C. MEDICAL CHARITIES

3023.1 The D.C. Medical Charities rates of reimbursement shall be as follows:

(a) Except as provided below, one hundred and six dollars ($106.00) per day for inpatient hospital services, and seventeen dollars ($17.00) per day for outpatient / emergency room services;

(b) Twenty-eight dollars ($28.00) per day for newborn care in the regular nursery and the premature nursery or the nursery for the care of the sick newborn;

(c) One thousand, one hundred dollars ($1,100.00) per day for discharge diagnoses of trauma under ICD-9 Diagnosis Codes 800 - 959, including burns; and

(d) Not more than forty-five dollars ($45.00) per day for residential drug therapy for patients with tuberculosis.

3023.2 The reimbursement rate set forth in §3023.1(d) shall apply to the following:

(a) Housing;

(b) Meals that are nutritionally appropriate for persons recovering from tuberculosis;

(d) Case management services.

3023.3 [Reserved]

3023.4 Reimbursement under the Medical Charities Program is available only for services provided to a person who meets the following eligibility requirements:

(a) The services to be provided are medically appropriate, as determined by the patient’s attending physician;

(b) The person requesting services has an annual income that is equal to or less than one hundred and eighty-five percent (185%) of the current federal non-farm poverty level and provides documentation of such income;

(d) The person requesting services is a resident of the District of Columbia on the date on which services are sought and can so document, including providing:

(1) For a person more than twenty-one (21) years of age, at least two (2) of the following:

(A) A current bill addressed to the person at an address in the District;

(B) A voter registration card with an address in the District;

(D) A motor vehicle registration certificate issued by the District government;

(E) A copy of a lease or agreement for real property located in the District;

(F) A cancelled check, money order receipt, or other receipt for payment of a mortgage, rent, or real property taxes for real property located in the District;

(G) A certified deed for real property located in the District;

(H) A payment receipt for a utility bill for real property located in the District;

(I) A withholding statement or tax statement for individual income taxes, including, a copy of a District tax return certified by the District Department of Finance and Revenue or a copy of a federal income tax return filed with the United States Internal Revenue Service for the tax year that immediately precedes the date on which services are sought;

(J) A non-driver identification card issued by the District government; or

(K) A Medicaid enrollment card or number; or

(2) For a person less than twenty-one (21) years of age, at least two (2) of the following:

(A) A motor vehicle operator’s permit issued by the District government;

(B) A non-driver identification card issued by the District government;

(C) An original, notarized statement by an adult person over twenty-one (21) years of age, which attests that the adult has personal knowledge that the person under the age of twenty-one (21) is a resident of the District;

(D) A school identification card from a District school; or

(E) A Medicaid enrollment card or number.

3023.5 Services under this program are available on a first-come first-serve basis. The availability of this service shall not be deemed to create or constitute an entitlement or right to payment for services by the District of Columbia government.

3023.6 Reimbursement shall be paid only to a health care provider that:

(a) Has a current provider agreement with the Department of Human Services to provide services to persons who are eligible for assistance through the D.C. Medical Charities Program;

(b) Ensures that each person requesting services consents to the services in writing; and

(c) Is certified by the Commission of Public Health as qualified to provide any residential drug therapy for patients with tuberculosis.

3023.7 Initial and continued funding for financial assistance under this program shall be subject to the annual appropriations for the Medical Charities Program.

History

AUTHORITY: The authority for this section is D.C. Code, 2001 Ed. §44-706; Mayor’s Order 86-37 (March 3, 1986); and Mayor’s Order 99-73 (May 4, 1999).
SOURCE: Final Rulemaking published at 33 DCR 7388 (November 28, 1986); as amended by Final Rulemaking published at 37 DCR 5896 (September 7, 1990); and by Final Rulemaking published at 41 DCR 7675 (November 25, 1994); and by Final Rulemaking published at 46 DCR 7290 (September 17, 1999).

22-B DCMR § 3024 MEDICAL SERVICES AT SHARPE HEALTH SCHOOL

3024.1 The fee for medical services at the Sharpe Health School shall be fifty dollars ($50) per day. No fee shall be charged for those medical services which are “related services” under§602(17) of the Individuals with Disabilities Education Act, as amended, 20 U.S.C. §1401(17).

3024.2 The fee established by §3024.1 shall be billed to Medicaid and third-party insurers.

3024.3 The fee established by §3024.1 shall be billed to self-paying patients, except as provided in §§ 3024.4 and 3024.5.

3024.4 Self-paying patients who qualify on the basis of income shall pay a percentage of the fee according to the sliding fee schedule under §3018.2, not to exceed two percent (2%) of the gross family income on an annual basis.

3024.5 Self-paying patients who are receiving assistance under Title VII of the District of Columbia Public Assistance Act of 1982 (D.C. Code, 2001 Ed. §§4-207.01 to 4-207.04) are exempt from the fee required by §3024.1.

History

AUTHORITY: The authority for this section is the Fees for Clinical Services and Asbestos Abatement Act of 1984, D.C. Code, 2001 Ed. §44-731.
SOURCE: Final Rulemaking published at 38 DCR 2129 (April 12, 1991).
EDITOR'S NOTE: Title VII of the District of Columbia Public Assistance Act of 1982, D.C. Code, 2001 Ed. §§ 4-207.01 to 4-207.04, referenced in § 3024.5, was repealed by D.C. Law 10-253 § 502(f).

22-B DCMR § 3025 COMMISSION ON MENTAL HEALTH SERVICES FEES

3025.1 The following fees shall apply to mental health services:

Description of Service

Fee

Inpatient care

$225.71 per diem

Outpatient care

Clinic visit

56.36 per visit

Physician visit

79.67 per visit

3025.2 The fees in §3025.1 shall be billed to Medicaid, Medicare and third party insured. Self-pay patients who qualify on the basis of income shall pay a percentage of those fees according to the sliding fee scale below:

Monthly Income

Charge Per Visit

Monthly Maximum

$ 0 to 830

$ 0

831 to 1,040

1,041 to 1,250

1,251 to 1,460

1,461 to 1,670

1,671 to 1,880

1,881 to 2,090

100

2,091 to 2,300

117

2,301 to 2,510

133

2,511 to 2,720

150

2,721 to 2,930

167

2,931 to 3,140

183

3,141 to 3,350

200

3,351 to 3,560

217

3,561 to 3,770

233

3,771 to 3,980

250

3,981 to 4,190

Full

267

4,191 to 4,400

Full

283

4,401 to 4,610

Full

300

4,611 to 4,820

Full

317

4,821 to 5,030

Full

333

5,031 to 5,240

Full

350

5,241 to 5,450

Full

367

5,451 to 5,660

Full

383

5,661 to 5,870

Full

400

5,871 to 6,080

Full

417

6,081 to 6,290

Full

433

6,291 or more

Full

450

History

AUTHORITY: The Authority for this section is D.C. Code, 2001 Ed. §21-586; and the Saint Elizabeth’s Hospital and District of Columbia Mental Health Services Act §9, Pub. L. 98-621.
SOURCE: Final Rulemaking published at 35 DCR 6026 (August 5, 1988).

22-B DCMR § 3026 ALCOHOL AND DRUG ABUSE SERVICES FEES

3026.1 The following fees shall apply to alcohol and drug abuse services:

ALCOHOL AND DRUG ABUSE TREATMENT FEES

FULL CHARGES

TYPE OF SERVICE

DESCRIPTION

FEE

Admission

Processing a client into the APRA treatment system.

$50.00

Evaluation

An in-depth medical (Comprehensive Level) psychological, and social evaluation, including a review of the client’s medical, personal and family history, and the interpretation of appropriate tests for the purpose of developing a comprehensive therapeutic program.

$210.00

Outpatient Treatment

(All Inclusive)

Physician-supervised drug-free ambulatory substance abuse treatment services, including individual counseling, group counseling, psychological vocational rehabilitation, educational and other related services during a single visit day.

$12.00

Methadone Maintenance Treatment Services

(All Inclusive)

Physician-supervised services, including dosage administration, monitoring and adjustment per individual treatment session, group treatment session, and other medical and medically-supervised services provided during a single visit day.

$15.00

Laboratory Testing

Urine analysis and other required studies to document treatment compliance.

$20.00

Inpatient Care

The full range of room and board services attendant to a 24-hour stay in a detoxification facility.

$200.00

Residential-Short Stay

The full range of room and board services attendant to a 24-hour stay in a residential treatment facility where the average length of stay is thirty (30) days or less.

$250.00

Residential-Long Stay

The full range of room and board services attendant to a 24-hour stay in a non-medical, residential treatment facility where the average length of stay is six (6) months or more.

$65.00

Residential-Pregnant Women and Children

The full range of room and board services attendant to a 24-hour stay in a medical residential treatment facility for pregnant women and their children.

$275.00

Transitional Housing

The full range of room and board services attendant to a 24-hour stay in a halfway house facility.

$70.00

Aftercare Vocational Services

Comprehensive vocational assessment and skills training services.

$80.00

Aftercare Community-Based Services

Services provided at community-based centers to assist a client to transition out of formal treatment.

$15.00

3026.2 The fees set forth in §3026.1 shall not be billed to Medicaid or Medicare patients. Third-party insured patients shall be responsible for any applicable co-payment or deductible. Self-pay patients who qualify on the basis of income shall pay a percentage of these fees according to the sliding fee scale below.

ADDICTION, PREVENTION AND RECOVERY ADMINISTRATION

SLIDING FEE SCALE

(CHARGES BASED UPON INCOME AND FAMILY SIZE)

Family

Size

($)

under 6,620

6,620 - 8,827

8,828 - 11,033

11,034 - 13,240

13,241 - 15,240

15,241 - 17,241

17,242 - 19,242

19,243 - 21,243

21,244 - 23,244

23,245 - 25,245

25,246 - 30,246

30,247 - 35,247

over

35,248

under

8,880

8,880 -

11,840

11,841 -

14,800

14,801 -17,760

17,761 - 19,760

19,761 - 21,761

21,762 - 23,762

23,763 - 25,763

25,764 - 27,764

27,765 - 29,765

29,766 - 34,766

34,767 - 39,767

over

39,768

under

11,140

11,140 -

14,853

14,854 -

18,567

18,568 - 22,280

22,281 - 24,280

24,281 - 26,281

26,282 - 28,282

28,283 - 30,283

30,284 - 32,284

32,285 - 34,285

34,286 - 39,286

39,287 - 44,287

over

44,288

under

13,400

13,400 -

17,867

17,868 -

22,333

22,334 - 26,800

26,801 - 28,800

28,801 - 30,801

30,802 - 32,802

32,803 - 34,803

34,804 - 36,804

36,805 - 38,805

38,806 - 43,806

43,807 - 48,807

over

48,808

under

15,660

15,660 -

20,880

20,881 -

26,100

26,101 -31,320

31,321 - 33,320

33,321 - 35,321

35,322 - 37,322

37,323 - 39,323

39,324 - 41,324

41,325 - 43,325

43,326 - 48,326

48,327 - 53,327

over 53,328

under

17,920

17,920 - 23,893

23,894 -

29,867

29,868 - 35,840

35,841 - 37,840

37,841 - 39,841

39,842 - 41,842

41,843 - 43,843

43,844 - 45,844

45,845 - 47,845

47,846 - 52,846

52,847 - 57,847

over 57,848

under

20,180

20,180 -

26,907

26,908 -

33,633

33,634 - 40,360

40,361 - 42,360

42,361 - 44,361

44,362 - 46,362

46,363 - 48,363

48,364 - 50,364

50,365 - 52,365

52,366 - 57,366

57,367 - 62,367

over

62,368

under

22,440

22,440 -

29,920

29,921 - 37,400

37,401 - 44,880

44,881 - 46,880

46,881 - 48,881

48,882 - 50,882

50,883 - 52,883

52,884 - 54,884

54,885 - 56,885

56,886 - 61,886

61,887 - 66,887

over

66,888

under

24,700

24,770 - 32,933

32,934 - 41,167

41,168 - 49,400

49,401 - 51,400

51,401 - 53,401

53,402 - 55,402

55,403 - 57,403

57,404 - 59,404

59,405 - 61,405

61,406 - 66,406

66,407 - 71,407

over

71,408

under

26,960

26,960 - 35,947

35,948 - 44,933

44,934 - 53,930

53,920 - 55,920

55,921 - 57,921

57,922 - 59,922

59,923 - 61,923

61,924 - 63,924

63,925 - 65,925

65,926 - 70,926

70,927 - 75,927

over 75,928

ALCOHOL AND DRUG ABUSE SERVICES ADMINISTRATION

PER VISIT/PER PATIENT DAY

SLIDING FEE SCALE

(ACTUAL FEES BASED ON INCOME AND FAMILY SIZE)

CATEGORY (Ambulatory)

($)

ADMISSION

EVALUATION

(COMPREHENSIVE LEVEL)

105

126

147

168

189

210

OUTPATIENT (ALL

INCLUSIVE EXCLUDING LAB)

METHADONE MAINTENANCE (ALL INCLUSIVE)

LABORATORY TESTING

AFTERCARE AND

VOCATIONAL

22-B DCMR § 3027 [REPEALED]

History

SOURCE: Final Rulemaking published at 44 DCR 5501 (September 26, 1997); as amended by Final Rulemaking published at 60 DCR 5614 (April 12, 2013).

22-B DCMR § 3028 [REPEALED]

History

SOURCE: Final Rulemaking published at 44 DCR 5501, 5502 (September 26, 1997); as amended by Final Rulemaking published at 60 DCR 5614 (April 12, 2013).

22-B DCMR § 3029 [RESERVED]

22-B DCMR § 3030 FOREST HAVEN AND D.C. VILLAGE MEDICAL SERVICES FEES

3030.1 The following are the maximum per diem rates for medical services provided by the Department of Human Services to patients at Forest Haven and D.C. Village:

Type of Care

Fee

Forest Haven Residential

$ 92.00

Forest Haven Intermediate

120.00

D.C. Village Intermediate

108.50

D.C. Village Skilled Nursing

133.50

History

AUTHORITY: The authority for this section is D.C. Code, 2001 Ed. §§1-204.22, 2-551 to 2-562, 47-2717.
SOURCE: Final Rulemaking published at 31 DCR 559 (February 10, 1984).

22-B DCMR § 3031 [RESERVED]

22-B DCMR § 3032 [RESERVED]

22-B DCMR § 3033 [RESERVED]

22-B DCMR § 3034 [RESERVED]

22-B DCMR § 3035 COPAYMENT CHARGES

3035.1 A Medicaid recipient shall pay a copayment as follows:

(a) Prescription drugs - fifty cents ($0.50) per prescription; and

(b) Eyeglasses - two dollars ($2.00) per pair.

3035.2 Services furnished by a health maintenance organization to enrollees and services furnished for purposes of family planning and emergency care shall be excluded from the copayment charges set forth in §3035.1.

3035.3 Copayment charges shall be imposed on both the categorically and medically needy, except for individuals under the age of eighteen (18) years, pregnant women, and persons who reside in institutions.

History

AUTHORITY: The authority for this section is D.C. Code, 2001 Ed. §1-307.02(b); and Mayor’s Reorganization Plan No. 4 of 1996, 3 D.C. Code, 2001 Ed. at 413.
SOURCE: Final Rulemaking published at 44 DCR 5671 (October 3, 1997).

22-B DCMR § 3099 DEFINITIONS

3099.1 When used in this chapter, the following terms shall have the meanings ascribed:

Child find requirements - policies and procedures that the District of Columbia will adhere to in order to identify, locate, and evaluate all infants and toddlers who are eligible for services under Part H of the Individuals with Disabilities Education Act.

Procedural Safeguards - procedures and protections which the District of Columbia must provide to eligible infants, toddlers and their families to ensure that:

(a) Informed consent is received whenever an action is proposed;

(b) A child’s confidentiality is protected;

(d) Prior notice is given to families before an action is taken affecting their child; and

(e) Families have the right to a fair administrative resolution of individual child complaints by an impartial decision maker.

Service Coordination Services - activities carried out by a service coordinator to assist and enable a child who is eligible under Part H and the child’s family to receive the rights, procedural safeguards, and services that are authorized to be provided under the District of Columbia’s Part H, Early Intervention Program.

History

SOURCE: Final Rulemaking published at 44 DCR 5501, 5505 (September 26, 1997).

22-B31 LICENSING OF HEALTH CARE AND COMMUNITY RESIDENCE FACILITIES

22-B DCMR § 3100 GENERAL PROVISIONS

3100.1 The licensing provisions in this chapter apply to health care facilities, except hospitals, covered under the District of Columbia Health Care and Community Residence Facility, Hospice and Home Care Licensure Act of 1983 (the "Act"), effective February 24, 1984, D.C. Code, 2001 Ed. §§44-501 to 44-509.

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is the D.C. Health-Care and Community Residence Facility, Hospice and Home Care Licensure Act of 1983, D.C. Code, 2001 Ed. §§44-501 to 44-509; Mayor's Order 84-105 (June 19, 1984).
SOURCE: Final Rulemaking published at 39 DCR 5098 (July 10, 1992).

22-B DCMR § 3101 RIGHT OF ENTRY AND INSPECTION

3101.1 The Director and any other duly authorized official of the Department of Consumer and Regulatory Affairs (hereinafter, the "Department") or of the District Government having jurisdiction over, or responsibility pertaining to any health care facility, or patient or resident in such facilities shall have the right, after presenting credentials of identification and authority issued by the Director or duly authorized representative, either with or without prior notice, to enter the premises of the following:

(a) A health care facility licensed pursuant to the Act and District government rules;

(b) A facility making application for licensure in order to determine the facility's compliance and verify information; and

(c) Subject to §3101.5, any unlicensed premises which the Director has reason to believe is being operated or maintained as a health care facility or is in violation of the Act.

3101.2 The authorized official shall conduct the entry and inspection with the least possible disruption to the patients.

3101.3 The authorized official shall have access to records, including patient or resident records, to staff, to patients or residents, to policies and procedures, contracts, and any other information necessary to determine the facility's compliance with the Act and District rules.

3101.4 The Director shall not release to the public information concerning the content of a facility's records unless patient or resident names have been deleted.

3101.5 The Director shall not enter or inspect an unlicensed premises without the permission of the owner or person in charge unless a search warrant is first obtained from the District of Columbia Superior Court, pursuant to D.C. Code, 2001 Ed. §11-941, authorizing the entry or inspection for the purpose of determining the applicability of and compliance with the Act and District rules.

3101.6 The Director may refer for appropriate legal action any case involving an unlicensed facility which the director determines is operating as a health care facility.

History

SOURCE: Final Rulemaking published at 39 DCR 5098 (July 10, 1992).

22-B DCMR § 3102 LICENSE REQUIREMENTS

3102.1 Except as otherwise expressly provided in these rules or the Act, no person shall operate or hold himself or herself out as operating, a health care facility in the District of Columbia, whether public or private, profit or not for profit, without being licensed as required by the Act, and these rules.

3102.2 A facility shall submit an application for initial licensure to the Director no later than sixty (60) days prior to the stated date of operation. The license fee shall accompany the application.

3102.3 A facility making application for initial licensure shall obtain a Certificate of Need and a Certificate of Occupancy and shall list approvals on the application. A community residence facility including a group home for mentally retarded persons shall obtain a Certificate of Occupancy only.

3102.4 A facility shall submit an application for licensure renewal to the Director no later than ninety (90) days before the expiration date of the current license. The facility shall submit the license fee with the application.

3102.5 The Director may impose a late application filing fee, in addition to the license fee, on a facility that fails to submit a licensure renewal application within the time prescribed.

3102.6 The Director may conduct background checks on the applicant or licensee to determine his or her suitability or capability to operate or to continue operating a health care facility. Background checks shall consist of, but not be limited to, the following:

(a) Contacts with the police to ascertain criminal convictions;

(b) Verification of licensure status;

(d) Verification of residency status; and

(e) Contacts with District and other state officials to determine outstanding warrants, complaints, criminal convictions, and records of malpractice actions.

3102.7 The licensee of a health care facility shall inform the Director of any change in the operation, program, or services of a facility of a degree or character which may affect its licensure within five (5) days of the change. The licensee shall promptly notify the Director of any change in the administrator of the facility.

3102.8 Each license in the licensee's possession shall be the property of the District Government and shall be returned to the Director immediately upon any of the following events:

(a) Suspension or revocation of the license;

(b) Refusal to renew the license;

(d) If operation is discontinued by the voluntary action of the licensee.

3102.9 The Director shall issue each license only for the premises and person or persons named as applicants in the application and the license shall not be valid for use by any other person or persons or at any place other than that designated in the license. Any transfer as to person or place without the approval of the Director shall cause the immediate forfeiture of the license.

3102.10 The Director shall classify each facility license as regular, provisional or restricted.

3102.11 The Director shall issue the license in the name of the owner and operator.

3102.12 The D.C. Fire Department shall conduct all inspections of a facility to determine compliance with fire safety requirements.

3102.13 The D.C. Fire Department shall determine a facility's compliance or noncompliance with fire safety.

3102.14 The D.C. Fire Department shall submit to the Director the findings from inspections with a determination regarding licensure of a facility. The Director shall incorporate the determination in the licensure recommendation.

3102.15 The D.C. Fire Department shall take action as deemed necessary against a facility for noncompliance with regulations under its jurisdiction.

3102.16 The Director may waive inspection requirements for home care agencies licensed in another jurisdiction if requesting authorization to deliver services within the District of Columbia.

3102.17 Subsections 3102.12 through 3102.15 shall not apply to a home care agency.

3102.18 Each facility shall meet the minimum requirements for insurance as prescribed in the rules governing the operation of the facility.

3102.19 Each facility shall comply with all Certificate of Need requirements. The Director may subject a facility to an adverse action based on failure to comply.

History

SOURCE: Final Rulemaking published at 39 DCR 5098, 5099 (July 10, 1992).

22-B DCMR § 3103 INITIAL LICENSURE

3103.1 Prior to initial licensure of a facility, the Director shall conduct an on-site inspection to determine compliance with the Act, and rules governing the facility.

3103.2 The Director shall send a written report of the findings to the facility no later than fifteen (15) days from the conclusion of the inspection.

3103.3 A facility with deficiencies shall correct them within thirty (30) days upon receipt of the written report prior to the issuance of a license. The facility may submit written proof of correction of deficiencies where appropriate.

3103.4 The Director may conduct a follow-up inspection to determine correction of deficiencies cited within ten (10) days following the thirty (30) day correction period or upon notification from the facility that the deficiencies have been corrected.

3103.5 The Director shall deny the application for licensure for a facility that has not corrected deficiencies. The facility shall reapply for licensure when deficiencies are corrected, or for a more limited license, if appropriate.

3103.6 The Director shall issue a provisional license, not to exceed ninety (90) days, to a facility initially approved.

3103.7 The Director shall conduct an unannounced on-site inspection of the facility within ninety (90) days of operation to assess the facility's continued compliance with the Act and rules governing the facility. The Director shall issue a regular license not to exceed one (1) year to a facility that is in full or substantial compliance.

3103.8 The Director shall renew a provisional license for a facility not in substantial compliance with the Act and the rules. Facilities taking ameliorative action to correct violations, but without deficiencies that pose a serious and imminent danger to the public's health, safety and welfare may apply for renewal.

3103.9 The facility shall correct the deficiencies within sixty (60) days and the Director may require the facility to submit a plan of correction.

3103.10 The Director shall conduct an on-site inspection after sixty (60) days to determine correction. The Director shall issue a regular license, not to exceed one (1) year, to the facility if found in substantial compliance.

3103.11 The Director shall not renew a provisional license or grant a regular license to a facility not in substantial compliance, not taking ameliorative action, or with deficiencies that pose a serious and imminent danger to the public's health, safety and welfare.

History

SOURCE: Final Rulemaking published at 39 DCR 5098, 5102 (July 10, 1992).

22-B DCMR § 3104 LICENSURE RENEWAL

3104.1 The Director shall conduct an on-site inspection of a facility to determine compliance with the Act and rules governing the facility prior to the expiration of the license. Unless otherwise notified, inspections shall be unannounced.

3104.2 The Director may accept private accreditation or federal certification in lieu of inspecting for licensure compliance for any or all provisions of the Act or the rules, consistent with the requirements contained in §6(b) of the Act.

3104.3 The Director shall send a written report of the findings to the facility no later than fifteen (15) days from the conclusion of the inspection.

3104.4 Consistent with the Act, its amendments and the rules governing the facility, the Director shall take adverse action against a facility found to have life threatening deficiencies, or a continuing pattern of deficiencies which pose a serious threat to the public's health and safety.

3104.5 The Director may require the facility to submit a written, signed and dated plan of correction to abate deficiencies cited no later than ten (10) days following the receipt of the written report of findings.

3104.6 The Director shall issue a renewal license for a period not to exceed one (1) year to a facility with no deficiencies or with minor deficiencies that can be corrected within thirty (30) days.

3104.7 The Director shall issue a provisional license not to exceed ninety (90) days to a facility that is not in substantial compliance with the Act and the rules, but does not have deficiencies that are life threatening or that endanger the public's health and safety.

3104.8 The Director shall issue a regular license not to exceed one (1) year to a facility issued a provisional license pursuant to §3104.7 that is in full or substantial compliance after ninety (90) days, based on a follow-up inspection.

3104.9 The Director shall renew the provisional license for a facility initially issued a provisional license pursuant to §3104.7 that is not in substantial compliance after ninety (90) days, but is making significant progress toward correction of deficiencies cited.

3104.10 The Director may prohibit a facility from accepting new patients and providing a service when he or she finds that the facility has violations of a serious nature, and no substantial corrective action has been taken.

3104.11 Consistent with the Act, its amendments and the rules governing the facility, the Director shall take adverse action against a facility that is not making substantial progress after issuance of the first provisional license, or its renewal, or a restricted license.

3104.12 The Director shall automatically suspend or convert to a provisional or restricted status the license of a facility that loses its federal certification until a determination is made regarding its continued operation and licensure status.

History

SOURCE: Final Rulemaking published at 39 DCR 5098, 5103 (July 10, 1992).

22-B DCMR § 3105 COMPLAINT INVESTIGATIONS

3105.1 The Director may receive any and all complaints alleging violations of the requirements contained in the Act and the rules, and may conduct unannounced investigations to determine the validity of the complaints.

3105.2 The facility shall permit the Director entry to investigate complaints. The Director shall conduct complaint investigations during time periods and staff shifts consistent with the allegations in the complaint when deemed appropriate.

3105.3 The Director shall submit a written report to the facility no later than ten (10) days after the conclusion of the investigation.

3105.4 The Director may require the facility to respond to the written report of findings with a written plan of correction no later than ten (10) days after the receipt of the report.

3105.5 The Director shall communicate the findings of the complaint investigation directly to the facility and complainant if the complaint is received directly by the Department. If the complaint is referred by another governmental agency, the Director shall send its findings to the referring agency. The referring agency shall communicate the findings to the complainant.

3105.6 The Director shall investigate complaint allegations of a life threatening nature or those that represent immediate danger within twenty-four hours (24 hrs.) of receipt of the complaint by the Department. All other complaints shall be investigated by the Director no later than thirty (30) days from their receipt or as deemed appropriate.

3105.7 The Director shall immediately suspend or revoke, in accordance with the Act and these rules, a provisional or restricted license, if a facility is found to have life threatening deficiencies or deficiencies which seriously endanger the public's health and safety.

3105.8 The Director shall require a facility which is found in violation of the Act and the rules, but whose deficiencies are not life threatening or seriously endangering to the public's health, safety and welfare to correct the deficiencies within thirty (30) days from receipt of the complaint investigation report.

3105.9 The Director shall issue a provisional or a restricted license, as appropriate, to a facility that has not corrected deficiencies within thirty (30) days.

3105.10 Where appropriate, the Director shall issue a restricted license to a facility which is found to have life threatening deficiencies or deficiencies which seriously endanger the public's health and safety. When not appropriate, the Director shall suspend or revoke the facility's license consistent with the Act and this chapter.

History

SOURCE: Final Rulemaking published at 39 DCR 5098, 5104 (July 10, 1992).

22-B DCMR § 3106 APPROVAL OF VARIANCES

3106.1 The Director may grant a variance from any of the requirements of the Act and the rules, if the applicant can show undue hardship and the variance can satisfy the following conditions:

(a) It is not inconsistent with other provisions of the Act;

(b) It is not deleterious to the public health and safety; and

3106.2 A facility requesting a variance shall submit in writing to the Director the following:

(a) The regulatory requirement(s) for which a variance from strict compliance is being requested;

(b) Specific justification as to why the facility cannot meet the requirement(s); and

3106.3 The Director shall grant a variance only to the extent necessary to ameliorate an undue hardship and only when compensating factors are present to give adequate protection to the public health without impairing the intent and purpose of the Act or these rules.

3106.4 If the Director believes that the conditions in §3106.1 of these rules are not met, the Director shall issue a written proposed denial together with advice to the applicant as to his or her right to a hearing on the matter which shall be conducted by the Director in accordance with §§3107.3 and 3110.

3106.5 The Director shall maintain a record, open to inspection by the public, of all variances granted. The record shall contain a complete written explanation of the basis for each variance.

3106.6 If a variance is requested from standards established pursuant to §§5(a) (3) or (4) of the Act, the Director shall provide the Director, Department of Human Services, with notice and an opportunity to comment before a decision is made.

History

SOURCE: Final Rulemaking published at 39 DCR 5098, 5106 (July 10, 1992).

22-B DCMR § 3107 DENIAL, SUSPENSION, OR REVOCATION OF A HEALTH CARE FACILITY LICENSE

3107.1 The Director may refuse to issue or renew or may revoke, or may suspend a license issued pursuant to this chapter for one or more of the reasons listed in §5(a)(2)(f) of the Act.

3107.2 Except for a conversion or summary suspension undertaken pursuant to §6(d) of the Act, D.C. Code, 2001 Ed. §44-505(d), every applicant for or holder of a license, or applicant for reinstatement after revocation, shall be afforded notice and an opportunity to be heard prior to the action of the Director, if the effect of which would be one of the following:

(a) To deny a license for cause which raised an issue of fact;

(b) To suspend a license;

(d) To refuse to restore a license;

(e) To issue a limited renewal license; or

(f) To refuse to issue a renewal license for any cause other than failure to pay the prescribed fees.

3107.3 When the Director contemplates taking any action of the type specified in §3107.2(a) of these rules, the Director shall give to the applicant a written notice containing the following statements:

(a) That the applicant has failed to satisfy the Director as to the applicant's qualifications;

(b) The respect in which the applicant has failed to satisfy the Director; and

(c) That the denial shall become final unless the applicant files a request for a hearing with the Director within fifteen (15) days of receipt of the notice.

3107.4 When the Director contemplates taking any action of the type specified in §§3107.2(b), (c), (d), (e), and (f) of these rules, the Director shall give the applicant a written notice containing the following statements:

(a) That the Director has sufficient evidence (setting forth the nature of the evidence), which if not rebutted or explained, justifies taking the proposed action; and

(b) That the Director shall take the proposed action unless within fifteen (15) days of the receipt of the notice the facility files with the Director a written request for a hearing or in the alternative submits documentary evidence for the Director's consideration before the Director takes final action.

3107.5 If the facility does not respond to the notice within the time specified, the Director may, without a hearing, take the action contemplated in the notice. The Director shall inform the applicant, in writing, of the action taken.

3107.6 If the facility chooses to submit documentary evidence but does not request a hearing, the Director shall consider the material submitted and take such action as is appropriate without a hearing. The Director shall notify the facility in writing of the action taken.

3107.7 Grounds for suspension, revocation, limitation, or refusal to issue or renew a license shall include the following:

(a) Failure to meet or maintain the standards required by these rules or the Act;

(b) Willful submission of false or misleading information to the Director in connection with an application for licensure or related to licensing procedures;

(c) Violation of this chapter, the Act, or other laws and regulations of the District of Columbia or United States relating to the operation of a facility and which are applicable to facilities operating in the District of Columbia;

(d) Failure to allow inspections pursuant to these rules;

(e) Failure to obey any lawful order of the Director, pursuant to these rules;

(f) Conviction and retention of a member of the governing body, a Director, Administrator, the Chief Executive Officer, department head, or other key staff member of a felony involving the management or operation of a facility, or which is directly related to the integrity of the facility or the public health or safety; or

(g) Any act which constitutes a threat to the public's health or safety.

History

SOURCE: Final Rulemaking published at 39 DCR 5098, 5107 (July 10, 1992).

22-B DCMR § 3108 SUMMARY SUSPENSION AND LICENSURE CONVERSION, HEARINGS

3108.1 Notwithstanding any other provision of these rules, the Director, pursuant to §6(d)(l) of the Act, D.C. Code, 2001 Ed. §44-505(d)(1), and under conditions described in that section may do the following:

(a) Convert the facility's license to a provisional or restricted license pending satisfactory completion of the inspection pursuant to these rules; or

(b) Suspend the facility's license if the Director finds that loss of accreditation or certification was prompted by deficiencies that constitute an immediate or serious and continuing danger to the health or welfare of its patients, clients, or residents.

3108.2 In addition to authority contained in §3108.1, the Director, pursuant to §6(d)(2) of the Act, as amended, D.C. Code, 2001 Ed. §44-505(d)(2) may suspend the license of any facility or convert its license to a provisional or restricted license if the Director determines that existing deficiencies constitute an immediate or serious and continuing danger to the health, safety, or welfare of its patients, clients, or residents.

3108.3 Upon taking action pursuant to §§3108.1 and 3108.2, the Director shall immediately give the facility written notice of the action, including a copy of the order of suspension or conversion, statement of the grounds for the action, and notification that the facility may, within seven (7) business days from the day written notice is received, file with the Director a written request for an expedited hearing with respect to the action.

3108.4 The Director shall convene a hearing within three (3) business days following receipt of the facility's timely request to review the reasonableness of the suspension or conversion.

3108.5 If a summary suspension or conversion hearing is requested, the request or hearing shall not serve to stay the order suspending or converting the license.

3108.6 Except as otherwise noted in this chapter or as provided in §6(d) (3) of the Act, all procedures relating to hearings as set forth in this chapter shall apply to hearings in summary suspensions and licensure conversions.

History

SOURCE: Final Rulemaking published at 39 DCR 5098, 5109 (July 10, 1992).

22-B DCMR § 3109 SERVICE OF NOTICE

3109.1 Any notice required by this chapter may be served either personally or by certified mail, return receipt requested, directed to the applicant or licensee at the last known address as shown by the records of the Department of Consumer and Regulatory Affairs.

3109.2 If notice is served personally, it shall be deemed by the Director to have been served at the time when delivery is made to the applicant or licensee.

3109.3 If notice is served by certified mail, it shall be deemed by the Director to have been served on the date written or stamped upon the return receipt showing delivery of the notice to the applicant or licensee, or refusal of the applicant or licensee to receive the notice.

3109.4 In the event that the applicant or licensee is no longer at the last known address as shown by the records of the Department of Consumer and Regulatory Affairs and no forwarding address is available, the notice shall be deemed by the Director to have been served on the date the return receipt bearing the notification is received by him or her.

3109.5 If an applicant or licensee scheduled for a hearing does not appear and no continuance has been or is granted, the Director may hear the evidence of the witnesses who have appeared, and the Director may proceed to consider the matter and render a decision on the basis of the evidence available.

History

SOURCE: Final Rulemaking published at 39 DCR 5098, 5110 (July 10, 1992).

22-B DCMR § 3110 CONDUCT OF HEARINGS

3110.1 Every hearing before the Director shall be open to the public.

3110.2 An applicant or licensee entitled to a hearing shall have the following rights:

(a) To be represented by counsel;

(b) To examine all opposing witnesses on any matter relevant to the issues; and

(c) To have subpoenas issued to compel the attendance of witnesses and the production of relevant books, papers, and documents upon making written request therefore to the Director.

3110.3 In connection with any hearing held pursuant to this chapter, the Director shall have the power to do the following:

(a) To administer oaths or affirmations to witnesses called to testify;

(b) To subpoena respondents and other witnesses and relevant books, papers, and documents;

(d) To examine witnesses;

(e) To direct the continuance of any case; and

(f) To enter into a consent agreement.

3110.4 In proceedings before the Director, if any person refuses to respond to a subpoena or refuses to take the oath or affirmation as a witness or thereafter refuses to be examined, or refuses to obey any lawful order of the Director contained in his or her decision rendered after hearing, the Director may make application to the proper court for an order requiring obedience thereto.

3110.5 In all proceedings the Director shall receive and consider any evidence or testimony. However, the Director may exclude incompetent, irrelevant, immaterial, or unduly repetitious evidence or testimony.

3110.6 In any proceeding resulting from the Director's contemplated action to deny new licensure or to restore a suspended license or to deny a variance request, the applicant shall have the burden of satisfying the Director of his or her qualifications.

3110.7 In any proceeding resulting from the Director's contemplated action to refuse to renew, to revoke, or to issue a limited renewal license, the Department shall have the burden of proving that such action should be taken.

3110.8 In a summary or conversion action the Department shall have the burden of establishing a prima facie case of immediate or serious and continuing endangerment.

3110.9 In all hearings conducted by the Director, a complete record shall be made of all evidence presented during the course of a hearing. Any party to the proceedings desiring it shall be furnished with a copy of the record, upon payment of the fee prescribed by the Director.

History

SOURCE: Final Rulemaking published at 39 DCR 5098, 5111 (July 10, 1992).

22-B DCMR § 3111 FINDINGS AND DECISIONS

3111.1 The Director shall render a decision, in writing, as soon as practicable, but no later than fifteen (15) calendar days, after the hearing is completed.

3111.2 A summary suspension or emergency licensure conversion shall be either affirmed or vacated at the conclusion of the emergency hearing.

3111.3 The decision of the Director shall contain the following:

(a) Findings of fact made by the Director;

(b) Application by the Director of the Act and rules to the facts as found by the Director;

(d) A statement informing the aggrieved person of his or her appeal rights and the time within which such review must be sought, or in the case of summary suspension or licensure conversion, the date and time for the final hearing if the action is upheld.

3111.4 Within seven (7) business days after the decision is rendered, the Director shall serve upon the applicant, the licensee, or the attorney of record, a copy of the written decision either personally or by certified mail.

3111.5 The Director's decision shall be final unless an appeal is timely filed pursuant to §3113 or upon receipt of a timely motion the Director reopens the proceedings.

History

SOURCE: Final Rulemaking published at 39 DCR 5098, 5112 (July 10, 1992).

22-B DCMR § 3112 RECONSIDERATION

3112.1 A petition for reconsideration may be filed by a party within ten (10) days after service of the decision by the Director.

3112.2 Neither the filing nor the granting of that petition shall operate as a stay of a final order unless specifically ordered by the Director. A stay shall be granted only upon good cause which shall consist of unusual or exceptional circumstances.

3112.3 The petition shall state briefly and specifically the following:

(a) The matters of record alleged to have been erroneously decided;

(b) The grounds relied upon; and

3112.4 If the petition is based in whole or in part on new or additional evidence, the new or additional evidence shall be set forth in an affidavit and accompanied by a statement that the petitioner could not with due diligence have known or discovered the new evidence prior to the date the case was presented to the Director for decision.

3112.5 The Director in his or her discretion may permit or require oral argument upon a petition for reconsideration.

3112.6 If, because of accident, illness, or other good cause, a person fails to receive a hearing or fails to appear for a requested hearing, and has been diligent in bringing the matter to the Director's attention, the Director may grant appropriate relief.

3112.7 The Director shall grant or deny a petition for reconsideration within ten (10) days after the filing of the petition. Failure of the Director to act within that period shall be deemed a denial of the petition.

3112.8 A facility shall not make a request for reinstatement of a license or for issuance of a new license imposed pursuant to this chapter until one year from the date of the Director's decision, unless the Director's decision should provide otherwise.

3112.9 A facility shall not make a request for removal of a restriction imposed pursuant to this chapter until at least ninety (90) days from the date of the Director's decision, unless the Director's decision should provide otherwise.

History

SOURCE: Final Rulemaking published at 39 DCR 5098, 5113 (July 10, 1992).

22-B DCMR § 3113 APPEALS

3113.1 Any adverse decision (except a summary action pursuant to §3108) by the Director may be appealed to the Board of Appeals and Review by filing a petition with that Board, in accordance with its rules, within fifteen (15) days of the decision of the Director or such other time as the Board by rule may prescribe.

3113.2 In the absence of a timely appeals petition filed pursuant to §3113.1, the Director's decision shall be final and not subject to appeal.

3113.3 The review by the Board of Appeals and Review shall be on the record of the case established before the Director. There shall be no evidentiary hearing before the Board.

3113.4 The Board shall uphold the Director's decision unless it is arbitrary, capricious, not supported by substantial evidence or contrary to law.

3113.5 The filing of a petition for review shall not itself stay enforcement of an order.

3113.6 A person aggrieved by an adverse decision of the Director, which is upheld by the Board of Appeals and Review, may seek a review of the Director's decision by the District of Columbia Court of Appeals by filing a petition for review in that Court within thirty (30) days from receipt of the decision of the Board of Appeals and Review or such other time as the Court by rule may prescribe. Failure to seek judicial review in the manner and within the time prescribed by the rules of the D.C. Court of Appeals, shall result in the Director's decision becoming final.

History

SOURCE: Final Rulemaking published at 39 DCR 5098, 5114 (July 10, 1992).

22-B DCMR § 3114 FEES FOR COMMUNITY RESIDENCE FACILITIES AND HEALTH CARE FACILITIES

3114.1 License fees for community residence facilities are as follows:

(a) 1-5 beds

Annual Fee

$50.00

Late Fee

25.00

(b) 6-10 beds

Annual Fee

75.00

Late Fee

37.50

Annual Fee

100.00

Late Fee

50.00

(d) 21-40 beds

Annual Fee

150.00

Late Fee

75.00

(e) 41-60 beds

Annual Fee

200.00

Late Fee

100.00

(f) 61-80 beds

Annual Fee

250.00

Late Fee

125.00

(g) 81-100 beds

Annual Fee

300.00

Late Fee

150.00

(h) 101-150 beds

Annual Fee

$350.00

Late Fee

175.00

(i) 151 or more beds

Annual Fee

400.00

Late Fee

200.00

3114.2 License fees for ambulatory surgical treatment centers are as follows:

(a) 1-1000 cases per year

Annual Fee

$150.00

Late Fee

50.00

(b) 1001-2000 cases per year

Annual Fee

300.00

Late Fee

150.00

Annual Fee

450.00

Late Fee

225.00

(d) 3001 or more cases per year

Annual Fee

600.00

Late Fee

300.00

3114.3 License fees for nursing homes are as follows:

(a) 1-50 beds

Annual Fee

$390.00

Late Fee

195.00

(b) 51-100 beds

Annual Fee

520.00

Late Fee

200.00

Annual Fee

1000.00

Late Fee

250.00

3114.4 License fees for intermediate care facilities for mentally retarded persons are as follows:

(a) 1-4 beds

Annual Fee

$50.00

Late Fee

25.00

(b) 5-8 beds

Annual Fee

$100.00

Late Fee

50.00

Annual Fee

150.00

Late Fee

75.00

3114.5 A fee in the amount of fifty dollars ($50) shall be charged to a community residence facility or a health care facility for each inspection after the first follow-up annual license renewal inspection.

3114.6 A fee in the amount of fifty dollars ($50) shall be charged for the validation or duplication of any license.

History

SOURCE: Final Rulemaking published at 43 DCR 4731, 4732 (August 30, 1996); as amended by Fiscal Year 2011 Budget Support Act of 2010, effective September 24, 2010 (D.C. Law 18-223), published at 57 DCR 6242, 6357 (July 23, 2010).

22-B DCMR § 3199 DEFINITIONS

3199.1 For purposes of these chapters, the following terms and phrases shall have the meanings ascribed (unless the context indicates otherwise):

Act - D.C. Law 5-48, the District of Columbia Health Care and Community Residence Facility, Hospice and Home Care Licensure Act of 1983, as amended, D.C. Code, 2001 Ed. §§44-501 to 44-509.

Administrator - the person who is responsible for the day-to-day operation of the facility to include the Residence Director and the Medical Director.

Certificate of Need - as defined in D.C. Code, 2001 Ed. §§44-1801 to 44-1817.

EDITOR’S NOTE: D.C. Code, 2001 Ed. §§44-1801 to 44-1817 were repealed by D.C. Law 9-197 §22, passed March 16, 1993. For current legislation regarding Certificates of Need, please refer to D.C. Code, 2001 Ed. §§44-401 to 44-421.

Department - the Department of Consumer and Regulatory Affairs.

Director - the Director of the Department of Consumer and Regulatory Affairs or the Director's designee.

Facility - a community residence facility, including a group home for mentally retarded persons, nursing home, hospice, home care agency, maternity center, ambulatory surgical facility, or end stage renal dialysis facility.

Person - an individual, firm, partnership, corporation, company, or association and including any administrators, guardians, trustees, directors, and agents.

Provisional License - a license issued to a facility which is not in substantial compliance with all applicable laws and regulations, but which is taking ameliorative action in accordance with a mutually agreed upon timetable to achieve compliance.

Regular License - a license which is issued for one year to a facility which is in compliance with all applicable laws and regulations

Restricted License - a license which permits operation of a facility but prohibits the facility from accepting new residents and patients or from delivering services that it would otherwise be authorized to deliver.

Substantial Compliance - meeting the majority of rules without jeopardizing health and safety.

History

SOURCE: Final Rulemaking published at 39 DCR 5098, 5115 (July 10, 1992).

22-B32 NURSING FACILITIES

22-B DCMR § 3200 PURPOSE

3200.1 Each nursing facility shall comply with the Act, these rules and the requirements of 42 C.F.R. Part 483, Subpart B, Sections 483.1 to 483.75; Subpart D, Sections 483.150 to 483.158; and Subpart E, section 483.200 to 483.206, all of which shall constitute licensing standards for nursing facilities in the District of Columbia.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3201 ADMINISTRATIVE MANAGEMENT

3201.1 An Administrator shall be present forty (40) hours per week during regular business hours, and shall be responsible for the operation of the facility twenty-four (24) hours per day, seven (7) days per week.

3201.2 The Administrator shall be:

(a) Licensed or otherwise approved as a nursing home administrator in the District of Columbia; and

(b) Certified annually by a licensed physician as having no physical or mental disabilities that would interfere with carrying out the Administrator's responsibilities.

3201.3 The Administrator shall appoint the Director of Nursing, the Medical Director, the Assistant Administrator, a licensed registered nurse and a department head or another licensed or approved Administrator to act as Administrator in his or her absence. The Acting Administrator shall have the necessary authority to act in any absence of the Administrator so that each facility has an authorized Administrator on duty during regular business hours.

3201.4 If the Administrator is absent for more than six (6) consecutive weeks the facility shall designate an acting administrator who is qualified to be an administrator and shall notify the licensing agency.

3201.5 Each facility shall have written guidelines on the authority and responsibilities of the Administrator and the Acting Administrator.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3202 PERSONNEL POLICIES

3202.1 Personnel policies shall be in writing and maintained in an employee manual that is given to each employee during orientation and shall be made available to the licensing agency.

3202.2 Each facility shall develop and maintain personnel policies which shall include methods used to document the presence or absence of communicable disease.

3202.3 A person whose name appears on the nurse aide abuse registry or who has been convicted of a crime involving one of the following with regard to a resident or an individual within that person's care shall not provide services in the facility:

(a) Physical or sexual abuse or mistreatment;

(b) Financial exploitation or misappropriation of property; or

3202.4 Each employee or person hired under contract who requires licensure, registration or certification in order to provide resident care shall be licensed, registered or certified under the laws and regulations of the District.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3203 LICENSES AND ADMINISTRATIVE RECORDS

3203.1 No facility shall operate without a license issued pursuant to the Act.

3203.2 A list of all employees, with the appropriate current license or certification numbers, shall be on file at the facility and available to the Director.

3203.3 Each facility license, permit, and documents of certification to operate the facility, if any, shall be posted in a conspicuous location in the room or hallway immediately inside the main or front door.

3203.4 Each facility shall comply with the number of authorized beds as indicated on each license.

3203.5 Each facility shall maintain the following administrative records:

(a) Payroll records;

(b) Reports of fire inspections;

(c) Compliance reports required to be maintained pursuant to the 1996 BOCA National Building Code, construction and permit regulations;

(d) Reports of inspections of the fire alarm system and fire drills;

(e) Reports of elevator inspections;

(f) Disaster plan and procedures;

(g) Certification of flame spread ratings of carpets, curtains and wall coverings;

(h) Each contract for professional and facility services;

(i) Radiation survey reports of x-ray equipment, if applicable;

(j) Summaries and analyses of each incident involving residents, staff, and visitors; and

(k) Policies and procedures governing the operations of the facility.

3203.6 A qualified employee shall be assigned the responsibility for ensuring that records are maintained, completed, and preserved.

3203.7 Each administrative record shall be retained for at least five (5) years from the date of creation.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3204 FEES

3204.1 License fees are established according to the number of resident beds in the facility and are as follows:

(a)

1 - 50 Beds

Annual Fee

$ 400

Late Fee

$ 150

(b)

51 - 100 Beds

Annual Fee

$ 500

Late Fee

$ 200

(c)

101 or More Beds

Annual Fee

$ 600

Late Fee

$ 250

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3205 INSURANCE COVERAGE

3205.1 Each facility shall carry sufficient insurance to cover the following exposures:

(a) Hazard (fire, extended coverage, and vandalism);

(b) Consequential (indirect) loss from operation breakdown;

(d) Legal risk (liability).

3205.2 The liability insurance shall include malpractice coverage of at least one million dollars ($ 1,000,000), and comprehensive general coverage of at least one million dollars ($ 1,000,000).

3205.3 Each facility shall carry Worker's Compensation insurance for all employees pursuant to the District of Columbia Worker's Compensation Act of 1979, as amended, effective July 1, 1980, D.C. Law 3-77, D.C. Code § 36-301, et seq.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3206 RESIDENT CARE POLICIES

3206.1 There shall be written policies to govern nursing care and related medical and other services provided, including written policies on:

(a) Nursing services;

(b) Physician services;

(d) Dental services;

(e) Ventilator services;

(f) Use of physical and chemical restraints;

(g) Infection control;

(h) Medication management;

Podiatry services;

(j) Dialysis services;

(k) Recreational services;

(l) Emergency water supply;

(m) Laundry and linen management;

(n) Fire and disaster preparedness;

(o) Resident emergency and non-emergency transportation;

(p) Continuity in assigning the same nursing staff to the same residents; and

(q) Therapeutic services.

3206.2 These policies shall be developed with the advice of a committee of professional personnel, including the Medical Director, the Director of Nursing and appropriate department heads as deemed necessary by the facility.

3206.3 Policies shall be reviewed by the committee at least annually with written notations, signatures, and dates of review.

3206.4 The Administrator shall be responsible for the execution of these policies.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002); as amended by Notice of Final Rulemaking published at 58 DCR 10619 (December 16, 2011).

22-B DCMR § 3207 PHYSICIAN SERVICES AND MEDICAL SUPERVISION OF RESIDENTS

3207.1 The Medical Director shall assume full responsibility for the overall supervision of the medical care provided in the facility. If the Medical Director is absent, he or she shall delegate the continuity and supervision of resident care to a qualified physician.

3207.2 The Medical Director shall:

(a) Coordinate medical care in the facility;

(b) Implement resident care policies;

(d) Serve as liaison with attending physicians to ensure the prompt issuance and implementation of orders;

(e) Review incidents and accidents that occur on the premises to identify hazards to health and safety;

(f) Ensure that medical components of resident care policies are followed;

(g) Assist the Administrator in arranging twenty-four (24) hours of continuous physician services a day for medical emergencies and in developing procedures for emergency medical care;

(h) Ensure that attending medical professionals who treat residents in the facility have current District of Columbia licenses and U.S. Drug Enforcement Agency and District of Columbia Controlled Substances registrations on file in the facility, along with initial and annual certifications of their freedom from communicable disease; and

(i) Ensure that each resident is seen by a physician within seventy-two (72) hours after admission and that the physician has included in the record information identified in subsection 3231.12.

3207.3 Except as specified in subsection 3207.5 of this section, a physician may delegate tasks to a licensed physician assistant or licensed nurse practitioner who:

(a) Meets the applicable definition in section 3299 of this Chapter; and

(b) Is acting within the scope of practice as defined by District of Columbia law.

3207.4 A physician's assistant shall be supervised by a physician.

3207.5 A physician may not delegate a task when regulations specify that the physician shall perform it personally, or when the delegation is prohibited under District law or by the facility's own policies.

3207.6 The physician shall prescribe a planned regimen of medical care which includes the following:

(a) Medications and treatment;

(b) Rehabilitative services;

(d) Special procedures and contraindications for the health and safety of the resident;

(e) Resident therapeutic activities; and

(f) Plans for continuing care and discharge in accordance with section 3234.

3207.7 A facility shall have available for each resident vaccines currently recommended by the U.S. Health Advisory Committee on Immunization Practices (ACIP) as appropriate for age, occupation, lifestyle, environmental situation, documented evidence of prior vaccine, if available, or immunity and current medical status.

3207.8 Each physician shall adhere to the written policies and regulations that govern the health services provided in the facility.

3207.9 The Medical Director shall make arrangements for the provision of medical care twenty-four (24) hours a day.

3207.10 Dated orders and dated progress notes in the resident's medical record shall be used to document medical supervision at the time of each visit and shall be signed and dated by the resident's physician or the resident's nurse practitioner or physician assistant, with countersignature by the resident's physician.

3207.11 Each resident shall have a comprehensive medical examination and evaluation of his or her health status at least every twelve (12) months, and documented in the resident's medical record.

3207.12 A schedule with the names and telephone numbers of each physician and days he or she is on call shall be kept at each nursing station.

3207.13 There shall be available at each nursing station written procedures on emergency care, including care of residents, persons to be notified and reports to be prepared.

3207.14 The facility shall make contact information of each resident’s attending physician available to facility staff as well as to each resident and his or her family, including the family designee, or legal representative upon request.

3207.15 Each facility shall obtain a medical order from a resident’s attending physician, the facility’s medical director, an on-staff physician, or an advance practice registered nurse prior to calling 911 for emergency medical assistance, except that a prior medical order shall not be required if it is determined that there is a situation that requires an immediate transfer to a hospital.

3207.16 If a nursing facility does not obtain a required medical order prior to calling 911, the facility shall document in the resident’s medical record why obtaining a medical order was not practicable.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002); as amended by Notice of Final Rulemaking published at 58 DCR 10619, 10620 (December 16, 2011).

22-B DCMR § 3208 NURSING SERVICES

3208.1 A licensed registered nurse shall be employed full-time as Director of Nursing Services, except as provided in this section.

3208.2 If the Director of Nursing is temporarily absent, the responsibility for continuity and supervision of nursing services shall be delegated to a licensed registered nurse.

3208.3 Each Director of Nursing hired after the effective date of these regulations shall have, at a minimum, a District of Columbia license as a registered nurse and:

(a) A Bachelor's degree; or

(b) Three (3) years of clinical experience in appropriate nursing specialties that may include geriatric, rehabilitation or psychiatric care and/or other related clinical areas.

3208.4 Each Director of Nursing shall participate annually in a minimum of twelve (12) hours of continuing education programs relating to geriatric, administration, or related areas of care.

3208.5 The Director of Nursing shall provide for, at a minimum, the following:

(a) Delivery of nursing care services in accordance with these rules;

(b) Developing and maintaining nursing service objectives, standards of practice, policy and procedure manuals, and written job descriptions for each level of nursing personnel;

(d) Coordinating nursing personnel, which includes the following:

(1) Recruitment;

(2) Selection;

(3) Position assignment;

(4) Orientation;

(5) In-service education;

(6) Supervision; and

(7) Termination;

(e) Developing a staffing plan that considers residents' needs for various types of nursing care;

(f) Working with the medical staff and the interdisciplinary team in developing and implementing policies for resident care;

(g) Working with other employees to ensure that the interdisciplinary care plan (ICP) is coordinated and maintained; and

(h) Working with the Administrator and the Medical staff or Medical Director in the allocation of funds for facility programs.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3209 NURSING SERVICES SUPERVISION

3209.1 A Nursing Services Supervisor shall be on duty at all times.

3209.2 Each Nursing Services Supervisor shall:

(a) Be qualified by education or experience in geriatric, rehabilitation or psychiatric nursing or other appropriate nursing discipline, with appropriate documentation; and

(b) Be currently licensed as a registered nurse in the District of Columbia.

3209.3 The Director of Nursing may serve as the Nursing Services Supervisor while on his or her regular tour of duty, if the facility has a licensed bed capacity of thirty (30) or less.

3209.4 A charge nurse may serve as the Nursing Services Supervisor when he or she is a registered nurse.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3210 LICENSED NURSING COVERAGE

3210.1 Each facility shall employ a charge nurse on each unit twenty-four (24) hours a day.

3210.2 Each charge nurse shall be a licensed registered nurse or licensed practical nurse in the District with experience in geriatric, rehabilitation, psychiatric, or other appropriate nursing discipline.

3210.3 When a licensed practical nurse serves as a charge nurse, he or she shall have ready access to consultation with a registered nurse.

3210.4 A charge nurse shall be responsible for the following:

(a) Making daily resident visits to assess physical and emotional status and implementing any required nursing intervention;

(b) Reviewing medication records for completeness, accuracy in the transcription of physician orders, and adherence to stop-order policies;

(d) Delegating responsibility to the nursing staff for direct resident nursing care of specific residents;

(e) Supervising and evaluating each nursing employee on the unit; and

(f) Keeping the Director of Nursing Services or his or her designee informed about the status of residents.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3211 NURSING PERSONNEL AND REQUIRED STAFFING LEVELS

3211.1 Sufficient nursing time shall be given to each resident to ensure that the resident receives the following:

(a) Treatments, medications, diet and nutritional supplements and fluids as prescribed, and rehabilitative nursing care as needed;

(b) Proper care to minimize pressure ulcers and contractures and to promote the healing of ulcers;

(c) Assistance in daily personal grooming so that the resident is comfortable, clean, and neat as evidenced by freedom from body odor, cleaned and trimmed nails, and clean, neat and well-groomed hair;

(d) Protection from accident, injury, and infection;

(e) Encouragement, assistance, and training in self-care and group activities;

(f) Encouragement and assistance to:

(1) Get out of bed and dress or be dressed in his or her own clothing, and shoes or slippers, which shall be clean and in good repair;

(2) Use the dining room if he or she is able; and

(3) Participate in meaningful social and recreational activities;

(g) Prompt, unhurried assistance if he or she requires or requests help with eating;

(h) Prescribed adaptive self-help devices to assist him or her in eating independently;

(i) Assistance, if needed, with daily hygiene, including oral care; and

(j) Prompt response to an activated call bell or call for help.

3211.2 Each facility shall have at least the following employees:

(a) At least one (1) registered nurse on a twenty-four (24) hour basis, seven (7) days a week;

(b) Twenty-four (24) hour licensed nursing staff sufficient to meet nursing needs of all residents;

(d) A minimum of two (2) nursing employees per nursing unit, per shift.

3211.3 Beginning no later than January 1, 2005, each facility shall employ sufficient nursing staff to provide a minimum daily average of three and half (3.5) nursing hours per resident per day. Nursing staff shall include registered nurses, licensed practical nurses, and certified nurse aides.

3211.4 Beginning January 1, 2011, each facility shall have either a physician, physician assistant, or an advanced practice registered nurse, excluding hours per week attributed to medical director duties, available on-site for a minimum of two tenths (0.2) hours per week for each resident at the facility.

3211.5 Beginning January 1, 2012, each facility shall provide a minimum daily average of four and one tenth (4.1) hours of direct nursing care per resident per day, of which at least six tenths (0.6) hours shall be provided by an advanced practice registered nurse or registered nurse, which shall be in addition to any coverage required by subsection 3211.4.

3211.6 The Director may adjust the staffing requirements and formulas set forth in subsections 3211.4 and 3211.5 based on the individual needs of a nursing facility; provided, that the staffing requirements of subsection 3211.5 shall not be reduced to less than three and half (3.5) hours of direct nursing care per resident per day.

3211.7 The Director may adjust the staffing requirements set out in subsections 3211.4 and 3211.5 to require more than the stated hours of care per resident if:

(a) Inadequate staffing or inadequate supervision of a resident is cited in four (4) consecutive on-site surveys. For the purposes of this paragraph, a survey shall be an on-site inspection, complaint investigation, or monitoring or compliance visit conducted by the federal government or the District of Columbia; or

(b) It is found that a resident has suffered demonstrable harm because of inadequate staffing or inadequate supervision.

3211.8 In accordance with subsection 3211.6, in order to have staffing requirements adjusted to require less than the stated hours of care per resident as set out in subsections 3211.4 and 3211.5, a nursing facility shall submit to the Director a written request based on the particular needs of the facility.

3211.9 In making a determination on the adjustment of staffing requirements in accordance with subsection 3211.8, the Director’s determination shall be based on one (1) or more of the following:

(a) Whether the facility has undergone a system-wide culture change and the impact the facility asserts that such change has had on resident care;

(b) The acuity levels of residents and how stable those levels are based on the case mix of residents; and

(c) Any other justification related to the needs of the facility that warrants revising the staffing pattern or ratio because of:

(1) A change in program or organizational structure; or

(2) An environmental or systemic change.

3211.10 The Department shall publish each request for an adjustment of a staffing ratio in the D.C. Register no later than fifteen (15) days after the written request is received by the Director.

3211.11 The Department shall publish each determination responding to a request for an adjustment in staffing ratios in the D.C. Register no later than sixty (60) days after the written request is received by the Director.

3211.12 Each facility shall maintain an organized process that promotes continuity in assigning the same nursing staff to the same residents as often as practicable in accordance with subsection 3206.1(p). The facility shall demonstrate and allow the Director access to the process upon request.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002); as amended by Notice of Final Rulemaking published at 49 DCR 6824 (July 19, 2002); as amended by Notice of Final Rulemaking published at 52 DCR 3608 (April 8, 2005); as amended by Notice of Final Rulemaking published at 58 DCR 10619, 10621 (December 16, 2011).

22-B DCMR § 3212 TEMPORARY NURSING PERSONNEL

3212.1 Each facility may hire temporary nurses, including contract nurses, who shall be licensed in the District of Columbia.

3212.2 The facility shall have policies and procedures for orienting qualified temporary nursing personnel to the facility and to residents.

3212.3 Each temporary employee who serves as a charge nurse on a nursing unit shall be supervised by a licensed registered nurse who is a permanent employee.

3212.4 A written agreement shall be executed between the facility and any contract agency employed to provide nursing personnel to the facility in compliance with the requirements of this chapter.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3213 RESTORATIVE NURSING CARE PROGRAM

3213.1 The facility shall have a restorative nursing care program to assist in maintaining the highest practicable level of physical, mental and psychosocial well-being of each resident.

3213.2 Each nursing employee shall provide restorative nursing in his or her daily care of residents, which shall include the following:

(a) Maintaining good body alignment and proper positioning of bedridden residents;

(b) Encouraging and assisting bedridden residents or those residents that are confined to a chair to change position at least every two (2) hours or more often as the resident's condition warrants, day and night, to stimulate circulation; prevent bed sores, pressure ulcers and deformities; and to promote the healing of pressure ulcers;

(c) Encouraging residents to be active and out of bed for reasonable periods of time, except when contraindicated by physician's orders;

(d) Encouraging residents to be independent in activities of daily living by teaching and explaining the importance of self-care, ensuring and assisting with transfer and ambulating activities, by allowing sufficient time for task completion by the residents, and by encouraging and honoring resident's choices;

(e) Assisting residents to adjust to their condition and to their use of prosthetic devices;

(f) Achieving good body alignment and balance for residents who use mechanical supports, which are properly designed and applied under the supervision of a licensed nurse;

(g) Identifying residents who would benefit from a bowel and bladder training program and initiating such a program to decrease incontinence and unnecessary use of catheters; and

(h) Assessing the nature, causes and extent of behavioral disorientation difficulty and implementing appropriate strategies and practices to improve the same.

3213.3 Each nursing employee who provides restorative nursing services shall attend educational programs in restorative nursing that includes practical experience.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3214 IN-SERVICE EDUCATION FOR NURSING PERSONNEL

3214.1 A comprehensive on-going in-service education program shall be provided by the facility and shall include training on the provision of resident care.

3214.2 Each nursing employee shall be trained in emergency procedures, disaster plans and fire evacuation plans.

3214.3 Each area of in-service training shall be conducted by a registered nurse, qualified and experienced in the area of instruction.

3214.4 A facility shall designate an In-Service Education Director who shall maintain records of training and orientation activities, which include the agenda, instructions, and participants. Records of each in-service education program shall be kept on file and available for inspection.

3214.5 Each nursing employee shall be encouraged to attend education and training programs conducted in the community that relate to nursing practice.

3214.6 Each facility shall have space for conducting in-service programs.

3214.7 Each nursing employee shall be trained in areas that address the special health care needs of the elderly and the needs of specific populations, including the following:

(a) Emergency procedures;

(b) Emergency transport of residents;

(d) Disaster plans and fire evacuation plans;

(e) Race;

(f) Ethnicity;

(g) Religious affiliation;

(h) Sexual orientation;

Gender; and

(j) Gender identity.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002); as amended by Notice of Final Rulemaking published at 58 DCR 10619, 10623 (December 16, 2011).

22-B DCMR § 3215 VENTILATOR CARE SERVICES

3215.1 The facility may care for ventilator patients in a ventilator care area upon compliance with Title III of the Nursing Home and Community Residence Facility Residents' Protections Act of 1985, effective April 18, 1986, D.C. Law 6-108, D.C. Code § 32-1431 et seq.

3215.2 Ventilator care shall be supervised by a physician who has special training and experience in diagnosing, treating and assessing problems related to ventilator patients.

3215.3 The facility shall ensure that ventilator care services are provided by a sufficient number of qualified staff and that personnel provide ventilator care services commensurate with their documented training, experience, and competence.

3215.4 As appropriate, ventilator care personnel shall be competent in the following:

(a) The fundamentals of cardiopulmonary physiology and of fluids and electrolytes;

(b) The recognition, interpretation and recording of signs and symptoms of respiratory dysfunction and medication side effects, particularly those that require notification of a physician;

(d) The mechanics of ventilation and ventilator function;

(e) The principles of airway maintenance, including endotracheal and tracheotomy care;

(f) The effective and safe use of equipment for administering oxygen and other therapeutic gases and providing humidification, nebulization, and medication;

(g) Pulmonary function testing and blood gas analysis when these procedures are performed within the ventilator care unit;

(h) Methods that assist in the removal of secretions from the bronchial tree, such as hydration, breathing and coughing exercises, postural drainage, therapeutic percussion and vibration, and mechanical clearing of the airway through proper suctioning technique;

(i) Procedures and observations to be followed during and after extubation; and

(j) Recognition of and attention to the psychosocial needs of residents and their families.

3215.5 The facility shall ensure that each ventilator is equipped with an alarm, designed to alert the nursing station, on both the pressure valve and the volume valve.

3215.6 In order to operate a ventilator unit, a facility shall develop and the Department of Health shall approve, a plan of operation which shall include:

(a) A description of the services to be provided;

(b) A description of the staffing pattern;

(d) A quality assurance plan which shall include:

(1) Assignment of responsibility for monitoring and evaluation activities;

(2) Identification of indicators and appropriate clinical critical criteria for monitoring the most important aspects; and

(3) Establishment of thresholds (levels or trends) for the indicators that will trigger evaluation of care;

(e) Policies and procedures on the following:

(1) The transfer or referral of residents who require services that are not provided by the nursing facility;

(2) The administration of medicines unique to the needs of the special care residents;

(3) Infection control measures to minimize the transfer of infection in the ventilator unit;

(4) Pertinent safety practices, including the control of fire and medical hazards; and

(5) Protocols for emergency situations.

3215.7 When the ventilator care services are provided by an outside contractor, the facility shall:

(a) Approve the contractor based on the contractor's credentials, qualifications and experience; and

(b) Ensure that all contractors:

(1) Provide services twenty-four hours a day;

(2) Meet all safety requirements;

(3) Abide by all pertinent policies and procedures of the facility;

(4) Provide services in accordance with the law governing the facility;

(5) Participate in the monitoring and evaluation of the appropriateness of services provided as required by the facility's quality assurance program; and

(6) Ensure that all contractural services are under the supervision of the facility's medical director or the physician employed by the facility to coordinate ventilator care services.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3216 FREEDOM FROM RESTRAINTS

3216.1 Each resident has the right to be free from unnecessary physical and chemical restraints.

3216.2 Each facility shall have written policies which define its approach to the use of physical and chemical restraints.

3216.3 If the facility employs a chemical or physical restraint, the facility shall include in the resident's interdisciplinary care plan a program to reduce or eliminate the use of the restraint.

3216.4 Physical restraints shall only be applied if:

(a) The facility has explored or tried less restrictive alternatives to meet the resident's needs and such trials have been documented in the resident's medical record as unsuccessful;

(b) The restraint has been ordered by a physician, to treat a medical symptom, for a specified period of time;

(c) The resident is released, exercised and toileted at least every two (2) hours, except when a resident's rest would be unnecessarily disturbed;

(d) The use of the restraint does not result in a decline in the resident's physical, mental, psychosocial or functional status; and

(e) The use of the restraint is assessed and re-evaluated when there is a significant change in the resident's condition, and on an ongoing basis until the need for the restraint no longer exists.

3216.5 In an emergency and when alternative actions are not successful, the placement of an appropriate physical restraint may be authorized by a registered nurse only to protect the resident from immediate injury to himself or herself or to protect others, in which case a written order of a physician or nurse practitioner shall be obtained by a licensed nurse within four hours.

3216.6 Chemical restraints shall not be administered unless:

(a) Ordered by a physician or nurse practitioner after thorough interdisciplinary assessment and care planning, including an evaluation of alternatives to the use of chemical restraints and behavioral interventions to manage and improve behavioral symptoms, which must be carried out and documented in the resident's medical record;

(b) The use of the chemical restraint does not result in a decline in the resident's physical, mental, psychosocial or functional status; and

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002); as amended by Notice of Final Rulemaking published at 49 DCR 6824 (July 19, 2002).

22-B DCMR § 3217 INFECTION CONTROL

3217.1 The facility shall have an Infection Control Committee composed of the Administrator or designee and members of the medical, nursing, dietary, pharmacy, housekeeping, maintenance, and other services.

3217.2 The Chairperson of the Infection Control Committee shall be knowledgeable about or have experience in infection control.

3217.3 The Infection Control Committee shall establish written infection control policies and procedures for at least the following:

(a) Investigating, controlling, and preventing infections in the facility;

(b) Handling food;

(d) Disposing of environmental and human wastes;

(e) Controlling pests and vermin;

(f) The prevention or spread of infection;

(g) Recording incidents and corrective actions related to infections; and

(h) Nondiscrimination in admission, retention, and treatment of persons who are infected with the HIV virus or who have a diagnosis of AIDS.

3217.4 The Infection Control Committee shall hold quarterly meetings, maintain minutes and submit written quarterly reports to the Administrator.

3217.5 The Infection Control Committee shall review infection control policies and procedures annually and revise them as needed.

3217.6 The Infection Control Committee shall ensure that infection control policies and procedures are implemented and shall ensure that environmental services, including housekeeping, pest control, laundry, and linen supply are in accordance with the requirements of this chapter.

3217.7 The Infection Control Committee shall ensure that in-service training on infection control policies and procedures is provided at least annually to each employee of each service represented on the Committee.

3217.8 Each occurrence of a communicable disease, as defined by District of Columbia law shall be reported immediately by the examining physician or chairperson of the Infection Control Committee to the Administrator, Director of Nursing Services, and the Department of Health.

3217.9 The Infection Control Committee shall use the latest edition of "Guidelines for Infection Control in Long Term Care Facilities" published by the Centers for Disease Control (CDC) or any additional guidelines published by the CDC for the purpose of developing policies and procedures.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3218 DIETARY SUPERVISION

3218.1 Nursing employees shall ensure that each resident receives the diet prescribed and shall note any dietary problem in the resident's medical record.

3218.2 Each resident who needs assistance to eat shall receive it promptly upon the serving of his or her meals.

3218.3 Special eating equipment and utensils shall be provided for each resident who needs them.

3218.4 The facility shall ensure that residents are fed in accordance with the comprehensive assessment and in accordance with section 3207.6 of this chapter.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3219 DIETARY SERVICES

3219.1 Food and drink shall be clean, wholesome, free from spoilage, safe for human consumption, and served in accordance with the requirements set forth in Title 23, Subtitle B, D.C. Municipal Regulations (DCMR), Chapters 24 through 40.

3219.2 Each facility shall employ sufficient food service employees who are competent and qualified to carry out the functions of the dietary services.

3219.3 A regularly scheduled program of in-service education shall be conducted for all food service employees hired after the effective date of these regulations. Records should be maintained on in-service programs and shall be available for review.

3219.4 The curriculum for regularly scheduled in-service education programs for food service employees may include, but not be limited to, the following:

(a) Disaster and emergency procedures;

(b) Infection control;

(d) Therapeutic diets;

(e) Food handling;

(f) Personal hygiene;

(g) Residents' rights; and

(h) Psychological aspects of aging.

3219.5 Each food service employee shall wear clean, washable garments while working, and shall keep his or her hands clean at all times.

3219.6 Each food service employee shall wear either a hair net or other head covering.

3219.7 No smoking or tobacco products shall be permitted in the food preparation area.

3219.8 Food waste shall be disposed of in a garbage disposal system or garbage grinder which is conveniently located near each activity and which has adequate capacity to dispose of all readily grindable food waste (garbage) produced.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3220 GENERAL DIETARY REQUIREMENTS

3220.1 Meals shall be adjusted to include fresh fruits and vegetables in season.

3220.2 The temperature for cold foods shall not exceed forty-five degrees (45 [degrees]) Fahrenheit, and for hot foods shall be above one hundred and forty degrees (140 [degrees]) Fahrenheit at the point of delivery to the resident.

3220.3 If a resident refuses food, appropriate substitutions of comparable nutritive value shall be offered at the same mealtime.

3220.4 Each therapeutic diet shall be prescribed by the attending physician and prepared under the guidance of a dietitian.

3220.5 Each therapeutic diet prescription shall be a part of the resident's medical record.

3220.6 Each change in a therapeutic diet order shall be authorized by the attending physician and shall be forwarded in writing to the Dietary Service.

3220.7 The dietitian preparing the therapeutic diet shall have access to the resident's medical record and shall document each observation, consultation and instruction regarding the resident's acceptance and tolerance of his or her prescribed diet.

3220.8 The supervisor or manager of food services shall make weekly rounds at mealtime to observe the preparation and serving of food to residents in order to determine general acceptance of the food by residents.

3220.9 An adequate supply of fresh water shall be available to residents at all times.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3221 DIETARY MANAGEMENT AND RECORDS

3221.1 Each menu, as planned and served, shall be filed and retained for one year.

3221.2 Documentation of the food purchased shall be retained for ninety (90) days.

3221.3 A three (3) day supply of non-perishable staples shall be maintained on the premises.

3221.4 A file of each tested recipe, adjusted to appropriate yield, shall be maintained and used by each employee who prepares food.

3221.5 A two (2) day supply of perishable foods shall be maintained on the premises.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002); as amended by Notice of Final Rulemaking published at 49 DCR 6824 (July 19, 2002).

22-B DCMR § 3222 IMMUNIZATIONS

3222.1 As described further in this Section, each facility shall ensure that each resident and each employee has either received immunization against influenza virus or has refused such vaccination, and that each resident and each employee indicated in subsection 3222.6 has either received immunization against pneumococcal disease or has refused such vaccination. The facility shall be required to maintain written evidence of each such immunization or refusal.

3222.2 Influenza and pneumococcal immunizations shall be provided and updated in accordance with the latest recommendations of the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention. To the extent that the ACIP recommendations may differ from the terms of this Section, the ACIP recommendations shall control.

3222.3 Except as provided in subsection 3222.9, each resident and each employee shall, no later than November 30th of each calendar year or six (6) weeks after the vaccination becomes readily available in the District of Columbia, whichever is later, undergo immunization for influenza virus as required pursuant to subsection 3222.2. The facility shall provide the immunization to each resident, except as described in subsection 3222.4, and shall document the immunization.

3222.4 Pursuant to subsection 3222.3, each resident or employee may obtain the required immunization from a medical provider of his or her choice. If the resident or employee obtains such immunization from a provider other than the facility, the resident or employee shall provide the facility, no later than November 30th or six (6) weeks after the vaccination becomes readily available in the District of Columbia, whichever is later, with documentation of the immunization. The facility shall record such documentation within twenty-four (24) hours of its receipt.

3222.5 The facility shall, for each resident admitted between December 1st and March 31st, and for each employee hired between December 1st and March 31st, determine, within seventy-two (72) hours of admission or the start of employment, whether the resident or employee has received immunization against influenza virus as required pursuant to subsections 3222.2, 3222.3, and 3222.4. If the facility determines that a resident has not received such immunization, the facility shall provide it within seventy-two (72) hours of the determination, except as provided in subsections 3222.4 and 3222.9. If the facility determines that an employee has not received such immunization, the facility shall instruct the employee to obtain the immunization and to provide documentation thereof, or of refusal, to the facility within seven (7) days of the determination.

3222.6 Except as provided in subsection 3222.9, each resident and each employee in the categories described below shall, no later than one hundred eighty (180) days after the effective date of this Section or thirty (30) days after admission to the facility or the start of employment, whichever is later, undergo immunization for pneumococcal disease as required pursuant to subsection 3222.2. The facility shall provide the immunization to each resident, except as described in subsection 3222.7, and shall document the immunization. The following persons shall undergo immunization for pneumococcal disease:

(a) Residents and employees sixty-five (65) years of age or older;

(c) Residents and employees under the age of sixty-five (65) years who are immunocompromised, receiving immunosuppressive therapy, or who have received an organ or bone marrow transplant.

3222.7 Pursuant to subsection 3222.6, each affected resident or employee may obtain the required immunization from a medical provider of his or her choice. If the resident or employee obtains such immunization from a provider other than the facility, the resident or employee shall provide the facility, no later than one hundred eighty (180) days after the effective date of this Section or thirty (30) days after admission to the facility or the start of employment, whichever is later, with documentation of the immunization. The facility shall record such documentation within twenty-four (24) hours of its receipt.

3222.8 Each resident and each employee affected by subsection 3222.6 shall be revaccinated against pneumococcal disease according to the schedule below. The facility shall provide the revaccination or shall obtain documentation of the revaccination provided elsewhere, as required by subsections 3222.6 and 3222.7, and shall document the revaccination, according to the schedule below. The following persons shall be revaccinated as indicated:

(a) Residents and employees sixty-five (65) years of age and older: a single revaccination at or after age sixty-five (65) if the person has been previously vaccinated and five (5) or more years have elapsed since the previous vaccination;

(b) Residents and employees under the age of sixty-five (65) years with chronic cardiovascular disease, chronic pulmonary disease, diabetes mellitus, alcoholism, chronic liver disease, or cerebrospinal fluid leaks: a single revaccination at or after age sixty-five (65) if the person has been previously vaccinated and five (5) or more years have elapsed since the previous vaccination; and

(c) Residents and employees under the age of sixty-five (65) years with functional or anatomic asplenia, or who are immunocompromised, receiving immunosuppressive therapy, or have received an organ or bone marrow transplant: a single revaccination if five (5) or more years have elapsed since the previous vaccination.

3222.9 No resident or employee shall be required to receive either an influenza virus immunization or a pneumococcal disease immunization if such immunization is medically contraindicated for that individual, or if such immunization is against the resident or employee's religious beliefs, or if the resident, the resident's representative or legal guardian, or the employee knowingly refuses such immunization.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002); as amended by Notice of Final Rulemaking published at 49 DCR 6824 (July 19, 2002).

22-B DCMR § 3223 REHABILITATIVE SERVICES

3223.1 Each rehabilitative service aide shall be under the supervision of a licensed therapist.

3223.2 There shall be a regularly scheduled program of in-service education programs for the rehabilitative services staff.

3223.3 Rehabilitative services shall be provided under a written plan of care which includes modality, frequency, duration, and goals of care.

3223.4 Each therapist's treatment plan and progress notes for each resident shall be signed, dated, and placed in the resident's medical record, and shall provide sufficient information so that the resident's activity can be maintained and supported by nursing employees.

3223.5 Each resident who receives therapy shall be reevaluated by his or her therapist at least every thirty (30) days and each such evaluation shall be signed by the resident's physician.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3224 SUPERVISION OF PHARMACEUTICAL SERVICES

3224.1 Each facility shall establish methods and written procedures for dispensing and administering drugs and biologicals.

3224.2 The pharmaceutical services shall be under the supervision of a licensed pharmacist for developing, coordinating and supervising pharmaceutical services.

3224.3 The supervising pharmacist shall do the following:

(a) Review the drug regimen of each resident at least monthly and report any irregularities to the Medical Director, Administrator, and Director of Nursing Services;

(b) Submit a written report to the Administrator on the status of the pharmaceutical services and staff performance, at least quarterly;

(c) Provide a minimum of two (2) in-service sessions per year to all nursing employees, including one (1) session that includes indications, contraindications and possible side effects of commonly used medications;

(d) Establish a system of records of receipt and disposition of all controlled substances in sufficient detail to enable an accurate reconciliation; and

(e) Determine that drug records are in order and that an account of all controlled substances is maintained and periodically reconciled.

3224.4 If the facility has an on-site pharmacy, it shall be administered by the supervising licensed pharmacist.

3224.5 If the facility does not have a pharmacy, it shall arrange for prompt and convenient methods to obtain prescribed medications and biologicals twenty-four (24) hours a day from a provider pharmacy and shall contract with a consultant pharmacist who shall supervise pharmaceutical services.

3224.6 Any arrangement by a facility to obtain prescribed medications and biologicals from a provider pharmacy shall be pursuant to a written agreement between the facility and the provider pharmacist; any arrangement by the facility to employ a consultant pharmacist shall be pursuant to a written agreement between the facility and the consultant pharmacist.

3224.7 If the facility does not have a pharmacy but maintains a supply of medications, the consulting or supervisory pharmacist shall do the following:

(a) Control all bulk medications and maintain records of receipt and disposition;

(b) Dispense medication, properly label them, and make them available to appropriate licensed nursing employees;

(d) Be a member of the Infection Control Committee and be available for resident care meetings.

3224.8 Controlled substances shall be handled and managed in accordance with the District of Columbia Uniform Controlled Substances Act of 1981, effective August 5, 1981, D.C. Law 4-29, D.C. Code 33-501 et seq.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3225 PHYSICIAN ORDERS FOR MEDICATIONS

3225.1 A medication may only be administered to a resident if it has been ordered in writing by a physician, except as provided by subsection 3225.2.

3225.2 Medication may be ordered by telephone if:

(a) The order is given by a physician or licensed advanced registered nurse;

(b) The order is reduced to writing immediately in the resident's medical record by the person taking the order; and

(c) The order is taken by a licensed registered or practical nurse and countersigned by the physician within ten (10) days.

3225.3 Physician orders may be transmitted by facsimile if the facility establishes adequate safeguards to ensure secure transmittal.

3225.4 Each medication order shall state:

(a) The name and strength of the medication;

(b) The dosage;

(d) The form of the drug;

(e) The frequency and time of administration; and

(f) The route of administration.

3225.5 The attending physician shall record on the resident's medical record each condition for which the medication has been ordered.

3225.6 Each allergy shall be documented in the resident's medical record.

3225.7 Each resident's attending physician shall be notified of any stop order policies and contacted promptly by the licensed nurse for renewal of each medication order to provide continuity of the resident's therapeutic regimen.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3226 ADMINISTRATION OF MEDICATION

3226.1 Unless administered under a self-administer order, all medication shall be prepared and administered only by a licensed physician or by a licensed nurse.

3226.2 Each dose of medication shall be properly and promptly recorded and initialed in the resident's medical record by the person who administers it.

3226.3 Each item necessary for the proper preparation and administration of medication shall be available at each nursing station.

3226.4 All medication shall be prepared immediately preceding administration and each person who prepares the medication shall administer the medication.

3226.5 The medication for self-administration shall be securely stored and accessible only to the appropriate resident and staff.

3226.6 Medication shall be released to a resident upon discharge only on the authorization of his or her physician.

3226.7 Current medication reference text and sources of information such as text on pharmacology, dosages, the "Physician's Desk Reference" or the "American Society of Hospital Pharmacists Formally" shall be available at each nursing station.

3226.8 No medication shall be administered to a resident more than sixty (60) minutes before or after the time stated in the prescription order by his or her physician.

3226.9 The facility shall document medication errors and error rates, and shall maintain the documentation for a period of three years from the date of the error.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3227 LABELING AND STORAGE OF MEDICATION

3227.1 Medication shall be stored in accordance with this section.

3227.2 Each medication area, including each cabinet or cart shall be well lighted and large enough to permit storage without crowding and shall be clean and orderly.

3227.3 Proper storage temperature shall be maintained for each medication according to the manufacturer's direction.

3227.4 Medication that is dispensed by a pharmacy within the facility for use within the facility shall be labeled to identify the generic chemical or brand name, strength, lot number and expiration date.

3227.5 Each label shall be securely affixed to the outside of each medication container.

3227.6 Each medication of each resident shall be kept in its original container.

3227.7 Each medication that requires refrigeration shall be kept in a pharmaceutical refrigerator or in a separate locked compartment within a refrigerator at each nursing station.

3227.8 Each refrigerator that is used for storage of medications shall operate at a temperature between thirty-six degrees (36 [degrees]) and forty-six degrees (46 [degrees]) Fahrenheit; each refrigerator shall be equipped with a thermometer that is easily readable, accurate and in proper working condition.

3227.9 Each medication that is labeled poisonous shall be kept separate from other medications in a locked cabinet.

3227.10 Each medication container that has a soiled, damaged, illegible or otherwise incomplete label on it shall be returned to the pharmacy for relabeling or shall be destroyed.

3227.11 No employee other than a pharmacist shall package, repackage, return to a container or label in whole or in part any medication, or alter in any way a medication label.

3227.12 Each expired medication shall be removed from usage.

3227.13 Each medication that is no longer in use shall be destroyed or returned to the in-house pharmacy.

3227.14 Destruction of controlled substances shall be witnessed by two (2) licensed nurses and a signed and dated notation shall be made in the resident's medical record.

3227.15 Each unopened, sealed medication may be returned to the issuing pharmacy.

3227.16 No medication container shall be reused.

3227.17 A separate double locked cabinet, permanently affixed compartment box or drawer within a locked cabinet shall provide for the storage of each substance that is controlled by the D.C. Uniform Controlled Substance Act, effective August 5, 1981, D.C. Law 4-29, D.C. Code § 33-501 et seq., and other drugs subject to abuse, except when the facility uses single unit package drug distribution systems in which the quantity stored is minimal and missing doses can be readily detected.

3227.18 Each facility shall comply with all applicable District and federal laws, regulations, standards, administrative guidelines, and rules that regulate the procurement, handling, storage, administering, and recording of medication.

3227.19 The facility shall label drugs and biologicals in accordance with currently accepted professional principles, and include the appropriate accessory and cautionary instructions, and their expiration date.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002); as corrected by Errata Notice published at 55 DCR 12957 (December 26, 2008).

22-B DCMR § 3228 PODIATRY SERVICES PROGRAM

3228.1 Each facility shall have a written agreement for obtaining regular podiatry services with a podiatrist licensed in the District of Columbia.

3228.2 Podiatry services shall include direct services to residents, as well as consultation and in-service training for nursing employees.

3228.3 Each facility shall make available podiatry services upon need or request by a resident.

3228.4 If podiatry services are established and staffed by the facility, appropriate space and proper maintenance of equipment shall be provided at all times.

3228.5 Each medication or treatment that is prescribed by the podiatrist shall be in writing and included as part of the resident's medical record.

3228.6 Each resident's attending physician shall be notified prior to implementation of the podiatrist's order.

3228.7 Nursing employees shall assist a resident in carrying out the podiatrist's orders.

3228.8 Each treatment by the podiatrist shall be documented at the time of each visit and included in the medical record of each resident and the resident's attending physician shall be contacted if there are abnormal findings.

3228.9 Each resident shall have the right to select his or her podiatrist.

3228.10 Each facility shall develop policies and procedures which describe the objectives and scope of podiatry services.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3229 SOCIAL SERVICES

3229.1 The facility shall provide social services to attain and maintain the highest practicable physical, mental, and psychosocial well-being of each resident.

3229.2 A nursing facility with more than 120 beds shall employ a full-time social worker who is licensed in the District of Columbia pursuant to the District of Columbia Health Occupations Revision Act of 1985, effective March 25, 1986, D.C. Law 6-99, D.C. Code § 2-3301 et seq.

3229.3 The facility shall meet the social services needs of its residents by either obtaining social services from an outside source or by furnishing the service directly.

3229.4 In conjunction with the resident's admission, stay, and discharge, the functions of the social services program shall include the following:

(a) Direct service, including therapeutic interventions, casework and group work services to residents, families and other persons considered necessary by the social worker;

(b) Advocacy on behalf of residents;

(d) Community liaison and services;

(e) Consultation with other members of the facility's Interdisciplinary Care Team;

(f) Safeguarding the confidentiality of social service records; and

(g) Annual in-service training to other staff of the facility on subjects including, but not limited to, resident's rights, psychosocial aspects of aging and confidentiality.

3229.5 The social assessment and evaluation, plan of care and progress notes, including changes in the resident's social condition, shall be incorporated in each resident's medical record, reviewed quarterly, and revised as necessary.

3229.6 Each facility shall provide space which ensures visual and auditory privacy for social service interviews with residents.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3230 RESIDENT ACTIVITIES

3230.1 In facilities of sixty (60) or more licensed beds, the activities program shall be directed by a recreational therapist or activities staff certified or recognized by an accredited body.

3230.2 Each resident shall be encouraged, but not required, to participate in the resident activities program.

3230.3 A resident activities program shall include, but not be limited to, the following:

(a) Active, passive, individual and group activities; and

(b) Activities for residents who are unable to leave their rooms, which shall be directed toward maintaining and promoting the well-being of each resident.

3230.4 Each facility shall provide the following:

(a) A diversity of physical, social, intellectual, spiritual, cultural, and recreational activities;

(b) Activities for bedridden residents, including, but not limited to:

(1) Large print books, current magazines and periodicals;

(2) A record or tape player;

(3) A television;

(4) A radio;

(5) Craft supplies; and

(6) Puzzles, games and playing cards;

(d) Opportunity for interested family members and friends of residents to participate in facility activities that are specifically designed to include interested family members and friends;

(e) Opportunity to participate in community activities;

(f) Indoor and outdoor activities; and

(g) The opportunity to implement a pet program and, if adopted, development of policies and procedures for the care and maintenance of the animals.

3230.5 The responsibilities of the director of the activities program or his or her designee shall include, but not be limited to, the following:

(a) To provide direction and quality guidelines of the program;

(b) To develop and maintain a plan for the program and procedures for implementing the plan;

(c) To plan and budget for the program, including the number and levels of employees to be hired and the equipment and supplies to be purchased;

(d) To coordinate and integrate the program with other resident care services provided in the facility and in the community;

(e) To assist in the development of and participate in staff orientation and annual education programs for all staff in the facility;

(f) To develop a written monthly activities schedule in a large print calendar that includes date, time and location of each scheduled activity;

(g) To post the activities schedule on the first working day of each month at each nursing unit, at a height that can be clearly seen by residents in wheelchairs;

(h) To assure that visually, hearing and cognitively impaired residents know about posted activities;

(i) To assess the therapeutic activity needs and interests of each resident within fourteen (14) days of admission; and

(j) To participate in the development of an interdisciplinary care plan and reassess each resident's responses to activities at least quarterly after reviewing with each resident his or her participation in the activities program.

3230.6 Based on a resident’s right to participate in resident and family groups, each facility shall make available to any resident or family group the following:

(a) Promotional and advertising assistance so that residents and residents’ family members are aware of their right to convene groups;

(b) Adequate meeting space and logistical assistance;

(c) Information regarding policies and procedures for nursing home care, resident rights and responsibilities, and laws and rules that apply to the facility and its residents;

(d) Staff for the operation of each meeting, upon request from the group; and

(e) Written feedback and responses to recommendations and grievances.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002); as amended by Notice of Final Rulemaking published at 58 DCR 10619, 10623 (December 16, 2011).

22-B DCMR § 3231 MEDICAL RECORDS

3231.1 The facility Administrator or designee shall be responsible for implementing and maintaining the medical records service.

3231.2 A designated employee of the facility shall be assigned the responsibility for ensuring that each medical record is maintained, completed and preserved.

3231.3 The training for the designated employee shall include the following areas:

(a) Medical terminology;

(b) Disease index coding systems;

(d) Filing;

(e) Storage; and

(f) Analysis of records.

3231.4 The facility shall provide in-service training on medical records policies and procedures on reporting, recording, and legal aspects of documentation annually to each employee who writes in the medical records.

3231.5 The medical records shall be completed within thirty (30) days from the date of discharge.

3231.6 Each medical record shall be indexed according to the name of the resident and final diagnosis to facilitate acquisition of statistical medical information and retrieval of records for research or administrative action.

3231.7 Basic information to be indexed by each diagnosis shall include at least the following:

(a) Medical record number;

(b) Age;

(d) Physician; and

(e) Length of stay in days.

3231.8 Each facility shall maintain an area for processing medical records with adequate space, equipment, supplies, and lighting for staff.

3231.9 Each medical record shall serve as a basis for planning resident care and shall provide a means of communication between the physician and other employees involved in the resident's care.

3231.10 Each medical record shall document the course of the resident's condition and treatment and serve as a basis for review, and evaluation of the care given to the resident.

3231.11 Each entry into a medical record shall be legible, current, in black ink, dated and signed with full signature and discipline identification.

3231.12 Each facility shall ensure that each medical record shall include the following information:

(a) The resident’s name, age, height, weight, sex, date of birth, race, marital status, home address, telephone number, and religion;

(b) Full names, addresses, and telephone numbers of the personal physician, dentist, and interested family member, including the designated family representative, or sponsor;

(d) Social security and other entitlement numbers;

(e) Date of admission, results of pre-admission screening, admitting diagnoses, and final diagnoses;

(f) Date of discharge and condition on discharge;

(g) Hospital discharge summaries or a transfer form from the attending physician;

(h) Medical history and allergies;

Descriptions of physical examinations, diagnoses, and prognoses;

(j) Rehabilitation potential;

(k) Vaccine history, if available, and other pertinent information about immune status in relation to vaccine-preventable disease;

(l) The current status of the resident’s physical and mental condition;

(m) Physician progress notes which shall be written at the time of observation to describe significant changes in the resident’s condition, when medication or treatment orders are changed or renewed or when the resident’s condition remains stable;

(n) The resident’s medical experiences upon discharge, which shall be summarized by the attending physician and shall include final diagnoses, course of treatment in the facility, essential information of illness, medications on discharge and location to which the resident was discharged;

(o) Nurse’s notes which shall be kept in accordance with the resident’s medical assessment and the policies of the nursing service;

(p) A record of the resident’s assessment and ongoing reports of physical therapy, occupational therapy, speech therapy, podiatry, dental, therapeutic recreation, dietary, and social services;

(q) The plan of care;

(r) Consent forms and advance directives; and

(s) A quarterly inventory of the resident’s personal clothing, belongings, and valuables.

3231.13 The facility shall permit each resident to inspect his or her medical records on request.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002); as amended by Notice of Final Rulemaking published at 58 DCR 10619, 10624 (December 16, 2011).

22-B DCMR § 3232 INCIDENT REPORTING

3232.1 Each facility shall maintain and keep for three (3) years, from the date of the incident, summaries and analyses of unusual incidents within the facility or on the premises with regard to a resident, visitor or employee, including but not limited to accidents, injuries, drug errors, abuse, neglect and misappropriation of resident funds.

3232.2 A summary and analysis of each incident shall be completed immediately and reviewed within forty-eight (48) hours of the incident by the Medical Director or the Director of Nursing and shall include the following:

(a) The date, time and description of the incident;

(b) The name of the witnesses;

(d) A statement indicating whether there is a pattern of occurrence; and

(e) A description of the corrective action taken.

3232.3 Summaries and analyses of incidents shall be reviewed at least monthly by the Administrator or designee in order to identify and correct health and safety hazards and patterns of occurrence.

3232.4 Each incident shall be documented in the resident's record and reported to the licensing agency within forty-eight (48) hours of occurrence, except that incidents and accidents that result in harm to a resident shall be reported to the licensing agency within eight (8) hours of occurrence.

3232.5 Incidents of abuse or neglect resulting in injury to a resident, or incidents of misappropriation of a resident's funds, shall be reported immediately to the appropriate agencies, including the Department of Health, the Metropolitan Police Department, the Long-Term Care Ombudsman and Adult Protective Services.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3233 GRIEVANCES

3233.1 Each facility shall provide each resident, or Resident's Representative, an opportunity to file a grievance with the Administrator, either orally or in writing, concerning any aspect of the resident's care, treatment or living conditions at the facility.

3233.2 Each facility shall provide each resident a written form on which a grievance may be filed, and an opportunity to file a copy of the grievance with the Director.

3233.3 If a grievance is filed orally, the Administrator shall ensure that the grievance is immediately reduced to writing and sets forth the name of the resident, date and time of the grievance, and the specific details of the grievance. The facility shall ensure that the resident has an opportunity to review the grievance as recorded and to file a copy thereof with the Director.

3233.4 The Administrator or designee of each facility shall review each grievance filed within seventy-two (72) hours of its filing and shall respond in writing to the resident or the Resident's Representative within five (5) business days.

3233.5 Each facility shall use its best efforts to resolve each grievance as soon as practicable, and shall report to the resident and the Resident's Representative on the status of the resolution of the grievance at least every thirty (30) days.

3233.6 Facility records on grievances shall be maintained by the facility for at least three (3) years after the date of filing and shall be available to the Director.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3234 ENVIRONMENTAL REQUIREMENTS

3234.1 Each facility shall be designed, constructed, located, equipped, and maintained to provide a functional, healthful, safe, comfortable, and supportive environment for each resident, employee and the visiting public.

3234.2 Each facility shall comply with applicable provisions of the BOCA National Building Code; the BOCA International Plumbing Code; the BOCA International Mechanical Code; the NFPA National Elevator Code and other applicable federal and District of Columbia laws, as provided in this chapter. Any other provision of this chapter related to environmental requirements shall not apply to a facility that is licensed on the effective date of these rules and provides evidence that compliance would require major renovation.

3234.3 The physical plant shall provide maximum environmental support for the goals of each service that is offered and shall be responsive to the needs of each resident, employee, and the visiting public.

3234.4 The provision of space and the way in which the facility is equipped, furnished, and maintained shall provide a home-like setting for each resident while providing the staff a pleasant and functional working environment.

3234.5 Utilization of decoration, color, and furnishings shall be designed in order to minimize the institutional character of the facility.

3234.6 The limited mobility of each resident shall be considered in designating uses and proximity relationships for various rooms in the facility.

3234.7 The facility shall provide one (1) or more rooms designated for resident social, recreational, and dining activities which shall be:

(a) Easily accessible from each resident's bedroom;

(b) Well ventilated with designated smoking areas identified;

(d) Have sufficient space to accommodate all activities.

3234.8 The facility and its lighting system shall be designed, equipped and maintained to avoid high brightness, highly reflective surfaces and glare.

3234.9 Lighting levels throughout the facility shall conform to the minimum lighting level, as set forth in 3234.9, provided that the facility shall provide any additional lighting level as may be needed by residents with visual impairments and as may be needed for special tasks.

3234.10 The following minimum lighting levels shall be used throughout the facility:

MINIMUM LIGHTING LEVELS (FOOT-CANDLES ON THE TASK)

(AREA/ACTIVITY)

(FOOT CANDLES)

Barber/Beauty area

Corridors:

Nursing areas - day

Nursing areas - night

Dietary

Elevators

Examination room

Employee Lounge

Employee Locker Room

Linens:

Sorting soiled linens

Central (clean) linen supply

Linens rooms/closets

Janitor closet

Lobby:

General

Receptionist

Administrative spaces:

General office

Medical records

Conference/interview area/room

Mechanical/electrical room/space

Nursing station:

General

Desk

Medication area

Nourishment center

Corridors - day

Corridors - night

Occupational therapy

Work area, general

Work benches/tables

Resident room:

General

Reading/bed

Toilet

Physical Therapy

Resident Lounge:

General

Reading

Resident dining

Speech therapy

Stairways

Storage, general

Toilet/shower/bath

3234.10 Every habitable room shall contain windows of size, area, and specifications in accordance with the 1996 BOCA National Building Code.

3234.11 In habitable rooms, windows shall be of openable type, with sills no higher than three (3) feet above the floor.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3235 ELECTRICAL SYSTEMS

3235.1 Each electrical system shall be designed, constructed, maintained, and inspected in accordance with the 1996 NFPA National Electrical Code, and all other applicable District rules and regulations.

3235.2 Each electrical cord, appliance, and equipment shall be maintained in a safe operating condition, and each frayed wire and cracked or damaged switch and plug shall be replaced.

3235.3 Each facility shall have available, and in working order, an emergency electrical system.

3235.4 Each emergency electrical system shall provide lighting and power for night lights and for lights at each entrance, exit, stairway, corridor, boiler room, each piece of life support equipment, and each fire detection, alarm and extinguishing system in the event that the normal electrical supply is interrupted.

3235.5 When life support systems are used, the facility shall provide emergency electrical power with an emergency generator (as defined in the 1996 NFPA National Electrical Code, Health Care Facilities) that is located on the premises.

3235.6 Emergency power shall be provided for at least one (1) elevator which is accessible to each resident area.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3236 WATER SUPPLY AND DISTRIBUTION

3236.1 Each water supply and distribution system shall conform with the 1995 BOCA International Plumbing Code, District of Columbia Construction Code Supplement, Title 12 DCMR, and all other applicable District laws and regulations.

3236.2 There shall be no cross-connection between the potable safe water supply and each water supply that is non-potable, or any source of pollution through which a safe supply might become contaminated.

3236.3 Each sink, bathroom, bathtub, and shower shall have a continuous supply of hot and cold running water.

3236.4 The temperature of hot water of each fixture that is used by each resident shall be automatically controlled and shall not exceed one-hundred and ten degrees Fahrenheit (110 [degrees] F) nor be less than ninety-five degrees Fahrenheit (95 [degrees] F).

3236.5 Each water system shall also include a separate or booster supply at higher temperatures for kitchen, dish washing, and laundry uses.

3236.6 Water pressure shall be at least fifteen (15) pounds per square inch (p.s.i.) on each floor during each period of peak demand.

3236.7 Each drinking fountain that is accessible to a resident shall be installed in an area that is available for general resident use.

3236.8 The facility shall establish procedures for the provision of a safe and functional supply of water for emergency use when the normal supply of water is lost.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3237 SEWAGE AND SOLID WASTE DISPOSAL

3237.1 Each system for the disposal of water-carried sewerage shall be constructed, operated, and maintained in accordance with the 1995 BOCA International National Plumbing Code, District of Columbia Construction Code Supplement, Title 12 DCMR and all other applicable District laws and regulations.

3237.2 Solid waste management, including each disposal and incineration facility, shall comply with the provisions of the Environmental Regulations (Title 20 DCMR), the Alcoholic Beverages and Food regulations (Title 23 DCMR), the 1996 BOCA National Building Code, and all other applicable District laws and regulations.

3237.3 The frequency of trash and garbage pick-ups shall be adequate to prevent storage periods longer than four (4) days.

3237.4 Adequate facilities shall be provided for the collection and storage of trash and all other refuse accumulations.

3237.5 Trash and waste shall be handled and stored in a manner pursuant to the requirements set forth in Titles 20 and 23 of the DCMR.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3238 HEATING AND COOLING

3238.1 Each piece of heating and air conditioning equipment and its installation shall comply with the 1996 BOCA International Mechanical Code (Heating, Air Conditioning and Refrigeration), and all other applicable District laws and regulations.

3238.2 Each heating system shall be of a size and capacity to maintain a minimum temperature of seventy-one degrees Fahrenheit (71 [degrees] F).

3238.3 Each room that is used by a resident shall be maintained at a minimum temperature of seventy-one degrees Fahrenheit (71 [degrees] F) and a maximum of eighty-one degrees Fahrenheit (81 [degrees] F) at all times when the room is occupied.

3238.4 Each heating and cooling system shall be thermostatically controlled from one (1) or more areas, and shall be accessible to appropriate facility staff.

3238.5 Each heating fixture shall be properly shielded for the safety of each resident.

3238.6 Each heating source shall be equipped with hand controls.

3238.7 No portable room heater or space heater shall be permitted in any room.

3238.8 A fireplace may be utilized for decorative, social, and recreational purposes only.

3238.9 Only authorized persons shall have access to the boiler and the mechanical equipment room.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002); as corrected by Errata Notice published at 55 DCR 12957 (December 26, 2008).

22-B DCMR § 3239 VENTILATION AND EXHAUST

3239.1 Each facility shall be well ventilated through the use of windows, forced air, or both.

3239.2 Both natural and mechanical ventilation and exhaust shall comply with the provisions of the 1996 BOCA International Mechanical Code (Heating, Air Conditioning and Refrigeration), and all other applicable District laws and regulations.

3239.3 If only a natural ventilation is relied upon, the total open area shall equal at least 4% of the floor area served.

3239.4 When an open area other than windows is included in the required area, at least fifty percent (50%) of the required area shall be furnished by a window or windows.

3239.5 Ventilating skylights may be permitted to furnish not more than fifty percent (50%) of the required open area.

3239.6 Mechanical ventilation shall be provided in accordance with the latest edition of "Pressure Relationships and Ventilation of Certain Areas of Long Term Care Facilities" from the American Institute of Architects Committee on Architecture for Health, with assistance from the U.S. Dept. of Health and Human Services.

3239.7 In each area in which food or drink is served, a minimum of two (2) cubic feet per minute air changes of outside air per hour shall be provided.

3239.8 Each respiratory isolation room and connected bathroom shall be ventilated with negative pressure that shall prevent contamination of other areas.

3239.9 Each cooking unit that creates smoke, steam, gases, fumes, odors, vapors, or excessive heat shall be hooded and vented or locally vented to the outside air by forced draft in accordance with Title 23 of the DCMR.

3239.10 Each small burner that is used intermittently for short periods of time such as warming equipment, a bread toaster, coffee urn, and radiant cooking units shall not be vented unless it or a combination of the units create a nuisance.

3239.11 Each cooking unit ventilation hood shall be provided with an automatic fire extinguishing system.

3239.12 Each ventilation and exhaust system shall be maintained in good operating order.

3239.13 Air filters shall be provided and shall be properly cleaned, regularly replaced, and maintained in each circulating air system, including each individual air conditioning unit in each resident's room.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3240 ACOUSTICAL INSULATION AND NOISE REDUCTION

3240.1 No resident room or area shall have a general noise level from external sources in excess of forty-five (45) decibels.

3240.2 In addition to meeting the requirement of subsection 3240.1 every effort shall be made in the facility to reduce noise levels, airborne sound transmission, and their impact.

3240.3 Air space around each duct, other openings into rooms, and air space under and around each door and partition shall be properly sealed in order to maintain sound isolation.

3240.4 In each duct and fan installation, noise generation shall not exceed by more than ten (10) decibels the permissible noise level attributable to the external source in the area served.

3240.5 Wall-to-wall carpeting suitable for use under wheelchairs and rolling equipment shall be used in each resident area where the general noise level would otherwise exceed forty-five (45) decibels at anytime.

3240.6 Window curtains of a soft fabric, fabric wall hangings, and other materials that absorb sound shall be used in each area of high noise generation.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3241 ELEVATORS

3241.1 Each elevator shall be designed, constructed, maintained, and inspected in accordance with the 1996 NFPA National Elevator Code, and all other applicable District laws and regulations.

3241.2 An electric or electrohydraulic elevator shall be installed in the facility if either a resident's bedroom or other resident area is located on a floor above the street level.

3241.3 The facility shall have at a minimum one elevator large enough to accommodate a wheeled stretcher.

3241.4 Each car door or non-hospital type elevator shall have a minimum clear opening of thirty-two (32") inches.

3241.5 Each elevator car floor shall stop automatically flush with each floor level.

3241.6 Each elevator shall be equipped with a by-pass switch in order to enable emergency express use.

3241.7 The number of elevators in the facility shall be determined by an elevator needs study submitted by the owner of a nursing facility to be approved by the Director, and shall be provided in accordance with the latest edition of the "Guidelines for Construction and Equipment of Hospitals and Medical Facilities," published by the American Institute of Architects.

3241.8 Each elevator shall be timed to allow safe entrance and exit of residents.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3242 WALLS, CEILINGS, FLOORS, AND FINISHES

3242.1 Walls and floors shall be designed and maintained to minimize the incidence of accidents.

3242.2 Walls shall be made of materials that will permit frequent washing.

3242.3 The finish in areas exposed to water, high humidity, or grease shall be moisture-proof or grease-proof, or both.

3242.4 Floors shall be easily cleaned, and either carpeted or of non-slip surface.

3242.5 Floor materials shall be mounted flush with adjacent materials to provide unbroken surfaces facilitating wheelchair use.

3242.6 Door threshold and expansion joint covers shall be flush with the floor.

3242.7 The ceiling of each unheated room or of each room where there is high heat generation, such as boiler or laundry room, kitchen, and similar room, shall be insulated to prevent heat loss or transfer when the floor directly above is used by residents.

3242.8 Floors on grade or above air spaces shall be insulated to prevent heat loss.

3242.9 Each facility shall use lead-free paint inside the facility and shall remove or cover old paint or plaster containing lead so that it shall not be accessible to residents.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3243 RAMPS, STAIRS, AND CORRIDORS

3243.1 Doorway, passageway, and stairwell designs shall meet the requirements of the 1996 BOCA National Building Code and applicable District laws and regulations, NFPA Standard No. 101, Section 10-1 and 10-2, and the Uniform Federal Accessibility Standards (published pursuant to the Architectural Barriers Act, 42 U.S.C. §§ 4151 - 4157).

3243.2 Each circulation route shall be kept free from any obstruction at all times.

3243.3 Each ramp, stairway, and corridor that is used by a resident shall be equipped with firmly secured handrails or banisters on each side.

3243.4 Each handrail or banister end shall return to the wall.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3244 OUTDOOR SPACE

3244.1 Each facility shall provide in its design and on its property some outdoor area for use by residents, staff, and the visiting public for quiet recreation.

3244.2 No set of steps shall be included in the design of the outdoor space, and the space shall be accessible from the ground floor level of the facility without the use of ramps or steps.

3244.3 Outdoor space shall be well-planted and maintained, and it shall be of sufficient size and shape to permit sitting areas that are reasonably private.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3245 NURSING UNIT DESIGN

3245.1 A nursing station space shall be provided on each unit for the supervision and care of each resident.

3245.2 No resident's bedroom shall be located more than one-hundred and twenty (120) feet from the nursing station.

3245.3 Adequate space and facility for the proper and easy maintenance of medical records shall be provided at each nursing station, and shall include an ample writing surface, be well-lighted, and be within easy reach of file cabinets and other record storage equipment.

3245.4 Each nursing station shall be well-ventilated, reasonably insulated from sound, and equipped with a telephone.

3245.5 At least one (1) toilet room with a sink shall be provided for the nursing staff.

3245.6 Where unit-dose or a similar medication system is not used, a medication preparation and storage room adjacent to the nurses station shall be provided.

3245.7 Each nurses station shall be well-lighted, equipped with hot and cold water fixtures, a locked refrigerator, and other locked cabinets used only for storage of medications and drug supplies, including controlled substances. Access to these areas shall be limited to authorized nursing, medical or pharmacy staff.

3245.8 A clean workroom shall be provided for nursing procedures and shall include a work area and counter space for medication preparation separate from those for nursing procedures. A single sink unit may be used for both activities.

3245.9 A telephone shall be provided for use by employees.

3245.10 A call system that meets the following requirements shall be provided:

(a) Be accessible to each resident, indicating signals from each bed location, toilet room, and bath or shower room and other rooms used by residents;

(b) In new facilities or when major renovations are made to existing facilities, be of a type in which the call can be terminated only in the resident's room;

(d) Be in good working order at all times.

3245.11 Adequate storage space shall be provided in each nursing unit for the storage of equipment, clean linens, and other non-pharmaceutical supply items.

3245.12 Adequate utility room space shall be provided in each nursing unit for the separate handling of various soiled functions.

3245.13 Separate rooms shall be provided when various soiled functions should not be mixed. Each nursing unit room for various soiled functions shall contain the following:

(a) Clinical sink;

(b) Adequate work counters;

(d) Waste receptacles; and

(e) Soiled linen receptacles.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3246 RESIDENT BEDROOMS

3246.1 Each resident bedroom shall be designed and equipped for providing adequate nursing care, comfort, and privacy of residents.

3246.2 Each bedroom shall provide a personal, home-like atmosphere which includes the use of an eye-level mirror, and other personal belongings.

3246.3 Each bedroom shall have direct access to a corridor and at least one (1) window to the outside.

3246.4 No resident bedroom shall be located on a floor that is below grade level.

3246.5 If the room is not for single occupancy, each bed shall have flameproof ceiling suspended curtains which extend around each bed in order to provide the resident total visual privacy, in combination with adjacent walls and curtains.

3246.6 Each bedroom shall be equipped for each resident with the following minimum items:

(a) A separate bed of proper size and height for the convenience of the resident and appropriate to the resident's physical condition;

(b) A clean, comfortable mattress;

(d) Functional furniture appropriate to the resident's needs and individual closet space with clothes racks and shelves accessible to the resident;

(e) A call system meeting the requirements of section 3245.10;

(f) A bedside table or cabinet with some lockable storage space; and

(g) One (1) chair.

3246.7 One (1) or more bedrooms shall be designated, when needed, as isolation facilities for any resident who has an infectious or contagious disease.

3246.8 Each resident room shall be ventilated and shall have separate, adjacent toilet and bathing facilities.

3246.9 Each new facility and each facility proposing renovation that involves reconfiguration of resident rooms shall be designed so that each resident bedroom shall have no more than two (2) occupants.

3246.10 At least three (3) feet of space shall be maintained between a resident's bed and the next bed, between a resident's bed and the door and between the foot of a resident's bed and the wall.

3246.11 Each multiple-occupancy room shall provide no less than eighty (80) square feet per resident, exclusive of closets, toilet rooms, wardrobes, and vestibules.

3246.12 Each single-occupancy room shall provide no less than one-hundred (100) square feet per resident, exclusive of closets, wardrobes, toilet rooms, and vestibules.

3246.13 Each resident bedroom shall be designated by distinct letters or numbers on the door or the wall beside the door.

3246.14 In each new facility telephone jacks shall be installed in each resident room.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3247 RESIDENT TOILETS AND BATHROOM

3247.1 A toilet room shall be directly accessible from each resident's room and from each central bathing area without going through the general corridor.

3247.2 One (1) toilet room may serve two (2) resident rooms, but not more than four (4) beds.

3247.3 The sink may be omitted from the toilet room if a sink is provided in the room of the resident served by the toilet room.

3247.4 Each sink shall be installed with a proper trap in order to prevent its drain from clogging.

3247.5 Grab bars shall be installed in each toilet and bathing compartment.

3247.6 Each toilet and bathroom shall be equipped with sturdily mounted handrails in order to provide adequate assistance to each resident.

3247.7 Each bathtub shall be safe for use by residents.

3247.8 Door hardware on each toilet stall shall be of the type that shall operate both from the inside and outside.

3247.9 Connection to the nurses call system shall be provided in each toilet, tub, and shower stall and in each toilet room or wash room that is used by a resident.

3247.10 Each shower in newly constructed facilities shall be no less than four (4) feet square in size, including curbs, to prevent the flow of water from inside the shower.

3247.11 Each toilet, shower, or tub shall be installed in a separate stall or room.

3247.12 No less than one (1) one bath tub or shower shall be provided for every twenty (20) residents not otherwise served by bathing facilities in resident rooms.

3247.13 When multiple toilets are installed in the same room, sinks shall be provided in the ratio of at least one (1) for every three (3) toilets or urinals.

3247.14 In multiple installations, urinals may be substituted for toilets in male bathrooms in compliance with the 1995 BOCA International Plumbing Code.

3247.15 No resident toilet or bathing unit shall be used by staff.

3247.16 There shall be adequate clearance space at the front and each of the sides of the toilet, as well as adequate room for other fixtures and equipment, as needed.

3247.17 In common living or dining areas on floors where no residents live, at least one (1) toilet and one (1) sink shall be provided for each sex, for every fifty 50) residents. These toilets shall be located adjacent to the common areas.

3247.18 Rooms shall not be arranged in the facility so that the sole entrance or exit from any bedroom or bathroom is by way of any other bedroom, bathroom, or food-handling area.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3248 REFRESHMENT STATIONS

3248.1 Each nursing unit shall have a refreshment station area for use by the staff for the storage and serving of between-meal snacks to residents.

3248.2 The refreshment station area shall contain a refrigerator for food stuffs only, a sink, and equipment for heating foods and drinks.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3249 RESIDENT RECREATION AND SOCIAL AREAS

3249.1 Each nursing unit shall have, on the same floor as the unit, social recreation spaces in the amount of twenty (20) square feet per the average number of residents in the unit.

3249.2 Sound-insulated flexible partitions may be used to divide larger spaces.

3249.3 Each social area may also be used for small group dining, if there exists other social space sufficient to accommodate the average number of residents who may wish to occupy it at any one time.

3249.4 Each social area shall contain at least one (1) window providing natural light.

3249.5 Whenever possible, each social area shall be located along walls that receive at least two (2) hours of direct sunlight a day.

3249.6 Each social area shall be attractively furnished and attractively decorated.

3249.7 Each social area may contain plants and pets of suitable temperament.

3249.8 Furniture shall be arranged to facilitate small group conversation.

3249.9 A refreshment station shall be located near or adjacent to each social area.

3249.10 At least one (1) social area on each nursing unit shall be designated for quiet privacy and may be utilized by each resident and his or her visitor.

3249.11 Each facility shall provide at least one (1) room large enough to accommodate residents and staff for special events.

3249.12 The dining area may be used for social purposes when it can be shown that use of the room can be accommodated without interference with the facility's food services.

3249.13 For each newly constructed facility and those where there has been a change in the configuration of facility space, the social area shall be large enough for more than ten (10) residents.

3249.14 The facility shall make accessible to residents a semiprivate space where a telephone can be used.

3249.15 At least one (1) telephone equipped with an amplifier shall be available to residents.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3250 FOOD SERVICE AREAS

3250.1 Each food service area shall be planned, equipped, and operated in accordance with Title 23 DCMR, Chapters 22, 23 and 24, and with all other applicable District laws and regulations.

3250.2 Each facility shall have a kitchen area adequate to meet its food service needs.

3250.3 Each kitchen area shall be well ventilated and maintained at a comfortable temperature to protect the health and safety of employees.

3250.4 When food is prepared on the premises, each kitchen area shall be arranged and equipped for the refrigeration, storage, preparation and serving of food, as well as for dish washing, utensil washing, and refuse storage and removal.

3250.5 Each food preparation area shall be arranged for the separation of each function and shall be located to permit efficient service to the residents.

3250.6 A hand washing facility with single service towels shall be provided for kitchen employees in the areas where food is handled and in each separate area of the food operation.

3250.7 No food preparation area shall be used for non-dietary functions.

3250.8 A well-lighted, well-ventilated area shall be provided in the facility for any resident who is able to eat outside his or her room.

3250.9 At least twelve (12) square feet of floor area shall be provided for each resident who uses the dining room.

3250.10 Provisions shall be made for group dining.

3250.11 When residents are unable to go to the central dining room, a convenient area close to their living quarters shall be designed for group dining.

3250.12 Each dining area shall have windows and shall be pleasantly furnished and decorated in a home-like style.

3250.13 Special tables and extra square footage shall be provided in the dining area for wheelchair seating as needed.

3250.14 The facility shall furnish separate locker room or similar space for male and female food service employees in an area near the food service department.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3251 THERAPY SERVICE AREAS

3251.1 Each facility shall have therapy areas of sufficient size to accommodate and store all necessary equipment and supply items, and to facilitate the movement of the residents and staff.

3251.2 Appropriate equipment for each function performed in the therapy service areas shall be provided and properly installed, with utilities properly safeguarded.

3251.3 Space shall be provided for examinations, treatment, and other therapeutic activities and shall include:

(a) A treatment table or special treatment chair;

(b) A sink with accessible controls;

(d) An instrument table;

(e) Necessary equipment for the therapy provided, instruments and supplies; and

(f) Handicapped bathrooms accessible for residents' use equipped with handrails and grab bars.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3252 OTHER RESIDENT SERVICE AREAS

3252.1 Each facility shall provide a gift shop or resident store for a minimum of two (2) hours a day, five (5) days per week, or a gift shop cart must be accessible two (2) hours per day, five (5) days per week.

3252.2 Various services provided shall afford each resident an opportunity to purchase items such as magazines, candies, small gifts, postage stamps, stationery, writing implements, and other supplies.

3252.3 Vending machines alone are not sufficient to meet with the requirements of this section.

3252.4 Each facility shall have personal grooming services for both male and female residents.

3252.5 The services of a licensed barber or licensed beautician shall be available to residents.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3253 PUBLIC AND STAFF FACILITIES

3253.1 Toilet and washroom facilities shall be provided for the public.

3253.2 Toilets and sinks shall be provided for the staff.

3253.3 In existing facilities, a locker shall be provided for each employee and provision shall be made for the use of a conveniently located change area for each sex.

3253.4 In newly constructed facilities, separate locker rooms shall be provided for employees of each sex who do not live on the premises, with separate lockers for each employee.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3254 LAUNDRY AREAS

3254.1 An employee of the facility shall be responsible for ensuring that linens are in good condition.

3254.2 There shall be a separate area provided for the reception of all resident laundry, and it shall not be in any area where residents sleep, eat or otherwise frequent.

3254.3 Suitable bags shall be provided for resident linen and laundry.

3254.4 No resident linen shall be sorted, laundered, rinsed, or stored in any bathroom, resident room, kitchen, or food storage area.

3254.5 The linen supply shall be at least three (3) times the amount that is needed for the licensed occupancy.

3254.6 There shall be enough sheets to allow for one (1) bed change per shift for incontinent residents.

3254.7 There shall be enough towels and wash cloths to provide for at least one (1) set each day for each resident with additional sets available to allow for two (2) sets per shift for each incontinent resident.

3254.8 Clean linen and clothing shall be stored in clean, dry, dust-free areas that are easily accessible to each nurse's station.

3254.9 Each laundry facility shall be located in an area that is separate from the resident units and shall be provided with the necessary washing, drying, and ironing equipment.

3254.10 No laundry area shall be used as a passageway.

3254.11 Each dryer shall be vented to the outside and equipped with a removable lint trap.

3254.12 Each piece of electrical equipment shall be grounded in accordance with the 1996 NFPA National Electrical Code.

3254.13 Each piece of laundry shall be handled, processed, stored, and transported in a manner designed to prevent transmission of infection.

3254.14 Soiled linen shall be stored in a separate well-ventilated area and shall not be permitted to accumulate in the facility.

3254.15 Contaminated laundry shall be placed in double, specially colored bags and processed separately.

3254.16 Each laundered article shall be free of dirt, irritating chemical residue, and pathogenic organisms.

3254.17 Laundered articles shall be transported in enclosed, linen hampers with removable liners, in enclosed carts or dollies, or securely wrapped.

3254.18 If a facility launders a resident's personal clothing, the personal clothing shall be returned to them in an appropriate manner and condition.

3254.19 Each facility shall develop written policies and procedures relating to the operation of the laundry and linen management, and they shall be available in each laundry area.

3254.20 To effectively disinfect soiled linens, hot water temperature shall be one hundred and fifty degrees (150 [degrees]) to one hundred sixty degrees Fahrenheit (160 [degrees] F) during the wash cycle.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3255 HOUSEKEEPING AND MAINTENANCE

3255.1 Adequate provision shall be made for the storage of each housekeeping supply item and each piece of equipment in a janitorial closet that is separate from any toilet or utility room.

3255.2 Each janitorial closet shall be well-lighted and ventilated and shall be equipped with a janitorial sink.

3255.3 Janitorial closets shall be locked when not in use.

3255.4 Each poison and toxic substance, including those used for pest control, shall be stored in the non-resident and non-food preparation areas of the facility.

3255.5 Each storage area containing a poison shall be locked and shall have limited access.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3256 HOUSEKEEPING AND MAINTENANCE SERVICES

3256.1 Each facility shall provide housekeeping and maintenance services necessary to maintain the exterior and the interior of the facility in a safe, sanitary, orderly, comfortable and attractive manner.

3256.2 Each housekeeping employee shall have as his or her primary responsibility the sanitary maintenance of the facility.

3256.3 No nursing or dietary employee shall perform housekeeping duties on a routine basis.

3256.4 Each housekeeping employee shall keep the facility free from offensive odors, accumulations of dirt, rubbish, dust, and hazards.

3256.5 Each storage area, attic, and basement shall be kept safe and free from any accumulation of extraneous materials such as refuse, discarded furniture, and other waste materials.

3256.6 Each combustible, such as cleaning rags and compounds, shall be kept in a closed container when not in use.

3256.7 The housekeeping staff shall thoroughly clean any bedroom that has been used by a resident before it is used by any other resident.

3256.8 Each resident room shall be cleaned and arranged in an orderly fashion and shall be well-ventilated.

3256.9 Odor control shall be achieved by cleanliness and proper ventilation.

3256.10 The facility shall develop policies and procedures relating to the operation of housekeeping and maintenance services.

3256.11 Maintenance services shall include the responsibility for the provision of light, heat, power, and water to each building and transmission points where they are to be used.

3256.12 Each building, each piece of equipment, and the grounds shall be regularly maintained and attended.

3256.13 Each building shall be maintained in good repair and shall be free of any hazard, such as cracks, warped or loose boards, loose tiles, loose or broken windowpanes.

3256.14 A regularly scheduled in-service training program shall be provided for housekeeping and maintenance staff.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3257 PEST CONTROL

3257.1 The facility shall have a pest control program that includes integrated pest management (IPM) principles to minimize the use of pesticides and encourage the use of the least toxic and least flammable effective insecticides and rodenticides.

3257.2 Pest control services shall be provided either by maintenance staff or by contract with a pest-control company.

3257.3 Each facility shall be constructed and maintained so that the premises are free from insects and rodents, and shall be kept clean and free from debris that might provide harborage for insects and rodents.

3257.4 Each openable window shall be screened.

3257.5 Each opening to the outside shall minimize the influx of insects.

3257.6 The facility shall use the least toxic and the least flammable effective insecticides and rodenticides.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3258 GENERAL SAFETY AND INSPECTION

3258.1 The facility shall have detailed written plans and procedures to meet all potential emergencies and disasters such as fire, severe weather, and missing residents.

3258.2 First aid supplies shall be readily available on each unit to each employee.

3258.3 The Administrator or his or her designee shall regularly inspect each building and grounds to ensure they are free from hazards of any kind and that sanitary standards and infection control standards are met.

3258.4 A written report of inspections shall be filed and maintained by the Administrator.

3258.5 Investigations into the causes of accidents shall be instituted immediately upon an accident occurring; and after a thorough investigation, corrective measures deemed necessary shall be adopted within a reasonable time.

3258.6 Each facility shall provide for safe storage and handling of flammable and non-flammable gases.

3258.7 No storage room for flammable compressed gases shall contain an oxidizing material.

3258.8 Each storage room for flammable and non-flammable gases shall be deemed a hazardous location.

3258.9 Each container or cylinder of flammable and non-flammable gas shall be securely racked and fastened at all times.

3258.10 Each cap of each cylinder of flammable and non-flammable gas shall be maintained in place at all times when the cylinder is not in use.

3258.11 No carpeting shall be used in any wet work area, kitchen, and treatment room.

3258.12 No throw or scatter rug shall be used, except for a non-slip entrance mat that is mounted flush with the floor surface.

3258.13 The facility shall maintain all essential mechanical, electrical, and patient care equipment in safe operating condition.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3259 FIRE AND EMERGENCY PREPAREDNESS

3259.1 The facility shall have a manual of action to be taken in the event of a fire, approved by the D.C. Fire Department.

3259.2 The fire instructions manual shall specify the following:

(a) The plan to be followed in case of fire, explosion, or other emergency;

(b) The persons to be notified;

(d) The evacuation routes;

(e) The procedures for evacuating the residents;

(f) The frequency of fire drills; and

(g) The assignment of specific tasks and responsibilities to the employees on each shift in the event of fire, explosion or other emergency.

3259.3 A fire plan shall be developed with the assistance of qualified fire and safety experts. Each employee shall be trained to perform specific tasks according to the fire plan.

3259.4 Simulated drills testing the effectiveness of the fire plan shall be conducted for each shift at least four (4) times a year.

3259.5 Fire and emergency evacuation plans shall be posted conspicuously on each floor and throughout the facility.

3259.6 The most recent fire inspection report with the date of the latest inspection of the alarm system shall be available in the Administrator's office.

3259.7 Curtains and other fabrics that are hung on walls shall be of flame-proof material and shall be maintained flame-resistant.

3259.8 Carpeting used in each nursing facility shall have a flame spread rating of not over seventy-five (75), or in fully sprinkler buildings, a rating of not over two hundred (200), and shall otherwise comply with the National Fire Prevention Association (NFPA) requirements.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3260 RESERVED

22-B DCMR § 3261 RESERVED

22-B DCMR § 3262 RESERVED

22-B DCMR § 3263 RESERVED

22-B DCMR § 3264 PHYSICAL STRUCTURE AND CONSTRUCTION

3264.1 Each physical plant of a facility shall conform to all applicable District and Federal rules and regulations pertaining to construction requirements.

3264.2 Each new construction of a facility, and each addition to or repair, and remodeling of an existing building that is used for the facility, shall conform to the 1996 BOCA National Building Code, to all other applicable District rules and regulations pertaining to building construction and all applicable NFPA standards.

3264.3 Each addition to an existing facility shall comply with the minimum requirements in the latest edition of the Guidelines for Construction and Equipment of Hospitals and Medical Facilities developed by the American Institute of Architects Committee on Architecture for Health with assistance from the U.S. Department of Health and Human Services.

3264.4 For the purpose of this chapter, each conversion of an existing building to a nursing facility shall be considered a new facility.

3264.5 Each existing nursing facility shall comply with all applicable provisions of the current edition of the NFPA National Electrical Code.

3264.6 A facility shall be considered to be in compliance with NFPA requirements as long as the facility:

(a) On November 26, 1982, complied, with or without waivers, with the requirements of the 1967 or 1973 editions of the Life Safety Code and continues to remain in compliance with those editions of the code; or

(b) On May 9, 1988, complied, with or without waivers, with the 1981 edition of the Life Safety Code and continues to remain in compliance with that edition of the code.

3264.7 When District of Columbia Code requirements conflict with those of the federal or national agencies incorporated by reference above, the more stringent requirements shall apply unless specifically superseded by federal law.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3265 WHEELCHAIR ACCESS AND HANDICAPPED ACCESS

3265.1 Ramps shall be generally designed for wheelchair use, with the maximum gradient of one (1) to twelve (12), or eight and thirty-three one hundredths percent (8.33%).

3265.2 At least one (1) toilet room and stall that is large enough to accommodate a resident in a wheelchair and an attendant shall be provided on each floor.

3265.3 Doors to each toilet room and stall shall have a minimum width of two (2) feet and ten (10) inches to admit a wheelchair.

3265.4 A sink and toilet that is designed for residents with disabilities, particularly those who use wheelchairs with staff attendants, shall be available directly adjacent to each therapy area.

3265.5 Wheelchair use shall be considered in the design and equipping of personal grooming services rooms.

3265.6 Wheelchair seating in the central dining room shall be available as needed.

3265.7 The primary entrance to the facility shall be accessible to and usable by each handicapped person, and each exterior walk leading to the primary entrance shall be graded to the entrance level.

3265.8 A properly designed parking area shall be reserved close to the building to allow room for each handicapped person to get in and out of an automobile on a surface useable by each person who is in a wheelchair.

3265.9 Each floor shall have a non-slip finish and, where used by a handicapped person, shall be on a common level or connected by a negotiable ramp.

3265.10 Each door that is used by a handicapped person shall be capable of being opened with a single effort by a person who uses a wheelchair.

3265.11 Each water fountain, public telephone, and bath and toilet room shall be easily accessible to and useable by handicapped persons.

3265.12 Each new construction of a facility and each addition to and remodeling of an existing building that is used for a facility shall conform to the requirements set forth in the Uniform Federal Accessibility Standards.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3266 ENFORCEMENT

3266.1 Enforcement of the provisions of this chapter shall be in accordance with and pursuant to 22 DCMR Chapter 31.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002).

22-B DCMR § 3267 MRSA INFECTION PREVENTION

3267.1 Each nursing facility shall have written infection prevention and control policies and procedures.

3267.2 Each nursing facility shall identify MRSA colonized patients in an intensive care unit or other at-risk unit.

3267.3 Each patient colonized or infected with MRSA shall be isolated in an appropriate manner consistent with guidelines for best practices. A patient who is infected or colonized shall be permitted to participate in group activities provided that any draining wounds are covered, bodily fluids are contained, and the patient is observed to have proper hygiene practices.

3267.4 Each nursing facility shall adhere to hand hygiene best practices to ensure, through education and monitoring, that healthcare personnel properly cleanse hands between patient care activities.

3267.5 Each nursing facility shall monitor trends in the incidence of MRSA in the nursing facility over time and enhance infection control interventions if rates do not decrease.

3267.6 Each nursing facility shall maintain a mechanism for identifying a MRSA patient who is readmitted to the nursing facility (i.e. flagging).

3267.7 Each nursing facility shall have a worker education requirement regarding modes of transmission, use of personal protective equipment, disinfection policies and procedures, and other preventive measures in accordance with current CDC guidelines on the use of “Standard Precautions” and “Transmission-Based Precautions”.

History

SOURCE: Notice of Final Rulemaking published at 56 DCR 848, 850 (January 23, 2009).

22-B DCMR § 3268 TEMPORARY MANAGERS AND MONITORS

3268.1 If a facility is issued a restricted or provisional license, the Director may, if he or she determines it is appropriate, appoint a temporary manager or monitor in accordance with a mutually agreed upon timetable or until the facility is found to be in substantial compliance with licensing and applicable federal participation standards.

3268.2 Except as provided in subsection 3266.4, the tenure of the temporary manager or monitor shall be concurrent with the provisional or restricted license, except that the temporary manager or monitor may be terminated when:

(a) A court determines the temporary manager or monitor is no longer necessary because the grounds on which the appointment was made no longer exist; or

(b) The facility is closing and all of its residents have been transferred or discharged.

3268.3 The temporary manager or monitor may be extended beyond the date of expiration of the provisional or restricted license if the Director determines that the temporary manager or monitor is needed until the facility closes or until the Director takes additional enforcement action on behalf of the welfare of residents.

3268.4 The Director shall not appoint as a temporary manager or monitor:

(a) An employee of a District government agency that licenses, operates, or provides a financial payment to any nursing facility licensed in the District of Columbia;

(b) A former employee of the facility unless agreed to by the facility;

(d) A parent, child, grandchild, spouse, domestic partner, sibling, first cousin, aunt, or uncle of one of the facility’s residents, whether the relationship arises by blood, marriage, domestic partnership, or adoption. For the purposes of this subparagraph, the term “domestic partner” shall have the same meaning as provided in D.C. Official Code § 32-701(3)(2010 Repl.), and the term “domestic partnership” shall have the same meaning as provided in D.C. Official Code § 32-701(4).

3268.5 A temporary manager shall:

(a) Take charge of or oversee the operation and management of the facility;

(b) Give notice of the temporary management to the facility’s residents and employees, each resident’s representative, the Long-Term Care Ombudsman, and any other person whom the Director orders must receive notice;

(d) Unless the facility is closing, take all steps necessary to achieve, maintain, or restore District licensure and federal Medicare/Medicaid certification;

(e) Preserve all property and records with which he or she is entrusted;

(f) Report to the Director at intervals to be determined by the Director as to the progress of the facility in reaching substantial compliance with licensing and federal certification standards; and

(g) Carry out any other duties established by the Director.

3268.6 A monitor shall:

(a) Observe the operation of the facility;

(b) Advise the facility on how to comply with licensing and federal participation standards;

(c) Give notice of the monitor to the facility’s residents and employees, each resident's representative, the Long-Term Care Ombudsman, and any other person whom the Director orders must receive notice; and

(d) Report to the Director and the owner of the facility at intervals to be determined by the Director as to the progress of the facility in reaching substantial compliance with licensing and federal participation standards.

3268.7 The temporary manager or monitor shall operate at the expense of the facility.

3268.8 Appointment of a temporary manager or monitor shall commence by notice from the Director to the facility. The notice shall include:

(a) A statement of the grounds for the action; and

(b) Notification that the facility may, within seven (7) business days after the day written notice is received, file with the Office of Administrative Hearings a written request for an expedited hearing. An expedited hearing shall be conducted within three (3) business days of a timely request.

3268.9 A request for a hearing shall not serve to stay the appointment of the temporary manager or monitor.

History

SOURCE: Notice of Final Rulemaking published at 58 DCR 10619, 10625 (December 16, 2011).

22-B DCMR § 3269 RESIDENTS’ RIGHTS

3269.1 Each resident in a nursing facility shall have the right to the following:

Freedom from discrimination in treatment or access to services based on reasons prohibited by the Human Rights Act of 1977, effective December 13, 1977 (D.C. Law 2-38; D.C. Official Code §§ 2-1401.01, et seq. (2007 Repl. & 2011 Supp.));

(b) To be fully informed by the nursing facility of all resident rights and all facility rules governing resident conduct and responsibilities upon admission and annually thereafter;

(c) To either manage his or her own personal finances, or be given a quarterly report of the his or her finances if this responsibility has been delegated in writing to the nursing facility;

(d) To be treated with respect and dignity and assured privacy during treatment and when receiving personal care;

(e) To not be required to perform services for the nursing facility that are not for therapeutic purposes, as identified in the plan of care for the resident;

(f) To associate and communicate privately with persons of the resident’s choice, unless medically contraindicated;

(g) To send and receive personal mail, unopened by personnel at the nursing facility;

(h) To participate in activities of social, family, resident, religious, and community groups at the discretion of the resident, unless medically contraindicated;

(i) To keep and use personal clothing and possessions, as space permits, unless to do so would infringe on other residents’ rights or is medically contraindicated;

(j) To maintain, at the nursing facility, a private locker, chest, or chest drawer that is large enough to accommodate jewelry and small personal property and that can be locked by the resident;

(k) To be provided with privacy for visits by the resident’s spouse or domestic partner, or, if spouses or domestic partners are both residents in the nursing facility, be permitted to share a room, unless medically or psycho-socially contraindicated;

(l) To be free from mental or physical abuse;

(m) To be free from chemical and physical restraints except as authorized pursuant to federal or District law and regulation;

(n) To be discharged from the nursing facility after receiving a consultation from a physician of the medical consequences of discharge; and

(o) Providing the administrator, physician, or a nurse of the nursing facility with written notice of the desire to be discharged; provided, that if the resident is a minor or a guardian has been appointed for a resident, the written request for discharge shall be signed by the resident’s guardian, unless there is a court order to the contrary.

History

SOURCE: Notice of Final Rulemaking published at 58 DCR 10619, 10627 (December 16, 2011).

22-B DCMR § 3270 DISCHARGE PLANNING

3270.1 A transfer or discharge of a resident from a nursing facility shall be done in accordance with the Nursing Home and Community Residence Facility Residents’ Protection Act of 1985, effective April 18, 1986 (D.C. Law 6-108; D.C. Official Code §§ 44-1003.01, et seq. (2005 Repl. & 2011 Supp.)).

3270.2 The facility shall conduct a discharge assessment of each resident within fourteen (14) days after admission and twice annually thereafter. The discharge assessment shall include:

(a) A timeframe for discharging the resident to return home or to another facility; and

(b) If the resident is likely to be discharged within six (6) months after the discharge assessment, a discharge plan.

3270.3 Upon oral and written notification of discharge, the nursing facility shall provide to the resident and his or her representative:

(a) A current assessment of the resident’s care needs and the kind of services and supports the resident will need upon discharge;

(b) Information about the resident’s right to receive counseling that explains the resident’s options of community-based care and care in the home, including the right to request that the facility arrange a visit to at least one (1) alternative community-based care facility; and

(1) Links the resident with community resources, including the District of Columbia Aging and Disability Resource Center;

(2) Explains the resident’s options of community-based care and care in the home, including the right to request that the facility arrange a visit to at least one (1) alternative community-based care facility; and

(3) Sets forth an arrangement for the resident and an immediate family member or legal representative, if any, to visit at least one (1) alternative community-based care facility, at the resident’s request.

History

SOURCE: Notice of Final Rulemaking published at 58 DCR 10619, 10628 (December 16, 2011).

22-B DCMR § 3271 PROVISION OF ON-SITE SERVICES

3271.1 For the purpose of reducing the need to transport residents off-site for routine health services, each facility shall provide needed services on-site if the Department has determined that the provision of such on-site services is appropriate. On-site services that may be required by the Department include:

(a) Podiatry;

(b) Rehabilitative services, such as physical therapy, speech therapy and

occupational therapy;

(d) Mental health; and

(e) Substance-abuse treatment.

3271.2 Each facility shall provide dialysis services on-site if the Department has determined that the provision of such services on-site is appropriate and the facility has been issued a Certificate of Need authorizing the provision of on-site dialysis services.

3271.3 In order to operate a substance-abuse treatment program wherein the facility administers a narcotic, such as methadone, to manage addiction, the facility would have to be registered with the Department of Justice, Drug Enforcement Administration as a Narcotic Treatment Program. If the facility is not registered with the Drug Enforcement Administration, any resident who is treated for addiction with the administration of a narcotic, must be so treated as a patient of a certified Narcotic Treatment Program.

3271.4 In any substance-abuse treatment program that does not use the administration of a narcotic to manage addiction, as referred to in subsection 3271.3, the resident’s participation shall be kept private and any and all records related to a resident’s participation shall be confidential. The facility shall include in its operating policies and procedures, protocols on maintaining privacy and confidentiality.

3271.5 Persons who provide counseling to participants in substance abuse treatment programs shall qualify and be certified to do so by and in accordance with standards of the D.C. Board of Professional Counseling.

History

SOURCE: Notice of Final Rulemaking published at 58 DCR 10619, 10629 (December 16, 2011).

22-B DCMR § 3299 DEFINITIONS

For purposes of this Chapter, the following terms shall have the meanings ascribed:

Act - Health-Care and Community Residence Facility, Hospice and Home Care Licensure Act of 1983, effective February 24, 1984, D.C. Law 5-48, D.C. Official Code § 44-501 et seq.

Administrator - a person who is licensed as a nursing facility administrator by the District of Columbia and who is responsible for the day-to-day operation of a nursing facility.

BOCA - Building Officials and Code Administrators.

Certified Nurse Aide - an individual who, as a result of training and demonstrated competencies, provides nursing-related services to residents in a nursing facility, and who has obtained certification or credentials from the District of Columbia as being qualified to perform such services, pursuant to Chapter 32 of Title 29 of the District of Columbia Municipal Regulations.

Chemical restraint - any drug prescribed to control mood, mental status or behavior.

Colonized - having a bacterial organism present on or in the body that is not causing illness.

Communicable disease - any disease denominated a communicable disease under Title 22 of the District of Columbia Municipal Regulations, Section 201, including without limitation, any illness due to an infectious agent or its toxic product, which is transmitted directly or indirectly to a well person from an infected person, animal, or ectoparasite; or any illness due to an infectious agent or its toxic product which is transmitted through the agency of an intermediate host, vector or by exposure within the immediate environment. Communicable disease also shall mean any disease occurring as an outbreak of illness or toxic conditions, regardless of etiology in an institution or other identifiable group of people.

DCMR - District of Columbia Municipal Regulations.

Dentist - an individual licensed to practice dentistry in the District of Columbia pursuant to the District of Columbia Health Occupations Revision Act of 1985, effective March 25, 1986, D.C. Law 6-99, D.C. Official Code § 3-1201.01 et seq.

Dietary service - an organized service applying principles of nutrition and management to menu planning, food preparation and service provided to residents and personnel in a facility.

Dietitian - a person who is qualified, based upon either registration by the Commission on Dietetic Registration of the American Dietetic Association or on the basis of education, training or experience, to identify dietary needs and to plan and implement dietary programs.

Director - the Director of the Department of Health.

District - the District of Columbia.

Emergency - an unexpected serious occurrence which usually requires immediate attention.

Facility - the overall organization, program, and services of a nursing facility, including staff personnel, the building or buildings, equipment, and supplies necessary for implementation of health and nursing services.

Food Service Manager - a qualified Dietitian; or a person who has successfully completed a two (2) year course in food service management, eligible for technician membership in the American Dietetic Association and has had supervised work experience in all phases of food services.

Interdisciplinary care plan - a comprehensive plan of care and treatment designed for an individual resident that includes measurable objectives and timetables to meet the resident's medical, nursing, mental and physical needs.

Interdisciplinary care team - all facility personnel involved in the care of a resident, including medical, nursing, social services, dietary, therapeutic activities, rehabilitation services and others involved as necessary.

Licensed practical nurse - a person who has graduated from a school of practical nursing approved by the National Association of Practical Nurse Education and who is currently licensed to practice in the District of Columbia in accordance with the District of Columbia Health Occupations Revision Act of 1985, effective March 25, 1986, D.C. Law 6-99, D.C. Official Code § 3-1201.01 et seq.

Licensee - the person or entity to whom a license to operate a nursing facility is issued, and who is legally responsible for operating a facility.

Medicaid - medical assistance provided under a State plan approved under the Social Security Act, approved August 4, 1935, P.L. 74-271, 49 Stat. 620, 42 U.S.C. §§ 1396-1396v, subchapter XIX, chapter 7.

Medical Director - a physician, appointed by a nursing facility, who is currently licensed to practice medicine in the District of Columbia, who has experience in adult medicine and has knowledge of geriatric medicine.

Medically contraindicated - should not be administered to an individual because of a condition that the individual has, such that administration of the treatment, service, medication, or immunization at issue will be detrimental to the individual's health.

Medicare - the federal health insurance program for the aged and disabled under the Social Security Act, approved August 4, 1935, P.L. 74-271, 49 Stat. 620, 42 U.S.C. §§ 1395-1395ccc, subchapter XVIII, chapter 7.

Methicillin-resistant staphylococcus aureus (MRSA) - a bacterium that is resistant to antibiotics known as beta-lactams. These antibiotics include methicillin, amoxicillin, oxacillin, and penicillin.

New facility - a nursing facility for which construction is begun after the effective date of these rules or a building for which conversion to a nursing facility is begun after the effective date of these rules.

NFPA - National Fire Prevention Association.

Nurse aide - an individual who, as a result of training and demonstrated competencies, provides nursing-related services to residents in a nursing facility. This definition includes certified nurse aides, as defined above. This definition does not include individuals who volunteer to provide such services without pay, but does include individuals who are hired by residents and their families to provide care to residents in a nursing facility, and includes nurse aides supplied by an agency as well as those actually employed by the facility.

Nurse practitioner - a person licensed as an advanced registered nurse under the District of Columbia Health Occupations Revision Act of 1985, effective March 25, 1986, D.C. Law 6-99, D.C. Official Code § 3-1201.01 et seq. to perform medical diagnosis, treatment, prescription and other functions authorized by the Act and in collaboration with a physician, osteopath or dentist who shall be responsible for the overall medical direction of the health-care team. A nurse practitioner may also be known as an Advanced Registered Nurse.

Nursing facility - a 24-hour institution or distinct part of a 24-hour institution that: (1) is primarily engaged in providing nursing care and related services to residents who require medical or nursing care, or rehabilitation services for the rehabilitation of persons who are injured, disabled, or sick; (2) is not primarily for the care and treatment of mental diseases; and (3) has in effect a transfer agreement that meets the requirements of 42 U.S.C. § 1395 with one (1) or more hospitals that have a provider agreement in effect that meets the requirements of 42 U.S.C. § 1395.

Nursing services - health-care related work performed by licensed nurses, licensed practical nurses and certified nurse aides for the benefit of nursing facility residents.

Nursing unit - a group of resident rooms, staff work areas, service areas and resident support areas, the size and configuration of which is based on the organizational patterns of staffing, functional operations and communications for the facility.

Person - an individual, partnership, corporation, association, organization, executor, administrator, guardian, trustee or agent.

Physical restraint - any physical device intended to confine or substantially restrict the movement of a resident, such as, but not limited to, a restrictive vest, a protective or safety device, such as a side rail, seat belt, padded mitts or geriatric chairs.

Physician - an individual licensed to practice medicine in the District of Columbia pursuant to the District of Columbia Health Occupations Revision Act of 1985, effective March 25, 1986, D.C. Law 6-99, D.C. Official Code § 3-1201.01 et seq.

Physician assistant - an individual licensed or certified in the District of Columbia as a physician assistant pursuant to the District of Columbia Health Occupations Revision Act of 1985, effective March 25, 1986, D.C. Law 6-99, D.C. Official Code § 3-1201.01 et seq.

Podiatrist - an individual licensed in the District of Columbia to practice podiatry pursuant to the District of Columbia Health Occupations Revision Act of 1985, effective March 25, 1986, D.C. Law 6-99, D.C. Official Code § 3-1201.01 et seq.

Registered nurse - a person who is licensed and currently registered as a registered nurse in the District of Columbia pursuant to the District of Columbia Health Occupations Revision Act of 1985, effective March 25, 1986, D.C. Law 6-99, D.C. Official Code § 3-1201.01 et seq.

Relocation - movement of a resident from a bed in the facility to another bed within the facility or to a distinct part of the facility.

Resident - an individual who, because of physical, mental, familial or social circumstances or mental retardation, is residing in a nursing facility.

Resident's Representative - (1) any person who is knowledgeable about a resident's circumstances and has been designated by that resident to represent him or her; or (2) any person who has been appointed by a court or government agency either to administer a resident's financial or personal affairs or to protect and advocate for a resident's rights. If no person has been designated or appointed in accordance with (1) or (2) above, a representative of the D.C. Office of the Long Term Care Ombudsman or a representative acting in accordance with the Health-Care Decisions Act of 1988, effective March 16, 1989, D.C. Law 7-189, D.C. Official Code § 21-2210, shall be the resident's Representative.

State Plan - the comprehensive written commitment by the District of Columbia to administer or supervise the administration of the Medicaid program in accordance with Federal requirements.

State Plan Administrator - the chief manager of the District of Columbia's State Plan.

Therapeutic diet - a dietary regime including the modification or control of calories, increase or decrease of nutrients, changes in textures of food, or restrictions of specific ingredients prescribed by a physician (1) for maintenance and repair of body tissues, and for proper function of body processes, or (2) for the treatment of a resident with a specific illness.

Uniform Federal Accessibility Standards - federal guidelines, published pursuant to the Architectural Barriers Act, 42 U.S.C. §§ 4151-4157, for the design, construction and alteration of buildings to facilitate access by physically handicapped persons.

Unit dose - an individually packaged measure of medication.

History

SOURCE: Notice of Final Rulemaking published at 49 DCR 473 (January 18, 2002); as amended by Notice of Final Rulemaking published at 49 DCR 6824 (July 19, 2002); as amended by Notice of Final Rulemaking published at 56 DCR 848, 851 (January 23, 2009).

22-B33 HEALTH CARE SAFETY NET ADMINISTRATION

22-B DCMR § 3300 GENERAL PROVISIONS

This chapter shall govern eligibility determinations for the District of Columbia (District) Health Care Alliance program (Alliance program) authorized under D.C. Official Code § 7-1401.

Pursuant to D.C. Official Code § 7-1401, the Department of Health Care Finance (DHCF or Department) shall be responsible for supervising and administering the Alliance program.

The Department may provide, by contract or by other means, comprehensive community-centered health care and medical services for beneficiaries enrolled in the Alliance program pursuant to D.C. Official Code § 7-1405.

Applicants and beneficiaries of the Alliance Program who were unjustly convicted and imprisoned in accordance with D.C. Official Code §§ 2-421 – 2-425 shall not be subject to the requirements set forth under §§ 3300.5 – 3300.6, 3300.7(c), §§ 3301.1 – 3301.19, 3302, 3303, 3304, and 3305 of this Chapter.

(a) All individuals applying for or enrolled in the Alliance program, with the exception of individuals described in § 3300.4, shall meet the following financial and non-financial eligibility factors:

Be a District resident pursuant to § 3302 of this Chapter;

Provide a Social Security Number (SSN), if assigned and available;

If aged twenty-one (21) or over:

Have a household income at or below:

Two hundred and ten percent (210%) of the Federal Poverty Level (FPL), if the individual is enrolled on or before September 30, 2025;

One hundred and thirty-three percent (133%) of the FPL, if the individual is enrolled between October 1, 2025, and September 30, 2026; or

Nineteen percent (19%) of the FPL, if the individual is enrolled between October 1, 2026, and September 30, 2027; and

Not be eligible for, or enrolled in, Medicare, the Children's Health Insurance Program (CHIP), Medicaid, excluding eligibility for Medicaid payment for the treatment of an emergency medical condition pursuant to 42 C.F.R. § 440.255, or enrolled in other third party medical or health coverage that meets the requirements of minimum essential coverage, as defined under 45 C.F.R. § 156.600;

(4) If aged nineteen (19) or twenty (20):

Have a household income at or below two hundred and sixteen percent (216%) of the FPL; and

Not be eligible for or enrolled in CHIP or Medicaid, excluding eligibility for Medicaid payment for the treatment of an emergency medical condition pursuant to 42 C.F.R. § 440.255; and

(5) If aged eighteen (18) or below:

Have a household income at or below three hundred and nineteen percent (319%) of the FPL; and

Not be eligible for or enrolled in CHIP or Medicaid, excluding eligibility for Medicaid payment for the treatment of an emergency medical condition pursuant to 42 C.F.R. § 440.255.

(b) Effective October 1, 2027, residents aged twenty-one (21) or over will no longer be eligible for application for or enrollment in the Alliance program; except as otherwise provided in § 3309.

(c) Income determinations under this section shall be subject to the income determination requirements set forth under§ 3304.

The Department shall use methodologies in accordance with §§ 3303 and 3304 (as applicable) of this Chapter when determining the following:

Income;

Household composition; and

Household size.

The Department shall apply the following general standards in the administration of the Alliance program:

Information explaining the policies governing eligibility determinations and appeals shall be provided in writing on the DHCF and Department of Human Services (DHS) websites, upon request, and at application and renewal, in plain language and in a manner that is accessible and timely to all applicants and beneficiaries, including those with limited or no English proficiency and those living with disabilities;

The Alliance program information shall be provided to applicants and beneficiaries who have limited or no English proficiency through the provision of language services at no cost to them pursuant to Title VI of the Civil Rights Act of 1964, effective July 2, 1964 (42 U.S.C. §§ 2000d, et seq.), the Language Access Act of 2004, effective June 19, 2004 (D.C. Law 15-167; D.C. Official Code §§ 2-1931 et seq.); and

Applicants and beneficiaries shall be informed at the time of application, renewal, or redetermination that the Department shall obtain and use available information to verify income, eligibility, and residency.

The Department shall establish and maintain policies that govern the types of information about applicants and beneficiaries that are protected under federal and District law against unauthorized disclosure for purposes unrelated to the determination of eligibility. Protected information shall include, but is not limited to, the following:

Name and address;

Phone number;

Social security number;

Medical services provided;

Social and economic conditions or circumstances;

Department evaluation of personal information;

Medical data, including diagnosis and past history of disease or disability;

Any information received for verifying income eligibility and the amount of medical payments; and

Any information received in connection with the identification of legally liable third-party resources pursuant to applicable federal regulations.

Protected information, in accordance with § 3300.8, shall not include beneficiary identification numbers.

The Department shall provide notice, consistent with the requirements set forth under § 3308, or other communications to the applicant or beneficiary concerning the applicant’s or beneficiary’s eligibility for the Alliance program.

The Department shall provide the following information in person, by mail, by telephone, or through other commonly available electronic means (including fax or online via a web-based portal), as appropriate, to all applicants and other individuals upon request:

Eligibility requirements;

Covered services;

The rights and responsibilities of applicants and beneficiaries; and

Appeals.

History

SOURCE: Final Rulemaking published at 69 DCR 004550 (May 6, 2022); as amended by the Fiscal Year 2026 Budget Support Act of 2025, effective December 6, 2025 (D.C. Law 26-55; 72 DCR 009825 (September 12, 2025). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3300

22-B DCMR § 3301 APPLICATION, REDETERMINATION, AND RENEWAL

An applicant shall apply for the Alliance program by submitting to the Department an application form designated by the Department, which may be found on its website at https://dhcf.dc.gov/service/how-apply-medical-coverage. The application form may be submitted to the Department:

In person;

By mail;

By phone; or

Through other commonly available electronic means, including fax or online via a web-based portal.

Applicants and beneficiaries for the Alliance program shall not be required to participate in an interview as a condition of eligibility during FY 2022. Waiver of participation in an interview in subsequent fiscal years is contingent on funding by the Council.

An application and any required verification may be submitted by:

The applicant;

An adult who is in the applicant’s household or family; or

An authorized representative of the applicant, pursuant to § 3301.23.

Where the Department requires additional information to determine eligibility, the Department shall provide written notice that includes a statement of the specific information needed to determine eligibility and the date by which an applicant or beneficiary shall provide the required information.

The Department shall issue an eligibility determination, consistent with the timeframe described under § 3301.9 based on the receipt of an application that includes, at a minimum:

The applicant’s name;

The applicant’s District address. If the applicant is homeless, attests to their homelessness (consistent with § 3302.4), and cannot provide contact information, the applicant may select a mailing address provided from a list maintained by the DHS, or provide an email address or phone number for the Department to be able to contact the applicant; and

A signature (via wet, digital, or electronic, as appropriate), under penalty of perjury.

The applicant shall complete the application process described in paragraphs (a) through (b) of this subsection in order for the Department to determine whether an applicant meets the eligibility factors for the Alliance program:

Provide a complete application for the Alliance program in accordance with § 3301.7; and

(b) Submit required verifications for financial and non-financial eligibility factors.

An application shall be considered complete if all of the following requirements are met:

All information including, demographic information, household composition, residency, and income, to determine eligibility is provided; and

The application is signed and dated, under penalty of perjury.

3301.8 The Department shall use the date an application is received by the Department, as described under § 3301.5, to determine the earliest date for which health care and medical services under the Alliance program can be effective, consistent with the enrollment requirements described under § 3305.1.

The Department shall issue written notice informing the applicant of the Department’s eligibility determination within forty-five (45) calendar days of the date an application is received by the Department. The Department may extend the forty-five (45) day period pursuant to DC Official Code § 4-205.26 when a delay is caused by unusual circumstances such as:

Circumstances wholly within the applicant’s control;

Circumstances beyond the applicant’s control such as hospitalization or imprisonment; or

An administrative or other emergency that could not be reasonably controlled by the Department.

An applicant or the applicant’s authorized representative pursuant to § 3301.23 may withdraw an application upon request, through a signed statement, and prior to an eligibility determination through the following means:

(a) In person;

(b) By mail;

(d) Through other commonly available electronic means, including fax or online via a web-based portal.

A beneficiary shall notify the Department within ten (10) calendar days of any change in circumstances that directly affects the beneficiary’s eligibility to receive benefits under the Alliance program.

The Department shall re-determine eligibility for beneficiaries identified at § 3301.11 at the time the change is reported.

3301.13 Each Alliance program beneficiary shall submit an application for recertification with the Department of Human Services:

In person;

Over the telephone; or

Through electronic means, including through a web-based portal.

Where the Department provides a beneficiary with a renewal form to begin the renewal process, the beneficiary shall:

Provide, at a minimum, the information listed in paragraphs (a) – (b) of § 3301.5;

Sign the form (via wet, digital, or electronic signature, as appropriate), under penalty of perjury; and

Submit the form to the DHS, Economic Security Administration (ESA) in person, by mail, by phone, or through other commonly available electronic means (including by fax or online via a web-based portal) at least thirty (30) days before the end of the beneficiary’s certification period.

The renewal process shall be complete if all of the following requirements are met:

(a) All information including, but not limited to demographic information, household composition, residency, and income, to determine eligibility is provided;

(b) The application is signed and dated, under penalty of perjury, consistent with § 3301.15(b); and

The Department shall issue a written notice of termination to the beneficiary if the beneficiary has not returned the renewal form or submitted a telephonic or online renewal, and ESA has not received all information necessary to renew eligibility by 30 days prior to the end of the beneficiary’s certification period.

Where a beneficiary has not submitted a complete renewal, as described under § 3301.16 by the end of the beneficiary’s certification period, the beneficiary shall be given an additional ninety (90) day grace period beyond the end of the beneficiary’s certification period to complete the renewal requirements. If the beneficiary completes the renewal consistent with requirements under § 3301.16 during this grace period, the beneficiary’s case will be re-opened without requiring the submission of a new application. In cases where the renewal is completed during the grace period, if the Department determines the individual remains eligible, coverage shall be reinstated retroactive to the end of the prior certification period without interruption. If the Department determines the individual ineligible for coverage, the Department shall issue a notice notifying the beneficiary that they are no longer eligible for coverage.

The Department shall begin the termination process for Alliance program eligibility in accordance with the requirements described in section 3308 when:

A beneficiary fails to complete the renewal requirements (described under § 3301.16) and meet the requirements set forth under § 3301.15 by thirty (30) days before the end of the certification period;

The beneficiary no longer meets all eligibility factors;

The beneficiary requests termination; or

The beneficiary fails to respond to a request for verification of information, as described under § 3301.4.

Upon receipt of a request for termination of eligibility by the beneficiary or the beneficiary’s authorized representative in writing (including a written request submitted through mail, or other commonly available electronic means including by fax or online via a web-based portal) or telephonically, the Department shall terminate the beneficiary’s eligibility on:

The last day of the month in which the Department receives the request where there are fifteen (15) or more days remaining in the month;

The last day of the month following the month in which the Department receives the request where there are fewer than fifteen (15) days remaining in the month; or

A date earlier than those referenced in paragraphs (a) and (b), upon request by the beneficiary.

A request to terminate Alliance program eligibility shall be complete if all of the following requirements are met:

The request is submitted in person, by mail, by phone, or through other commonly available electronic means (including fax or online via a web-based portal);

The request is signed and dated by the beneficiary or the beneficiary’s authorized representative, under penalty of perjury;

The request includes all information necessary to determine the identity of the individual seeking termination, including but not limited to the individual’s name, date of birth, address, phone number, and beneficiary identification number (if one was assigned and is available).

The Department shall provide written notice of voluntary, and may waive the requirement that notice be provided no later than fifteen (15) calendar days before the action as stated under § 3308.4.

An individual may designate someone to be an authorized representative to act on the individual’s behalf and assist with an application, a redetermination of eligibility, and other on-going communications with the Department. If so, the Department shall require the following:

The designation of an authorized representative shall be in writing and signed by the individual seeking representation, except that legal documentation of authority to act on behalf of an individual under District law, including a court order establishing legal guardianship or power of attorney, may serve in the place of a signed written authorization;

The authority of an authorized representative shall be valid until the represented individual or authorized representative notifies the Department that the representative is no longer authorized to act on the individual’s behalf, or there is a change in the legal document of authority to act on the individual’s behalf; and

Any authorized representative to agree to maintain, or be legally bound to maintain, the confidentiality of any information regarding the represented individual provided by the Department.

History

SOURCE: Notice of Final Rulemaking published at 48 DCR 9140 (October 5, 2001); as amended by Notice of Final Rulemaking published at 53 DCR 4135 (May 19, 2006); as amended by Final Rulemaking published at 69 DCR 004550 (May 6, 2022); as amended by Final Rulemaking published at 71 DCR 004695 (April 26, 2024); as amended by the Fiscal Year 2026 Budget Support Act of 2025, effective December 6, 2025 (D.C. Law 26-55; 72 DCR 009825 (September 12, 2025). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3301

22-B DCMR § 3302 RESIDENCY

An individual shall be a resident of the District and document such residency as a condition of Alliance program eligibility.

3302.2 In verifying an applicant's residency, the Department shall require at least two (2) forms of proof that reasonably attests to District residency as identified in §§ 3302.3 and 3302.4 below.

3302.3 Acceptable forms of verification of residency (either copies or originals) shall be limited to the following items in the name of the applicant:

An active lease, rental receipt, or rental agreement for real property located in the District of Columbia;

A deed, settlement agreement, or mortgage statement for real property located in the District of Columbia;

A telephone or utility bill (water, gas, electric, oil, cable, or landline telephone) issued within the last sixty (60) days for real property located in the District of Columbia;

A non-expired, valid motor vehicle operator's permit (or a non-driver identification card) that is issued by the District's Department of Motor Vehicles;

A pay stub or earning statement issued within the previous thirty (30) days with the individual's name and District of Columbia address;

A property tax bill issued within the last sixty (60) days for real property located in the District of Columbia; and

Proof of enrollment in a District of Columbia public school.

3302.4 The Department may consider exceptions to the residency verification requirement established by §§ 3302.2 and 3302.3 for exceptional circumstances. Exceptional circumstances shall include:

Homelessness;

Domestic violence;

Instances where a noncustodial parent refuses to release documentation germane to verification of residency; and

(d) Other exceptional circumstances as may be identified and approved on a case-by case basis by the Department.

3302.5 The Department shall conduct periodic electronic data matches to update or confirm District residency between annual renewal periods.

3302.6 If the data checks identify residency outside of the District, the Department shall notify individuals of the discrepancy by written notice to the address provided by the beneficiary to the Department, and the individual shall return documentation to the Department to resolve the discrepancy within fifteen (15) calendar days.

3302.7 If the individual is unable to resolve a discrepancy, the Department shall initiate termination of the individual’s Alliance eligibility, consistent with the requirements set forth under section 3308.

History

SOURCE: Notice of Final Rulemaking published at 48 DCR 9140 (October 5, 2001); as amended by Final Rulemaking published at 69 DCR 004550 (May 6, 2022); as amended by the Fiscal Year 2026 Budget Support Act of 2025, effective December 6, 2025 (D.C. Law 26-55; 72 DCR 009825 (September 12, 2025). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3302

22-B DCMR § 3303 VERIFICATION OF ADDITIONAL NON-FINANCIAL ELIGIBLITY FACTORS

The Department shall verify non-financial eligibility factors necessary for an eligibility determination at the time of application, at each renewal of eligibility, and at each redetermination of eligibility. The Department may also periodically review and request verification of non-financial eligibility factors, as needed, during the eligibility period.

An applicant or an applicant’s authorized representative, as identified in § 3301.23, shall attest to the following non-financial eligibility factors:

Household composition;

Age;

SSN, if assigned and available;

Relationship of a caretaker relative to an applicant or eligible child;

(e) Ineligibility and unenrollment in Medicaid or Medicare, or unenrollment in other third party medical or health coverage that meets the requirements of minimum essential coverage, as defined in 45 C.F.R. § 156.600.

The Department shall accept attestation of household composition, age, and relationship for the purposes of determining eligibility without verification, unless the attestation is not reasonably compatible with information available to the Department.

3303.4 The Department shall use electronic data sources to verify residency, SSN (if assigned and available), and Medicare eligibility status. If the Department cannot verify residency, SSN (if assigned and available), or Medicare eligibility through electronic data sources, the Department shall require documentation from the applicant.

3303.5 The Department may waive non-financial verification requirements under exceptional circumstances, including the following:

Homelessness;

Domestic violence;

Where a noncustodial parent refuses to release documentation germane to verification of one (1) or more eligibility factors; and

Other circumstances as identified and approved on a case-by-case basis by the Department.

History

SOURCE: Notice of Final Rulemaking published at 48 DCR 9140 (October 5, 2001); as amended by Notice of Final Rulemaking published at 53 DCR 4135 (May 19, 2006); as amended by Final Rulemaking published at 69 DCR 004550 (May 6, 2022). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3303

22-B DCMR § 3304 FINANCIAL ELIGIBILITY REQUIREMENTS

3304.1 The Department shall determine an applicant’s financial eligibility by determining countable income pursuant to § 3300.5(d) following Modified Adjusted Gross Income (MAGI) methodologies (based on federal income tax rules) to determine household composition, family size, and how income is counted during eligibility determinations for MAGI eligibility groups.

For individuals who expect to file a federal income tax return or who expect to be claimed as a tax dependent by another tax filer for the taxable year in which an eligibility determination is made, household composition shall be determined as follows:

The household of an individual who expects to be a tax filer consists of the tax filer and all of the tax dependents the tax filer expects to claim;

The household of a tax dependent, except individuals identified at § 3304.5, consists of the tax filer claiming the tax dependent and all other tax dependents expected to be claimed by that tax filer;

The household of a married individual who lives with their spouse consists of both spouses regardless of whether they expect to file a joint federal tax return or whether one (1) or both spouses expect to be claimed as a tax dependent by another tax filer;

The household of a married individual who does not live with their spouse but who files a joint federal tax return with their spouse includes both spouses;

The household of a married individual who does not live with their spouse and who is filing a federal tax return separately from their spouse, does not include the spouse in the individual’s household; and

The household of a pregnant woman consists of the pregnant woman plus the number of children she is expected to deliver. In the case of determining the family size of other individuals who have a pregnant woman in their household, the pregnant woman is counted herself plus the number of children she is expected to deliver.

The Department shall consider an individual who expects to be both a tax filer and a tax dependent to be a tax dependent.

For individuals who do not expect to file a federal income tax return or be claimed as a tax dependent for the taxable year in which an eligibility determination is made, household composition shall be determined as follows:

The household of an individual who expects to be a non-filer consists of the non-filer and, if living with the non-filer:

The non-filer’s spouse; and

The non-filer’s children under age nineteen (19).

3304.5 Household composition shall be determined under § 3305.4 for individuals who expect to be claimed as a tax dependent by a tax filer who is not their spouse or biological, adoptive, or stepparent, regardless of the individual’s age.

MAGI-based income shall be determined using federal income tax rules for determining adjusted gross income except as otherwise provided in this Section. Countable income shall include the following:

Wages, salaries, tips, and other forms of earned income;

Taxable and tax-exempt interest;

Ordinary dividends;

Qualified dividends;

Taxable refunds, credits, or offsets of state and local income taxes;

Alimony received;

Business income or losses;

Capital gains or losses;

Other taxable gains or losses;

Taxable Individual Retirement Account distributions;

Taxable pensions and annuities;

Income from certain investments such as rental real estate, royalties, partnerships, S corporations, trusts;

Farm income or losses;

Unemployment compensation;

Taxable and tax-exempt Social Security benefits except as provided in § 3304.7(r) below;

Lump sum payments, which shall be counted as follows:

Qualified lottery winnings and qualified lump sum income shall be counted using the following formula (lottery winnings paid out in installments shall not be considered “qualified lottery winnings” and shall be considered unearned, recurring income that is counted in the month they are received):

Single payment winnings less than eighty thousand dollars ($80,000.00) shall be counted in the month received in their entirety, only for the individual who received the winnings;

Single payment winnings of at least eighty thousand dollars ($80,000.00) but less than ninety thousand dollars ($90,000.00) shall be counted as income over two (2) months, with an equal amount counted in each month, only for the individual who received the winnings. For other household members, the winnings should be counted under § 3304.6(p)(2); and

For every additional ten thousand dollars ($10,000.00) of single payment winnings, one (1) month is added to the period over which total winnings are divided, in equal installments, and counted as income up to a maximum of one hundred twenty (120) months only for the individual who received the winnings. This calculation shall be consistent with the table showing the amount of monthly income attributed to increasing amounts of winnings and the number of months over which the winnings are counted found in the Centers for Medicare and Medicaid Services (CMS) State Health Official Letter # 19-003, Attachment B, pages 12 – 13, at https://www.medicaid.gov/federal-policy-guidance/downloads/sho19003.pdf (last visited on June 28, 2022). For other household members, the winnings shall be counted under § 3304.6(p)(2); and

Other lump sum payments that are not qualified lottery winnings or qualified lump sum income are counted in the month received; and

Any other income reported on the Internal Revenue Service (IRS) Form 1040.

Countable income shall exclude the following:

Income scholarships, awards, or fellowship grants used for education purposes and not for living expenses;

American Indian/Alaska Native income as defined in 42 C.F.R. § 435.603(e);

Educator expenses;

Certain business expenses of reservists, performing artists, and fee-based government officials;

Health savings account deductions;

Moving expenses for active duty members of the military who are ordered to move or change duty stations. For individuals that are not active duty members of the military, moving expenses shall not be excluded from income through tax year 2025;

Deductible parts of self-employment taxes;

Self-employed Simplified Employee Pension (SEP), Savings Incentive Match Plan for Employees (SIMPLE), and qualified plans;

Self-employed health insurance deduction;

Penalties on early withdrawal of savings;

Alimony paid pursuant to a separation or divorce agreement finalized on or before December 31, 2018 that has not been modified after December 31, 2018;

Alimony received pursuant to a separation or divorce agreement finalized on or after January 1, 2019, or pursuant to a pre-existing agreement modified on or after January 1, 2019;

Individual Retirement Arrangements (IRA) deductions;

Student loan interest deductions;

Discharged student loan debt of a borrower if the debt is discharged due to the death or permanent and total disability of the student, as described under Section 11031 of the Tax Cuts and Jobs Act of 2017, approved on December 22, 2017 (Pub. L. No. 115-97, 131 Stat. 2054);

Public assistance benefits;

Domestic production activities deductions;

Supplemental Security Income (SSI) benefits under Title XVI of the Social Security Act; and

Compensation of a parent mentor, as defined under 42 U.S.C. § 1397mm (f)(5) of the Social Security Act, that assists families with children that are eligible, but not enrolled, in Medicaid, in accordance with Section 3004 of the Helping Ensure Access for Little Ones, Toddlers, and Hopeful Youth by Keeping Insurance Delivery Stable Act of 2017, approved on January 22, 2018 (Pub. L. No. 115-120, 132 Stat. 28) (HEALTHY KIDS Act).

Household income shall include the MAGI-based income of all individuals in a household except that:

The MAGI-based income of an individual who is included in the household of his or her natural, adopted, or step parent and is not expected to be required to file a federal tax return for the taxable year of an eligibility determination, shall not be included in household income, whether or not the individual files a federal tax return; and

The MAGI-based income of a tax dependent, other than a spouse or child under age nineteen (19), who is not expected to be required to file a separate federal tax return for the taxable year of an eligibility determination, is not included in the household income of the tax filer who expects to claim the tax dependent, whether or not such tax dependent files a federal tax return.

An amount equivalent to five percent (5%) of the Federal Poverty Level (FPL) for the applicable family size shall be deducted from household income only in cases where the individual’s income is at or above the upper income eligibility limit for the individual.

The Department shall base current financial eligibility for the Alliance program on current monthly income.

Current monthly income shall be calculated as follows:

Income received on a yearly basis or less often than monthly, that is predictable in both amount and frequency, shall be converted to a monthly amount or prorated;

If the amount or frequency of regularly received income is known, the Department shall average the income over the period between payments; or

If neither the amount nor the frequency is predictable, the Department shall not average the income but count income only for the month in which it is received.

An applicant or an authorized representative of an applicant, as described in § 3301.23, shall attest to household income.

The Department shall verify financial eligibility through one (1) or more federal and state electronic data sources, except for qualified lottery winnings and qualified lump sum payments, for which the Department shall accept self-attestation, subject to post-eligibility verification using available electronic data sources.

The Department shall use a reasonable compatibility standard to match financial information obtained from federal and State electronic data sources with attested application information.

The reasonable compatibility standard for financial information shall be met when:

The attestation and data sources are both above the District Alliance program’s applicable income standard;

The attestation and data sources are both below the District Alliance program’s applicable income standard;

The attestation is below the District Alliance program’s applicable income standard and the data sources are above the applicable income standard, when the difference between them is less than twenty percent (20%) of the amount given by data sources; or

The attestation is zero (0) income and no income data is available from electronic data sources.

The Department may require supplemental information where electronic data is unavailable or application information is not reasonably compatible with information obtained from an electronic data source.

The Department may accept supplemental information reflecting current monthly income in the following forms:

Paystubs;

Completed employer verification form;

Statement showing retirement income, disability income, Workers Compensation income, or a pension statement;

Bank and checking account statement;

Paper, electronic, or telephonic documentation; or

If other documentation is not available, a statement which explains the discrepancy.

The Department shall provide written notice to the applicant or beneficiary to provide supplementary information to verify financial eligibility, and the date by which an applicant or beneficiary shall provide the required information, consistent with § 3301.4.

The Department may waive the verification required under this section for exceptional circumstances.

Exceptional circumstances shall include:

Homelessness;

Domestic violence;

Employer moved to another state or country;

Business no longer operating;

Employer will not release information;

Self-employed individuals who cannot produce documentation of income; or

Other circumstances as identified on a case-by-case basis and approved by the Department.

3304.21 An individual whose income exceeds the applicable Medicaid Modified Adjusted Gross Income (MAGI) income limit due to the application of the formula for qualified lottery winnings and qualified lump sum income, as described in § 3304.6(p)(1), may continue to be eligible to the extent the Department determines that the denial of eligibility of the individual would cause an undue medical or financial hardship as determined on the basis of criteria as may be established by the Secretary of the U.S. Department of Health and Human Services.

History

SOURCE: Final Rulemaking published at 48 DCR 9140 (October 5, 2001); as amended by Final Rulemaking published at 53 DCR 4135 (May 19, 2006); as amended by Final Rulemaking published at 56 DCR 9452 (December 18, 2009); as amended by Final Rulemaking published at 60 DCR 8948 (June 14, 2013); as amended by Final Rulemaking published at 69 DCR 004550 (May 6, 2022); as amended by Final Rulemaking published at 71 DCR 005092 (May 3, 2024); as corrected by Errata Notice published at 71 DCR 007433 (June 28, 2024); as amended by the Fiscal Year 2026 Budget Support Act of 2025, effective December 6, 2025 (D.C. Law 26-55; 72 DCR 009825 (September 12, 2025). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3304

22-B DCMR § 3305 ENROLLMENT AND SERVICES

3305.1 Beneficiaries who are determined eligible for the Alliance program shall be automatically enrolled into a managed care plan, and shall be considered enrolled on the first day of the month in which an application is received by the Department pursuant to § 3301.6.

3305.2 A beneficiary in the Alliance program shall not be eligible for retroactive medical coverage prior to the month that the beneficiary is considered enrolled under § 3305.1.

3305.3 Health care and medical services provided pursuant to this Chapter shall be provided by an MCO that has a current contract with the Department to provide managed care health services on a capitated basis, except for services for the treatment of an emergency medical condition described under 42 C.F.R. § 440.255.

3305.4 Beneficiaries may opt to change their managed care provider within ninety (90) days from the date of the written notice submitted to the beneficiary under § 3301.9.

3305.5 Health care and medical services available pursuant to this Chapter (except for emergency medical services described under 42 C.F.R. § 440.255) are subject to District annual appropriations for this purpose, the allocation of funds for specific services, and limitations set forth in contracts with health care providers.

3305.6 The Department may limit coverage of health care and medical services by requiring prior authorization of certain services, limiting provider referrals, or instituting other measures to limit health care services.

History

SOURCE: Final Rulemaking published at 48 DCR 9140 (October 5, 2001); as amended by Final Rulemaking published at 53 DCR 4135 (May 19, 2006); as amended by Final Rulemaking published at 60 DCR 8948 (June 14, 2013); as amended by Final Rulemaking published at 69 DCR 004550 (May 6, 2022). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3305

22-B DCMR § 3306 INMATES

3306.1 If an Alliance beneficiary becomes an inmate, the Department shall suspend capitation payments to the MCO in which the Alliance beneficiary is enrolled for the duration of the Alliance beneficiary’s incarceration. Alliance program participation and capitation payments for an Alliance beneficiary can be initiated on the date of release from the correctional institution.

3306.2 Inmate shall mean an individual in custody and held involuntarily through operation of law enforcement authorities in a correctional institution, which includes facilities operated by, or under contract with, the United States, a state, a territory, a political subdivision of a state or territory, or an American Indian/Alaska Native tribe for the confinement or rehabilitation of persons charged with or convicted of a criminal offense or other persons held involuntarily in lawful custody through operation of law enforcement authorities (e.g., state or federal prisons, local jails, detention facilities, or other penal settings such as boot camps and wilderness camps).

3306.3 An individual is not considered an inmate if the individual resides in a child care institution, publicly operated community residence that serves no more than sixteen (16) residents, a public educational or vocational training institution, or a halfway house.

History

SOURCE: Notice of Final Rulemaking published at 48 DCR 9140 (October 5, 2001); as amended by Notice of Final Rulemaking published at 53 DCR 4135 (May 19, 2006); as amended by Final Rulemaking published at 69 DCR 004550 (May 6, 2022). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3306

22-B DCMR § 3307 UNJUSTLY CONVICTED AND IMPRISONED INDIVIDUALS

3307.1 Individuals determined to have been unjustly convicted and imprisoned in accordance with D.C. Official Code §§ 2-421 – 2-425 are eligible for health care benefits under the Alliance program.

3307.2 In order to be determined eligible for the Alliance program as an unjustly convicted and imprisoned individual, the individual must:

(a) Receive an approved petition for compensation, as described under D.C. Official Code § 2-423.01; and

(b) Indicate to the Office of Victims Services and Justice Grants that they wish to receive health coverage.

3307.3 Upon receipt of an approved petition for compensation from the District Office of Victims Services and Justice Grants, the Department shall determine an unjustly convicted and incarcerated individual eligible for Alliance coverage on the first day of the month in which the petition was received.

3307.4 An individual determined eligible for Alliance program coverage under § 3307.1 will be continuously eligible until the individual:

(a) Indicates that they no longer wish to receive health coverage under this program; or

(b) Dies.

3307.5 Unjustly convicted and imprisoned individuals determined eligible under the Alliance program shall receive comprehensive health coverage.

3307.6 Unjustly convicted and imprisoned individuals under this Chapter shall be subject to the requirements set forth under §§ 3300.1 – 3300.4, 3300.7(a)-(b), 3300.8 – 3300.11, 3301.20 – 3301.23, 3306 – 3399.

3307.7 Alliance program requirements and limitations outlined under §§ 3300.5 – 3300.6, 3300.7(c), §§ 3301.1 – 3301.19, 3302, 3303, and 3304, and 3305 of this Chapter shall not apply to unjustly convicted and imprisoned individuals.

History

SOURCE: Final Rulemaking published at 69 DCR 004550 (May 6, 2022). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3307

22-B DCMR § 3308 NOTICE AND FAIR HEARING RIGHTS

3308.1 The Department shall provide timely notice of eligibility and enrollment determinations and the right to appeal to Alliance program applicants and beneficiaries consistent with the requirements set forth in District law and rules.

3308.2 The Department shall provide timely and adequate notice to Alliance program applicants and beneficiaries in cases of intended adverse action such as an action to deny, discontinue, terminate, or change the manner or form of Alliance program services.

3308.3 An adequate notice shall include:

A statement of the intended action(s);

The reason(s) for the intended action(s);

Specific law and regulations supporting the action, or the change in federal or District law that requires the action(s);

An explanation of an applicant or beneficiary’s right to request an administrative or fair hearing; and

The circumstances under which Alliance program benefits are provided during the pendency of a hearing.

3308.4 A timely notice of an adverse action shall be issued (based on the postmark for physical mail or time stamp for electronic submissions) at least fifteen (15) calendar days before the date an adverse action would become effective, except as permitted under §§ 3308.5 and 3308.7.

3308.5 The Department may dispense with timely notice, but shall send adequate notice under the following circumstances:

(a) The Department has factual information confirming the death of a beneficiary;

(b) The Department receives a documented and signed statement from a beneficiary:

(1) Stating that Alliance program benefits is no longer required; or

(2) Providing information which requires termination or reduction of Alliance program benefits and indicating that a beneficiary understands the consequence of supplying the information;

(c) A beneficiary’s whereabouts are unknown and Department mailings, directed to the beneficiary, have been returned by the post office indicating no known forwarding address; or

(d) A beneficiary has been deemed eligible for health care or medical services in another state and that fact has been verified.

Under the circumstances identified in § 3308.5, the Department shall issue notice no later than the effective date of the adverse action.

The Department may issue a notice no later than five (5) calendar days before the date of action if the Department has facts related to probable fraud by the beneficiary; and those facts have been verified, if possible, through secondary sources.

The Department shall automatically schedule an administrative review of an adverse action from the Department prior to the fair hearing. The scheduling of an administrative review shall not affect the individual’s right to request a fair hearing.

The Department shall grant an opportunity for a fair hearing when:

An application for the Alliance program is denied;

Eligibility for the Alliance program is suspended;

Eligibility for the Alliance program is terminated;

An applicant or beneficiary believes the Department has taken an action which affects the receipt, termination, amount, kind, or conditions of the Alliance program in error;

A beneficiary was denied coverage of, or payment for, medical services;

A beneficiary who is dissatisfied with the District’s determination that disenrollment from an MCO is appropriate; or

A claim was denied or not acted upon with reasonable promptness pursuant to D.C. Official Code § 4-210.02(a).

The Department shall not grant a hearing if the sole issue is a federal or District law requiring an automatic change that adversely affects some or all beneficiaries.

The Office of Administrative Hearings (OAH) may grant a hearing, or deny or dismiss a request for a fair hearing in accordance with its rules under Chapter 28 of Title 1 of the DCMR..

An individual, an adult who is in the individual’s household, or an authorized representative shall submit a fair hearing request via:

Telephone;

Fax;

Mail;

In person; or

Through other commonly available electronic means (including online via

a web-based portal.

An applicant or beneficiary seeking a fair hearing shall submit a fair hearing request no later than ninety (90) days following the date of the notice of adverse action.

Where the Department provides notice as required under §§ 3308.3 through 3308.7, and the beneficiary requests a fair hearing before the date of adverse action, the Department may not terminate or reduce services until a hearing decision is rendered unless:

It is determined at the hearing that the sole issue is one of Federal or District law or policy; and

The Department promptly informs the beneficiary in writing that medical services will be terminated or reduced pending the hearing decision.

The Department may reinstate services under the Alliance program if a beneficiary requests a hearing no more than ten (10) days after the date of action.

Reinstated services shall continue until a hearing decision is reached unless, the hearing has determined that the sole issue is one of federal or District law or policy.

The Department shall reinstate and continue services until a hearing decision is rendered if action was taken without timely notice, when timely notice is required by law, and the recipient requests a hearing within ten (10) days of the postmark of the written notice of the action.

If a beneficiary's whereabouts are determined to be unknown, discontinued services shall be reinstated if the beneficiary’s whereabouts become known during the time the beneficiary is eligible for services.

Fair hearings and appeals for the Alliance program shall be administered through the OAH in accordance with §§ 2970 through 2978 of Title 1 of the DCMR, and D.C. Official Code § 4-210.01 et seq..

History

SOURCE: Final Rulemaking published at 69 DCR 004550 (May 6, 2022). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3308

22-B DCMR § 3309 MORATORIUM ON NEW ENROLLMENT; EXIT OF INDIVIDUALS

3309.1 (a) Effective October 1, 2025, no individual aged twenty-six (26) or over shall be eligible for new enrollment into the Alliance program.

(b) An enrollee who newly enrolled in the Alliance program between October 1, 2025, and September 30, 2026, and who turns twenty-six (26) between October 1, 2025, and September 30, 2026, shall not be exited from the Alliance program until September 30, 2026.

3309.2 Effective October 1, 2026, an individual aged twenty-one (21) to twenty-six (26) who newly enrolled in the Alliance program between October 1, 2025, and September 30, 2026, shall not be eligible for continued enrollment in the Alliance program and shall be exited from the Alliance program.

3309.3 Effective October 1, 2026, no individual aged twenty-one (21) or over shall be eligible for new enrollment into the Alliance program.

3309.4 Effective October 1, 2026, any individual enrolled in the Alliance program who turned or will turn twenty-one (21) between October 1, 2025, and September 30, 2027, shall not be eligible for continued enrollment in the Alliance program and shall be exited from the Alliance program; provided, that no individual shall be exited from the Alliance program pursuant to this subsection until the individual reaches the age of twenty-one (21).

History

SOURCE: Fiscal Year 2026 Budget Support Act of 2025, effective December 6, 2025 (D.C. Law 26-55; 72 DCR 009825 (September 12, 2025)). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3309

22-B DCMR § 3399 DEFINITIONS

For the purposes of this chapter, the following terms shall have the meanings ascribed:

American Indian/Alaska Native – Any individual who is a member of any Indian tribe, band, nation, or other organized group or community, including any Alaska Native village or regional or village corporation as defined in, or established pursuant to, the Alaska Native Claims Settlement Act (85 Stat. 688; 43 U.S.C. §§ 1601 et seq.), which is recognized as eligible for the special programs and services provided by the United States to Indians because of their status as Indians.

Applicant – An individual who is seeking an eligibility determination for the Alliance program through an application submission or a transfer from another insurance affordability program.

Application – The current version of the combined application for food, medical, and cash benefits, as made available electronically, telephonically, or by hardcopy.

Authorized Representative – Legally authorized individual able to consent on behalf of a prospective applicant.

Beneficiary – An individual who has been determined eligible and is currently receiving Alliance program benefits.

Certification Period – Alliance program eligibility is determined for a twelve (12) month period. This period is called a certification period.

Custodial Parent – A court order or binding separation, divorce, or custody agreement establishing physical custody controls; or if there is no such order or agreement or in the event of a shared custody agreement, the custodial parent is the parent with whom the child spends most nights pursuant to 42 C.F.R §435.603 (f)(2)(iii)(A)-(B).

Department – For the purposes of this chapter, the term “the Department” shall refer to the Department of Health Care Finance (DHCF) or its designee.

Eligibility determination – An approval or denial of eligibility as well as a renewal or termination of eligibility.

Fair Hearings – An administrative procedure that gives applicants and beneficiaries the opportunity to contest adverse decisions regarding eligibility and benefit determinations.

Federal Poverty Level– A measure of income levels updated periodically in the Federal Register by the Secretary of Health and Human Services under the authority of 42 U.S.C. Section 9902(2), as in effect for the applicable budget period used to determine an individual's eligibility for Medicaid in accordance with 42 C.F.R. § 435.603(h).

Household Composition – Determined by individuals living together and their relationships to one another. The composition of the household determines an individual’s family size.

Household Income – The countable income of every individual included in an applicant or beneficiary’s household.

Institution – Means Institution and Medical institution, as defined in 42 C.F.R. § 435.1010.

Limited or no-English proficiency – As defined by D.C. Official Code § 2-1931 (2012 Repl.) as the inability to adequately understand or to express oneself in the spoken or written English language.

Modified adjusted gross income– Income calculated using the financial methodologies used to determine modified adjusted gross income as defined in 26 U.S.C. § 36B(d)(2)(B) and 42 C.F.R. § 435.603.

Other lump sum payments – non-recurring payments that are not qualified lottery winnings or gambling winnings, and may include but not be limited to backpay, a retroactive benefit payment, state tax refund, or an insurance settlement.

Parent – A person who has a natural or biological, adopted, or step-child.

Parent mentor - as defined under 42 U.S.C. § 1397mm (f)(5).

Qualified lottery winnings – as defined under 42 U.S.C. § 1396a(e)(14)(K)(v).

Qualified lump sum income – as defined under § 1396a(e)(14)(K)(vi) (i.e., gambling winnings).

Renewal – Periodic review to evaluate continued eligibility for the Alliance program.

Resident – A person who is presently and voluntarily living in the District of Columbia, with the intention to continue living in the District of Columbia.

Self-Employed Simplified Employee Pension– A written plan that allows individuals to make contributions toward their own retirement and their employees’ retirement without getting involved in a more complex qualified plan.

State – Includes any of the fifty (50) constituent political entities of the United States and the District of Columbia.

Tax dependent – Tax dependent has the same meaning as the term “dependent” under Section 152 of the Internal Revenue Code, as an individual for whom another individual claims a deduction for a personal exemption under § 151 of the Internal Revenue Code for a taxable year.

Voluntary Termination – A voluntary request by an applicant to terminate eligibility for the Alliance program.

History

SOURCE: Notice of Final Rulemaking published at 48 DCR 9140 (October 5, 2001); as amended by Notice of Final Rulemaking published at 53 DCR 4135 (May 19, 2006); as amended by Final Rulemaking published at 69 DCR 004550 (May 6, 2022); as amended by Final Rulemaking published at 71 DCR 005092 (May 3, 2024). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3399

22-B34 COMMUNITY RESIDENCE FACILITIES

22-B DCMR § 3400 RESIDENCE DIRECTORS

3400.1 A community residence facility shall have a Residence Director who may be the licensee of the community residence facility and who shall have the following qualifications:

(a) He or she shall be at least twenty-one (21) years of age;

(b) He or she shall be certified annually by a physician as being in good physical and mental condition, capable of doing physical household tasks or of directing the work of household assistants, and free of communicable diseases as defined in Chapter 2 of this title;

(c) At the time of the initial application for a license for a community residence facility, the Residence Director shall be examined orally by the Mayor as to his or her understanding of the requirements of Chapters 30 through 34 of this subtitle and ability to provide adequate care to residents within the community residence facility; and

(d) The Residence Director of a community residence facility with thirty (30) or more residents shall hold a bachelor’s degree or have at least three (3) years full-time experience in a field directly related to the administration of the program or the services of the community residence facility.

3400.2 The Residence Director shall have the following responsibilities, except in those areas in which the governing board of the community residence facility has retained the responsibility:

(a) The supervision of the day-to-day operation of the community residence facility;

(b) The implementation of policies, practices, and procedures of the community residence facility, including the screening of prospective residents;

(d) The preparation of the budget and the supervision of financial matters;

(e) The supervision of the community residence facility’s sanitation, safety, laundry, and dietary standards and services, and of its services relating to the health, education, and welfare of its residents;

(f) The maintenance of the community residence facility’s records and reports relating to residents and finances; and

(g) The supervision and direction of the other employees of the community residence facility.

3400.3 The Residence Director shall not be employed outside the community residence facility and shall be present in the community residence facility and within call of the residents at all times, or shall assign his or her duties for a period not to exceed twelve hours (12) to an individual who is at least twenty-one (21) years of age and who is capable of recognizing visible changes in the residents’ physical and mental conditions and of taking responsible action in the case of an emergency.

3400.4 If the Residence Director is to be temporarily absent for periods to exceed twelve (12) hours, he or she shall designate an assistant Residence Director who shall be capable of assuming the responsibilities of the Residence Director.

3400.5 If all of the residents of a community residence facility are regularly occupied or employed away from the community residence facility during certain hours, the Mayor, upon application by the Residence Director, may permit that community residence facility to be unattended during those hours and the Residence Director to be otherwise employed. The Residence Director shall ensure that the community residence facility will be properly supervised in the event of a resident’s illness or an emergency.

History

AUTHORITY: Reorganization Plan No. 3 of 1967 §§402(4), 402(5), 402(134) and 402(391), 1 D.C. Code, 2001 Ed. at 125; D.C. Code, 2001 Ed. §§ 1-303.03, 1-303.04, 7-131, and 47-2842.
SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1465 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3401 MEDICAL COVERAGE

3401.1 Each resident shall provide for his or her own medical care, at his or her own expense, if able, or under Titles 17 and 19 of the Social Security Act, or at the expense of any other public or private plan or agency.

3401.2 Nothing in this section shall be considered to require a resident to have a medical relationship with a licensed physician when the resident relies solely upon generally recognized treatment by prayer or spiritual means, unless his or her failure to obtain medical care represents a threat to the health or safety of others.

3401.3 All residents shall be seen by a physician not more than thirty (30) days prior to admission to a community residence facility and at least one (1) time each year after admission.

3401.4 If a resident is unable to make arrangements for his or her annual examination, the Residence Director shall make the arrangements and assist the resident in complying with this requirement.

3401.5 A community residence facility with thirty (30) or more residents shall, by written agreement, retain the services of a licensed physician who shall advise on medical matters, review the community residence facility’s program of residential health care, and handle medical emergencies if a resident’s personal physician is unavailable.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1469 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3402 PERSONNEL

3402.1 There shall be a sufficient number of qualified employees, staff, or other adults in each community residence facility to provide for the welfare, comfort, and safety of residents at all times of the day and night.

3402.2 In a community residence facility with more than six (6) unrelated occupants, personnel policies shall be written and available to all staff and to agents of the Mayor. These policies shall include, but not be limited to, the following:

(a) Wage scales, hours of work, vacations, sick leave, insurance, and other benefits;

(b) Plans for the orientation of all employees and for regularly scheduled staff meetings;

(d) Position descriptions for each category of employee.

3402.3 All persons employed in a community residence facility shall have a pre-employment medical examination by a licensed physician and shall be certified annually by the examining physician to be in good health and free of communicable diseases as defined in Chapter 2 of this title.

3402.4 Accurate personnel records shall be maintained by each community residence facility.

3402.5 Personnel records shall include each employee’s name; address; sex; social security number; current professional license or registration number, if any; a resume of education, training, experience, and places of previous employment; and a current health certification.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1470 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3403 ADMISSION POLICIES

3403.1 A prospective resident shall be admitted to and retained by a community residence facility only if the prospective resident, the sponsor (if any), and the Residence Director agree, and the resident’s personal physician certifies in writing, that the resident is not in need of professional nursing care and can be assisted safely and adequately within a community residence facility.

3403.2 The Mayor shall prepare a form to be used by physicians in certifying residents for placement in community residence facilities that clearly states the limitations placed on community residence facilities with regard to the services they are licensed to provide and the condition of persons they are authorized to accept as residents.

3403.3 Residents shall be able to perform the activities of daily living with minimal assistance, generally be oriented as to person and place, and capable of proper judgment in taking action for self-preservation under emergency conditions.

3403.4 Persons not generally oriented as to time and place or persons substantially ambulatory but needing limited personal assistance in case of an emergency may be admitted to a community residence facility by special permission of the Mayor.

3403.5 Permission to admit a patient needing limited personal assistance under § 3403.4 shall only be granted if the Mayor is satisfied that the community residence facility has sufficient staff to ensure the safety of those residents.

3403.6 Admission requirements that are predicted upon religion, sex, organizational membership, or similar requirements shall be in writing.

3403.7 Whenever a community residence facility denies an applicant admission to the community residence facility, the reason for the denial shall be given to the applicant in writing, if requested in writing.

3403.8 Each resident shall have a pre-admission medical examination by a physician not more than thirty (30) days prior to his or her admission to a community residence facility.

3403.9 The examining physician shall certify that the resident is free of communicable disease as defined in Chapter 2 of this title, and shall provide the community residence facility with a written report, including sufficient information concerning the resident’s health to assist the community residence facility in providing adequate care, including any treatment orders, drugs prescribed, special diets, and a rehabilitation program.

3403.10 Each resident who is on convalescent leave from a psychiatric hospital, or who has been determined to be mentally incompetent or in need of treatment under the 1964 Hospitalization of the Mentally Ill Act approved September 14, 1965 (D.C. Code, 2001 Ed. § 21-501), shall have had a psychiatric examination not more than thirty (30) days prior to his or her admission.

3403.11 The examining physician shall provide the community residence facility with a written report providing sufficient information on the resident’s condition to enable the community residence facility to assist the resident toward rehabilitation, together with a record of any prescriptions, treatment orders, or special instructions for the management and protection of the resident.

3403.12 In the case of group homes for mentally retarded persons, no person shall be eligible for admission to a group home until the person has, prior to admission (but in no event more than six (6) months prior to admission), undergone a comprehensive evaluation that has resulted in a determination that the individual is mentally retarded and is in need of or would benefit from habilitation.

3403.13 Upon admission of a person who would benefit from habilitation under the provisions of § 3403.12, but in no event later than ten (10) days after the date of admission, an individual plan for habilitation shall be developed by appropriate professionals to meet the specific needs of the resident.

3403.14 The provisions of §§ 3403.1 through 3403.5 of this section and the provisions of §§ 3403.10 and 3403.11 of this section shall not apply to admission policies and requirements for prospective residents of group homes for mentally retarded persons.

3403.15 The Mayor shall issue regulations specifying standards for group homes for mentally retarded persons.

3403.16 The standards required under § 3403.15 shall include, but not be limited to, the following:

(a) Staffing appropriate to the residential needs of the persons in a home, in light of the individual habilitation plans of those persons; and

(b) Accessibility of the facility to those persons who are not ambulatory.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1472 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004). EDITOR’S NOTE: For regulations regarding group homes for mentally retarded persons, please refer to Chapter 35 of this title.

22-B DCMR § 3404 RESIDENT STATUS POLICIES

3404.1 In addition to the pre-admission medical examination required by § 3403.8, each resident shall have an annual examination by a physician. The physician’s report and his or her recommendations shall be included in the resident’s permanent file.

3404.2 The Residence Director shall communicate orally or in writing with each resident’s sponsor, if any, at least every six (6) months regarding the general condition of the resident, any unusual incidents that may have occurred, any changes in the resident’s health status, and any changes in the care or services to be provided to the resident.

3404.3 In cases of serious illness or accident, medical care shall be secured immediately by the resident, if he or she is able, or by the Residence Director who shall first attempt to notify the resident’s physician.

3404.4 If the Residence Director is unable to contact the resident’s physician, he or she shall then secure assistance from the community residence facility’s medical advisor, if any, or from another licensed physician.

3404.5 The Residence Director shall immediately notify the next of kin or sponsor, if any, of the incident and document it in the resident’s permanent record.

3404.6 The provisions of § 3206 of Chapter 32 of this title shall apply to community residence facilities.

EDITOR’S NOTE: 22 DCMR § 3206 was deleted by Final Rulemaking published at 42 DCR 567 (January 27, 1995).

3404.7 In the case of death, both the resident’s attending physician and the next of kin or sponsor, if any, shall be notified promptly.

3404.8 Death shall be determined and pronounced only by a physician. The community residence facility shall provide for deaths to be investigated in accordance with § 3 of Title I of the Act of July 29, 1970 (D.C. Code, 2001 Ed. § 5-1402).

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1475 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3405 TRANSFER AND DISCHARGE POLICIES

3405.1 The Residence Director shall promptly notify a resident’s sponsor, if any, or physician when a resident’s physical or mental condition deteriorates so that the resident needs continuing professional nursing services and should be transferred to an appropriately licensed facility.

3405.2 Short-term nursing care, up to seventy-two (72) hours, may be provided by a community residence facility when needed if the community residence facility can provide or arrange for the provision of the physical environment and professional services appropriate to the resident’s condition.

3405.3 If the Residence Director is not able to obtain appropriate medical care for the resident, he or she shall notify the Mayor of the need for assistance.

3405.4 No resident shall be involuntarily transferred to another community residence facility or asked to leave a community residence facility on a non-emergency basis without both of the following:

(a) A written statement signed by the Residence Director or the supervising agency (if any), describing the reasons for the transfer or departure, and providing timely (at least two (2) weeks) notice to the resident and sponsor, if any; and

(b) An opportunity for the resident to discuss the request with his or her personal physician, sponsor (if any), legal representative, or other person as he or she desires, and to plan for an appropriate new placement.

3405.5 Except in the case of a resident of a group home for mentally retarded persons, no resident shall be prevented from leaving the community residence facility or be subject to a curfew.

3405.6 If a Residence Director has reason to believe that a resident appears to be irrational and may do harm to himself or herself or to others, the Residence Director shall promptly notify the resident’s personal physician and attempt to obtain appropriate medical assistance.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1472 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3406 RESIDENTS’ RIGHTS

3406.1 A supportive and protective environment shall be provided to each resident to promote his or her comfort, self-esteem, and personal dignity, and to ensure that the resident’s property and civil rights are respected.

3406.2 A written copy of the rights and privileges (which may be obtained from the Mayor) set forth in §§ 3406.3 through 3406.11 shall be given to each resident and his or her sponsor, if any, upon admission.

3406.3 Each resident shall be permitted to receive visitors at any reasonable hour in an area permitting private conversation.

3406.4 Residents shall have the right of privacy in their rooms, and community residence facility personnel shall respect this right by knocking on the door before entering a resident’s room.

3406.5 A resident’s mail shall be delivered unopened unless medically contraindicated (as documented by a physician in the patient’s medical record), or unless the mail relates to financial affairs for which responsibility has been delegated to the community residence facility in accordance with the provisions of § 3207.

EDITOR’S NOTE: 22 DCMR § 3207 was deleted by Final Rulemaking published at 42 DCR 567 (January 27, 1995).

3406.6 Residents shall have access to a telephone for outgoing and incoming calls located so that they can speak privately, and shall have the right to install and use a private telephone at their own expense.

3406.7 Physical and mental harassment or abuse of residents is prohibited.

3406.8 Provisions shall be made to meet the spiritual needs of the residents by advising the proper clergyman of a resident’s admission to the community residence facility, if requested to do so by the resident or his or her sponsor, if any, or by allowing residents to attend religious services of their choice in the community. No religious beliefs or practices shall be imposed on any resident.

3406.9 Residents or those acting on their behalf shall be provided the right of registration and disposition of complaints without the residents being intimidated by a threat of discharge or other reprisal.

3406.10 All residents, next of kin, and sponsors (if any) shall be provided with the address and telephone number of the District government office that licenses health care facilities.

3406.11 The community residence facility shall carry sufficient insurance to cover hazards (fire and extended coverage) and legal risk of liability.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1478, 1481-1483 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3407 RESIDENTS’ PERSONAL PROPERTY

3407.1 A community residence facility shall take appropriate measures to safeguard and account for personal articles of residents that are brought to the community residence facility, including providing each resident with a cabinet, designated drawer, or other place in which he or she can keep and lock small items and personal papers.

3407.2 Safe storage of and assistance in managing modest cash resources of residents for use in meeting their personal incidental expenses is an appropriate service that shall be provided by a community residence facility if the service is requested in writing by the resident, if competent, or by the sponsor of the resident, if any.

3407.3 The community residence facility shall provide the resident or his or her sponsor, if any, with a receipt for all personal property received by it for safekeeping.

3407.4 Provisions shall be made for residents who desire to bring personal possessions and furnishings to their living quarters in the community residence facility unless the community residence facility can demonstrate that it is not practical, feasible, or safe.

3407.5 A separate and accurate record shall be kept of all funds and personal property deposited for safekeeping with or received to be managed by the community residence facility for the benefit of the resident. That record shall include the following:

(a) The date and amount of any money received;

(b) The date and amount of each withdrawal by the resident or disbursement by the community residence facility for the resident’s benefit;

(d) The current balance.

3407.6 A copy of the record required in § 3407.5 shall be made available to the resident or his or her sponsor, if any, at any time upon demand, and shall be presented to the resident or his or her sponsor, if any, semi-annually and upon the resident’s transfer or discharge from the community residence facility.

3407.7 Residents shall be encouraged and allowed to wear their own clothing.

3407.8 If clothing is provided by the community residence facility, it shall be appropriate, clean, and well-fitting.

3407.9 No Residence Director shall require, in consideration for the admission of a resident or in consideration for continuing to care for a resident, that the resident give, transfer, or assign to the Residence Director an interest in or title to any property owned by the resident, nor shall the Residence Director accept any such gift, transfer, or assignment.

3407.10 Nothing contained in this section shall be construed as prohibiting a Residence Director from requiring a resident to pay, at periodic intervals, the sum of money that has been agreed in writing shall be paid for the care given the resident, nor shall anything in this section be construed as prohibiting a resident from selling property to a Residence Director, if the price received is the reasonable market value of the property at the time of the sale.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1478 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3408 [RESERVED]

History

SOURCE: As amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3409 [RESERVED]

History

SOURCE: As amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3410 ADMINISTRATIVE RECORDS AND REPORTS

3410.1 The Residence Director shall maintain current and accurate records and reports which shall be on file and available at all times for inspection and review by the Mayor.

3410.2 All administrative records and reports required to be kept under this section shall be filed and retained for five (5) years by the community residence facility.

3410.3 Each community residence facility shall keep, and the Residence Director shall report annually within thirty (30) days after the end of each calendar year to the Mayor on appropriate forms to be provided by the Mayor, the following information:

(a) Total number of admissions;

(b) Total number of discharges;

(d) Total number of resident days.

3410.4 At least quarterly, each Residence Director shall notify the Central Referral Bureau established under Chapter 30 of this title of any changes in his or her community residence facility’s occupancy level since the previous report.

3410.5 A community residence facility shall maintain for the Mayor’s inspection at any time the following records and reports:

(a) A list of current charges and fees for services;

(b) Payroll records and weekly staff schedules (if applicable);

(d) Agreements with professional consultants;

(e) A list of the telephone numbers of each resident’s personal physician, the advisory physician, if any, or at least three (3) other licensed physicians who could be called in case of an emergency; the poison control center; the rescue squad; the fire department; the police department; and any other resources available to aid in an emergency;

(f) A roster of residents;

(g) A Day and Night Report Book in which emergencies and other unusual occurrences involving residents are recorded by the responsible person on duty at the time of the occurrence; and

(h) Records listing residents’ personal property entrusted to the community residence facility for safekeeping.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1483 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3411 RESIDENTS’ RECORDS

3411.1 A community residence facility shall keep a permanent record concerning each resident to be retained by the community residence facility for at least two (2) years after the resident’s discharge or death.

3411.2 All information contained in the permanent personal record shall be confidential and shall not be open to public inspection, except by officials of the District for the enforcement of this regulation, without the written consent of the resident indicating to whom the records are to be released and for what purpose.

3411.3 Each record shall be kept current, dated, and signed with the full name of the record keeper and shall include, but not be limited to, the following information:

(a) The resident’s name;

(b) The resident’s age and sex;

(d) The resident’s home address;

(e) The date the resident was admitted, and the date the resident was discharged or the date of the resident’s death;

(f) The name, address, and telephone number of the resident’s personal physician;

(g) The name, address, and telephone number of the resident’s next of kin or sponsor, if any;

(h) The source of referral;

(i) The resident’s religious affiliation, if any, and the name and telephone number of the resident’s minister, priest, or rabbi;

(j) Reports and recommendations from physicians, social workers, or other health care professionals (including, in the case of group homes for mentally retarded persons, the comprehensive evaluation for each resident and reports and recommendations from appropriate professionals) regarding the resident’s care;

(k) A current record of any funds managed by the community residence facility for the resident’s benefit as required in § 3407; and

(l) In the case of group homes for mentally retarded persons, the individual plan for habilitation required by § 3403. The plan shall be reviewed and appropriately revised at least annually.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1485 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3412 CONFIDENTIALITY OF RECORDS

3412.1 Reports and records of a community residence facility specifically identifying residents of a community residence facility and permanent records of each resident shall be confidential and shall not be made available for public inspection to persons not involved in the resident’s health care unless the names of residents and other identifying characteristics of the residents are removed or the resident gives his or her written consent to the other use.

3412.2 The provisions of § 3412.1 shall not apply to officials of the District responsible for the enforcement of chapters 30 through 34 of this title.

3412.3 No studies based on any community residence facility records shall identify the community residence facility by name without its written consent, or any resident by name without the resident’s written consent or that of his or her sponsor, if any.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1487 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3413 PROGRAM STATEMENTS

3413.1 Each community residence facility shall develop in writing or supply on forms to be provided by the Mayor a statement of the following:

(a) Program and facilities;

(b) Staffing patterns;

(d) Activities offered;

(e) Fees and charges;

(f) Payment and refund policies;

(g) Group or groups of persons to be served, including any sex or age characteristics;

(h) Admission and discharge policies, including parameters of length of stay;

(i) Limitation, if any, on sources of referral; and

(j) Formal and informal relationships to community health services and social services.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1487 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3414 [RESERVED]

History

SOURCE: As amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3415 PHYSICAL RESTRAINT AND BEHAVIORAL MODIFICATION

3415.1 A community residence facility shall not use physical restraint or confinement except in an emergency to protect a resident from harming himself or herself or others.

3415.2 When action is required, the Residence Director shall immediately notify the resident’s personal physician and sponsor, if any, and also shall take steps to obtain appropriate care for the resident.

3415.3 Programs designed to control or change a resident’s behavior shall be described in writing, subject to the approval of the Mayor.

3415.4 Restraint, control, and behavior modification programs that have been approved by the Mayor shall be conducted only under the direct supervision of a qualified person having a graduate degree in psychology, sociology, social work, special education, vocational rehabilitation, or psychiatry, and having direct, supervised experience and training in the method employed.

3415.5 Restraint, control, and behavior modification programs shall not utilize deprivation or deprive any resident of his or her basic rights.

3415.6 Personnel of the community residence facility shall not employ physical or mental abuse.

3415.7 A resident shall not be forcibly secluded in a locked room, nor shall he or she be locked out of his or her room at any time.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1488 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3416 MEDICATION STORAGE AND DISPOSAL

3416.1 The community residence facility shall provide each resident with a means for keeping his or her medications secure and separate from those of other persons.

3416.2 Pharmaceuticals requiring refrigeration shall be stored in a locked refrigerator or in a secure container within a refrigerator.

3416.3 Narcotics shall be kept in locked containers or cabinets and the Residence Director shall keep a record of the kind and amount of narcotics in the possession of each resident.

3416.4 Medications of each resident shall be stored in their original containers and shall not be transferred to other containers.

3416.5 The Mayor shall prescribe procedures for community residence facilities to follow for the proper disposition and disposal of all medicines and narcotics on the discharge or death of the resident and when the medicines and narcotics are no longer in use.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1489 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3417 DIETARY SERVICES

3417.1 Community residence facilities shall recognize and provide for the reasonable nutritional, emotional, religious, cultural, and therapeutic dietary requirements of its residents.

3417.2 All food and drink shall be clean, wholesome, and free from spoilage.

3417.3 At least three (3) meals that are nutritious and suited to the special needs of residents shall be served, provided for, or arranged for on a daily basis.

3417.4 Where residents are provided meals at another location, it shall be the responsibility of the Residence Director to ensure that the meals (including box lunches or other meals) are nutritious, suited to the special needs of the residents, and otherwise appropriate.

3417.5 Meals shall be attractively served at the proper temperature and in a home-like atmosphere where group dining is offered to all residents.

3417.6 The community residence facility shall conform to § 3222 requirements.

EDITOR’S NOTE: 22 DCMR § 3222 was deleted by Final Rulemaking published at 42 DCR 567 (January 27, 1995).

3417.7 The Mayor shall make a current diet manual available to all community residence facilities, and shall offer the consultant services of a dietitian to community residence facilities so that each facility can meet the requirements of this section.

3417.8 All food shall be prepared so as to be safe for human consumption and served in accordance with Chapters 20 through 25 of title 23 DCMR, with the following exceptions:

(a) Community residence facilities with fewer than twenty (20) residents need not meet the requirements of 23 DCMR § 2500.2, but each facility shall organize plumbing facilities to ensure that the food that is processed is safe for human consumption;

(b) Community residence facilities with fewer than ten (10) employees on a shift need not comply with the provisions of 23 DCMR § 2500.2 insofar as they require separate toilet facilities for male and female employees; and

(c) Community residence facilities with five (5) or fewer unrelated residents plus the Residence Director and his or her family need not meet the requirements of 23 DCMR §§ 2207, 2208, 2300, 2301.

3417.9 All multi-use utensils and equipment used in the preparation, cooking, and serving of food or drink shall be thoroughly washed in hot water, at least one hundred ten degrees Fahrenheit (110N F.), and detergent after each use.

3417.10 Community residence facilities shall provide sufficient qualified dietary and food service personnel to meet the general and specific needs of all residents, and shall comply with the requirements of §§ 3221.8 and 3221.9 of this title.

EDITOR’S NOTE: 22 DCMR § 3221 was deleted by Final Rulemaking published at 42 DCR 567 (January 27, 1995).

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1490 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3418 THERAPEUTIC DIETS

3418.1 All community residence facilities that accept or retain residents in need of special or therapeutic diets shall provide for those diets to be planned, prepared, and served as prescribed by the attending physician. Those community residence facilities shall consult regularly with a dietitian.

3418.2 The dietitian shall have access to the resident’s permanent record containing the physician’s prescriptions for medications and special diet and shall document in that record all observations, consultations, and instructions regarding the resident’s acceptance and tolerance of prescribed diets.

3418.3 The dietitian and the Residence Director, or a qualified person designated by the Residence Director, shall review the therapeutic diets of a community residence facility’s residents at least every six (6) months.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1492 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3419 [RESERVED]

History

SOURCE: As amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3420 REHABILITATION

3420.1 A major goal of each community residence facility shall be to assist its residents in achieving an optimum level of function and self-care through education and retraining in the activities of daily living.

3420.2 Toward the goal specified in § 3420.1, community residence facilities shall maintain as culturally normal routines and procedures as possible, providing for sleeping periods, meal times, social and recreational activities, responsibilities, and resident autonomy that approximate, as nearly as is consistent with the proper care of the resident, the living patterns of independent persons of their age in the community.

3420.3 In the case of group homes for mentally retarded persons, in addition to the provisions of §§ 3420.1 and 3420.2, each community residence home shall ensure that each resident is enrolled in and attends a daytime program, such as (but not limited to) a program conducted by a public school, day care, sheltered employment, or other appropriate activity center; provided, that the program shall be consistent with a person’s overall plan for habilitation.

3420.4 Whenever possible, residents shall be encouraged to return to their homes or other residential living arrangements.

3420.5 The Residence Director and other personnel employed by the community residence facility who are designated by the Mayor shall attend the training courses provided by the Mayor, at little or no cost, to increase their knowledge and skill concerning rehabilitation and rehabilitation techniques that can be employed in the community residence facility.

3420.6 The Residence Director shall assist each resident in obtaining rehabilitation services from qualified therapists, including but not limited to physical, occupational, and speech and hearing therapists, as the resident may need, at the resident’s own expense, if the resident is able to pay, or under Titles XVIII and XIX of the Social Security Act, or at the expense of any other public or private plan or agency.

3420.7 Each community residence facility shall grant access to, and to the best of its ability cooperate with, any licensed therapist who is hired to provide services to a resident of the community residence facility.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1493 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3421 HOUSEKEEPING AND LAUNDRY SERVICES

3421.1 The interior and exterior of each community residence facility shall be maintained in a safe, clean, orderly, attractive, and sanitary manner free from accumulations of dirt, rubbish, and objectionable odors.

3421.2 Each community residence facility shall provide appropriate procedures, personnel, and equipment to ensure sufficient clean linen supplies and the proper sanitary washing and handling of linen and personal clothing of residents.

3421.3 An adequate supply of linen, including replacements, shall be maintained.

3421.4 All bed linens shall be changed and cleaned as often as necessary to maintain clean linen on the beds at all times, but in no case shall bed linens be changed less often than once a week.

3421.5 Soiled linen shall be handled in a sanitary manner.

3421.6 Personal laundry of residents and personnel shall be collected, transported, sorted, washed, and dried in a sanitary manner, separate from bed linen.

3421.7 When feasible, arrangements shall be made so that residents who wish to do so shall have a safe and convenient place to wash out and dry small amounts of personal laundry.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1495 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3422 SOCIAL SERVICES

3422.1 Each community residence facility with fewer than thirty (30) residents shall assist residents in obtaining needed social services, as provided in this section.

3422.2 Prior to admission, if possible, or as soon as possible after admission, the Residence Director shall assist each resident who wants assistance in obtaining a professional evaluation of the resident’s social needs and a plan, developed in cooperation with the resident, for obtaining services that may be necessary to meet the health-related emotional and social needs of the resident.

3422.3 The evaluation required under § 3422.2 shall be at the resident’s expense if the resident is able to pay for it, or shall be funded from any available private or public social service resources.

3422.4 A written summary of each resident’s social services plan, including personal and situation information important to the management of the resident’s care and his or her probable length of stay, shall be included in the resident’s permanent record.

3422.5 The Residence Director or personnel designated by him or her shall assist the resident in carrying out his or her social services plan by doing the following:

(a) Aiding the resident in finding public and private social service resources;

(b) Arranging appropriate transportation to the source of social services, if necessary; and

3422.6 Each community residence facility with more than thirty (30) residents shall comply with § 3304 of this title, and shall provide the services of a social worker for a minimum of eight hours (8) per week.

EDITOR’S NOTE: 22 DCMR § 3304 was deleted by Final Rulemaking published at 42 DCR 567 (January 27 1995). For current provisions regarding Nursing Facilities, please refer to Chapter 32 of this title.

3422.7 Each community residence facility with more than eighty (80) residents shall provide the services of a social worker twenty (20) hours per week.

3422.8 Each community residence facility with more than one hundred (100) residents shall provide the services of a social worker on a full-time basis.

3422.9 The Mayor shall make available to all community residence facilities a list of all private and public social service resources in the community, together with a description of the services offered by each, their locations, and the persons to whom their services are available.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1496 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3423 RESIDENT ACTIVITIES

3423.1 Each community residence facility with fifty (50) or more residents shall employ a full-time resident activities specialist who shall hold current registration in the National Therapeutic Recreation Society as a therapeutic recreation specialist, or possess the qualifications necessary for that registration, or have two (2) years paid experience in a program or service directly related to therapeutic recreation.

3423.2 Each community residence facility shall provide, without additional charge, books, periodicals, newspapers, and audio and audio-visual entertainment within the community residence facility.

3423.3 Community residence facility staff shall become aware of and familiar with appropriate local activities and events that the residents might enjoy and shall actively encourage the residents to participate in them.

3423.4 Local activities shall include, but not be limited to, those that stimulate interest and participation in reading, hobbies, music, religion, drama, arts and crafts, games, sports and, where appropriate, senior citizens’ clubs and meal programs.

3423.5 To the maximum extent possible, each community residence facility shall utilize the services of public and voluntary resources in promoting resident participation in activities.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1498 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3424 ENVIRONMENTAL REQUIREMENTS

3424.1 Each community residence facility shall be within easy walking distance of public transportation to stores, restaurants, movies, parks, recreational facilities, libraries, post offices, churches, and similar facilities.

3424.2 Location in a remote area is not acceptable, except when it can be shown that there is a special need for services in the area or when the community residence facility provides transportation for its residents.

3424.3 When possible, a community residence facility shall be located away from known sources of loud and irritating noises and in areas where interior sounds can be maintained at reasonable comfort levels.

3424.4 Each community residence facility shall be located in an area reasonably free from noxious, hazardous smoke and fumes.

3424.5 The location of each community residence facility shall otherwise be in compliance with the D.C. Air Quality Regulations enacted July 7, 1972 (Regulation No. 72-12).

3424.6 A community residence facility shall not use a name that is misleading as to the type of care provided by the community residence facility nor a name that is suggestive of chronic illness, dependence, or death.

3424.7 A community residence facility need not be given any name, if the licensee so desires.

3424.8 The provisions of §§ 3424.1 and 3424.2 of this title shall not apply to group homes for mentally retarded persons.

3424.9 The locations of group homes for mentally retarded persons shall be governed by applicable sections of the D.C. Zoning Regulations.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1499 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3425 STRUCTURAL REQUIREMENTS

3425.1 Before the physical facilities of any community residence facility are constructed, added to, remodeled, or otherwise altered to the extent a building permit is required, the owner of the community residence facility shall notify the Mayor of all contemplated changes before a building permit is issued so the Mayor can review and approve the changes that may relate to the requirements of this title.

3425.2 In addition to the requirements of this section, the physical structure of a community residence facility shall conform to all applicable provisions of the D.C. Housing Code (DCMR 14), the D.C. Building Code (DCMR 12), the applicable provisions of this title, and all other applicable District rules and regulations, except as provided in § 3417 of this subtitle.

3425.3 Each community residence facility with five (5) or fewer residents plus the Residence Director and his or her family shall conform to Chapters 1 (except § 103), 3, 4, 5, 6 (except § 607), 7, 8, and 9 (except §§ 901 through 906) of title 14 DCMR (the D.C. Housing Code).

3425.4 Each community residence facility with more than six (6) occupants shall comply with Chapters 1 (except § 103), 3, 4, 5, 6 (except § 607), 7, 8, and 9 (except §§ 901 through 906) of title 14 DCMR (D.C. Housing Code), and all other provisions of the Housing Code relating to rooming and boarding houses, apartment houses, and hotels or motels, depending on the nature of the community residence facility and the number of residents, except §§ 1003, 1303, and 1305.

3425.5 A community residence facility may be classified as a residential occupancy and may be located in a single or multi-family dwelling.

3425.6 The provisions of §§ 3424.1 and 3424.2 of this title shall not apply to group homes for mentally retarded persons.

3425.7 The locations of group homes for mentally retarded persons shall be governed by applicable sections of the D.C. Zoning Regulations.

3425.8 The provisions of § 3425.4 shall not apply to group homes for mentally retarded persons that have (or are intended when fully occupied to have) eight (8) or fewer mentally retarded persons as residents; provided, that those group homes shall at all times comply with the provisions of § 3425.3.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1501 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3426 LIGHTING

3426.1 All habitable rooms shall have window areas and ventilation levels in accordance with the D.C. Building Code (12 DCMR).

3426.2 Obscure glass, glass blocks, or similar non-transparent or distortion-producing material for openings shall not satisfy window area requirements for habitable rooms under this section.

3426.3 General lighting levels in non-sleeping rooms throughout each community residence facility shall be not less than ten (10) foot-candles.

3426.4 Incandescent fixtures shall be equipped with at least sixty (60) watt light bulbs.

3426.5 Additional lighting levels shall be provided by each community residence facility in the kitchen and laundry areas and as may be needed for special tasks, or at the request of a resident.

3426.6 Night lights shall be provided in bathrooms, hallways and, if requested, in residents’ bedrooms.

3426.7 Outside entrances shall be well lighted at times when they are likely to be in use.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1502 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3427 WATER SUPPLY

3427.1 The water supply and distribution systems for each community residence facility shall conform to all applicable District codes, rules, and regulations.

3427.2 An adequate supply of hot water for the use of residents shall be available at all times.

3427.3 The temperature of hot water at fixtures used by residents shall be automatically controlled and shall not exceed one hundred ten degrees Fahrenheit (110N F.).

3427.4 The water supply may also include a separate or boosted supply at higher temperatures for the kitchen and for dishwashing and laundry uses.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1503 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3428 HEAT, VENTILATION, AND INSULATION

3428.1 Each community residence facility shall have a heating system that conforms to all applicable District codes, rules, and regulations, and that is of sufficient size and capacity to maintain a temperature of at least sixty-five degrees Fahrenheit (65N F.) in winter temperatures.

3428.2 The heating system shall be thermostatically controlled.

3428.3 No portable room heaters, space heaters, or fireplaces shall be permitted unless specifically approved by the Mayor as not presenting a fire hazard, although fireplaces may be utilized for decorative, social, and recreational purposes.

3428.4 Each room used by residents shall be maintained at a minimum temperature of sixty-five degrees Fahrenheit (65N F.) between 7:00 a.m. and 10:00 p.m., and at sixty degrees Fahrenheit (60N F.) at all other times, whenever the room is occupied.

3428.5 Each community residence facility with more than thirty (30) residents shall meet the requirements of § 3248 of Chapter 32 of this title, except §§ 3248.8, 3248.11, and 3248.12 of that section.

EDITOR’S NOTE: 22 DCMR § 3248 was deleted by Final Rulemaking published at 42 DCR 567 (January 27, 1995).

3428.6 Each community residence facility with more than thirty (30) residents shall meet the requirements of §§ 3249.1 through 3249.3 and 3249.7 and 3249.8 of Chapter 32 of this title.

EDITOR’S NOTE: 22 DCMR § 3249 was deleted by Final Rulemaking published at 42 DCR 567 (January 27, 1995).

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1504 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3429 [RESERVED]

History

SOURCE: As amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3430 ARCHITECTURAL REQUIREMENTS

3430.1 The provision of space in a community residence facility and the way in which the community residence facility is equipped, furnished, and maintained shall provide a comfortable, congenial, home-like setting for residents and staff.

3430.2 Residents shall be provided access to and encouraged to utilize fully all space required by this section to be provided in the community residence facility.

3430.3 When it is necessary to restrict certain space from residents’ use, that space shall be located in the most remote portions of the community residence facility possible.

3430.4 Group living space shall be provided for social and recreational purposes, including a living room or recreation room, and a dining room.

3430.5 If minimum area requirements for community space in community residence facilities can be met, dining and living areas may be located within the same room.

3430.6 The combined total of all community space provided by the community residence facility shall afford at least twenty-five square feet (25 ft.2) of space above the basement per resident.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1505 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3431 BEDROOMS

3431.1 Bedrooms shall be occupied in conformance with the minimum square foot requirements for bedrooms as specified in § 402 of the D.C. Housing Code (14 DCMR), except that, regardless of the bedroom size, no bedroom shall have more than four (4) occupants.

3431.2 Every resident’s bedroom shall be equipped or provided with a bed, a bedside table or cabinet with an individual reading lamp with at least a seventy-five (75) watt bulb, a comfortable armchair, and suitable, sufficient storage space for each resident’s personal clothing and personal effects.

3431.3 At least one (1) desk and chair shall be provided in the community residence facility for the use of every ten (10) residents.

3431.4 Residents who are students shall be provided with a desk and chair, upon request, in a part of the community residence facility that is quiet and conducive to study.

3431.5 At least weekly, each community residence facility shall provide to each resident clean linens consisting of two (2) sheets and pillow slips, a bath towel, a hand towel, and a wash cloth.

3431.6 Beds shall be located only in rooms designated solely as bedrooms.

3431.7 In community residence facilities in which residents are given keys to their sleeping rooms, staff shall have access to duplicate keys for use in emergency situations and for regularly scheduled routine housekeeping.

3431.8 Each bed shall be placed at least three feet (3 ft.) from any other bed and at least three feet (3 ft.) from any radiator or window.

3431.9 A flame-resistant, washable bedside curtain or portable screen that completely conceals the bed to ensure privacy shall be made available to any resident in a multi-resident bedroom who requests one.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1506 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3432 BATHING AND TOILET FACILITIES

3432.1 Bathing and toilet facilities shall be provided in accordance with the fixtures ratios established for each or both of them in Chapter 6 of the D.C. Housing Code (14 DCMR).

3432.2 In each community residence facility employing more than three (3) full-time employees (including the Residence Director), toilet and lavatory facilities separate from the rooms used by residents shall be provided.

3432.3 In each community residence facility with more than thirty (30) residents, when residents have the use of common living or eating space on floors other than floors on which their bedrooms are located, additional toilets and lavatories shall be provided on those floors in the proportion of (1) toilet and lavatory for each thirty (30) residents.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1507 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3433 FIRE SAFETY

3433.1 There shall be a written manual of instructions and plans, approved by appropriate officials of the District Fire Department, which shall be followed in case of fire, explosion, or other emergency.

3433.2 The manual shall specify persons to be notified, locations of alarm signals and fire extinguishers, evacuation routes, frequency of fire drills, and the assignment of specific tasks and responsibilities to the staff of each shift.

3433.3 All personnel shall be trained to perform specific fire safety tasks.

3433.4 Simulated drills testing the effectiveness of the plan shall be conducted for each shift at least four (4) times a year.

3433.5 The fire safety plan shall be posted throughout the community residence facility.

3433.6 The most recent fire inspection report with the date of the latest inspection of the alarm system shall be kept in the records of each community residence facility.

3433.7 Notwithstanding the provisions of § 3 of the Smoke Detector Act (D.C. Law 2-81), each community residence facility shall install smoke detectors in accordance with §§ 4 through 9 of the Smoke Detector Act.

3433.8 Fire exits shall be clearly designated on the community residence facility’s disaster plan, clearly identified by signs, and kept clear of obstructions.

3433.9 Each community residence facility with more than twenty (20) residents shall be equipped with a manual fire alarm system.

3433.10 The provisions of §§ 3273.1 through 3273.4 of Chapter 32 of this title shall apply to community residence facilities.

EDITOR’S NOTE: 22 DCMR § 3273 was deleted by Final Rulemaking published at 42 DCR 567 (January 27, 1995).

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1509 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3434 FIRE EXTINGUISHERS

3434.1 Fire extinguishers, properly maintained, meeting the requirements of § 1202 of the D.C. Building Code (12 DCMR), and approved for their specific use by an official of the District Fire Department, shall be located as required in the Building Code.

3434.2 A fire extinguisher effective in extinguishing grease and oil fires shall be located within fifteen feet (15 ft.) of any stove, oven, cooking burner, or other cooking device.

3434.3 Within five feet (5 ft.) of the main heating plant and hot water heater, there shall be located a fire extinguisher or extinguishers of a type and sufficient capacity to extinguish fires originating in that equipment.

3434.4 Each community residence facility shall have at least one (1) fire extinguisher located on each floor, including the basement and first floors, in a central location where it is accessible to all residents and personnel.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1510 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004). EDITOR’S NOTE: The Building Code referenced in this section has been superseded by the Construction Codes Approval and Amendments Act of 1986, D.C. Code, 2001 Ed. §§ 6-1401 to 6-1409, effective March 21, 1987. Please refer to those sections of the D.C. Code for current provisions relating to building and other construction codes.

22-B DCMR § 3435 EGRESS REQUIREMENTS AND FIRE DOORS

3435.1 Notwithstanding any conflicting provisions contained in any District rules and regulations, as defined by the D.C. Administrative Procedure Act, the provisions of this section shall apply to community residence facilities.

3435.2 Each community residence facility that has residents in sleeping rooms above the second floor, or which has more than six (6) residents in sleeping rooms above the street floor level shall provide the following:

(a) Access to two (2) separate means of exit for all sleeping rooms above the street level, at least one (1) of which shall consist of an enclosed interior stair, or a horizontal exit, or a fire escape, all arranged to provide a safe path of travel to the outside of the building without traversing any corridor or space exposed to an unprotected vertical opening; or

(b) Alternative arrangements or methods which, according to reasonable equivalency criteria and in the opinion of the Mayor, secure safety to life from fire.

3435.3 Each community residence facility shall comply with § 914 of the D.C. Building Code (DCMR Title 12).

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1511 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004). EDITOR’S NOTE: The Building Code referenced in this section has been superseded by the Construction Codes Approval and Amendments Act of 1986, D.C. Code, 2001 Ed. §§ 6-1401 to 6-1409 , effective March 21, 1987. Please refer to those sections of the D.C. Code for current provisions relating to building and other construction codes.

22-B DCMR § 3436 [RESERVED]

History

SOURCE: As amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3437 [RESERVED]

History

SOURCE: As amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3438 [RESERVED]

History

SOURCE: As amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3439 [RESERVED]

History

SOURCE: As amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3440 HALFWAY HOUSES

3440.1 The provisions of § 3400.3 of this chapter shall not apply to halfway houses, but at all times the Residence Director of a halfway house or another responsible adult (other than a resident of the community residence facility) who is capable of taking action in case of emergencies shall be within call or within reach by telephone at a telephone number made known to all residents, and shall be within a reasonable distance of the community residence facility so as to available to assist within one half (1/2) hour in an emergency.

3440.2 The provisions of § 3404.1 of this chapter shall not apply to halfway houses. Instead, in addition to the pre-admission medical examination required by § 3403.8 of this title, and the pre-admission psychiatric examination required by § 3403.10, each resident shall have an annual psychiatric examination a written report of which, together with a record of any prescription, treatment orders, or special instructions for the management and protection of the resident, shall be made a part of the resident’s permanent record.

3440.3 The provisions of § 3407.1 of this chapter shall not apply to halfway houses.

3440.4 The provisions of § 3406.8 of this chapter shall not apply to halfway houses. No religious beliefs or practices shall be imposed on any halfway house resident, except that religious observances organized by the community residence facility shall be permitted in a halfway house that predicates admissions on religious qualifications in compliance with the terms of §§ 3403.6 and 3403.7 of this chapter.

3440.5 The provisions of §§ 3417.1 through 3417.7 of this chapter shall apply to halfway houses, except that required meals need not be served to residents but may be otherwise made available to them at reasonable times.

3440.6 The requirements of § 2207 of title 23 DCMR shall not apply to halfway houses.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1513 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3441 PAYMENT OF DISTRICT FUNDS

3441.1 No funds of the District shall be paid to any community residence facility or to any person residing in a community residence facility for his or her maintenance in that facility unless the community residence facility is licensed by the District under these regulations.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1513 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3442 MINIMUM INSURANCE STANDARDS

3442.1 All Community Residence Facilities, licensed under D.C. Law 2-35 shall carry sufficient insurance to cover the following:

(a) Hazards (fire and extended coverage) in the amount of five hundred dollars ($500) per resident to protect belongings with a minimum of two thousand dollars ($2,000) of coverage per facility; and

(b) Premises, personal injury, and products liability for at least the limits set forth as follows:

No. of beds

Limit per occurrence (combined

single limit and aggregate limit)

1 - 2

$100,000

3 - 9

$300,000

10 or more

$500,000

(c) Incidental malpractice coverage in respect only of duties required of a resident Director or staff member pursuant to this title, for a limit of at least one hundred thousand dollars ($100,000).

3442.2 In the case of a facility which is not owned by the operator, the operator shall be responsible for obtaining proof of the owner’s premises liability coverage (such as a certificate of standard landlord coverage) or placing the owner on the operator’s policy as an additional named insured.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by Final Rulemaking Published at 27 DCR 2932 (July 4, 1980); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004).

22-B DCMR § 3499 DEFINITIONS

3499.1 The provisions § 3099 of Chapter 30 of this title and the definitions set forth in that section shall apply to this chapter.

History

SOURCE: Regulation No. 74-15 (June 14, 1974); as amended by the Community Residence Facilities Act of 1977 § 101(e), D.C. Law 2-35, 24 DCR 1458, 1513 (August 19, 1977); as amended by ERRATA published at 51 DCR 9308 (October 1, 2004). EDITOR’S NOTE: 22 DCMR § 3099, as it existed when this section was enacted, was deleted by Final Rulemaking published at 39 DCR 5098 (July 10, 1992).

22-B35 COMMUNITY RESIDENCE FACILITIES FOR PERSONS WITH INTELLECTUAL DISABILITIES (CRFPID)

22-B DCMR § 3500 GENERAL PROVISIONS

3500.1 For purposes of this chapter, a group home for persons with intellectual disabilities, as defined in §2 of the Act, shall be known as a Community Residence Facility for Persons with Intellectual Disabilities (CRFPID). CRFPID shall serve as substitute for the term “group home for persons with intellectual disabilities” for the purposes of this chapter.

3500.2 Each CRFPID shall comply with Chapter 31 of Title 22-B of the District of Columbia Municipal Regulations (DCMR), entitled Licensing of Health Care and Community Residence Facilities. Chapter 31 includes administrative procedures on the issuance and renewal of licenses as well as enforcement actions.

3500.3 Each CRFPID shall comply with all applicable Federal and District laws and regulations, including D.C. Law 2-137, the Citizens with Intellectual Disabilities Constitutional Rights and Dignity Act of 1978 (D.C. Official Code §7-1301.01 et seq.). Providers of Home and Community-Based Waiver Services (“HCBS”), known as residential habilitation service settings, shall also comply with Subsection 3500.4 of this Chapter.

3500.4 Each provider of services under the HCBS shall be certified by the Department of Disability Services (DDS) to be in compliance with Chapter 19 of Title 29 of the District of Columbia Municipal Regulations (DCMR), entitled Home and Community-Based Waiver Services for Individuals with Intellectual and Developmental Disabilities. Each provider of waiver services shall comply with this Chapter, 22-B DCMR Chapter 35, in order to obtain and maintain licensure.

3500.5 Each CRFPID participating in the HCBS must be certified by DDS at the time of the Department’s annual licensure survey.

3500.6 Each CRFPID that is certified as an Intermediate Care Facility (ICF) shall not provide HCBS program services.

3500.7 Each CRFPID shall comply with the terms of its license, and the number of persons living at the home shall not exceed the number permitted by the license and shall not exceed the statutory limitation of eight (8) people.

3500.8 Each CRFPID Residence Director shall abide by all District of Columbia laws and regulations relating to the rights of persons with intellectual disabilities.

3500.9 Each CRFPID shall provide recreational activities, community integration and inclusion activities outside the home for all of the persons residing there in accordance with the person’s choice as identified through the person-centered assessment process and as documented in the person’s Individual Support Plan (ISP).

3500.10 Each CRFPID shall have equipment to provide a variety of recreational activities inside the home (including, but not limited to, games, crafts, books, television and radio) and shall maintain such equipment in good repair.

3500.11 Persons shall have access to and open their own mail, packages, texts, emails, or any other form of electronic communication, e.g. FaceTime or Skype. No mail or other forms of communication shall be read by CRFPID staff unless written permission to do so is granted by the person or his or her representative in the form of a memorandum or ISP documentation.

3500.12 Visits by friends, relatives or other persons not paid to be in a CRFPID shall be encouraged and permitted by the CRFPID in accordance with a person’s wishes, provided there is no undue disruption to CRFPID operations and the privacy concerns of other persons or an assessed need and justified in his or her person-centered plan.

3500.13 Each CRFPID shall ensure that each person residing there has privacy in his or her personal space, including entrances that are lockable by the person (with staff having keys as needed and approved in the person’s ISP or within other written documentation).

3500.14 Each CRFPID shall ensure that each person residing there has control and access to his or her personal funds and bank accounts.

3500.15 Each CRFPID shall allow appropriate personnel of the Department of Health (hereinafter “Department”) full access, whether the visit is announced or unannounced, to all CRFPID locations, including access to the persons receiving supports and all records in any form. For purposes of this section, the term “records” includes, but is not limited to, all information relating to the provider, the services and supports being provided, and the persons for whom services are provided; and any information which is generated by or in possession of the CRFPID; the information required by D.C. Law 2-137 (D.C. Official Code § 7-1301, et seq.); and any information required by the regulations implementing CRFPID.

3500.16 The CRFPID shall not use any advertising that contains false, misleading or deceptive statements or claims, or false or misleading disclosures of fees and payment for services. The CRFPID’s name shall not imply that it is providing services it is not licensed to provide or does not deliver.

History

SOURCE: Final Rulemaking published at 39 DCR 3280 (May 8, 1992); as amended by Final Rulemaking published at 68 DCR 4282 (April 23, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3500

22-B DCMR § 3501 COMPLIANCE AND VARIANCES

3501.1 Each CRFPID that was licensed before the effective date of these regulations shall have one year to comply with the provisions herein.

3501.2 The Director may grant a variance from any of the requirements of these rules, if the applicant can show undue hardship and the variance can satisfy the following conditions:

(a) It is not inconsistent with other provisions of the Act;

(b) It is not deleterious to the public health and safety; and

3501.3 A CRFPID requesting a variance shall submit in writing to the Director, the following:

(a) The regulatory requirement(s) for which a variance from strict compliance is being requested;

(b) Specific justification as to why the CRFPID cannot meet the requirement(s); and

3501.4 The Director shall grant a variance only to the extent necessary to ameliorate an undue hardship and only when compensating factors are present to give adequate protection to the public health without impairing the intent and purpose of these rules.

3501.5 If the Director determines that the applicant has not justified undue hardship, he or she shall issue a written proposed denial advising the applicant as to his or her right to a hearing by the Office of Administrative Hearings (OAH) in accordance with OAH rules.

3501.6 The Director shall maintain a record, open to inspection by the public, of all variances granted. The record shall contain a complete written explanation of the basis for each variance.

History

SOURCE: Final Rulemaking published at 39 DCR 3280 (May 8, 1992); as amended by Final Rulemaking published at 68 DCR 4282 (April 23, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3501

22-B DCMR § 3502 ENVIRONMENTAL REQUIREMENTS

3502.1 No CRFPID shall use a name on the exterior of the facility or display a logo which distinguishes it as being different from any other residence in the neighborhood.

3502.2 Each CRFPID is a person’s home and shall be physically accessible to the person and allow the person access to all common areas. The CRFPID must be integrated in the community and support full access to the greater community.

3502.3 A CRFPID is a residential occupancy and may be located in a single or multi-family dwelling.

3502.4 Each CRFPID shall be in good general condition in accordance with Subsection 3503.3.

3502.5 Each CRFPID shall be within walking distance of public transportation or demonstrate that it can and does provide accessible transportation to persons, upon reasonable request, to community activities which may include but are not limited to:

(a) Stores;

(b) Restaurants;

(d) Parks;

(e) Recreational facilities;

(f) Libraries;

(g) Post offices;

(h) Places of worship; and

(i) Other recreational facilities.

3502.6 Each CRFPID shall be located away from known sources of loud and irritating noises and hazardous conditions including, but not limited to, noxious smoke and fumes.

3502.7 All electrical, plumbing and mechanical equipment shall be kept in safe and operating condition. All fire safety equipment, including, at a minimum, smoke detectors, carbon monoxide detectors and fire extinguishers, shall be in good working order.

3502.8 Each CRFPID shall ensure that it has at all times a working water supply, trash disposal system and sewage disposal system. The CRFPID shall ensure that recycling, composting and garbage disposal do not create a nuisance or a breeding place for insects and rodents.

3502.9 The CRFPID’s hot water tank shall be of such size to provide an adequate supply of hot water to the kitchen, bathrooms and laundry. The hot water temperature of all fixtures used by persons residing in the home shall be maintained at a minimum one hundred degrees Fahrenheit (100°F) and not to exceed one hundred and ten degrees Fahrenheit (110°F).

3502.10 The CRFPID shall have a central heating and air conditioning system, radiators or electric built-in heaters and/or air conditioning window units that are installed so as to prevent hazards to persons residing in the home or to room furnishings.

3502.11 Active radiators shall be covered to protect persons from burns. Space heaters and kerosene heaters shall be prohibited.

3502.12 The physical environment shall be well-ventilated. Temperature inside the CRFPID in all rooms shall be maintained to meet persons’ preference. The temperature shall not fall below seventy-two degrees Fahrenheit (72°F) or exceed eighty degrees Fahrenheit (80°F).

3502.13 The CRFPID shall ensure that all rooms have adequate lighting. All community space, as defined herein, shall be illuminated sufficiently to meet persons’ needs, provided that at a minimum such space shall be illuminated to provide 30-foot candles of light at floor level.

3502.14 Each sliding glass door or transparent panel shall be made of tempered glass and shall be marked conspicuously.

3502.15 Space shall be provided for social and recreational purposes including, but not limited to, a living room or recreation room, and dining area. Space shall also be provided for the activities of daily living, including, but not limited to, a kitchen for cooking and preparing meals, and one or more bathrooms for bathing, toileting and grooming. All space defined in this subsection shall be termed community space for purposes of this chapter. The CRFPID shall ensure that persons have access to all designated community space.

3502.16 Each person living in the CRFPID shall have access to and shall be encouraged to fully utilize all community space.

3502.17 Community space (excluding kitchens and bathrooms) shall be at least twenty-five square feet per person above the basement level. Renovated lower floors used as recreation or family rooms with a separate outside exit are not considered a basement.

3502.18 Each person in an educational program, including but not limited to a school-age student, shall be provided an area within the CRFPID that is quiet and conducive to study. The area shall have appropriate lighting, and shall have a desk or table with one or more chairs of appropriate height for the table or desk and sufficient in number to provide seating for all persons residing in the home who use the area.

3502.19 No smoking shall be permitted inside the CRFPID. If smoking is permitted on the premises, the CRFPID shall designate areas where persons may smoke.

History

SOURCE: Final Rulemaking published at 39 DCR 3280, 3282 (May 8, 1992); as amended by Final Rulemaking published at 68 DCR 4282 (April 23, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3502

22-B DCMR § 3503 HOUSEKEEPING

3503.1 Each CRFPID shall ensure that each person residing there has the freedom to furnish and decorate his or her personnel space.

3503.2 All CRFPID furnishings shall be comfortable, functional and in good repair, and in accordance with the preference of the persons who reside there, as well as appropriate for persons who work in the CRFPID.

3503.3 The interior and exterior of each CRFPID shall be maintained in a safe, clean, orderly, attractive, and sanitary manner, and be free of clutter, accumulations of dirt, rubbish, and objectionable odors.

3503.4 Floors shall be leveled, free of debris, constructed of non-skid and non-abrasive materials, in good repair and promote mobility. Rugs shall be stationary, clean and in good repair.

3503.5 Each CRFPID shall be free of insects, rodents and vermin.

3503.6 Each CRFPID that is cited by the Department for violation of Subsection 3503.5 shall contract with a licensed exterminator to provide services for elimination of any infestation within seventy-two hours (72 hrs.) of receipt of written notice by the Department.

3503.7 No cleaning agent, bleach, insecticide or any other poisonous, dangerous, or flammable material shall be accessible to a person where access to such substance is contraindicated in the person’s ISP.

3503.8 Each CRFPID shall provide appropriate procedures, personnel, and equipment in order to ensure sufficient clean linen supplies and the proper sanitary washing and handling of linen and personal clothing of each person.

3503.9 Each CRFPID shall provide at a minimum two (2) sets of the following linens that are appropriate to the size of the bed, clean, and free from stains or tears, appropriate to the needs and in accordance with the preferences of the person:

(a) Four (4) sheets;

(b) Two (2) pillowcase;

(d) Two (2) hand towel; and

(e) Two (2) washcloth.

3503.10 Each CRFPID shall also provide to each person at a minimum one (1) clean blanket and one (1) bedspread that is clean and free from rips, stains or tears, in accordance with the person’s preferences, and that is cleaned as necessary and does not present a risk to health or safety.

3503.11 Each CRFPID shall maintain two (2) additional spare blankets and bedspreads for every four (4) persons.

3503.12 Each CRFPID shall provide a washer and dryer, or make alternative provisions so that each person who wishes to shall have a safe and convenient place to wash and dry personal laundry.

3503.13 Each CRFPID shall assure that each person has at least seven (7) changes of clothing appropriate to his or her preferences, age, activities, culture and season.

3503.14 Each CRFPID shall provide adequate storage areas for clean and dirty linen and shall ensure that each person’s clothing is kept in good condition, laundered, cleaned and is well-fitted. Personal clothing, linens and laundered items shall be kept separately for use by the person to whom they belong and no other person.

History

SOURCE: Final Rulemaking published at 39 DCR 3280, 3284 (May 8, 1992); as amended by Final Rulemaking published at 68 DCR 4282 (April 23, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3503

22-B DCMR § 3504 MEALS AND DINING

3504.1 Each CRFPID shall ensure that each person residing there has access to food at any time, unless there is a restriction based upon assessment, approved by a physician and justified in the person’s ISP.

3504.2 Each CRFPID shall offer each person a nourishing, well-balanced diet in accordance with dietary guidelines established by the United States Department of Agriculture.

3504.3 Menus shall be developed with consideration of average portion sizes for menu items, person preferences, shall be developed on a weekly basis, shall provide a variety of food choices at each meal, and shall be available to persons during mealtimes and otherwise. Each menu shall vary from week to week and adjusted for seasonal changes. Menus shall be available for each person’s review. Mealtime protocols containing personal dietary needs shall not be displayed publicly.

3504.4 If a person requires a modified diet, it shall be prescribed by a physician and documented in the person’s ISP. A “modified diet” is any diet that requires specialized or restricted textures, restricted or increased calories or any other therapeutic restrictions or use of dietary supplements.

3504.5 A recommendation by a licensed dietitian for a modified diet shall be reviewed by a physician within five (5) business days, and shall be implemented only if ordered. If the diet is to be modified based on a medical emergency, the modification must be approved by a physician order within twenty-four (24) hours.

3504.6 Any modified diet shall be planned, prepared, and served by staff members who have received instruction and training on modified diets from a licensed dietitian. Subsequent training can be conducted by a licensed health professional trained by a licensed dietitian.

3504.7 Modified diets shall be reviewed at least quarterly by a dietitian, and as necessary according to any change in the person’s condition. The review shall ensure that each diet provides adequate nutrition.

3504.8 All food and drink shall be free from spoilage, contamination and debris.

3504.9 The CRFPID shall offer at least three (3) meals per day that are nutritious and suited to the needs and choice of each person, along with the availability of nutritious snacks at the times of a person’s choosing. The meals shall be offered at reasonable times as follows:

(a) There shall not be more than fourteen (14) hours between the time a substantial evening meal is offered and breakfast the following day is offered; and

(b) There shall not be more than ten (10) hours between the time breakfast and the evening meal of the same day is offered.

3504.10 A person shall not be required to eat at the three regularly scheduled meal times. Any variation from the requirements of Subsection 3504.9 shall be documented in the person’s record.

3504.11 Each CRFPID shall be responsible for ensuring that meals served away from the CRFPID are suited to the dietary needs of the person as indicated in his or her ISP.

3504.12 No person may be denied a meal as a form of punishment.

3504.13 Each CRFPID shall provide table service for all persons who can and want to eat at a table, including persons in wheelchairs. The dining room shall have tables and chairs sufficient in number to seat all persons residing in the home who utilize the dining room.

3504.14 Each CRFPID shall equip dining areas with tables, chairs, eating utensils, and dishes designed to meet the needs of each person.

3504.15 Persons, as needed, shall be provided training to develop eating skills and to use special eating equipment and utensils if such training is indicated in the ISP.

3504.16 Each CRFPID shall train the staff in the use of proper mealtime protocols and how to assist persons who require special mealtime protocols or utensils.

3504.17 Each CRFPID shall ensure that all direct care staff who prepare, cook or serve food are trained in the storage, preparation and serving of food, the cleaning and care of equipment, and food preparation in order to maintain sanitary conditions at all times.

3504.18 Training in food storage and preparation, serving of food, and cleaning and care of equipment shall be done by a certified food manager in accordance with Title 25-A DCMR, Food and Food Operations.

3504.19 There shall be at least a three (3) day supply of perishable food and a five (5) day supply of nonperishable food in the CRFPID based on the menus for both regular and modified diets.

3504.20 Dry or staple food items shall be stored at least twelve (12) inches above the floor in a room not subject to sewage or waste water backflow, or contamination by condensation, leakage, rodents or vermin.

3504.21 Each CRFPID shall have and utilize effective procedures for cleaning all equipment and work areas used in the preparation and serving of foods.

3504.22 Dishes, eating utensils and cooking equipment shall be cleaned after each meal, appropriately dried and stored to maintain their sanitary condition.

3504.23 Hot and cold water, soap, and towels shall be provided in or adjacent to food preparation areas for hand washing.

3504.24 Each CRFPID shall serve meals at temperatures in accordance with Title 25-A DCMR, Food and Food Operations. If a person requires mealtime assistance, food shall be maintained at serving temperature until assistance is provided. Food that is not promptly consumed shall be refrigerated, if necessary, and reheated.

3504.25 Food requiring refrigeration shall be maintained at temperatures in accordance with Title 25-A DCMR, Food and Food Operations, until preparation for consumption or, if appropriate, for consumption while cold.

3504.26 Frozen foods shall be maintained frozen in accordance with Title 25-A DCMR, Food and Food Operations until preparation for consumption or, if appropriate, for consumption while frozen.

3504.27 Foods that must be cooked to safe temperatures (including but not limited to raw animal, seafood or plant foods) before consumption, shall be heated and reheated to the temperatures in accordance with Title 25-A DCMR, Food and Food Operations.

History

SOURCE: Final Rulemaking published at 39 DCR 3280, 3285 (May 8, 1992); as amended by Final Rulemaking published at 68 DCR 4282 (April 23, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3504

22-B DCMR § 3505 BEDROOMS

3505.1 Each person’s bed shall be located in a room that is designated solely as a bedroom.

3505.2 Each occupied bedroom shall accommodate no more than two (2) people, and measure at least sixty (60) square feet per person in multiple client bedrooms, and at least eighty (80) square feet in single person’s bedrooms.

3505.3 Persons who live in the CRFPID shall not share a bedroom with staff or other non-live-in individuals.

3505.4 A room that can only be accessed through a bathroom or another bedroom shall not be used as a bedroom. An attic or basement shall not be used as bedroom.

3505.5 Each bed shall be placed at least three feet (3 ft.) from any other bed.

3505.6 Each bedroom shall be equipped with at least the following items for each person at all times, and must be in accordance with the person’s preference:

(a) Standard single, queen, king or twin-sized bed;

(b) Clean pillow with appropriate and adequate fill and firmness;

(d) Night stand;

(e) Lamp;

(f) A clean, supportive mattress that has no rips, no tears, and no broken springs; and

(g) At least one chair for each person, if appropriate for the person’s abilities.

3505.7 Each bedroom shall contain at least one closet, and shall have accessible sufficient storage space for each person’s personal effects and seasonal personal clothing.

3505.8 Bedroom doors and windows shall provide adequate privacy. Windows shall have curtains, blinds or shutters. All blinds, curtains and shutters shall be in good repair.

3505.9 Each bedroom shall have at least one external window that shall be appropriately secured to prevent unauthorized entry and to ensure the safety of each person.

3505.10 A person who cannot move up and down the steps independently shall not occupy a bedroom on an upper floor unless functioning mechanisms are employed to ensure the person’s safety while ascending and descending stairs. Such mechanisms must be functional and employable in the event of an emergency.

3505.11 Each person shall have privacy in his or her sleeping and living unit.

3505.12 Each bedroom door shall have a functioning lock to which the person and appropriate staffs have keys, as identified in the ISP.

3505.13 Persons have the freedom to furnish and decorate their sleeping units within the lease or other agreement.

History

SOURCE: Final Rulemaking published at 39 DCR 3280, 3286 (May 8, 1992); as amended by Final Rulemaking published at 68 DCR 4282 (April 23, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3505

22-B DCMR § 3506 BATHROOMS

3506.1 One (1) bathroom consisting of a working toilet, lavatory (sink for hand washing) and bathing facility that is appropriate for the needs of the persons residing in the CRFPID shall be provided for the use of no more than three (3) persons.

3506.2 Each bathroom shall have appliances, fixtures or devices which shall be appropriate to the needs of each person who lives and works in the CRFPID, and which shall allow persons in the CRFPID to achieve maximum independence. Appliances, fixtures and devices shall be in good repair.

3506.3 Each shared bathroom shall be equipped with adequate light, toilet tissue, paper towels, liquid soap for hand washing, and a mirror, as appropriate to the persons’ abilities.

3506.4 A person shall not go through another person’s bedroom in order to enter a bathroom. A person shall not go through one bathroom in order to have access to a second bathroom.

3506.5 Bathrooms shall provide adequate privacy. Each tub or shower shall have privacy partitions or curtains. A bathroom shall not have more than one toilet.

History

SOURCE: Final Rulemaking published at 39 DCR 3280, 3288 (May 8, 1992); as amended by Final Rulemaking published at 68 DCR 4282 (April 23, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3506

22-B DCMR § 3507 PROGRAM STATEMENT

3507.1 Each CRFPID shall have a written program statement that outlines its operating standards and that shall include, at a minimum, the following:

(a) The philosophy, goals and mission of the CRFPID;

(b) The maximum number of persons to be served;

(d) A description of the supports available to persons (including local community resources);

(e) Staffing positions and numbers, in ratio, if applicable;

(f) The sources of referrals of persons;

(g) The CRFPID’s relationship with the person, parents, advocates and legal guardians or other support team members;

(h) The name(s) of the licensee and Residence Director; and

Exclusion criteria, if any.

3507.2 The program statement shall be made available for distribution to each person who requests it.

3507.3 The program statement shall be revised as needed, and the Department shall be advised in writing of any change at least thirty (30) days prior to the change.

3507.4 The CRFPID shall only admit those persons whose service needs are consistent with the program statement, and shall not implement services that are inconsistent with its most current service description as set forth in the program statement.

3507.5 The CRFPID shall update the program statement as needed.

History

SOURCE: Final Rulemaking published at 39 DCR 3280, 3288 (May 8, 1992); as amended by Final Rulemaking published at 68 DCR 4282 (April 23, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3507

22-B DCMR § 3508 POLICIES AND PROCEDURES

3508.1 Each CRFPID shall have on site a written or electronic manual that contains its most current policies and procedures, which shall be as detailed as is necessary to meet the needs of each person served and provide guidance to each staff member.

3508.2 The on-site manual shall have been approved by the management of the CRFPID. The CRFPID management shall review the manual at least annually and revise it as necessary. All policies and procedures shall be in final form and signed and approved by the CRFPID management.

3508.3 The manual shall be available for review and approval by government personnel who have licensing responsibility over CRFPIDs.

3508.4 The CRFPID shall ensure that all staff and contractors are aware of the policies and procedures required by this section and that all policies and procedures are implemented. All employees and contractors shall be kept informed of policy changes that affect the performance of their duties.

3508.5 The manual shall incorporate policies and procedures for at least the following:

(a) Admission and readmission, which covers admission criteria and exclusions; transfer and discharge; assessments and who shall conduct assessments; services offered; program planning;

(b) Appropriate conduct between staff and persons residing in the CRFPIDs, and the monitoring of such conduct;

(d) Confidentiality of protected health information;

(e) Emergencies and safety, which cover fire safety, emergency evacuation, infection control, and continuity of operations planning;

(f) Protocols for managing affairs related to the death of a person;

(g) Protocols for medical emergencies, first aid and changes in a person’s health status;

(h) General administration, which covers the organization charts, internal assessment of the quality of care, and fiscal management;

(i) Grievance procedures indicating how a person is to present complaints, including complaints regarding staff, person’s rights and investigation of complaints; procedures must include ability for a person to complain anonymously;

(j) Health care, which covers treatment of acute and chronic health conditions; ensuring the availability of physician and dental services for preventative treatment and emergencies; and development and implementation of medical care plans in accordance with the person’s needs and the ISP;

(k) People’s rights and the formation and composition of a human rights committee in compliance with D.C. Law 2-137, the Citizens with Intellectual Disabilities Constitutional Rights and Dignity Act of 1978 (D.C. Official Code §7-1301.01 et seq.);

(l) Maintenance and use of medical and adaptive equipment;

(m) Medication management which covers administration of medication, medication administration errors, medication storage and disposal (in accordance with Section 3521);

(n) Personnel, which shall include job descriptions and qualifications, staff/person ratios, training and competency evaluations, staff development, health inventories and criminal background checks (in accordance with Section 3512);

(o) Electronic and manual recordkeeping, including confidentiality, accessibility, security, and retention of records (in accordance with Section 3517);

(p) Prohibition of mistreatment, neglect or abuse of persons by staff (in accordance with Section 3524);

(q) Identifying, investigating, managing and reporting of unusual incidents;

(r) Policies for handling funds of persons receiving services, which shall include:

Providing for separate accounting for personal funds and prohibiting comingling of personal and CRFPID funds;

Requirements that persons control their own funds whenever possible, be provided training in money management whenever needed, endorse checks made out to them unless a legal guardian or personal representative has been authorized by law to endorse their checks; and

Requirement that persons receive receipts of funds unless the person has been deemed by court to be incompetent, in which case the receipts shall be given to a guardian or personal representative;

(s) Policies and procedures detail a Quality Assurance Program in accordance with which the CRFPID shall evaluate its operations, staff, contractors and quality of services; and

(t) Policies regarding fees, payments, refunds and services, which shall be available at the time of admission. Policies regarding fees related to the Home and Community-Based Services Waiver Program shall be determined by DDS.

History

SOURCE: Final Rulemaking published at 39 DCR 3280, 3289 (May 8, 1992); as amended by Final Rulemaking published at 68 DCR 4282 (April 23, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3508

22-B DCMR § 3509 ADMISSIONS

3509.1 An interdisciplinary team (IDT) shall make the determination of whether to admit a person to the CRFPID. The IDT for purposes of determining admission shall be comprised of at least the following:

(a) The nursing staff;

(b) The Qualified Intellectual Disabilities Professional (QIDP) and/or the Residence Director;

(d) Other members of the person’s support team.

3509.2 Prior to admission, a person’s health, competency or independence levels, training and support needs shall be assessed to determine the appropriateness of the placement in the CRFPID.

3509.3 Any participant of HCBS program shall have a person-centered service plan developed through a person-centered planning process overseen by the DDS.

3509.4 If the admission is from a source other than DDS, the CRFPID shall complete the assessment and shall address:

(a) Nature, and onset of diagnosis of disability in addition to duration of disability;

(b) Social, behavioral, developmental and family history;

(d) Previous interventions and outcomes;

(e) Financial resources and benefits;

(f) Health history and current medical needs;

(g) Legal status, including guardianship;

(h) Daily living skills;

(i) Social and family supports; and,

(j) Housing arrangements.

3509.5 Based on the assessment required by Subsection 3509.2, the CRFPID shall state in writing the appropriateness of placement in the CRFPID as determined by the needs of the person, and the qualified staff and resources of the CRFPID.

3509.6 The CRFPID shall admit only those persons who are determined through the admission assessment to be candidates for placement in the CRFPID or after other options are explored and proves to be the least restrictive place for the person.

3509.7 The CRFPID shall maintain documentation of the admission assessment and the names of the employee(s) conducting the assessment.

3509.8 A CRFPID may rely on a person’s prior ISP to determine the appropriateness of the placement, provided that the prior ISP has been reviewed and updated within the past year.

3509.9 The CRFPID shall conduct a reassessment to determine the appropriateness of the placement when there is a significant change in the medical, behavioral or psychiatric status of the person as determined by a member of the IDT.

3509.10 The CRFPID shall maintain written documentation of each assessment and reassessment. In addition to the update of documentation required by this section, each reassessment shall include the following:

(a) The date of initial assessment;

(b) Name, age and gender of the person;

(d) Presenting needs including psychiatric/medical problems, current medications and history of medical care; and

(e) Name of the screening employee or contractor and his or her experience and qualifications; and

(f) The habilitative assessment tool(s) utilized; and findings.

3509.11 For persons not admitted, documentation of the assessment shall be retained for at least six (6) months.

3509.12 Each CRFPID shall obtain from the person, sponsoring agency or guardian, as appropriate, information about any known health problems or communicable diseases of a person upon his or her being admitted or readmitted.

3509.13 Each person who has a communicable disease may be admitted only to a CRFPID that is capable of implementing environmental and hygienic procedures appropriate to the specific disease as prescribed by a physician, which shall include treatment of the condition and prevention of the spread of the disease.

3509.14 Each CRFPID shall obtain upon admission for each person a record of all medications the person is currently taking, and other information, including:

(a) Names and of all prescribed controlled substances;

(b) A reason for each medication; and

3509.15 Each CRFPID shall obtain a health inventory screening, conducted by a physician, for each newly admitted person prior to admission if possible but no later than within fifteen (15) days of admission.

3509.16 A physical examination shall be documented, signed and dated by the physician and shall include the following:

(a) Assessment of general physical condition;

(b) A complete medical history including allergies, modified diets, medication orders, recent physical complaints and medical conditions, chronic conditions, past serious illnesses and injuries, current and past drug use (including both prescription and illicit drugs), vaccination history, and any condition that may predispose the person to acquiring or transmitting infectious diseases;

(d) Evaluation for communicable diseases, including tuberculosis and a determination of the Hepatitis B antigen and antibody status of each person relevant to acquiring or transmitting infectious diseases;

(e) Immunization updates, as needed;

(f) Evaluation of the need for other testing; and

(g) Any other test deemed appropriate by the examining physician.

3509.17 The CRFPID shall ensure that each newly admitted person receives a dental examination within one year of admission or as soon as practicable.

3509.18 Each CRFPID shall secure a written report of the health screening that shall provide sufficient information concerning the person’s health to enable the CRFPID to provide appropriate services to meet that person’s needs. The CRFPID shall implement all of the physician’s orders and any physician recommendations approved by the IDT.

3509.19 Persons receiving or in need of hospice care shall not be admitted to a CRFPID. This restriction shall not apply to persons who were admitted to a CRFPID prior to the initiation of or a recommendation for hospice care.

3509.20 Admission policies shall be available for review by each person contemplating residency in the home or his or her authorized representative.

3509.21 A person’s original records shall follow the person and be available at admission.

History

SOURCE: Final Rulemaking published at 39 DCR 3280, 3290 (May 8, 1992); as amended by Final Rulemaking published at 68 DCR 4282 (April 23, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3509

22-B DCMR § 3510 DISCHARGES AND TRANSFERS

3510.1 A person shall be discharged or transferred from a CRFPID as provided by D.C. Law 2-137; D.C. Official Code §§ 7-1303.07 to 7-1303.10.

3510.2 Each CRFPID shall have written policies which shall specify criteria and procedures for transfer to either a more or less restrictive setting and discharge from a CRFPID.

3510.3 Reasons for transfer from a community residence facility shall include, but not limited to, the following:

(a) The medical needs as determined by a physician;

(b) The behavior of the person or other circumstances which pose an imminent danger to the person or other persons in the home; and

(c) The determination by the interdisciplinary team that the person's habilitative needs would be better met by another setting.

3510.4 Each CRFPID shall plan for voluntary or involuntary transfer or discharge of a person on a non-emergency basis and shall provide the following:

(a) Thirty (30) days notification to appropriate individuals or sponsoring agencies of reasons for the need to transfer or discharge;

(b) Comprehensive relocation assistance and counseling to a person being transferred or discharged;

(d) Reason(s) for changing or terminating services.

3510.5 Each CRFPID shall document in writing its compliance with this section.

3510.6 Transfer of a person for emergency medical treatment may be made by the CRFPID director with appropriate notification to the person's physician.

3510.7 Each CRFPID shall have procedures for medical treatment in place which adequately detail the transfer and return process.

3510.8 Prior to or at the time of discharge or transfer of a person, the CRFPID shall provide a complete copy of the person's comprehensive record to the new residence or to the sponsoring agency.

History

SOURCE: Final Rulemaking published at 39 DCR 3280, 3292 (May 8, 1992); as amended by Final Rulemaking published at 68 DCR 4282 (April 23, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3510

22-B DCMR § 3511 MANAGEMENT OF OPERATIONS

3511.1 Each CRFPID shall provide adequate administrative support to efficiently meet all the needs of each person and to meet all the requirements of District and federal law as applicable to CRFPIDs.

3511.2 The CRFPID shall have a person or persons who oversee the management and operations of the CRFPID and shall ensure compliance with the terms of its license, and is ultimately responsible to the Department for maintaining operating and licensing standards. The names of these persons and their relationship to the CRFPID shall be provided to the Department and the Department shall be notified within forty-eight (48) hours of any change in employment status of these persons.

3511.3 If the CRFPID is a participant in the HCBS, it shall have a person or persons responsible for the management of the waiver program and overseeing of the waiver program and responsibilities monitored by the Department on Disability Services or the Department of Health Care Finance. The name(s) shall be provided to the Departments and within forty-eight (48) hours of any change in employment status of these persons.

3511.4 Each CRFPID operated by a corporation or partnership shall maintain in an accessible location, a copy of its Articles of Incorporation, Certificate of Authority, or partnership agreement, as applicable.

3511.5 Each CRFPID shall have an organizational chart that shows the following:

The CRFPIDs management as specified in Subsection 3511.2;

(b) The personnel who supervise the CRFPIDs programs;

(d) The lines of authority;

(e) The name of the Residence Director/Administrator; and,

(f) The name of the designated House Manager, if applicable.

3511.6 The management shall appoint a Residence Director to whom it shall delegate in writing the authority and responsibility for the administrative direction of the CRFPID and its services. Nothing in this regulation shall prevent the CRFPID from appointing as Residence Director, the QIDP or other senior staff.

3511.7 The management shall approve the CRFPID’s program statement, policies and procedures, and budget.

3511.8 Each CRFPID shall maintain for at least six (6) years documentation of services provided by contractual agreement when such services are in accordance with a person’s Individual Support Plan.

3511.9 Each CRFPID shall maintain a full and complete accounting of each person’s personal funds entrusted to the facility on behalf of the person.

3511.10 Each CRFPID licensee shall carry or ensure that the premise carries the following insurance in at least the following amounts:

(a) Hazard (fire and extended coverage) in the minimum amount of five hundred thousand dollars ($500,000) per person to protect belongings, with a minimum of one million dollars ($1,000,000) per CRFPID; and

(b) Liability coverage (premises, personal injury, and products liability) in the amount of one million dollars ($1,000,000) per occurrence; and professional liability in an amount appropriate to the services provided by the CRFPID.

3511.11 The CRFPID shall notify the Department in writing of its intent to discontinue services no later than sixty (60) days prior to cessation of services. The CRFPID shall continue to provide all services that are identified in each person’s ISP after it has given notice of its intent to cease operations and until each person is appropriately discharged or transferred. The CRFPID shall continue to maintain compliance with all applicable regulations as it is in the process of discontinuing its services.

3511.12 All persons and, as applicable, the person’s parent guardians, or chosen support team shall be notified of the CRFPID’s intent to cease services in writing at least thirty (30) days prior to cessation of services.

History

SOURCE: Final Rulemaking published at 39 DCR 3280, 3293 (May 8, 1992); as amended by Final Rulemaking published at 68 DCR 4282 (April 23, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3511

22-B DCMR § 3512 PERSONNEL

3512.1 Personnel policies which meet the requirements of this section shall be developed according to the CRFPID's particular needs and distributed to each employee. All employees and contractors shall be kept informed of any policy changes that affect the performance of their duties.

3512.2 A staffing plan is maintained and includes the following:

(a) Each CRFPID shall develop and implement a staffing plan that includes the type and responsibilities of all employees and contractors, and reflects the needs of the population served, the type of services offered, the service description, and the number of persons served; and

(b) The staffing plan shall describe the supervisory chain for all employees and contractors. Supervision shall be appropriate to the services provided and shall be a documented plan to ensure there is always an emergency on-call plan to ensure sufficient staff are on duty at all times.

3512.3 Each CRFPID staffing plan shall include the following positions:

The Residence Director, who shall be responsible for the administrative direction of the CRFPID and its services; or

(b) A Qualified Intellectual Disabilities Professional (QIDP), who shall have the responsibility for daily oversight of persons and programs. The QIDP can function as the Residence Director; and

(c) Direct care staff, who shall be at least eighteen (18) years of age and have a high school diploma or a General Education Diploma (GED).

3512.4 In accordance with this chapter each Residence Director who also is employed as a QIDP (and vice versa) shall be qualified as both and must perform the applicable duties adequately.

3512.5 The CRFPID shall employ sufficient staff and contractors to provide needed direct care and services for every person at the home in accordance with each person’s ISP, provided that the CRFPID shall maintain the minimum staff ratios required by this chapter and shall ensure that there is direct care staff on duty and awake on a twenty-four (24) hour basis whenever persons are present in the CRFPID.

3512.6 Employees and contractors shall comply, as required, with all licensing requirements of the Department.

3512.7 The CRFPID shall provide adequate staffing to ensure that the residence is clean and in good repair. Housekeeping shall not interfere with the delivery of direct care services in accordance with a person’s ISP.

3512.8 Each CRFPID staff person shall have a written job description which details each of his or her major responsibilities and duties, supervisory control and the minimum knowledge, skills, abilities, experience and/or professional qualifications required. Any person who assumes the responsibilities of any employee position shall meet the minimum requirements of the position as determined by the job description.

3512.9 Each Residence Director or QIDP or a designee shall discuss the contents of job descriptions with each employee at the beginning of employment.

3512.10 Each employee shall be given a copy of his or her job description to review and sign at the beginning of employment.

3512.11 Each job description shall be reviewed annually. Each job description shall be updated and revised when the duties and responsibilities of the job change when those changes occur and are expected to remain with the job.

3512.12 Each employee, within ninety (90) days prior to employment and annually thereafter, shall provide certification from a physician attesting that he or she is fit to perform the required duties of the job and is free from any active communicable disease.

3512.13 The CRFPID shall comply with and shall not employ a worker who does not comply with District of Columbia standards on criminal background checks as set out in D.C. Law 14-98, the Health-Care Facility Unlicensed Personnel Criminal Background Check Amendment Act of 2002 and implementing regulations, 22B DCMR Chapter 47. The CRFPID shall obtain enough information from each applicant to comply with criminal background check requirements even if obtaining such information is in addition to information obtained in compliance with Subsection 3512.14. In addition, each CRFPID shall comply with background checks in accordance with applicable federal law and shall not employ a person who has a history of the following:

Child abuse or abuse of someone under his or her care and supervision, including misappropriation of property;

(b) Neglect;

(d) Conviction for a sexual offense or violent crime; or

(e) A conviction for criminal violation(s) that would indicate behavior potentially harmful to persons.

3512.14 Each CRFPID shall obtain from each applicant employment information from the last seven (7) years (if the applicant was in the workforce) or the three (3) most recent employment positions, whichever time period is longer, including the name of the employer, the name of the immediate supervisor, the dates of employment, and the reason for leaving the employment, and shall make reasonable efforts to verify the employment information provided.

3512.15 The CRFPID shall maintain a personnel record for each employee and contractor that includes identifying information; professional license, if applicable, and any adverse actions by licensing bodies; employment history; results of reasonable efforts to secure job-related references and verification of employment history; results of criminal, sexual abuse, and child abuse and neglect background checks; performance evaluations; and any disciplinary actions taken by the CRFPID.

3512.16 The CRFPID shall have and implement a written policy that clearly defines and communicates the requirements for the use and responsibilities of students and volunteers including selection and supervision. The CRFPID shall not rely on students and volunteers for direct care services, and the staffing plan shall not include students and volunteers.

3512.17 In addition to complying with this section, each CRFPID shall have a Residence Director or QIDP available and accessible at all times.

History

SOURCE: Final Rulemaking published at 39 DCR 3280, 3294 (May 8, 1992); as amended by Final Rulemaking published at 68 DCR 4282 (April 23, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3512

22-B DCMR § 3513 RESIDENCE DIRECTOR

3513.1 A Residence Director shall have the following qualifications:

(a) He or she shall be at least twenty-one (21) years of age;

(b) He or she shall be certified annually by a physician as being in good physical and mental condition, and be free of communicable diseases (unless he or she is under a physician’s care for and in compliance with treatment for the prevention of the communicable disease);

a bachelor’s degree in a behavioral science;
an associate’s degree and at least two (2) years of full-time experience working with person’s with an intellectual disability; or
four years of full-time experience working in a licensed home with persons with an intellectual disability; and

(d) He or she shall take at least twelve (12) hours of documented training annually related to the management of CRFPIDs and the support of persons with intellectual disabilities.

3513.2 The CRFPID shall inform the Department and any person residing in the home at least thirty (30) days in advance whenever there is a change in the Residence Director, except that such thirty (30) day notice period shall not apply in the event a Residence Director resigns or is terminated with less than thirty (30) days’ notice, in which case the Department and any person in the home shall receive notice within twenty-four (24) hours or the next business day or whenever practicable.

3513.3 The Residence Director shall be responsible for the administrative direction of the CRFPID and its services.

3513.4 The Residence Director may deliver direct care to persons no more than fifty (50) percent of his or her time in the home.

3513.5 The Residence Director shall not be employed outside the CRFPID in any position that will create a conflict of interest with his or her responsibilities as a Residence Director.

3513.6 If a Residence Director will be absent from any CRFPID for longer than two (2) weeks he or she shall designate a person to act as Residence Director who shall be qualified in accordance with the requirements in this chapter for a Residence Director.

History

SOURCE: Final Rulemaking published at 39 DCR 3280, 3294 (May 8, 1992); as amended by Final Rulemaking published at 68 DCR 4282 (April 23, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3513

22-B DCMR § 3514 QUALIFIED INTELLECTUAL DISABILITIES PROFESSIONAL (QIDP)

3514.1 The QIDP shall oversee the initial admission assessments of persons, participate in the development of the ISP and monitor, integrate and coordinate services.

3514.2 The QIDP shall be one of the following:

A psychologist with specialized training or one (1) year of experience in intellectual disabilities;

A physician licensed to practice medicine in the District and with specialized training in intellectual disabilities or with one (1) year of experience in treating persons with intellectual disabilities;

(c) An educator with a degree in education from an accredited program and with specialized training or one (1) year of experience in working with persons with intellectual disabilities;

(d) A social worker with a master's degree from an accredited school of social work and with specialized training in intellectual disabilities or with one (1) year of experience in working with persons with intellectual disabilities;

(e) A rehabilitation counselor who is certified by the Commission on Rehabilitation Counselor Certification and who has specialized training in intellectual disabilities or one (1) year of experience in working with persons with intellectual disabilities;

(f) A therapeutic recreation specialist who is a graduate of an accredited program and who has specialized training or one (1) year of experience in working with persons with intellectual disabilities;

(g) A human service professional with at least a bachelor’s degree in a human services field (including, but not limited to sociology, special education, rehabilitation counseling, and psychology) and who has specialized training in intellectual disabilities or one (1) year of experience in working with persons with intellectual disabilities; or

(h) A registered nurse with specialized training in intellectual disabilities or with one (1) year experience in working with persons with intellectual disabilities.

3514.3 The QIDP shall have the following responsibility for implementing day to day protocols for the operation of the CRFPID, including but not limited to:

(a) Management of services and accommodations; direct all facets of the active treatment effort, including the IDT creation of relevant ISPs tailored to meet person needs;

(b) Effectively coordinate internal and external program services and supports to facilitate the acquisition of person skills and adaptive behaviors;

(d) Ensure implementation of policies, practices, and procedures of the CRFPID; and

(e) Supervise and direct other employees, except clinicians (e.g. nurses).

History

SOURCE: Final Rulemaking published at 39 DCR 3280, 3295 (May 8, 1992); as amended by Final Rulemaking published at 68 DCR 4282 (April 23, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3514

22-B DCMR § 3515 STAFF TRAINING

3515.1 For each position, orientation training for each new employee shall be complete within thirty (30) days of the date on which each employee begins work in the CRFPID or directly with the person.

3515.2 Orientation shall be conducted by persons or entities with specialized training in the subjects to be covered in the orientation.

3515.3 Each CRFPID shall maintain a written copy of the orientation training program and materials, including the subjects covered, the number of hours of orientation, and the names and qualifications of the persons conducting the orientation. The written copy shall be available to the Department for review.

3515.4 Orientation shall include an overview of intellectual disabilities including, but not limited to, the definition and causes of intellectual disabilities, associated health implications, frequently used medications, and each person’s history of care with intellectual disabilities.

3515.5 Orientation training shall also cover the following in accordance with each employee’s responsibilities and the CRFPID’s goals:

Prevention of abuse, neglect and exploitation;

(b) Compliance with the policies and procedures of the CRFPID, including a review and discussion of relevance of them;

(d) Confidentiality requirements, including a review of HIPAA;

(e) Responding to emergencies, including reporting responsibilities, fire safety, vehicle safety evacuation procedures, disaster plans, first aid, CPR and any other emergency protocols;

(f) Providing personal care to persons;

(g) Nutrition;

(h) Meal preparation and food storage;

Mealtime protocols;

(j) Behavior management;

(k) Persons rights;

(l) Community integration and inclusion;

(m) Communication skills and techniques;

(n) Adaptive Equipment and assistive technologies;

(o) Transfer and mobility procedures;

(p) Behavior supports;

(q) Sexuality, as indicated by the needs of the person;

(r) Infection control and universal precautions for staff and persons;

(s) Specialty areas related to the specific needs of the person;

(t) Implementing ISPs; and

(u) Training of the person in activities of daily living, including the maintenance of oral health and hygiene.

3515.6 Each direct care staff shall be currently certified in cardiopulmonary resuscitation (CPR) and First Aid. The CPR certification must be obtained in a classroom setting.

3515.7 The CRFPID shall provide on-the-job training as necessary for the performance of job assignments in accordance with the requirements of this section. Employees shall be directly supervised until the Residence Director or QIDP deems that competence in the performance of all job duties has been achieved.

3515.8 The CRFPID shall provide to each employee, at least, twelve (12) hours of annual training in the areas of intellectual disabilities, to include training on protecting persons from abuse, neglect, and mistreatment. The CRFPID shall document in writing each employee’s annual training, including the subjects covered and the number of hours of each subject. The CRFPID shall maintain copies of all training materials.

3515.9 Each training program agenda and record of staff participation shall be available for review by the Department.

History

SOURCE: Final Rulemaking published at 39 DCR 3280, 3295 (May 8, 1992); as amended by Final Rulemaking published at 68 DCR 4282 (April 23, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3515

22-B DCMR § 3516 DIRECT CARE STAFF RATIOS

3516.1 Each CRFPID shall ensure that adequate qualified staff is on-site to manage and fulfill the needs of persons supported.

3516.2 Staffing ratios shall be maintained at the persons supported levels of need but no fewer than the following to the extent that the CRFPID is providing the service in accordance with:

(a) 1:6 during the waking hours of the day, approximately 6:00 a.m. to 2:00 p.m., when persons remain in the CRFPID during the day;

(b) 1:4 during the period of approximately 2:00 p.m. to 10:00 p.m.; and

3516.3 Staffing ratios may be changed if there are changes to persons needed supports, or changes in the population residing in the CRFPID.

3516.4 Staff is not required to be in the CRFPID when all people are away, provided that a staff person is available or on-call for emergencies that may require a person to return to the CRFPID.

3516.5 The CRFPID must provide sufficient support staff so that direct care staff is not required to perform support services to the extent that these duties interfere with the exercises of their primary direct client care duties.

History

SOURCE: Final Rulemaking published at 39 DCR 3280, 3295 (May 8, 1992); as amended by Final Rulemaking published at 68 DCR 4282 (April 23, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3516

22-B DCMR § 3517 RECORDKEEPING

3517.1 The CRFPID shall maintain current and accurate records and reports as required by this section.

3517.2 Each record shall be kept in a centralized file or stored electronically and made available at any time requested for inspection and review by Department personnel. Any records that are stored off-site must be made available for review in the CRFPID within three (3) hours of request.

3517.3 Active and closed records containing any information about persons shall be stored in a locked cabinet or room. A back-up plan, and physical and data security controls shall be implemented for electronic records.

3517.4 Each record and report that is required to be kept in accordance with this chapter shall be filed and retained for six (6) years by the CRFPID, unless otherwise specified. Records required to be kept for person’s residing in CRFPIDs shall be maintained for at least six (6) years after the person’s discharge or death.

3517.5 The CRFPID shall implement a review process to evaluate both current and closed records for completeness, accuracy and timeliness of entries. The process shall be in writing and shall be available for review by the Department.

3517.6 The CRFPID shall maintain the following records:

Administrative Records, which shall include:

(i) List of current charges and fees for services;

(ii) Personnel records for all staff, which includes the following:

(A) Identifying information, including name, social security number and if applicable driver’s license number;

(B) Education and training history;

(D) Results of the provider credentialing process, including methods of verification of applicable professional licenses or certificates;

(E) Results of reference checks and verification of prior employment;

(F) Results of criminal background checks;

(G) Results of performance evaluations; and

(H) Records of any disciplinary actions taken by the CRFPID or any other entity.

(iii) Weekly staff schedules, including substitutions;

(iv) Disaster plans and procedures and documentation of evacuation drills;

(v) Signed agreements or contracts for professional services, if applicable;

(vi) A current master alphabetical index of all persons serviced by the CRFPID that contains the following information:

(A) The person’s name;

(B) The name, address and phone number of the parent(s), guardian or authorized representative;

(D) The funding source, if applicable, and a contact person or position at the source;

(vii) A log in which emergencies and other unusual occurrences involving persons is recorded;

(viii) A complaint log, including the results of any investigation initiated pursuant to a complaint; and

(ix) A record of discharges and transfers, including transfer and discharge summaries.

(b) Persons Clinical and Habilitation Record shall include:

Identifying information, including name of the person; current residence; social security number; gender; marital status; date of birth; name of parent, guardian or authorized representative; name, address and phone number of emergency contacts; and date of admission to the CRFPID;

All current and former ISPs and Individual Program Plans (IPPs) for the last six (6) years;

(iii) A listing of the person’s physician and other licensed health care professionals and contact information;

(iv) Clinical and habilitation progress notes;

(v) Medical records, including physician orders, diagnosis, immunizations, health consultation recommendations, nursing care plans, nursing notes, and nursing services; and

(vi) Medication administration record.

3517.7 The CRFPID shall ensure that all medical records accurately reflect the person’s current condition and are updated as necessary. Any changes made to a person’s records shall be signed with the date, by each employee or contractor who makes the entry.

3517.8 If a person’s records, or components of records, are provided to another CRFPID, agency or hospital during any short-term transfer (such as hospitalization or other emergency placement), the CRFPID shall ensure that the receiving agency manages such records subject to the access, use, and disclosure requirements set forth in The Health Insurance Portability and Accountability Act of 1996 (HIPAA).

3517.9 If there is a medical emergency involving a person, the CRFPID shall censure that any medical information necessary for the appropriate treatment of the person is available to the treating medical personnel.

History

SOURCE: Final Rulemaking published at 39 DCR 3280, 3296 (May 8, 1992); as amended by Final Rulemaking published at 68 DCR 4282 (April 23, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3517

22-B DCMR § 3518 PROFESSIONAL SERVICES

3518.1 Each person who resides in a CRFPID shall receive the professional service(s) required to meet his or her needs as identified in his or her ISP, and any other care plan or prescription.

3518.2 Each person who resides in a CRFPID shall receive professional services from persons of their choice. Those persons who need assistance in choosing a professional service, assistance may be provided by their support group.

3518.3 Each CRFPID shall ensure that qualified professional staff reviews and evaluates a person’s health status, and carries out and monitors necessary professional interventions, in accordance with the goals and objectives of every ISP.

3518.4 Professional services shall include, as applicable, but not be limited to, those services provided by individuals trained, qualified, and licensed as required by District of Columbia law in one or more of the following disciplines or areas of services:

(a) Medicine;

(b) Dentistry;

(d) Nutrition;

(e) Nursing;

(f) Occupational or Physical Therapy;

(g) Psychology;

(h) Social Work;

(i) Speech and language therapy; or

(j) Recreation.

3518.5 The CRFPID shall ensure that anyone providing professional services to a person is qualified to provide such services, including ensuring proper licensure and/or certification as required in the District.

3518.6 The CRFPID shall maintain on-site proof of current licensure and/or certification for any staff member or professional providing on-site services to a person.

3518.7 Professional services shall be provided in accordance with generally accepted professional standards relevant to the service being provided.

3518.8 Direct care staff may provide professional services as delegated to them and supervised by a licensed professional and as permitted by District or federal law.

3518.9 Professional services shall include diagnosis and evaluation, including identification of developmental levels and needs, treatment services, and services designed to prevent deterioration or further loss of function by the person. Professional services appropriate for each person shall be included in the person’s ISP.

3518.10 Each professional service provider shall participate in each person’s IDT as appropriate to the person’s needs, if the person agrees to professional service provider’s participation. The ISP shall include the rationale for the selection or exclusion of specific team members.

3518.11 Each CRFPID shall ensure that employees who assist in the provision of professional services are properly instructed and trained on the implementation of a person’s programs.

3518.12 Each professional service and outcomes shall be documented in each person’s record.

3518.13 Each CRFPID shall obtain from each professional service provider a written report when significant changes occur to warrant revisions to a person’s ISP. In the absence of any significant changes, a written report shall be submitted by each professional service provider no less than once every six (6) months.

3518.14 If a person requires professional service (s), the CRFPID shall ensure that arrangements are made within ten (10) calendar days of the identified need.

History

SOURCE: Final Rulemaking published at 39 DCR 3280, 3297 (May 8, 1992); as amended by Final Rulemaking published at 68 DCR 4282 (April 23, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3518

22-B DCMR § 3519 MEDICAL AND NURSING SERVICES

3519.1 Each CRFPID shall ensure a designated primary care physician for each person.

3519.2 Each CRFPID shall ensure that all persons have access to appropriate medical and health care providers of their person’s choice, subject to the person’s health insurance coverage.

3519.3 The CRFPID shall ensure appropriate referral and follow-up to meet the routine, chronic and acute health care needs of the person and in accordance with the person’s choice of provider.

3519.4 The CRFPID must employ or arrange for licensed nursing services appropriate to care for person’s health care needs, including persons with medical care plans, using the provider of the person’s choice.

3519.5 The CRFPID shall ensure that its staff responds immediately to emergencies and provides care and intervention in accordance with the CRFPID’s policies and procedures.

3519.6 The CRFPID shall ensure that a person’s health records include the diagnosis of any current condition, and that any diagnoses are based on relevant, objective and accurate data, and are updated as necessary to reflect the person’s current condition.

3519.7 Verbal orders shall be transcribed onto a physician order form by a nurse and countersigned and dated by the physician within twenty-four (24) hours for all controlled substances and psychotropic medications, and within ten (10) calendar days for other drugs. The CRFPID shall retain a copy of the signed order in the person’s record.

3519.8 The CRFPID shall ensure that a person’s primary care physician receives reports of recommendations or orders from all other health or medical specialists to whom the person is referred within twenty-four (24) hours or the next business day. The CRFPID shall retain a copy of the signed recommendations or orders in the person’s record.

3519.9 The person’s physician or advanced practice nurse must develop in coordination with licensed nursing personnel a medical care plan of treatment for people, if the physician determines that a person requires twenty-four (24) hours of licensed nursing care. The plan must be integrated in the person’s ISP and monitored by the nursing and medical team as appropriate.

3519.10 A physician or registered nurse shall implement with other members of the IDT appropriate protective and preventive health measures that include, but are not limited to:

(a) Training persons and staff as needed in appropriate health and hygiene methods;

(b) Control of communicable diseases and infections, including the instruction of other personnel in methods of infection control; and

(c) Training direct care staff in detecting signs and symptoms of illness or health condition and basic skills required to meet the health needs of the person.

3519.11 The CRFPID must utilize registered nurses as appropriate and as required by District of Columbia law to perform the health services specified in this section.

3519.12 If the CRFPID utilizes only licensed practical nurses to provide health services, it must have a formal arrangement with a registered nurse or nurse practitioner to be available for verbal or on-site consultation and supervision to the licensed practical nurse.

3519.13 The CRFPID may utilize trained medication employees practicing under the scope of their certification in accordance with Title 17 of the District of Columbia Municipal Regulations Chapter 61 (17 DCMR Chapter 61).

3519.14 Non-licensed nursing personnel who work with persons under a medical care plan must do so under the supervision of a licensed nurse or medical physician.

3519.15 A registered nurse may only delegate nursing functions to a licensed practical nurse in accordance with the Nurse Practice Act of the District of Columbia. A registered nurse or licensed practical nurse may not delegate nursing functions other than those aspects of care which address activities of daily living to direct support staff.

History

SOURCE: Final Rulemaking published at 39 DCR 3280, 3298 (May 8, 1992); as amended by Notice of Final Rulemaking published at 47 DCR 1898 (March 17, 2000); as amended by Final Rulemaking published at 68 DCR 4282 (April 23, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3519

22-B DCMR § 3520 HABILITATION AND TRAINING

3520.1 Each CRFPID shall provide meaningful, and integrated, community-based adult activities for persons to participate in their communities. The CRFPID must optimize, but not regiment, person’s initiative, autonomy, and independence in making life choices, including but not limited to, daily activities, physical environment, and with whom to interact. This shall include providing support for meaningful daytime activities, employment exploration, as well as building and maintaining relationships.

3520.2 If a person is admitted without a current ISP (one that was completed within the past year); the person’s support team must develop an ISP and IPP within thirty (30) days of admission.

3520.3 If a person is admitted to the CRFPID with a current ISP (one that has been reviewed and updated within the past year), the CRFPID may implement it provided that the ISP is reviewed, approved and updated as necessary by the IDT upon admission. The ISP shall be reviewed, updated and completed within thirty (30) days of admission. The ISP shall be implemented immediately upon the IDT approval.

3520.4 The ISP shall be developed by the IDT, and shall include at a minimum, based on the person’s choice, the following members: the person; the parent or guardian; supported decision-making authority for the person; the QIDP; and any health care professional relevant to the person’s needs as identified through the initial admission assessment or a prior ISP.

3520.5 Each ISP shall be used by all staff who plan, provide, or evaluate services for the person.

3520.6 The ISP shall include an assessment of the strengths and weaknesses of the person; the preferences of the person; goals and objectives and their target dates; necessary services including, but not limited to, medical, therapeutic, nursing, assistive technology, specialized staffing; and the frequency of services. The ISP shall also include appropriate supports and competency building, skill development, aimed at teaching the person to increase his or her skills and self-reliance which may include, but may not be limited to, the following:

(a) Eating and drinking (including table manners, use of adaptive equipment, and use of appropriate utensils);

(b) Toileting (including use of equipment);

(d) Dressing (including purchasing, selecting, and access to clothing);

(e) Grooming (including shaving, combing and brushing hair, and caring for nails);

(f) Health care (including skills related to nutrition, use and self-administration of medication, first aid, care and use of prosthetic and orthotic devices, preventive health care, and safety);

(g) Communication (including language development and usage, signing, use of the telephone, letter writing, and availability and utilization of communications media, such as books, newspapers, magazines, radio, television, telephone, and such specialized equipment as may be required);

(h) Interpersonal and social skills;

(i) Home management (including maintenance of clothing, shopping, meal planning and preparation, and housekeeping);

(j) Employment and work adjustment and appropriate day programs;

(k) Mobility (including ambulation, transportation, mapping and orientation, and use of mobility equipment);

(l) Time management (including use of leisure time and scheduling activities);

(m) Financial management (including budgeting and banking, management of benefits);

(n) Academic and pre-academic skills (including development of attention span, discrimination, association, memory, numbers, time, and spatial concepts);

(o) Motor and perceptual skills (including balance, posture, and gross and fine motor skills);

(p) Problem-solving and decision-making (including opportunities to experience consequences of decisions);

(q) Sexuality education;

(r) Opportunity for social, recreational and religious activities utilizing community resources;

(s) Behavior management, which shall be consistent with applicable federal and District laws and regulations;

(t) Skill building in support of self-determination and self-advocacy; and

(u) Personal skills essential for privacy and independence is appropriate for each person.

3520.7 The CRFPID shall involve the person, to the extent that he or she is able to participate, in development, review, and revision of the ISP. If the person has been adjudicated to be incompetent, he or she shall be represented by an advocate, guardian or supported decision maker as appropriate or as requested by the person.

3520.8 The QIDP and/or Residential Director shall document on each person’s ISP monthly to evaluate the progress of the person including determining when the person requires a less restrictive level of care or setting.

3520.9 The QIDP and/or Residential Director shall ensure that each person’s ISP is updated as needed and approved by the IDT. The CRFPID shall maintain records of any revisions to the ISP, including any reasons for making or not making any changes.

3520.10 The CRFPID shall develop an IPP for each person to implement the ISP. All training shall be implemented as prescribed by the ISP.

3520.11 The IPP shall contain the following elements:

(a) Reasons for training and habilitation as identified in the ISP;

(b) Measurable objectives for addressing each identified training need, habilitation need and/or goals;

(d) Services, supports and frequency to accomplish goals and objectives;

(e) Implementation strategies and dates;

(f) Target dates for accomplishment of goals and objectives;

(g) Estimated duration of training and habilitation; and

(h) The employees or contractors responsible for coordination, performance and integration of services.

3520.12 The ISP shall be signed and dated at a minimum by the person(s) responsible for developing the ISP, and the person or legal representative. If the signature of the person or legal representative is not obtained, the CRFPID shall document the reason.

3520.13 The QIDP or Residential Director shall, in the implementation of the ISP, consider each recommendation made by the IDT and consult with professionals or experts as necessary to ensure that implementation of the ISP is accurate.

3520.14 The IDT shall review and make modifications as necessary to persons IPP at least every six (6) months or when the person:

(a) Has successfully completed an objective or objectives identified in the ISP;

(b) Is regressing or losing skills already gained;

(d) Is being considered for training toward a new objective or objectives;

(e) Has a change in his or her health status;

(f) Experiences a deterioration in mood or behavior; or

(g) Has a change in cognitive skills.

3520.15 Each CRFPID shall ensure that habilitation and training programs for persons do the following:

(a) Utilize the least restrictive circumstances and methods and materials that are culturally normative and appropriate to the chronological age of the person, unless the use of non-normative or non-age appropriate methods and materials is justified in the person’s ISP;

(b) Provide for direct or consulting services from those professionally qualified persons necessary to assist the staff in conducting training; and

3520.16 Each CRFPID shall ensure that each person is provided an opportunity for placement in an appropriate educational, employment, or daytime training program, to include opportunities for supported work in a competitive, non-disability specific setting. The CRFPID shall include opportunities for each person to participate in choosing the placement, as appropriate, and shall ensure that the placement allows for the person’s self-management to the extent possible. The placement shall be consistent with the person’s ISP.

3520.17 Each CRFPID shall develop an activity schedule that is individualized and consistent with what is important to and for the person, as well as to promote opportunities for community integration as indicated in the ISP.

3520.18 No person shall be forced or coerced to participate in any activity.

3520.19 Each person’s activity schedule shall be available to direct care staff and be carried out daily, and shall be reviewed and amended as necessary.

History

SOURCE: Final Rulemaking published at 39 DCR 3280, 3299 (May 8, 1992); as amended by Final Rulemaking published at 44 DCR 7445 (December 5, 1997); as amended by Final Rulemaking published at 68 DCR 4282 (April 23, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3520

22-B DCMR § 3521 MEDICATIONS

3521.1 The CRFPID shall comply with all federal and local laws and regulations relating to controlled substances.

3521.2 Drugs shall be administered to persons only by licensed physicians, licensed nurses, or professional licensees whose license or certification authorizes the administration of medication(s).

3521.3 A registered nurse or physician shall assess each person’s capability to self-administer medications. The assessment shall reflect the person’s skills and abilities and shall determine whether technology can be used to promote self-management. Assessment findings shall be available to the IDT for determining the person’s training and support needs, in accordance with Subsection 3519.6.

3521.4 If the IDT determines that self-medication is an appropriate objective based on the assessment, the CRFPID shall obtain a physician’s order indicating that the person may engage in self-medication training.

3521.5 All drugs shall be administered in accordance with physician orders.

3521.6 All drug orders must be documented on a physician order form, signed and dated by the physician or advanced practice registered nurse within twenty-four (24) hours for all controlled substances and psychotropic medications, and within ten (10) calendar days for other drugs.

3521.7 A pharmacist, physician, or advanced practice registered nurse shall review each person’s complete drug regimen whenever the drug regimen is changed, to ensure that the person is being provided medication as prescribed.

3521.8 The RN or LPN shall report any irregularities in the person’s drug regimen to the primary care physician. An “irregularity” is any deviation from the person’s prescribed schedule or dosage, and shall be recorded in the person’s record.

3521.9 The CRFPID shall maintain an accurate medication administration record for each person, including a daily log of all medications administered or refused by the person, and medication not administered due to lack of availability. The log shall identify who administered the medication. Each record shall be kept current and updated as necessary.

3521.10 The CRFPID shall maintain in one central location on site all current prescriptions and physician orders.

3521.11 Medication requiring refrigeration shall be maintained in a separate and secure medication refrigerator.

3521.12 Each medication shall be stored in its original container and shall not be transferred to another container by the CRFPID or taken or used by another person. All medications given to persons to be taken outside of the CRFPID’s control (for example, if the person is going home on a visit) must be pre-packaged by a pharmacist.

3521.13 Each medication shall be stored under proper conditions of light and temperature as indicated on its label.

3521.14 Each CRFPID shall promptly and appropriately dispose prescribed medications that are discontinued by the physician or has reached the expiration date in accordance with Title 22-B DCMR Chapter 5 Safe Disposal of Unused Pharmaceuticals in Health Care Facilities.

3521.15 Upon discharge or transfer from a CRFPID, all medications currently prescribed and a copy of the person’s medication record shall be given to the person or authorized medical decision maker, or forwarded to any other residential setting to which the person is transferred.

3521.16 Any CRFPID to which a person is transferred shall ensure that it receives a copy of the medication record, all medications currently prescribed, and a reconciliation and accounting of all medication.

3521.17 In the event of a medication error or drug reaction, the person’s physician shall be notified as soon as possible. Any errors or reactions shall be documented in the person’s medication record.

3521.18 Upon the death of a person, all medication shall be retained by the CRFPID until it has been determined that disposal would be in accord with the investigation and reporting of deaths under the jurisdiction of the Medical Examiner.

3521.19 All prescriptions for controlled substances and psychotropic medications shall be written with an expiration date, which shall not exceed thirty (30) days from the date prescribed and in accordance with D.C. Law 2-137, the Citizens with Intellectual Disabilities Constitutional Rights and Dignity Act of 1978 (D.C. Official Code §7-1301.01 et seq.).

3521.20 Medication shall not be used as a punishment, for the convenience of staff, as a substitute for programs, or in quantities that interfere with the person’s habilitation program.

3521.21 The CRFPID shall maintain records of receipt and disposition of all controlled substances.

History

SOURCE: Final Rulemaking published at 39 DCR 3280, 3301 (May 8, 1992); as amended by Final Rulemaking published at 44 DCR 7445, 7446 (December 5, 1997); as amended by Final Rulemaking published at 68 DCR 4282 (April 23, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3521

22-B DCMR § 3522 BEHAVIOR SUPPORT

3522.1 The CRFPID shall designate and use a specially constituted committee(s) to review, identify, address and monitor person’s behavior and their rights that the committee(s) deems at risk. This committee shall be called the Human Rights Committee (HRC).

3522.2 The HRC required under this section shall consist of representatives of CRFPID staff, parents, legal guardians, persons as appropriate and qualified individuals who have either experience or training in contemporary practices to change people behavior, and persons with no ownership or controlling interest in the CRFPID.

3522.3 Programs approved by the HRC and established by the CRFPID in accordance with this section shall be implemented only with the written informed consent of the person, the person’s parent or the person’s legal guardian.

3522.4 A behavior support plan shall, if necessary, be developed as part of the ISP in response to behavioral or medical needs identified through the habilitative assessment process which shall specify all interventions.

3522.5 A CRFPID may use restrictive intervention, through physical and/or pharmacological means only if such intervention is justified and included in a behavior support plan or is otherwise utilized in accordance with this section.

3522.6 The behavior support plan shall be developed by a health care provider licensed in psychology or psychiatry, and shall be implemented as prescribed in the ISP.

3522.7 The use of restrictive intervention is permitted on a time-limited basis provided that less restrictive methods to safeguard persons and/or property have been attempted and failed or if there is no time to attempt less restrictive methods under one or more of the following conditions:

When a person’s health or safety is at risk;

When intervention is court ordered;

When health-related protection is ordered by a physician;

As a means to protect a person or others from harm; or

As a means of preventing the destruction of property.

3522.8 A person for whom physical restrictive intervention is being utilized must be visually monitored at all times and the method of intervention examined at least every five (5) minutes by a staff person trained in the use of the type of intervention used for a maximum duration of thirty (30) minutes. Monitoring shall be documented. The use of restrictive intervention shall be employed for no longer than thirty (30) minutes and shall be discontinued as soon as the person is stable if less than thirty (30) minutes.

3522.9 The CRFPID shall document the initiation, monitoring and termination of the intervention, including a chronological update of the person’s outward mental and physical status.

3522.10 Physical intervention shall be used so as not to cause injury to the person, to cause the least possible discomfort and to impose the least possible restriction given its purpose.

3522.11 A person for whom restrictive intervention has been employed shall be provided the opportunity for liquid intake and toileting as well as other necessary functions, if needed. Restrictive intervention may continue if disrupted when it is feasible and for the welfare of the person.

3522.12 The CRFPID shall closely monitor any person who has been prescribed psychotropic medications for responses and any adverse consequences. Monitoring shall be documented in writing and accessible to government officials.

3522.13 Psychotropic medications may not be given on an as-needed basis (PRN).

3522.14 Restrictive intervention cannot be used in lieu of adequate staffing or to discipline a person. The following are prohibited:

Prevention of contacts and visits with attorney, probation officer, placing agency representative, minister or chaplain;

(b) Any action that is humiliating, degrading, harsh, punitive, painful, or abusive that causes undue trauma or deprivation of rights, that is used as a means of coercion, discipline, or retaliation, or that is used solely or primarily for the convenience of staff;

(d) Subjection to unsanitary living conditions;

(e) Deprivation of opportunities for bathing or access to toilet facilities, except as ordered by a licensed physician for a legitimate medical purpose and documented in the person's record;

(f) Deprivation of appropriate services and treatment;

(g) Deprivation of health care;

(h) Administration of laxatives, enemas, or emetics except as ordered by a physician or other professional acting within the scope of their license for a legitimate medical purpose and documented in the person's record;

(i) Applications of aversive stimuli;

(j) Deprivation of drinking water or food necessary to meet a person’s daily nutritional needs except as ordered by a licensed physician for a legitimate medical purpose and documented in the person’s record;

(k) Prohibition on contacts and visits with family or legal guardian except as permitted by other applicable state regulations or by order of a court of competent jurisdiction;

(l) Delay or withholding of incoming or outgoing mail except as permitted by other applicable state and federal regulations or by order of a court of competent jurisdiction;

(m) Deprivation of opportunities for sleep or rest except as ordered by a licensed physician for a legitimate medical purpose and documented in the person's record;

(n) Mechanical devices used to restrict a person’s movement such as straightjackets, shackles and belted jackets that the person cannot remove;

(o) Seclusion or time-out rooms;

(p) The use or application of painful stimuli; and

(q) The use of any restraint which is not time-limited. Restraints must be removed as soon as the person is no longer an imminent threat to himself or others.

3522.15 The CRFPID shall maintain records documenting any time behavior intervention were used including why it was used, what was done, who was involved, and other information to show compliance with this section.

History

SOURCE: Final Rulemaking published at 39 DCR 3280, 3304 (May 8, 1992); as amended by Final Rulemaking published at 44 DCR 7445, 7447 (December 5, 1997); as amended by Final Rulemaking published at 68 DCR 4282 (April 23, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3522

22-B DCMR § 3523 EMERGENCIES

3523.1 Each CRFPID shall maintain written policies and procedures which address emergency situations, including fire or general disaster, missing persons, serious illness or trauma, and death.

3523.2 The policies and procedures shall include, but not limited to:

(a) Written plan to evacuate persons from the CRFPID;

(b) Documentation of contact and coordination with local and federal authorities to determine local risks and community-wide plans to address different disaster and emergency situations;

(c) Analysis of the CRFPID’s capabilities and potential hazards that could disrupt the normal course of service delivery;

(d) Specific responsibilities of staff members in an emergency;

(e) Management of response activities, coordination of logistics, and communications during an emergency;

(f) Procedures for warning and notifying persons receiving services of an emergency;

(g) Evacuation and relocation, if necessary, of persons receiving services;

(h) Alerting emergency personnel;

(i) Notification to parents and guardians; and

(j) Recovery and restoration of services.

3523.3 The CRFPID shall review the policy annually to determine whether it is current and adequately addresses potential emergencies. Any revisions will be communicated to employees, contractors and volunteers, and incorporated into future trainings.

3523.4 The CRFPID shall develop and implement periodic training on emergency procedures in accordance with Section 3515 for all employees, contractors and volunteers.

3523.5 Operable flashlights or battery lanterns shall be readily accessible to employees and contractors that operate between dusk and dawn to use in emergencies.

3523.6 Each CRFPID shall maintain written documentation that each employee has been trained in carrying out the policies and procedures set forth in this section.

3523.7 Each CRFPID shall ensure that telephones are accessible for emergency purposes, and shall make available near each telephone, emergency numbers which include at least fire and rescue squads, the local police department, the nearest hospital, a poison control center, each person’s physician, Director of Nursing, Service Coordinator (if applicable) and the Residence Director.

3523.8 The CRFPID shall maintain a well-stocked first aid kit which shall be maintained and readily accessible for minor injuries and medical emergencies. Such kit shall be maintained at each service location, and available to employees, volunteers or contractors providing services at the CRFPID or travelling with persons. At a minimum, the kit shall contain a thermometer, bandages, saline solution, band-aides, sterile gauze, tweezers, instant ice-pack, adhesive tape, antibiotic cream, and antiseptic soap.

3523.9 Each CRFPID shall ensure that at least one employee or contractor is on duty at all times who holds a current certificate, issued by a recognized local, state or national authority, in standard first aid and cardiopulmonary resuscitation (CPR). A registered nurse or physician who holds a current license shall be deemed to have a current certificate in first aid, but not in CPR.

3523.10 If there is an unusual incident involving a person, the CRFPID shall promptly notify the person’s authorized emergency contact, his or her next of kin if the person has no guardian, or the representative of the sponsoring agency of the person’s status as soon as possible, followed by written notice and documentation no later than twenty-four (24) hours or the next business day after the incident.

3523.11 Each CRFPID shall document each unusual incident and enter the follow-up actions into the person’s permanent record, which shall be made available for review by authorized people. The record shall include the date and time of the emergency incident, details of the incident, interventions or treatments provided, employees and/or contractors involved, and outcome.

3523.12 Each CRFPID shall notify promptly after a person’s death the person’s guardian or next of kin, the placement agency and the Office of the Chief Medical Examiner.

3523.13 In addition to the reporting requirement in Subsection 3523.10, each CRFPID shall notify the Department, of any other unusual incident that substantially interferes with a person’s health, welfare, living arrangement or well-being or in any other way places a person at risk. Such notification shall be made by telephone immediately when the staff is aware and shall be followed up by written notification within twenty-four (24) hours or the next business day.

3523.14 Each CRFPID shall have in place a procedure which describes the process for arranging funeral services and burials and for assuring the notification and involvement of significant others.

3523.15 Each CRFPID shall comply with all applicable District of Columbia fire safety requirements as interpreted and enforced by the District of Columbia Fire Chief in accordance with Chapter 31, Title 22-B DCMR.

3523.16 Each CRFPID shall be free from fire hazards and shall have adequate smoke detectors and working and updated fire extinguishers. The fire extinguishers shall be properly maintained and located as required by the Fire Chief, including at least one (1) all-purpose fire extinguisher, which is a minimum 2A 10BC on each level of the CRFPID.

3523.17 Each CRFPID shall have on the premises the following items:

(a) Written policies and procedures shall be kept readily accessible to staff and persons and shall include the following:

(i) The instructions and plans that are to be followed in case of fire;

(ii) The persons to be notified;

(iii) The location of alarm signals;

(iv) The locations of fire extinguishers;

(v) The evacuation routes;

(vi) The frequency of fire drills;

(vii) The assignment of specific tasks and responsibilities to the staff of each shift;

(b) Records of the training of all personnel who are to perform the specific tasks designated in the manual described in paragraph (a) of this subsection;

(d) Dates of the test of alarm appliances.

3523.18 Each CRFPID shall conduct fire drills in order to test the effectiveness of the plan at least once every three months for each shift. An actual evacuation must be documented during at least one drill, each year on each shift.

3523.19 Each CRFPID shall maintain records of each fire drill.

3523.20 Each CRFPID shall ensure that all personnel on all shifts are familiar with the use of the CRFPID fire protection features.

History

SOURCE: Final Rulemaking published at 39 DCR 3280, 3305 (May 8, 1992); as amended by Final Rulemaking published at 68 DCR 4282 (April 23, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3523

22-B DCMR § 3524 ABUSE AND NEGLECT

3524.1 In addition to the reporting requirement in Subsection 3523.13, each CRFPID shall establish mechanisms for the reporting of complaints alleging the neglect, abuse or mistreatment of any person.

3524.2 The CRFPID must comply with all applicable federal, local and relevant agencies requirement for reporting unusual incidents, abuse neglect, or mistreatment of any person.

3524.3 The CRFPID shall immediately notify the Department of all suspected or alleged incidents of abuse, neglect, mistreatment, and exploitation, as well as deaths. The Department shall be notified by telephone immediately, and the CRFPID shall follow-up by written notification to the Department within twenty-four (24) hours or the next business day.

3524.4 Any person accused or suspected of abuse or neglect shall immediately be removed from any duties involving direct care of persons.

3524.5 If the perpetrator of any alleged, suspected or substantiated abuse or neglect is not known, the CRFPID shall prevent further potential abuse or neglect of person’s pending an investigation.

3524.6 The CRFPID shall complete an investigation of any alleged incident within five (5) working days unless additional time is requested of and approved by the Department. The result of such investigation shall be reported to the Department within two (2) days of the conclusion of the investigation. A copy of the investigative report shall be provided to the Department upon request. Any substantiated claim of abuse, neglect or mistreatment shall be reported to the appropriate law enforcement entities.

3524.7 The CRFPID shall take immediate corrective action in the event that any alleged incident of abuse or neglect is substantiated pursuant to the investigation.

History

SOURCE: Final Rulemaking published at 68 DCR 4282 (April 23, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3524

22-B DCMR § 3525 VENTILATOR SERVICES

3525.1 The CRFPID may care for ventilator person’s in a ventilator care area upon compliance with Title III of the Nursing Home and Community Residence Facility Residents' Protections Act of 1985, effective April 18, 1986, D.C. Law 6-108, D.C. Code § 32-1431 et seq. The CRFPID shall notify the Department of all relevant information regarding this service, including the names of the physician and nurses in charge of providing the service.

3525.2 Ventilator care shall be supervised by a physician who has special training and experience in diagnosing, treating and assessing problems related to ventilator patients.

3525.3 The CRFPID shall ensure that ventilator care services are provided by a sufficient number of qualified staff and that personnel provide ventilator care services commensurate with their documented training, experience, and competence.

3525.4 As appropriate, ventilator care personnel shall be competent in the following:

(a) The fundamentals of cardiopulmonary physiology and of fluids and electrolytes;

(b) The recognition, interpretation and recording of signs and symptoms of respiratory dysfunction and medication side effects, particularly those that require notification of a physician;

(d) The mechanics of ventilation and ventilator function;

(e) The principles of airway maintenance, including endotracheal and tracheotomy care;

(f) The effective and safe use of equipment for administering oxygen and other therapeutic gases and providing humidification, nebulization and medication;

(g) Pulmonary function testing and blood gas analysis when these procedures are performed within the CRFPID providing ventilator care;

Procedures and observations to be followed during and after extubation; and

(j) Recognition of and attention to the psychosocial needs of persons, their families and supported decision maker.

3525.5 The CRFPID shall ensure that each ventilator is equipped with an alarm, designed to alert the registered nurse in charge of monitoring the ventilator, on both the pressure valve and the volume valve.

3525.6 In order to operate ventilator services, the CRFPID shall develop a plan of operation approved by the Department which shall include:

(a) A description of the services to be provided;

(b) A description of the staffing pattern;

(d) A quality assurance plan which shall include:

(1) Assignment of responsibility for monitoring and evaluating activities;

(2) Identification of indicators and appropriate clinical critical criteria for monitoring the most important aspects; and

(3) Establishment of thresholds (levels or trends) for the indicators that will trigger evaluation of care;

(e) Policies and procedures on the following:

(1) The transfer or referral of persons who require services that are not provided by the CRFPID;

(2) The administration of medicines unique to the needs of the ventilator person;

(3) Infection control measures to minimize the transfer of infection in the CRFPID;

(4) Pertinent safety practices, including the control of fire and medical hazards; and

(5) Protocols for emergency situations.

3525.7 When the ventilator care services are provided by an outside contractor, the CRFPID shall document the following:

(a) Approve the contractor based on the contractor's credentials, qualifications and experience; and

(b) Ensure that all contractors:

(1) Provide services twenty-four hours a day;

(2) Meet all safety requirements;

(3) Abide by all pertinent policies and procedures of the CRFPID;

(4) Provide services in accordance with the law governing the CRFPID;

(5) Participate in the monitoring and evaluation of persons;

(6) Participate in the monitoring and evaluation of the appropriateness of services provided as required by the CRFPID's quality assurance program; and

(7) Ensure that all contractual services are under the supervision of the CRFPID's medical director or the physician employed by the CRFPID to coordinate ventilator care services.

History

SOURCE: Final Rulemaking published at 68 DCR 4282 (April 23, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3525

22-B DCMR § 3599 DEFINITIONS

When used in this chapter, the following terms and phrases shall have the meaning ascribed:

Abuse – the willful infliction of injury, unreasonable confinement, intimidation or

punishment with resulting physical harm, pain or personal anguish.

Advocate – a person who has experience in assuring that persons with intellectual disabilities are treated with respect and dignity and in accordance with all laws and regulations pertaining to the rights of persons with disabilities, and who can independently speak on behalf of persons with intellectual disabilities.

Act – the Health Care and Community Residence Facility, Hospice, Home Care Licensure Act of 1983, D.C. Law 5-48, Official Code § 7-1301 - Citizens with Intellectual Disabilities, et seq.

Advanced Practice Registered Nurse (APRN) – a person licensed to practice registered nursing under the Health Occupation Revision Act of 1985 (“Act”), effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq.) and Chapter 54 District of Columbia Municipal Regulations.

Controlled Substance – a drug, substance, or immediate precursor, as set forth in Schedules I through V of Subchapter 2 of the District of Columbia Uniform Controlled Substances Act of 1981, effective August 5, 1981(D.C. Law 4-29; D.C. Official Code §§ 48-901 et seq.).

Community Residence Facility for Persons with Intellectual Disabilities (CRFPID) – a community residence facility that provides a home-like environment for at least 4 but no more than 8 related or unrelated individuals who on account of intellectual disabilities require specialized living arrangements, and maintains the necessary staff, programs, support services, and equipment for their care and habilitation. A CRFPID is synonymous with the term “group home for persons with intellectual disabilities” that is utilized by the Act.

Department – The District of Columbia Department of Health (DC Health).

Direct Care Staff – individuals employed to work in the CRFPID who render the day-to-day personal assistance and aid persons in meeting the goals and objectives of their individual program.

Director – Director of the District of Columbia Department of Health (DC Health).

Discharge – The permanent movement of a person to a new CRFPID or another setting which operates independently of the person’s current CRFPID.

Emergency care – appropriate services in a variety of settings accessible to individuals designed to meet an immediate need and restore or maintain the physical or mental well- being of the person or provider.

Habilitation – the process by which a person is assisted to acquire and maintain those life skills which enable him or her to cope more effectively with the demands of his or her own person and of his or her own environment, and to raise the level of his or her physical, intellectual, social, emotional, and economic efficiency. The term includes, but is not limited to, the provision of community-based services.

Health Inventory – health history, including present illnesses and symptoms and physician’s assessment of current health status.

HIPAA – The Health Insurance Portability and Accountability Act of 1996, 42 U.S.C. § 1320d-9 (2010), which provides protections for health information that is in the possession of the certain covered agencies, including health care facilities.

Immediate (as in reporting) – no delay between staff awareness of the occurrence and reporting to the administrator or other officials in accordance with District of Columbia law unless the situation is unstable in which case reporting should occur as soon as the safety of all persons is assured.

Individual Program Plan (IPP) – a written document for each person, the purpose of which is to implement the ISP.

Individual Support Plan (ISP) – a plan developed for the habilitation of a person.

Intellectual Disability – a condition characterized by a substantial limitation in capacity that manifests before eighteen (18) years of age and is characterized by significantly below average intellectual functioning, existing concurrently with two (2) or more significant limitations in adaptive functioning.

Interdisciplinary Team (IDT) – a group of individuals with special training and experience in the diagnosis and habilitation of persons with intellectual disabilities which has the responsibility of performing a comprehensive evaluation of each person and participating in the development, implementation, and monitoring of the persons individual support plan.

Intermediate Care Facility – in accordance with 42 CFR 435.1009, an institution for persons with intellectual disabilities (or a distinct part of an institution) that is primarily for the diagnosis, treatment, or rehabilitation of the instinctually disabled or persons with related conditions; and Provides, in a protected residential setting, ongoing evaluation, planning 24-hour supervision, coordination, and integration of health or rehabilitative services to help each person function at this greatest ability.

Level of Need – a comprehensive assessment of the support needs and risk screening for participants in the ICF/IDD and ID/DD Home and Community Based Services Waiver programs.

Licensed Practical Nurse (LPN) – a person licensed to practice practical nursing under the Health Occupations Revision Act of 1985 (“Act”), effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq.) and Chapter 55 District of Columbia Municipal Regulations.

Medical Care Plan – a plan of treatment developed by a physician or advanced practice nurse, individually or in coordination with licensed nursing personnel, for persons who are either acutely ill and require licensed nursing care and monitoring temporarily on a 24 hour basis, or persons whose chronic medical conditions require or indicate 24 hour licensed nursing care and monitoring. The physician determines when 24 hour nursing care is required, type of care, scope, duration, and the frequency of treatment ordered.

Mistreatment – behavior or facility practices that result in any type of person exploitation such as financial, physical, sexual, or criminal. Mistreatment also refers to the use of behavioral management techniques outside of their use as approved by the specially constituted committee and facility policies and procedures.

Neglect – failure to provide goods and services necessary to avoid physical harm, mental anguish or mental illness. Staff failure to intervene appropriately to prevent self-injurious behavior may constitute neglect. Staff failure to implement facility safeguards, once person to person aggression is identified, may also constitute neglect.

Person/People – a person who has been diagnosed as having an intellectual disability.

Physical Restraint – any manual method or device that the person cannot remove easily and that restricts the free movement or normal functioning of or normal access to a portion or portions of a person’s body.

Qualified Health Care Professional – practicing under the scope of his or her license in accordance with the District of Columbia Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code 3-1201 §§ et seq. (“HORA”).

Qualified Intellectual Disabilities Professional (QIDP) – also known as Qualified Developmental Disabilities Professional or QDDP, is someone who implements the day-to-day operations of a community residence facility by overseeing the initial habilitative assessment of a person; develops, monitors, and reviews ISPs, and integrates and coordinates Waiver services.

Registered Nurse (RN) – a person licensed to practice registered nursing under the Health Occupations Revision Act of 1985 (“Act”), effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq.) and Chapter 54 District of Columbia Municipal Regulations.

Residential Habilitation Service Setting – a community residence facility for persons with intellectual disabilities that is a provider in the Home and Community Based Waiver Services Residential Habilitation Service Settings (HCBS) Program, authorized by 29 DCMR Chapter 19 under the supervision of the Department of Disability Services.

Seclusion – The placement of a person alone in a locked room or in an obviously isolated portion of a room.

Service Coordinator – The DDS staff responsible for coordinating a person’s services pursuant to their ISP and Plan of Care.

Transfer – The temporary movement of a person between CRFPIDs, or the permanent movement of a person between living units of the same CRFPID.

Trained Medication Employee (TME) – a person who is certified in accordance with Title 17 of the District of Columbia Municipal Regulations Chapter 61 (17 DCMR Chapter 61).

Unusual Incident – any occurrence or event which substantially interferes with a person's health, welfare, living arrangement, well-being or in any way places the person at risk. These incidents may include but are not limited to natural disaster or other events which cause damage to the CRFPID or threaten the person, outbreaks of disease, filing of bankruptcy, labor disputes or any event which may interfere with the operation of the CRFPID, allegations or incidents involving neglect, abuse, assault, or sexual assault of a person, sudden death of a person and allegations or incidents of drug possession or distribution by a staff person of the CRFPID.

History

SOURCE: Final Rulemaking published at 39 DCR 3280, 3305 (May 8, 1992); as amended by Notice of Final Rulemaking published at 47 DCR 1898 (March 17, 2000); as amended by Final Rulemaking published at 68 DCR 4282 (April 23, 2021). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 3599

22-B36 COMMUNITY RESIDENCE FACILITY LOAN PROGRAM

22-B DCMR § 3600 GENERAL PROVISIONS

3600.1 The Community Residence Facility Loan Program is intended to improve the quality and quantity of housing for low-income residents of Community Residence Facilities.

3600.2 The loan program shall not be used to promote the convenience, sustenance, or financial solvency of operators of facilities.

3600.3 Loans shall be made to operators of facilities which accept primarily low-income persons as residents and which have not yet passed the required life-safety inspections for licensure.

3600.4 Loans shall be made to operators of facilities who can demonstrate that they provide or will provide to low-income persons, quality care, home-like environment, and a program that meets the full requirements of D.C. Law 2-35, the Community Residence Facility Licensure Act.

EDITOR’S NOTE: Subsequent to the adoption of this chapter, the Community Residence Facility Licensure Act, D.C. Law 2-35, was superseded by the Health-Care and Community Residence Facility, Hospice and Home Care Licensure Act of 1983, D.C. Code, 2001 Ed. §§ 44-501 to 44-509.

3600.5 The Loan Program shall make funds available in amounts of no more than ten thousand dollars ($10,000) per facility at low or no interest rates for purposes of meeting specific costs of compliance with life-safety code requirements.

3600.6 The use of funds shall be limited to the following items:

(a) The purchase of a sprinkler system;

(b) The installation of fire doors or other fire prevention features; or

3600.7 Licensed facilities may apply for loans for catastrophic repair costs, such as the replacement of a defective heating system.

3600.8 Licensed facilities may also apply for loans to increase their capacity (within certain limits) and for other purposes identified in this chapter.

History

AUTHORITY: Pub. L. No. 89-183, effective September 14, 1965; and Mayor's Order 80-59 (February 8, 1980).
SOURCE: Final Rulemaking published at 27 DCR 2932 (July 4, 1980), incorporating text of Proposed Rulemaking published at 27 DCR 2076 (May 16, 1980). EDITOR’S NOTE: This chapter, previously designated Chapter 35, was redesignated Chapter 36 by Final Rulemaking published at 39 DCR 3280 (May 8, 1992).

22-B DCMR § 3601 RESTRICTIONS

3601.1 The Mayor shall make available three hundred thousand dollars ($300,000) from the Escheated Property Fund for the purpose of the Community Residence Facility Loan Program.

3601.2 Eligibility for loans shall be restricted to new applicants and licensed facilities as specified in this section.

3601.3 New applicants may apply for loans to assist them in complying with the life-safety code requirements of D.C. Law 2-35.

EDITOR’S NOTE: Subsequent to the adoption of this chapter, D.C. Law 2-35 was superseded by the Health-Care and Community Residence Facility, Hospice and Home Care Licensure Act of 1983, D.C. Code, 2001 Ed. §§ 44-501 to 44-509.

3601.4 For purposes of this chapter, "new applicants" are those facilities which have expressed an intent to operate a Community Residence Facility by completing an application with the Department of Human Services, but which have not been approved as in compliance with the life-safety code requirements as determined by the CRF Life-Safety Inspection Coordinator.

3601.5 Licensed Community Residence Facilities may apply for loans to increase their capacity. As the concept of Community Residence Facilities couples the safety and standardized quality of a licensed health care facility with the personalized environment of a private home, the CRF loan program shall restrict all loan applications by licensed facilities wishing to increase their capacity to facilities proposing to house eight (8) or fewer clients.

3601.6 Licensed facilities housing fewer than fifty (50) clients may also apply for emergency repair loans to assist them in meeting catastrophic repair costs. These loans shall be limited to situations where the operator can show that the work required is necessary to protect the health and safety of the clients and is otherwise statutorily required.

History

SOURCE: Final Rulemaking Published at 27 DCR 2932 (July 4, 1980), incorporating text of Proposed Rulemaking published at 27 DCR 2076 (May 16, 1980).

22-B DCMR § 3602 APPLICATIONS

3602.1 Applications for Community Residence Facility loans shall be addressed to the Long Term Care Administration, Department of Human Services (DHS), 1875 Connecticut Avenue, Northwest, Washington, D.C. 20009. Complete applications shall consist of the following elements:

(a) A letter or completed DHS application form signed by the facility operator which contains the following information:

(1) The amount of the loan requested;

(2) The specific proposed purpose of the loan;

(3) The address and telephone number of the facility;

(4) The number of clients residing in the facility at the time of application;

(5) The number of proposed clients;

(6) The number of existing and proposed clients who will be recipients of public assistance, SSI payments or who are otherwise classified as low-income persons;

(7) The number of other persons who reside in the facility and their identification and relationship to the operator;

(8) The previous history of the facility (whether it was operated as a personal care home, rooming and boarding house, or other type of facility in the past); and

(9) The history of the operator's contacts with the CRF life-safety code inspectors who identified the need for the item or items for which the loan will be used;

(b) A statement of the operator's and the facility's financial status, listing all sources and amounts of current resources, income and expenses and listing the source and amount of anticipated future resources, income and expenses to cover the anticipated term of the loan;

(c) Two (2) or more written estimates from local contractors for the work to be performed; these statements may be prepared by the applicant but shall include the contractors' names, addresses, telephone numbers and permits if any (the estimated cost of the work to be performed shall be verified during the evaluation of the loan application);

(d) Proof of ownership of the premises (such as a copy of the property mortgage), a recent real estate tax assessment or a property title); in the event that the operator of the facility does not own the premises, he or she shall hold a long-term lease (five (5) or more years beyond date of application) with the owner and shall submit a copy of the lease; and

(e) A statement of the source of income which shall be used to repay the loan and a proposed repayment schedule.

History

SOURCE: Final Rulemaking Published at 27 DCR 2932 (July 4, 1980), incorporating text of Proposed Rulemaking published at 27 DCR 2076 (May 16, 1980).

22-B DCMR § 3603 REVIEW

3603.1 Applications received from facilities meeting the restrictions stated in a previous section and consisting of the complete documentations as described in this section shall be reviewed by officials of the Department of Human Services (including the Chief of the Office of Licensing and Consultation Services, the Long Term Care Administrator, the Chief of the Central Referral Bureau), the Office of Occupational and Professional Licensure Administration (including the Coordinator of CRF Life-Safety Inspections) and, when appropriate, by the D.C. Office on Aging.

3603.2 The officials cited in §3603.1 may verify the cost estimates, conduct site visits to the facility, interview the operator, consult licensure records, if any, request additional information, and verify the need, under the requirements of D.C. Law 2-35, for the work proposed to be done.

3603.3 Recommended applications shall be forwarded by the Director of the Department of Human Services to the City Administrator for approval and transmittal to the Office of Financial Management.

History

SOURCE: Final Rulemaking Published at 27 DCR 2932 (July 4, 1980), incorporating text of Proposed Rulemaking published at 27 DCR 2076 (May 16, 1980).

22-B DCMR § 3604 EVALUATION CRITERIA

3604.1 Loan applications shall be evaluated according to the following criteria:

(a) Ability to serve a low-income population over the long term;

(b) Verified need for the proposed improvements to be financed by the loan; and

(c) Verification that the improvements are proposed at the least necessary cost and in the form most beneficial to the residents.

History

SOURCE: Final Rulemaking Published at 27 DCR 2932 (July 4, 1980), incorporating text of Proposed Rulemaking published at 27 DCR 2076 (May 16, 1980).

22-B DCMR § 3605 LOAN AWARDS

3605.1 The Office of Financial Management, either through contract with a financial institution or in cooperation with other District agencies, shall supervise the disbursement of loan monies, the negotiation of a repayment period, and the monitoring of repayment.

3605.2 The application review officials in the Department of Human Services and the Office of Occupational and Professional Licensure Administration may recommend repayment terms according to their findings of financial need and ability to repay.

History

SOURCE: Final Rulemaking Published at 27 DCR 2932 (July 4, 1980), incorporating text of Proposed Rulemaking published at 27 DCR 2076 (May 16, 1980).

22-B DCMR § 3606 COMPLIANCE

3606.1 The DHS, Long Term Care Administration shall monitor facilities which are awarded loans to ensure that the loan monies are properly utilized and will work with operators who are reported by the Office of Financial Management to be in default in their loan payment.

History

SOURCE: Final Rulemaking Published at 27 DCR 2932 (July 4, 1980), incorporating text of Proposed Rulemaking published at 27 DCR 2076 (May 16, 1980).

22-B DCMR § 3607 PENALTY

3607.1 A facility which receives a loan under this program is expected to remain in operation as a licensed CRF throughout the term of repayment and for a minimum of five (5) years thereafter.

3607.2 In the event that unforeseen circumstances force a facility to close, the balance of the loan shall become due within five (5) months of the facility closing.

3607.3 The Mayor may, at his or her discretion, impose a penalty of up to twenty-five percent (25%) of the original loan amount if a facility closes without good reason before the five (5) year period after repayment has expired.

History

SOURCE: Final Rulemaking Published at 27 DCR 2932 (July 4, 1980), incorporating text of Proposed Rulemaking published at 27 DCR 2076 (May 16, 1980).

22-B37 CENTRAL REFERRAL BUREAU

22-B DCMR § 3700 SCOPE AND PURPOSES

3700.1 The Mayor shall establish a Central Referral Bureau which shall have the functions provided under this chapter.

3700.2 The Central Referral Bureau shall keep and make available to the public an accurate and current listing of all licensed skilled care, intermediate care, and community residence facilities in the District, indexed according to their classification, location, size, admission restrictions, the ratings assigned them by the Central Referral Bureau, and their most recent occupancy reports.

3700.3 The Central Referral Bureau shall develop, in cooperation with District medical associations, nurses' associations, pharmaceutical associations, associations of nursing home directors and community residence facility residence directors, mental health associations, associations for retarded persons, senior citizens' associations, and any other interested community associations, criteria and a monitoring system for rating licensed facilities based on the excellence with which they perform their recognized functions.

3700.4 The Central Referral Bureau shall not be responsible for any assessments that are normally the responsibility of District licensing authorities.

History

AUTHORITY: Sections 402(4), 402(5), 402(134) and 402(391) of Reorganization Plan No. 3 of 1967, effective February 29, 1892, 27 Stat. 394; D.C. Code §§1-319, 1-322, 6-117, 33-505, and 47-2842 (1981).
SOURCE: Council Regulation No. 74-15 effective June 14, 1977, as amended by §401 of the Community Residence Facilities Licensure Act of 1977, D.C. Law 2-35, 24 DCR 1458, 1517 (August 19, 1977).

22-B DCMR § 3701 RECORDS ON LICENSED COMMUNITY RESIDENCE FACILITIES

3701.1 The Central Referral Bureau shall keep on file for public inspection the following records concerning each licensed facility:

(a) For community residence facilities only, the community residence facility's program statement required under §3413 of chapter 34;

(b) The facility's current charges;

(d) The facility's current occupancy level reports;

(e) The Central Referral Bureau's rating of the facility according to the Bureau's criteria and the basis upon which the rating is made; and

History

SOURCE: Council Regulation No. 74-15 effective June 14, 1977, as amended by §401 of the Community Residence Facilities Licensure Act of 1977, D.C. Law 2-35, 24 DCR 1458, 1517 (August 19, 1977).

22-B DCMR § 3702 PLACEMENT SERVICES

3702.1 The Central Referral Bureau shall recommend placements in community residence facilities for the following:

(a) All persons seeking such living arrangements who are receiving a supplement to their Supplementary Security Income from the District;

(b) All persons who are receiving general public assistance from the District;

(c) All persons who are on convalescent leave from Saint Elizabeth's Hospital, if their hospitalization was paid for in part by the District; and

(d) Any other persons to whom the District is responsible for the cost of their care and maintenance.

3702.2 Recommended placements shall be based on an evaluation of the applicant's physical, mental, and social needs made by a team of physicians, nurses, social workers, and other professional and paraprofessional personnel made available to the Central Referral Bureau for that purpose.

3702.3 The Central Referral Bureau shall be responsible for certifying that a person is eligible for the supplementation of his or her Supplementary Security Income by the District government.

3702.4 The Central Referral Bureau shall recommend placements in specific skilled care, intermediate care, or community residence facilities for any other person seeking such living arrangements at the request of the prospective resident or his or her next of kin, doctor, or sponsor.

3702.5 Placement recommendations shall be based on evaluations of the prospective resident's physical, mental, and social needs as determined by the prospective resident's own physician or the professionals made available to the Central Referral Bureau by the District government.

3702.6 For persons having no access to private or institutional social service assistance in actual placement in the facility, the Central Referral Bureau shall arrange assistance.

History

SOURCE: Council Regulation No. 74-15 effective June 14, 1977, as amended by § 401 of the Community Residence Facilities Licensure Act of 1977, D C. Law 2-35, 24 DCR 1458, 1517 (August 19, 1977).

22-B DCMR § 3703 FEES

3703.1 The Central Referral Bureau shall charge a fee for its service that takes into account, the income and resources of the prospective resident.

History

SOURCE: Council Regulation No. 74-15 effective June 14, 1977, as amended by §401 of the Community Residence Facilities Licensure Act of 1977, D.C. Law 2-35, 24 DCR 1458, 1517 (August 19, 1977).

22-B DCMR § 3704 PUBLIC INFORMATION

3704.1 The Central Referral Bureau shall advise the public, through the mass media and other reasonable means, of its functions.

History

SOURCE: Council Regulation No. 74-15 effective June 14, 1977, as amended by §401 of the Community Residence Facilities Licensure Act of 1977, D.C. Law 2-35, 24 DCR 1458, 1517 (August 19, 1977).

22-B DCMR § 3705 COMPLAINTS

3705.1 The Central Referral Bureau shall receive complaints from residents, prospective residents, next of kin, sponsors of residents (if any), and other interested persons about skilled, intermediate, or community residence facilities and, after an initial screening of the complaint, shall refer those complaints to the proper District official.

3705.2 The Central Referral Bureau's conclusion as to the validity of any complaints shall be made known in writing to the residence director of the facility involved, if any, and the appropriate District licensing authority.

History

SOURCE: Council Regulation No. 74-15 effective June 14, 1977, as amended by §401 of the Community Residence Facilities Licensure Act of 1977, D.C. Law 2-35, 24 DCR 1458, 1517 (August 19, 1977).

22-B DCMR § 3706 REASSESS PLACEMENT OF RESIDENTS

3706.1 The Central Referral Bureau shall reassess the placement of each resident of a community residence facility who is described in §3702.1 periodically as it deems necessary, but in no case less often than once every two (2) years, for the purpose of determining whether the community residence facility in which the resident resides is able to meet his or her physical, mental, and social needs within the limits of its license.

3706.2 The reassessment by the Central Referral Bureau shall be based on the following:

(a) Records required to be kept by the facility under §§3410 through 3412 and 3440 of this title when applicable;

(b) Any additional information solicited or received by the Central Referral Bureau from the resident, his or her sponsor (if any), personal physician, and the residence director; and

(c) Any reevaluation of the resident's physical, social, and mental needs made by professionals available to the Central Referral Bureau that the Bureau may request to be made.

3706.3 The Central Referral Bureau shall be responsible for the development of training programs as considered necessary for the administrators, residence directors, and other community residence facility staff in order to provide pertinent information concerning the following:

(a) Nutrition;

(b) Aspects of mental health, mental retardation, and aging;

(d) Social and recreational programming; and

(e) Administration and financial management.

History

SOURCE: Council Regulation No. 74-15 effective June 14, 1977, as amended by §401 of the Community Residence Facilities Licensure Act of 1977, D.C. Law 2-35, 24 DCR 1458, 1517 (August 19, 1977).

22-B38 COMMUNITY RESIDENCE FACILITIES FOR MENTALLY ILL PERSONS [REPEALED]

22-B DCMR § 3800 GENERAL PROVISIONS

3800.1 A public or private mental health community residence facility (MHCRF) shall meet the requirements of these rules in order to be licensed.

3800.2 A MHCRF shall be a publicly or privately owned residence that houses individuals, eighteen (18) or older, with a principal diagnosis of mental illness and who require twenty-four hour (24 hr.) on site supervision, personal assistance, lodging, and meals and who are not in the custody of the District of Columbia Department of Corrections.

3800.3 The categories of MHCRFs shall be Supported Residence, Supported Rehabilitation Residence, and Intensive Residence.

3800.4 This chapter shall not apply to Independent Living Arrangements, Supported Independent Living Arrangements, or Crisis Stabilization Beds, as defined in §3899, or any residence that does not provide twenty-four hour (24 hr.), on-site staff.

3800.5 Each residence that is licensed as a community residence facility (CRF) under 22 DCMR, Chapter 38, that houses a person with a primary diagnosis of mental illness, shall apply for a new license under this chapter prior to the termination date of its existing license. A provisional license may be issued by the Department of Consumer and Regulatory Affairs (DCRA) in accordance with procedures developed by DCRA in Chapter 31, Title 22 DCMR. Nothing in this subsection shall be intended to amend D.C. Code, 2001 Ed. § 44-502.

3800.6 This chapter supersedes Chapter 34 of this title insofar as it applies to community residential facilities that house mentally ill persons.

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is the Health-Care and Community Residence Facility, Hospice and Health-Care Licensure Act of 1983 § 5, D.C. Code, 2001 Ed. § 44-504; and Mayor's Order 84-105 (June 19, 1984).
SOURCE: Final Rulemaking published at 42 DCR 569 (January 27, 1995).

22-B DCMR § 3801 RESIDENT'S RIGHTS AND RESPONSIBILITIES

3801.1 Prior to the admission of each resident to a MHCRF, the Residence Director, or the Residence Director's designee, shall explain to the resident or any designated representative of the resident the rights and responsibilities of the resident as set forth in §§3801.2 through 3801.32 and provide a written statement of rights and responsibilities to the resident. Additionally, a copy of the rights shall be available to residents upon request. If a resident cannot read or understand English, the notice shall be given orally and in writing in a language the resident can understand. The Residence Director shall answer any questions the resident may have regarding the resident's rights and responsibilities.

3801.2 Each resident shall receive treatment and services which shall be in compliance with relevant federal and District of Columbia law, rules, and regulations, without discrimination in the quality or quantity of a service based on age, gender, race, physical or mental disability, HIV status, religion, sexual orientation, national origin, marital status or the source of payment for the service.

3801.3 Prior to admission, the resident and the resident’s legal representative, if any, shall be given a written admission contract, which shall be signed by the Residence Director, the resident, or the resident’s legal representative, and that sets forth, at a minimum, the following details:

(a) The monthly fee payable by the resident;

(b) The care and services covered by the monthly fee; and

3801.4 Each resident, or any authorized person acting on the resident's behalf, shall be permitted to register grievances or complaints without the threat of the resident's discharge or other reprisal by MHCRF staff.

3801.5 Each MHCRF shall provide each resident at the time of admission with a copy of any grievance or complaint procedures.

3801.6 Each resident shall have the right to privacy in the provision of personal and medical care.

3801.7 Each resident shall have the right to participate actively in the development of the resident's individual treatment plan.

3801.8 Each resident shall have the right to receive adequate and humane treatment by competent, qualified, professional staff.

3801.9 Each resident shall have the right to be informed of his or her condition and progress.

3801.10 Each resident shall have the right to have his or her treatment record and all information contained therein kept confidential in accordance with the Mental Health Information Act, D.C. Code, 2001 Ed. §§7-1201.01 to 7-1208.07, and any other District or federal law that governs treatment records.

3801.11 Each resident shall have the right to meet with the physician and other members of the treatment team.

3801.12 Each resident shall have the right to periodic review of the treatment plan.

3801.13 Each resident shall have the right to visit, in private, with the resident’s personal physician, attorney, clergy, family members, friends and other persons of the resident’s choice at reasonable times.

3801.14 Each resident shall have the right to send and receive sealed mail.

3801.15 Each resident shall have the right to communicate freely and confidentially with the resident's attorney, the courts, the Commission on Mental Health Services (CMHS) Patient Advocate, the Long Term Care Ombudsman, and the organization responsible for protection and advocacy under the Mentally III Individuals Act, 42 U.S.C. §10801 and Part C of the Developmental Disabilities Assistance and Bill of Rights Act, 42 U.S.C. §§ 6041 - 6043, and representatives of the District of Columbia government.

3801.16 Each resident shall have reasonable access to a telephone to make and receive confidential calls.

3801.17 Each resident shall have the right to accept or refuse life sustaining medical treatment and to execute advanced directives about medical treatment decisions.

3801.18 Each resident shall have a limited right to refuse psychiatric treatment and supportive services, subject to federal or District law, court order, or CMHS policy governing the involuntary administration of medication.

3801.19 Representatives of the District of Columbia government and the Long Term Care Ombudsman, upon presentation of proper identification, shall have immediate access to residents in MHCRFs.

3801.20 Each MHCRF shall assist the resident in registering and exercising the resident's right to vote.

3801.21 No resident shall have any religious belief or practice imposed upon him or her.

3801.22 Each resident shall have the right to participate in social, religious or community activities that do not interfere with the rights of other residents or cause a substantial disruption to the normal functioning of the residence.

3801.23 Representatives of the Office of the District of Columbia Long-Term Care Ombudsman Program shall have access to residents in MHCRFs in accordance with the Federal Older Americans Act, 42 U.S.C. §3027(a)(12) and the District of Columbia Long-Term Care Ombudsman Program Act, D.C. Code, 2001 Ed. §§ 7-701.01 to 7-706.01.

3801.24 Representatives of the agency responsible for the protection and advocacy system for persons with mental illness and developmental disabilities shall have access to residents in community residence facilities in accordance with the Protection and Advocacy for Mentally III Individuals Act, 42 U.S.C. §§ 10801 - 10851, and Part C of the Developmental Disabilities Assistance and Bill of Rights Act, 42 U.S.C. §§ 6041 - 6043.

3801.25 Each resident shall have the right to manage his or her own financial affairs unless the resident has a duly appointed conservator, representative payee or guardian.

3801.26 No research using residents as subjects may be conducted unless the resident consents and the research complies with federal and District laws, rules, and regulations and CMHS policy. A copy of the resident's consent form shall be kept in the resident's record.

3801.27 Other than routine household duties, no resident shall be required to perform unpaid work unless the work is part of the resident's Individual Treatment Plan.

3801.28 Except as provided at D.C. Code, 2001 Ed. §§ 21-501 to 21-592, each transfer, discharge or relocation of a resident within the facility shall comply the Title III of the Nursing Home and Community Residence Facility Residents' Protection Act of 1985, D.C. Code, 2001 Ed. §§ 44-1003.01 to 44-1003.13, and § 3830 of this chapter.

3801.29 Upon admission, each resident shall be provided a copy of the MHCRF's rules.

3801.30 At a minimum, each MHCRF shall have rules concerning the following:

(a) The use of tobacco and alcohol;

(b) The use of the telephone;

(d) Movement of residents in and out of the facility.

3801.31 The resident shall comply with the MHCRF's rules during his or her residency at the MHCRF.

3801.32 Each resident shall pay the MHCRF on a monthly basis the amount which has been agreed upon in writing for the care provided to the resident.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 570 (January 27, 1995).

22-B DCMR § 3802 ENVIRONMENTAL REQUIREMENTS

3802.1 No MHCRF shall use a name on the exterior of the facility or display any logo that distinguishes the facility from any other residence in the neighborhood.

3802.2 When space permits, a MHCRF shall have landscaping, plantings, trees, and green areas which shall be properly maintained by the provider and accessible to all residents.

3802.3 Each MHCRF shall be located in an area reasonably free from noxious, hazardous smoke and fumes, away from known sources of loud and irritating noises and in areas where interior sounds may be maintained at reasonably comfortable levels.

3802.4 Each MHCRF shall be designed, constructed, located, equipped, and maintained to provide a functional, healthy, safe, comfortable, and supportive environment.

3802.5 A pest control program shall be in operation in the MHCRF, and the premises shall be free from insects and rodents and from debris that might provide harbor for insects and rodents.

3802.6 First aid supplies shall be maintained in a place known and readily accessible to residents and employees.

3802.7 Residents shall be protected from the hazards of asbestos in the residence in accordance with 20 DCMR, Chapter 8.

3802.8 Each residence shall be equipped, furnished, and maintained in such a manner as to provide a comfortable, congenial, home-like setting for each resident and staff member.

3802.9 Adequate facilities shall be provided for the collection, storage and removal of all trash and other refuse.

3802.10 Each window shall be screened during insect season.

3802.11 Each rug or carpet that is used in the residence shall be securely fastened or shall have a non-skid pad.

3802.12 Each hallway, porch, stairway, stairwell and basement shall be kept free from any obstruction at all times.

3802.13 Each ramp and stairway that is used by a resident shall be equipped with a firmly secured handrail or banister.

3802.14 Lead-free paint shall be used inside each residence, and each residence shall remove or cover old paint or plaster containing lead so that it shall not be accessible to residents.

3802.15 Each wall and floor shall be designed and maintained to minimize accidents.

3802.16 Plants and pets shall be permitted in a MHCRF, at the discretion of the Residence Director and as specified in the Program Statement. Pets shall be examined by a licensed veterinarian within sixty (60) days of admission to a MHCRF and once a year thereafter, or as often as necessary. All pets shall have current vaccinations.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 573 (January 27, 1995).

22-B DCMR § 3803 STRUCTURAL REQUIREMENTS

3803.1 Except as provided in §3803.2 the maximum number of occupants in a MHCRF shall be no greater than ten (10), and must conform to the maximum occupancy standard specified in §§3835 - 3838, unless the maximum number is waived by the Director, DCRA in writing.

3803.2 Notwithstanding §3803.1, a MHCRF that was granted a license prior to December 23, 1991, may have up to twenty-five (25) residents, exclusive of staff.

3803.3 Waivers of the maximum number of occupants shall be granted only when a determination is made by DCRA that:

(a) The health, safety, or welfare of the residents or MHCRF staff shall not be adversely affected by granting the waiver; and

(b) The MHCRF shall demonstrate that the size of the facility does not compromise a home-like, non-institutional atmosphere.

3803.4 A MHCRF may be located in a single or multi-family dwelling.

3803.5 Each residence shall be physically accessible to each resident that is served.

3803.6 If the physical structure of any MHCRF is constructed, added to, remodeled, or otherwise altered to the extent a building permit is required, the owner shall submit to DCRA for review and approval each intended change that may relate to the requirements of this chapter before a building permit shall be issued in accordance with the requirements of DCRA.

3803.7 Each MHCRF with eight (8) or fewer residents, excluding the Residence Director and his or her family, shall conform to Chapters 1 (except §103) 3, 4, 5, 6 (except §607.2, to obviate the necessity of providing keys to residents), 7, 8, and 9 (except §§901 through 906) of the D.C. Housing Code (14 DCMR).

History

SOURCE: Final Rulemaking published at 42 DCR 569, 574 (January 27, 1995).

22-B DCMR § 3804 LIGHTING

3804.1 Each room in a MHCRF shall have adequate light, and each bedroom having sufficient light for reading (at a minimum one hundred (100) watt bulb).

3804.2 A night light shall be in each bathroom, hallway and offered to residents for use in their sleeping rooms.

3804.3 Each outside entrance shall be lighted.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 575 (January 27, 1995).

22-B DCMR § 3805 WATER SUPPLY

3805.1 Each MHCRF shall ensure that its water supply and distribution system conform to applicable District laws and regulations and shall report to DCRA the lack of a water supply within twelve hours (12 hrs.) of discontinuation of services.

3805.2 Each MHCRF shall have plumbing sized, installed, and maintained that is adequate to carry quantities of hot and cold water in the facility in a manner which would not constitute an unsanitary condition or a nuisance.

3805.3 The temperature of hot water at each fixture that is to be used by each resident shall be automatically controlled and shall be maintained within the range of five degrees Fahrenheit (5° F.) over or under one-hundred and twenty degrees Fahrenheit (120° F.).

3805.4 The water supply may also include a separate or boosted supply at higher temperatures for the kitchen and for dishwashing and laundry uses.

3805.5 Each MHCRF shall provide hot and cold running water, under pressure, to each area where food is prepared, where food equipment, utensils or containers are washed, and to the laundry, bath, and toilet.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 575 (January 27, 1995).

22-B DCMR § 3806 HEAT, VENTILATION, AND INSULATION

3806.1 Each MHCRF shall have a heating and cooling system that conforms to applicable District laws and regulations, and shall be of sufficient size and capacity to maintain a minimum of sixty-eight degrees Fahrenheit (68° F.) during the hours of 6:30 a.m. to 11:00 p.m., and sixty-five degrees Fahrenheit (65° F.) during the hours 11:00 p.m. to 6:30 a.m., between October 15th and April 15th. Fans or air conditioning shall be available in sleeping rooms and in the main living room between April 15th and October 15th to maintain a maximum temperature of ninety degrees Fahrenheit (90° F.).

3806.2 Each heating system shall be thermostatically controlled.

3806.3 A MHCRF shall not supplement its heating system with a portable room heater, space heater, or fireplace unless its usage is specifically approved by the District of Columbia Fire Department.

3806.4 A fireplace may be utilized for decorative, social, and recreational purposes. If utilized, the chimney must be cleaned at least once a year.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 576 (January 27, 1995).

22-B DCMR § 3807 BEDROOMS

3807.1 Each bedroom shall have a minimum of eighty square feet (80 ft.2) for single occupancy and one hundred square feet (80 ft.2) for double occupancy. No bedroom shall have more than four (4) occupants. If a bedroom has more than two (2) occupants there shall be an additional forty feet (40 ft.) of space or more for each additional occupant.

3807.2 Each resident's bedroom shall be equipped with at least:

(a) A bed, which shall not be a cot;

(b) A mattress, which shall meet the requirements of 22 DCMR § 115;

(c) A bedside table or cabinet with lockable storage space and an individual reading lamp with at least a one hundred (100) watt bulb;

(d) Suitable sufficient storage space for each resident's personal clothing and personal effects; and

(e) A waste receptacle and clothes hamper with lid.

3807.3 Each bed shall be located only in a room that is designed solely as a bedroom.

3807.4 Each bed shall be placed at least three feet (3 ft.) from any other bed and from a radiator.

3807.5 Each MHCRF shall provide at least one (1) desk and chair for the use of every eight (8) residents.

3807.6 Each resident who is enrolled on a full or part-time basis in a course of academic or vocational study shall be provided with a work area in the residence MHCRF that is quiet and conducive to study.

3807.7 Each bedroom shall have direct access to a major corridor and at least one (1) window.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 576 (January 27, 1995).

22-B DCMR § 3808 BATHING AND TOILET FACILITIES

3808.1 Each MHCRF shall provide toilet and lavatory facilities which comply with the fixture ratios set forth in Chapter 6 of 14 DCMR (D.C. Housing Code).

3808.2 Each toilet room or lavatory shall be adequately equipped with:

(a) Toilet paper holder and toilet paper;

(b) Clean towels;

(d) Mirror;

(e) Adequate lighting; and

(f) Waste receptacle.

3808.3 Each MHCRF shall ensure that properly anchored grab bars or handrails are provided in toilet and bathing areas, if needed by any resident in the facility.

3808.4 Adequate provision shall be made to ensure each resident's privacy and safety in each toilet, lavatory, and bathing facility.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 577 (January 27, 1995).

22-B DCMR § 3809 FIRE SAFETY

3809.1 Each MHCRF shall comply with Chapter 21 of the current edition of the Life Safety Code of the National Fire Protection Association and the District's Smoke Detection Act, D.C. Code, 2001 Ed. §§6-751.01 to 6-751.10.

3809.2 Where a specific provision of this section conflicts with chapter 21 of the Life Safety Code of the National Fire Protection Association, the specific provisions of this section shall apply.

3809.3 Each MHCRF shall have a written manual of instructions and plans, approved by the District of Columbia Fire Department, which shall be followed in case of fire, explosion, or any other emergency, which shall be available for review in each MHCRF.

3809.4 The manual shall specify the following:

(a) The persons to be notified;

(b) The locations of alarm signals and fire extinguisher;

(d) The frequency of fire drills; and

(e) The assignment of specific tasks and responsibilities to the staff of each shift.

3809.5 Drills testing the effectiveness of the fire plan shall be conducted for each resident individually upon admission, and for current residents within two (2) weeks of the implementation of these regulations. In addition, fire drills shall be conducted at least twice annually in all MHCRFs, with at least one drill conducted during the night. The exceptions listed in §31.9 of the current edition of the Life Safety Code shall apply.

3809.6 Each MHCRF shall maintain in its records the most recent fire inspection report with the date of the latest inspection of the alarm system.

3809.7 Each MHCRF shall install and maintain smoke detectors in accordance with §§4 through 9a of the Smoke Detector Act, as amended (D.C. Code, 2001 Ed. §§ 6-751.03 to 6-751.09).

3809.8 If all sleeping rooms are not located on the same level, the MHCRF shall install and maintain a smoke detector system composed of interconnected smoke detectors, unless the licensee can show to the satisfaction of the Fire Department that another detector system would be audible in all sleeping areas.

3809.9 Subsection 3809.7 shall apply to each MHCRF that is newly licensed or substantially renovated after the effective date of these rules.

3809.10 Each existing MHCRF shall meet the requirements of this section within six (6) months following the effective date of this chapter.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 577 (January 27, 1995).

22-B DCMR § 3810 FIRE EXTINGUISHER

3810.1 A fire extinguisher that is effective in extinguishing grease and oil fires shall be located within fifteen feet (15 ft.) of any stove, oven, cooking burner, or other cooking device.

3810.2 Each MHCRF shall have at least one (1) working fire extinguisher on each floor, including the basement and first floor, and in a central location where it is accessible to residents and employees.

3810.3 A fire extinguisher of a type and capacity sufficient to extinguish fires originating in the main heating plant and hot water heat shall be located within five feet (5 ft.) of that equipment.

3810.4 Each fire extinguisher shall:

(a) Be properly maintained; and

(b) Be approved for its specific use by an official of the District of Columbia Fire Department.

3810.5 Each fire extinguisher shall be recharged immediately after use, except that a water type extinguisher equipped with pressure gauge shall need only to be inspected and tagged.

3810.6 Each fire extinguisher shall have attached to it a tag giving the date when the service was performed, a description of the service performed, and the name and address of the person performing the service.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 579 (January 27, 1995).

22-B DCMR § 3811 EGRESS REQUIREMENTS AND FIRE DOORS

3811.1 Each MHCRF shall have a fire exit that:

(a) Is clearly designated on the MHCRF's disaster plan;

(b) Is clearly identified for residents;

(d) Is accessible from sleeping rooms.

3811.2 If the area or floor served by a fire exit door is to be occupied, the door shall not be locked in a manner that would require a key to unlock the door from the inside or that would require more than thirty (30) seconds to unlock.

3811.3 Each MHCRF that has residents in sleeping rooms above the second floor, or which has more than eight (8) residents in sleeping rooms above the street level, shall provide:

(a) Access to two (2) separate means of exit for sleeping rooms above street level, at least one (1) of which shall consist of an enclosed interior stair, or a horizontal exit, or a fire escape, all arranged to provide a safe path of travel to the outside of the building without traversing any corridor or space exposed to an unprotected vertical opening; or

(b) Alternative arrangements or method which, according to reasonable equivalency criteria set out in Chapter 21 of the current edition of the Life Safety Code, secure safety of life from fire.

3811.4 Each MHCRF shall comply with the requirements set forth in 12 DCMR §914.

3811.5 No MHCRF shall permit smoking in bedrooms.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 579 (January 27, 1995).

22-B DCMR § 3812 PAYMENT OF DISTRICT FUNDS

3812.1 No District Income Maintenance Funds shall be paid to any MHCRF or to any person residing in a MHCRF for his or her maintenance in that facility unless the MHCRF is licensed by the District or otherwise complies with D.C. Code, 2001 Ed. § 44 502.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 580 (January 27, 1995).

22-B DCMR § 3813 DIETARY SERVICES

3813.1 Each MHCRF shall have a current food handler certificate (23 DCMR, Chapters 20 - 25) and shall apply generally accepted principles of nutrition and management to each menu planning, food preparation, and service for residents of the facility.

3813.2 Each MHCRF shall promote each resident's participation and skill development in menu planning, shopping, food storage, and kitchen maintenance.

3813.3 Each MHCRF shall serve, provide for, or arrange on a daily basis at least three (3) meals and between meal snacks that meet one hundred percent (100%) of the required daily allowance as defined by the Food and Nutrition Board of the National Academy of Science and are suited to the special needs of each resident, and adjust meals and snacks for seasonal changes, particularly to allow for the use of fresh fruits and vegetables.

3813.4 If a resident is provided meals at another location by the MHCRF, the Residence Director shall ensure that each meal, including any box lunch, is nutritious as required by §3813.3 and suited to the special needs of the resident.

3813.5 Each meal shall be scheduled so that the maximum interval between each meal shall be no more than six hours (6 hrs.), except that there shall be no more than fourteen hours (14 hrs.) between a substantial evening meal and breakfast the following day.

3813.6 Each food and drink item shall be clean, wholesome, free from spoilage, prepared in manner that is safe for human consumption, and served in accordance with Chapters 20 through 25 of Title 23 DCMR, with the following exceptions:

(a) A MHCRF with fewer than twenty (20) residents shall not be required to comply with 23 DCMR §2500.2, but shall organize plumbing facilities to ensure that the food processed is safe for human consumption;

(b) A MHCRF with fewer than ten (10) employees on a shift shall not be required to comply with 23 DCMR §2501.2 which requires separate toilet facilities for male and female employees; and

(c) A MHCRF with five (5) or fewer unrelated residents plus the Residence Director and his or her family shall not be required to comply with 23 DCMR §§2207, 2208, 2300, or 2301.

3813.7 Each MHCRF shall have fresh water and clean drinking glasses available for each resident at all times.

3813.8 Each resident who needs assistance to eat shall be given the assistance promptly upon receipt of meals.

3813.9 A MHCRF shall not permit the use of tobacco products during food preparation.

3813.10 A MHCRF shall retain a copy of each menu, as planned and served, for thirty (30) days.

3813.11 If a resident refuses food or misses a scheduled mealtime, appropriate substitutions of comparable nutritional value shall be offered.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 580 (January 27, 1995).

22-B DCMR § 3814 THERAPEUTIC DIETS

3814.1 Each MHCRF with a resident in need of a special or therapeutic diet shall ensure that the diet is planned, prepared, and served as prescribed by the attending physician.

3814.2 Each MHCRF with residents who are in need of special or therapeutic diets shall consult at least every six (6) months with a dietitian or nutritionist.

3814.3 As authorized by the Mental Health Information Act, the dietitian or nutritionist shall have access to each resident's record, which shall contain the physician's prescription for medications and special diets, and he or she shall document in that record each observation, consultation, and instruction regarding the resident's acceptance and tolerance of each prescribed diet.

3814.4 The dietitian or nutritionist, the Residence Director, or designee of the Director, the resident and the resident’s legal guardian shall review the therapeutic diet of the resident at least every six (6) months.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 582 (January 27, 1995).

22-B DCMR § 3815 HOUSEKEEPING AND LAUNDRY SERVICES

3815.1 The interior and exterior of each MHCRF shall be maintained in a safe, clean, orderly, attractive, and sanitary manner and shall be free from accumulations of dirt, rubbish, and objectionable odors.

3815.2 Each MHCRF shall provide appropriate procedures, personnel, and equipment to ensure sufficient clean linen supplies and the proper sanitary washing and handling of linen and personal clothing of residents.

3815.3 At least one (1) towel, bedspread, pillow, blanket and mattress cover in good repair and clean shall be maintained for each resident.

3815.4 Each piece of towel and bed linen shall be changed and cleaned as often as necessary to maintain cleanliness at all times, but in no case shall towels and bed linen be changed less often than once each week.

3815.5 Each blanket, bedspread, and mattress cover shall be cleaned regularly and when soiled or transferred from one (1) resident to another.

3815.6 Arrangements shall be made to provide each resident with a safe and convenient place to wash and dry personal laundry.

3815.7 Each MHCRF shall ensure that the personal laundry of each resident is laundered in a sanitary manner, separate from bed linen.

3815.8 Clean linen and clothing shall be stored in clean, dry, dust free areas that are easily accessible to residents.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 582 (January 27, 1995).

22-B DCMR § 3816 PERSONAL PROPERTY AND FINANCES OF RESIDENTS

3816.1 No Residence Director or licensee shall increase the fee for care in a MHCRF more than once within a twelve (12) month period, unless the following occurs:

(a) The increase is justified in writing;

(b) The increase is caused by an unusual escalation in the expense of the facility or services to the resident; and

3816.2 Each MHCRF shall permit each resident to bring reasonable personal possessions and furnishings to his or her living quarters in the MHCRF unless the MHCRF can demonstrate that it is not practical, feasible, or safe.

3816.3 Each MHCRF shall take appropriate measures to safeguard and account for personal articles brought by a resident. Each MHCRF shall inventory the articles and provide a copy of the inventory, signed by the resident and staff, to the resident.

3816.4 The MHCRF shall provide the resident, his conservator or legal guardian, if any, with a receipt for all personal property held by it for safekeeping.

3816.5 Each MHCRF shall maintain a separate and accurate record of all funds and personal property, deposited with the MHCRF for safekeeping or managed by the MHCRF for the benefit of the resident. That record shall include the following:

(a) The date, amount of all money, and value of all property received;

(b) The date and amount of each withdrawal by the resident or disbursement by the MHCRF for the resident's benefit, including signed receipts;

(d) The current balance; and

(e) Signatures of the resident and facility staff.

3816.6 Each MHCRF shall make a copy of the record required in subsection 3816.5 available to the resident, his conservator or legal guardian, if any, on a quarterly basis, when the resident is to be transferred or discharged from the facility, or upon the resident’s request.

3816.7 No Residence Director or employee of a MHCRF shall require a resident to give, transfer, or assign to the Residence Director or an employee an interest in or title to any property owned by the resident, nor shall the Residence Director or employee of the MHCRF accept any such gift, transfer, or assignment. This provision shall not apply to funds used for care of the resident as agreed in §3801.3 where the Residence Director is the representative payee.

3816.8 Nothing in this section shall be construed to prohibit a Residence Director from requiring a resident to pay the sum of money for his or her care that has been agreed upon in writing as set forth in §3801.3.

3816.9 Upon admission of a resident, each MHCRF shall explain to the resident or his conservator or legal guardian, the option as to the manner in which the resident's personal allowance funds shall be handled during her or his stay at the residence. Each MHCRF shall obtain written authorization from the resident or his conservator or legal guardian, before handling or managing the resident’s personal funds, which shall be reviewed at least annually.

3816.10 Upon each resident's discharge from the MHCRF, the residence shall promptly provide the remaining personal allowance funds or personal property to the resident or her or his conservator, guardian or legal representative. The resident, conservator, guardian or legal representative may be required to sign a statement acknowledging the receipt of the funds. A copy shall be placed in the resident's record.

3816.11 Each MHCRF shall encourage residents to wear their own clothing, which should be appropriate, clean, and seasonable.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 583 (January 27, 1995).

22-B DCMR § 3817 MEDICAL COVERAGE

3817.1 Each resident shall have the right to choose, and shall provide for his or her own medical or dental care, at his or her own expense, or under relevant provisions of the Social Security Act. Alternatively, each eligible resident may seek medical or dental care from a public agency at public expense in accordance with laws and regulations governing the agency.

3817.2 Each resident shall be examined by a physician at least one (1) time every year.

3817.3 Each resident's permanent records shall include copies of his or her medical examinations, all physicians' reports, and the physicians' recommendations for the resident care.

3817.4 If a resident is unable to make arrangements for his or her annual physical examination or any medical or dental examination, the Residence Director shall assist the resident in making arrangements for the examinations.

3817.5 Each MHCRF shall maintain in the residence a list of the names and telephone numbers of each resident's physician.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 584 (January 27, 1995).

22-B DCMR § 3818 RESIDENCE DIRECTOR

3818.1 Each MHCRF shall have a Residence Director who may be the licensee of the community residence facility. and:

(a) Is at least twenty-one (21) years of age, has a high school diploma or the equivalent, at least two (2) years of experience in human services including (1) year of working with persons with mental illness and demonstrates supervisory capability;

(b) Has passed an oral and written examination on his or her understanding of these rules and ability to provide adequate care to each resident within the MHCRF;

(c) Is annually certified by a physician as in good physical and mental condition, capable of doing physical housework tasks or of directing the work of household assistants, and free of communicable diseases as defined in chapter 2 of this title;

(d) Participates in training, workshops and seminars developed for MHCRF operators by the CMHS;

(e) Meets the additional requirements to operate Transitional and Intensive Residences as specified in §§3837.9 and 3838.7, if applicable;

(f) Has not been convicted of a felony; and

(g) Has not willfully failed or refused to comply with any statute or regulations governing MHCRFs.

3818.2 Each Residence Director of a MHCRF licensed prior to the effective date of these rules who does not meet the requirements in §3818.1 (a), (b) or (d) shall take and pass a written examination that is administered by DCRA within two (2) years of the effective date of these rules.

3818.3 Each MHCRF Director's certificate verifying successful completion of the examination required by §3818.2 shall be available for inspection at the main office where personnel records are stored, if the main office is located in the District of Columbia, or in the residence.

3818.4 Each Residence Director shall have, at a minimum, the following responsibilities, except in those areas of responsibility retained by the licensee or governing board of the MHCRF:

(a) Supervision of the day-to-day operation of the residence, including sanitation, safety, laundry, dietary services, and other services relating to the health and welfare of each resident;

(b) Implementation of policies, practices, and procedures of the MHCRF, including the screening of prospective residents and staff;

(d) Preparation of the budget and supervision of the residence's financial matters;

(e) Maintenance of the MHCRF's records and reports relating to each resident and, if the facility is handling the residents' personal funds pursuant to a signed written authorization, the resident's finances; and

(f) Supervision and direction of the other employees of the MHCRF.

3818.5 If the Residence Director is absent or temporarily away from the residence, the Residence Director shall ensure that the MHCRF is properly supervised at those times when residents are present, by an individual who is not a resident and who is capable of recognizing visible changes in each resident's physical and mental condition and is capable of taking responsible action in the case of an emergency.

3818.6 If each resident of a MHCRF is regularly scheduled in activities, programs or employment away from the residence during certain hours, DCRA, upon application by the Residence Director, may permit the Residence Director to be absent during those hours in which all residents are absent. Nothing in this section shall be construed to permit a Residence Director to require residents to attend day programs or activities or be absent from the facility during the day, particularly during periods of medical illness, where the resident may require bed rest.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 585 (January 27, 1995).

22-B DCMR § 3819 PERSONNEL

3819.1 No person who is known to have abused or mistreated any person shall provide services, either as an employee or volunteer, or own or operate a MHCRF.

3819.2 Each MHCRF shall have written personnel policies which shall be available to each staff member and shall include the following:

(a) The wage scales, hours of work, vacations, sick leave, insurance, and other benefits if any;

(b) Provisions for an annual evaluation of each employee's performance by appropriate supervisors;

(d) Provisions for orientation and annual in-service training of staff.

3819.3 At the time of initial employment, and at least annually thereafter, or as necessary, each person employed in a MHCRF shall have a physical examination completed by a physician. The results of the physical examination shall be used to secure the appropriate screening and immunizations prescribed by the Department of Human Services' Commission of Public Health prior to and during employment.

3819.4 Each MHCRF shall maintain accurate personnel records, which shall include the following information:

(a) Name, address, sex and social security number of employee;

(b) Current professional license or registration number, if any;

(c) Resume of education, training, prior employment, evidence of attendance at orientation, training, workshops and seminars sponsored by CMHS;

(d) Current health certification, including results of annual intradermal tuberculin skin test or chest x-ray indicating no active TB;

(e) Verification of previous employment, if any, before hiring;

(f) Copies of annual evaluations;

(g) Documentation of conviction record;

(h) Certification in emergency first aid, CPR and the Heimlich Maneuver; and

(i) Position description.

3819.5 A MHCRF shall make reasonable efforts to ensure that a person known to have previously abused or mistreated any person does not provide services in a residence.

3819.6 No employee or volunteer may provide direct services to residents if that person:

(a) Is under the influence of alcohol or any mind-altering drug or combination thereof; or

(b) Has a communicable disease which poses a legitimate and real health risk to residents which cannot be safely addressed by reasonable accommodations.

3819.7 Each person who requires licensure, certification or registration to provide care to residents shall be licensed, certified, or registered under the laws and regulations of the District of Columbia.

3819.8 Each employee shall be assigned duties consistent with his or her license, job description, training, and experience.

3819.9 The provisions of §3819.4 shall apply to paid staff but not to volunteers.

3819.10 The Residence Director shall be responsible for ensuring that any person working in the residence in a direct service capacity to the client as an employee, under contract or as a volunteer; receives job-related training which includes, at a minimum, the following:

(a) Emergency first-aid, including CPR and the Heimlich maneuver;

(b) Emergency evacuation procedures;

(d) Residents' rights and responsibilities; and

(e) DHS scheduled training.

3819.11 A MHCRF shall do the following for each volunteer who works in a MHCRF:

(a) Screen each volunteer to ensure that he or she is competent for the duties or services he or she is to provide and holds a professional license or certificate, when required, for any professional service he or she is to provide;

(b) Provide orientation and regular training for the services to be provided;

(c) Ensure that each volunteer engaged in direct services does not have any health or medical problems that would pose an undue risk to residents;

(d) Ensure that no volunteer has been assessed as having the potential for or history of physical or mental abuse toward residents;

(e) Maintain a simple record to document its compliance with the requirements of §§3819.11 (a) to (d);

(f) Train the volunteer regarding residents' rights and responsibilities; and

(g) Ensure that volunteers shall not be used as a substitute for facility staff.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 587 (January 27, 1995).

22-B DCMR § 3820 ADMINISTRATIVE RECORDS

3820.1 Each Residence Director shall maintain current and accurate records in a central file.

3820.2 Each MHCRF shall retain each administrative record and report compiled pursuant to this chapter for five (5) years.

3820.3 Each MHCRF shall retain the following information for the preceding fiscal year:

(a) The total number of admissions and discharges;

(b) The authorized bed capacity; and

3820.4 Each Residence Director shall notify DCRA of any changes in the MHCRF's occupancy level.

3820.5 Each MHCRF shall maintain the following records and reports for inspection and review by DCRA and others with authority to review such records:

(a) A list of current charges and fees for services;

(b) The payroll records and weekly staff schedules for the last six (6) months, as appropriate;

(d) The fire drill and evacuation plan;

(e) Any agreements with professional consultants;

(f) A list of the following telephone numbers:

(1) 911;

(2) Each resident's personal physician;

(3) Three (3) licensed physicians who could be contacted in an emergency;

(4) Emergency Psychiatric Response Division in the CMHS;

(5) The CMHS' Patients' Advocate Office;

(6) Information, Protective and Advocacy Center for Handicapped Individuals;

(7) Adult Protection Services;

(8) The Long Term Care Ombudsman; and

(9) Other resources available to assist in an emergency;

(g) A roster of residents;

(h) A day and night report book in which emergencies or other unusual occurrences are recorded by the responsible person on duty; and

(i) The records listing each resident's personal funds and property entrusted to the MHCRF for safekeeping.

3820.6 Each Residence Director shall thoroughly investigate any allegations of mistreatment by an MHCRF employee, volunteer or resident, and promptly report any findings or actions taken as a result of the investigation to the resident, the resident’s legal representative, if any, DCRA, the Long Term Care Ombudsman, Adult Protective Services, and to the CMHS. The investigation shall be documented and signed and dated by the investigator.

3820.7 Each MHCRF shall upon request make available resident financial records for audit by government agencies and other offices with authority to review such records.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 589 (January 27, 1995).

22-B DCMR § 3821 RESIDENT RECORDS

3821.1 Each MHCRF shall maintain a permanent record on each resident, which shall be retained for at least five (5) years after the resident's discharge or death.

3821.2 Each resident's record shall be current with each entry dated and signed with the full name of the recordkeeper, and shall include the following information on each resident:

(a) Administrative information, including name, date of birth, sex and social security number, and marital status;

(b) Medical insurance numbers, including Medicare and Medicaid, if any;

(d) Date of discharge or death, discharge reason and final diagnosis;

(e) Names, addresses, and telephones numbers of the resident’s legal guardian, CMHS designated case manager, if any, and next-of-kin;

(f) Names, addresses and telephone numbers of the personal physician and dentist;

(g) Religious affiliation, if any, including the name and telephone number of the resident's minister, priest, or rabbi;

(h) Medical history, including the resident's allergies and vaccine histories;

(i) A current record of any funds managed by the residence for the resident's benefit pursuant to §3816 of this chapter;

(j) Medication, diet, treatment and any other procedures that are required for the safety and well-being of the resident;

(k) A daily record of each medication and treatment given;

(l) Notes or incident reports of any serious illness, accident or unusual occurrence, including medication errors or adverse reaction which shall include the date, time and description of the incident or accident; and

(m) Source of the referral to the MHCRF.

3821.3 Each entry in the record shall be legible, current, in ink, dated and signed by the transcriber with his or her position identified. Errors shall be corrected by crossing out the incorrect information, but may not be erased.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 591 (January 27, 1995).

22-B DCMR § 3822 CONFIDENTIALITY OF RECORDS

3822.1 Each resident's record and any record of the MHCRF that has information identifying residents shall be confidential except as provided in §3823.2.

3822.2 Disclosure and redisclosure of information pertaining to a resident's mental health and client's access to his own record, shall be governed by the District of Columbia Mental Health Information Act, D.C. Code, 2001 Ed. §§ 7 1201.01 to 7 1208.07, and any other District or Federal law governing these records.

3822.3 In the event of a resident's authorized release of information to a third party, a copy of the resident's written authorization shall be maintained in the resident's records and must conform to the Mental Health Information Act.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 592 (January 27, 1995).

22-B DCMR § 3823 MEDICATION

3823.1 Prior to the admission of each resident, the Residence Director shall obtain a record of each medication that the resident is currently taking, including identification of each prescribed controlled substance and a list of each known allergy.

3823.2 Subsection 3823.1 shall not apply to Transitional Residence beds, as defined in §3838. However, the MHCRF shall compile a medication history within forty-eight hours (48 hrs.) of admission by contacting any known service providers.

3823.3 Each medication record shall be kept in a manner that ensures it is not accessible to other residents or visitors.

3823.4 The Residence Director shall ensure that each resident who has been certified, in writing, by a physician, as capable of self-administering his or her medication, is taking his or her medication as prescribed. Each certification shall be reviewed annually for appropriateness by the resident's physician.

3823.5 If a resident is unable to administer his or her own medication, the Residence Director shall ensure that the medication is administered by a licensed nurse or physician.

3823.6 The Residence Director shall keep each resident's medicines secure and separate from those of other residents, with proper identification and under proper conditions of light and temperature as indicated on the medicine's label.

3823.7 Each medication of each resident shall be stored in its original container and shall not be transferred to another container or to another resident, and medication for external use shall be stored separately from medications for internal use.

3823.8 Each residence shall comply with District and Federal laws and regulations governing the procurement, handling, storage, administering, recording, dispensing and disposal of medications and controlled substances.

3823.9 Each dose of medication administered shall be properly and promptly recorded and initialed in the resident's record by the person who administers or supervises the medication.

3823.10 Each medication error, reaction or adverse response to a medication shall be immediately reported to the resident's physician and documented in the resident's record as well as in an incident report.

3823.11 Each resident's refusal of a medication shall be documented in his or her record and reported to the resident's physician in a manner that is consistent with sound nursing procedures and good medical practice.

3823.12 Each MHCRF shall remove and dispose properly of expired medication and medication that is no longer in use.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 592 (January 27, 1995).

22-B DCMR § 3824 INSURANCE

3824.1 Each MHCRF shall carry insurance for at least the following:

(a) Hazards (fire and extended coverage), in the amount of five hundred dollars ($500) per resident to protect belongings with a minimum of two thousand dollars ($2,000) of coverage per facility;

(b) Premises, personal injury and products liability for at least the following:

(1) One (1) to two (2) beds for one hundred thousand dollars ($100,000) per occurrence;

(2) Three (3) to nine (9) beds for three hundred thousand dollars ($300,000) per occurrence; and

(3) Ten (10) or more beds for five hundred thousand dollars ($500,000) per occurrence; and

(c) Incidental malpractice coverage in respect only of duties required of a Residence Director or staff member for a limit of at least one hundred thousand dollars ($100,000).

3824.2 If the MHCRF is not owned by the operator, the operator shall obtain proof of the owner's premises liability coverage, such as a certificate of standard landlord coverage, or shall place the owner on the operator's policy as an additional named insured.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 593 (January 27, 1995).

22-B DCMR § 3825 PROGRAM STATEMENTS

3825.1 Each MHCRF shall have a written program statement to be provided to the DCRA and CMHS which shall include, a description of:

(a) The program and facilities;

(b) The staffing patterns;

(d) The fees and charges;

(e) The payment and refund policies;

(f) The group or groups of persons to be served, including any sex, age, or health characteristics;

(g) The admission policy and discharge procedures; and

(h) The house rules of the facility.

3825.2 Each MHCRF shall make its program statement available to each resident upon admission and to the public for inspection or copying upon request, at the public's expense.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 594 (January 27, 1995).

22-B DCMR § 3826 DISTRICT CERTIFICATION OF COMMUNITY RESIDENTIAL PLACEMENTS

3826.1 The Director, DHS or his designee shall certify persons for placement in a MHCRF in conjunction with the resident and the resident's treatment team.

3826.2 The CMHS designated case manager shall monitor each resident's progress, status and the continued appropriateness of services provided in the MHCRF at least every three (3) months for mentally ill persons in the MHCRF who are on the District's rolls.

3826.3 If a person is hospitalized or absent from a residence for thirty (30) days or more, the Director, DHS or his designee, in conjunction with the resident and the resident's treatment team, shall determine the appropriate level of service and whether the person is likely to return to his or her previous residence within sixty (60) days. Residents are eligible to return to their residence within ninety (90) days from hospitalization.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 594 (January 27, 1995).

22-B DCMR § 3827 GENERAL ELIGIBILITY AND ADMISSION REQUIREMENTS

3827.1 A MHCRF shall admit and retain only those persons for whom it can care for safely and adequately and who require the care and supervision that the facility provides.

3827.2 A person may not be disqualified from placement in a MHCRF simply because the person:

(a) Is not ambulatory;

(b) Needs assistance with medication administration, including injections;

(d) Needs limited or intermittent nursing care.

3827.3 Each MHCRF shall follow written admission criteria which shall be submitted to the Director, DHS, and presented to the resident or his guardian or conservator upon the person's admission to the facility.

3827.4 No person, eighteen (18) years or older, shall be denied admission based upon the person's age, gender, race, physical or mental disability, HIV status, religion, sexual orientation, national origin, marital status, or source of payment for the service, unless deemed inappropriate for placement based on criteria enumerated in this chapter.

3827.5 Whenever a MHCRF denies admission to an applicant, the MHCRF shall provide written reasons for the denial to the Director, DHS, or his designee, and if requested, to the applicant. A copy of the written reason for denial shall be included in the facility's file.

3827.6 No MHCRF shall refuse to make reasonable accommodations necessary to admit or retain a resident who is deaf, blind, non-English speaking, non-ambulatory or otherwise physically or mentally disabled.

3827.7 Each resident shall have a pre-admission medical examination by a physician not more than sixty (60) days prior to her or his admission to a MHCRF.

3827.8 Prior to a resident's admission and in accordance with the Mental Health Information Act, each MHCRF shall obtain for each resident sufficient information concerning the resident's physical and mental condition to assist the resident to maintain the highest practical level of functioning. The information shall include:

(a) A written care or treatment plan;

(b) Prescribed medications;

(d) A copy shall be maintained in the resident's file.

3827.9 Prior to admission, a physician shall certify that a resident is free of any communicable disease as defined in chapter 2 of this title, or if the resident has a communicable disease, that the communicable disease is not in an acute stage.

3827.10 A resident with a communicable disease not in the acute stage but which has a prolonged state of communicability may be admitted to any MHCRF which is capable of providing environmental and hygienic procedures appropriate to the specific disease in accordance with the latest precautions and guidelines for specific diseases published by the Centers for Disease Control, United States Public Health Service.

3827.11 Subsections 3827.7, 3827.8, and 3827.9 shall not apply to admission to Transitional Residential beds as defined in §3838. However, a physical examination by a physician and certification regarding communicable diseases must be attempted for each resident within seven (7) calendar days of placement in a Transitional bed.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 595 (January 27, 1995).

22-B DCMR § 3828 INDIVIDUAL TREATMENT PLAN (ITP)

3828.1 Each MHCRF shall participate in the development and review of an Individual Treatment Plan (ITP) with the CMHS designated case manager and shall maintain a copy of the ITP in the resident's record. The MHCRF shall describe in writing, the following:

(a) The resident's functional strengths and limitations in performing daily living activities;

(b) Any medical or health issues which are relevant to the services needed by the resident;

(d) Goals, objectives and specific interventions designed to attain goals; and

(e) Client's legal status.

3828.2 Each MHCRF shall write the name, address, and telephone number of the provider of each service the resident receives for inclusion in the ITP.

3828.3 The Residence Director and residential staff shall assist in reviewing and updating the ITP in collaboration with the CMHS designated case manager, the resident and his or her guardian, if any, and a multi-disciplinary team which may include, but not be limited to, the resident's attending physician, psychiatrist, social worker, and significant others.

3828.4 The initial ITP shall be developed by the CMHS designated case manager prior to the time the resident moves into the MHCRF and shall be revised, if needed, within thirty (30) days. The ITP shall be reviewed and updated as often as necessary but not less than every three (3) months. The MHCRF may request a review of the ITP by the resident's treatment team through the CMHS designated case manager.

3828.5 The resident shall have the right to participate in planning all phases of his or her ITP, may request participation of a family member, and shall be offered the opportunity to sign his or her ITP or indicate disagreement with particular aspects of the plan or the whole of the plan.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 596 (January 27, 1995).

22-B DCMR § 3829 RESIDENT STATUS POLICIES

3829.1 The Residence Director shall orally notify CMHS and the resident's legal guardian, if any, within twenty-four hours (24 hrs.) of any serious illness, accident, or unusual incident involving the resident, and shall document the incident in the resident's permanent record.

3829.2 Each oral notice required by §3829.1 shall be followed by a written notice within forty-eight hours (48 hrs.) of the unusual incident. The Residence Director shall ensure that a copy of the written notices are placed in the resident's permanent record.

3829.3 Each MHCRF shall have written policies and procedures governing the care of residents in an emergency, including a communicable disease episode, food poisoning outbreak, when a resident is critically ill or dies or has a change in mental status that endangers himself or herself or others.

3829.4 In case of the death of a resident, the Residence Director shall promptly notify the resident's attending physician and the next-of-kin, legal guardian, if any, the CMHS, DCRA, and, as required, the D.C. Medical Examiner.

3829.5 If a resident dies, the following procedures shall be followed, as applicable:

(a) If any part of a resident's personal funds, while in the facility, has been provided under an assistance program by a District or federal agency, the Residence Director shall immediately notify the agency of the resident's death and shall determine the disposition of the resident's property in conjunction with the appropriate agency;

(b) When a residence has possession of a deceased resident's funds, valuables, or other assets, these items shall not be released to any person, firm, corporation, or agency except to the appointed personal representative of the resident's estate;

(c) If no claim for the resident's real and personal property is made within six (6) weeks of death, the deceased's assigned case manager, or if the resident had no case manager, the Residence Director shall make reasonable attempts to locate the resident's personal representative(s), or heir(s), and shall adequately store and safeguard the property or valuables; and

(d) If no surviving spouse or relatives can be located, the Mayor of the District of Columbia should be notified of the deceased resident's remaining real and personal property so that it can escheat to the city, in accordance with D.C. Code, 2001 Ed. § 19-701.

3829.6 Each MHCRF shall abide by the District of Columbia laws governing the investigation and reporting of deaths under the jurisdiction of the Medical Examiner.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 597 (January 27, 1995).

22-B DCMR § 3830 TRANSFER, DISCHARGE AND RELOCATION POLICIES

3830.1 The Residence Director shall promptly notify the CMHS and physician when the resident's physical or mental condition changes such that the resident needs a service which may require relocating the resident.

3830.2 Except as provided at D.C. Code, 2001 Ed. § 21-501, the discharge, transfer, or relocation of any resident shall be in accordance with the resident's Individual Treatment Plan and Title III of the Nursing Home and Community Residence Facility Residents' Protection Act of 1985, effective April 18, 1986, (D.C. Code, 2001 Ed. §§44-1003.01 to 44-1003.13).

3830.3 The discharge, transfer, or relocation, of any resident of a MHCRF that receives contract funds from the CMHS shall be subject to the approval of the CMHS Contract Administrator in addition to the specifications in this chapter.

3830.4 Each resident who has been transferred from the MHCRF for hospitalization may return to the MHCRF within ninety (90) days if the resident’s needs are consistent with services provided by the MHCRF as determined by the resident's treatment team in conjunction with the resident.

3830.5 A resident whose income is SSI shall have his or her MHCRF bed held if he or she is admitted to a public mental institution or a facility in which Medicaid is paying fifty percent (50%) or more of the cost of care.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 598 (January 27, 1995).

22-B DCMR § 3831 RESTRAINTS

3831.1 No restraints as defined in §3899 shall be used in a MHCRF.

3831.2 No resident shall be confined in a locked room nor shall he or she be locked in or out of the facility or bedroom at any time.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 598 (January 27, 1995).

22-B DCMR § 3832 REHABILITATION

3832.1 Each resident's rehabilitative services shall be provided in accordance with a written ITP and shall be developed with the goal of assisting the resident to achieve and maintain the highest level of self-care, self-esteem, and independence.

3832.2 Each MHCRF shall, consistent with the proper care of each resident, maintain as culturally normal routines and procedures as possible, providing for sleeping periods, meal times, social and recreational activities, responsibilities, and resident autonomy similar to the living patterns of independent persons in the community.

3832.3 A Residence Director shall assist each resident, as he or she may require, in obtaining rehabilitative services from qualified professionals, including physical, occupational, speech, and hearing therapists.

3832.4 Each MHCRF shall grant access to and cooperate with any licensed therapist who is hired to provide services to a resident.

3832.5 Each MHCRF shall encourage each resident to engage in daytime activities, such as, but not limited to, education, socialization, psychosocial day programs and employment.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 599 (January 27, 1995).

22-B DCMR § 3833 SERVICE COORDINATION, CASE MANAGEMENT AND SUPPORT SERVICES

3833.1 Each Residence Director shall assist each resident who is eligible for CMHS services with obtaining case management and support services and shall document such assistance in the resident's files.

3833.2 Each Residence Director and staff of the MHCRF shall work with the CMHS designated case manager to ensure that the resident's needs are met. CMHS designated case managers shall respond promptly to requests for assistance from operators, staff and residents.

3833.3 Any case management services shall be provided by a qualified and trained individual who shall be familiar with the needs of the resident and the services available.

3833.4 Each Residence Director, and any other individual involved in the resident's treatment and support shall maintain contact with the CMHS designated case manager to determine that the resident's needs are being met and to assist the resident as necessary, and shall be available to the resident and CMHS designated case manager to assist when issues involving the resident arise.

3833.5 Each MHCRF, in conjunction with the CMHS designated case manager, shall monitor each resident's progress, status and the continued appropriateness of the services provided in the MHCRF on a regular basis.

3833.6 Each MHCRF, in conjunction with the CMHS designated case manager, shall assure the resident in obtaining financial or other services such as mental health services, social services, health care services, recreation, and leisure activities are provided to each resident.

3833.7 Each MHCRF, in conjunction with the CMHS designated case manager, shall assist the resident in obtaining financial or other available assistance from public and private agencies.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 599 (January 27, 1995).

22-B DCMR § 3834 RESIDENT ACTIVITIES

3834.1 Each MHCRF shall provide or arrange for suitable activities sufficient to stimulate and promote the well-being of each resident, to encourage independence and maintenance of normal activities and to maintain and promote an optimal level of functioning.

3834.2 Each MHCRF shall have available and accessible to residents books, periodicals, games, current newspapers, radio and a television. The MHCRF, if possible, shall have activities that reflect the residents' interests.

3834.3 To the maximum extent possible, each MHCRF shall use the services of public and voluntary resources in promoting resident participation in activities.

3834.4 Each MHCRF shall provide or arrange for educational and skill building activities, either in or outside the facility, which promote the development of independent living skills for each resident such as, but not limited to, the following areas:

(a) Shopping, food storage, menu planning, and cooking;

(b) Housekeeping chores that promote skills in maintaining a safe, clean and orderly living environment;

(d) Money management; and

(e) Use of recreational time.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 600 (January 27, 1995).

22-B DCMR § 3835 SUPPORTED RESIDENCE

3835.1 A Supported Residence shall be a homelike setting where residential care is provided for eight (8) or fewer individuals who require twenty-four hour (24 hr.) staff supervision and assistance.

3835.2 The maximum number of residents that shall be located in a Supported Residence is eight (8), excluding the adult supervisor, unless this requirement is waived by DCRA.

3835.3 Limited nursing care, intermittent nursing care, or both may be provided in a supported residence.

3835.4 In a Supported Residence staff shall be on-site and responsible for providing assistance with the tasks of daily living, supervision, meals, and lodging to the residents, and for ensuring the overall health, safety and welfare of the residents.

3835.5 Each Supported Residence shall maintain at least one (1) staff person at the residence, whenever a resident is present and a 1:8 staff-to-resident ratio during times of peak activity, such as mealtimes.

3835.6 MHCRF's established prior to December 1, 1991, and that are licensed as CRFs under 22 DCMR, chapter 38, and housing residents with a principal diagnosis of mental illness, may be certified as a Supported Residence, if the facility meets the staffing standard in §3835.5.

3835.7 Each Supported Residence shall have a Residence Director who shall provide or arrange for supervision and coordinate services to ensure that each resident's health, safety, and welfare are protected.

3835.8 Each person seeking residential placement in a Supported Residence shall have a principal diagnosis of mental illness and be in need of twenty-four hour (24 hr.) staff supervision to assist with activities of daily living, meals, lodging, and recreation. Residents may remain in the residence, work or participate in a structured day program, or other daily activity. Attendance at a day program shall not be mandatory for persons seeking placement in a Supported Residence.

3835.9 The resident's treatment team shall determine whether a person is appropriately placed in a Supportive Residence.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 600 (January 27, 1995).

22-B DCMR § 3836 SUPPORTED REHABILITATIVE RESIDENCE

3836.1 A Supported Rehabilitative Residence shall be a homelike setting where residential and rehabilitative services are provided in an apartment or house for eight (8) or fewer residents who require twenty-four hour (24 hr.) staff supervision and on-site rehabilitation.

3836.2 The maximum number of residents in one site shall be eight (8), excluding staff, unless this requirement is waived by DCRA.

3836.3 Specialized services, such as limited and intermittent nursing care or physical therapy, shall be provided if necessary on a scheduled basis as established in the resident's ITP, by properly licensed staff. Intermittent nursing care may be provided by residence staff or home health aides if required.

3836.4 Each Supported Rehabilitative Residence shall maintain a staff to resident ratio of 1:8, twenty-four hours (24 hr.) per day whenever a resident is present and 2:8 during periods of peak activity, such as meals and when most residents are home and awake.

3836.5 Staff shall be responsible for providing assistance with activities of daily living, personal supervision, meals, lodging and rehabilitative and specialized services.

3836.6 Staff shall provide a consistent and therapeutic environment, where through daily contact and interaction, the resident's needs and progress are assessed.

3836.7 Rehabilitation in a MHCRF shall be coordinated under the direction of the resident's CMHS designated treatment team and such care will be provided in or out of the residence by direct care staff with the assistance of the facility operator or an identified adult from the home.

3836.8 The Supported Rehabilitative Residence shall be appropriate for adults with a principal diagnosis of mental illness requiring twenty-four hour (24 hr.) supervision, rehabilitation, and assistance and supervision in self-care activities. Attendance at a day program shall not be mandatory for residents in a Supported Rehabilitative Residences.

3836.9 Each Supported Rehabilitative Residence shall have a Residence Director who shall provide or arrange for supervision and coordination of services to ensure that each resident's health, safety, and welfare are protected.

3836.10 The resident's treatment team shall determine whether a person is appropriately placed in a Supportive Rehabilitative Residence.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 601 (January 27, 1995).

22-B DCMR § 3837 INTENSIVE RESIDENCE

3837.1 An Intensive Residence shall be a supportive program that provides twenty-four hour (24 hr.) supervision. The maximum number of residents that shall be served in a facility is eight (8), excluding staff, unless this requirement is waived by the DCRA.

3837.2 Specialized programming shall be provided in an Intensive Residence and may include medical, psychiatric, nursing, behavioral, vocational, social or recreational services.

3837.3 Limited nursing care, intermittent nursing care, or both may be provided in an intensive residence.

3837.4 An Intensive Residence shall have a staff-to-resident ratio of 2:8, for sixteen hours (16 hrs.) a day during awake hours, whenever a resident is present. Additional staff shall be available during times of high activity, and the residence shall have the capacity to provide 1:1 staffing when necessary as determined by the resident's treatment plan.

3837.5 Staffing specialists shall be provided in accordance with special program needs of clients including geriatric, dual diagnosis, behavioral or physical care.

3837.6 An Intensive Residence is appropriate for adults with a principal diagnosis of mental illness who have special needs and require twenty-four hour (16 hr.) staff supervision or the intensity of psychiatric symptoms requires the capacity for periodic one-to-one support. Attendance at a day program shall not be mandatory for applicants in an Intensive Residence.

3837.7 Each Intensive Residence shall have a Residence Director who shall provide or arrange for supervision and coordination of services to ensure that each resident's health, safety, and welfare are protected.

3837.8 The Residence Director or staff member shall be present whenever residents are at the residence. In addition, the Residence Director or designee shall arrange for clinical back-up services. The mental health professional designated to provide back-up services shall:

(a) Be available by telephone at all times;

(b) Be able to reach the residence within thirty (30) minutes in case of an emergency; and

3837.9 Each Residence Director of an Intensive Residence shall meet the requirements of §3818 of this chapter and shall have at least two (2) additional years experience working with persons with a principal diagnosis of mental illness.

3837.10 The resident's treatment team shall determine whether a person is appropriately placed in an Intensive Residence.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 602 (January 27, 1995).

22-B DCMR § 3838 TRANSITIONAL RESIDENTIAL BEDS

3838.1 A Transitional Residential bed shall be a service specifically provided for persons with a principal diagnosis of mental illness and who are homeless. Transitional Residential beds may be located in facilities such as a Supported Residence, Supported Rehabilitation Residence, Intensive Residence crisis-bed program, or staffed apartment.

3838.2 The length of stay in a Transitional Residential bed shall be contingent upon the person’s ability to accept a permanent living arrangement.

3838.3 Not more than ten (10) beds shall be located in one (1) facility, unless specifically exempted by the DCRA.

3838.4 A Transitional Residential bed may provide services to persons with dual diagnoses of mental illness and substance abuse and who may need extensive medical and psychiatric evaluation or require intermittent or limited nursing care. Attendance at a day program shall not be mandatory for transitional residence applicants.

3838.5 A 1:10 staff to resident ratio shall be maintained twenty-four hours (24 hrs.) per day whenever residents are present.

3838.6 Each Transitional Residence shall have a Residence Director who shall provide or arrange for supervision and coordinate services to ensure that each resident's health, safety, and welfare are protected. The Residence Director or a staff member shall be present whenever clients are at home. In addition, the Residence Director or designee shall arrange for clinical back-up services. The mental health professional designated to provide back-up services shall:

(a) Be available by telephone at all times;

(b) Be able to reach the residence within thirty (30) minutes in case of an emergency; and

3838.7 Each Residence Director of a Transitional Residence and back up personnel shall meet the requirements of §3818 and have at least one (1) year additional experience in working with homeless persons.

3838.8 It shall be the responsibility of the resident's treatment team to determine if a person is appropriately placed in a Transitional Residence as defined by the Director, DHS or CMHS designee.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 603 (January 27, 1995).

22-B DCMR § 3899 DEFINITIONS

3899.1 For purposes of this chapter, the following terms shall have the meanings described:

Activities of daily living -

(a) Ambulating and transferring;

(b) Bathing, dressing, and grooming;

(d) Eating.

Active substance abuse - the overuse of alcohol or prescriptive drugs or the use of nonprescriptive drugs over a six (6) month period that interferes with a person’s capacity to carry out activities of daily living or participate in mental health treatment and support services.

Ambulatory - the ability to move from one place to another without mechanical or personal assistance.

Case management - the coordination of services for residents in accordance with the Individual Treatment Plan to ensure that planned treatment and residential and supportive services necessary to community adjustment and continuity of care are provided for each resident.

CMHS - Commission on Mental Health Services

CMHS designated case manager - the individual designated as the resident's case manager by the Commission on Mental Health Services. The case manager may be either CMHS staff or a staff person of a contractor of the District of Columbia.

Consulting physician - a licensed physician who is available to the facility to provide medical consultation related to resident care policies and procedures and who provides medical care in the facility in emergencies or the absence of the resident's private physician.

Contract agency - any private, non-profit or for-profit entity/individual that provides a service under contract with the District of Columbia.

Crisis stabilization bed - a bed provided in a residential setting that offers substantial quantities of psychological assistance to individuals in psychiatric crisis, until the immediate emotional crisis passes and an acceptable level of stability is regained, usually within thirty (30) days.

Dentist - an individual who is currently licensed to practice dentistry in the District of Columbia.

DCRA - Department of Consumer and Regulatory Affairs.

DHS - Department of Human Services.

DHS Director’s designee - a person designated by the Director, DHS to act on behalf of the Director, DHS.

Diagnosed psychiatric disorder - a psychiatric diagnosis by a licensed psychiatrist or licensed psychologist, according to the criteria enumerated in the DSM-III-R or IV Manual, including any mental illness as defined in D.C. Code, 2001 Ed. § 21-501.

Dietician - an individual who meets the qualifications and standards for membership in the American Dietetic Association, and who applies the principles of nutrition and management to menu planning, food preparation and service.

Food service personnel or employees - persons who prepare or serve food or who are involved in the use or maintenance of kitchen equipment, or sanitation and housekeeping functions associated with the preparation and service of food.

Full time - the number of days per week and hours per day that constitute the regularly scheduled week.

Habitable room - undivided, enclosed space with natural light and ventilation, including rooms for living, eating and sleeping, that comply with applicable District of Columbia building codes, rules and regulations.

Home health care - nursing and specialized rehabilitative services such as speech, physical and occupational therapy, home health aide support, and social work services.

Home-like environment - an environment in which the amenities and living areas are suitable for long-term residence by individuals and are similar to those found in typical private residences or apartments.

Independence - the quality of being self-reliant and free from the control of others.

Independent living - living alone, with friends or relatives in private homes, apartments or rooming houses.

Individual Treatment Plan (ITP) - a written plan for a resident’s continued treatment and care that includes goals, objectives and interventions developed by a mufti disciplinary treatment team in consultation with the client.

Intermittent nursing care - simple nursing care tasks provided on a periodic basis in a residence home under the supervision of a registered nurse, including blood pressure monitoring and dressing changes.

Legal representative - any person or entity authorized by law to act on behalf of another as a fiduciary or in a representative capacity.

Licensed Practical Nurse (LPN) - a person who is currently licensed to practice as an LPN in the District of Columbia.

Licensee - a person or entity to whom a license to operate a mental health community residence facility is issued, and who is legally responsible for the operation of the facility.

Limited nursing care - simple nursing tasks provided in the home under the supervision of a registered nurse on a regular basis, including insulin injections or blood pressure monitoring.

Long-Term Care Ombudsman - the person designated under 42 U.S.C. § 3027(a)(12) and referenced in § 101(7) of the Nursing Home and Community Residence Facility Residents Protection Act of 1985, effective March 16, 1989 (D.C. Code, 2001 Ed. § 44-1001.01(7)) to perform the functions of the Long Term Care Ombudsman in the District of Columbia.

Medication supervision - direct oversight by staff of a resident who administers her or his own medication.

Mental health professionals - persons who are specifically trained and, if required, licensed to provide services to mentally ill persons.

MHCRF - Mental Health Community Residence Facility.

Non-ambulatory - the inability to walk without personal or mechanical assistance.

Occupational therapist - a person who is licensed as an occupational therapist in the District of Columbia.

Owner - any person who, individually or with others, has legal title to any building or premises that is arranged, designed or used, in whole or in part, to house one (1) or more persons with mental illness.

Permissible occupancy - the maximum number of residents for which a facility is licensed to provide care.

Person - an individual, partnership, corporation, association, executor, administrator, guardian, trustee, or agency.

Personal assistance - help with grooming, bathing, eating, walking, toileting, personal money management, budgeting, making appointments, arranging transportation and other activities associated with daily living, Personal assistance may involve supervision, prompting, oversight, or hands-on care.

Personal care attendant - a person who is trained and certified to provide hands-on assistance to an individual who needs or desires personal assistance.

Pharmacist - a person who is currently licensed to practice pharmacy in the District of Columbia.

Physical therapist - a person currently licensed to practice physical therapy in the District of Columbia.

Principal diagnosis of mental illness - the condition chiefly responsible for the evaluation or admission to clinical care and the main focus of attention or treatment. The principal diagnosis of mental illness shall be made by a licensed professional who is authorized by law to evaluate or admit to clinical care.

Professional nursing services - services that pertain to the curative, restorative, and preventive aspects of nursing care that are performed or supervised by a licensed registered nurse or licensed practical nurse under the direction of a physician.

Program statement - a written, accurate statement or description of a community residence facility’s program and facilities.

Provider - a person or agency that provides mental health and support services to a resident, including but not limited to the CMHS Mental Health Services; Community Mental Health Centers; the Emergency Psychiatric Response Division; agencies that contract with the District of Columbia to provide mental health, medical and other services; hospitals; private clinics; and Medicaid providers.

Registered Nurse (RN) - a person who is currently licensed to practice as a registered nurse in the District of Columbia.

Rehabilitation services - services that are appropriate for a resident who has some continued need on a one-on-one basis for additional teaching, assistance or support in the performance of activities of daily living and social competency within the resident’s community residence facility which may be an adjunct to such a day activity program.

Representative - “Resident representative” as defined in § 101(11) of the Nursing Home and Community Residence Facility Residents Protection Act of 1985, effective March 16, 1989 (D.C. Code, 2001 Ed. § 44-1001.01(11)).

Residence director - the person responsible for supervising the day to day operation of the community residence facility.

Resident - an individual other than community residence facility personnel or the Residence Director who resides in a facility.

Restraints -

(a) Physical - a physical or mechanical device, material, or equipment attached or adjacent to a resident’s body that restricts freedom of movement or normal access to a person’s body and cannot be removed easily, including leg restraints, arm restraints, hand mitts, soft ties or vests, wheelchair safety bars, and geriatric chairs.

(b) Chemical - medication administered by MHCRF staff, at their discretion, to control behavioral outbursts, for discipline, or for the convenience of the staff, but does not include medication prescribed by a physician to treat symptoms or behaviors related to the resident’s mental illness when used in the manner prescribed.

Self-medication - the taking of medication by a resident without direct assistance and with minimal supervision.

Social worker - a person currently licensed to practice social work in the District of Columbia.

Supervision - direct or indirect oversight and responsibility for an act, function, or activity.

Supported independent living - means living alone, with friends or with a group of compatible persons in an apartment or house, with assistance and training in daily-living activities, home management and community skills. The assistance maybe provided in or outside the residence, on a scheduled basis as frequently as determined by the resident’s Individualized Treatment Plan, but less than twenty-four (24) hours by persons who do not live in the residence.

Supportive services - assistance to residents in maintaining adequate personal hygiene, nutrition, social, community and family activities; supervision of the taking of prescribed medications; and assistance to residents in obtaining adequate medical, social, and health services.

Therapeutic diet - a regimen prescribed by a physician for the treatment of a resident with a specific illness through modification or control of calories, increase or decrease of nutrients, changes in texture of food, or restriction of specific ingredients.

Unusual incident - any significant occurrence or extraordinary event that is different from regular routine activities or that varies from established procedures.

Volunteer - a person who donates his or her services to a specific MHCRF by his or her free choice and without payment for the services rendered.

History

SOURCE: Final Rulemaking published at 42 DCR 569, 605 (January 27, 1995).

22-B39 HOME CARE AGENCIES

22-B DCMR § 3900 GENERAL PROVISIONS

3900.1 These rules are implemented pursuant to and in accordance with the Health Care and Community Residence Facility, Hospice and Home Care Licensure Act of 1983 (hereinafter "the Act"), effective February 24, 1984, D.C. Law 5-48, D.C. Official Code §§ 44-501(b) and 44-504(a).

3900.2 Each home care agency serving one or more patients in the District of Columbia shall be licensed, and shall comply with the requirements set forth in this Chapter and with those set forth in Chapter 31 of Title 22 of the District of Columbia Municipal Regulations (DCMR), which contains provisions on inspections, licensing and enforcement actions pertaining to home care agencies and other facilities authorized under the Act. Each home care agency serving one or more patients in the District of Columbia under the auspices of the Medicare Program or the D.C. Medicaid Program shall also comply with all applicable requirements and conditions of participation of that program.

3900.3 Each home care agency serving one or more patients in the District of Columbia and having an office within the District of Columbia on the effective date of this Chapter shall apply for licensure no later than one hundred eighty (180) days after the effective date of this Chapter. Each home care agency serving one or more patients in the District of Columbia but not having an office within the District of Columbia on the effective date of this Chapter shall apply for licensure no later than one (1) year after the effective date of this Chapter.

3900.4 A licensed home care agency shall provide at least one of the following services:

(a) Skilled nursing;

(b) Physical therapy;

(d) Speech language pathology;

(e) Intravenous therapy;

(f) Medical social services; or

(g) Home health aide or personal care aide services.

3900.5 Each home care agency serving one or more patients in the District of Columbia shall maintain an operating office within the District of Columbia. This office shall be staffed, at a minimum, eight hours per day, Monday through Friday.

3900.6 The operating office located within the District of Columbia shall contain, at a minimum, the patient records for all patients served within the District of Columbia and the agency's policies and procedures developed pursuant to this Chapter. All records and documents required under this Chapter and other applicable laws and regulations which are not maintained within this operating office shall be produced for inspection within twenty-four (24) hours, or within a shorter reasonable time if specified, upon the request of the Department of Health.

3900.7 Each home care agency shall post its license in a conspicuous place within the District of Columbia operating office.

3900.8 Each home care agency shall comply with these regulations and with all other applicable federal and District laws and rules

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B DCMR § 3901 INSURANCE

3901.1 Each home care agency shall maintain the following minimum amounts of insurance coverage:

(a) Blanket malpractice insurance for all professional employees in the amount of at least one million dollars ($1,000,000) per incident.

(b) General liability insurance covering personal property damages, bodily injury, libel and slander in the amount of at least one million dollars ($1,000,000) per occurrence.

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B DCMR § 3902 LICENSE FEES

3902.1 License fees for home care agencies shall be based upon an annual census of admissions of patients served in the District of Columbia. The fees shall be as follows:

(a)

Initial Application

$ 600

(b)

1 - 150 Patients

Annual Fee

$ 400

Late Fee

$ 100

(c)

151 - 750 Patients

Annual Fee

$ 700

Late Fee

$ 100

(d)

751 - 1250 Patients

Annual Fee

$ 1100

Late Fee

$ 100

(e)

1251 or More Patients

Annual Fee

$1300

Late Fee

$ 100

(f)

Duplicate of License

$ 50

(g)

Certification of Validity of

License

$ 50

3902.2 Time periods for the submission of applications and fee payments shall be in accordance with Chapter 31 of Title 22 of the District of Columbia Municipal Regulations.

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B DCMR § 3903 GOVERNING BODY

3903.1 Each home care agency shall have a governing body that shall be responsible for the operation of the home care agency.

3903.2 The governing body shall do the following:

(a) Establish and adopt by-laws and policies governing the operation of the home care agency;

(b) Designate a home care Director who is qualified in accordance with section 3904 of this Chapter; and

(c) Review and evaluate, on an annual basis, all policies governing the operation of the agency to determine the extent to which services promote patient care that is appropriate, adequate, effective and efficient. This review and evaluation must include the following:

(1) The evaluation shall include feedback from a representative sample consisting of either ten percent (10%) of total District of Columbia patients or forty (40) District of Columbia patients, whichever is less, regarding services provided to those patients.

(2) The evaluation shall include a review of all complaints made or referred to the agency, including the nature of each complaint and the agency's response thereto.

(3) A written report of the results of the evaluation shall be prepared and shall include recommendations for modifications of the agency's overall policies or practices, if appropriate.

(4) The evaluation report shall be presented to, and acted upon, by the governing body at least annually. The results of the action taken by the governing body shall be documented, maintained, and available for review by government officials.

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B DCMR § 3904 DIRECTOR

3904.1 The governing body shall appoint a Director who shall be responsible for managing and directing the agency's operations, serving as liaison between the governing body and staff, employing qualified personnel, and ensuring that staff members are adequately and appropriately trained.

3904.2 The Director shall be a person who:

(a) Is a licensed physician;

(b) Is a licensed registered nurse; or

(c) Has training and experience in health services administration, including at least one (1) year of supervisory or administrative experience in home health care or related health programs.

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B DCMR § 3905 POLICIES AND PROCEDURES

3905.1 Each home care agency shall have written operational policies and procedures that address the day-to-day operations of the agency. These policies and procedures shall be approved by the governing body and shall be available for review by appropriate government officials.

3905.2 Written policies and procedures shall be developed for, at a minimum, the following:

(a) Contractor agreements;

(b) Personnel;

(d) Discharges and referrals;

(e) Records retention and disposal;

(e) Patient rights and responsibilities;

(f) Complaint process;

(g) The provision of each service offered;

(h) Infection control; and

(i) Unusual incidents.

3905.3 Written policies and procedures should be readily available for use by staff at all times.

3905.4 Written policies and procedures shall be available to patients, prospective patients, and their designated representatives, upon request.

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B DCMR § 3906 CONTRACTOR AGREEMENTS

3906.1 If a home care agency offers a service that is provided by a third party or contractor, agreements between the home care agency and the contractor for the provision of home care services shall be in writing and shall include, at a minimum, the following:

(a) A description of the services to be provided;

(b) The location where services are to be provided;

(d) The procedure for submitting clinical and progress notes, periodic patient evaluation, scheduling of visits, and other designated reports;

(e) The procedure for payment for services and payment terms for services furnished;

(f) The procedures used for managing and monitoring the work of personnel employed on a contractual basis;

(g) The duration of the agreement, including provisions for renewal, if applicable; and

(h) Assurance that the contractor will comply with:

(1) All applicable agency policies, including the assurance that contract personnel meet the qualifications and fulfill the responsibilities of agency employees as set out in these rules;

(2) Insurance and bonding requirements as set out in section 3901 of these regulations; and

(3) All applicable federal and District laws and regulations.

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B DCMR § 3907 PERSONNEL

3907.1 Each home care agency shall have written personnel policies that shall be available to each staff member and shall include the following:

(a) The terms and conditions of employment, including but not limited to wage scales, hours of work, personal and medical leave, insurance, and benefits;

(b) Provisions for an annual evaluation of each employee's performance by appropriate supervisors;

(c) Provisions pertaining to probationary periods, promotions, disciplinary actions, termination and grievance procedures;

(d) A position description for each category of employee; and

(e) Provisions for orientation, periodic training or continuing education, and periodic competency evaluation.

3907.2 Each home care agency shall maintain accurate personnel records, which shall include the following information:

(a) Name, address and social security number of each employee;

(b) Current professional license or registration number, if any;

(c) Resume of education, training certificates, skills checklist, and prior employment, and evidence of attendance at orientation and in-service training, workshops or seminars;

(d) Documentation of current CPR certification, if required;

(e) Health certification as required by section 3907.6;

(f) Verification of previous employment;

(g) Documentation of reference checks;

(h) Copies of completed annual evaluations;

(i) Documentation of any required criminal background check;

(j) Documentation of all personnel actions;

(k) A position description;

(l) Results of any competency testing;

(m) Documentation of acceptance or declination of the Hepatitis Vaccine; and

(n) Documentation of liability insurance, if applicable.

3907.3 Each home care agency shall comply with the Health-Care Facility Unlicensed Personnel Criminal Background Check Act of 1998, effective April 20, 1999, D.C. Law 12-238, and subsequent amendments thereto, D.C. Official Code § 44-551 et seq.

3907.4 Each home care agency shall maintain its personnel records for all personnel serving patients within the District of Columbia in its operating office within the District of Columbia, or shall produce these records for inspection within twenty- four (24) hours, or within a shorter reasonable time if specified, upon the request of the Department of Health.

3907.5 Each employee shall have a right to review his or her personnel records.

3907.6 At the time of initial employment of each employee, the home care agency shall verify that the employee, within the six months immediately preceding the date of hire, has been screened for and is free of communicable disease.

3907.7 Each employee shall be screened for communicable disease annually, according to the guidelines issued by the federal Centers for Disease Control, and shall be certified free of communicable disease.

3907.8 No employee may provide home care services, and no agency may knowingly permit an employee to provide home care services, if the employee:

(a) Is under the influence of alcohol, any mind-altering drug or combination thereof; or

(b) Has a communicable disease which poses a confirmed health risk to patients.

3907.9 Each employee who is required to be licensed, certified or registered to provide services shall be licensed, certified or registered under the laws and rules of the District of Columbia.

3907.10 Each home care agency shall document the professional qualifications of each employee or provider to ensure that the applicable licenses, certifications, accreditations or registrations are valid.

3907.11 Each home care agency shall ensure that each employee or contract worker shall present a valid agency identification prior to entering the home of a patient.

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B DCMR § 3908 ADMISSIONS

3908.1 Each home care agency shall have written policies on admissions, which shall include, at a minimum, the following:

(a) Admission criteria and procedures;

(b) A description of the services provided;

(d) Policies governing fees, payments and refunds;

(e) Advance directives;

(f) Do Not Resuscitate orders;

(g) Consent for services; and

(h) Consent for interagency sharing of information.

3908.2 A written summary of the agency's admissions policies, including all of the items specified at subsection 3908.1, shall be made available to each prospective patient upon request, and shall be given to each patient upon admission.

3908.3 The agency shall evaluate each request for home care services according to the following criteria:

(a) The ability of the program to provide or coordinate the services that the patient needs;

(b) The patient's general health and the patient's psychosocial condition or functioning status pertinent to the services being requested, as determined in consultation with the patient's physician;

(d) The ability of the patient to participate in his or her own care, or the availability of an individual willing to assume the appropriate level of responsibility when the patient is unable to do so.

3908.4 The home care agency shall notify each entity referring a potential patient to the agency, and each individual requesting services from the agency, of the availability or unavailability of service, and the reason(s) therefor, within 48 hours after the referral or request for services.

3908.5 A home care agency shall maintain records on each person requesting services whose request is not accepted. The records shall be maintained for at least one year from the date of non-acceptance and shall include the nature of the request for services and the reason for not accepting the patient.

3908.6 Each home care agency shall conduct an initial assessment, including a home visit, based on information provided by the prospective patient or the patient's representative and on other pertinent data.

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B DCMR § 3909 DISCHARGES, TRANSFERS AND REFERRALS

3909.1 Each home care agency shall have written policies that describe transfer, discharge, and referral criteria and procedures.

3909.2 Each patient shall receive written notice of discharge or referral no less than seven (7) calendar days prior to the action. The seven (7) day written notice shall not be required, and oral notice may be given at any time, if the transfer, referral or discharge is the result of:

(a) A medical or social emergency;

(b) A physician's order to admit the patient to an in-patient facility;

(c) A determination by the home care agency that the referral or discharge is necessary to protect the health, safety or welfare of agency staff;

(d) A determination, made or concurred in by a physician, that the condition that necessitated the provision of services no longer exists; or

(e) The refusal of further services by the patient or the patient's representative.

3909.3 Each home care agency shall document activities related to discharge planning for each patient in the patient's record.

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B DCMR § 3910 RECORDS RETENTION AND DISPOSAL

3910.1 Each home care agency shall maintain a clinical record system that shall include the following:

(a) Written policies that provide for the protection, confidentiality, retention, storage, and maintenance of clinical records; and

(b) Written procedures that address the transfer or disposition of clinical records in the event of dissolution of the home care agency.

3910.2 If an agency is dissolved and there is no identified new owner, the clinical records shall be stored in a public warehouse within one hundred (100) miles of the District of Columbia or, with the approval of the patient, in the offices of the patient's physician.

3910.3 Each home care agency shall inform the Department of Health and each patient in writing, within thirty (30) days of dissolution of the agency, of the location of the clinical records and how each patient may obtain his or her clinical records.

3910.4 A home care agency shall maintain the clinical records of a patient for at least five (5) years after the date of discharge of the patient.

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B DCMR § 3911 CLINICAL RECORDS

3911.1 Each home care agency shall establish and maintain a complete, accurate, and permanent clinical record of the services provided to each patient in accordance with this section and accepted professional standards and practices.

3911.2 Each clinical record shall include the following information related to the patient:

(a) Admission data, including name, address, date of application, date of birth, sex, agency case number, next of kin or responsible party, date accepted by the agency to receive services, and source of payment, if applicable;

(b) Source of referral, including date of discharge if from a hospital or extended care facility;

(d) Plan of care for each service provided;

(e) Physician's orders;

(f) History of sensitivities and allergies;

(g) Medication sheet;

(h) Clinical, progress, and summary notes, and activity records, signed and dated as appropriate by professional and direct care staff;

(i) Documentation of supervision of home care services;

(j) Documentation of discharge planning, if appropriate;

(k) Discharge summary, including the reason for termination of services and the effective date of discharge;

(l) Documentation of coordination of services, if applicable;

(m) Type and frequency of diagnostic services;

(n) Type of medical equipment used by the patient;

(o) Dates and times of collection of specimens;

(p) Results of diagnostic services and dates of reporting;

(q) Communications between the agency and all health care professionals involved in the patient's care;

(r) Documentation of consent for specialized services; and

(s) Documentation of training and education given to the patient and the patient's caregivers.

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B DCMR § 3912 PATIENT RIGHTS AND RESPONSIBILITIES

3912.1 Each home care agency shall develop a written statement of patient rights and responsibilities that shall be given, upon admission, to each patient who receives home care services.

3912.2 Each home care agency shall develop policies to ensure that each patient who receives home care services has the following rights:

(a) To be treated with courtesy, dignity, and respect;

(b) To control his or her own household and life style;

(1) Services to be provided by the agency, including any limits on service availability;

(2) Whether services are covered by health insurance, Medicaid, Medicare, or any other sources, and the extent of uncovered expenses for which the patient may be liable;

(3) The amount charged for each service, and procedures for billing;

(4) Prompt notification of acceptance, denial or reduction of services;

(5) Complaint and referral procedures;

(6) The name, business address, and telephone number of the agency supervising the patient's care; and

(7) The telephone number of the Home Health Hotline maintained by the Department of Health;

(d) To receive treatment, care and services consistent with the agency/patient agreement and with the patient's plan of care;

(e) To participate in the planning and implementation of his or her home care services;

(f) To receive services by competent personnel who can communicate with the patient;

(g) To be informed of his or her condition by the health care provider in accordance with generally accepted professional standards;

(h) To refuse all or part of any treatment, care, or service, and to be informed of the consequences of refusal;

(i) To be free from mental and physical abuse, neglect, and exploitation by agency employees or contract personnel;

(j) To be assured confidential handling of clinical records as provided by law;

(k) To be educated about and trained in matters related to the services to be provided;

(l) To voice a complaint or other feedback in confidence and without fear of reprisal from the agency or any agency personnel, in writing or orally, including an in-person conference if desired, and to receive a timely response to a complaint as provided in these rules; and

(m) To have access to his or her own clinical records.

3912.3 Each home care agency shall inform all patients that they have the right to make complaints and/or to provide feedback concerning the services rendered by the agency to the Department of Health, in confidence and without fear of reprisal from the agency or any agency personnel, in writing or orally, including an inperson conference if desired.

3912.4 Each home care agency shall develop a statement of patient responsibilities regarding the following:

(a) Treating agency personnel with respect and dignity;

(b) Providing accurate information when requested;

(d) Cooperating in making a safe environment for care within the home.

3912.5 Written policies on patient rights and responsibilities shall be made available to the general public.

3912.6 The home care agency shall take appropriate steps to ensure that all information is conveyed, pursuant to these rules, to any patient who cannot read or who otherwise needs accommodations in an alternative language or communication method. The home care agency shall document in the patient's records the steps taken to ensure that the patient has been provided with all required information.

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B DCMR § 3913 COMPLAINT PROCESS

3913.1 Each home care agency shall develop and implement policies and procedures for an internal complaint process that shall allow the patient or his or her representative to present a complaint to agency staff, contract personnel, or the home care Director.

3913.2 A written summary of the complaint process shall be disseminated as follows:

(a) Given to the patient or his or her representative upon acceptance or denial of services; and

(b) Given to all patients receiving service from a home care agency on the effective date of these rules.

3913.3 The telephone number of the Home Health Hotline maintained by the Department of Health shall be posted in the home care agency's operating office in a place where it is visible to all staff and visitors.

3913.4 A complaint may be presented orally or in writing.

3913.5 The home care agency shall respond to the complaint within fourteen (14) calendar days of its receipt, and shall document the response.

3913.6 If the patient indicates that he or she is not satisfied with the response, the agency shall respond in writing within thirty (30) calendar days from the date of the agency's initial response. The response shall include the telephone number and address of all District government agencies with which a complaint may be filed and the telephone number of the Home Health Hotline maintained by the Department of Health.

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B DCMR § 3914 PATIENT PLAN OF CARE

3914.1 Each home care agency shall develop, with the participation of each patient or his or her representative, a written plan of care for that patient.

3914.2 The plan of care shall be approved by the patient's physician.

3914.3 The plan of care shall include the following:

(a) Physician orders for skilled services;

(b) Advanced practice registered nurse orders, when appropriate and permissible according to applicable law;

(c) The goals of the services to be provided, including the expected outcome, based upon the immediate and long-term needs of the patient;

(d) A description of the services to be provided, including: the frequency, amount, and expected duration; dietary requirements; medication administration, including dosage; equipment; and supplies;

(e) Identification of agency personnel who are responsible for the provision of each service, including, if applicable, contract providers by job title or discipline;

(f) Provisions relating to the reevaluation of services, discharge planning, referral of services and continuation or renewal of services;

(g) Physical assessment, including all pertinent diagnoses;

(h) Prognosis, including rehabilitation potential;

(i) Activities permitted or precluded because of functional limitations;

(j) Psychosocial needs of the patient;

(k) Safety measures required to protect the patient from injury;

(l) Identification of employees in charge of managing emergency situations;

(m) Emergency protocols; and

(n) Types and frequency of laboratory tests ordered, if applicable.

3914.4 Each plan of care shall be approved and signed by a physician within thirty (30) days of the start of care; provided, however, that a plan of care for personal care aide services only may be approved and signed by an advanced practice registered nurse. If a plan of care is initiated or revised by a telephone order, the telephone order shall be immediately reduced to writing, and it shall be signed by the physician within thirty (30) days.

3914.5 Each home care agency that provides more than one skilled service shall record, in the plan of care, evidence of coordination of care, and specific information related to the provision of each skilled service as set out in subsequent relevant sections of these regulations.

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B DCMR § 3915 HOME HEALTH AND PERSONAL CARE AIDE SERVICES

3915.1 A home care agency may offer home health or personal care aide services and shall employ or contract with qualified home health or personal care aides to perform those services.

3915.2 A home health aide or personal care aide shall be qualified by completing seventy-five (75) hours of classroom and supervised practical training, with at least sixteen (16) hours devoted to supervised practical training, and by passing a competency evaluation.

3915.3 Sixteen (16) hours of classroom training must be completed before an individual receives supervised practical training.

3915.4 A certified nurse aide shall be qualified as a home health aide upon satisfactory completion of a supplemental training program in home health care, consisting of at least twelve (12) hours of instruction in the following:

(a) Infection control in the home;

(b) Meal preparation and special diets;

(d) Duties of a home health aide;

(e) Maintenance of a clean, safe, and healthy environment; and

(f) Documentation of patient status and care rendered.

3915.5 Training may be provided by a community college or by another training program approved by the District of Columbia, by the National Foundation for Hospice and Home care, or by another state.

3915.6 After the first year of service, each aide shall be required to obtain at least twelve (12) hours of continuing education or in-service training annually, which shall include information that will help maintain or improve his or her performance. This training shall include a component specifically related to the care of persons with disabilities.

3915.7 Each home health or personal care aide shall be supervised by a registered nurse or other health professional for performing tasks specific to that profession. On-site supervision of skilled services shall take place at least once every two (2) weeks. On-site supervision of all other services shall take place at least once every sixty-two (62) calendar days.

3915.8 Home health or personal care service activities that are performed by an aide shall be explained to the patient by the registered nurse or other health professional, as authorized by a physician and in accordance with the plan of care.

3915.9 Each home care agency shall define the duties of home health aides and personal care aides.

3915.10 Personal care aide duties may include the following:

(a) Basic personal care including bathing, grooming, and assistance with toileting or bedpan use;

(b) Changing urinary drainage bags;

(d) Assisting the patient with self-administration of medication;

(e) Reading and recording temperature, pulse, and respiration;

(f) Observing, recording, and reporting the patient's physical condition, behavior, or appearance;

(g) Meal preparation in accordance with dietary guidelines, and assistance with eating;

(h) Infection control;

(i) Tasks related to keeping the patient's living area in a condition that promotes the patient's health and comfort;

(j) Accompanying the patient to medical and medically-related appointments, to the patient's place of employment, and to approved recreational activities;

(k) Assisting the patient at his or her place of employment; and

(l) Shopping for items related to promoting the patient's nutritional status and other health needs.

3915.11 Home health aide duties may include the following:

(a) Basic personal care including bathing, grooming, and assistance with toileting or bedpan use;

(b) Changing urinary drainage bags;

(d) Assisting the patient with self-administration of medication;

(e) Reading and recording temperature, pulse, and respiration;

(f) Observing, recording, and reporting the patient's physical condition, behavior, or appearance;

(g) Meal preparation in accordance with dietary guidelines, and assistance with eating;

(h) Infection control;

(i) Tasks related to keeping the patient's living area in a condition that promotes the patient's health and comfort;

(j) Simple dressing changes that do not require the skills of a licensed nurse;

(k) Assisting the patient with activities that are directly supportive of skilled therapy services; and

(l) Routine care of prosthetic and orthotic devices.

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B DCMR § 3916 SKILLED SERVICES GENERALLY

3916.1 Each home care agency shall review and evaluate the skilled services provided to each patient at least every sixty-two (62) calendar days. A summary report of the evaluation shall be sent to the patient's physician.

3916.2 Each home care agency shall develop written policies for documenting the coordination of the provision of different services. Written policies shall include, at a minimum, the following:

(a) Ensuring that the person supervising the provision of each service delivered participates in the planning and development of the plan of care;

(b) Communicating patient needs to agency personnel and identifying other agencies that can meet patient needs;

(c) Coordinating services with other agencies actively involved in the patient's care, through written communication and/or interdisciplinary conferences, in accordance with the patient's needs; and

(d) Utilizing interagency agreements to ensure the coordination of services between agencies.

3916.3 Skilled services shall be provided in accordance with a plan of care, as outlined in section 3914.

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B DCMR § 3917 SKILLED NURSING SERVICES

3917.1 Skilled nursing services shall be provided by a registered nurse, or by a licensed practical nurse under the supervision of a registered nurse, and in accordance with the patient's plan of care.

3917.2 Duties of the nurse shall include, at a minimum, the following:

(a) Initial assessment and evaluation;

(b) Coordination of care and referrals;

(d) Implementing preventive and rehabilitative nursing procedures;

(e) For registered nurses, supervision of nursing services delivered by licensed practical nurses, including on-site supervision at least once every sixty-two (62) calendar days;

(f) Supervision of services delivered by home health and personal care aides and household support staff, as appropriate;

(g) Recording progress notes at least once every thirty (30) calendar days and summary notes at least once every sixty-two (62) calendar days;

(h) Reporting changes in the patient's condition to the patient's physician;

(i) Patient instruction, and evaluation of patient instruction; and

(j) Discharge planning.

3917.3 Except as described further in this subsection, wound care and tube feeding shall be provided only by a registered nurse or by a licensed practical nurse. Simple wound care and gastrostomy tube feeding may be provided by a home health aide or personal care aide, provided that the aide receives adequate training prior to performing the service and provided that the service is monitored continuously, with on-site supervision by a licensed nurse at least every two (2) weeks.

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B DCMR § 3918 PSYCHIATRIC NURSING SERVICES

3918.1 If psychiatric nursing services are provided, they shall be provided in accordance with the patient's plan of care.

3918.2 Psychiatric nursing services shall be provided by a registered nurse with:

(a) A master's degree in psychiatric or mental health nursing;

(b) A Bachelor of Science in Nursing (BSN) and 1 year of related work experience in an active treatment program for adult or geriatric patients in a psychiatric health care setting;

(c) A diploma or associate degree in nursing and 2 years of related work experience in an active treatment program for adult or geriatric patients in a psychiatric health care setting; or

(d) American Nurses' Association certification in psychiatric or community health nursing.

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B DCMR § 3919 MONITORING SERVICES

3919.1 If monitoring services are provided, they shall be provided in accordance with the patient's plan of care.

3919.2 Monitoring services shall be provided by the following persons:

(a) A registered nurse certified to perform cardiopulmonary resuscitation (CPR) and who has additional training and experience working with patients with disorders requiring fetal monitors, cardiac monitors, apnea monitors, or any other monitoring device or emergency intervention;

(b) A physician certified to perform cardiopulmonary resuscitation (CPR) and who has additional training or experience working with patients with disorders requiring fetal monitors, cardiac monitors, apnea monitors, or any other monitoring device or emergency intervention;

(c) A certified emergency medical technician who has additional training or experience working with patients with disorders requiring fetal monitors, cardiac monitors, apnea monitors, or any other monitoring device or emergency intervention; or

(d) In the case of respiratory monitoring only, a licensed respiratory therapist.

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B DCMR § 3920 INTRAVENOUS THERAPY SERVICES

3920.1 If intravenous therapy services are provided, they shall be provided in accordance with the patient's plan of care and administered by a registered nurse or licensed practical nurse who shall have training or experience in intravenous therapy.

3920.2 The intravenous therapy service plan shall include, at a minimum, the following:

(a) Type, amount, flow rate, duration, and mode of administration of nutritional formula or intravenous solution;

(b) Type, dosage, frequency, duration, and mode of administration of medication;

(d) Information on use of an anticoagulant in connection with intermittent intravenous therapy; and

(e) Specific laboratory test limits.

3920.3 Each clinical record shall include, at a minimum, the following information related to intravenous therapy:

(a) The intravenous therapy service plan, as ordered by the patient's physician;

(b) A copy of the consent form for intravenous therapy executed by the provider of the intravenous therapy product, or a copy of the consent form for intravenous therapy executed by the home care agency, including risks, benefits and alternatives;

(c) Documentation of training provided to the patient, patient's caregiver, or other responsible person in intravenous therapy;

(d) Information on composition, amount, rate, mode, duration, date, and time of administration of nutrition, medication, and intravenous solution;

(e) History of drug allergies and adverse reaction to medication therapy;

(f) Date and time of venous access insertion, and type and gauge of needle or catheter used;

(g) Information on change of solution, intravenous fluid administration, filter, tubing, and dressings;

(h) Observation of the patient and the access site;

(i) Laboratory monitoring;

(j) Information on all medication administered, including type, dosage, frequency, duration, route of administration, and toxic or side effects;

(k) Progress notes at least every thirty (30) calendar days; and

(l) A summary report at least every sixty-two (62) calendar days.

3920.4 The first dosage of an antibiotic or chemotherapy shall not be administered by a home care agency, unless an anaphylactic kit is immediately available for administration.

3920.5 The home care agency shall have written policies and procedures concerning intravenous therapy that address the following:

(a) Patient selection criteria;

(b) Monitoring of patients and emergency care;

(d) Preparation and storage of intravenous solutions, special nutrition formulas, and medications;

(e) Infection control;

(f) Disposal of sharps, catheters, tubing and dressings;

(g) Equipment care and maintenance;

(h) Administration guidelines, including adverse reaction protocol;

(i) Obtaining medical supplies;

(j) Blood transfusions; and

(k) Adverse reactions.

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B DCMR § 3921 NUTRITIONAL SUPPORT SERVICES

3921.1 If a home care agency provides nutritional support services, it shall provide and monitor those services in accordance with the patient's plan of care.

3921.2 Nutritional support services shall be provided by or under the supervision of a licensed health professional qualified in accordance with HORA.

3921.3 Specialized nutritional services provided in accordance with a physician's plan of care for a patient with special needs shall be provided by a qualified dietitian or nutritionist who has a minimum of one (1) year's training or experience in nutrition associated with these services.

3921.4 Each patient's clinical record shall include the following information about nutritional support services, in addition to the basic requirements, as appropriate:

(a) A signed and dated physician's plan of care which includes nutritional needs;

(b) Documentation of nutritional counseling and education of the patient to meet normal as well as therapeutic needs;

(d) A summary statement to the physician every sixty-two (62) calendar days.

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B DCMR § 3922 OCCUPATIONAL THERAPY SERVICES

3922.1 If a home care agency provides occupational therapy services, it shall provide those services in accordance with the patient's plan of care.

3922.2 Occupational therapy services shall be provided by order of a physician by a licensed occupational therapist.

3922.3 Occupational therapy shall be designed to maximize independence, prevent further disability, and maintain health.

3922.4 The occupational therapist shall conduct an initial evaluation and shall prepare clinical and progress notes.

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B DCMR § 3923 PHYSICAL THERAPY SERVICES

3923.1 If physical therapy services are provided, they shall be provided in accordance with the patient's plan of care.

3923.2 Physical therapy services shall be provided by a licensed physical therapist.

3923.3 The licensed physical therapist shall:

(a) Conduct an initial physical therapy evaluation and assessment of the patient prior to the provision of physical therapy services;

(b) Monitor and assess the extent to which services meet the therapeutic goals that are established; and

(c) Monitor and assess the degree to which therapy treats the identified physical dysfunction or the degree to which pain associated with movement is reduced.

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B DCMR § 3924 RESTRICTIONS ON SERVICE TO PATIENTS REQUIRING SPECIAL CARE

3924.1 A home care agency shall accept a ventilator-dependent patient only if:

(a) The patient is ventilator stabilized;

(b) A successful home equipment trial has been conducted; and

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B DCMR § 3925 SPEECH LANGUAGE PATHOLOGY SERVICES

3925.1 If speech language pathology services are provided, they shall be delivered in accordance with the patient's plan of care.

3925.2 Speech language pathology services shall be provided by order of a physician by a certified speech language pathologist.

3925.3 Speech language pathology services shall include, at a minimum, the following:

(a) Screening to identify individuals who require evaluation to determine the presence or absence of a communicative disorder;

(b) Evaluating and diagnosing speech and language disorders;

(d) Planning, directing, and conducting rehabilitation programs; and

(e) Discharge planning.

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B DCMR § 3926 SOCIAL SERVICES

3926.1 If social services are provided, they shall be provided in accordance with the patient's plan of care and in consultation with the patient.

3926.2 Social services shall be provided by order of a physician by a licensed independent clinical social worker, a licensed independent social worker, or a licensed graduate social worker, in accordance with HORA.

3926.3 Social services shall include:

(a) Evaluating the social and emotional needs of a patient;

(b) Assessing whether supplemental services, such as household support, are adequate for the patient's needs;

(b) Acting as a consultant to agency staff.

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B DCMR § 3999 DEFINITIONS

3999.1 For the purpose of this Chapter, the following terms shall have the meanings ascribed below:

Activity record - documentation of home health aide and personal care aide services as recorded by home health and personal care aides.

Advanced practice registered nurse - a person licensed or permitted to practice advanced registered nursing under HORA, also referred to as a "nurse practitioner".

Agency - a home care agency as defined in this section.

Caregiver - a person over the age of eighteen (18) years who has assumed responsibility for the care of the patient, voluntarily or by order of a court of competent jurisdiction.

Certified Nurse Aide - a person who performs nursing aide services, and who has obtained certification or credentials from the District of Columbia as being qualified to perform such services, pursuant to Chapter 32 of Title 29 of the District of Columbia Municipal Regulations.

Clinical record - a comprehensive compilation of medical and other data that identifies the patient and justifies and describes the diagnosis and treatment of the patient.

Communicable disease - any disease denominated a communicable disease, including, without limitation, any illness due to an infectious agent or its toxic product, which is transmitted directly or indirectly to a well person from an infected person, animal, or ectoparasite; or any illness due to an infectious agent or its toxic product which is transmitted through the agency of an intermediate host, vector, or by exposure within the immediate environment. Communicable disease also shall mean any disease occurring as an outbreak of illness or toxic conditions, regardless of etiology, in an institution or other identifiable group of people.

Dietitian - a person licensed or permitted to practice dietetics in the District of Columbia pursuant to HORA.

Governing body - the group, agency, partnership or corporation designated to assume full legal responsibility for the policy determinations, management, operation and financial liability of the home care agency.

Health professional - a person licensed or permitted to practice as a health professional under HORA.

Home Health Aide - a person who performs home health aide services, and who is qualified to perform such services pursuant to Chapter 51 of Title 29 of the District of Columbia Municipal Regulations.

Home care agency - an agency, organization, or distinct part thereof, other than a hospice, that provides, either directly or through a contractual arrangement, a program of health care, habilitative or rehabilitative therapy, personal care services, household support services, chore services, or other supportive services to sick or disabled individuals living at home or in a community residence facility. The term "home care agency" shall not be construed to require the regulation and licensure of non-medical services delivered by or through a religious organization on a small-scale, volunteer basis.

HORA - the District of Columbia Health Occupations Revision Act of 1985, effective March 25, 1986, D.C. Law 6-99, D.C. Official Code § 3-1201.01 et seq.

Household support services - services provided to supplement a patient's capabilities in such areas as light housekeeping, home management, meal planning and preparation, shopping, and care of dependent children.

Intravenous therapy - the provision, administration and monitoring of medical and nutritional substances taken by intravenous infusion through a peripheral vein, a direct central line, or a central line through a peripheral vein, with filters, and with or without intravenous pumps or controllers.

Licensed practical nurse - a person licensed or permitted to practice practical nursing under HORA.

Monitoring services - services utilizing mechanical appliances by which certain conditions or phenomena can be observed and recorded, including, but not limited to, diagnostic x-rays, electrocardiographs, apnea monitors, and emergency response systems.

Nutritional services - services prescribed in accordance with a plan of care that assesses and addresses the nutritional needs of a patient.

Nutritionist - a person licensed or permitted to practice nutrition under HORA.

Occupational therapist - a person licensed or permitted to practice occupational therapy under HORA.

Occupational therapy - the evaluation and treatment of individuals whose ability to manage normal daily functions is threatened or impaired by developmental deficits, the aging process, poverty, cultural differences, physical injury or illness, or psychological and social disability, utilizing task-oriented activities to prevent or correct physical or emotional disabilities and to enhance developmental and functional skills.

Office - the primary business location within the District of Columbia of a home care agency licensed in the District of Columbia, that maintains published open business hours, a working staff, and records.

Personal Care Aide - a person who performs personal care aide services, and who is qualified to perform such services pursuant to Chapter 50 of Title 29 of the District of Columbia Municipal Regulations.

Physical therapist - a person licensed or permitted to practice physical therapy under HORA.

Physical therapy services - treatment of human disability, injury, or disease by supervised therapeutic procedures embracing the specific application of physical measures to secure the functional rehabilitation and maintenance of the human body, as well as patient and family education.

Physician - a person licensed to practice medicine under HORA.

Plan of care - a plan of action formulated by one or more health care professionals, based upon the nature of the patient's illness, the treatment prescribed by the physician and the assessment of the patient's needs. The plan shall include the patient's health care needs, how these needs can be met, methods and approaches recommended, and modifications necessary to ensure the best results.

Progress note - a dated, written notation by a member of the health care team that summarizes facts about care and the patient's response during a given period of time.

Psychiatric nursing - skilled nursing services provided in conjunction with the diagnosis, treatment or prevention of mental illness.

Registered nurse - a person licensed or permitted to practice registered nursing under HORA

Respiratory therapist - a person who has completed a two (2) year program in respiratory care accredited by the Joint Review Personnel Committee of Respiratory Therapy Evaluation of the American Medical Association (AMA) and who is licensed to practice respiratory therapy under HORA.

Respiratory therapy - the performance, in collaboration with a licensed physician, of actions responsible for the treatment, management, diagnostic testing, control and care of patients with deficiencies and abnormalities associated with the cardiopulmonary system.

Skilled nursing services - nursing services that are required to be delivered by licensed nurses who operate within the scope of practice as outlined in HORA and rules implemented pursuant thereto.

Skilled services - health care services that are required to be delivered by licensed health-care professionals or under the direction of licensed health care professionals.

Social worker - a person licensed or permitted to practice social work under HORA.

Speech language pathologist - a person who:

(1) Meets the education and experience requirements for a Certificate of Clinical Competence in speech language pathology granted by the American Speech and Hearing Association; or

(2) Meets the educational requirements for certification and is in the process of accumulating the supervised experience required for certification.

History

SOURCE: Final Rulemaking published at 51 DCR 2876 (March 19, 2004).

22-B40 CERTIFICATES OF NEED

22-B DCMR § 4000 GENERAL PROVISIONS

4000.1 The provisions of Chapters 40 through 45 shall apply to a review of an application for a Certificate of Need (CON) required under Section 7 of the District of Columbia Health Services Planning Program Re-Establishment Act of 1996 as amended (Act), effective April 9, 1997 (D.C. Law 11-191; D.C. Official Code § 44-406).

4000.2 No person shall undertake any activity for which a CON is required if:

The original term of the CON has expired and the person has not obtained an extension pursuant to Section 4007; or

The Director has revoked the CON pursuant to Section 4010 or Section 4308 of this title.

4000.3 A CON shall be valid for up to three (3) years.

4000.4 A CON shall be valid upon its issuance. However, because the Director may revoke or modify a CON after reconsideration or an appeal decision, a CON holder proceeds solely at its own risk during the period when reconsideration or appeal may be requested and during any period that any reconsideration or appeal is in process.

4000.5 The issuance of a CON, if required under the Act, shall be a condition precedent to the issuance of any license, permit, or any other type of official approval (except zoning approval) by any agency or officer or employee of the District government that is necessary for the project in addition to the CON.

4000.6 A CON shall be for a specific site, except that a proposed change of site within the same Advisory Neighborhood Commission shall not require further CON review if the change is made before the project is implemented. Any proposed change in the location of an approved service or facility outside the same Advisory Neighborhood Commission shall require application for a new CON.

4000.7 For the purpose of Subsection 4000.6, the term "official approval" shall mean final approval by the District government subject only to appeal.

4000.8 SHPDA shall not be required to issue a CON before an administrative budget review body approves a budget request that is under consideration by the Council because the project relies on the appropriation of funds from the District budget.

4000.9 For the purposes of Chapters 40 through 45 the term “major medical equipment” includes:

(a) Equipment used for providing medical or health services acquired by lease, purchase, donation, or other comparable arrangement by or on behalf of a health care facility, or by or on behalf of any private group practice of diagnostic radiology or radiation therapy, for which the fair market value exceeds one million five hundred thousand dollars ($1,500,000) adjusted from time to time to reflect changes in the Consumer Price Index; or

(b) A single piece of diagnostic or therapeutic equipment acquired by lease, purchase, donation, or other comparable arrangement by or on behalf of a physician or group of physicians, or an independent operator of the equipment, for which the fair market value exceeds two hundred and fifty thousand dollars ($250,000) adjusted from time to time to reflect changes in the Consumer Price Index.

4000.10 For the purposes of Chapters 40 through 45 the term “major medical equipment” excludes medical equipment acquired by or on behalf of a clinical laboratory to provide clinical laboratory services when it is independent of a physician’s office or a hospital and satisfies the requirements of § 1861(s)(10) and (11) of the Social Security Act, approved August 14, 1935 (49 Stat. 420; 42 U.S.C. 1395x(s)).

4000.11 For the purposes of Chapters 40 through 45 an entity is “acquiring effective control” if it does any of the following:

(a) Transferring, assigning, or otherwise disposing of fifty percent (50%) or more of the stock, voting rights thereunder, ownership interest, or operating assets of a corporation or other entity that is a health care facility (HCF) or is the operator or owner of an HCF;

(b) Engaging in a transaction that results in any person, or any group of persons acting in concert, owning or controlling, directly or indirectly, fifty percent (50%) or more of the stock, voting rights thereunder, ownership interest, or operating assets of a corporation or other entity that is an HCF;

(c) Engaging in a transaction that results in any person, or any group of persons acting in concert, having the ability to elect or cause the election of a majority of the board of directors of a corporation that is an HCF; or

(d) Engaging in a conversion that results in the selling, transferring, leasing, exchanging, conveying, or otherwise disposing of, directly or indirectly, all the assets or a material amount of the assets, of a nonprofit HCF to a for-profit entity, whether a corporation, mutual benefit corporation, limited liability partnership, general partnership, joint venture, or sole proprietorship, including an entity that results from, or is created in connection with, the conversion.

4000.12 For the purposes of Chapters 40 through 45 a facility is considered a “diagnostic health care facility” if the facility is not operated by a hospital and is not the offices of a private physician or dentist, unless one (1) or more pieces of major medical equipment is located within the office, and is:

(a) A diagnostic imaging center accredited by the American College of Radiology whose primary business is providing diagnostic imaging services to the public;

(b) A cardiac catheterization laboratory;

(d) An independent diagnostic laboratory whose primary business is providing diagnostic imaging services to the public at which at least three (3) of the following are performed:

(1) Magnetic resonance imaging;

(2) CAT scan;

(3) Nuclear medicine;

(4) Ultrasound;

(5) X-ray; or

(6) Mammography.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4000

22-B DCMR § 4001 STATE HEALTH PLANNING AND DEVELOPMENT AGENCY AND STATEWIDE HEALTH COORDINATING COUNCIL

4001.1 The project application and review files of SHPDA shall be open for public inspection and review during regular business hours.

4001.2 SHPDA shall duplicate CON documents for any person upon request and upon payment of the reasonable costs of duplicating the requested documents. SHPDA shall restrict access of the general public to portions of applications or supporting documents that contain detailed descriptions of security systems, medical record systems, controlled storage systems, or proprietary financial information.

4001.3 The Director shall provide information on the status of any review or on the status of any outstanding CON upon request.

4001.4 The Director may establish charges for all SHPDA studies, reports, data compilations, publications, or other types of documents. The charges shall be reasonably related to the costs of preparing, developing, retrieving, duplicating, and paying postage, where applicable.

4001.5 The review meetings of SHPDA and the Statewide Health Coordinating Council (SHCC) shall be open to the public.

4001.6 SHCC shall:

(a) Assist SHPDA with developing the Health Systems Plan (HSP);

(b) Review and make recommendations to SHPDA on the HSP; and

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4001

22-B DCMR § 4002 PRE-APPLICATION CONSULTATION WITH PROSPECTIVE APPLICANT

4002.1 A prospective applicant for a CON may consult with a designated member of SHPDA staff before submitting a Letter of Intent for any project and during the application process.

4002.2 The Director shall assign a staff person to assist each applicant for a CON. The applicant shall consult with the assigned SHPDA staff person throughout the application process, except during any period for which ex parte contacts are prohibited under Section 4305 and D.C. Official Code § 44-409(i).

4002.3 SHPDA staff shall:

(a) Review with the applicant the procedures and criteria that SHPDA will follow during the application review;

(b) Provide technical assistance on information required in the application;

(d) Provide other assistance that may be helpful to the applicant.

4002.4 Consulting with SHPDA staff before applying for a CON shall not relieve an applicant from the requirement to file a formal Letter of Intent pursuant to Section 4003. Pre-application consultation shall not commit SHPDA to issuing a CON and shall not represent SHPDA’s official position concerning an application submitted subsequent to the consultation.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4002

22-B DCMR § 4003 LETTER OF INTENT AND PUBLIC NOTICE

4003.1 Before submitting a formal application for a CON, an applicant shall submit a Letter of Intent to the Director for the purposes of notifying SHPDA that an application for a CON will be forthcoming and providing SHPDA sufficient time to prepare for application review. The Letter of Intent shall contain the following information:

(a) The name, address, and telephone number of the applicant;

(b) The name of an individual authorized to respond to SHPDA staff questions regarding the application;

(d) A brief description of the proposed health care facility, health service, or other entity, including its cost and the projected date of implementation.

4003.2 The applicant's chief executive officer or a person authorized to act on behalf of the chief executive officer shall sign the Letter of Intent.

4003.3 An applicant shall provide notice to the community of its intent to file a CON application by publishing a notice in a newspaper of general distribution within the District of Columbia that generally describes the proposed project and states that the Letter of Intent will be filed with SHPDA.

4003.4 An applicant shall submit the Letter of Intent to SHPDA at least sixty (60) days but not more than one hundred eighty (180) days before filing the application for a CON and shall include with the Letter of Intent a copy of the notice required by Section 4003.3.

4003.5 An applicant may submit an application after consulting with SHPDA staff.

4003.6 The Director shall designate a SHPDA staff member to assist the applicant upon filing of a Letter of Intent.

4003.7 If an applicant has not submitted a CON application within one hundred eighty (180) days after submitting the Letter of Intent, the Letter of Intent shall be void unless the applicant requests and receives written approval for an extension to file the CON application.

4003.8 An applicant may request one (1) extension of not more than one hundred eighty (180) days. The request shall be made in writing before the initial one hundred eighty (180) day period expires. The Director shall respond to the request in writing and may grant an extension of one hundred eighty (180) days or less.

4003.9 SHPDA may use the period of time after receiving a Letter of Intent and before receiving a formal application for a CON to do the following:

(a) Answer inquiries concerning the requirements for a CON;

(b) Advise the applicant on appropriate joint planning with other

HCFs, HMOs, and affected parties; and

(c) Advise the applicant on the involvement of other community and public agencies, providers, and consumers in the long and short-range planning of the applicant.

4003.10 SHPDA shall provide technical assistance to individuals and public and private entities for obtaining and completing the form necessary for preparing an application.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4003

22-B DCMR § 4004 CONDITIONAL CERTIFICATES OF NEED

4004.1 SHPDA may require an applicant to comply with certain conditions when granting a CON, provided that the conditions relate directly to an adopted SHPDA review criteria.

4004.2 The expiration date, if any, of each condition shall be specified in the CON.

4004.3 If a CON holder violates a condition of a CON, the Director shall issue the CON holder written notice of the violation and may revoke the CON using the procedure for noncompliance with the CON, as specified in Section 4010.

4004.4 If the Director determines that the applicant has violated a condition and is not permitted to begin full operation, the applicant may appeal in the same manner as with any decision to issue or not issue a CON.

4004.5 The completed application for a CON and related documentation shall be considered to be a part of any CON issued after review and approval of the application.

4004.6 The CON holder shall proceed only in compliance with the CON and the related application and documentation that the Director has approved.

4004.7 In the case of an application approved for a CON with conditions, SHPDA may (if no licensing or operating approval is required by any other District agency) grant the CON holder the authority to begin "conditional operation" while the CON holder demonstrates its compliance with the conditions attached to the CON.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 42 DCR 7286 (December 29, 1995); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4004

22-B DCMR § 4005 PROPOSED CHANGES IN APPROVED PROJECTS

4005.1 The Director shall specify in the CON the maximum amount of capital expenditure that may be obligated under the CON.

4005.2 A CON holder shall report a proposed change in the project budget that will result in an expenditure greater than the maximum capital expenditure specified in the CON.

4005.3 A CON holder shall request the Director’s approval for a proposed change in the project budget that will result in an expenditure that is twenty-five per cent (25%) or more larger than the approved capital expenditure specified in the CON. The Director shall issue a decision on a proposed change in not more than thirty (30) days after receiving a request to modify the project budget. A CON holder shall not commence work on the proposed changes that are twenty-five per cent (25%) or more than the maximum capital expenditure before the Director approves the modification.

4005.4 A CON holder shall report cumulative costs of individual budget changes to the Director for review and approval as part of the CON holder’s regular, periodic reports. A CON holder shall submit a new application for any proposed change that exceeds the proposed budget by more than fifty per cent (50%) of the approved capital expenditure.

4005.5 Except for routine construction change orders, the purpose of which is to correct architectural or engineering errors or to compensate for errors in “as built” drawings of existing buildings, errors in surveys, or similar types of errors, all proposed changes to an approved project budget shall be promptly reported to SHPDA.

4005.6 A CON holder shall report routine construction change orders when the CON holder reports completion of the project.

4005.7 If the Director determines that a proposed non-budgetary change will not affect patient care, the Director may approve the change (subject to reconsideration and appeal) without referring the change to SHCC for review. If the Director approves a change pursuant to this subsection, the Director shall notify SHCC of the change at the next monthly meeting of SHCC.

4005.8 If patient care is not significantly affected, and, if either of the following conditions is met, SHPDA shall approve or disapprove the change without referral to SHCC, and shall notify SHCC at the next scheduled SHCC meeting:

(a) The cost increase is directly related to inflation, unforeseen construction difficulties, or changes in building plans in the nature of routine change orders consistent with the CON application approved by SHPDA; or

(b) The cost increase involves changes in acquisition plans from lease or similar arrangements to purchase or vice versa (if the change is economically justifiable as determined by SHPDA).

4005.9 If a new CON is required pursuant to Subsection 4005.4, the Director shall consider the date of issuance of the original CON to be the date of issuance of the consolidated CON for all SHPDA purposes, including quarterly reports and extension schedules.

4005.10 A CON holder shall report each proposed change to the specifications (as stated in the approved CON) of a project. This report shall include any service, any equipment, and any other type of change whatsoever to the specifications of an approved project.

4005.11 If the Director determines that a proposed non-budgetary change will not significantly affect patient care, the Director may issue a decision that the change may be made (subject to reconsideration and appeal) without prior approval of the SHCC.

4005.12 SHPDA shall update its files concerning the nature of the change and shall notify the SHCC at the next scheduled SHCC meeting.

4005.13 If the Director finds that a proposed non-budgetary change would substantially affect patient care, the Director shall require the CON holder to apply for and receive a new CON before the proposed change may be implemented.

4005.14 If a new CON is required under Subsection 4005.13, SHPDA shall consider the date of issuance of the original CON to be the date of issuance of the consolidated CON for all SHPDA purposes, including quarterly reports and extension schedules.

4005.15 A proposed change in a completed project associated with a capital expenditure for which SHPDA has previously issued a CON shall require review and issuance of a new CON if the change is proposed within two (2) years after the date the activity for which the expenditure was approved is undertaken. (For example, if a hospital receives approval to construct a new wing, the hospital will “undertake the activity” when it begins to provide services in the wing. If, in the two (2) years after undertaking the activity, the hospital decides to increase the number of beds in the wing by a number that would not otherwise trigger a review, a review would still be required.). For the purposes of this section, a CON holder has undertaken an activity when it begins to provide services under the CON.

4005.16 The provisions of Subsection 4005.15 shall apply to a change associated with capital expenditures that are subject to review under this title.

4005.17 SHPDA review and approval shall be required regardless of whether a capital expenditure is associated with the proposed change.

4005.18 A “change in a project” shall include, at a minimum, any change in the bed capacity of a facility or the addition or termination of a health service.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4005

22-B DCMR § 4006 PRE-OPERATIONAL INSPECTION

4006.1 A CON holder shall not begin operation of an approved project until SHPDA has conducted a preoperational inspection and has determined that the project is in compliance with the CON requirements.

4006.2 For a large project that may be completed in phases, the Director may approve the project in phases as the phases are completed and after a CON holder requests phased implementation of the project in writing.

4006.3 Not later than thirty (30) days before the date that the CON holder proposes beginning operation, the CON holder shall inform the Director in writing of the proposed date for operation of the facility or service (or a part of the facility) approved under a CON.

4006.4 After the notification required by Subsection 4006.3, SHPDA shall conduct an on-site pre-operational inspection and review for compliance with all CON requirements.

4006.5 The CON Holder shall make all portions of the facility or service available for inspection and shall produce all records, including cost records, SHPDA deems necessary to determine compliance with the specifications of the approved CON.

4006.6 The CON holder shall not begin operation without a Letter of Completion. If, after inspection, the Director determines that a project, or an operational portion of a project, is substantially complete, and that the CON holder has satisfied all requirements and specifications of the CON, the Director shall issue a Letter of Completion for that project or an operational portion of the project.

4006.7 If all phases of a project are completed, receipt of the Letter of Completion issued under Subsection 4006.6 terminates the CON review process, provided that all conditions included in the CON that have continuing applicability shall remain in effect.

4006.8 If the Director determines that a project, or an operational portion of a project, is not substantially complete or is not in compliance with all requirements of the CON, the Director shall notify the CON holder in writing of the deficiencies.

4006.9 A notice of deficiency issued pursuant to Subsection 4006.8 shall:

(a) Identify the parts of the project that are not complete;

(b) Identify any deficiencies regarding the requirements for the project; and

4006.10 A CON holder may request reconsideration of, and appeal, a notice of deficiency as if the notice was a denial of a CON, pursuant to Chapter 43 of this title.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4006

22-B DCMR § 4007 ISSUANCE AND EXTENSION OF CERTIFICATE OF NEED

4007.1 A CON shall be issued for a period of up to three (3) years as the Director determines to be appropriate. An applicant may request, and the Director may grant, an applicant’s written request for a CON period of less than three (3) years.

4007.2 The Director may grant an extension of an expiring CON for a period of up to four (4) years, including the original term and excluding any administrative extensions that may have been granted, upon a written showing of substantial progress or a justification for lack of progress.

4007.3 For purposes of this section, the phrase “substantial progress” means reasonable compliance with SHPDA-approved schedule for the project.

4007.4 For purposes of this section, the phrase “justification for lack of progress” means an explanation acceptable to the Director for the CON holder’s non-compliance with the SHPDA-approved schedule, and may include factors beyond the control of the CON holder.

4007.5 SHPDA shall extend or deny an extension of a CON based on the quarterly progress reports filed by the CON holder under Section 4008 and any additional information required by this chapter.

4007.6 The "SHPDA-approved schedule" shall be the latest of the following:

(a) The final schedule submitted for approval in the applicant's CON application;

(b) The schedule required by SHPDA in any condition of a CON; or

4007.7 If the applicant has not made substantial progress, SHPDA shall issue a ninety (90) day administrative extension of the CON for the purpose of allowing SHPDA to commence proceedings for revoking the CON under the provisions of Section 4010.

4007.8 If an applicant has made substantial progress but there has been a deviation from another aspect of the approved application, and the Director intends to grant an extension, SHPDA may require the applicant to comply with the previously approved requirements or a SHPDA-approved modification of those requirements.

4007.9 The Director’s decision to extend or not extend a CON may be appealed under the provisions of Chapter 43 of this title.

4007.10 The Director may grant an administrative extension of the validity of a CON for up to ninety (90) days for good cause, which may include a showing that the project is within ninety (90) days of completion.

4007.11 A CON that is not extended shall be void.

4007.12 A CON holder requesting extension of a CON beyond a total of four (4) years shall submit a new application for a CON for the project to SHPDA no later than six (6) months before the current CON expires.

4007.13 If a CON holder provides written assurance that the project will be completed within six (6) months after the expiration of its current CON, including any extension up to but not exceeding a total of four (4) years, SHPDA may grant an additional administrative extension for up to six (6) months without the need for an applicant to submit a new CON application.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4007

22-B DCMR § 4008 PROGRESS REPORTS

4008.1 A CON holder shall make quarterly progress reports to SHPDA.

4008.2 A progress report shall include the following information, if applicable:

(a) Original CON registration number;

(b) Status of the project, including current estimated completion date, in relation to the SHPDA-approved construction schedule, and any revised construction schedule reported in previous quarterly progress reports but not yet approved by SHPDA;

(d) Any events that might delay or halt future progress, and actions to be taken in response to these events, if applicable;

(e) Any changes in the proposed schedule and justification for those changes;

(f) Changes in the scope of the project or program approved in the CON (if there are changes, submit copies of revised construction drawings, specifications, leases, or other relevant documentation);

(g) An itemization of any changes in the project’s cost from those approved by SHPDA, and as modified in previous quarterly progress reports;

(h) A statement of the current means of financing the project, and the continued adequacy of the financing;

(i) Any foreseeable events that might jeopardize financing, and the proposed response to an event that could jeopardize financing;

(j) A description of efforts made toward complying with any conditions of the CON; and

(k) Other pertinent supplemental information the CON holder wishes to bring to the Director’s attention or other information the Director specifically requests that relates to the project.

4008.3 The Director may request additional information after receiving a progress report if the Director determines that the report is not complete.

4008.4 The Director may approve or deny a request for a CON extension without submitting the extension request to the SHCC, unless the request would require submission of a new application and full review.

4008.5 SHPDA staff shall prepare a memorandum of the progress made by the CON holder receiving the complete progress report for the third (3rd) quarter of each CON year. The analysis shall include the following:

(a) The project’s rate of progress according to the most recent SHPDA-approved schedule for the project;

(b) Whether any reported delay is beyond the control of the CON holder;

(d) Whether any change in the proposed schedule is reasonable with respect to the health requirements of District residents and visitors;

(e) Whether any cost changes exceed the rate of inflation for construction projects in the District;

(f) Whether the CON holder has minimized costs;

(g) Whether financing for the project continues to be adequate;

(h) Whether the CON holder is continuing to comply with any conditions of the CON; and

(i) Whether the project continues to be adequate with respect to all review criteria, except those for need and conformance to the State Health Plan.

4008.6 SHPDA staff shall make a recommendation to the Director about whether to issue an extension for a CON under Section 4007 or to take action under Section 4010 to revoke a CON.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4008

22-B DCMR § 4009 SALE OR TRANSFER OF EFFECTIVE CONTROL

4009.1 Pursuant to D.C. Official Code § 44-411 a CON may not be sold or transferred. The sale or transfer of effective control over a project for which a current CON has been granted shall cause the CON to be subject to review and approval by SHPDA. The process for reviewing a CON resulting from transfer of effective control is subject to the requirements of D.C. Official Code § 44-406(b) and this section. For the purpose of this section, a current CON means authorization from SHPDA that has not been fully implemented.

4009.2 For purposes of this section the term “effective control” includes:

(a) The ability of any person, by reason of a direct or indirect ownership interest, whether of record or beneficial, in a corporation, partnership, or other entity that holds a CON, to direct or cause the direction of the management or policies of that corporation, partnership, or other entity; and

(b) Creation of a new legal entity regardless of whether the owners remain the same.

4009.3 If a current CON is held by a partnership, either general or limited, the addition of a general partner who was not identified as a general partner in the certificate of partnership on file with SHPDA at the time the original CON was issued, or the succession of a general partner who was named as a general partner by another person at any time after issuance of the original CON, shall be reviewed and approved by SHPDA, or shall cause withdrawal of the CON, effective as of the time at which the addition or succession of a general partner occurs.

4009.4 Any transfer, assignment, or other disposition of ten per cent (10%) of the stock or voting rights thereunder of a corporation or other entity that operates a health care facility, or any transfer, assignment, or other disposition of the stock or voting rights thereunder of he corporation or other entity that results in the ownership or control of more than ten percent (10%) of the stock or voting rights of the corporation or other entity by any person shall, when that corporation or entity holds a current CON, shall cause the CON to be subject to review and approval by SHPDA.

4009.5 For a partnership, ten percent (10%) of the stock or voting rights shall include the following:

(a) The obligation of any partner to provide ten percent (10%) or more, including property and services, of the total capital contribution of the partnership, as reflected in an amendment of the original certificate of partnership;

(b) The right of any partner to receive distribution of ten percent (10%) or more of the profits of the partnership, as reflected in an amendment of the original certificate of partnership; or

(c) The right of any partner, upon dissolution of the partnership, to receive ten percent (10%) or more of partnership assets remaining after payment of all partnership debts, as reflected in an amendment of the original certificate of partnership.

4009.6 A party proposing to gain effective control of a project for which a CON has been granted, or of an entity that holds a CON, shall apply for a new CON. No Letter of Intent shall be required in this circumstance.

4009.7 The criteria and standards normally applicable to a CON application shall apply to a sale or transfer of effective control. SHPDA shall also weigh the qualifications of the party proposing to gain effective control to effectively operate the project.

4009.8 SHPDA shall review a CON application under this section by examining the financial responsibility and business interests of the person or entity seeking to obtain the effective control in addition to any other prescribed and published SHPDA review criteria.

4009.9 Under D.C. Official Code § 44-416(e), failure to obtain a new CON before effecting the sale, transfer, assignment, or other disposition of effective control over, or the acquisition of ten per cent (10%) or more of stock or voting rights, in the holder of record of a current CON shall cause the automatic revocation of the current CON, effective as of the time at which the acquisition, sale, transfer, assignment, or other disposition occurs.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4009

22-B DCMR § 4010 ENFORCEMENT AND REMEDIES FOR NONCOMPLIANCE

4010.1 The Director may request that the Office of the Attorney General enjoin the activities of a person offering, developing, or operating a health care facility in violation of the Act, as specified in D.C. Official Code § 44-416(b).

4010.2 The Director may revoke a current CON, after holding a hearing to ascertain the facts. If the Director finds that a person has violated a provision of the Act or 22 DCMR Chapters 40 through 45, the Director may take action to revoke a current CON even though action has been initiated to criminally prosecute, sue for injunctive relief, or impose a civil fine, penalty, or fee for a violation of the Act or Title 22 Chapters 40 through 45.

4010.3 The Director may revoke a current CON for lack of substantial progress under this chapter.

4010.4 Before revoking a CON, the Director shall publish a notice of alleged violation or lack of substantial progress in a newspaper of general circulation in the District, and shall notify all interested parties, including the CON holder.

4010.5 The notice shall include a detailed description of the alleged violation or lack of substantial progress and shall provide the time and location of a public hearing to consider the alleged violation.

4010.6 The public hearing shall be held no sooner than fourteen (14) days from the date of the notice and no later than thirty (30) days from that date.

4010.7 The hearing shall be conducted according to the procedures specified in chapter 43 of this title for reconsideration hearings, except that the SHPDA staff person in charge of a CON review, or a designee, shall have up to one (1) hour to present the details of the alleged violation or lack of substantial progress. Following this presentation, the CON holder may question the SHPDA staff person.

4010.8 The CON holder shall have up to one (1) hour to make its presentation, after which SHPDA staff may ask questions of the CON holder. Other persons may then testify.

4010.9 Following all testimony, the CON holder may make a ten (10) minute closing statement.

4010.10 The Director shall decide whether to revoke a CON within thirty (30) days following the close of the public hearing. The Director’s decision shall be:

(a) Written;

(b) Based on the complete record of the withdrawal action; and

4010.11 There shall be no ex parte contacts between the CON holder and SHPDA staff or the SHCC following the public hearing and before the Director issues a decision.

4010.12 The Director’s decision to revoke a CON may be appealed to the Office of Administrative Hearings without further reconsideration by the Director.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4010

22-B DCMR § 4011 NOTICE OF CERTAIN CAPITAL EXPENDITURES

4011.1 A health care facility or service (except an HMO exempt under D.C. Official Code § 44-407(c) and 22 DCMR 4109) shall notify SHPDA that it intends to obligate an expenditure of two million five hundred thousand dollars ($ 2,500,000) or more for construction, repairs, or renovation of facilities, when that action requires issuance of any type of permit from the District government notwithstanding that the capital expenditure intended is less than the CON review threshold.

4011.2 A health care facility or service shall submit with the notice either of the following:

(a) A summary of the project, including total estimated capital expenditure; or

(b) A copy of the required permit application filed with the appropriate District government agency or agencies.

4011.3 The notice shall contain a description of any related capital construction repairs or renovations that the facility may consider undertaking within two (2) years of the completion of the work for which notification is presently being given.

4011.4 The health care facility or service shall file notice with SHPDA at least ninety (90) days before undertaking the construction, repairs, or renovation in question.

4011.5 A health care facility or service, except an HMO exempt under Chapter 41, shall notify SHPDA of its intention to obligate an expenditure to acquire by lease, donation, or other transfer, any major equipment. Notice shall be given not less than thirty (30) days before acquiring the equipment.

4011.6 A health care facility or service, except an HMO exempt under Chapter 41, shall notify SHPDA of its intention to acquire by lease, donation, or other transfer, diagnostic or medical treatment equipment (including the replacement of parts of existing equipment that enhance the original capabilities of the equipment), whether a single unit or system with related functions, the fair market value of which is under one million five hundred thousand dollars ($1,500,000). Notice shall be given not less than thirty (30) days before acquiring the equipment.

4011.7 The notice required by Subsections 4011.5 and 4011.6 shall include:

(a) The purchase price or fair market value of each item of equipment to be obtained;

(b) Each item’s function;

(d) A description of functionally related equipment extensions or enhancements that the facility may consider purchasing within two (2) years of putting the equipment described in the notice into operation.

4011.8 If the Director determines that the activity described in the notice is related to subsequent action to be taken within the two (2) year period and should be considered a single project, a CON review shall be required when the total cost of the present and subsequent actions exceeds the capital expenditure threshold for CON review.

4011.9 If a health care facility or service, except an HMO exempt under Chapter 41, intends to undertake related construction, repairs, or renovations, or intends to acquire functionally related equipment, extensions or enhancements to equipment not describe in a notice to SHPDA, the additional activities or equipment shall be subject to CON review when the total cost within a given two (2) year period exceeds the capital expenditure threshold for CON review.

4011.10 SHPDA shall conduct an expedited review of a CON application required under this section, and the applicant shall not be required to file a letter of intent.

4011.11 The Director’s determination under this section that intended action by a health care facility or service is subject to CON review may be appealed by an affected person to the District of Columbia Office of Administrative Hearings.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4011

22-B DCMR § 4012 GENERAL CRITERIA AND STANDARDS FOR REVIEW

4012.1 Whenever a criterion or standard requires proof of a fact, the applicant shall have the burden of affirmatively proving that fact.

4012.2 The criteria and standards set forth in this section shall apply to every CON application other than an application that relates to acquiring an existing health care facility.

4012.3 Each project shall conform to the general provisions, defined priorities, goals, objectives, recommended actions, criteria, and standards contained in the State Health Systems Plan (HSP) and the Annual Implementation Plan (AIP) for the development of health facilities or services, if applicable.

4012.4 Each project shall be consistent with the applicant’s long range development plan.

4012.5 Each project shall be consistent with non-health sector plans for the service area of the proposed facility or service. The applicant shall demonstrate consistency by providing evidence and assurances that:

(a) It has considered other plans adopted or endorsed by the District, including public and private transportation, housing, and economic development that will impact the area the facility or service serves; and

(b) The proposal is consistent with those plans specified in subsection (a).

4012.6 Each applicant shall demonstrate the need for the project on a health care system wide basis (for those projects that substantially affect patient care). The applicant shall demonstrate need by meeting the following standards:

(a) The applicant shall provide evidence and assurances that the project is needed to meet service or facility levels required for the District as specified in the HSP. If a proposal serves a geographic area larger than the District, the applicant shall document that the project is needed to meet the service or facilities requirements of the larger area as specified in the HSP.

(b) If the HSP does not specify need, the applicant shall provide evidence and assurances that the project is needed based on a special analysis of the District or larger area service and facility needs. This study shall consider the utilization rates of the same or similar services of the applicant and other providers.

(c) If the application involves new technology, the applicant shall provide evidence and assurances of the developmental level of the technology and the extent to which it has been proven to be beneficial in controlled trials comparing its use with the use of conventional techniques or equipment. Applications involving new technology that has not been proven to the satisfaction of the Director to be beneficial in controlled trials shall not be considered needed unless the applicant proposes to conduct the trials in addition to providing patient care.

(d) An application involving new technology that has been proven to the satisfaction of the Director to be generally accepted by the scientific community as beneficial in controlled trials shall also demonstrate that other actual or potential applicants that might more appropriately be given approval for acquisition of the new technology:

(1) Already have the technology or have SHPDA approval for its acquisition and that an additional need for the technology to meet patient requirements exists; or

(2) Will not seek approval to acquire the new technology within (12) months of the application date. The applicant shall identify other actual or potential applicants considering the following:

(A) The number of beds operated;

(B) Teaching programs;

(D) Current or approved specialized units or specialized services provided; and

(E) Current or approved special capabilities in terms of equipment and personnel skills.

(e) The Director shall consider the special needs and circumstances of an applicant, as documented by the applicant, for an application from an entity that provides a substantial portion of its services or resources, or both, to individuals from outside the metropolitan area.

4012.7 Each applicant shall demonstrate need for the project on an institutional basis by providing evidence and assurances that the project is required to meet institutional needs.

4012.8 Each applicant shall satisfy the criterion of availability of training opportunities by meeting the following standards:

(a) An applicant shall provide evidence and assurances that the proposed project will not negatively impact opportunities for health professional training if a health profession school or program asserts, and the Director agrees, that training opportunities are necessary; and

(b) If the Director finds that a project is not otherwise needed under the criteria in Subsections 4012.5 and 4012.6, an applicant may provide evidence that the project is needed to provide reasonable access to training opportunities in operating services.

4012.9 Each applicant shall satisfy the criterion for requirements of research projects and programs by meeting the following standards:

(a) An applicant shall provide evidence and assurances that the proposed project will not negatively impact the availability of facilities and equipment needed for biomedical and behavioral research projects designed to meet a national need and for which local conditions offer special advantages, as determined by the Director; and

(b) If the Director finds that a project is not otherwise needed, an applicant may provide evidence that a project is essential to meeting the reasonable needs of biomedical or behavioral research projects that are designed to meet a national need and for which local conditions offer special advantages, as determined by the Director.

4012.10 Each applicant shall satisfy the criterion for the schedule for project implementation by providing evidence and assurances that the proposal, if approved, will be implemented in a prompt and orderly fashion consistent with the approved schedule and public need for the service or facility and cost containment in project implementation.

4012.11 Each applicant shall satisfy the criterion for the effect of operating policies, personnel capabilities, and the physical structure on the proposed project’s care of patients, patient accessibility to medical care, and patient understanding of medical care by meeting the following standards:

(a) An applicant shall provide evidence and assurances that the project will not negatively impact services available to the following:

(1) Service area ethnic populations who speak a language other than English;

(2) Low-income residents;

(3) Persons with physical or mental disabilities;

(4) Racial and ethnic minorities;

(5) Women;

(6) Elderly persons;

(7) Persons whose care is paid for by Medicaid, Medicare, public medical assistance programs, or other public programs;

(8) Persons uninsured or who have limited insurance coverage; and

(9) Other under-served groups.

(b) An applicant shall provide evidence and assurances that access to care is not unreasonably restricted by its admissions policies, requirements, or hours of operation. If an application is for major medical equipment, unless otherwise specified in the HSP for specific types of equipment, not otherwise exempt, the standard for this criterion shall not be considered met unless the equipment is regularly scheduled for operation at least fifty (50) hours per week, fifty-two (52) weeks per year and is available for emergency use at all other times, if the equipment is of a type reasonably expected to be necessary for emergency care.

4012.12 Each applicant shall satisfy the criterion for compliance with uncompensated care and community service requirements. The standard for satisfying this criterion is by providing evidence and assurances of compliance with applicable provisions of § 11 of the Act (D.C. Official Code § 44-410) as well as the following:

(a) An applicant that has not previously held a CON shall provide assurances of prospective compliance; and

(b) An applicant that has previously held a CON shall provide evidence of past compliance and assurances of prospective compliance.

4012.13 Each applicant shall satisfy the criterion for involvement of the community in the process of project planning and development. The standard for satisfying this criterion is by providing evidence and assurances of opportunities for community participation in the preparation and development of the project through the following:

(a) Public notice of the project to affected Advisory Neighborhood Commissions (ANC’s); and

(b) Consideration of comments received from community agencies, groups, and individuals.

4012.14 Each applicant shall satisfy the criterion for impact of the proposed project on the health system and the health of District residents and visitors. The standard for satisfying this criterion is by providing evidence and assurances that the project, if it involves a direct patient care service, will not adversely impact the health care system and the health of the public in terms of health status as measured by industry standards, such as hospital admissions, emergency room visits, length of stay, and other relevant measures.

4012.15 Each applicant shall satisfy the criterion for observance of rights of patients. The standard for satisfying this criterion is by providing evidence and assurances of the applicant’s mechanism for guaranteeing patient’s rights. Minimal compliance with this standard requires compliance with all federal and District laws and regulations regarding patient rights.

4012.16 Each applicant shall satisfy the criterion for assurance that the care to be provided is of acceptable quality. The standard for satisfying this criterion is by providing evidence and assurances that it will meet professional and community standards of quality care. The applicant shall document compliance with this standard by showing that the project conforms to the requirements of District and federal regulatory agencies and recognized accreditation bodies including the Joint Commission on the Accreditation of Health Care Organizations and the Commission on Accreditation of Rehabilitation Facilities.

4012.17 Each applicant shall satisfy the criterion for compliance with building and equipment requirements. The standard for satisfying this criterion is by providing evidence and assurances that all new construction meets the standards contained in minimum requirements of latest edition of Guidelines for Design and Construction of Health Care Facilities, and District construction and licensing codes and regulations, as applicable to the type of project proposed. A remodeling project shall satisfy as many of these requirements as are reasonably practical, as determined by the Director, acting in consultation with District licensing and construction authorities.

4012.18 Each applicant shall satisfy the criterion for selection of the best of alternative means of providing the project’s services. The standard for satisfying this criterion is by providing a description of the alternatives the applicant considered, and the findings that led the applicant to select the proposed approach rather than an alternative approach. The applicant shall select the most favorable alternative available by evaluating and comparing the final selected plan with the following alternative means:

(a) If shared services are not proposed, the applicant shall demonstrate why shared services are not practical or cost effective;

(b) If a merger is not proposed, the applicant shall demonstrate why a merger agreement is not desirable or practical;

(c) The applicant shall demonstrate that the proposed method for providing services, whether provided in-house or contracted out, is more desirable than the alternative. Where applicable, the estimated costs for both contract and in-house services should be presented;

(d) The applicant shall demonstrate that the option of taking no action is not desirable; or

(e) The applicant shall demonstrate that it considered other alternatives and demonstrate why they were considered less desirable.

4012.19 Each applicant shall satisfy the criterion for the effect of operational costs of the project on general costs, rates, or consumer charges. The standard for satisfying this criterion is by providing evidence and assurances that the project will reduce costs or charges for the service in question and for related services to the maximum practical extent or increase cost and charges to the minimum practical extent, consistent with benefits provided, if any. Unless a different standard is adopted in the HSP for a specific service, projects that are projected to operate at less than eighty percent (80%) utilization of available capacity in their third (3rd) year of operation, given operating hours determined by the Director to be reasonable, shall be deemed not to meet this standard. The Director may consider special circumstances concerning utilization for teaching and research in determining compliance with the utilization rate standard.

4012.20 Each applicant shall satisfy the criterion for the effect of operational costs of the project on the applicant’s budget. The standard for satisfying this criterion is by providing evidence and assurances that the applicant’s operating cost and revenue analysis show that the project will not substantially negatively affect the applicant’s continuing financial operational viability, given reasonable revenue and volume projections.

4012.21 Each applicant shall satisfy the criterion for adoption of energy conservation techniques. The standards for satisfying this criterion are as follows:

(a) If a project is designed to conserve energy, the applicant shall provide evidence and assurances that the proposal is the most cost effective and practical means available and that over the life cycle of the facility the proposal will result in reduced costs; and

(b) If a project is not designed primarily to conserve energy, if construction or equipment replacement is involved in the project, the applicant shall provide evidence and assurances that the project incorporates the most cost effective and practical energy conservation techniques over the life cycle of the project.

4012.22 Each applicant shall satisfy the criterion for effect on competition. The standards for satisfying this criterion are as follows:

(a) If a new service does not involve capital expenditures of an amount that would otherwise require a CON review, the applicant shall provide evidence and assurances that the project will positively affect competitive factors and result in a more appropriate supply of services at lower charges or at charges no higher than is justified by the benefits of its more appropriate availability, quality, and other features; and

(b) For all other projects, including acquisitions, the applicant shall provide evidence and assurances that the project will not adversely affect competition or an adequate supply of services.

4012.23 Each applicant shall satisfy the criterion for efficiency and effectiveness of existing services. The standards for satisfying this criterion are as follows:

(a) If an application proposes to modernize a service, to replace equipment, or to expand a service, an applicant shall provide evidence and assurances that the results of the proposed modernization, service expansion, or equipment replacement cannot be achieved by reasonable increases in the applicant’s efficiency or effectiveness, including reasonable changes in operating hours, more efficient use of other equipment, use of revised procedures, better scheduling of services, or referral to other providers; and

(b) For a proposed new service, an applicant shall provide evidence and assurances that the proposal is the most efficient, effective, and practical manner of providing needed services, considering not only alternatives that the applicant might offer but also the operations or potential operations of other providers.

4012.24 Each applicant shall satisfy the criterion for construction plan design and specification alternatives. The standard for satisfying this criterion is by providing evidence and assurances that the construction methods and material specifications selected are the most cost effective over the life cycle of the proposed project, taking construction, energy, operating, and maintenance costs into consideration.

4012.25 Each applicant shall satisfy the criterion for financial viability of project operation. The standard for satisfying this criterion is by providing evidence and assurances that sufficient financial resources are available, not only to complete the project but also to sustain operations for at least two (2) years. Financial resources that may be used to meet this requirement include:

(a) Reserves for start-up costs; and

(b) Patient revenue, based on estimated patient volume, payer mix, and reimbursements the Director determines to be reasonable. Reimbursements and projected patient volume are not reasonable if the projections are based, in whole or in part, providing services that are inconsistent with the criterion and standard specified in Subsection 4012.27.

4012.26 Each applicant shall satisfy the criterion for availability of required capital. The standard for satisfying this criterion is by providing evidence and assurances that the proposed source of funds, including loans, are fully described, to the extent possible at the time of proposal submission for the project review. Each proposed loan agreement shall be accompanied by information on duration and repayment terms. The applicant shall provide evidence and assurances that more favorable financial arrangements cannot be obtained. The financial arrangements shall be reasonable when compared to those for other similar projects.

4012.27 Each applicant shall satisfy the criterion for compatibility with the reimbursement policies of third-party payers, where applicable. The standard for satisfying this criterion is by providing evidence and assurances that the applicants proposed services are reimbursable by third-party payers (including Medicare and Medicaid) if the third-party payers reimburse other providers in the District for providing the same services.

4012.28 Each applicant shall satisfy the criterion for availability of personnel. The standard for satisfying this criterion is by providing evidence and assurances that the proposal includes adequate qualified personnel and that the required personnel can be obtained without substantial negative effects on other services the applicant or other providers offer.

4012.29 Each applicant shall satisfy the criterion for management capability. The standard for satisfying this criterion is by providing evidence and assurances of a stable and competent background in the administration and conduct of existing programs, if any, and demonstrating the ability to conduct the proposed program in a competent and effective manner.

4012.30 Each applicant shall satisfy the criterion for availability of ancillary services, as required. The standard for satisfying this criterion is by providing evidence and assurances that required ancillary or support services necessary for operation of a proposed facility or service shall be available within the applicant’s existing operation, through supply agreement with another provider, or as a part of the proposal.

4012.31 Each applicant shall satisfy the criterion for relationship of the project to the health care system. The standard for satisfying this criterion is by providing evidence and assurances that clearly define the relationship of the proposed project to existing services and facilities in the health care system, and the effect of the project on other facilities and services, including those of other providers. The applicant shall demonstrate appropriate linkages to ensure continuity of care.

4012.32 The general criteria set forth in Subsections 4012.33 and 4012.34 shall be applicable to applications submitted by HMOs.

4012.33 Each HMO applicant shall satisfy the criterion for need for the project to meet the needs of enrolled members of the HMO (or combination of HMOs) and to meet the needs of reasonably anticipated new members. The standard for satisfying this criterion is by providing evidence and assurances that the proposed project is reasonably required to meet the health care needs of the HMO members or future members who can be expected to use the proposed service or facility.

4012.34 Each HMO applicant shall satisfy the criterion for reasonable availability of the proposed service or facility only through direct provision by the applicant HMO. A proposed service or facility is presumed not to be reasonably available to an HMO other than by direct provision by the HMO (or group of HMOs) unless the Director determines that the proposed facility or service:

(a) Would be available to the HMO under a contract, lease, or similar arrangement of at least five (5) years duration;

(b) Would be reasonably available and conveniently accessible through physicians and other health professionals associated with the HMO (for example, HMO physicians having full staff privileges at a non-HMO hospital);

(d) Would be available in a manner that is administratively feasible to the HMO.

4012.35 The general criteria set forth in Subsections 4012.36 through 4012.40 shall apply to applications proposing decreases in bed capacity or closure of services.

4012.36 If the Director determines that a proposed closure of beds or of a service does not comply with life safety, or licensure codes, the proposed closure shall satisfy the criterion of financial capability of the applicant to bring the facility, beds, or service into compliance with life safety and licensure standards. The standard for satisfying this criterion is by providing evidence and assurances that the applicant is financially incapable of taking actions necessary to bring the beds or service into code or standards compliance.

4012.37 When a proposed closure of beds or of a service is based on the applicant’s claim of financial infeasibility of continued operations, the proposed closure shall satisfy the criterion for financial feasibility of continued operations. The standard for satisfying this criterion is by providing evidence and assurances that, despite operation of the facility in accordance with recognized management procedures and reasonable levels of efficiency, continued operation of the beds or service would produce continuing significant long term financial losses.

4012.38 For proposed bed reductions or service closures not subject to Subsections 4012.36 or 4012.37, the proposed reduction or closure shall satisfy the criterion for consistency of the proposed bed reduction or service closure with the goals of the HSP and AIP. The standard for complying with this criterion is by providing evidence and assurances that the project complies with the goals of the HSP and AIP.

4012.39 For proposed bed reductions or service closures not subject to Subsections 4012.36 or 4012.37, the proposed reduction or closure shall satisfy the criterion for degree of patient impact. The standard for complying with this criterion is by providing evidence and assurances that a proposed reduction or closure will not negatively affect consumers of health care services by causing any of the following:

(a) Substantially increasing the cost of health care;

(b) Substantially reducing the quality of health care;

(d) Substantially reducing the acceptability of health care;

(e) Substantially reducing continuity of health care; or

(f) Substantially reducing the accessibility of health care.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4012

22-B DCMR § 4013 FEES

4013.1 Pursuant to D.C. Official Code § 44-420(a), SHPDA shall collect application fees for a CON request. SHPDA may collect fees for data, analyses, and reports published by SHPDA. SHPDA shall also collect an annual user fee for private hospitals in lieu of a CON application fee. SHPDA may also establish user fees for other classes of facilities. All fees collected under this section shall be non-refundable.

4013.2 Pursuant to D.C. Official Code § 44-420(a), SHPDA may adjust user fees periodically to reflect changes in the Consumer Price Index. User fees stated in this section reflect changes in the Consumer Price Index through 2009. SHPDA may make further adjustments to the user fees by publishing notice of the revised fee in the D.C. Register, and the change shall become effective upon publication of the notice.

4013.3 The schedule of fees for application for CON and user fees shall be as follows:

(a) The CON application fee shall be the greater of three percent (3%) of the proposed capital expenditure for a proposed project or five thousand dollars ($5,000);

(b) The annual user fees for private hospitals shall be four dollars ($4.00) per inpatient admission; and

(c) The CON application fee for a project receiving funds through the Medical Homes DC Initiative, operated by the District of Columbia Primary Care Association shall be five thousand dollars ($5,000).

4013.4 SHPDA may adjust the annual user fee required of private hospitals under § 4013.3(b) to reflect changes in the Consumer Price Index issued by the Bureau of Labor Statistics by publishing the change in fee in the D.C. Register.

4013.5 The schedule of fees for data, analyses, and reports published by SHPDA shall be as follows:

(a) RESERVED.

(b) RESERVED.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4013

22-B DCMR § 4014 RESERVED

22-B DCMR § 4015 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4015

22-B DCMR § 4016 RESERVED

22-B DCMR § 4017 RESERVED

22-B DCMR § 4018 RESERVED

22-B DCMR § 4019 RESERVED

22-B DCMR § 4020 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4020

22-B DCMR § 4021 RESERVED

22-B DCMR § 4022 RESERVED

22-B DCMR § 4023 RESERVED

22-B DCMR § 4024 RESERVED

22-B DCMR § 4025 RESERVED

22-B DCMR § 4026 RESERVED

22-B DCMR § 4027 RESERVED

22-B DCMR § 4028 RESERVED

22-B DCMR § 4029 RESERVED

22-B DCMR § 4030 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4030

22-B DCMR § 4031 RESERVED

22-B DCMR § 4032 RESERVED

22-B DCMR § 4033 RESERVED

22-B DCMR § 4034 RESERVED

22-B DCMR § 4035 RESERVED

22-B DCMR § 4036 RESERVED

22-B DCMR § 4037 RESERVED

22-B DCMR § 4038 RESERVED

22-B DCMR § 4039 RESERVED

22-B DCMR § 4040 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4040

22-B DCMR § 4041 RESERVED

22-B DCMR § 4042 RESERVED

22-B DCMR § 4043 RESERVED

22-B DCMR § 4044 RESERVED

22-B DCMR § 4045 RESERVED

22-B DCMR § 4046 RESERVED

22-B DCMR § 4047 RESERVED

22-B DCMR § 4048 RESERVED

22-B DCMR § 4049 RESERVED

22-B DCMR § 4050 [REPEALED]

History

SOURCE: Final Rulemaking published at 30 DCR 5429 (October 21, 1983); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4050

22-B DCMR § 4099 DEFINITIONS

4099.1 When used in Chapters 40 through 45 of this title, the following terms and phrases shall have the meanings ascribed:

Act—the Health Services Planning Program Re-establishment Act of 1996, effective April 9, 1997 (D.C. Official Code § 44-401 et seq.).

Acute long-term care—services provided by a hospital in a separate unit set aside for patients requiring hospital level care for periods longer than thirty (30) days.

Ambulatory care facility or clinic—

(1) An institution, place, or building devoted primarily to providing health care services to outpatients through any organizational arrangement other than solely through the private practice of one (1) or more physicians acting as a sole practitioner or a group practice. A group practice shall not include any arrangement in which one (1) or more physicians are hired as employees, as contractors, or other comparable arrangement to provide health services. This term does not include facilities maintained by employers solely to provide first aid or primary health care services to their employee during the employee’s hours of work. This term does not include a health fair that continues for less than seven (7) days;

(2) An entity that received federal grant support, a block grant, or other program for the operation of a community or neighborhood health center; or

(3) An entity that receives donations for providing health services to outpatients.

Ambulatory surgical facility—a facility that is not a part of a hospital that provides surgical treatment to patients not requiring hospitalization and that is licensed or proposed to be licensed as an ambulatory surgical treatment center by the District under the Health-Care and Community Residence Facility, Hospice and Home Care Licensure Act of 1983, effective February 24, 1984 (D.C. Law 5-48; D.C. Official Code § 44-501 et seq.).

Annual Implementation Plan or AIP—the annual plan prepared by SHPDA and SHCC to specify actions that will achieve the goals and objectives of the State Health Systems Plan.

Applicant—a person who consults with SHPDA before applying for a CON or a person who applies for a CON.

Certificate of Need or CON—the documentation demonstrating approval from SHPDA that is required before a person may offer or develop a new institutional health service or obligate a capital expenditure to obtain an asset.

Director—the Director of the SHPDA of the Department of Health.

Ex parte contact—an oral or written communication not on the official record where reasonable contemporaneous notice to all parties is not given.

Freestanding hemodialysis facility—a kidney disease treatment facility, not located within a hospital, that provides chronic maintenance hemodialysis services.

General hospital—an institution that primarily provides to inpatients, by or under the supervision of physicians, diagnostic services and therapeutic services for medical diagnosis, treatment, and care of injured, disabled, or sick persons, or rehabilitation services for the rehabilitation of injured, disabled, or sick persons, and that is licensed or proposed to be licensed as a hospital by the District government.

Health care facility or HCF—a private general hospital, psychiatric hospital, other specialty hospital, rehabilitation facility, skilled nursing facility, intermediate care facility, ambulatory care center or clinic, ambulatory surgical facility, kidney disease treatment center, freestanding hemodialysis facility, diagnostic health care facility, home health agency, hospice, or other comparable health care facility that has an annual operating budget of at least five hundred thousand dollars ($500,000). This term shall not include Christian Science sanitariums, operated, listed, and certified by the First Church of Christ Scientist, Boston, Massachusetts; the private office facilities of a health professional or group of professionals, where the health professional or group of health professionals provides conventional office services limited to medical consultation, general non-invasive examination, and minor treatment, or a health facility licensed or to be licensed as a community residence facility, or an Assisted Living Residence.

Health Maintenance Organization or HMO—a private organization that is a qualifying HMO under federal regulations or has been determined to be an HMO under 22 DCMR Chapters 40 through 45.

Health service—a medical or clinical related service, including a service that is diagnostic, curative, or rehabilitative, and those related to alcohol abuse, drug abuse, inpatient mental health services, home health care, hospice care, medically supervised day care, and renal dialysis. This term shall not include services provided by physicians, dentists, HMOs, and other individual providers in individual or group practice.

Health Systems Plan or HSP—the comprehensive health plan prepared by SHPDA and the SHCC according to the requirements of the Act.

Home health agency—a public agency or private organization, or a subdivision of an agency or organization, that is primarily engaged in providing skilled nursing services and at least one (1) other therapeutic service to individuals in their residences, that has at least one (1) employee in addition to the proprietor if the agency is a sole proprietorship. This term does not include an entity that provides only housekeeping services.

Inpatient—the provision of health care services over a period of twenty-four (24) consecutive hours or longer.

Intermediate care facility or ICF—an institution that provides, on a regular basis, health-related care and services to individuals who do not require the degree of care and treatment which a hospital or skilled nursing facility provides, but who, because of their mental or physical condition, require health-related care and services (above the level of room and board), that is licensed or proposed to be licensed as an intermediate care facility by the District government.

Other specialty hospital—an institution primarily engaged in providing to inpatients diagnosis and treatment for the limited category of illness or illnesses for which the institution is or proposes to be licensed as a “special hospital” by the District government. The term does not include a psychiatric hospital, rehabilitation facility, or rehabilitation hospital.

Outpatient—the provision of health care services over less then twenty-four (24) consecutive hours.

Psychiatric hospital—an institution that primarily provides to inpatients, by or under the supervision of a physician, specialized services for the diagnosis, treatment, and rehabilitation of mentally ill and emotionally disturbed persons, that is licensed or proposed to be licensed as a hospital by the District government.

Rehabilitation facility or rehabilitation hospital—a facility that is operated for the primary purpose of assisting in the rehabilitation of disabled persons through an integrated program of medical and other services which are provided under competent professional supervision, and that, if it serves inpatients, is licensed or proposed to be licensed as a “special hospital” by the District government.

Skilled nursing facility or SNF—an institution or a distinct part of an institution that primarily provides to inpatients skilled nursing care and related services for patients who require medical or nursing care, or rehabilitation services for the rehabilitation of injured, disabled, or sick persons, that is licensed or proposed to be licensed as a skilled nursing facility by the District government.

Year—unless otherwise indicated, any period of three hundred sixty-five (365) consecutive days.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4099

22-B41 CERTIFICATE OF NEED REVIEW

22-B DCMR § 4100 NEW HEALTH SERVICES

4100.1 Except for a new institutional health service offered solely for research, no person shall construct, develop, or otherwise establish a new institutional health service including a new health care facility, health care service, or home health or nursing service without first obtaining a CON. A person establishing a new institutional health service solely for research shall notify SHPDA in writing of its intent to do so and the purpose of the new institutional health service.

4100.2 The following shall be institutional health services for purposes of this title:

(a) Acute medical-surgical services not otherwise specified;

(b) Cardiac catheterization services;

(d) Coronary care services;

(e) Computed tomography services;

(f) Neonatal intensive care services;

(g) Newborn services;

(h) Obstetric services;

(i) Pediatric services;

(j) Pediatric cardiac surgery services;

(k) Physical medicine and rehabilitation services;

(l) Psychiatric care services, short-term;

(m) Psychiatric care services, long-term;

(n) Emergency medical services;

(o) Physical therapy services;

(p) Occupational therapy services;

(q) Home health services;

(r) Hospice care;

(s) Diagnostic radiology and ultrasound services;

(t) Radiation therapy services;

(u) Burn services;

(v) Ambulatory surgery services;

(w) Primary care centers’ services;

(x) Alcoholism-chemical dependency services

(y) Acute long-term services;

(z) Skilled nursing services;

(aa) Acute dialysis services, including inpatient hemodialysis and inpatient intermittent peritoneal dialysis;

(bb) Outpatient staff-assisted in-facility chronic maintenance hemodialysis services;

(cc) Outpatient self-care in-facility chronic maintenance hemodialysis services, including training;

(dd) Outpatient self-care in-facility intermittent peritoneal dialysis services, including training;

(ee) Training for home intermittent peritoneal dialysis;

(ff) Training and follow-up services for continuous ambulatory peritoneal dialysis;

(gg) Renal dialysis services based on dialysis technologies not otherwise specified;

(hh) Renal transplantation services;

(ii) New technology as determined by SHPDA;

(jj) Transplant services; and

(kk) Open heart surgery.

4100.3 The Director may periodically assess and update the list set forth in Subsection 4100.2, as warranted by changes in medical technology and practice, and may add a health service to the list when, in his or her judgment, a new medical technique is of a highly specialized nature.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4100

22-B DCMR § 4101 NEW HEALTH SERVICES DETERMINATIONS

4101.1 A person shall request a determination from SHPDA as to whether a new technique constitutes a new institutional health service subject to review before offering any new medical technique of a highly specialized nature not appearing on SHPDA list of health services.

4101.2 No person shall offer any new medical technique, other than for research or emergency purposes, before receiving a final determination from SHPDA that the technique does or does not constitute a new health service.

4101.3 The Director shall make a determination whether a medical technique constitutes a new health service within one hundred twenty (120) days after receiving the request. SHPDA may request additional documentation from the person in support of the request to assist SHPDA in making its determination.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4101

22-B DCMR § 4102 CAPITAL EXPENDITURES

4102.1 Except for a capital expenditure made solely for research, no person shall make or obligate a capital expenditure for a health service or facility before first obtaining a CON if:

(a) The capital expenditure is two million five hundred thousand dollars ($2,500,000) or more;

(b) The capital expenditure is for major medical equipment valued at one million five hundred thousand dollars ($1,500,000) or more; or

(c) The capital expenditure is for a single piece of diagnostic equipment for which the cost or value is two hundred fifty thousand dollars ($250,000) or more.

4102.2 A person intending to make a capital expenditure solely for the purpose of research shall notify SHPDA of its intent in writing and describe the nature of the capital expenditure to be made for research purposes.

4102.3 For the purposes of this section, capital expenditure includes the cost of any studies, surveys, designs, plans, working drawings, specifications, or other services (including staff effort) associated with the capital expenditure.

4102.4 A capital expenditure unrelated to patient care valued at eight million dollars ($8,000,000) or more, by an existing health facility shall require CON review unless the facility or activity is specifically exempted from CON review.

4102.5 A capital expenditure by a non-health facility component of a larger institution that also includes a hospital or other health facility or service (such as those made by a university or medical school that operates a hospital) shall not be treated as relating to the health service or facility unless either of the following applies:

(a) Any part of the capital expenditure is made by or represents an obligation of the health facility or service component; or

(b) The expenditure actually or potentially directly affects patient charges or the cost of providing care.

4102.6 An obligation for a capital expenditure shall be considered to be incurred by or on behalf of a health care facility:

(a) On the date that a health care facility, or another entity on behalf of the HCF, enters into a contract enforceable under law for the construction, acquisition, lease, or financing of a capital asset;

(b) On the date that the governing board of the health care facility takes formal action to commit its own funds for a construction project undertaken by the HCF as its own contractor; or

4102.7 An obligation for a capital expenditure that is contingent on the issuance of a CON shall be considered not to be incurred until SHPDA issues the CON.

4102.8 The provisions of Subsection 4102.1 shall not limit any form of preliminary budget approval for inclusion in the budget by the applicant’s administrative review authority.

4102.9 Budget inclusion shall be a prerequisite for submitting a complete application for a CON.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4102

22-B DCMR § 4103 MAJOR MEDICAL EQUIPMENT

4103.1 Except for the acquisition of major medical equipment solely for research, no person or HCF shall acquire (in whole or in part) through lease, rental, donation, or any comparable arrangement, or put into operation, major medical equipment (a single unit or system with related functions) without first obtaining a CON.

4103.2 A HCF acquiring major medical equipment solely for research shall notify SHPDA in writing of its intent to acquire the equipment and describe the use to be made of the major medical equipment.

4103.3 If major medical equipment is acquired by a lease or comparable arrangement, or any other type of transfer by two (2) or more persons acting in concert, and if the aggregate cost of the acquisition would be one million five hundred thousand dollars ($1,500,000) or more, or two hundred fifty thousand dollars ($250,000) or more for a single piece of diagnostic equipment, if the acquisition had been by purchase at fair market value, the acquisition shall be deemed an acquisition of major medical equipment requiring CON review, notwithstanding that the cost or value to each participating person of that acquisition may be less than the monetary threshold for major medical equipment.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4103

22-B DCMR § 4104 REVIEW OF PROPOSALS: BEDS

4104.1 No person shall increase, decrease, or redistribute among health service categories the bed capacity of a HCF by ten percent (10%) or ten (10) beds, whichever is less, in any two (2) year period.

4104.2 The distribution of bed types shall use the following categories:

(a) Medical-surgical;

(b) Coronary care;

(d) Obstetrics-gynecology;

(e) Normal nursery and neonatal intermediate care;

(f) Neonatal Intensive care;

(g) Pediatrics;

(h) Alcoholism, chemical dependency;

(i) Rehabilitation;

(j) Extended acute long-term care;

(k) Medical-surgical or skilled nursing;

(l) SNF;

(m) ICF; and

(n) Skilled nursing or intermediate care (swing in a facility licensed as both a SNF and ICF).

4104.3 A person may lawfully close a bed without obtaining a CON under the following circumstances:

(a) A HCF has not staffed or otherwise held the bed ready for immediate use by patients for twelve (12) consecutive months; and

(b) The bed, when taken together with the sum of all other beds closed and opened does not represent a net change of more than ten (10) beds or ten percent (10%) of the total number of beds authorized in the HCF or particular service during the twenty-four (24) month period preceding the closure.

4104.4 The date on which the HCF removes the last patient from a recognized unit shall begin the consecutive twelve (12) month period under Subsection 4104.3(a) for every bed in the unit proposed for closure.

4104.5 Reopening one (1) or more beds by re-staffing it and otherwise holding it ready for immediate use, while at the same time removing staff and otherwise removing the same or a similar number of other beds of the same general type from immediate use by patients shall not constitute the beginning of another consecutive twelve (12) month period.

4104.6 Rotating short-term suspensions of individual beds or units shall not be used to circumvent the consecutive twelve (12) month period specified in Subsection 4104.3(a).

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4104

22-B DCMR § 4105 REVIEW OF PROPOSALS: NEW SERVICES

4105.1 No person shall offer an institutional health service by or through an HCF that was not offered by the same HCF on a regular basis within the twelve (12) month period before the time the service would begin without first obtaining a CON.

4105.2 For purposes of this section, the term “offer a service on a regular basis” shall mean being staffed and otherwise prepared to deliver the service at all times or on a regularly scheduled basis. Inability to deliver a service as scheduled for reasons beyond the control of the provider in emergency situations of short duration shall not affect a provider’s offering of a service on a regular basis.

4105.3 A service offered “through” an HCF or an HMO includes a service that is offered to a substantial extent (as determined by SHPDA) on behalf of that institution by others and not offered physically in the institution subject to review.

4105.4 A service offered at a different facility shall not satisfy the requirement that the service has been offered on a regular basis.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4105

22-B DCMR § 4106 REVIEW OF PROPOSALS: RENAL DIALYSIS

4106.1 No person shall increase the number of renal dialysis stations in an HCF or health service or move stations from one HCF to another without first obtaining a CON.

4106.2 For purposes of this section, a “renal dialysis station” means a station certified for participation in the Federal End Stage Renal Disease (ESRD) Program under Medicare, or an equivalent station.

4106.3 Renal dialysis stations shall be categorized into the following types, with each type considered a separate health care service:

(a) Acute dialysis services, including inpatient hemodialysis and inpatient intermittent peritoneal dialysis;

(b) Outpatient staff-assisted, in-facility, chronic maintenance hemodialysis services;

(d) Outpatient self-care, In-facility, Intermittent peritoneal dialysis services, including training;

(e) Training for home intermittent peritoneal dialysis; and

(f) Any other dialysis service approved by the Director.

4106.4 An increase in renal dialysis services not involving stations may be subject to CON review under other provisions of Chapters 40 through 45 of this title.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4106

22-B DCMR § 4107 REVIEW OF PROPOSALS: CLOSURES

4107.1 No person shall permanently close a health care facility or health service, without notifying SHPDA, in writing and obtaining its approval.

4107.2 For purposes of this section, the phrase “permanently close a health care or service” means removing staff or equipment necessary to operate a facility or service for a period longer than twelve (12) consecutive months.

4107.3 Removing equipment shall include allowing equipment that is not operational to remain in place.

4107.4 The date of the removal for inpatient facilities is the date that the last patient is removed from the facility and shall be the beginning of the twelve (12) consecutive month period under Subsection 4107.2.

4107.5 An HCF shall maintain nurse staffing schedules, daily patient census, and other relevant records so that compliance with the requirements of this section may be readily demonstrated, and shall permit SHPDA inspection of those records upon request.

4107.6 A person proposing to permanently close an HCF or health service shall notify SHPDA of the proposed closing not later than ninety (90) days before the proposed closing.

4107.7 The notice required by Subsection 4107.6 shall include the following information:

(a) A description of what is to be closed;

(b) The name of the owner of the HCF or health service to be closed;

(d) The number, type, and condition of patients affected;

(e) The provisions that the provider is making for the continuing care of the affected patients; and

(f) A detailed explanation for the closure.

4107.8 SHPDA shall provide assistance for an orderly transition of patient care to the extent possible.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4107

22-B DCMR § 4108 ACQUISITIONS

4108.1 No person shall acquire an existing HCF by purchase, lease, or other arrangement to acquire effective control over a facility without first obtaining a CON.

4108.2 For purposes of this section, the phrase “acquire effective control” includes:

(a) A transfer, assignment or other disposition of fifty per cent (50%) or more of the stock, voting rights thereunder, ownership interest, or operating assets of the corporation or entity;

(b) A transaction resulting in a person, or a group of persons acting in concert, owning or controlling, directly or indirectly, fifty per cent (50%) or more of the stock, voting rights thereunder, ownership interest, or operating assets of the corporation or entity;

(c) A transaction resulting in a person, or a group of persons acting in concert, having the ability to elect or cause the election of a majority of the board of directors of a corporation or entity; or

(d) A conversion that results in selling, transferring, leasing, exchanging, conveying, or otherwise disposing of, directly or indirectly, all the assets or a material amount of the assets of a nonprofit HCF to a for-profit entity, whether a corporation, mutual benefit corporation, limited liability partnership, general partnership, joint venture, or sole proprietorship, including an entity that results from, or is created in connection with, the conversion.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4108

22-B DCMR § 4109 HEALTH MAINTENANCE ORGANIZATIONS

4109.1 A Health Maintenance Organization (HMO), or combination of HMOs, shall obtain a CON before undertaking any activity for which a CON is required unless it applies for and receives an exemption from SHPDA under this section.

4109.2 In its application for exemption, the HMO, or combination of HMOs, shall provide information to demonstrate the following:

(a) The facility in which the service will be provided is or will be geographically located in a place that is reasonably accessible to the enrolled individuals; and

(b) At least seventy-five percent (75%) of the patients who can reasonably be expected to receive the health service will be individuals enrolled in the HMO (or HMOs in combination).

4109.3 SHPDA shall grant a HMO an exemption under this section after a review of not more than fifteen (15) days if it has not begun to provide health care services on the date an application is submitted for an exemption and it satisfies the criteria in Subsection 4109.2.

4109.4 Any decision by SHPDA to approve or deny an application for an HMO exemption shall be based solely on the record established in the administrative proceedings held with respect to the application.

4109.5 No exemption shall be granted solely because SHPDA failed to reach a decision within the fifteen (15) day review period.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4109

22-B DCMR § 4110 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4110

22-B DCMR § 4111 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4111

22-B DCMR § 4112 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4112

22-B DCMR § 4113 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4113

22-B DCMR § 4114 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4114

22-B DCMR § 4115 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4115

22-B DCMR § 4116 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4116

22-B DCMR § 4117 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4117

22-B DCMR § 4118 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4118

22-B DCMR § 4119 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4119

22-B DCMR § 4120 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4120

22-B DCMR § 4121 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4121

22-B DCMR § 4199 DEFINITIONS

4199.1 The provisions of Section 4099 of this title, and the definitions set forth in that section shall apply to this chapter.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4199

22-B42 APPLICATION FOR CERTIFICATE OF NEED REVIEW

22-B DCMR § 4200 SUBMISSION OF APPLICATIONS

4200.1 An applicant shall submit an application for a CON in writing on a form prescribed by SHPDA. The form shall contain the information that SHPDA uniformly prescribes and publishes as requirements for a CON.

4200.2 An application for major medical equipment or a capital expenditure shall specify the applicant’s proposed timetable to make that service or equipment available and to complete the project, as well as other information SHPDA shall require for evaluating the application under the appropriate review criteria, the State Health Plan, and the requirements of the District of Columbia Health Services Planning Program Re-Establishment Act of 1996, (D.C. Official Code § 44-401 et seq.).

4200.3 SHPDA shall use a single form for each type of application, except transfer of ownership, even though not all questions on the form may be relevant for a particular type of application. SHPDA, in a pre-application meeting between the applicant and an assigned SHPDA staff member, shall specify for each applicant the questions that require responses for that application.

4200.4 If SHPDA determines that an application is incomplete, and that additional information is needed to evaluate the application, SHPDA shall request additional information from the applicant pursuant to the requirements of Subsections 4200.5 through 4200.7. The information requirements may vary according to the purpose of the review or the type of health service being reviewed.

4200.5 A request from SHPDA for information from the applicant pursuant to § 4200.4 and in connection with a CON review shall be in writing and limited to the information that is necessary for SHPDA and SHCC to perform their reviews.

4200.6 SHPDA shall notify the applicant in writing when it has determined that the application is complete.

4200.7 SHPDA may review an application that has not been determined to be complete if the applicant has declined to provide further information and shall base its findings on the information available from the applicant that will demonstrate that the application complies with the HSP or the applicable criteria and standards for the service or HCF.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4200

22-B DCMR § 4201 [RESERVED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4201

22-B DCMR § 4202 REVIEW PROCESS

4202.1 SHPDA shall begin a review at the beginning of one (1) of twelve (12) review cycles to be held each calendar year.

4202.2 The regular or expedited review cycles for an application shall be determined by the day on which the application is complete or deemed complete upon refusal of the applicant to supply further information. The review cycle for a CON application shall begin on the twentieth (20th) day of each month, or on the first (1st) business day following, if that day falls on a weekend or holiday. The review period for a regular review shall end ninety (90) days after the beginning of the review cycle. The review period for an expedited review shall end thirty (30) days after the beginning of the review cycle.

4202.3 SHPDA shall complete the review within the time period specified in Subsection 4202.2 unless the applicant requests, and SHPDA approves, an extended review period.

4202.4 If SHPDA fails to approve or deny an application within the applicable time period, the applicant may, within a reasonable period of time following expiration of the applicable time period, bring an action in Superior Court to require SHPDA to approve or deny the application. No CON shall be issued solely because SHPDA failed to reach a decision within the specified review period.

4202.5 An applicant may request in writing to SHPDA that either the regular ninety (90) day review period or the thirty (30) day expedited review period be extended for up to twelve (12) months. SHPDA may grant an extension of the review period for a period of time that is not longer than the applicant’s request.

4202.6 For a batched review, a request for extension of the review period shall affect each application in the batched review. The request for extension of time to complete the review shall not be granted unless there is agreement to the extension of time from each applicant involved in that particular batched review.

4202.7 If SHPDA denies an extension of time for a batch review, the requesting party may:

(a) Go forward with the batch review;

(b) Request review of the application at a later date; or

4202.8 If SHPDA or SHCC requires additional information necessary to performing the review after the review period has begun, an applicant shall have fifteen (15) days to provide the information. The applicant’s response time shall extend the ninety (90) day review period.

4202.9 If SHPDA finds it impractical to complete a review within ninety (90) days, SHPDA may extend the review period for the following administrative reasons:

(a) When an application modification is extensive but not so substantial as to require withdrawal and resubmission under Subsections 4203.1 and 4203.3;

(b) When the SHCC or a SHCC committee requests that SHPDA perform additional staff analysis of an application modified as described in paragraph (a) of this subsection and in accordance with § 4202.9 after the staff has substantially completed the initial analysis;

(c) When there is a sudden or unexpected major disruption of normal SHPDA operations, including those resulting from utility failure, natural disasters, and equipment failure; or

(d) When a public hearing is held during the review period.

4202.10 When there is an administrative extension of the review process as provided in Subsection 4202.9, SHPDA shall complete the review as expeditiously as is reasonable in the circumstances, and shall inform the applicant and other affected persons of the projected timetable for completing the review.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4202

22-B DCMR § 4203 SUBSTANTIAL MODIFICATION OF APPLICATION

4203.1 When an applicant proposes a substantial modification of a CON application the applicant may be required to withdraw the original application and submit a new application reflecting the modifications.

4203.2 The new application constitutes a wholly separate application and is subject to all elements of the review process, including submission of a Letter of Intent for the new application. SHPDA shall waive the sixty (60) day waiting period following the submission of a Letter of Intent for the submission of a new application when the application results from substantial modification of an original application.

4203.3 For purposes of this section, the term "substantial modification" includes:

(a) A change in the location of the facility to a different Advisory Neighborhood Commission, service, or the type of facility or service;

(b) A change in the proposed capital expenditure budget of thirty percent (30%) or more;

(c) A change increasing or decreasing patient load or units of service by forty percent (40%) or more from the capacity originally proposed; or

(e) A change in the ownership or effective control of the entity seeking to obtain a CON that, if the entity already held a valid CON, would cause the revocation of the CON under Section 4009 of this title.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4203

22-B DCMR § 4204 MORATORIUM ON APPLICATIONS

4204.1 If SHPDA determines that it needs additional time to develop and adopt CON application review criteria and standards for specific types of facility or service, SHPDA may impose a moratorium on consideration of all applications for that specific type of facility or service for which a review has not begun.

4204.2 For the purposes of this section, development and adoption of CON application review criteria and standards shall include development and adoption of, or revision of, the HSP if the HSP will contain the required criteria and standards.

4204.3 A moratorium imposed pursuant to Subsection 4204.1 shall last for not more than one hundred twenty (120) days in a twelve (12) month period.

4204.4 SHPDA shall give general notice in a newspaper of general circulation within the District of Columbia and on the Department of Health website of the terms and conditions of the moratorium within fifteen (15) days after a decision to declare a moratorium on a specific type of facility or service. SHPDA shall also give specific notice within 15 days to:

(a) The SHCC; and

(b) Every person who has submitted a Letter of Intent.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4204

22-B DCMR § 4205 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4205

22-B DCMR § 4206 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4206

22-B DCMR § 4207 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4207

22-B DCMR § 4208 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4208

22-B DCMR § 4209 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4209

22-B DCMR § 4210 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4210

22-B DCMR § 4299 DEFINITIONS

4299.1 The provisions of § 4099 of Chapter 40 of this title, and the definitions set forth in that section, shall apply to this chapter.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4299

22-B43 CERTIFICATE OF NEED REVIEW PROCEDURES

22-B DCMR § 4300 GENERAL PROVISIONS

4300.1 An application that SHPDA determines to be complete by the tenth (10th) day of any month shall be reviewed during the review that begins on or after the twentieth (20th) day of the same month.

4300.2 An application that SHPDA determines to be complete after the tenth (10th) day of any month shall be reviewed during the next regular review that begins on or after the twentieth (20th) day of the following month.

4300.3 SHPDA shall conduct batched reviews for the types of applications specified in the following schedule:

APPLICATION TYPE MONTHS

Alcoholism/chemical dependency services January, July

Diagnostic radiology and ultrasound services February, August

Home health services April, October

Renal disease services March, September

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4300

22-B DCMR § 4301 REGULAR AND EXPEDITED REVIEWS

4301.1 SHPDA shall review each CON application by either a regular or an expedited process.

4301.2 Except as provided in Subsection 4301.3, the expedited review process shall be used for each application that proposes major medical equipment or a new institutional health service for which there is an explicit finding of need in the HSP.

4301.3 SHPDA shall not conduct an expedited review for an otherwise qualified project related to a service for which the HSP states there is an excess of capacity or that has not been included in the HSP.

4301.4 SHPDA shall review an application through the regular review process at the request of an applicant even though the application qualifies for expedited review.

4301.5 The Director shall render a written decision regarding a request for expedited review. A person may request reconsideration of the decision in writing upon providing good cause. A request for reconsideration shall not be referred to the SHCC.

4301.6 The results of an expedited review shall be reported to the SHCC at the next regularly scheduled SHCC meeting.

4301.7 SHPDA shall use the same criteria and standards that apply to projects reviewed by the regular process for an application that will receive expedited review, and designation for expedited review shall in no way imply automatic approval of the application by SHPDA.

4301.8 The expedited review process differs from the regular review process as follows:

(a) An application reviewed through the expedited process shall not be referred to the SHCC for review and comment before the Director approves or denies an application; and

(b) An expedited review shall be completed within thirty (30) days after receipt of a completed application.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4301

22-B DCMR § 4302 PUBLIC HEARINGS

4302.1 SHPDA may call a public hearing on its own initiative on an application during the first thirty (30) days of the CON application review period.

4302.2 SHPDA shall also call a public hearing at the request of an affected person. The request for public hearing shall be in writing and submitted no later than thirty (30) days after the beginning of the review period or the date of notice required pursuant to Subsection 4302.6, whichever is later.

4302.3 For the purposes of this section, an affected person includes:

(a) The applicant;

(b) A person who participated in the proceedings before SHPDA or the Office of Administrative Hearings;

(d) A person who resides within the boundaries of the Advisory Neighborhood Commission where the facility or service will be located or provide services;

(e) An HCF or HMO located in the health service area in which the project is proposed to be located that provides services similar to the services of the facility under review;

(f) An HCF or HMO that, prior to SHPDA’s receipt of the proposal being reviewed, has formally indicated an intention to provide similar services in the future;

(g) A third party payer who reimburses an HCF for services in the health service area in which the project is proposed to be located; and

(h) A person who regularly uses an HCF within the geographic area where the facility or service is to be located or provided.

4302.4 An affected person shall have the right to be represented by counsel and to present oral or written testimony and evidence relevant to the matter that is the subject of the public hearing.

4302.5 SHPDA shall maintain a verbatim electronic record of the public hearing.

4302.6 RESERVED

4302.7 The notice shall include:

(a) The name of the applicant;

(b) The service to be provided;

(d) The date, time, and location of the meeting;

(e) The planned hearing agenda; and

(f) A description of matter to be discussed.

4302.8 SHPDA shall hold the public hearing no sooner than fourteen (14) days after the date of the notice of the public hearing.

4302.9 SHPDA shall not charge a fee to hold a public hearing.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4302

22-B DCMR § 4303 STATEWIDE HEALTH COORDINATING COUNCIL

4303.1 Unless SHPDA has determined that it cannot complete a regular review within ninety (90) days for a reason specified in § 4200 or the Applicant has requested postponement of the review, SHPDA shall forward to the members of the appropriate SHCC committee or the entire SHCC, as directed by the SHCC, a staff analysis of an application being reviewed under the regular review process no later than fifty-five (55) days after the beginning of the regular review process.

4303.2 SHPDA analysis under Subsection 4303.1 shall include positive and negative aspects of the application in relation to the HSP and adopted criteria.

4303.3 After SHCC receives SHPDA staff analysis, the SHCC shall review and comment on the application pursuant to the SHCC by-laws.

4303.4 A SHCC member who has a conflict of interest concerning an application shall follow the provisions of the SHCC by-laws regarding conflicts of interest.

4303.5 During the SHCC review and before the SHCC adopts a formal recommendation, the SHCC may require a public hearing on the application.

4303.6 The Director shall schedule a public hearing required by the SHCC pursuant to Subsection 4303.5 pursuant to the procedures specified in Section 4302. The Director shall provide notice for meetings of the SHCC according to the procedures set forth in Subsections 4302.5 through 4302.7. The Director shall make the minutes and hearing record available according to the requirements set for in Subsection 4302.10.

4303.7 If the SHCC fails to make a recommendation concerning an application within eighty (80) days after receiving the SHPDA staff analysis, the Director may render a decision on the CON application without the advice of the SHCC.

4303.8 The Director shall consider a timely made recommendation of the SHCC in making a decision.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4303

22-B DCMR § 4304 INSPECTION OF RECORDS

4304.1 Except as provided in Subsection 4304.3, a person may inspect a CON application and other information contained in SHPDA project files during regular business hours.

4304.2 A person may receive a copy of a document subject to inspection upon the payment of a reasonable fee to cover the cost of reproduction.

4304.3 A person shall not inspect or copy a portion of a CON application or other document related to a CON application that contains detailed technical descriptions of proprietary financial information, security systems, medical records systems, or controlled substance storage systems if SHPDA designates that portion of an application as “restricted”.

4304.4 SHPDA may designate a portion of a CON application as “restricted” by the following procedures:

(a) The applicant shall make a written request to SHPDA to restrict the material at the time the applicant submits the application;

(b) SHPDA shall maintain the material to be categorized as “restricted” separate from the remainder of the CON application retained in SHPDA files until it renders a decision about whether the material should be restricted;

(c) The SHPDA staff person in charge of the CON review shall make a determination whether the information in question would provide information for a person to violate the security of the system in question or reveal proprietary information that would give a competitor an unfair advantage; and

(d) If SHPDA agrees to restrict material, the applicant shall provide a non-restricted and non-technical summary of the “restricted” material and submit the original information printed on paper, other than white or blue, and marked on each page at top and bottom with the statement “Restricted Security System Information; Not for Public Inspection.”

4304.5 If the applicant disagrees with the SHPDA staff person in charge of the CON review concerning a request for classifying material as “restricted,” the applicant may appeal the decision by making a written request for a meeting to review the matter with the Director, who shall make the final decision.

4304.6 An applicant shall not submit medical records that identify individual patients to SHPDA. Any patient record the applicant provides to SHPDA that includes personal identifying information, such as copies of driver’s licenses, social security cards, that is submitted inadvertently shall not be available for public inspection.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4304

22-B DCMR § 4305 EX PARTE CONTACTS

4305.1 There shall be no ex parte contacts between:

(a) A person acting on behalf of the applicant or a CON holder, or any person opposed to or in support of issuing or modifying a CON or in favor of withdrawing a CON; and

(b) A person in SHPDA who exercises responsibility for reviewing the application or withdrawing the application.

4305.2 There shall be no oral ex parte contacts after the commencement of a hearing for an application for a CON, a proposed modification, or withdrawal of a CON and until SHPDA makes a decision. An interested person, including the applicant, may make written ex parte contacts to the SHPDA after commencement of the hearing if SHPDA keeps the hearing record open after the hearing.

4305.3 When SHPDA will not hold a hearing for a CON, a proposed modification, or a withdrawal, there shall be no oral ex parte contacts after the conclusion of the project review committee meeting for that application. An interested person, including the applicant, may make written ex parte contacts after the conclusion of the project review committee meeting if the project review committee allows additional time for an interested party to supply additional information.

4305.4 If a SHPDA staff person or SHCC member receives an ex parte contact prohibited under this section, he or she shall, within forty-eight (48) hours after first having reason to believe that there was a prohibited contact, prepare and deliver a written statement summarizing the substance of an oral contact or the written communication, or a copy, to the Director’s designee, or deliver to the person the Director designates.

4305.5 The Director or his or her designee shall make the statements or contacts available for inspection by placing them in a file separate from the public record of the application or proposed withdrawal under review.

4305.6 If a member of SHCC occupies an employment, fiduciary, consulting, or other similar relationship (as described in the SHCC by-laws provision governing conflict of interest) with an applicant or a CON holder, the SHCC member shall be considered to be acting on behalf of the applicant or CON holder; and any contact between the SHCC member and SHPDA staff, Director, or other SHCC members occurring in the period specified in Subsection 4305.2 shall be subject to the ex parte contacts prohibition of this section, provided that the contacts are related to the matter in question.

4305.7 For purposes of this section, the phrase “SHPDA staff” shall include the Director, staff, and the SHCC.

4305.8 A request for information concerning the status of a review made in accordance with Section 4201 shall not be considered an ex parte contact.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4305

22-B DCMR § 4306 CLOSING THE PROJECT RECORD

4306.1 The record for a decision on issuing or modifying a CON shall close at the end of the second (2nd) business day following the meeting of a Committee of the SHCC at which the Committee makes the initial recommendation on the application; provided, that the record shall include those proceedings of the SHCC during which the application was considered, concluding with the final SHCC vote taken on the application.

4306.2 When SHPDA conducts an expedited review the record shall close five (5) business days before the date of decision.

4306.3 The Director may order that the record remain open for a longer period of time if the Director determines that keeping the record open is necessary to ensure an adequate record.

4306.4 The SHCC and the Director shall not consider information received from a person after the date specified in the notice (unless the Director extends the record) to make a recommendation or render a decision on an application.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4306

22-B DCMR § 4307 CONSIDERATIONS AND CRITERIA FOR REVIEW

4307.1 SHPDA and the SHCC, shall develop, adopt, and use general criteria and standards set forth in Section 4012 of this title and the specific considerations and criteria in this section to conduct a CON review. The applicant shall bear the burden of producing evidence and assurances sufficient to persuade the Director that the applicant can satisfy the requirements of each applicable criterion or standard.

4307.2 SHPDA shall evaluate an HMO, an ambulatory care facility, or HCF that is controlled, directly or indirectly, by an HMO or combination of HMOs, by the criteria and considerations set forth in Subsection 4307.15.

4307.3 A review may consider the relationship between the health services being proposed and the applicable AIP and HSP. Each decision of SHPDA, or the appropriate judicial or administrative review body, to issue a CON shall be consistent with the HSP, except in emergency circumstances that pose an imminent threat to public health.

4307.4 A review may consider the availability of less costly or more effective alternative methods of providing the services to be offered, expanded, reduced, relocated, or eliminated.

4307.5 A review may consider the immediate and long-term financial feasibility of the proposal, and the probable impact of the proposal on the costs of and charges for providing health services by the person proposing the service.

4307.6 A review may consider the need that the population served or to be served has for the services proposed to be offered or expanded, and the extent to which all residents of the area, particularly low income persons, racial and ethnic minorities, women, persons with disabilities, the elderly, or other underserved groups, are likely to have access to those services.

4307.7 A review may consider the contribution of the proposed service in meeting the health related needs of members of medically underserved groups that have traditionally experienced difficulties in obtaining equal access to health services (such as low income persons, racial and ethnic minorities, women, and persons with disabilities), particularly those needs identified in the applicable AIP and HSP as deserving priority.

4307.8 SHPDA may consider the following for the purpose of determining accessibility of the proposed service:

(a) The rate at which medically underserved populations currently use the applicant’s services as compared to the percentage of the population in the applicant’s service area that is medically underserved, and the rate at which medically underserved populations are expected to use the proposed services;

(b) The applicant’s performance with meeting its obligation, if any, under any applicable federal and District regulations requiring the applicant to provide uncompensated care, community service, or access by minorities, and persons with disabilities to programs receiving Federal financial assistance (including the existence of any civil rights access complaints against the applicant);

(d) The extent to which the applicant offers a range of means for a person to access its services (e.g., outpatient services, admission by house staff, admission by personal physicians).

4307.9 A review may consider the relationship of the services proposed to be provided to the existing health care delivery system.

4307.10 A review may consider the availability of resources (including health personnel, management personnel, and funds for capital and operating needs) for providing the services proposed to be provided and the need for alternative uses for those resources as identified by the applicable AIP and HSP.

4307.11 A review may consider the relationship of the health services proposed to be provided to ancillary or support services.

4307.12 A review may consider the effect of the means proposed for the delivery of health services on the clinical needs of health professional training programs in the area where the services are to be provided.

4307.13 A review may consider the special needs and circumstances of those entities that provide a substantial portion of their services or resources, or both, to individuals not residing in the District or in an adjacent health service area. Those entities may include medical and other health professions schools, multidisciplinary clinics, and specialty centers.

4307.14 A review may consider the special needs and circumstances of HMOs. Those needs and circumstances shall be limited to the following:

(a) The needs of enrolled members and reasonably anticipated new members of the HMO for the health services proposed to be provided by the organization; and

(b) The availability of the new health services from non-HMO providers or other HMOs in a reasonable and cost-effective manner that is consistent with the basic method of operation of the HMO. In assessing the availability of these health services from these providers, SHPDA shall consider only whether the services from these providers would meet the following requirements:

(1) The services shall be available under a contract of at least five (5) years’ duration;

(2) The services shall be available and conveniently accessible through physicians and other health professionals associated with the HMO (such as, whether physicians associated with the HMO have or will have full staff privileges at a non-HMO hospital);

(3) The services shall cost no more than if the services were provided by the HMO; and

(4) The services shall be available in a manner that is administratively feasible to the HMO.

4307.15 A review may consider the special needs and circumstances of biomedical and behavioral research projects that are designed to meet a national need and for which local conditions offer special advantages.

4307.16 A review of a construction project may consider the following:

(a) The costs and methods of the proposed construction, including the costs and methods of providing energy;

(b) The probable impact of the construction project under review on the costs of providing health services by the applicant and on the costs and charges to the public of providing health services by other persons; and

4307.17 If proposed health services are to be available in a limited number of facilities, a review may consider the extent to which the health professional schools in the area will have access to the services for training purposes.

4307.18 A review may consider the special circumstances of an HCF with respect to the need for conserving energy.

4307.19 A review may consider the effect of competition on the supply of the health services being reviewed.

4307.20 A review may consider improvements or innovations in financing and delivering health services that foster competition and serve to promote quality assurance and cost effectiveness.

4307.21 A review may consider the efficiency and appropriateness of using existing services and facilities similar to the health services or facilities proposed to be provided.

4307.22 A review may consider the quality of care provided by existing facilities for a review of existing services or facilities.

4307.23 When an osteopathic or allopathic facility applies for a CON to construct, expand, or modernize an HCF, acquire major medical equipment, or add services, SHPDA may consider the need for that construction, expansion, modernization, acquisition of equipment, or addition of services based on the need for and the availability in the community of services and facilities for osteopathic and allopathic physicians and their patients. SHPDA may consider the application in terms of its impact on existing and proposed institutional training programs for doctors of osteopathy and medicine at the student, internship, and residency training levels.

4307.24 Criteria used for reviews in accordance with this section may vary according to the purpose for which a particular review is being conducted or the type of health service reviewed.

4307.25 SHPDA may adopt or revise review criteria and standards for all applications or particular types of applications.

4307.26 SHPDA may establish or revise criteria and standards by including them in an adopted HSP.

4307.27 The criteria and standards adopted by SHPDA under Subsections 4307.25 and 4307.27 shall be incorporated in this title by reference.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4307

22-B DCMR § 4308 REVIEW DECISIONS

4308.1 The Director’s decision to approve, deny, modify, or revoke a CON shall be in writing and shall be based on the following:

(a) The review conducted pursuant to the Act and rules promulgated pursuant to the Act; and

(b) The record established in an administrative proceeding related to a CON application review, reconsideration, or a SHPDA proposal to revoke or modify a CON application. For the purposes of this section the record shall include SHPDA staff research, testimony from a public hearing, and the information the applicant has provided.

4308.2 The written decision shall state the findings of fact related to the CON, including:

(a) Whether the project is needed;

(b) Whether the project will meet SHPDA’s CON application review criteria and standards; and

4308.3 SHPDA shall provide a copy of the written decision to the applicant and make a copy available to any other person upon request.

4308.4 If SHPDA approves the CON application the CON shall constitute the decision document.

4308.5 The Director shall not issue a CON unless the Director finds that the applicant has satisfied all of the requirements specified in Subsection 4308.2.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4308

22-B DCMR § 4309 NOTIFICATION OF REVIEW DECISIONS

4309.1 The Director shall notify the applicant of a review decision by issuing a CON or notifying the applicant by regular mail of findings denying the CON application.

4309.2 The Director shall provide the notice required by this section no later than the end of the review period, including any extension, established for the application.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4309

22-B DCMR § 4310 RECONSIDERATION OF REVIEW DECISIONS

4310.1 An affected person may request reconsideration of the review decision within thirty (30) days after the date of decision.

4310.2 The Director shall grant a request for reconsideration and shall hold a public hearing, if good cause is shown.

4310.3 For purposes this section “good cause” may be demonstrated as follows:

(a) By presenting significant and relevant information not previously considered by SHPDA. Information that could have been presented during the course of review with reasonable diligence shall not be considered good cause for the purpose of this section;

(b) By demonstrating that there has been a significant change in a factor or circumstance the Director relied on to reach a review decision. Those factors may include the opening or closure of other facilities, changes in reimbursement policies of major third party payers, or changes in SHPDA’s criteria or standards or the HSP after the date of the review decision (but before expiration of the period to request reconsideration);

(c) By demonstrating that SHPDA materially failed to follow its review procedures as specified in the Act and this title. A “material failure” is one that may reasonably be believed to have affected the outcome of the Director’s review decision, that prevented the presentation of relevant information in time to be considered by the Director, or that involves an alleged violation of the prohibition on ex parte contacts specified in D.C. Official Code § 44-409(i); or

(d) By presenting other information that leads the Director to conclude that “good cause” is shown and a public hearing for reconsideration is in the public interest.

4310.4 If the Director finds good cause and grants reconsideration, the Director shall convene a public hearing within forty-five (45) days after a finding of good cause.

4310.5 The Director shall give notice of the hearing to the person requesting the hearing, the applicant for the CON in question, SHCC, and the general public.

4310.6 Notice of the public hearing shall be published in a newspaper of general distribution within the District.

4310.7 There shall be no ex parte contacts between any party and any member of SHPDA staff or SHCC related to the decision after the reconsideration hearing adjourns.

4310.8 A reconsideration public hearing is an informational hearing at which the CON applicant and any other person may submit oral or written testimony. The hearing is not a “contested case” hearing as that term is defined in D.C. Official Code § 2-502.

4310.9 A person proposing to give oral testimony at a public hearing for reconsideration (except the person requesting the hearing and the applicant or CON holder being reconsidered) shall schedule testimony with SHPDA at least one (1) business day before the hearing.

4310.10 A person who does not schedule oral testimony in advance shall be permitted to testify after all scheduled testimony has been presented.

4310.11 The person who requested reconsideration and the CON holder (if different from the person requesting reconsideration) shall each have one (1) hour to make a presentation. One (1) or more persons may present testimony on behalf of the applicant or the person who requested the reconsideration.

4310.12 Any other person or group shall be permitted to present oral testimony for up to ten (10) minutes.

4310.13 A member of SHPDA staff may address questions, at the discretion of the hearing officer, to a person presenting oral testimony.

4310.14 The time spent asking and responding to questions shall not count against the time limit of the person testifying.

4310.15 A person may submit written testimony to SHPDA before the hearing, at the hearing, or at any time before the hearing record closes.

4310.16 The hearing officer may close the record at the end of all oral testimony or hold the record open for a period of time not to exceed fourteen (14) days following the end of oral testimony.

4310.17 The Director or the hearing officer may, under special circumstances, extend the time limits for presentations prescribed in this section.

4310.18 The Director may limit the scope of the hearing as follows:

(a) To the matters for which “good cause” was demonstrated in the reconsideration request;

(b) To issues of substantial progress or justification for lack of progress for a CON proposed to be withdrawn because of lack of progress; or

4310.19 SHPDA shall maintain a verbatim record of the hearing by making a sound recording or by making a transcription of the proceeding.

4310.20 SHPDA shall make a copy of the recorded hearing available upon payment of a reasonable fee to cover the cost of duplication.

4310.21 The Director shall issue a written decision, including findings of fact and conclusions of law, within thirty (30) days following the close of the hearing record.

4310.22 The Director may affirm, modify, or reverse the original SHPDA decision.

4310.23 The Director’s decision shall constitute the final decision of SHPDA for all purposes.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4310

22-B DCMR § 4311 APPEAL OF REVIEW DECISIONS

4311.1 The Director’s finding regarding a showing of “good cause” and the final decision resulting from a reconsideration review may be further appealed to the Office of Administrative Hearings by any person directly affected, including the applicant, the person who requested reconsideration, previously appearing parties, and the SHCC, within fifteen (15) days of the date of Director’s finding or decision.

4311.2 A person adversely affected by a SHPDA decision may appeal the decision to the District of Columbia Court of Appeals after exhausting all administrative remedies including an appeal to the Office of Administrative Hearings.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4311

22-B DCMR § 4312 APPLICATION FEES

4312.1 Notwithstanding any other provision of Chapters 40 through 45 of this title, SHPDA shall not accept an application for CON review until the applicant first pays a non-refundable application fee in the amount specified in D.C. Official Code § 44-420(a). Acceptable forms of payment include a certified check or money order for the application fee made payable to the “D.C. Treasurer”.

4312.2 A CON holder shall not be required to pay an application fee for an extension of a CON pursuant to Section 4007. A CON holder seeking extension beyond a fourth (4th) year, except for an administrative extension, shall submit a new CON application pursuant to Subsection 4007.14 and pay the applicable fee.

4312.3 An applicant shall not pay an application fee after withdrawing and resubmitting an application as a result of a substantial modification of an application pursuant to Section 4203, provided that the new application is submitted to SHPDA and judged to be complete by SHPDA within six (6) months of the date of withdrawal. If the applicant fails to re-submit an application within six (6) months, the application shall be deemed void, and any further request for CON review shall require the payment of a new application fee. If the resubmitted application requires a fee higher than that charged for the initial (withdrawn) application, the applicant shall pay the difference between the fee previously paid and the fee that would apply if the resubmitted application had been originally submitted.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4312

22-B DCMR § 4313 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4313

22-B DCMR § 4314 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4314

22-B DCMR § 4315 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4315

22-B DCMR § 4399 DEFINITIONS

4399.1 The provisions of § 4099 of Chapter 40 of this title, and the definitions set forth in that section, shall apply to this chapter.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4399

22-B44 PROVISION OF UNCOMPENSATED CARE

22-B DCMR § 4400 GENERAL PROVISIONS

4400.1 This chapter implements the requirements of the District of Columbia Health Services Planning Program Re-Establishment Act of 1996 (Act), effective April 9, 1997 (D.C. Law 11-191; D.C. Official Code § 44-401 et seq.), for the provision by health care facilities of uncompensated care as a condition of holding a Certificate of Need (CON).

4400.2 As a condition for issuance of a CON to a health care facility or health service that operates on a payment for services rendered basis, the health care facility or health service shall provide uncompensated care in an amount not less than three percent (3%) of the health care facility's or health service's annual operating expenses, less the amount of reimbursements it receives from Titles XVIII and XIX of the Social Security Act (Medicaid and Medicare), without regard for contractual allowances. In addition, the health care facility or health service shall comply with any uncompensated care obligations required pursuant to the Act in a previous CON.

4400.3 The State Health Planning and Development Agency (SHPDA) may require each health care facility or health service subject to an uncompensated care obligation through a CON to submit data to verify compliance with the uncompensated care obligation.

4400.4 Each health care facility or health service subject to an uncompensated care obligation shall provide uncompensated care at the annual compliance level required by § 4400.2, for each fiscal year, or any part thereof, in which it is subject to the uncompensated care obligation.

4400.5 Each health care facility or health service that has an uncompensated care obligation shall make uncompensated care available to the extent of that obligation to all eligible persons, without discrimination on the grounds of race, color, creed, national origin, sex, age, marital status, personal appearance, sexual orientation, family responsibilities, matriculation, political affiliation, physical handicap, source of income, or any other grounds unrelated to an individual's need for the service or the availability of the needed service.

History

SOURCE: Final Rulemaking published at 36 DCR 5819 (August 11, 1989); as amended by Final Rulemaking published at 52 DCR 8258 (September 2, 2005); as amended by Final Rulemaking published at 53 DCR 4808 (June 16, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4400

22-B DCMR § 4401 [RESERVED]

History

SOURCE: Final Rulemaking published at 36 DCR 5819 (August 11, 1989); as amended by Final Rulemaking published at 52 DCR 8258 (September 2, 2005); as amended by Final Rulemaking published at 53 DCR 4808 (June 16, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4401

22-B DCMR § 4402 CERTIFICATE OF NEED HOLDER PARTICIPATION IN THIRD PARTY PAYER PROGRAMS

4402.1 Each CON holder may make arrangements, if eligible to do so, for reimbursement for services from:

(a) Those principal District and state third party payers that provide reimbursement for services; and

(b) Federal governmental third-party programs, including Medicare and Medicaid.

4402.2 Each CON holder shall take all actions necessary to ensure that admission to and receipt of its services are available to beneficiaries of the governmental programs specified in § 4402.1, without discrimination or preference because they are beneficiaries of those programs.

History

SOURCE: Final Rulemaking published at 36 DCR 5819 (August 11, 1989); as amended by Final Rulemaking published at 52 DCR 8258 (September 2, 2005); as amended by Final Rulemaking published at 53 DCR 4808 (June 16, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4402

22-B DCMR § 4403 PROHIBITION OF EXCLUSIONARY ADMISSIONS POLICIES

4403.1 A CON holder shall be out of compliance with § 4400.4, if it uses an admissions practice that has the effect of excluding persons who are eligible for uncompensated care under § 4406.

4403.2 Prohibited admissions practices include the following:

(a) Limiting admission to patients who are referred by physicians with staff privileges at the CON holder's facility (or facilities);

(b) Maintaining an operational structure that includes few or no physicians with staff privileges who will treat persons who are eligible for uncompensated care; or

(c) Requiring advance deposits (preadmission or pre-service deposits) from persons who qualify or appear to qualify for uncompensated care before admitting or serving these persons.

4403.3 A CON holder may have in effect a policy or practice described in § 4403.2(a) and still comply with this chapter if the CON holder makes alternative arrangements to treat those persons who would otherwise be unable to gain admission to, or obtain services available from, the CON holder. Alternative arrangements may include the following:

(a) Authorizing the individual's physician, if licensed and otherwise qualified, to treat the patient at the facility even though the physician does not have staff privileges at the facility;

(b) Obtaining the voluntary agreement of physicians with staff privileges at the facility to accept referrals regularly of patients who do not have a physician (e.g. rotating referrals to the physicians with staff privileges);

(c) Requiring acceptance of referrals of patients who do not have a physician as a condition of obtaining or renewing staff privileges;

(d) Establishing a hospital-based primary care clinic through which patients needing hospitalization may be admitted; or

(e) Hiring or contracting with qualified physicians to treat patients who do not have private physicians.

4403.4 A CON holder need not require all its staff physicians to accept Medicaid or Medicare patients to remedy a violation of § 4403.2(b). If the Department of Health, Medical Assistance Administration, determines that a CON holder or CON applicant is out of compliance with Medicaid or Medicare obligations, the CON applicant or CON holder shall be deemed out of compliance with admissions and service requirements until the CON applicant or CON holder takes steps to ensure that Medicaid and Medicare program beneficiaries have full access to all of the CON applicant's or CON holder's available services.

4403.5 A CON holder that engages in a practice prohibited by § 4403.2(c) is not required to forego the use of a deposit policy in all situations. The CON holder can remedy this violation by making alternative arrangements to ensure that persons who probably can pay for services are not denied them simply because they do not have the available cash at the time services are requested. A CON holder shall not deny admission or a service to a person who probably can pay because of the person's inability to pay a deposit at the time the person requests admission or a service.

History

SOURCE: Final Rulemaking published at 36 DCR 5819 (August 11, 1989); as amended by Final Rulemaking published at 52 DCR 8258 (September 2, 2005); as amended by Final Rulemaking published at 53 DCR 4808 (June 16, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4403

22-B DCMR § 4404 UNCOMPENSATED CARE COMPLIANCE REQUIREMENTS

4404.1 Each CON holder shall provide uncompensated care pursuant to § 4400.2 to eligible persons. The uncompensated care to be provided shall be based upon these rules or contractual obligations between the health care provider and the District of Columbia Government, whichever standard provides the higher dollar value.

4404.2 If, during any fiscal year, a CON holder fails to meet its annual uncompensated care obligation, the CON holder shall, during a subsequent fiscal year, provide uncompensated care in a dollar value sufficient to remediate that deficit, pursuant to a compliance plan under § 4413 approved by the SHPDA. The compliance plan shall include the following:

(a) The conditions or circumstances that caused or contributed to the deficit;

(b) Specific actions the CON holder plans to take to remediate the deficit;

(d) The name of a staff person who will be responsible for administering the compliance plan; and

(e) The dates on which the compliance plan will begin and is expected to be completed.

4404.3 A deficit incurred during any fiscal year shall be made up within not more than three (3) fiscal years after the end of the fiscal year during which the deficit occurred.

4404.4 A CON holder shall begin to make up a deficit during the fiscal year immediately following the fiscal year during which it incurred the deficit.

4404.5 The SHPDA shall complete its review of the compliance plan within forty-five (45) days of receipt from the CON holder. The compliance plan shall expire after the CON holder remedies the deficit for which it submitted the compliance plan.

4404.6 The Director may extend the period of time within which a CON holder may make up a deficit.

4404.7 The amount of an uncompensated care deficit for any fiscal year shall be the difference between a CON holder's annual compliance level for that fiscal year and the amount of uncompensated care provided during that fiscal year.

4404.8 If a CON holder provides uncompensated care during a fiscal year in an amount exceeding its annual compliance level, the CON holder may request that the Director apply the excess amount as a credit towards an existing deficit or its annual compliance level for any subsequent fiscal year. To be eligible for a credit, the excess dollar value above the annual compliance level must have been provided pursuant to the requirements of this chapter.

History

SOURCE: Final Rulemaking published at 36 DCR 5819 (August 11, 1989); as amended by Final Rulemaking published at 52 DCR 8258 (September 2, 2005); as amended by Final Rulemaking published at 53 DCR 4808 (June 16, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4404

22-B DCMR § 4405 NOTICE OF AVAILABILITY OF UNCOMPENSATED CARE

4405.1 Each CON holder shall publish, in a newspaper of general circulation within the District of Columbia, and submit to the Director before the beginning of the CON holder's fiscal year, a notice of its uncompensated care obligation. The notice shall include:

(a) The dollar value of uncompensated care that the CON holder intends to make available during the fiscal year or a statement that the CON holder will provide uncompensated care to all persons unable to pay for treatment who request uncompensated care;

(b) An explanation of the difference between the amount of uncompensated care the CON holder proposes to make available and the annual compliance level for the CON holder, if any; and

(c) A statement whether the CON holder has satisfied all outstanding uncompensated care obligations from previous reporting periods, or a statement indicating that it will, during a specified period, satisfy any outstanding obligations.

4405.2 The CON holder shall post the following notice:

"Under District of Columbia law, this health care provider must make its services available to all people in the community. This health care provider is not allowed to discriminate against a person because of race, color, religion, national origin, sex, age, marital status, personal appearance, sexual orientation, family responsibilities, matriculation, political affiliation, physical handicap, source of income, or place of residence or business, or because a person is covered by a program such as Medicare or Medicaid.

"This health care provider is also required to provide a reasonable volume of services without charge or at a reduced charge to persons unable to pay. Ask the staff if you are eligible to receive services either without charge or at a reduced charge. If you believe that you have been denied services or consideration for treatment without charge or at a reduced charge without a good reason, contact the Admissions or Business Office of this health care provider, and call the State Health Planning and Development Agency through the Citywide Call Center at 202-727-1000.

"If you want to file a complaint, forms are available from the State Health Planning and Development Agency."

4405.3 The notice required by § 4405.2 shall also include the CON holder's eligibility criteria for uncompensated care.

4405.4 The CON holder shall post the notice required by § 4405.2 in plain view in areas of the CON holder's facility or service that are easily accessible to the public. Those areas shall include the admissions areas, the business office, and the emergency room.

4405.5 The notice required by § 4405.2 shall be printed in the following languages:

(a) English;

(b) Spanish; and

(c) Any other language that is the usual language of households of ten percent (10%) or more of the population of the District of Columbia, according to the most recent figures published by the Bureau of Census.

4405.6 Each CON holder shall communicate the contents of the posted notice to any person who the CON holder has reason to believe cannot read the notice.

4405.7 During any period of a fiscal year when uncompensated care is available in the CON holder's facility or service, the CON holder shall provide written notice of the availability of the services to each person who seeks services from the CON holder, whether on his or her own behalf or on behalf of another. The written notice of availability shall include the following:

(a) The information set out in the notice in § 4405.2.

(b) The location in the CON holder's facility or service where any person seeking uncompensated care may request it; and

(c) A statement that the CON holder is required to make a written determination whether the person will receive uncompensated care; and

(d) The date by, or period within which, the determination will be made.

4405.8 Each CON holder shall provide the written notice required by § 4405.7 before providing services, except where the emergency nature of the services makes prior notice impractical. In emergency situations, the CON holder shall provide the written notice to the patient as soon as practical, or to the next of kin. The CON holder shall give the notice not later than when presenting the first bill for services.

History

SOURCE: Final Rulemaking published at 36 DCR 5819 (August 11, 1989); as amended by Final Rulemaking published at 52 DCR 8258 (September 2, 2005); as amended by Final Rulemaking published at 53 DCR 4808 (June 16, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4405

22-B DCMR § 4406 UNCOMPENSATED CARE ELIGIBILITY CRITERIA

4406.1 A person is eligible to receive uncompensated care if the person is unable to pay for health services and satisfies the following additional requirements:

(a) Is not covered, or receives services that are not covered, under a third-party insurer or governmental program;

(b) Has an annual individual or family income that is not greater than two hundred percent (200%) of the federal poverty level; and

4406.2 Financial eligibility for uncompensated care shall be calculated by either of the following methods:

(a) Multiplying by four (4) the person's individual or family income, as applicable, for the three (3) months preceding the request for uncompensated care; or

(b) Using the person's or family's actual income, as applicable, for the twelve (12) months preceding the request for uncompensated care.

4406.3 For purpose of determining income eligibility for uncompensated care pursuant to § 4406.1(b), revisions to the federal poverty level used to calculate eligibility shall be effective sixty (60) days after the date of publication in the Federal Register.

History

SOURCE: Final Rulemaking published at 36 DCR 5819 (August 11, 1989); as amended by Final Rulemaking published at 52 DCR 8258 (September 2, 2005); as amended by Final Rulemaking published at 53 DCR 4808 (June 16, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4406

22-B DCMR § 4407 [RESERVED]

History

SOURCE: Final Rulemaking published at 36 DCR 5819 (August 11, 1989); as amended by Final Rulemaking published at 52 DCR 8258 (September 2, 2005); as amended by Final Rulemaking published at 53 DCR 4808 (June 16, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4407

22-B DCMR § 4408 WRITTEN DETERMINATION OF ELIGIBILITY FOR UNCOMPENSATED CARE

4408.1 Each CON holder shall give written notice of its determination of eligibility for uncompensated care in response to each request for uncompensated care to the person requesting care. The CON holder shall give notice in person at the time uncompensated care is requested or by regular mail to the address the person requesting services provided. If the person requesting care has not provided an address and is not available to receive notice in person, the CON holder may post at the facility, in a conspicuous place such as the admissions office or the emergency services department, a notice that the person's eligibility status is available in the administrative office within that facility.

4408.2 Each CON holder shall communicate the contents of the written determination to any person requesting uncompensated care that the CON holder has reason to believe cannot read the determination.

4408.3 Each determination of eligibility for uncompensated care shall include the following statements:

(a) That the CON holder will, will with conditions, or will not provide uncompensated care;

(b) That there will be no charge for uncompensated care;

(d) The date on which the CON holder made the determination;

(e) The annual individual or family income, as applicable, and family size of the person who requested uncompensated care;

(f) The date on which services were, or will be, provided; and

(g) The reason for denial, if applicable.

4408.4 As a condition of providing uncompensated care, a CON holder may:

(a) Require the person requesting uncompensated care to furnish any information that is reasonably necessary to substantiate eligibility; and

(b) Require each person requesting uncompensated care to apply for any benefits under third party insurer or governmental programs to which the person requesting uncompensated care is, or could be, entitled upon application.

4408.5 A conditional eligibility determination shall state the conditions that the person requesting uncompensated care must satisfy to be eligible.

4408.6 CON holders shall make eligibility determinations as follows:

(a) Each hospital shall make an eligibility determination for uncompensated care within five (5) business days of a request for an outpatient service or before discharge for an inpatient service;

(b) Each ambulatory surgical facility shall make an eligibility determination for uncompensated care within five (5) business days of a request for an outpatient service; and

(c) Any other CON holder shall make a determination of eligibility for uncompensated care within ten (10) business days following the date of admission or delivery of services.

History

SOURCE: Final Rulemaking published at 36 DCR 5819 (August 11, 1989); as amended by Final Rulemaking published at 52 DCR 8258 (September 2, 2005); as amended by Final Rulemaking published at 53 DCR 4808 (June 16, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4408

22-B DCMR § 4409 [RESERVED]

History

SOURCE: Final Rulemaking published at 36 DCR 5819 (August 11, 1989); as amended by Final Rulemaking published at 52 DCR 8258 (September 2, 2005); as amended by Final Rulemaking published at 53 DCR 4808 (June 16, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4409

22-B DCMR § 4410 UNCOMPENSATED CARE REPORTING REQUIREMENTS

4410.1 Each CON holder shall submit an annual report to the SHPDA on uncompensated care. The report shall be on a schedule prescribed by the SHPDA. The report shall be submitted within one hundred and twenty (120) days after the close of the CON holder's fiscal year. The report shall include:

(a) The dollar value of uncompensated care that the CON holder was required to provide;

(b) The dollar value of uncompensated care the CON holder actually provided, with the dollar value of charity care and bad debt reported separately;

(d) Other documentation SHPDA may require to determine if a CON holder has met its annual compliance level for the period covered by the report;

(e) The dollar value of services and care provided to District residents;

(f) A copy of the notice required by § 4405.1, including the date the notice was published and the name of the newspaper that printed the notice;

(g) If the CON holder failed to provide the required annual level of uncompensated care, the reason and any documentation that supports its reason for failing to meet the annual compliance level; and

(h) Any other documentation the Director may request.

4410.2 The Director may require a CON holder to submit the report required by § 4410.1 more frequently when:

(a) The Director determines that during the preceding fiscal year the CON holder did not provide uncompensated care at its required annual compliance level; or

(b) The Director notifies the CON holder, in writing, that additional reports are needed for proper administration of the CON program.

4410.3 If the Director requests additional reports pursuant to § 4410.2, the CON holder shall submit the report within ninety (90) days after receiving the request or within ninety (90) days after the close of the fiscal year, whichever is later. The Director may, for good cause shown, extend the time within which the CON holder must submit the report.

4410.4 Not later than ten (10) days after being served with a summons or complaint regarding uncompensated care or any other activity relating to the CON, each CON holder shall notify the Director of any legal action brought against it that alleges that it has failed to comply with the requirements of this chapter.

History

SOURCE: Final Rulemaking published at 36 DCR 5819 (August 11, 1989); as amended by Final Rulemaking published at 52 DCR 8258 (September 2, 2005); as amended by Final Rulemaking published at 53 DCR 4808 (June 16, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4410

22-B DCMR § 4411 UNCOMPENSATED CARE RECORDS MAINTENANCE REQUIREMENTS

4411.1 Each CON holder shall maintain and provide to the Director, upon request, any records necessary to document the CON holder's compliance with the requirements of this chapter. Each CON holder shall make available for public inspection the records it maintains to document its compliance. Patient identifying information shall be removed from records provided for public inspection.

4411.2 The CON holder shall maintain uncompensated care records, including the following:

(a) Any documents from which the information required to be reported under § 4410 was obtained;

(b) Documents that clearly segregate uncompensated care from other accounts;

(d) Documentation that verifies compliance with the requirements of this chapter during any fiscal year, including documents from which information required to be reported under § 4410.1 was obtained.

4411.3 Each CON holder shall retain records to document its compliance with this chapter for five (5) years from the date of the last entry for a particular fiscal year. The Director may require a CON holder to maintain the records for a longer period.

History

SOURCE: Final Rulemaking published at 36 DCR 5819 (August 11, 1989); as amended by Final Rulemaking published at 52 DCR 8258 (September 2, 2005); as amended by Final Rulemaking published at 53 DCR 4808 (June 16, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4411

22-B DCMR § 4412 INVESTIGATION AND CERTIFICATION OF COMPLIANCE

4412.1 Any person may file a complaint with the Director that a CON holder is not complying with the requirements of this chapter.

4412.2 Each complaint shall include the following information:

(a) The name and address of the complainant;

(b) The name and address of the CON holder;

(d) A statement describing the event or incident that the complainant believes violates the requirements of this chapter.

4412.3 The filing date of a complaint shall be the date of receipt by the SHPDA.

4412.4 The Director shall provide a copy of the complaint to the CON holder named in the complaint within ten (10) business days after receiving the complaint.

4412.5 The Director shall initiate an investigation of each complaint filed pursuant to the provisions of this section within thirty (30) business days of its receipt.

4412.6 The CON holder shall provide the Director with documents, records, or other requested information that may assist in investigating the complaint.

4412.7 A CON holder shall be out of compliance with its uncompensated care obligations if it fails to provide documentation the Director requests to determine the CON holder's compliance with this chapter.

4412.8 The Director shall determine the merit of a complaint based on:

(a) Information contained in the complaint;

(b) Documents the CON holder provides; and

4412.9 If the Director determines that a complaint is not substantiated, the Director shall dismiss the complaint.

4412.10 The Director shall make periodic reviews of the uncompensated care requirements and activities of each CON holder to determine whether a CON holder is complying with its obligations.

4412.11 The Director shall conduct audits to determine each CON holder's compliance with its uncompensated care obligation according to standard audit procedures.

4412.12 After completing the audit the Director may certify that a CON holder has substantially complied with its uncompensated care obligation for a specific fiscal year or years. The certification shall confirm that the CON holder has provided the uncompensated care stated for the period covered by the certification.

4412.13 The Director shall base each certification of substantial compliance on the amount of uncompensated care properly claimed by the CON holder, using procedures and reviewing individual account data the Director determines to be sufficient to establish that the CON holder has substantially complied with its uncompensated care obligation for the period covered by the certification.

4412.14 The Director may certify substantial compliance when he or she determines that, for the period covered by the certification, the CON holder provided uncompensated care to eligible persons who had equal opportunity to apply for uncompensated care.

4412.15 To determine whether a CON holder has substantially complied with its obligations, the SHPDA shall consider each of the following in descending order of importance:

(a) Whether the CON holder took corrective action prescribed pursuant to § 4413;

(b) Whether the CON holder's noncompliance with its uncompensated care obligation may be remedied by corrective action under § 4413; and

(c) Whether the CON holder had procedures in place that complied with the applicable notice, eligibility, and record keeping requirements of §§ 4405, 4406, 4408, 4410, and 4411, and systematically and correctly followed the procedures.

4412.16 The Director shall determine and certify the amount of creditable service required by each CON holder for the three (3) fiscal years ending prior to the effective date of these rules. The Director shall base the determination on information necessary to establish the CON holder's substantial compliance with its uncompensated care obligation during the period being reviewed.

4412.17 To determine creditable service during the three (3) fiscal years ending prior to the effective date of these rules, each CON holder shall submit to the Director for each fiscal year the following:

(a) The number of persons to whom it provided care without charge or below its normal and customary charge;

(b) The total dollar amount of uncompensated care it provided in each fiscal year and the method used to determine that dollar amount; and

History

SOURCE: Final Rulemaking published at 36 DCR 5819 (August 11, 1989); as amended by Final Rulemaking published at 52 DCR 8258 (September 2, 2005); as amended by Final Rulemaking published at 53 DCR 4808 (June 16, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4412

22-B DCMR § 4413 UNCOMPENSATED CARE ENFORCEMENT

4413.1 If the Director finds, based on an investigation, review, or audit under § 4412, that a CON holder has not complied with the requirements of this chapter, the Director may take any action authorized by law to secure compliance, including:

(a) Voluntary agreement;

(b) Judicial enforcement of the obligations under this chapter; and

4413.2 Each CON holder that has denied uncompensated care to any person because it failed to comply with its uncompensated care obligation shall be out of compliance until it takes the actions necessary to remedy fully the noncompliance, including;

(a) Providing uncompensated care to applicants improperly denied;

(b) Repaying amounts improperly collected from persons eligible to receive uncompensated care; and

4413.3 The Director may disallow all of the uncompensated care claimed in a fiscal year if the Director finds that a CON holder was in substantial noncompliance with its uncompensated care obligation because it failed to do any of the following:

(a) Have a system for providing notices to eligible persons as required by § 4405;

(b) Comply with the applicable reporting requirements of § 4410;

(d) Take corrective action pursuant to § 4413.2;

(e) Comply with the applicable eligibility standards in § 4406; or

(f) Comply with the written determination procedures in § 4408.

4413.4 If the Director determines, based on investigation, audit, or review under § 4412, that a CON holder has limited its services in violation of its uncompensated care obligation, the Director may require the CON holder to establish a compliance plan to ensure that the CON holder's services are available according to the requirements of this chapter.

4413.5 In the absence of a finding of noncompliance in any fiscal year, the Director may disallow uncompensated care claimed by a CON holder in the fiscal year to the extent that the services are not documented as uncompensated care according to this chapter.

History

SOURCE: Final Rulemaking published at 36 DCR 5819 (August 11, 1989); as amended by Final Rulemaking published at 52 DCR 8258 (September 2, 2005); as amended by Final Rulemaking published at 53 DCR 4808 (June 16, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4413

22-B DCMR § 4414 [RESERVED]

History

SOURCE: Final Rulemaking published at 36 DCR 5819 (August 11, 1989); as amended by Final Rulemaking published at 52 DCR 8258 (September 2, 2005); as amended by Final Rulemaking published at 53 DCR 4808 (June 16, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4414

22-B DCMR § 4499 DEFINITIONS

4499.1 The provisions of § 4099 of Chapter 40 of this title and the definitions set forth in that section shall apply to this chapter.

4499.2 When used in this chapter, the following terms and phrases shall have the meaning ascribed below:

Act - the Health Services Planning Program Re-establishment Act of 1996, effective April 9, 1997 (D.C. Law 11-191; D.C. Official Code § 44-401 et seq.).

Certificate of Need or CON - authorization for a health care facility or health service to develop a new institutional health service, purchase major medical equipment, or obligate a capital expenditure to obtain an asset worth more than two million five hundred thousand dollars ($2,500,000).

Certificate of Need applicant or CON applicant - a person who applies for a CON.

Certificate of Need holder or CON holder - a person who has applied for and received a Certificate of Need pursuant to this chapter. For the purpose of this chapter, a person continues to be a CON holder after the completion of the project for which the CON was obtained.

Compliance plan - the means by which a CON holder that violates this chapter or is out of compliance with its uncompensated care obligations proposes to remedy the violations or other noncompliance.

Director - Director of the District of Columbia State Health Planning and Development Agency, Department of Health.

Health care facility- a private general hospital, psychiatric hospital, other specialty hospital, rehabilitation facility, skilled nursing facility, intermediate care facility, ambulatory care center or clinic, ambulatory surgical facility, kidney disease treatment center, freestanding hemodialysis facility, diagnostic health care facility, home health agency, hospice, or other comparable health care facility that has an annual operating budget of at least $500,000. This term shall not include Christian Science sanitariums operated, listed, and certified by the First Church of Christ Scientist, Boston, Massachusetts; the private office facilities of a health professional or group of health professionals, where the health professional or group of health professionals provides conventional office services limited to medical consultation, general non-invasive examination, and minor treatment, or a health care facility licensed or to be licensed as a community residence facility, or an Assisted Living Residence as defined by § 102.01(4) of the Assisted Living Residence Regulatory Act of 2000, effective June 24,2000 (D.C. Law 13-127; 44-102.01(4)).

Health service - any medical or clinical related service, including services that are diagnostic, curative, or rehabilitative, as well as those related to alcohol abuse, inpatient mental health services, home health care, hospice care, medically supervised day care, and renal dialysis. This term shall not include those services provided by physicians, dentists, HMOs, and other individual providers in individual or group practice.

Request for uncompensated care - any indication by or on behalf of an individual seeking health care from a CON holder of the individual's inability to pay for the services that is made at any time, including following institution of a collection action against the individual.

SHPDA - State Health Planning and Development Agency, Department of Health.

History

SOURCE: Final Rulemaking published at 36 DCR 5819 (August 11, 1989); as amended by Final Rulemaking published at 52 DCR 8258 (September 2, 2005); as amended by Final Rulemaking published at 53 DCR 4808 (June 16, 2006). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4499

22-B45 DATA REPORTING

22-B DCMR § 4500 REPORTS

4500.1 Pursuant to D.C. Official Code §44-405(b), a HCF or a person holding a CON under the Act shall submit to SHPDA periodic data reports related to the development of proposals subject to CON review.

4500.2 The requirements of this chapter may be supplemented, from time to time, with requirements for additional data when the data is reasonably necessary for SHPDA to carry out its mission under the Act. When the Director requires additional data from an HCF, the Director shall give written notice of the requirement not less than sixty (60) days before implementing the requirement. The notice required by this section shall include the basis for the requirements.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4500

22-B DCMR § 4501 DATA REPORTING

4501.1 An HCF subject to the requirements of Subsection 4500.1 shall submit to SHPDA, or to a data processing agent specified by SHPDA, the data described in this chapter, or other similar data that SHPDA may request.

4501.2 A person or entity required to file a report under this chapter shall report the data in the form and format and according to the schedule SHPDA designates. The data shall be submitted on a form prescribed by SHPDA.

4501.3 An annual report required by this chapter shall be submitted not later than ninety (90) days after the end of the report period.

4501.4 Data due less often than annually shall be submitted no later than sixty (60) days following the end of the report period.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4501

22-B DCMR § 4502 REPORT CATEGORIES

4502.1 A report submitted pursuant to Sections 4506 and 4507 of this chapter shall use the following age categories:

(a) Eighteen (18) years of age and younger; and

(b) Over (18) years.

4502.2 A report that requires listing a patient’s residence under Sections 4506, 4507, and 4511 of this chapter shall use the following categories:

(a) District of Columbia;

(b) Maryland--Calvert County;

(d) Maryland--Montgomery County;

(e) Maryland--Prince George’s County;

(f) Maryland--St. Mary’s County;

(g) Maryland--other counties;

(h) Virginia--Alexandria City;

(i) Virginia--Arlington County;

(j) Virginia--Fairfax County (including Fairfax City and Falls Church);

(k) Virginia--Loudon County;

(l) Virginia--Prince William County (including Manassas and Manassas Park);

(m) Virginia--other counties;

(n) Other states and foreign countries; and

(o) Residence unknown.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4502

22-B DCMR § 4503 FINANCIAL REPORTS

4503.1 An HCF or health service shall submit to SHPDA, not later than one-hundred and twenty (120) days following the end of the fiscal year being reported upon, a copy of its audited financial report.

4503.2 The audited financial report and supplemental data supplied with the report shall include the following information, as applicable:

(a) Balance sheet;

(b) Income statement;

(d) Costs statement, including payroll costs, inpatient care costs, outpatient care costs, capital costs, and operating costs;

(e) Per Diem rates for inpatient room types;

(f) Rate structure;

(g) Average cost per patient day;

(h) Average cost and average charge per outpatient visit;

(i) Average cost and average charge per emergency room visit; and

(j) Revenues, including specification of Medicaid revenue, Medicare revenue, other third-party revenue, and self-pay revenue.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4503

22-B DCMR § 4504 ANNUAL REPORTS

4504.1 A hospital of any type, unless specifically exempted by SHPDA, shall provide annually, the data required in Subsection 4504.2 for each of the following services:

(a) Total medical-surgical services (including intensive care beds, and cardiac care services);

(b) Intensive care service;

(d) Obstetrics service;

(e) Obstetrics-gynecology swing service;

(f) Nursery service;

(g) Intermediate neonatal and neonatal intensive care services;

(h) Pediatric service;

(i) Psychiatric service;

(j) Rehabilitation service;

(k) Alcoholism-chemical dependency service;

(l) Diagnostic imaging;

(m) Emergency service;

(n) Radiation therapy; and

(o) Any other service that SHPDA specifies after giving notice to the hospital at least thirty (30) days before the beginning of the period for which the data is required.

4504.2 A hospital subject to § 4504.1 shall submit a report including the following information for each service specified in that subsection:

(a) The number of patients admitted during the reporting period for the purpose of receiving inpatient nursing care; in the nursery service, the number of admissions refers to newborn infants admitted to the hospital following birth and infants admitted following transfer from home or another hospital; in the intensive and coronary care units, the number of admissions include only those patients directly admitted to the units; patients initially admitted to the medical-surgical service and later transferred to intensive care shall be reported as intra-hospital transfers to those units;

(b) The number of deliveries, the complete expulsion or extraction from its mother of a product of conception, regardless of the duration of pregnancy (excludes induced abortions); the number of deliveries includes live births and fetal deaths; multiple births shall be counted as one (1) delivery;

(c) The number of emergency room registrants, including the sum of visits to the emergency room and psychiatric emergency services that result in the acceptance of the patient for the purpose of receiving inpatient nursing care within the hospital;

(d) The number of deaths that occur before the complete expulsion or extraction from its mother of a product of conception; death is indicated by the fact that after separation from the mother, a fetus does not breathe or show any other evidence of life, such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscles (excludes induced abortions);

(e) The number of patients receiving surgical procedures that are performed exclusively on an outpatient basis;

(f) The number of live births, which is the complete expulsion or extraction from its mother of a product of conception (regardless of the duration of pregnancy) that, after separation from its mother, breathes or shows any other evidence of life (such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscles) whether or not the umbilical cord has been cut or the placenta is attached;

(g) The number of bassinets or cribs regularly maintained for use by infants as of the last day of the reporting period;

(h) The number of beds regularly maintained for use by inpatients as of the last day of the reporting period;

(i) The number of patients who registered to receive care in an organized outpatient department;

(j) The total number of patient days of care rendered during the reporting period (i.e., the cumulative sum of the number of occupied beds in a particular service on each day of the reporting period); and

(k) Other data that SHPDA may require.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4504

22-B DCMR § 4505 ANNUAL DISCHARGE DATA REPORTS

4505.1 Each hospital, unless specifically exempted by SHPDA, shall provide annually, in a form, format, and medium designated by SHPDA, a hospital discharge data set including the following information for each patient:

(a) Age;

(b) Sex;

(d) Major hospital service;

(e) Disposition;

(f) Patient residence;

(g) Admission date;

(h) Discharge date;

(i) Expected source of payment;

(j) Principal diagnosis and other diagnoses;

(k) Principal procedure and other procedures;

(l) Hospital identification;

(m) Patient sequence number (assigned in a way unrelated to the medical record number);

(n) Birth weight in grams (neonates only);

(o) Financial data;

(p) Ward; and

(q) Other data that SHPDA may require.

4505.2 Hospital discharge data shall be submitted not later than one-hundred and twenty (120) days following the end of the year being reported upon.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4505

22-B DCMR § 4506 HEART SURGERY REPORTS

4506.1 Each hospital, unless specifically exempted by SHPDA, shall report annually the number of open heart surgery operations performed by patient age and patient residence categories for each of the following:

(a) Congenital heart disease;

(b) Valvular heart disease;

(d) Other.

4506.2 Each hospital, unless specifically exempted by SHPDA, shall report annually the number of closed heart surgery operations and the number of all other cardiac operations not reported under Subsection 4506.1, reported by the patient age and patient residence categories specified in Section 4502, performed for the following:

(a) Congenital heart disease;

(b) Valvular heart disease; and

4506.3 Each hospital, unless specifically exempted by SHPDA, shall report annually the cardiac surgery operative mortality (the number of deaths within thirty (30) days) reported by the patient age categories specified in Section 4502, for the following:

(a) Open heart surgery - coronary bypass;

(b) Open heart surgery - all others;

(d) Other cardiac surgery.

4506.4 For the purposes of this section, the term “open heart surgery” includes an operation that uses a mechanical pump to temporarily perform the function of circulation during surgery.

4506.5 For the purposes of this section, the term “closed heart surgery” includes an operation that does not require the use of a mechanical pump during surgery. Closed heart surgery shall include the following:

(a) Valve commissurotomy;

(b) Thoracic aneurysm repair or transection;

(d) Ligation/division of patent ductus arterlosus;

(e) Resection of coarctation of aorta;

(f) Pulmonary artery banding; and

(g) Valvulotomy.

4506.6 For the purposes of this section, pacemaker implantations and implants of pulsation balloons are excluded from the category of operations defined as “closed heart surgery.”

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4506

22-B DCMR § 4507 CARDIAC CATHETERIZATION REPORTS

4507.1 Each hospital, unless specifically exempted by SHPDA, shall report annually the number of procedures performed in the cardiac catheterization laboratory in the categories specified below by the patient age and patient residence categories specified in Section 4502 (the procedure includes all diagnostic studies, angiographic and physiologic, performed on a patient during one (1) session in the laboratory):

(a) Right heart catheterizations (with and without angiography);

(b) Left heart catheterizations without coronary angiography;

(d) Combined right and left heart catheterizations without angiography;

(e) Combined right and left heart catheterizations with angiography (other than coronary angiography);

(f) Combined right and left heart catheterizations with coronary angiography;

(g) Permanent pacemaker implantation;

(h) Other cardiac procedures (includes temporary pacemakers);

(i) Electrophysiological studies (e.g., HIS Bundle);

(j) Percutaneous transluminal coronary angioplasty (PTCA);

(k) Streptokinase thrombolysis; and

(l) Other non-cardiac angiographic procedures.

4507.2 Each hospital, unless specifically exempted by SHPDA, shall report annually the number of cardiac catheterization patients in the following categories by each patient age and patient residence category specified in Section 4502:

(a) Number of cardiac patients studied;

(b) Number of non-cardiac patients studied;

(1) Coronary artery disease;

(2) Coronary artery and valvular or congenital disease;

(3) Valvular or congenital disease only; and

(4) Other diseases.

4507.3 Each hospital, unless specifically exempted by SHPDA, shall report annually the cardiac catheterization mortality (the number of deaths when mortality occurs during or immediately following surgery), reported by the patient age and patient residence categories specified in Section 4502.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4507

22-B DCMR § 4508 EMERGENCY ROOM REPORTS

4508.1 Each hospital, unless specifically exempted by SHPDA, shall report annually, on the basis of a one (1) week sample survey, the number of emergency room encounters that were judged not to require emergency service.

4508.2 SHPDA shall notify a hospital at least three (3) months in advance of the selected week for the survey required in Subsection 4508.1.

4508.3 Each hospital, unless specifically exempted by SHPDA, shall report quarterly the data listed below:

(a) Average daily hours of operation;

(b) Average daily hours on diversion;

(d) Average daily number of patients; and

(e) Severity quotient.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4508

22-B DCMR § 4509 REPORTS OF OTHER FACILITIES

4509.1 Each SNF and each ICF shall provide the following data annually:

(a) The number of operating (staffed and otherwise held ready for occupancy) beds, by bed category (i.e., SNF and ICF);

(b) The number of patient days by bed category;

(c) The jurisdiction of residence of patients at the time of admission, by bed category (using the jurisdiction categories specified in Section 4502);

(d) The number of admissions by bed category;

(e) The number of discharges by bed category;

(f) The average length of stay by bed category;

(g) Payment source by days of care by bed category; and

(h) Long-term acute care.

4509.2 Each renal dialysis facility shall report annually, by jurisdiction of patient residence (using the categories as specified in Section 4502), the number of patients regularly receiving each type of service the facility offers, the number of treatments given by type, and the facility’s hours of operation.

4509.3 Each home health agency and each home care hospice shall report annually the number of patients serviced, and the number of visits provided, by type and major payment source (Medicaid, Medicare, other third party, and self-pay) and any other information SHPDA may request.

4509.4 Each ambulatory surgical facility, neighborhood health center, drug treatment center, alcohol treatment clinic, and other freestanding medical facility subject to CON requirements, shall report annually the number of patients serviced, the number of patient encounters, and, if applicable, the number of enrollees by major payment source.

4509.5 Each HMO shall annually report the number of enrollees by the following categories:

(a) Jurisdiction of residence as specified Section 4502;

(b) The number of ambulatory visits;

(d) The number of inpatient days of care (by hospital and service).

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4509

22-B DCMR § 4510 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4510

22-B DCMR § 4511 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4511

22-B DCMR § 4512 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4512

22-B DCMR § 4513 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4513

22-B DCMR § 4514 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4514

22-B DCMR § 4515 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4515

22-B DCMR § 4516 [REPEALED]

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4516

22-B DCMR § 4599 DEFINITIONS

4599.1 The provisions of § 4099 of Chapter 40 of this title, and the definitions set forth in that section shall apply to this chapter.

History

SOURCE: Final Rulemaking published at 29 DCR 5569 (December 17, 1982), enacting Proposed Rulemaking published at 29 DCR 4742 (October 29, 1982); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4599

22-B46 REVISED SPECIAL CERTIFICATE OF NEED PROCEDURES, CONSIDERATIONS AND CRITERIA FOR REVIEW OF MAGNETIC RESONANCE IMAGING (MRI) SCANNERS [REPEALED]

22-B DCMR § 4600 [REPEALED]

History

SOURCE: Final Rulemaking published at 35 DCR 5803 (July 29, 1988); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4600

22-B DCMR § 4601 [REPEALED]

History

SOURCE: Final Rulemaking published at 35 DCR 5803 (July 29, 1988); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4601

22-B DCMR § 4602 [REPEALED]

History

SOURCE: Final Rulemaking published at 35 DCR 5803 (July 29, 1988); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4602

22-B DCMR § 4603 [REPEALED]

History

SOURCE: Final Rulemaking published at 35 DCR 5803 (July 29, 1988); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4603

22-B DCMR § 4604 [REPEALED]

History

SOURCE: Final Rulemaking published at 35 DCR 5803 (July 29, 1988); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4604

22-B DCMR § 4605 [REPEALED]

History

SOURCE: Final Rulemaking published at 35 DCR 5803 (July 29, 1988); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4605

22-B DCMR § 4606 [REPEALED]

History

SOURCE: Final Rulemaking published at 35 DCR 5803 (July 29, 1988); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4606

22-B DCMR § 4607 [REPEALED]

History

SOURCE: Final Rulemaking published at 35 DCR 5803 (July 29, 1988); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4607

22-B DCMR § 4699 [REPEALED]

History

SOURCE: Final Rulemaking published at 35 DCR 5803 (July 29, 1988); as amended by Final Rulemaking published at 61 DCR 1666 (February 28, 2014). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 4699

22-B47 HEALTH-CARE FACILITY UNLICENSED PERSONNEL CRIMINAL BACKGROUND CHECK

22-B DCMR § 4700 GENERAL PROVISIONS

4700.1 These rules are promulgated pursuant to the Health-Care Facility Unlicensed Personnel Criminal Background Check Act of 1998, effective April 20, 1999, as amended by the Health-Care Facility Unlicensed Personnel Criminal Background Check Amendment Act of 2002, effective April 13, 2002, (D.C. Laws 12-238 and 14-98), D.C. Official Code § 44-551 et seq., (hereinafter "the Act").

4700.2 These rules are applicable to each facility licensed pursuant to the Health-Care and Community Residence Facility, Hospice and Home Care Licensure Act of 1983, effective February 24, 1984 (D.C. Law 5-48, D.C. Official Code § 44-501 et seq.) and to any entity furnishing Medicaid services.

History

SOURCE: Final Rulemaking published at 48 DCR 294 (January 12, 2001); Final Rulemaking published at 49 DCR 6835 (July 19, 2002).

22-B DCMR § 4701 BACKGROUND CHECK REQUIREMENT

4701.1 A facility, long-term care facility or provider, shall not offer to employ or contract with any unlicensed person having direct patient, resident, or client access, or person licensed, registered, or certified under Chapter 12 of Title 3 of the D.C. Official Code unless within a forty-five (45) day period immediately preceding the date of initial employment or initial commencement of contract services the following has occurred:

Pursuant to § 4701.2 and 4701.3, the person has undergone fingerprinting or live scan performed in the District of Columbia which has resulted in a criminal history, that reveals all convictions that have occurred within the District of Columbia and the fifty (50) states;

(b) The Department of Health verifies that the person has not been convicted, within the seven (7) years before the criminal background check, of any of the offenses listed in § 4705.1;

(c) The Department of Health and those facilities identified pursuant to § 4701.1 verify by means of a check, that the person’s name is not on the Dru Sjodin National Sex Offender Public Website coordinated by the United States Department of Justice, or the Nurse Aide Abuse Registry of the District of Columbia or such registry in the state or states in which the person has lived or worked; and

(d) The person provides a sworn statement affirming that there are no

criminal matters pending against him or her.

Each facility, long-term care facility or provider, identified in § 4701.1 shall cause each prospective employee or contract worker who will have, or foreseeably may have direct patient, resident, or client access, to undergo a criminal background check that shall reveal the criminal history, if any, in the District of Columbia and the fifty (50) states. Fingerprinting or live scan shall be performed in the District of Columbia utilizing the Metropolitan Police Department (MPD) or a private agency. The criminal background check shall be performed, following fingerprinting or live scan, by the MPD and Federal Bureau of Investigation (FBI) in an FBI-approved environment. The results of the criminal background checks shall be forwarded to the Department of Health.

4701.3 The results of the criminal background check shall disclose the criminal history, if any, of the prospective employee or contract worker for the previous seven (7) years before the check.

4701.4 An employee or a contract worker shall be required to undergo a subsequent criminal background check every four (4) years after the date of his or her initial background check, provided that if the name of the employee appears in the FBI databank when the “rap back” system is implemented, the employee shall not be required to have a subsequent criminal background check performed.

4701.5 The Department of Health shall notify a facility, long-term care facility or provider that employs the subject of a criminal background check which returns positive results for any of the offenses listed in § 4705.1 within forty-five (45) days prior to the commencement of the subjects employment.

4701.6 A facility, long-term care facility or provider shall inform the Department of Health within ten (10) days of the resignation or termination of any employee subject to criminal background checks under this chapter whose resignation or termination was for criminal, unprofessional, or unethical conduct.

4701.7 A contract worker shall not be considered resigned or terminated for purposes of §4701.6 as long as the employment contract with the facility is renewed within forty-five (45) days of its satisfaction.

4701.8 Nothing in this section shall prohibit a facility from requiring, in a contract agreement, that the criminal background checks for contract workers be obtained by the contractor.

History

SOURCE: Final Rulemaking published at 48 DCR 294 (January 12, 2001); as amended by Final Rulemaking published at 49 DCR 6835 (July 19, 2002); as amended by Final Rulemaking published at 60 DCR 1169 (February 1, 2013).

22-B DCMR § 4702 FEES

4702.1 In order to obtain the criminal background check, the facilities or provider identified in § 4701.1, prospective employee, or contract worker shall pay the fee that is established to have the criminal background check performed by the Metropolitan Police Department and the Federal Bureau of Investigation (FBI), or a private agency.

4702.2 Nothing in this section shall preclude the facility from seeking reimbursement of the fee paid for the criminal background check from the applicant for employment or contract work.

History

SOURCE: Final Rulemaking published at 48 DCR 294 (January 12, 2001); as amended by Final Rulemaking published at 49 DCR 6835 (July 19, 2002); as amended by Final Rulemaking published at 60 DCR 1169 (February 1, 2013).

22-B DCMR § 4703 PERSONNEL EMPLOYED ON THE EFFECTIVE DATE OF RULES

4703.1 A facility may obtain a criminal background check on each unlicensed person who is employed by the facility or whose contract services are used by the facility on the effective date of these rules.

4703.2 A facility shall not continue to employ or use the contract services of a person whose criminal history is found to be in noncompliance with section 4705.

History

SOURCE: Final Rulemaking published at 48 DCR 294 (January 12, 2001); Final Rulemaking published at 49 DCR 6835 (July 19, 2002).

22-B DCMR § 4704 RECORDKEEPING

4704.1 Each facility shall maintain, in the personnel record of each employee covered by these rules, the following:

(a) The date of hire;

(b) The date on which a criminal background check was requested;

(d) Official documentation of the criminal background check results;

(e) Documentation of a check of the District of Columbia Nurse Aide Abuse Registry;

(f) Any sworn statements submitted by the employee; and

(g) Documentation of any actions taken by the facility as a result of information obtained from the criminal background check.

4704.2 A facility shall not disclose criminal background check records obtained for the purpose of hiring or continuing to employ a person, except:

(a) To the Director or his or her designee during an official inspection or investigation of the facility;

(b) To the person who is the subject of the criminal background check;

(d) To any person, with the written consent and authorization of the person who is the subject of the criminal background check.

4704.3 Recordkeeping and disclosure of information maintained on the District of Columbia Nurse Aide Abuse Registry shall be managed by each facility in accordance with rules on Certified Nurse Aides, 29 DCMR 3250-3254, effective April 5, 1991 (38 DCR 2023).

4704.4 Each facility shall maintain the criminal background records required by subsection 4704.1 in the facility for at least one (1) year after the end of the employment of the person to whom the records relate.

History

SOURCE: Final Rulemaking published at 48 DCR 294 (January 12, 2001); Final Rulemaking published at 49 DCR 6835 (July 19, 2002).

22-B DCMR § 4705 CRIMINAL OFFENSES

4705.1 Except as provided in subsection 4705.2, a facility shall not employ or use the contract services of an unlicensed person who has been convicted, within the seven (7) years prior to a criminal background check conducted pursuant to these rules, of one or more of the following offenses or the equivalent thereof:

(a) Murder;

(b) Attempted murder;

(d) Arson;

(e) Assault;

(f) Battery;

(g) Assault and battery;

(h) Assault with a dangerous weapon;

(i) Mayhem;

(j) Threats to do bodily harm;

(k) Burglary;

(l) Robbery;

(m) Kidnapping;

(n) Theft;

(o) Fraud;

(p) Forgery;

(q) Extortion;

(r) Blackmail;

(s) Illegal use of a firearm;

(t) Illegal possession of a firearm;

(u) Rape;

(v) Sexual assault;

(x) Sexual battery;

(y) Sexual abuse;

(z) Child abuse;

(aa) Cruelty to children;

(bb) Unlawful distribution of a controlled substance; and

(dd) Unlawful possession of a controlled substance with intent to distribute.

4705.2 A facility may employ or use the contract services of an unlicensed person who has been convicted only of one (1) offense listed in section 4705.1 at the misdemeanor level, provided that:

(a) The misdemeanor offense did not involve abuse or moral turpitude;

(b) There are no criminal matters pending against the person on the date of the person's employment or commencement of contract service with the facility; and

4705.3 The facility must verify, by information obtained in the original criminal background check or by one or more supplemental checks, that the unlicensed person meets the requirements for employment or contract service contained in subsection 4705.2.

History

SOURCE: Final Rulemaking published at 48 DCR 294 (January 12, 2001); Final Rulemaking published at 49 DCR 6835 (July 19, 2002).

22-B DCMR § 4706 PENALTIES

4706.1 Any person who discloses any information in violation of the Act or of these rules shall be guilty of a misdemeanor, and upon conviction thereof shall be punishable by a fine not to exceed three hundred dollars ($ 300), a term of imprisonment not to exceed thirty (30) days, or both.

4706.2 Civil fines, penalties, and fees may be imposed as sanctions for any violation of the Act or of these rules, pursuant to Titles I-III of the Department of Consumer and Regulatory Affairs Civil Infractions Act of 1985, effective October 5, 1985 (D.C. Law 6-42, D.C. Official Code § 6-2701, et seq., D.C. Official Code § 2-1801.01, et seq.).

4706.3 Any person who makes a false statement concerning a material matter

required by this chapter shall be subject to prosecution.

History

SOURCE: Final Rulemaking published at 48 DCR 294 (January 12, 2001); as amended by Final Rulemaking published at 49 DCR 6835 (July 19, 2002); as amended by Final Rulemaking published at 60 DCR 1169 (February 1, 2013).

22-B DCMR § 4799 DEFINITIONS

4799.1 For the purposes of this chapter, the following terms shall have the meanings ascribed:

Contract services - services provided on behalf of a facility by a person or entity other than the facility pursuant to a contractual agreement.

Contract worker - a compensated contractor, or the agent or employee of a contractor, for whom it is foreseeable that he or she will come in direct contact with patients.

Criminal background check - an investigation into a person's criminal history to determine whether, within the seven (7) years preceding the background check, the person has been convicted, in the District of Columbia or in any other state or territory of the United States where such person has worked or resided, of any criminal offenses.

Direct patient, resident, or client access - access to a patient, resident, or client of a facility, long-term care facility or provider, that involves, or may foreseeably involve, presence in a room occupied by a patient, client, or resident while not under the immediate and contemporaneous supervision of a licensed health care professional employed by the facility. However, the term does not include a volunteer unless the volunteer has duties that are equivalent to the duties of a direct patient, resident, or client access employee and those duties involve, or may involve, presence in a room occupied by a patient, resident, or client of the long-term care facility, or other facility while not under the immediate and contemporaneous supervision of a licensed health care professional employed by the facility.

Director - the Director of the Department of Health or his or her designee.

Employee - a person who is hired and compensated directly by a facility.

Facility - any entity required to be licensed pursuant to the Health-Care and Community Residence Facility, Hospice and Home Care Licensure Act of 1983, effective February 24, 1984 (D.C. Law 5-48, D.C. Official Code § 44-501 et seq.) and any entity furnishing Medicaid services under a provider agreement with the District of Columbia in accordance with regulations promulgated under Title XIX of the Social Security Act, approved July 30, 1965 (Pub. L. 89-97; 42 U.S.C. § 1396 et seq.).

Long-term care facility or provider - means the following facilities or providers which receive payment for services under Title XVIII or XIX of the Social Security Act:

(a) A provider of hospice care (as defined in § 1861(dd) (1) of 42

U.S.C. 1395x (dd) (1);

(b) A long-term care hospital as described in § 1886(d) (1) (B) (iv) of 42 U.S.C. 1395ww (d) (1) (B) (iv);

(c) A residential care provider that arranges for, or directly provides, long-term care services, including an assisted living facility that provides a level of care established by the Secretary; and

(d) Any other facility or provider of long-term care services under such titles as the District of Columbia deems appropriate.

Medicaid services - nursing facility services, home health-care services, inpatient hospital and nursing services for individuals 65 years of age or older in an institution for mental disease, services in an intermediate care facility for the mentally retarded, home and community care for functionally disabled elderly individuals, and community supported living arrangement services as defined in Title XIX of the Social Security Act, approved July 30, 1965 (Pub. L. 89-97; 42 U.S.C. § 1396 et seq.).

Nurse Aide Abuse Registry - a record, maintained by the District of Columbia in accordance with the Omnibus Budget Reconciliation Act of 1987, Pub. L. 100-2032, and pursuant to 29 DCMR 3250-3254, containing names of persons who worked as nurse aides and were determined to have abused, neglected or misappropriated the property of a nursing home resident.

Person - an individual human being.

Private Agency - an entity or person that offers customer assistance in the use of criminal background checks for employment purposes.

Unlicensed person - a person who is not licensed pursuant to the Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99, D.C. Official Code § 3-1201.01 et seq.) and who functions in a complementary or assistance role to licensed health care professionals in providing direct patient care or carrying out common nursing tasks, such as nurse aides, orderlies, assistant technicians, attendants, home health aides, personal care aides, medication aides, geriatric aides, or other health aides. "Unlicensed person" also includes housekeeping, maintenance, and administrative staff for whom it is foreseeable that the person will come in direct contact with patients.

History

SOURCE: Final Rulemaking published at 48 DCR 294 (January 12, 2001); as amended by Final Rulemaking published at 49 DCR 6835 (July 19, 2002); as amended by Final Rulemaking published at 60 DCR 1169 (February 1, 2013).

22-B49 NURSE STAFFING AGENCIES

22-B DCMR § 4900 GENERAL PROVISIONS

4900.1 These rules are implemented pursuant to and in accordance with the Nurse Staffing Agency Act of 2003 (hereinafter "the Act"), effective March 10, 2004, D.C. Law 15-74, D.C. Official Code § 44-1051.01 et seq. Each nurse staffing agency must comply with the Act and with these rules, which together constitute standards for licensing and operation of nurse staffing agencies within the District of Columbia.

4900.2 Except as otherwise expressly provided in the Act or these rules, no person or entity may operate, or hold himself, herself or itself out as operating, a nurse staffing agency for the purpose of rendering temporary nursing services or related health aide services within the District of Columbia, whether public or private, for profit or not for profit, without being licensed as required by the Act and these rules.

4900.3 Each person or entity operating within the District of Columbia as a nurse staffing agency, as defined in the Act, on the effective date of these rules, must submit an application for licensure within ninety (90) days or cease operation within the District of Columbia within ninety (90) days of the effective date of these rules.

4900.4 Each nurse staffing agency must develop and implement policies and procedures in accordance with section 15 of the Act. The policies and procedures shall comply with the Act and these rules.

History

SOURCE: Final Rulemaking published at 51 DCR 10633 (November 19, 2004).

22-B DCMR § 4901 LICENSING

4901.1 Each applicant for licensure as a nurse staffing agency must submit an application for initial licensure to the Department no later than ninety (90) days before its intended commencement of operation.

4901.2 As part of its initial application for licensure, the applicant must submit to the Department all information listed as required in section 4 of the Act, and the following other information:

(a) All additional names, if any, under which the applicant or a subordinate part thereof intends to do business as a nurse staffing agency within the District of Columbia;

(b) The name, professional title, and District of Columbia license number of the agency's nursing personnel and health aide supervisor(s), as further described in section 4904.2;

(c) If the applicant's District of Columbia operations headquarters is located within the District of Columbia, a copy of the Certificate of Occupancy issued by the District of Columbia government to the applicant for that premises;

(d) If the applicant's District of Columbia operations headquarters is located outside of the District of Columbia, a copy of each document certifying the responsible jurisdiction's approval of the use of that location or premises as a nurse staffing agency, including approval related to the appropriate zoning, building and fire codes, if applicable;

(e) If the applicant's District of Columbia operations headquarters is located outside of the District of Columbia, the name, address and telephone number of:

(1) If the applicant is a corporation, the corporation's registered agent within the District of Columbia, appointed pursuant to the District of Columbia Business Corporation Act, D.C. Law 9-144, D.C. Official Code §§ 29-101.10 through 101.12; or

(2) If the applicant is not a corporation, the applicant's attorney-in-fact or general agent, who must maintain a business office or residence within the District of Columbia, and who must be employed or appointed by the applicant as the person upon whom all judicial and other process or legal notice directed to the agency, relative to conduct governed by the Act and by these rules, may be served.

(f) A copy of the agency's policies and procedures manual;

(g) The required fee(s); and

(h) Any other information that the Department may require in order to properly consider the application.

4901.3 Each nurse staffing agency seeking renewal of its license to operate must submit an application for license renewal to the Department no later than ninety (90) days before the expiration date of its current license. The required renewal license fee must accompany the application.

4901.4 The Department may impose a late application fee, in addition to the established license fee, if a nurse staffing agency fails to submit its license renewal application within the time prescribed.

4901.5 Each nurse staffing agency license shall be the property of the District of Columbia government, and must be returned to the Department immediately upon any of the following events:

(a) Suspension or revocation of the license;

(b) Non-renewal of the license;

(d) If operation of the agency is discontinued by the voluntary action of the licensee.

4901.6 The Department shall issue each license only for the premises and the person or persons named as applicant(s) in the license application, and the license shall not be valid for use by any other person or persons or at any place other than that designated in the license. Any transfer as to person or place without the approval of the Department shall cause the immediate forfeiture of the license.

4901.7 Each applicant for licensure intending to operate in premises located within the District of Columbia must comply with all applicable District of Columbia laws and regulations regarding zoning, fire safety and building construction for all agency premises before an initial or renewal license will be issued.

4901.8 Each applicant for licensure intending to operate in premises located outside the District of Columbia must provide proof of compliance with the applicable jurisdiction's laws regarding zoning, fire safety and building construction for all agency premises as part of the agency's application for an initial or renewal license.

4901.9 If a completed renewal application is filed timely pursuant to these rules, the continued operation of the nurse staffing agency past the stated expiration date on the current license shall not be unlawful if the Department has not yet taken official action on the application for renewal.

4901.10 The Department shall have the authority to issue regular, provisional, and restricted licenses, as further described in these rules, and to classify each issued license as regular, provisional or restricted.

4901.11 The Department shall issue a regular initial license or renewal license, for a period not to exceed one (1) year, to each nurse staffing agency that is in substantial compliance with the Act and with these rules.

4901.12 The Department may issue a provisional license, not to exceed ninety (90) days, to a nurse staffing agency that is not in substantial compliance with the Act or these rules, when the Department determines that the agency is taking appropriate ameliorative action in accordance with an established timetable.

4901.13 A provisional license issued pursuant to section 4901.12 may be renewed no more than once.

4901.14 The Department may issue a restricted license, prohibiting a nurse staffing agency from accepting new clients or from delivering one or more specified services, for a period not to exceed one (1) year, to an agency that is not in substantial compliance with the Act or these rules, as an alternative to suspension, revocation or denial of renewal of the agency's license.

4901.15 Each licensed nurse staffing agency that ceases to operate within the District of Columbia must notify the Department within five (5) business days of ceasing operation, and must return its license to the Department within ten (10) business days of ceasing operation.

History

SOURCE: Final Rulemaking published at 51 DCR 10633 (November 19, 2004).

22-B DCMR § 4902 FEES

4902.1 The fee for each initial license shall be $1000.

4902.2 The fee for each renewal license shall be $500.

4902.3 The additional fee for a late application shall be $100.

4902.4 A fee of $50 shall be charged for a duplicate license.

4902.5 A fee may be imposed for an on-site inspection of an agency located outside of the Washington Metropolitan Statistical Area, as further explained in Section 4906.3.

History

SOURCE: Final Rulemaking published at 51 DCR 10633 (November 19, 2004); as amended by Emergency and Proposed Rulemaking published at 52 DCR 6232 (July 1, 2005) [EXPIRED]; as amended by Final Rulemaking published at 52 DCR 7824 (August 12, 2005).

22-B DCMR § 4903 INSURANCE

4903.1 Each nurse staffing agency must maintain the following minimum amounts of insurance coverage:

(a) Blanket malpractice insurance for all professional employees in the amount of at least one million dollars ($1,000,000) per occurrence and at least three million dollars ($3,000,000) in the aggregate; and

(b) General liability insurance covering personal property damages and bodily injury in the amount of at least one million dollars ($1,000,000) per occurrence and at least three million dollars ($3,000,000) in the aggregate.

History

SOURCE: Final Rulemaking published at 51 DCR 10633 (November 19, 2004).

22-B DCMR § 4904 PERSONNEL

4904.1 All nursing personnel and health aides, as defined in the Act and in these rules, must be employees of the nurse staffing agency.

4904.2 All nursing personnel and health aides, as defined in the Act and in these rules, must be evaluated by and must report to a Registered Nurse licensed in the District of Columbia who is a full-time employee of the nurse staffing agency. Each nurse staffing agency must have at least one supervisory employee, qualified as described herein, accessible by and available to the agency and to its staff at all times.

4904.3 Each nurse staffing agency must have written personnel policies, that are available to each employee and staff member, and that include the following:

(a) Terms of employment or contract, including wage scale, hours of work, vacation, sick leave, insurance, and other benefits, if any;

(b) Provisions for monitoring and evaluating each employee's or staff member's performance by appropriate supervisors;

(c) Provisions pertaining to probationary periods, promotions, disciplinary actions, termination and grievance procedures;

(d) A position description for each category of employee and staff member; and

(e) Provisions for orientation, periodic training or continuing education, and periodic competency evaluation.

4904.4 Each nurse staffing agency must maintain accurate personnel records, which shall include the following information for each employee and staff member:

(a) Name, address and social security number:

(b) Current professional license, certification or registration number, if required;

(d) Resume of education, training certificates acquired, prior employment including references, skills checklist, and evidence of attendance at orientation and in-service training, workshops and/or seminars;

(e) Verification of previous employment;

(f) Documentation of reference checks;

(g) Documentation of any required criminal background check as provided in section 15(j) of the Act;

(i) Results of all competency testing;

(j) A position description;

(k) Copies of completed performance evaluations;

(l) Documentation of all disciplinary actions, if any;

(m) Health certification as required by section 4904.7 or 4904.8;

(m) Documentation of acceptance or declination of immunizations; and

(n) Documentation of drug testing, as required by clients.

4904.5 Each nurse staffing agency must maintain its personnel records for all nursing personnel and health aides rendering services within the District of Columbia, and for all staff members performing duties ancillary to nursing services rendered within the District of Columbia, in its District of Columbia operations headquarters.

4904.6 Each employee and staff member must have the right to review his or her personnel records.

4904.7 At the time of initial employment of each employee or staff member for whom it is reasonably foreseeable that he or she will come into contact with one or more patients, the nurse staffing agency must verify that the employee or staff member has been screened for communicable disease within the previous twelve (12) months, or according to superseding time guidelines issued by the federal Centers for Disease Control and Prevention, and that the employee or staff member is certified to be free of communicable disease.

4904.8 Each employee or staff member for whom it is reasonably foreseeable that he or she will come into contact with one or more patients must be screened at least annually for communicable disease, according to the guidelines issued by the federal Centers for Disease Control and Prevention, and must be certified to be free of communicable disease.

4904.9 No employee may provide nursing or health aide services, and no nurse staffing agency may knowingly permit an employee to provide such services, if the employee:

(a) Is under the influence of alcohol, any mind-altering drug, or any combination thereof; or

(b) Has a communicable disease which poses a confirmed health risk to other persons.

History

SOURCE: Final Rulemaking published at 51 DCR 10633 (November 19, 2004); as amended by Emergency and Proposed Rulemaking published at 52 DCR 6232 (July 1, 2005) [EXPIRED]; as amended by Final Rulemaking published at 52 DCR 7824 (August 12, 2005).

22-B DCMR § 4905 COMPLAINT, INCIDENT, AND DISCIPLINARY REPORTING PROCEDURES

4905.1 Each nurse staffing agency must develop and implement policies and procedures for:

(a) Receiving, recording, and investigating complaints;

(b) Recording, reporting, and investigating incidents; and

(c) Reporting to the Board of Nursing or to the Department, as required by the Act and by this Chapter, information that may be grounds for disciplinary action under the Health Occupations Revision Act or the Certified Nurse Aide regulations.

4905.2 Each agency's policies and procedures must provide that a complaint may be presented orally or in writing.

4905.3 Each agency must respond to each complaint received by it within fourteen (14) calendar days of receipt of the complaint, must investigate the complaint as soon as reasonably possible, and must, upon completion of the investigation, provide the complainant with the results of the investigation.

4905.4 Each agency must report any incident, as further defined in this Chapter, to the Department, if that incident is related to the operation of the nurse staffing agency or to the services provided by the agency's employees and if that incident results in injury, illness, harm, or the potential for significant harm to any patient or client receiving services from the agency.

4905.5 Each agency must report each incident described in subsection 4905.4, above, to the Department no later than twenty-four (24) hours after the agency learns of the incident, must investigate the incident as soon as reasonably possible, and must provide the Department with the results of the investigation upon completion of the investigation.

4905.6 Each agency must report any action taken by, or any condition affecting the fitness to practice of, a Licensed Practical Nurse or a Registered Nurse that might be grounds for enforcement or disciplinary action under the Health Occupations Revision Act to the Board of Nursing within (5) business days of the nurse staffing agency's receipt or development of the information.

4905.7 Each agency must report any action taken by a Certified Nurse Aide that might be grounds for listing that individual on the Nurse Aide Abuse Registry to the Department within five (5) business days of the nurse staffing agency's receipt or development of the information.

4905.8 Each agency must develop and implement a system of recording complaints and incidents, which must reflect all complaint, incident, and investigative activity for each calendar year, and which must include, for each complaint or incident:

(a) The name, address and phone number of the complainant, if known;

(b) If the complaint is anonymous, a statement so indicating;

(d) The date and time the incident occurred;

(e) The date and time the incident is reported to the Department;

(f) A description of the complaint or incident;

(g) The date on which the complaint or incident investigation is completed;

(h) Whether the complaint is substantiated; and

(i) Any subsequent action taken as a result of the complaint or incident, and the date on which that action is taken.

4905.9 The information required pursuant to subsection 4905.8, above, must be maintained by each agency for at least three (3) years after the date on which the complaint is received or on which the agency learns of the incident.

4905.10 All records related to incidents and complaints must be made accessible to the Department at all times, and must be furnished to the Department immediately upon request.

History

SOURCE: Final Rulemaking published at 51 DCR 10633 (November 19, 2004).

22-B DCMR § 4906 INSPECTIONS AND INVESTIGATIONS BY THE DEPARTMENT

4906.1 The Department shall be authorized to take the following actions to determine whether an applicant or a licensee is in compliance with the Act and with these rules:

(a) On-site inspection, which may include review of records, interviews of employees, staff members, clients, and patients, and observation of nursing personnel and other staff;

(b) Review of records, timely delivered to the Department upon its request, by the applicant or licensee;

(d) Any combination of the above.

4906.2 In the case of a nurse staffing agency whose District of Columbia operations headquarters is located outside of the District of Columbia, the Department may require that the agency's responsible party, owner or president, and/or other authorized representative, present himself or herself in person at the Department to submit the agency's application and/or to verify required information at the request of Department officials.

4906.3 In the case of a nurse staffing agency whose District of Columbia operations headquarters is located outside of the Washington Metropolitan Statistical Area, and of which the Department determines that an on-site inspection is required in order to assess the agency's compliance with the Act and these rules, the Department may impose a fee for the inspection, not to exceed the Department's actual costs in performing the inspection.

4906.4 Each nurse staffing agency or applicant for licensure as a nurse staffing agency must permit authorized officials of the Department, upon presentation of identification, to enter all premises of the agency, regardless of whether the officials' visit is previously announced or unannounced, and must permit these officials to conduct unimpeded inspection, as the officials deem is needed, to:

(a) Determine whether a licensee is in compliance or noncompliance with the Act and these rules; or

(b) Verify information submitted by an applicant to determine whether the applicant qualifies for licensure.

4906.5 Each nurse staffing agency must permit authorized officials of the Department, upon presentation of identification or upon presentation of an official letter of request, to have unimpeded access to all records relating to the District of Columbia operations of the agency, including client records, employee and staff records, policies and procedures, contracts, and any other information deemed necessary by the Department to determine compliance with the Act and these rules.

4906.6 Failure to permit entry and/or inspection as described in subsection 4906.4, or failure to permit access to records as described in subsection 4906.5, shall be cause for refusal to issue, refusal to renew, revocation, or suspension of the agency's license.

4906.7 Authorized officials of the Department, upon presentation of identification, shall have the right to enter and inspect all premises of an entity which the Department has reason to believe is operating as a nurse staffing agency without being licensed as required by the Act and these rules, provided that they obtain:

(a) The permission of the owner or operator; or

(b) An Order of the Superior Court of the District of Columbia

4906.8 The Department may refer, for appropriate legal action, any case involving an unlicensed entity that the Department has reason to believe is operating as a nurse staffing agency in violation of the Act or of these rules.

History

SOURCE: Final Rulemaking published at 51 DCR 10633 (November 19, 2004).

22-B DCMR § 4907 ENFORCEMENT

4907.1 The Department may refuse to issue, refuse to renew, revoke, or suspend a nurse staffing agency's license for any of the following reasons:

(a) Willful submission or use of false or misleading information in connection with an application for or with the use of a license;

(b) Violation of the Act, of these rules, or of any other federal or District of Columbia law or regulation applicable to nurse staffing agencies operating in the District of Columbia;

(d) Failure to allow inspection or access to records as provided by these rules;

(e) Failure to comply with any lawful order of the Department pursuant to the Act or to these rules; or

(f) Any act that constitutes a threat to the public's health or safety.

4907.2 Each nurse staffing agency licensee, and each nurse staffing agency applicant that has submitted a complete application, shall be afforded notice and an opportunity to be heard prior to the action of the Department, if the intent of the Department is to refuse to issue, refuse to renew, revoke, or suspend the agency's license, except that a license may be summarily suspended before a hearing in accordance with this Section as further described below.

4907.3 If the Department intends to refuse to issue, refuse to renew, revoke, or suspend an agency's license, it must provide the agency with a written notice, which must include:

(a) The violation(s) and/or other unlawful or harmful act(s) that form the basis of the Department's proposed action, including a brief description of the facts of each violation or unlawful or harmful act; and

(b) A statement informing the agency that the proposed action will become final unless the agency submits, within fifteen (15) days, a written request to the Office of Adjudication and Hearings for a hearing on the proposed action.

4907.4 If the agency does not respond to the notice within the time and in the manner specified in the notice, the Department may, without a hearing, take the action contemplated in the notice, at which time it must notify the agency, in writing, of the action taken.

4907.5 The Department may summarily suspend a nurse staffing agency's license if the operation of the agency poses an imminent danger to the health, safety or welfare of the public.

4907.6 If the Department summarily suspends a nurse staffing agency's license, it must immediately provide the agency with written notice of the action, which must include:

(a) A copy of the order of suspension;

(b) A statement of the violation(s) and/or other unlawful or harmful act(s) that form the basis of the suspension, including a brief description of the facts of each violation or unlawful or harmful act; and

(c) A statement informing the agency that it may, within seven (7) days of its receipt of the notice, appeal the suspension by submitting a written request to the Office of Adjudication and Hearings for an expedited hearing on the suspension.

4907.7 If a nurse staffing agency files a timely request for a hearing on the summary suspension of its license, as provided in subsection 4907.6, the Department, by and through the Office of Adjudication and Hearings, must convene the hearing within three (3) business days of its receipt of the agency's timely request.

4907.8 An agency's request for a hearing, as provided in subsections 4907.6 and 4907.7, shall not serve to stay the order suspending the agency's license.

History

SOURCE: Final Rulemaking published at 51 DCR 10633 (November 19, 2004).

22-B DCMR § 4908 CIVIL PENALTIES

4908.1 Civil fines, penalties, and fees may be imposed as sanctions for any violation of the Act or of these rules, pursuant to titles I-III of the Department of Consumer and Regulatory Affairs Civil Infractions Act of 1985, effective October 5, 1985 (D.C. Law 6-42, D.C. Official Code § 2-1801.01, et seq.) and to the regulations promulgated pursuant thereto.

History

SOURCE: Final Rulemaking published at 51 DCR 10633 (November 19, 2004).

22-B DCMR § 4909 CONDUCT OF HEARINGS

4909.1 Hearings shall be conducted and appeals shall be heard in accordance with the rules governing the conduct of administrative hearings for health-care facilities, located at 22 DCMR 3110, 3111 and 3112.

History

SOURCE: Final Rulemaking published at 51 DCR 10633 (November 19, 2004).

22-B DCMR § 4999 DEFINITIONS

For the purposes of these rules, the following terms shall be defined as follows:

Applicant - a person or entity that has timely filed an application for initial licensure or license renewal.

Board or Board of Nursing - the District of Columbia Board of Nursing.

Client - a health care facility or agency, or an individual, which enters into an agreement or a contract with a nurse staffing agency for the provision or referral of nursing personnel, Home Health Aides or Personal Care Aides.

Complaint - a report, by whatever means, made to a nurse staffing agency, that alleges a problem related to the operation of a nurse staffing agency or to the services provided by the agency's employees.

Department - the District of Columbia Department of Health.

District of Columbia operations headquarters - the nurse staffing agency's office from which the agency conducts its business for the provision of nursing services within the District of Columbia.

Health aide - a Home Health Aide or Personal Care Aide, qualified and authorized to perform home health aide services or personal care services in accordance with Title 29 of the District of Columbia Municipal Regulations, Chapters 50 and 51.

Health care facility or agency - any entity providing health care services that is defined or designated as a health care facility or agency pursuant to the Health-Care and Community Residence Facility, Hospice and Home Care Licensure Act of 1983, D.C. Law 5-48, D.C. Official Code § 44-501 et seq. This includes, but is not limited to, hospitals, nursing homes, hospices, community residence facilities, maternity centers, ambulatory surgical facilities, renal dialysis facilities, and home care agencies.

Health Occupations Revision Act or HORA - the District of Columbia Health Occupations Revision Act, D.C. Law 6-99, D.C. Official Code § 3-1201.01 et seq.

Incident - an occurrence related to the operation of a nurse staffing agency or to the services provided by the agency's employees that results in injury, illness, harm, or the potential for significant harm to any patient or client receiving services from the agency. "Incident" includes, but may not be limited to: death; physical, sexual, or verbal abuse; mistreatment; exploitation; neglect; physical injury; improper use of restraints; medication error; illness resulting from mistreatment or neglect, whether intentional or unintentional; theft of a patient or client's personal property or funds; and any other occurrence requiring the services of a law enforcement agency or of emergency personnel.

Licensee - a nurse staffing agency operating under the authority of a license that has not been denied, suspended or revoked.

Nurse Aide Abuse Registry - a listing of Certified Nurse Aides who have been found to have abused, neglected, or misappropriated funds of one or more patients, pursuant to Title 29 of the D.C. Municipal Regulations, Chapter 32.

Nurse staffing agency - any person, firm, corporation, partnership, or other business entity engaged in the business of providing or referring nursing personnel to a health care facility or agency, or to an individual, for the purpose of rendering temporary nursing services within the District of Columbia, and as further defined in the Nurse Staffing Agency Act of 2003, effective March 10, 2004, D.C. Law 15-74, D.C. Official Code § 44-1051.01 et seq.

Nursing personnel - any individual who is licensed by the District of Columbia Board of Nursing as a Licensed Practical Nurse or as a Registered Nurse, or any individual who is certified as a Certified Nurse Aide in accordance with Title 29 of the District of Columbia Municipal Regulations, Chapter 32.

Patient - any individual who receives nursing services from one or more staff members or employees of a nurse staffing agency.

Responsible party - the employee or other affiliate of a nurse staffing agency who directs the nurse staffing agency's day-to-day nurse staffing operation.

Washington Metropolitan Statistical Area - an area composed of the District of Columbia and portions of the surrounding states, also known as the Washington DC-VA-MD-WV Metropolitan Statistical Area, and so designated by the Executive Office of the President of the United States, Office of Management and Budget, as a core area containing a substantial population nucleus, together with adjacent communities having a high degree of social and economic integration with that core.

History

SOURCE: Final Rulemaking published at 51 DCR 10633 (November 19, 2004).

22-B50 D.C. GENERAL HOSPITAL

22-B DCMR § 5000 CHANGES IN HOSPITAL RATES

5000.1 Any changes resulting in and increase of hospital charges shall be made in accordance with D.C. Code, 2001 Ed. §44-1924. Such changes shall be needed for annual inflationary reasons or to make hospital rates comparable with other similar institutions. A notice of these changes shall be published in the D.C. Register and a public hearing shall be held at the hospital within a 30 day notice period.

5000.2 Where a new procedure, drug or supply item (that did not exist in the past at the hospital) is provided to a patient, the hospital shall charge a reasonable rate to avoid a loss. The rate shall be approved by the Director, Financial Management Division, D.C. General Hospital on a cost plus basis. A notice of such procedures and rates shall be published in the D.C. Register at a later date.

5000.3 Corrections to the rates shall be determined by the Director, Financial Management Division, D.C. General Hospital using reasonable judgment. Where a correction or several corrections combined result in an overall reduction of the rates, they shall be implemented immediately. Where the corrections requires an overall increase in the rates, a notice of the changes shall be published in the D.C. Register in accordance with D.C. Code, 2001 Ed. §44-1924.

History

AUTHORITY: Unless otherwise noted, this chapter was enacted under the authority of the D.C. General Hospital Commission Act, D.C. Code, 2001 Ed. §§44-1901 to 44-1957. Subsequent to the enactment of this chapter, the D.C. General Hospital Commission Act was repealed by the Health and Hospitals Public Benefit Corporation Act of 1996 §402, D.C. Law 11-212, 43 DCR 4962 (September 13, 1996).
SOURCE: Final Rulemaking published at 31 DCR 4417 (September 7, 1984). EDITOR’S NOTE: Pursuant to the terms of this chapter, the Executive Director, District of Columbia General Hospital, gave notice of changes to rates in the following Notices of Final Rulemaking: 31 DCR 6258 (December 14, 1984) 34 DCR 189 (January 9, 1987) 38 DCR 881 (February 1, 1991) 38 DCR 6777 (November 8, 1991) 41 DCR 4166 (June 24, 1994)

22-B55 STANDARDS FOR PREPAID PROVIDERS QUALIFYING TO SERVE DISTRICT OF COLUMBIA MEDICAID RECIPIENTS

22-B DCMR § 5500 PURPOSE

5500.1 The purpose of this chapter is to set forth the standards under which a Health Maintenance Organization (HMO) or other health care provider may qualify to serve District Medicaid recipients on a prepaid basis.

5500.2 Organizations willing and able to offer quality health care services to voluntarily enrolled subscribers for a fixed prepaid fee, including HMOs, preferred provider organizations, community health centers, insurance companies, and physician groups, are referred to throughout these standards as Qualifying Organizations (QOs).

5500.3 Only organizations meeting the criteria in these standards shall qualify for consideration as prepaid providers for District Medicaid recipients.

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is D.C. Code, 2001 Ed. §1-307.02; and Reorganization Plan No. 2 of 1979, 3 D.C. Code, 2001 Ed. at 338.
SOURCE: Final Rulemaking published at 34 DCR 1550 (March 6, 1987).

22-B DCMR § 5501 PROVIDER QUALIFICATIONS

5501.1 Except for QOs operated by Department or D.C. General Hospital, each QO shall be incorporated in the District of Columbia.

5501.2 Each QO shall demonstrate to the satisfaction of the Department that it, if it is a new organization, a majority of its participating primary care physicians, has had experience in serving low income, diversified population groups in the District.

5501.3 Each QO shall have agreements in place that shall assure all its Medicaid enrollees will receive their hospital inpatient care in a District hospital unless one (1) of the following conditions exist:

(a) Emergency care is required and a non-District facility is the closest provider; or

(b) The enrollee requires a specialized service not available in a District hospital.

5501.4 The QO shall have the professional, financial, and administrative ability and staffing to carry out its duties and responsibilities under its contract with the Department.

5501.5 Within one (1) year from the date of qualification under this chapter, at least one-third (1/3) of the QO board shall be selected from QO subscribers.

5501.6 The subscriber board membership selection process shall be structured in a manner that prevents undue influence on the selection process by non-subscriber members of the board and obtains diverse representation of broad segments of subscribers covered under contracts with the QO.

5501.7 The QO shall establish a Medicaid Advisory Committee, which shall meet at least quarterly, to advise the board on matters regarding service to Medicaid enrollees.

5501.8 Except as otherwise provided, a QO shall maintain the sum of its membership of Medicaid and Medicare beneficiaries below seventy-five percent (75%) of its total enrollment.

5501.9 The requirement set forth in §5501.8 may be waived for up to three (3) years from the date the Regional Administrator has given the Department written notice that the QO meets the definition of an HMO, provided the QO submits annual reports demonstrating to the Regional Administrator’s satisfaction, that it is making continuous efforts and progress toward achieving compliance with the seventy-five percent (75%) ceiling requirement.

5501.10 The seventy-five (75%) ceiling for QOs operated by the Department or by D.C. General Hospital may be waived by the Regional Administrator so long as there continues to be special circumstances that justify a waiver and the QO demonstrates it is making reasonable efforts to enroll individuals who are not eligible for Medicare or Medicaid.

5501.11 The seventy-five percent (75%) ceiling requirement shall not apply to a QO which is receiving, and has received during the previous two (2) years, at least one-hundred thousand dollars ($100,000) in federal funds under §330(d)(1) of the Public Health Service Act.

5501.12 The seventy-five percent (75%) ceiling requirement shall apply to each QO permitted by contract with the Department to lock-in a Medicaid recipient as provided under §5509.10 of this chapter, unless the QO is an entity described in §5501.11.

History

SOURCE: Final Rulemaking published at 34 DCR 1550 (March 6, 1987).

22-B DCMR § 5502 FINANCIAL REQUIREMENTS

5502.1 The QO shall assure through its contracts, subcontracts, and any other appropriate manner that neither enrollees or the Department are held liable for debts of the QO in the event of its insolvency.

5502.2 The QO shall deposit into an escrow account, cash, securities, letters of credit or an acceptable combination of these in one (1) of the amounts set forth in §§ 5502.3 and 5502.4.

5502.3 The amount held in escrow for a start-up organization shall be the greater of the following:

(a) Five percent (5%) of its estimated expenditures for health care services for its first year of operation;

(b) Twice its estimated average monthly uncovered expenditures for its first year of operation; or

5502.4 An on-going organization shall deposit the following amounts:

(a) An initial deposit equal to the larger of one percent (1%) of the preceding twelve (12) months uncovered expenditures or one-hundred thousand dollars ($100,000);

(b) In the second contract year, the amount of the additional deposit shall be equal to two percent (2%) of its estimated annual uncovered expenditures;

(c) In the third contract year, the additional deposit shall be equal to three percent (3%) of its estimated annual uncovered expenditures for that year; and

(d) In the fourth and subsequent contract years, the additional deposit shall be equal to four percent (4%) of its estimated annual uncovered expenditures for each year.

5502.5 For the purposes of §5502.4, each year’s estimate, after the first year of operation shall reasonably reflect the prior year’s operating experience and delivery arrangements.

5502.6 The deposit requirement shall not apply if any one (1) of the following situations exist:

(a) When an organization has achieved a net worth not including land, buildings and equipment of at least one million dollars ($1,000,000) or has achieved a net worth including land, buildings, and equipment of at least five million dollars ($5,000,000);

(b) If the total amount of the accumulated deposit is equal to twenty-five percent (25%) of the organization’s estimated annual uncovered expenditures for the next calendar year; or

5502.7 The Department may require a QO to update its insolvency deposits on a quarterly basis if the QO is experiencing rapid growth, and may order suspension of new Medicaid enrollment until the appropriate deposit is certified to the Department.

5502.8 All income from deposits shall belong to the depositing organization and shall be paid to the depositing organization as the income becomes available.

5502.9 All funds of QOs shall be invested only in securities or other investments permitted by the laws of the District for the investment of assets constituting the legal reserves of life insurance companies.

5502.10 Unless otherwise provided in this chapter, reinsurance in the form of individual stop loss protection shall be mandatory and shall be provided by the Department if the QO requests it.

5502.11 The reinsurance protection offered by the Department shall provide eighty percent (80%) coverage of hospital bills (not including physician fees) incurred on behalf of an individual enrollee in a twelve (12) month period (while a recipient is enrolled in a QO and Medicaid eligible) which collectively exceed fifteen thousand dollars ($15,000), calculated in terms of Medicaid reimbursement policy and adjusted, if necessary, from a per discharge to a per diem rate.

5502.12 A QO may elect not to accept the Department’s reinsurance and have its capitation payment increased by the actuarial value of the reinsurance under any of the following conditions:

(a) The QO is a federally qualified HMO;

(b) The QO has more than forty thousand (40,000) prepaid members;

(d) The QO has purchased equivalent reinsurance from a private carrier.

5502.13 Any director, officer, employee or partner of a QO who receives, collects, disburses, or invests funds in connection with the activities of the QO shall be responsible for the funds in a fiduciary relationship to the organization.

5502.14 The QO shall maintain in force a fidelity bond on officers and employees with a fiduciary responsibility in an amount not less than one-hundred thousand dollars ($100,000) per person.

History

SOURCE: Final Rulemaking published at 34 DCR 1550, 1552 (March 6, 1987).

22-B DCMR § 5503 AUDIT AND REPORTING REQUIREMENTS

5503.1 Each QO shall annually file a financial statement, verified by at least two (2) principal officers within ninety (90) days after the close of its fiscal year.

5503.2 The QO shall have the financial statement described in §5503.1 audited by an independent certified public accountant.

5503.3 The audited financial statement shall give a clear indication of both total expenses and revenues and those attributable to Medicaid enrollees.

5503.4 The QO shall, upon the Department’s request, assist any accountant chosen by the Department to verify the audit report.

5503.5 The Department may inspect and audit any financial records of a QO or its subcontractors relating to the QO’s ability to bear the risk of potential financial loss.

5503.6 Annual audit reports and records shall be retained by the QO for a period of five (5) years after the latest date for which the record is applicable.

5503.7 If any litigation, claim, negotiation, audit, or other action involving the records described in §5503.6 has been started before the expiration of the five (5) year period, the records shall be retained until completion of the action and resolution of all issues which arise from it, or until the end of the regular five (5) year period, whichever is later.

5503.8 Each QO shall submit quarterly summaries of program utilization under its Medicaid contract that give the following information for each Medicaid eligibility category:

(a) The total member months in the quarter;

(b) The number of new enrollees;

(d) The total inpatient days incurred;

(e) The total physician visits provided;

(f) The total out-of-plan referrals; and

(g) The number of emergency room encounters.

5503.9 Each QO shall be required to prepare semiannual summaries of financial performance under its Medicaid contract in terms of total clinical expenditures incurred plus assigned contribution to overhead.

5503.10 The reports filed under §5503.9 shall only be used to negotiate prospectively for future rates of payment.

5503.11 The quarterly utilization summary and semiannual financial summary, shall be submitted to the Department within ninety (90) days after the close of the quarter of the six (6) month period.

History

SOURCE: Final Rulemaking published at 34 DCR 1550, 1554 (March 6, 1987).

22-B DCMR § 5504 REQUIRED INFORMATION

5504.1 Each QO shall submit the following information to the Department, at the time of application for a contract:

(a) A copy of the basic organizational documents of the QO, such as articles of incorporation, and each amendment;

(b) A copy of the by-laws or similar documents regulating conduct of the internal affairs of the QO;

(c) A description of the organization’s ownership and a list of major owners (stockholders having five percent (5%) or more of outstanding shares);

(d) A list of board members and their affiliations;

(e) A roster of key personnel and their qualifications;

(f) A list of subcontracts and a copy of each type of subcontract;

(g) The number of clinical, administrative and marketing employees;

(h) The form of evidence of coverage to be issued to enrollees;

(i) For on-going organizations, financial statements showing the organizations assets, liabilities and sources of financial support, including the most recent audited financial statement;

(j) For start-up organizations, pro forma operating statements and balance sheets and a statement as to sources of working capital and other sources of funding;

(k) A description of the proposed method of marketing;

(l) A description of the enrollee grievance process;

(m) A description of the procedures and programs to assure the availability and accessibility of high quality services;

(n) A description of the enrollment process;

(o) A statement of policies and procedures governing claim payments to providers and distribution of revenues to owners;

(p) A written description of the medical record, and statistical reporting systems;

(q) A statement on the organization’s background and experience in serving low income, diversified population groups in the District; and

(r) A statement of the proposed methods of handling out-of-plan emergency and out-of-area coverage.

5504.2 The QO shall notify the Department’s Office of Health Care Financing in writing within thirty (30) days of any material modifications cited under §5504.1 on file.

History

SOURCE: Final Rulemaking published at 34 DCR 1550, 1555 (March 6, 1987).

22-B DCMR § 5505 MARKETING PRACTICES

5505.1 The QO shall submit to the Department for prior written approval all marketing plans, procedures and materials including the following items:

(a) Marketing brochures and fliers;

(b) Advertising copy and public service announcements;

(d) Descriptions of proposed marketing approaches.

5505.2 The QO shall not engage in deceptive marketing practices that mislead, confuse, or defraud eligible enrollees or the Department.

5505.3 Marketing materials shall be clear and include at least the following:

(a) A description of the benefits;

(b) Hours of service available;

(d) Telephone numbers for emergencies; and

(e) Enrollment and disenrollment rights.

5505.4 The QO shall not provide cash, gift incentives or rebates to prospective members.

5505.5 The QO shall not claim superior medical care or provider skills or threaten, coerce or make untruthful statements regarding the merits of the plan.

5505.6 If the QO employs a system of compensation for marketing representatives based on commissions or other incentives, the QO shall assure the Department that sales activities are adequately supervised to conform to allowable practices.

5505.7 Each eligible Medicaid recipient in the category or categories covered under the contract shall be considered a potential enrollee and may not be discriminated against on the basis of health status or need for health care services.

5505.8 The QO marketing personnel and their supervisors may be required to participate in training sessions presented by the Department that set forth the Department’s requirements, expectations and limitations.

5505.9 No QO shall represent to any D.C. Medicaid recipient that he or she is required to enroll in any prepaid plan.

History

SOURCE: Final Rulemaking published at 34 DCR 1550, 1557 (March 6, 1987).

22-B DCMR § 5506 EVIDENCE OF COVERAGE

5506.1 Each QO shall prepare and submit for prior written approval of the Department a form that is evidence of coverage.

5506.2 The QO shall provide each enrollee with written evidence of coverage prior to the effective date of enrollment which shall include the following:

(a) Notification of the recipient’s effective date of enrollment;

(b) A plan membership card;

(d) An explanation of the procedure for obtaining benefits, including the address and telephone number of primary care physicians, and the hours and days the facilities are open and service is available;

(e) Where and how emergency medical care is available on a twenty-four (24) hour, seven (7) day a week basis, and an explanation of out-of-plan coverage;

(f) Notification that loss of Medicaid eligibility will likewise result in loss of plan enrollment under Medicaid sponsorship (except as otherwise provided in the contract);

(g) Notification of the enrollee’s responsibility for reporting any third party payment source;

(h) A description of the grievance process; and

(i) Information regarding allowable reasons and procedures for disenrolling from the plan.

History

SOURCE: Final Rulemaking published at 34 DCR 1550, 1558 (March 6, 1987).

22-B DCMR § 5507 SERVICE DELIVERY AND QUALITY ASSURANCE PROVISIONS

5507.1 The QO shall provide each enrollee with health care of consistent quality, delivered with dignity, at locations which assure reasonable availability and accessibility to enrollees.

5507.2 The QO shall provide, or arrange through subcontractors for the provision of each service in the benefit package.

5507.3 The QO shall assure that emergency medical care is available on a twenty-four (24) hour basis, seven (7) days a week, either in the QO’s own facilities or through other appropriate facilities.

5507.4 Each Medicaid enrollee of a QO shall receive service through the same providers and facilities serving non-Medicaid enrollees.

5507.5 Each Medicaid enrollee shall be fully integrated into plan membership and shall not be treated differently than a non-Medicaid enrollee.

5507.6 The QO shall allow each enrollee, to the maximum extent feasible, the freedom to choose among its participating providers for primary health care.

5507.7 The QO shall provide health education programs for its enrollees in languages understood by the population being served, that at least include the following items:

(a) Information on available preventive care and its value;

(b) Information on dangers of teenage pregnancies and the importance of prenatal care and well baby care; and

5507.8 The QO shall have a system for follow-up of patient care for enrollees with chronic and acute illnesses, including an appointment follow-up system for “no-shows.”

5507.9 Waiting times for appointment shall not exceed those of non-Medicaid members.

5507.10 The QO shall maintain adequate medical records on each enrollee.

5507.11 The QO shall establish and maintain a quality assurance program, approved by the Department, to review the quality, appropriateness and timeliness of the services performed.

5507.12 The quality assurance program shall meet at least the following requirements:

(a) Be consistent with federal Medicaid utilization control regulations;

(b) Provide for review by appropriate health care professionals of the process followed in providing health services; and

History

SOURCE: Final Rulemaking published at 34 DCR 1550, 1558 (March 6, 1987).

22-B DCMR § 5508 ENROLLEE GRIEVANCE SYSTEM

5508.1 Each QO shall establish and maintain a grievance system with reasonable procedures for the prompt resolution of complaints initiated by enrollees.

5508.2 Each QO shall submit its plans and procedures for a grievance system to the Department for written approval prior to instituting the procedures.

5508.3 At a minimum, the following elements shall be included in the grievance system:

(a) A Grievance Committee for reviewing member complaints comprised of at least fifty percent (50%) QO members of which Medicaid enrollee representatives shall equal the percent of Medicaid enrollees to total enrollment; and

(b) Two (2) levels of review:

(1) Grievance Committee; and

(2) Board of Directors or its Grievance Subcommittee.

5508.4 Records of Grievance Committee and related hearings shall be maintained and available to the Department upon written request.

5508.5 Each QO shall submit to the Department an annual report of grievances, due within ninety (90) days of the close of its fiscal year, which shall include the following:

(a) The total number of grievances initiated by enrollees;

(b) A summary description of the types of grievance initiated; and

History

SOURCE: Final Rulemaking published at 34 DCR 1550, 1560 (March 6, 1987).

22-B DCMR § 5509 ENROLLMENT AND DISENROLLMENT PROCEDURES

5509.1 Enrollment by Medicaid recipients shall be voluntary and without regard to any of the following:

(a) Health status or need or services;

(b) Physical or mental condition or handicap;

(d) Sex;

(e) National origin;

(f) Race;

(g) Creed;

(h) Marital status; or

(i) Sexual orientation.

5509.2 A QO shall request Department approval for enrollment of each eligible applicant identified, which approval shall be granted.

5509.3 Each QO shall include in its enrollment activities an orientation program to inform recipients of available programs and facilities if eligibility conditions are met.

5509.4 If the Department approves the enrollment by the fifteenth (15th) of a month, the recipients enrollment shall be effective on the first day of the following month.

5509.5 If the Department approves the enrollment after the fifteenth (15th) of the month, the recipients enrollment shall be effective on the first day of the second month after the month in which the Department approves the enrollment.

5509.6 Except as provided in §§ 5509.9 and 5509.10, a Medicaid enrollee may voluntarily disenroll from any QO without cause.

5509.7 To disenroll, a Medicaid enrollee shall complete a disenrollment form and submit it to the QO, prior to the Department’s monthly deadline for receipt of disenrollment requests.

5509.8 The disenrollment shall be effective not later than the first day of the second month after the month in which the recipient requests termination.

5509.9 If the QO’s contract with the Department permits, during months two (2) through six (6) of membership, a Medicaid enrollee may only disenroll with good cause after exhausting the grievance process.

5509.10 Contracts permitting the QO to restrict Medicaid disenrollment can be signed only with QOs that meet the requirements of §§1903(m)(2)(F) or (G) of the Social Security Act.

5509.11 A QO shall be able to disenroll members who are disruptive or abusive or whose use of services is fraudulent or deceptive.

5509.12 A QO shall submit a written request to the Department, for written approval of each proposed involuntary disenrollment.

5509.13 An involuntary disenrollment shall be effective not later than the first day of the second month following the approval of the action by the Department.

5509.14 No enrollee shall be disenrolled solely because of an adverse change in health status.

5509.15 Each enrollee covered under this program whose enrollment is subsequently terminated due to loss of Medicaid eligibility shall have the opportunity to convert to a non-group enrollment contract consistent with conversion privileges offered to members of other groups enrolled in the QO.

History

SOURCE: Final Rulemaking published at 34 DCR 1550, 1561 (March 6, 1987).

22-B DCMR § 5510 MEDICAID PROGRAM AND RECIPIENTS HELD HARMLESS

5510.1 A QO shall hold harmless the District of Columbia government, the Department, and Medicaid recipients against any loss, damage, expense and liability of any kind arising out of any action of the QO in the service of Medicaid enrollees.

5510.2 Each subcontract shall contain a provision that the subcontractor shall look solely to the QO for payment of covered services rendered.

History

SOURCE: Final Rulemaking published at 34 DCR 1550, 1562 (March 6, 1987).

22-B DCMR § 5511 ASSIGNMENT OF RIGHTS

5511.1 No QO shall assign or transfer any of the rights gained by qualifying as contractor to the Department

History

SOURCE: Final Rulemaking published at 34 DCR 1550, 1563 (March 6, 1987).

22-B DCMR § 5512 SANCTIONS FOR NON-COMPLIANCE

5512.1 If the Department determined that a QO has failed to comply with this chapter or other applicable federal and District laws and regulations, the Department may do any of the following:

(a) Suspend further enrollment of Medicaid recipients;

(b) Withhold all or part of the monthly payments; and

5512.2 Before taking any action described in §5512.1, the Department shall provide written notice to the QO, which shall include the following:

(a) Identification of the sanction to be applied;

(b) The basis for the Department’s determination that the sanction should be taken;

(d) The timeframe and procedure for the QO to appeal the Department’s determination, including a time, place and date that a hearing on the matter will be held at the written request of the QO.

5512.3 The Department shall give reasonable written notice to Medicaid recipients enrolled in the QO and others who may be affected by the proposed sanction.

History

SOURCE: Final Rulemaking published at 34 DCR 1550, 1563 (March 6, 1987).

22-B DCMR § 5513 THIRD PARTY LIABILITY RECOVERY

5513.1 The QO shall attempt and require its subcontractors to attempt to recover monies resulting from third party liability cases involving workman’s compensation, accidental injury suits and other subrogation of benefits settlements.

5513.2 The Department shall notify each QO of any reported third party payment sources.

5513.3 The QO shall verify third party payment sources directly, when appropriate.

5513.4 Each third party collection by a QO for a Medicaid enrollee shall be reported to the Department as revenue for rate-setting purposes.

History

SOURCE: Final Rulemaking published at 34 DCR 1550, 1563 (March 6, 1987).

22-B DCMR § 5514 CONFIDENTIALITY OF INFORMATION

5514.1 All information, records and data collected and maintained by the QO or its subcontractors relating to enrollees shall be protected by the QO from unauthorized disclosure.

5514.2 Except as otherwise provided in Federal law or regulations, use or disclosure of information concerning enrollees shall be restricted to purposes directly connected with the administration of the Medicaid program.

5514.3 Purposes directly related to the Medicaid program shall include the following:

(a) Establishing eligibility;

(b) Providing services; or

(c) Conducting or assisting in a investigation, prosecution, civil or criminal proceeding relating to the administration of the Medicaid program.

5514.4 The type of information to be safeguarded shall include at least the following:

(a) Names and addresses of enrollees;

(b) Medical services provided;

(d) Social and economic conditions and circumstances.

History

SOURCE: Final Rulemaking published at 34 DCR 1550, 1564 (March 6, 1987).

22-B DCMR § 5515 PAYMENT FOR SERVICES

5515.1 The QO shall be paid by the Department on a monthly per capita basis for the services it gives to Medicaid enrollees pursuant to its Medicaid benefits package.

5515.2 Each QO shall file with the Department both its community rate worksheets, and community rate worksheets adjusted to reflect the Medicaid program benefits package and characteristics of the segment of the Medicaid population it proposes to serve, such as aged, blind, disabled, child, and parent.

5515.4 No QO shall be paid a monthly capitation rate in excess of ninety percent (90%) of historical Medicaid program costs for the Medicaid population it proposes to serve.

5515.5 Each QO contract with the Department shall be for a twelve (12) month period.

5515.6 Each capitation rate specified in the contract shall be in effect for the entire twelve (12) month period.

5515.7 No QO shall impose any co-payment requirement or other fees on Medicaid enrollees.

5515.8 The Department shall pay the QO each month for each Medicaid recipient who is enrolled as of the fifteenth (15th) of the prior month.

5515.9 The QO shall enroll only those Medicaid recipients who are categorically eligible for assistance and are receiving monthly cash assistance under the Aid to Families with Dependent Children or the Supplemental Security Income Program.

5515.10 Except as provided in §5515.11, when an enrollee loses Medicaid eligibility, the Department shall not make capitation payments of the QO for that enrollee as of the second month following the loss of eligibility.

5515.11 The Department shall continue to pay the premium for six (6) months from the effective date of the recipient’s enrollment, even if the recipient loses eligibility during that time, if the following exists:

(a) The QO is a qualified health maintenance organization as defined in Title XIII of the U.S. Public Health Service Act, or an entity described in § 1903(m)(2)(G) of the Social Security Act; and

(b) The contract between the QO and the Department provided a six (6) month enrollment guarantee.

History

SOURCE: Final Rulemaking published at 34 DCR 1550, 1564 (March 6, 1987).

22-B DCMR § 5516 ACCESS TO INFORMATION

5516.1 The Department may make an examination of the affairs of any QO and its subcontractors including onsite inspections and periodic medical audits as often as is reasonably necessary for the protection of the interests of the Department and Medicaid recipients in the District.

History

SOURCE: Final Rulemaking published at 34 DCR 1550, 1565 (March 6, 1987).

22-B DCMR § 5599 DEFINITIONS

5599.1 When used in this chapter, the following terms and phrases shall have the meanings ascribed:

Community rate - the system under which prepaid providers set rates on per person or per family basis that are equivalent for all individuals and for all families of similar composition.

Contract - the agreement between the QO and the Department.

Department - the District of Columbia Department of Human Services, or its designee.

District - the District of Columbia.

Emergency medical care - the sudden unexpected onset of a condition requiring medical or surgical care; which condition may result in permanent physical injury or a threat to life if care is not secured immediately after the onset of the condition or as soon thereafter as the care can be made available.

Enrollee - a Medicaid recipient who is enrolled in a QO that has a contract with the Department.

Enrollment - the initial process by which new enrollees apply and are approved by the QO and the Department.

Evidence of coverage - any certificate, agreement or contract issued to an enrollee setting out the coverage to which he or she is entitled.

Federally qualified HMO - an HMO that has been determined by the U.S. Public Health Service to be a qualified HMO under § 1310(d) of the Public Health Service Act.

Involuntary disenrollment - a QO terminates the membership of an enrollee under conditions permitted by this chapter or the Medicaid contract.

Marketing - any procedure or materials intended to induce Medicaid recipients to become QO enrollees.

Medicaid benefits package - all health services to which recipients are entitled under the District Medicaid Program, except services in a skilled nursing facility, an institution for mental diseases, and other services specifically excluded in the contract.

Prepayment - a predetermined sum of money paid on a periodic basis prior to and independent of the rendering of services.

Provider - any physician, hospital, or other person or facility which is licensed or otherwise authorized in the District to furnish health care services.

On-going organization - a health plan which has provided prepaid services to members for more than twelve (12) months.

Out-of-plan referrals - medically necessary Medicaid covered services arranged for and authorized by the QO.

Regional Administrator - the Administrator, Region III, Health Care Financing Administration, U.S. Department of Health and Human Services.

Reinsurance - insurance protection for costs over a certain level incurred by a QO for providing services to an enrollee.

Reserves - a sum of money accumulated by a QO that can be used as follows:

(a) Applied against known liabilities not yet paid;

(b) Used as contingency for unanticipated expenses; or

Risk - a QO’s potential exposure to financial loss for providing services under a prepayment contract.

Start-up organization - a health plan which has provided prepaid services to members for less than twelve (12) months.

Stop loss - a mechanism which limits the financial liability of a QO for expenses incurred for rendering services to an enrollee under a prepaid contract.

Subcontract - any written agreement between the QO and another party to fulfill service obligations or benefit requirements.

Uncovered expenditures - the cost of health care services that are provided by a QO’s subcontractors for which a non-Medicaid enrollee would be liable in the event of the QO’s insolvency.

Voluntary disenrollment - an enrollee chooses to leave a QO under conditions permitted by this chapter.

History

SOURCE: Final Rulemaking published at 34 DCR 1550, 1566 (March 6, 1987).

22-B60 HEALTH BENEFITS PLAN MEMBERS BILL OF RIGHTS

22-B DCMR § 6000 ESTABLISHMENT OF INTERNAL GRIEVANCE PROCESS

6000.1 Each insurer shall establish and maintain an internal grievance system that provides for the presentation and resolution of grievances brought by members or member representatives.

6000.2 A member or member representative shall have a right to file a grievance with an insurer for a review of an adverse decision.

6000.3 Each insurer shall provide each member with written notice in English or Spanish, as appropriate, of the components of a grievance as required by § 6001.1 (a) and (b) at the time the member first enrolls with the insurer. The notice shall also include:

(a) The telephone numbers and business addresses of the insurer's representatives responsible for grievance resolution;

(b) A statement that describes a member's or member representative's right to contact the Director if dissatisfied with the resolution reached through the insurer's internal grievance system; and

(c) A statement that describes a Medicaid enrollee's right to appeal externally to the Office of Fair Hearings at any time, if applicable.

6000.4 Each insurer shall:

(a) File with the Director a copy of its internal grievance procedures within sixty (60) business days after the effective date of these rules;

(b) File with the Director any amendment to its internal grievance procedures at least thirty (30) business days before the effective date of the amendment;

(c) Include with the filing required under §6000.4 (a) a copy of the notice, plan, certificate, enrollment materials, contract or other evidence of their coverage, as well as sample notices of grievance denials and any other notices to be used by the insurer in administering the grievance system; and

(d) Submit to the Director an annual grievance report not later than October 30th of each year that includes:

(1) The name and location of the reporting insurer;

(2) The applicable reporting period;

(3) The names of the individuals responsible for the operation of the insurer's grievance process;

(4) The total number of grievances received by the insurer, categorized by cause, insurance status, and disposition;

(5) The total number of requests for expedited review categorized by cause, length of time for resolution, and disposition;

(6) The total number of requests for external review, categorized by cause, length of time for resolution and disposition; and

(7) A description of any changes that have been made to the grievance process during the preceding year.

6000.5 The Director may request additional information from the insurer, and the insurer shall respond to such requests for additional information within ten (10) business days.

6000.6 An insurer shall not limit, reduce, terminate or otherwise change the services to be provided by the insurer, or take any other action to diminish the rights of the member or services to be rendered to the member, solely because the member exercised grievance or review rights pursuant to the Act or this chapter.

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is the Health Benefits Plan Members Bill of Rights Act of 1998 § 401, D.C. Code, 2001 Ed. § 44-304.01; and Mayor’s Order 99-159 (October 13, 1999).
SOURCE: Final Rulemaking published at 47 DCR 229 (January 14, 2000).

22-B DCMR § 6001 REQUIREMENTS FOR INTERNAL GRIEVANCE SYSTEM

6001.1 Each insurer's internal grievance system shall include the following:

(a) The right of a member or member representative to file a grievance regarding any aspect of the insurer's health care services related to the adverse decision by the insurer;

(b) A procedure for filing a review from a grievance decision by the insurer;

(d) The availability of a member services representative to assist members with filing a grievance each business day during regular business hours;

(e) The right of a member to designate an outside independent representative or representatives to assist the member in following the grievance procedures;

(f) A specific time for responding to reviews of adverse grievance decisions;

(g) Oral and written procedures disseminated to members describing how grievances are processed and resolved;

(h) Procedures for notifying a member or member representative when additional information is required to process a grievance, and the method to be used to inform all parties of resolution;

(i) An expedited grievance procedure for use in cases involving urgent or emergency medical conditions whereby a member or member representative may request expedited informal or formal review;

(j) Procedures governing urgent or emergency medical conditions which specify:

(1) How a member may request an expedited review;

(2) The title of the employee and an alternate who will expedite reviews when a grievant asserts an emergency case;

(3) The factors to be considered in making the determination about the existence of an emergency case; and

(4) The method for communicating to the member or member representative any decision regarding an urgent or emergency medical condition;

(k) Procedures to allow a grievance to be filed on behalf of a member by a member representative; and

(l) Provisions that require the insurer to:

(1) Orally communicate any grievance decision to the member or member representative made by the insurer; and

(2) Within five (5) business days after the grievance decision has been made, send the written grievance decision to the member or the member representative.

6001.2 All grievance records shall be maintained for three (3) years from the date of final resolution and shall be made available for inspection by the member, member representative or Director upon request. Each request to review records shall be granted within five (5) business days of the request.

6001.3 If an insurer reduces or terminates services contrary to the recommendation of a treating physician or advance practice registered nurse, the insurer shall provide the member or member representative with twenty-four (24) hours prior verbal notification, and shall issue a written decision as soon as practicable, but not more than five (5) business days after the decision.

6001.4 The written grievance decision shall include the following:

(a) The reviewer's understanding of the grievance;

(b) The reviewer's decision in clear terms;

(c) The contractual basis or medical reason in sufficient detail for the member or member representative to understand and respond to the insurer's position, provided that general terms such as "experimental procedures not covered", "cosmetic procedures not covered", "service included under another procedure", and "not medically necessary" shall not be used, unless reference is made to a specific provision or medical evidence that verifies the insurer's position; and

(d) All applicable instructions, including the telephone numbers and titles of persons to contact, and applicable time frames to request a review of the decision at the next level in at least 12 point type face.

History

SOURCE: Final Rulemaking published at 47 DCR 229 (January 14, 2000).

22-B DCMR § 6002 INFORMAL INTERNAL REVIEW

6002.1 Any member dissatisfied with an adverse decision shall be provided an opportunity to discuss and review the decision with the insurer's medical director, physician or other designee who rendered the decision.

6002.2 The member has the right to designate a member representative to participate in the grievance process.

6002.3 Each informal internal review shall be concluded as soon as possible, considering the medical exigencies of the review, but not later than fourteen (14) business days after the request for an informal internal review has been filed, except as provided in § 6002.4.

6002.4 If a request for an informal internal review results from a decision involving an urgent or emergency medical condition, the review shall be concluded within twenty-four (24) hours of receipt of the notification from the member or member representative.

6002.5 Each insurer shall provide a written explanation of a grievance decision to the member or member representative and shall notify the member or member representative of the right to request a formal internal review of the decision.

6002.6 Each written explanation provided pursuant to § 6002.5 shall set forth the information required by § 6001.4.

History

SOURCE: Final Rulemaking published at 47 DCR 229 (January 14, 2000).

22-B DCMR § 6003 FORMAL INTERNAL REVIEW

6003.1 A member or member representative dissatisfied with the grievance decision rendered in the informal internal review process may seek a formal internal review before a reviewer, physician, or panel of physicians, advanced practice registered nurses, or other health care professionals selected by the insurer based upon the specific issues presented by the grievance.

6003.2 Each request for a formal internal review shall be acknowledged by the insurer, in writing, to the member or member representative within ten (10) business days of receipt.

6003.3 A reviewer physician or member of a panel selected by the insurer pursuant to § 6003.1 shall not have been involved in the grievance decision under review.

6003.4 In all reviews requiring medical expertise, the reviewer or panel shall include at least one medical reviewer trained and certified, by a recognized specialty board listed in the current Directory of Medical Specialists, in the same specialty as the matter at issue.

6003.5 Each medical reviewer shall be a physician or an advanced practice registered nurse or other health care provider possessing a nonrestricted license to practice or provide care anywhere in the United States and have no history of disciplinary action or sanctions pending or taken against them by any governmental or professional regulatory body.

6003.6 Each formal internal review shall be concluded as soon as possible after receipt of all necessary documentation by the insurer, but in no event later than thirty (30) business days after the insurer has received notice of the request for a formal internal review, except as provided in § 6003.7.

6003.7 If the formal internal review is from a decision regarding an emergency or urgent medical condition, the insurer shall complete the review within twenty-four (24) hours of the receipt of the request for a formal internal review.

6003.8 An insurer shall determine within ten (10) business days of the filing of a request for a formal internal review whether the insurer has sufficient information to complete its review process. If the information is insufficient, the insurer shall:

(a) Notify the member or member representative who filed the grievance that it cannot proceed with the grievance unless additional information is provided;

(b) Specify all additional information required to be filed; and

6003.9 The time within which an insurer must render a decision pursuant to this section may be extended only upon the written request of the member or member representative.

6003.10 If a grievance decision by the insurer after a formal internal review is adverse to the member, the insurer shall provide the member or member representative with a written explanation of the decision and notification of the member's right to seek a formal external review of the decision.

6003.11 The written notification required by § 6003.10 shall include:

(a) The reviewer's understanding of the grievance;

(b) The reviewer's decision in clear terms;

(c) The contractual basis or medical reason in sufficient detail for the member or member representative to understand and respond to the insurer's position, provided that general terms such as "experimental procedures not covered", "cosmetic procedures not covered", "service included under another procedure", and "not medically necessary" shall not be used, unless reference is made to a specific contract provision or medical evidence that verifies the insurer's position; and

(d) All pertinent instructions, in at least 12 point type face, including the telephone numbers and titles of persons to contact, any forms required to initiate an external review, and applicable time frames to request a formal external review of the decision.

6003.12 If the insurer fails to comply with any deadline for completion of a formal internal review, the member or member representative shall be relieved of the duty to exhaust the formal internal review process, and may proceed directly to the external review process.

History

SOURCE: Final Rulemaking published at 47 DCR 229 (January 14, 2000).

22-B DCMR § 6004 EXPEDITED REVIEW PROCESS IN EMERGENCY OR URGENT MEDICAL CONDITION CASES

6004.1 An expedited review is required for an adverse decision involving an emergency or urgent medical condition in accordance with this section if:

(a) The adverse decision is rendered for health care services that are proposed but have not been delivered; and

(b) The services are necessary to treat a condition or illness that, without prompt or immediate medical attention, would place the health of the individual in serious jeopardy, result in serious impairment to bodily functions, result in serious dysfunction of any bodily organ or jeopardize the life or health of the member or the member's ability to regain maximum function, or cause the member to be a danger to self or others.

6004.2 In emergency or urgent medical condition cases, the insurer shall send notice in writing of any adverse decision to the member or the member representative within one (1) business day after a decision has been orally communicated to the member or member representative.

6004.3 An insurer shall render a final grievance decision in an emergency or urgent medical condition case within twenty-four (24) hours after the grievance was filed pursuant to the insurer's internal grievance process.

6004.4 The content of any written notice by an insurer of an adverse grievance decision under these rules shall comply with § 6001.4 of this Chapter.

6004.5 In emergency or urgent medical condition cases, a request for an external review may be filed with the Director if a grievance decision reached in an informal or formal internal review is not rendered within twenty-four (24) hours after the filing of the grievance pursuant to the insurer's internal grievance process.

6004.6 After external review of a grievance by an independent review organization (“IRO”) in an emergency or urgent medical condition case, the Director shall send written notice to all parties of the IRO's recommendations within twenty-four (24) hours after the Director or the Director's designee has informed the member or member representative and the insurer of the recommendation through an oral communication.

History

SOURCE: Final Rulemaking published at 47 DCR 229 (January 14, 2000).

22-B DCMR § 6005 EXHAUSTION OF INTERNAL REVIEW PROCESS

6005.1 Except as provided in § 6005.2, a member or member representative shall exhaust the insurer's internal grievance process prior to filing a request for an external review with the Director under this chapter. Medicaid recipients need not exhaust the internal grievance process and may appeal immediately to the Office of Fair Hearing.

6005.2 A member or a member representative may file a grievance without first exhausting the insurer's internal review process in the case of an emergency or urgent medical condition, if the grievance demonstrates to the satisfaction of the Director a compelling reason to do so, including a showing that the potential delay in receipt of a health care service until after the member or member representative exhausts the internal grievance process could result in loss of life, serious impairment to a bodily function, serious dysfunction of a bodily organ, or the member remaining seriously mentally ill with symptoms that cause the member to be a danger to self and others, or the review is from an emergency grievance which the insurer has not resolved within twenty-four (24) hours, or when the insurer fails to meet timelines specified by the Act.

History

SOURCE: Final Rulemaking published at 47 DCR 229 (January 14, 2000).

22-B DCMR § 6006 GENERAL PROCEDURES FOR EXTERNAL REVIEW

6006.1 Within thirty (30) business days after the date of receipt of an adverse formal internal review grievance decision, the member or member representative may file a request for an external review with the Director.

6006.2 Each member or member representative filing a request for external review shall file with the insurer and Director a written consent form executed by the member authorizing the release of the member's medical records to third parties for the sole purpose of conducting the review.

6006.3 Unless a request to extend the time for rendering a grievance decision has been made pursuant to § 6003.9, a request for external review may be filed if the grievance decision is not received by the 30th business day after the filing of the grievance.

6006.4 The Director may refuse to accept a request for external review if the member or member representative fails to provide a signed consent form.

6006.5 Within five (5) business days after receipt of a request for external review, the Director shall send written notice to the insurer, stating that a request for an external review has been filed and specifying any information required by the Director to be submitted by the insurer.

6006.6 Except for matters involving an emergency or urgent medical condition, the insurer shall provide to the Director any information requested by the Director in the written notice within seven (7) business days after the date the insurer is notified of a request for an external review.

History

SOURCE: Final Rulemaking published at 47 DCR 229 (January 14, 2000).

22-B DCMR § 6007 EXTERNAL REVIEW OF ADVERSE GRIEVANCE DECISIONS

6007.1 Upon the filing of a request for an external review, the Director shall make the determinations required under §107(c) of the Act, D.C. Code, 2001 Ed. §44-301.07(c), and shall notify the member, member representative and insurer in writing, within five (5) business days, as to whether the request has been accepted for processing.

6007.2 In responding to an external review an insurer may not rely on any basis not stated in its internal grievance decision, except that the Director may allow an insurer, a member or member representative to provide supplemental information as may be relevant for the IRO to make a final decision on the grievance.

6007.3 If a request for external review is not accepted, the Director shall provide a written statement of the denial to the member, the member representative and the insurer within five (5) business days of its filing. In emergency or urgent medical condition cases, such statement shall be provided within twenty-four (24) hours.

6007.4 If the request is accepted, the Director shall assign the external review to a certified IRO, on a rotating basis, for a full review after verifying that the IRO conducting the review has no material professional, familial, or financial conflict with any person or entity specified in § 108(f)(1) of the Act, D.C. Code, 2001 Ed. §44-301.08(f)(1).

6007.5 The Director shall deny an assignment to an IRO if the Director determines that making an assignment would result in a conflict of interest or would create an appearance of impropriety.

6007.6 The Director, upon receipt of the IRO's recommendations, shall forward copies of the recommendation to the member, the member representative and the insurer.

6007.7 The Director may refer matters not within the Director's jurisdiction to any other appropriate federal or District government agency for disposition or resolution, including but not limited to the Department of Insurance and Securities Regulation and the Office of Fair Hearings.

History

SOURCE: Final Rulemaking published at 47 DCR 229 (January 14, 2000).

22-B DCMR § 6008 INDEPENDENT REVIEW ORGANIZATIONS

6008.1 Each entity or organization seeking to operate as an IRO shall be certified by the Director.

6008.2 Each organization or entity seeking certification shall submit to the Director an application for certification as an IRO on a form specified by the Director.

6008.3 The IRO shall, in addition to the submissions required under § 108(e) of the Act, D.C. Code, 2001 Ed. §44-301.08(e), and § 6008.2, attach a review plan which includes the following:

(a) Types of reviews performed, including methodology for reviewing:

(1) Pre-authorization decisions;

(2) Pre-admission decisions;

(3) Admission decisions;

(4) Emergency admission decision; and

(5) Second surgical opinion decisions;

(b) Copies of specific criteria and standards to be used in conducting reviews of proposed or delivered health care services including:

(1) List of interpretive guidelines used by IRO that identifies the titles, author, publisher and edition of the guideline;

(2) Copies of interpretive guidelines for which there are no applicable copyright laws; and

(3) A written protocol describing each type of review performed;

(d) Specified time frames in which the organization completes its review, to include at a minimum:

(1) For matters involving emergency or urgent medical conditions, the IRO shall make a determination within seventy-two (72) hours from the time the Director assigns the external review; and

(2) For non-emergency matters, the IRO shall make a determination within thirty (30) business days from the time the Director assigns the external review;

(e) Qualifications and background of the personnel making the final determination; and

(f) Policies and procedures to ensure the confidentiality and non-disclosure of documents and other records used in conducting reviews.

6008.4 In determining the capability of an IRO, the Director shall determine whether the entity or organization:

(a) Maintains a policy or procedure to conduct a review in strict confidence;

(b) Uses qualified, independent professional and medical reviewers in all reviews;

(c) Demonstrates the ability to render decisions in an equitable and timely manner consistent with the Act and these rules; and

(d) Is not a subsidiary of or in any way owned or controlled by a health benefits plan, insurer, or trade organization of health care providers.

6008.5 The Director shall certify the entity or organization as an IRO when the requirements of § 108(e) of the Act, D.C. Code, 2001 Ed. §44-301.08(e), and these rules have been satisfied. IROs shall be re-certified every two (2) years.

6008.6 All applications and submissions made by an IRO in accordance with § 108(e) of the Act, D.C. Code, 2001 Ed. §44-301.08(e) shall be treated as public documents.

6008.7 The IRO shall, as a part of the contract process, submit to the Director and shall maintain with the Director a current list fully identifying all insurers, health care facilities and other health care providers with whom the IRO maintains any health related business arrangement. The list shall include a description of the nature of such arrangements and shall be updated annually.

6008.8 The terms and conditions of a contract entered into by the Director pursuant to § 108(j) of the Act, D.C. Code, 2001 Ed. §44-301.08(j), shall provide for an assessment of costs for the external review process, not including the costs of representation of a member, to be paid by the insurer.

History

SOURCE: Final Rulemaking published at 47 DCR 229 (January 14, 2000).

22-B DCMR § 6009 DENIAL, SUSPENSION AND REVOCATION OF CERTIFICATION

6009.1 The Director may deny an application for certification and suspend or revoke a certification issued to an IRO pursuant to the Act and these rules if:

(a) The Director finds that the entity or organization does not meet the requirements for certification under § 108 of the Act, D.C. Code, 2001 Ed. §44-301.08, and § 6008 of these rules;

(b) The IRO is operating in a manner that is significantly inconsistent with its basic organizational documentation;

(d) The IRO cannot demonstrate sufficient financial, managerial or technical expertise to efficiently and timely review and issue final decisions.

6009.2 The denial, suspension or revocation of a certification shall be in writing, and shall be final.

History

SOURCE: Final Rulemaking published at 47 DCR 229 (January 14, 2000).

22-B DCMR § 6010 CONDUCT OF EXTERNAL REVIEWS

6010.1 The IRO, in conducting external reviews assigned by the Director, shall use at least two (2) physicians licensed to practice medicine in the District of Columbia, Maryland or Virginia, except that:

(a) Medical reviewers licensed elsewhere in the United States may be used when necessary based on the medical, surgical, or mental condition under review; and

(b) The licensed medical reviewers selected shall not have any history of disciplinary action or sanctions pending or taken against them by a governmental or professional regulating body.

6010.2 The IRO in reaching a determination shall follow the criteria set forth in § 107(j) of the Act, D.C. Code, 2001 Ed. §44-301.07(j).

6010.3 The IRO, its employees, or agents may not disclose or publish individual medical records or any other confidential medical information obtained in the performance of independent review activities.

History

SOURCE: Final Rulemaking published at 47 DCR 229 (January 14, 2000).

22-B DCMR § 6011 EXTERNAL REVIEW HEARINGS

6011.1 The IRO shall schedule and hold a hearing within the District of Columbia as soon as possible after receiving a request for a hearing from a member or a member representative, but in no event later than fifteen (15) business days after receipt of the request.

6011.2 The IRO shall utilize a hearing process which complies with § 107(k) of the Act, D.C. Code, 2001 Ed. §44-301.07(k).

6011.3 All recommendations of the IRO shall be in writing and approved by the medical director of the IRO. The final determinations shall:

(a) Reference the specific terms and standards, including interpretive guidelines, upon which the final decision is based; and

(b) State in detailed, clear, and understandable language the specific factual basis for the decision.

6011.4 Within five (5) business days of the receipt of the IRO's recommendation from the Director, the insurer shall submit a written report to the Director and the member or member representative indicating whether it will accept and implement the recommendations, or whether it will reject the IRO's recommendations. In the case of rejection, the insurer shall specifically indicate in writing to the Director each and every basis for its rejection.

History

SOURCE: Final Rulemaking published at 47 DCR 229 (January 14, 2000).

22-B DCMR § 6012 ANNUAL REPORT OF INDEPENDENT REVIEW ORGANIZATIONS

6012.1 Each IRO shall submit to the Director on or before October 30th of each year an annual report.

6012.2 The annual report shall include the following information:

(a) Name and address of the reporting IRO;

(b) The reporting period in question;

(c) The total number of grievances reviewed, categorized by insurer, cause, disposition, and length of time for resolution;

(d) The total number of grievances decided in favor of the member categorized by insurer, cause, disposition, and length of time for resolution, and the total number decided in favor of the insurer; and

(e) Total number of expedited reviews, length of time for resolution and disposition.

History

SOURCE: Final Rulemaking published at 47 DCR 229 (January 14, 2000).

22-B DCMR § 6013 ASSESSMENT OF THE INSURER

6013.1 In accordance with § 109 of the Act, D.C. Code, 2001 Ed. §44-301.09, the Director or a designee shall annually send a Notice of Assessment to each insurer. The assessment payable by each insurer shall be calculated by taking the total cost of the program multiplied by the percentage of non-Medicare or non-Medicaid gross direct premiums written in the District of Columbia attributable to that insurer in the prior calendar year, provided that each insurer shall be subject to a minimum annual assessment of no less than $ 100. Payment shall be made by the insurer within ten (10) business days of receipt of the assessment notice.

6013.2 The monies collected from each insurer subject to the assessment shall be placed in the General Fund in a dedicated account to pay the costs and expenses incurred by the Department of Health related to the implementation and administration of the Act.

History

SOURCE: Final Rulemaking published at 47 DCR 229 (January 14, 2000); as amended by Final Rulemaking published at 48 DCR 6444 (July 20, 2001).

22-B DCMR § 6014 NON-APPLICABILITY OF RULES

6014.1 These rules shall not apply in cases directly involving coverage determinations or benefit requirements under the Federal Medicare Program.

History

SOURCE: Final Rulemaking published at 47 DCR 229 (January 14, 2000).

22-B DCMR § 6099 DEFINITIONS

6099.1 The following terms shall have the meanings ascribed below:

Act - means the Health Benefits Plan Members Bill of Rights Act of 1998, effective April 27, 1999, D.C. Code, 2001 Ed. §§44-301.01 to 44-304.01.

Adverse decision - means a determination made by an insurer, or its designee, that an admission, availability of care, continued stay, or other health care service is or is not a covered benefit; and if it is a covered benefit, that it has been reviewed and does not meet the insurer's requirements for medical necessity, appropriateness, health care settings, level of care or effectiveness, and the requested service is therefore denied, reduced, limited, delayed or terminated.

Certificate - means a letter indicating that the Independent Review Organization is registered with the Department of Health.

Director - means the Director, District of Columbia Department of Health

Emergency medical condition - means a medical condition manifesting itself by acute symptoms of sufficient severity such that the absence of immediate medical attention could reasonably be expected to result in:

(a) Placing the health of the individual in serious jeopardy;

(b) Serious impairment of bodily functions; or

Evidence of coverage - means a statement of the essential features and covered services of the health care plan, which is given to the member by the insurer or by the group contract holder.

Grievance - means a written request by a member or member representative for review of a decision of an insurer to deny, reduce, limit, terminate or delay covered health care services to a member.

Grievance decision - means a determination accepting or denying the basis or requested remedy of the grievance.

Health benefits plan - means a group or individual insurance policy or contract, medical or hospital service agreement, membership or subscription contract, or similar group arrangement provided by an insurer or subcontracting facility of an insurer for the purpose of providing, paying for, or reimbursing expenses for health related services. "Health benefits plan" does not include disability income or accident only insurance.

Health care services - means items or services provided under the supervision of a physician or other person trained or licensed to render health care necessary for the prevention, care, diagnosis, or treatment of human disease, pain, injury, deformity or other physical or mental condition, including the following: preadmission, outpatient, inpatient, and post discharge care; home care; physician care; nursing care; medical care provided by interns or residents in training; other paramedical care; ambulance care and service; bed and board; drugs; supplies; appliances; equipment; laboratory services; any form of diagnostic imaging or therapeutic radiological services; and services mandated under the Drug Abuse, Alcohol Abuse, and Mental Illness Insurance Coverage Act of 1986, effective February 28, 1987 (D.C. Code, 2001 Ed. §§31-3101 to 31-3111).

Health related services - means services related to the direct delivery of health care services designed to diagnose or treat an illness, injury or medical condition.

Independent Review Organization (IRO) - means an impartial, certified health entity engaged by the Director to review any adverse grievance decision by an insurer, including an insurer's decision to deny, terminate, or limit covered health care services.

Insurer - means an individual, partnership, corporation, association, fraternal benefit association, hospital and medical services corporation, health maintenance organization, or other business entity that issues, amends, or renews group or individual health insurance policies or contracts, including health maintenance organization membership contracts, in the District.

Medically necessary care - means the care which, in the opinion of the treating physician, is reasonably needed to:

(a) Prevent the onset or worsening of an illness, condition, or disability;

(b) Establish a diagnosis;

(d) Assist the individual to achieve or maintain maximum functional capacity in performing daily activities, taking into account both the functional capacity of the individual and those functional capacities that are appropriate for individuals of the same age.

Member - means an individual who is enrolled in a health benefits plan.

Member representative - means any person acting on behalf of a member with the member's written consent.

Urgent medical condition - means a condition which, if non-treated within 24 hours, could reasonably be expected to result in:

(a) Placing the health of the individual in serious jeopardy;

(b) Serious impairment to bodily function; or

History

SOURCE: Final Rulemaking published at 47 DCR 229 (January 14, 2000).

22-B61 HEALTH PROFESSIONAL RECRUITMENT PROGRAM

22-B DCMR § 6100 GENERAL PROVISIONS

6100.1 The provisions of this chapter shall apply to an applicant for, or recipient of, loan repayment funds under the District of Columbia Health Professional Recruitment Program Act of 2005, effective March 8, 2006 (Act) (D.C. Law 16-71; D.C. Official Code § 7-751.01 et seq.).

6100.2 The Program was established for the purpose of recruiting health professionals to provide services in a Medically Underserved Area (MUA) or a Health Professional Shortage Area (HPSA) within the District by paying a percentage of a participant’s tuition and educational expenses through loan repayment. The amount of loan repayment is set forth in D.C. Official Code § 7-751.08.

6100.3 The Program is administered by the Department of Health, which is authorized to:

Establish the application process;

Certify acceptable Service Obligation Sites;

Conduct surveys to ensure participant compliance with the Program;

Disburse all awarded funds; and

Administer any other necessary Program functions.

6100.4 Payment to persons eligible for the Health Professional Recruitment Program shall be subject to the availability of funds in the Health Professional Recruitment Fund established by section 16a of the Act (D.C. Official Code § 7-751.16a).

History

Source: Final Rulemaking published at 57 DCR 7667 (August 20, 2010).

22-B DCMR § 6101 APPLICATION FOR PARTICIPATION IN PROGRAM

6101.1 An applicant proposing to provide services at an approved Service Obligation Site that is not in a MUA is eligible for loan repayment if the applicant provides services related to the HPSA designation where the Service Obligation Site is located. HPSA designations are set forth in section 6108.5. For example, a dentist applicant would qualify for loan repayment if the Service Obligation Site was a Dental HPSA but would not be eligible if the Service Obligation Site provided dental services but was not located in a Dental HPSA.

6101.2 An applicant for the Health Professional Recruitment Program shall apply during one (1) of two (2) application periods. The first application period shall be from January 1 to January 31 of each calendar year, and the second application period shall be from June 1 to June 30 of each calendar year.

6101.3 Application shall be made on a form prescribed by the Director and shall include such information and documents the Director may require.

History

Source: Final Rulemaking published at 57 DCR 7667, 7668 (August 20, 2010).

22-B DCMR § 6102 RENEWAL OF PARTICIPATION IN PROGRAM

6102.1 A participant in the Health Professional Recruitment Program who has completed the original contracted two (2) year term of service may apply to renew his or her contract for up to two (2) additional years of service. The maximum term of service of a participant in the Program shall be four (4) years, including the original contracted term and any renewal terms.

6102.2 A participant seeking to renew his or her contract shall:

(a) Request a one (1) year contract modification for each additional year of service requested;

(b) Request the one (1) year contract modification at least three (3) months before the expiration of the current original contract or contract modification;

(c) Provide verification of personal and employment information at least thirty (30) days before the expiration of the current contract;

(d) Provide at least thirty (30) days before the expiration of the current contract a letter signed by the participant’s employer confirming the participant’s continued employment for the period of the proposed contract addendum; and

(e) Provide current professional licensing verification at least thirty (30) days before the expiration of the current contract.

History

Source: Final Rulemaking published at 57 DCR 7667, 7668 (August 20, 2010).

22-B DCMR § 6103 REVIEW AND APPROVAL OF APPLICATION

6103.1 The Director shall review each application and provide a written decision to each applicant by March 1 for the first application period and by September 1 for the second application period. The Director shall provide a written reason for rejection of an application. The Director shall review and select applications for participation based on the following:

(a) Professional qualifications and relevant experience, including:

(1) Board eligibility or certification in a specialty;

(2) Professional achievements; and

(3) Other indicators of competency received from supervisors, department chairs, and program directors; and

(b) A demonstrated commitment to serve in a HPSA or MUA.

6103.2 The Director shall give priority in making an offer of participation to an applicant and shall give priority to renewing the contract of an existing participant based on the following:

(a) District of Columbia residency;

(b) Graduation from a District of Columbia health profession school or program;

Columbia;

(d) Immediate eligibility or availability for service;

(e) Commitment to longer periods of service;

(f) Service at a site that is also a qualified Medical Homes DC

provider; and

(g) Target percentages of participants in health disciplines as follows:

(1) Sixty percent (60%) participation by primary health care providers;

(2) Twenty percent (20%) participation by mental health care providers; and

(3) Twenty percent (20%) participation by dental health providers.

6103.3 The Director may deny an application for an otherwise qualified applicant if:

(a) The application is for a health care provider in an over-represented discipline;

(b) There are insufficient funds available in the Fund established by section 16a of the Act; or

(c) Either or both of the conditions in paragraphs (a) and (b) apply and the applicant receives low priority under section 6103.2.

6103.4 If the Director receives qualified applications that exceed either the total funding availability or an individual discipline threshold, the Director shall prioritize Program participation by giving priority according to the following criteria:

(a) A higher application score shall receive higher priority;

(b) If the number of Program participants already assigned to the applicant’s chosen practice site or organization is high, then the application shall receive lower priority;

(c) If the applicant will serve in an area where there is a documented provider shortage and higher need, then the application shall receive higher priority;

(d) If the numbers of National Health Service Corps and or HPLRP participants already assigned to the applicant’s chosen practice site or organization are high, then the application shall receive lower priority; and

(e) Additional information provided by the primary care office about the application may affect priority of the applicant.

History

Source: Final Rulemaking published at 57 DCR 7667, 7669 (August 20, 2010).

22-B DCMR § 6104 RETENTION OF APPLICATIONS

6104.1 The Department shall not be required to keep on file a rejected application for more than two (2) months after the applicant is notified of his/her rejection.

6104.2 An applicant receiving notice of rejection may reclaim the application no later than two (2) months after notification.

History

Source: Final Rulemaking published at 57 DCR 7667, 7670 (August 20, 2010).

22-B DCMR § 6105 REAPPLICATION

6105.1 An applicant who is not accepted into the Program for any reason may re-apply during any subsequent application cycle.

History

Source: Final Rulemaking published at 57 DCR 7667, 7671 (August 20, 2010).

22-B DCMR § 6106 PARTICIPATION CONTRACTS

6106.1 Each participant in the Program shall sign a contract with the Department of Health setting out the terms and conditions of his or her participation.

6106.2 An applicant who receives preliminary notice of approval of his or her application shall sign a contract and return it to the Department of Health for the Director’s signature by March 15 for an application submitted in the first application period and by September 15 for an application submitted in the second application period.

6106.3 The contract start dates shall be April 1 for the first application period and October 1 for the second application period.

History

Source: Final Rulemaking published at 57 DCR 7667, 7671 (August 20, 2010).

22-B DCMR § 6107 INVOICES

6107.1 A participant shall submit an invoice for each quarter of service on a form provided by the Department of Health.

6107.2 Once completed with all required information, the form shall be scanned and attached to an e-mail to the appropriate Department personnel.

6107.3 An invoice for any period of service that began before September 30 of any calendar year shall be submitted by October 30 of that calendar year. Payment for service begun before September 30 and submitted after October 30 is not guaranteed and depends on the availability of funds in the Fund for the fiscal year ending on September 30.

6107.4 A participant who fails to submit an invoice pursuant to section 6102.1 for two (2) consecutive service quarters shall be deemed in breach of contract and shall be subject to the penalties provided in section 14 of the Act.

History

Source: Final Rulemaking published at 57 DCR 7667, 7671 (August 20, 2010).

22-B DCMR § 6108 ELIGIBLE SITES

6108.1 In order to be eligible to participate in the Program, the applicant or participant must provide primary care, mental health, or dental services at a site approved by the Director as a Service Obligation Site.

6108.2 The following are eligible to become Service Obligation Sites:

(a) A nonprofit entity located in a Health Professional Shortage Area or Medically Underserved Area within the District that provides primary care, mental health, or dental services to District residents regardless of their ability to pay;

(b) A Department of Health program that provides primary care, mental health, or dental services in a Health Professional Shortage Area or Medically Underserved Area within the District;

(c) A Department of Mental Health program that provides primary care, mental health, or dental services in a Health Professional Shortage Area or Medically Underserved Area within the District;

(d) A District of Columbia Public School (DCPS) located in a Health Professional Shortage Area or Medically Underserved Area within the District; and

(e) A District of Columbia Department of Corrections (DOC) site located in a federally designated Health Professional Service Area or Medically Underserved Area within the District of Columbia that provides primary care, mental health, or dental services to District of Columbia residents regardless of ability to pay.

6108.3 An eligible site that participates, or seeks to participate, in the Program shall submit a site certification application and renew its certification annually at the start of the District’s fiscal year (October 1).

6108.4 A health facility should verify with the Health Resources and Services Administration of the U.S. Department of Health and Human Services or the Department of Health that it resides in a MUA or Health Professional Shortage Area appropriate for the facility and the services the facility offers before submitting an application.

6108.5 A Health Professional Shortage Area (HPSA) may be designated as:

(a) A Primary Care HPSA;

(b) A Dental HPSA;

(d) Any combination of the designations listed in paragraphs (a) through (c).

6108.6 A health facility may be approved as a Service Obligation Site for each HPSA designation for which it qualifies. For example, a facility that provides primary care, dental, and mental health services and is located in an area that is designated only as a Dental HPSA and a Mental Health HPSA could qualify as a Service Obligation Site for dental and mental health services but not for primary care services.

History

Source: Final Rulemaking published at 57 DCR 7667, 7671 (August 20, 2010).

22-B DCMR § 6199 DEFINITIONS

6199.1 For the purpose of this chapter, the following terms shall have the meanings ascribed below:

Act—the District of Columbia Health Professional Recruitment Program Act of 2005, effective March 8, 2006 (D.C. Law 16-71; D.C. Official Code § 7-751.01 et seq.).

Director—the Director of the Department of Health.

Fund—the fund established by section 16a of the Act (D.C. Official Code § 7-751.16a).

Health Professional Shortage Area or HPSA—a geographic area in the District of Columbia designated by the United States Department of Health and Human Services as lacking a sufficient number of primary care, dental, or mental health professionals to provide care for residents of the area or community.

Medically Underserved Area or MUA—a geographic area in the District of Columbia designated by the United States Department of Health and Human Services as medically underserved.

Participant—a person who is in an eligible health profession and has signed a contract to provide health care services in a Service Obligation Site.

Program—the District of Columbia Health Professional Recruitment Program established by section 3 of the Act (D.C. Official Code § 7-751.03).

Service obligation site—a nonprofit health facility or a District of Columbia Department of Health or Department of Mental Health program that provides primary health, mental health, or dental services located in a federally designated Health Professional Shortage Area or Medically Underserved Area within the District of Columbia that provides care to District of Columbia residents regardless of ability to pay.

History

Source: Final Rulemaking published at 57 DCR 7667, 7673 (August 20, 2010). 7

22-B67 RADIATION: ADMINISTRATION AND ENFORCEMENT

22-B DCMR § 6700 GENERAL PROVISIONS

6700.1 The purpose of the radiation provisions of this title (chapters 67 through 69) is to specify the requirements in the use of all radiation, radiation machines, and radioactive materials to ensure the maximum protection of the public health and the maximum safety to all persons at, or in the vicinity of, the place of use, storage, or disposal of radiation, radiation machines, and radioactive materials.

6700.2 The radiation provisions of this title are intended to be consistent with the best use of radiation machines and radioactive materials, and to encourage the constructive uses of radiation.

6700.3 Except as otherwise specifically provided, the radiation provisions of this title shall apply to all persons who receive, possess, use, transfer, own, or acquire any source of radiation; Provided, however, that nothing in these provisions shall apply to any person to the extent such person is subject to regulation by the Nuclear Regulatory Commission (the "NRC").

6700.4 Nothing in the radiation provisions of this title shall be interpreted as limiting the intentional exposure of patients to radiation for the purpose of diagnosis or therapy.

6700.5 Regulation of source material, byproduct material, and special nuclear material in quantities not sufficient to form a critical mass is subject to the provisions of any agreement between the District and the NRC, and to part 150 of the NRC's regulation (10 C.F.R. Part 150).

6700.6 Each section of chapters 67 through 69, and every part of each section, is declared independent of every other section, and the finding of any section, or part of a section, to be void or ineffective for any reason shall not be deemed to affect any other section, or part of a section.

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is the Atomic Energy Act of 1946, as amended, 60 Stat. 755 (current version at 42 U.S.C. § 2011 et seq.); Commissioners’ Order No. 64-193 (February 11, 1964) (Organization Order No. 141); and Commissioners’ Order No. 70-83 (March 6, 1970). EDITOR’S NOTE: This chapter was previously codified as Chapter 20 of Title 20 of the District of Columbia Municipal Regulations.
SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR §§ 8-2:1001, 8-2:1036; as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6701 RADIATION STANDARDS

6701.1 After notice and public hearing, the Director of the Department of Health (the Director) shall prescribe standards for the protection against sources of radiation and other requirements as may be reasonable and necessary to carry out the intent and purpose of the radiation provisions of this title.

6701.2 The standards and requirements prescribed by the Mayor pursuant to §6701.1 shall, as far as is practicable, be reasonably compatible with and, in any event, shall not be less restrictive than standards established by the NRC, the Federal Radiation Council, or the National Committee on Radiation Protection and Measurement.

6701.3 The Director may cause the standards and requirements specified by the Mayor to be codified in a form that the Director shall prescribe.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR § 8-2:1003; as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6702 TESTS AND RECORDS

6702.1 Upon instruction from the Director, each licensee and registrant under the radiation provisions of this title shall perform or permit the Director to perform any reasonable test as the Director deems appropriate or necessary, including, but not limited to, tests of the following:

(a) Sources of radiation;

(b) Facilities wherein sources of radiation are used or stored;

(d) Other equipment and devices used in connection with utilization or storage of licensed or registered sources of radiation.

6702.2 Each licensee and registrant under the radiation provisions of this title shall keep records showing the receipt, transfer, and disposal of all sources of radiation, and any other records as the Director may, by order, require.

6702.3 Each licensee and registrant shall make available to the Director for inspection, upon reasonable notice, records maintained pursuant to the radiation provisions of this title.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR §8-2:1005; as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6703 RESERVED

History

SOURCE: Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6704 INSPECTIONS

6704.1 The Director or the Director's authorized representatives shall have the power to enter at all reasonable times upon any private or public property for the following purposes:

(a) To determine whether there is compliance with or violation of the radiation provisions of this title, and with the standards and requirements issued pursuant to those provisions; and

(b) To inspect sources of radiation and the premises and facilities wherein the sources of radiation are stored.

6704.2 Entry into areas under the jurisdiction of the federal government shall occur only with the concurrence of the federal government or its duly designated representative.

6704.3 Entry upon private property shall be in accordance with the law.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR §8-2:1004; as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6705 EMERGENCIES, IMPOUNDMENTS AND STOP ORDERS

6705.1 Whenever the Director finds that an emergency exists requiring immediate action to protect the public health and safety, the Director, may, without notice or hearing, issue an order stating the existence of the emergency, and requiring that action be taken as necessary to meet the emergency.

6705.2 In the event of an emergency constituting a hazard to the health of employees of the public or others, the Director may impound or order the impounding of sources of ionizing radiation in the possession of any person who is not equipped to observe, or fails to observe, the radiation provisions of this title.

6705.3 If all or part of any machine, device, or equipment is in a dangerous condition, or if it is not properly safeguarded, notice of the situation shall be given by the Director to any individual owning, operating, or possessing the machine, device, or equipment.

6705.4 Upon notice as required by §6705.3, and until the notice is withdrawn by the Director, use of the machine, device, or equipment shall be forbidden. The Director may withdraw the notice if he or she is satisfied that the machine, device or equipment has been made safe, or that proper safeguards have been instituted for operation, or for other reasons found pursuant to a hearing as provided for in §6709 of this chapter.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR §8-2:1007; as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6706 INTRASTATE TRANSPORTATION OF MATERIALS

6706.1 No licensee shall transport any radioactive material outside of the confines of the licensee's plant or other authorized location of use, or deliver any radioactive material to a carrier for transportation, unless the licensee complies with the requirements as specified in §6706.2.

6706.2 Each licensee shall transport materials with all requirements appropriate to the mode of transportation, relating to the packaging of the radioactive material and to the marking and labeling of the package and transporting vehicle, of the rules and regulations published by the U.S. Department of Transportation (46 C.F.R. §148.04-1, 49 C.F.R. §§173-179, and 14 C.F.R. §103) to the same extent as if the transportation were subject to the rules and regulations of that agency.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR §8-2:1035; as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6707 RECIPROCITY

6707.1 Any person who possesses a specific license or equivalent licensing document issued by the NRC, or any agreement state, may conduct the activities authorized in the licensing document within the District for a period not in excess of twenty (20) days in any period of twelve (12) consecutive months without obtaining a specific license from the Director; Provided that the provisions of §§6707.2 through 6707.7 shall be met.

6707.2 The licensing document shall not limit the activity authorized by the document to specified installations or locations.

6707.3 The out-of-state licensee shall notify the Director in writing at least two (2) days prior to engaging in the activity.

6707.4 The notification required by §6707.3 shall indicate the location, period, and type of proposed possession and use within the District, and shall be accompanied by a copy of the pertinent licensing document.

6707.5 If, for a specific case, the two (2) day notification period would impose an undue hardship on the out-of-state licensee, the licensee may, upon making application to the Director, obtain permission to proceed sooner.

6707.6 The out-of-state licensee shall comply with all applicable radiation provisions of this title, and with all the terms and conditions of the licensee's licensing document. The licensee need not comply with any terms and conditions that may be inconsistent with the radiation provisions of this title.

6707.7 The out-of-state licensee shall supply any information the Director may request in addition to the information required by §§6707.2 through 6707.6.

6707.8 To the extent authorized by §§6800, 6801 through 6807, 6810, and 6811, a person may transfer, receive, acquire, own, possess, and use any equipment, device, commodity, or other product containing radioactive material that has been manufactured, processed, or produced in accordance with a specific license or equivalent licensing document issued by the NRC or any agreement state.

6707.9 Notwithstanding the provisions of §§6707.1 through 6707.7, any person who holds a specific license or equivalent licensing document issued by the NRC or an agreement state authorizing the holder to manufacture, install or service a device described in §§6803.1 through 6803.5 within areas subject to the jurisdiction of the licensing body shall be granted a general license to install and service the device in the District; Provided, that the following requirements are met:

(a) The person shall file a report with the Director within thirty (30) days after the end of each calendar quarter in which any device is transferred to or installed in the District. Each report shall identify each general licensee by name and address, the type of device transferred, and the quantity and type of radioactive material contained in the device;

(b) The device shall be manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific license or equivalent licensing document issued to the person by the NRC or an agreement state;

(c) The person shall assure that any labels required to be affixed to the device under regulations of the authority which licensed the manufacture of the device bear a statement that, "REMOVAL OF THIS LABEL IS PROHIBITED"; and

(d) The holder of the specific license or equivalent licensing document shall furnish to each general licensee to whom the holder transfers the device, or on whose premises the holder installs the device, a copy of the general license contained in §6803.

6707.10 The Director may withdraw, limit, or qualify his or her acceptance of any specific license or equivalent licensing issued by another agency, or any product distributed pursuant to the licensing document, upon determining that the action is necessary in order to prevent undue hazard to public health and safety or property.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR §8-2:1034; as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6708 VARIANCES

6708.1 The Director shall keep a properly indexed record of all variances and exceptions permitted from any rule or regulation or standard. The record shall be open to public inspection.

6708.2 The Director may, upon written application of any person affected by the radiation provisions of this title, permit variations from any of those provisions.

6708.3 The Director may, upon receiving a written application to do so, excuse a person from the performance of any act required by the radiation provisions of this title, either in whole or in part, upon a finding by the Director that the application of a provision or the full performance of an act would result in unnecessary hardship or practical difficulty.

6708.4 A variance or exception under §§6708.2 or 6708.3 shall be allowed only where and to the extent necessary to ameliorate the unnecessary hardship or practical difficulty, and only when compensating factors are present that give adequate protection to the public health and public welfare, and that do not impair the intent and purpose of the radiation provisions of this title.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR §8-2:1034; as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6709 HEARINGS

6709.1 Each licensee or registrant, or applicant for licensing or registration, who is aggrieved by a proposed action of the Director that would result in the refusal to issue a license or registration, or that would modify, suspend, terminate, or revoke a license or registration, shall be afforded notice and an opportunity to be heard prior to the action by the Director.

6709.2 A request for a hearing to review an adverse action proposed by the Director must be made in writing within fifteen (15) days following notification to the applicant, licensee, or registrant of the contemplated action and of his or her right to a hearing with respect to the action.

6709.3 Upon failure by an applicant, licensee, or registrant to request a timely hearing, or upon failure of the person to appear at a scheduled hearing and for which no continuance has been or is granted, the Director may, without a hearing, take the action contemplated in the notice.

6709.4 When the Director issues a notice pursuant to §6705 of this chapter to cease and desist from the use of any machine, device, or equipment by a licensee or registrant, the Director shall inform the licensee or registrant that an opportunity to be heard and to contest the notice shall be afforded within thirty (30) days of the issuance of the notice.

6709.5 In any matter involving denying, modifying, suspending, or revoking any license issued under chapters 67 through 69 of this title, or in a hearing concerned with the issuance of a notice to cease and desist the use of any machine, device, or equipment, the procedure shall be in accordance with the District of Columbia Administrative Procedure Act, approved October 4, 1968, as amended (82 Stat. 1203; D.C. Official Code §§ 2-501 to 2-510 (2001)).

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR §8-2:1010; as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6710 PENALTIES

6710.1 Any person who fails to comply with any provision of the radiation provisions of this title, or of the standards issued by the Director, or any person who refuses, interferes with, or prevents any inspection authorized by the radiation provisions of this title, shall be punished by a fine of not more than three hundred dollars ($300), or by imprisonment not to exceed ninety (90) days.

6710.2 In the event of any violation of, or failure to comply with, the radiation provisions of this title or with standards issued by the Director, each and every day of the violation or failure shall constitute a separate offense; and the penalties prescribed in this section shall be applicable to each separate offense.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970), 6A DCRR §8-2:1009; as amended by the Department of Consumer and Regulatory Affairs Civil Infractions Act of 1985 Technical and Clarifying Amendments Act of 1990 §22, D.C. Law 8-237, 38 DCR 314, 325 (January 11, 1991); as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6799 DEFINITIONS

6799.1 When used in chapters 67 through 69 of this title, and in forms prescribed under those chapters, where not otherwise distinctly expressed or manifestly incompatible with the intent of the District of Columbia Low-Level Radioactive Generator Policy Act of 1990, effective March 7, 1991, as amended (D.C. Law 8-226; D.C. Official Code § 8-1501 to 8-1506 (2001)) (Act) or those chapters, the following terms shall have the meanings ascribed:

Agreement state - any state with which the Nuclear Regulatory Commission or the Atomic Energy Commission has entered into an effective agreement under subsection 274b. of the Atomic Energy Act of 1954, as amended (73 Stat. 689).

Airborne radioactive material - any radioactive material dispersed in the air in the form of dust, fumes, mists, vapors, or gases.

Byproduct material - any radioactive material (except special nuclear material) yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear material.

Calendar quarter - not less than twelve (12) consecutive weeks, nor more than fourteen (14) consecutive weeks. Calendar quarters shall be arranged so that no day in any year is omitted from inclusion within a calendar quarter. No licensee or registrant shall change the method observed by him or her of determining calendar quarters for purposes of this chapter, except at the beginning of a calendar year.

C.F.R. - Code of Federal Regulations.

Department - the Department of Health or a successor agency.

Director - the Director of the Department of Health or a successor agency or her or his designee.

District - the District of Columbia.

Health physicist - a safety professional in the field of radiation protection who uses his or her knowledge of the physical and biological effects of radiation in order to ensure the safety of both users of radioactive sources and of the general public.

Human use - the internal or external administration of radiation or radioactive material to human beings.

Individual - any human being.

License - except where otherwise specified, a license issued pursuant to 22 DCMR §6800.

Occupational exposure - exposure of an individual to radiation in a restricted area or in the course of employment in which the individual's restricted area or in the course of employment in which the individual's duties involve exposure to radiation, except that "occupational exposure" shall not be deemed to include any exposure of an individual to radiation for the purpose of medical diagnosis or medical therapy of the individual.

Person - any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, political subdivision or agency state. This term shall not include the United States Atomic Energy Commission or any other federal agency.

Pharmacist - an individual licensed by the District of Columbia to compound and dispense drugs, prescriptions, and poisons.

Physician - an individual licensed by the District of Columbia to dispense drugs in the practice of medicine.

Radiation - gamma rays and X-rays, alpha and beta particles, high-speed electrons, neutrons, and other nuclear particles; but not sound or radio waves, lasers, or visible, infrared, or ultra-violet light.

Radioactive material - any material, solid, liquid, or gas that emits radiation spontaneously.

Research and development - theoretical analysis, exploration, or experimentation, or the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes; including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings.

Restricted area - any area to which access is controlled by the licensee or registrant for purposes of protection of individuals from exposure to radiation or radioactive materials. A "restricted area" shall not include any areas used for residential quarters, although a separate room or rooms in the residential building may be set apart as a restricted area.

Sealed source - radioactive material that is permanently bonded or fixed in a capsule or matrix designed to prevent release and dispersal of the radioactive material under the most severe conditions that are likely to be encountered in normal use and handling.

Source material - uranium or thorium, or any combination of these two materials, in any physical or chemical form; or ores that contain by weight one-twentieth of one percent (0.05%) or more of uranium, thorium, or any combination of uranium and thorium. "Source material" does not include special nuclear material.

Source of radiation - any radioactive material, or any device or equipment, emitting or capable of producing radiation.

Special nuclear material in quantities not sufficient to form a critical mass - uranium enriched in the isotope U-235 in quantities not exceeding three hundred fifty (350) grams of contained U-235; uranium 233 in quantities not exceeding two hundred (200) grams; or any combination of them in accordance with the following formula: For each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified above for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed "1". For example, the following quantities in combination would not exceed the limitation and are within the formula:

175 (grams contained U-235) + 50 (grams U-233) + 50 (grams Pu) = 1

350 200 200

State - any one of the states and the District of Columbia.

Unrefined and unprocessed ore - ore in its natural form prior to any processing, such as grinding, roasting, beneficiating, or refining.

Unrestricted area - any area to which access is not controlled by the licensee or registrant in order to protect individuals from exposure to radiation and radioactive materials; and any area used for residential quarters.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR §8-2:1002; as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B68 LICENSING USERS OF RADIOACTIVE MATERIAL

22-B DCMR § 6800 GENERAL PROVISIONS

6800.1 No person shall receive, possess, use, transfer, own, or acquire radioactive material, except as authorized in a specific or general license issued pursuant to this chapter, or as otherwise provided in this chapter.

6800.2 All other sources of radiation, unless exempt from this chapter, shall be registered with the Director in accordance with the requirements of §§ 6920 through 6922 of chapter 69 of this title.

6800.3 Licenses for radioactive materials shall be general and specific.

6800.4 General licenses are effective without the filing of applications with the Department or the issuance of licensing documents to particular persons.

6800.5 Specific licenses are issued to named persons upon applications filed pursuant to this chapter.

6800.6 Subject to the provisions of this chapter, a general license shall be issued to own radioactive material without regard to quantity.

6800.7 Notwithstanding any provision of this chapter, the general license does not authorize the manufacture, production, transfer, receipt, possession, or use of byproduct material.

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is the Atomic Energy Act of 1946, as amended, 60 Stat. 755 (current version at 42 U.S.C. §§ 2011 et seq.); Commissioners’ Order No. 64-193 (February 11, 1964) (Organization Order No. 141); and Commissioners’ Order No. 70-83 (March 6, 1970). EDITOR’S NOTE: This chapter was previously codified as Chapter 21 of Title 20 of the District of Columbia Municipal Regulations.
SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR §§ 8-2:1011, 8-2:1016, 8-2:1018(f); as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6801 GENERAL LICENSES: SOURCE MATERIALS

6801.1 A general license shall be granted for the use and transfer of not more than fifteen (15) pounds of source material at one (1) time by persons in the following categories:

(a) Pharmacists using the source material solely for the compounding of medicinals;

(b) Physicians using the source material for medicinal purposes;

(c) Persons receiving possession of source material from pharmacists and physicians in the form of medicinals or drugs; and

(d) Commercial and industrial firms, and research, educational and medical institutions for research, development, educational, or commercial purposes.

6801.2 Pursuant to the issuance of a general license, no person shall receive more than a total of one hundred fifty (150) pounds of source material in any one (1) calendar year.

6801.3 Each person who receives, possesses, uses, or transfers source material pursuant to the general license issued in §6801.1 is exempt from the radiation standards issued by the Director to the extent that the receipt, possession, use, or transfer is within the terms of the general license; Provided, that this exception shall not be deemed to apply to any person who is also in possession of source material under a specific license issued pursuant to this chapter.

6801.4 A general license shall be granted for the receipt of title to source material without regard to quantity.

6801.5 The general license issued under this section shall not authorize any person to receive, possess, use, or transfer source material.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR § 8-2:1017; as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6802 GENERAL LICENSES: OTHER RADIOACTIVE MATERIALS

6802.1 A general license shall be granted to transfer, receive, acquire, own, possess, and use radioactive material incorporated in a device or equipment that is listed under standards issued by the Director and that has been manufactured pursuant to a specific license or equivalent licensing document issued by the Director, the NRC, or any agreement state, and to authorize distribution under the general license of this section or its equivalent.

6802.2 A general license shall be granted to transfer, receive, acquire, own, possess, and use quantities of radioactive material listed under standards issued by the Director; Provided, that no person shall at any one (1) time possess or use, pursuant to the general licensing provisions of this section, more than a total of ten (10) scheduled quantities.

6802.3 Each person who transfers, receives, acquires, owns, possesses, or uses scheduled items or quantities of radioactive material pursuant to a general license provided under §§ 6801.1 and 6801.2 shall not do the following:

(a) Cause an increase in the radioactivity of the scheduled items or quantities by adding other radioactive material to the items, by combining radioactive material from two (2) or more item quantities, or by altering them in any other manner that increases the rate of radiation from them;

(b) Administer externally or internally, or direct the administration of, all or any part of the scheduled items or quantities to a human being for any purpose, including, but not limited to, diagnostic, therapeutic, and research purposes;

(c) Add, or direct the addition of, all or part of the scheduled items or quantities to any food, beverage, cosmetic, drug, or other product designed for ingestion or inhalation by, or application to, a human being; or

(d) Include all or part of the scheduled items or quantities in any device, instrument, or apparatus (including component parts and accessories to the parts) intended for use in diagnosis, treatment, or prevention of disease in human beings or animals or otherwise intended to affect the structure or any function of the body of human beings or animals.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR §8-2:1018(a), (b); as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6803 MEASURING, GAUGING, AND CONTROLLING DEVICES

6803.1 A general license shall be granted to own, receive, acquire, possess, and use radioactive material when the material is contained in devices designed and manufactured for the purpose of detecting, measuring, gauging, or controlling thickness, density, level, interface location, radiation leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere, when the devices are manufactured in accordance with the specifications contained in a specific license or equivalent licensing document issued to the supplier pursuant to §6912 or its equivalent by the Director, the NRC, or any agreement, state, and authoring distribution under the general license of this section or its equivalent; Provided, that the devices meet the requirements of §§ 6803.2 and 6803.5.

6803.2 Each device shall be labeled in accordance with the provisions of the specific license or equivalent-licensing document that authorizes its distribution.

6803.3 Each device shall bear a label containing information as may be required by the Director.

6803.4 Each device shall be installed on the premises of the general licensee by a person authorized to install the device under a specific license or equivalent licensing document issued to the installer by the Director, the NRC, or any agreement state, if a label affixed to the device at the time of receipt states that installation by a specific licensee is required.

6803.5 The requirement of §6803.4 shall not apply while a device is held in storage in the original shipping container pending installation by a specific licensee.

6803.6 Each person who owns, receives, acquires, possesses, or uses a device pursuant to a general license issued under this section shall not transfer, abandon, or dispose of the device, except by transfer to a person duly authorized to receive the device by a specific license or equivalent licensing document issued by the Director, the AEC, or any agreement state.

6803.7 Each person who owns, receives, acquires, possesses, or uses a device pursuant to a general license issued under this section shall furnish to the Director, within thirty (30) days after any transfer, a report containing the following information:

(a) The name of the manufacturer of the device;

(b) The type of device;

(d) The name and address of the person receiving the device.

6803.8 Each person who owns, receives, acquires, possesses, or uses a device pursuant to a general license issued under this section shall ensure that all labels affixed to the device at the time of receipt and bearing the statement, "REMOVAL OF THE THIS LABEL IS PROHIBITED," are maintained on the device and shall comply with all instructions contained in the label.

6803.9 Each person who owns, receives acquires, possesses, or uses a device pursuant to a general license issued under this section shall have the device tested for leakage of radioactive material and proper operation of the on-off mechanism and indicator, if any, at the time of installation of the device or replacement of the radioactive material on the premises of the general licensee.

6803.10 Each device shall be re-tested at no longer than six (6) month intervals, or at intervals not to exceed three (3) years as is specified in the label required by this section.

6803.11 Devices containing only krypton need not be tested for leakage, and devices containing only tritium need not be tested for any purpose.

6803.12 Each person who owns, receives, acquires, possesses, or uses a device pursuant to a general license issued under this section shall have the tests required by §6803.9 and all other services involving the radioactive materials, and its shielding and containment, performed by the supplier or other person duly authorized by a specific license or equivalent licensing document issued by the Director, the NRC, or any agreement state, to manufacture, install, or service the device.

6803.13 Each person who owns, receives, acquires, possesses, or uses a device pursuant to a general license issued under this section shall, within thirty (30) days after the occurrence of a failure of or damage to the shielding of the radioactive material, or the on-off mechanism or indicator, or upon the detection of five one-thousandths (0.005) of a microcurie or more of removable radioactive material, furnish to the Director a report containing the following information:

(a) The name of the manufacturer of the device;

(b) The type of device;

(d) A brief description of the event and the remedial action taken.

6803.14 Each person who owns, receives, acquires, possesses, or uses a device pursuant to a general license issued under this section shall maintain records of all tests performed on the device as required under this section, including the dates and results of the tests and the names of the persons conducting the tests.

6803.15 Each person who owns, receives, acquires, possesses, or uses a device pursuant to a general license issued under this section shall, upon the occurrence of a failure of or damage to the shielding or containment of the radioactive material, of the on-off mechanism or indicator, immediately suspend operation of the device until it has been repaired by a person holding a specific license or equivalent licensing document issued by the Director, the NRC, or any agreement state to receive the radioactive material contained in the device.

6803.16 Each person who owns, receives, acquires, possesses, or uses a device pursuant to a general license issued under this section shall, within ten (10) days after the receipt of the device, notify the director of the type of device and the name and address of the supplier.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR §8-2:1018(c); as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6804 LUMINOUS SAFETY DEVICES FOR AIRCRAFT

6804.1 A general license shall be granted to own, receive, acquire, possess, and use tritium or promethium 147 contained in luminous safety devices for use in aircraft; Provided that the requirements of this section are met.

6804.2 Each device shall contain not more than ten (10) curies of tritium or three hundred (300) millicuries of promethium 147.

6804.3 Each device shall have been manufactured, assembled, or imported in accordance with a specific license issued by the NRC, or each device shall have been manufactured or assembled in accordance with the specifications contained in a specific license or equivalent licensing document issued by the Director or any agreement state to the manufacturer or assembler of the device pursuant to licensing requirements equivalent to those in §32.53 of 10 C.F.R., Part 32.

6804.4 The general license provided in this section shall not authorize the manufacture, assembly, or repair of luminous safety devices containing tritium or promethium 147.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR §8-2:1018(d); as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6805 CALIBRATION AND REFERENCE SOURCES

6805.1 The following persons shall be granted a general license to own, receive, acquire, possess, use, and transfer, in accordance with the provisions of §§6805.3 through 6805.5 of this section, americium 241 in the form of the calibration or reference sources:

(a) Any person who holds a specific license issued by the Director which authorizes the person to receive, possess, use, and transfer radioactive material; and

(b) Any person who holds a specific license issued by the NRC which authorizes the person to receive, possess, use and transfer special nuclear material.

6805.2 A general license shall be granted to receive, possess, use, and transfer plutonium in the form of calibration or reference sources in accordance with the provisions of §§6805.3 through 6805.5 of this chapter to any person who holds a specific license issued by the director which authorizes the person to receive, possess, use, and transfer radioactive material.

6805.3 The general license in §§6805.1 and 6805.2 shall apply only to calibration or reference sources that have been manufactured in accordance with the specifications contained in a specific license issued to the manufacturer or importer of the sources by the NRC pursuant to §32.57 of 10 C.F.R. Part 32 or §70.39 of 10 C.F.R. Part 70, or that have been manufactured in accordance with the specifications contained in a specific license or equivalent licensing document issued to the manufacturer by the Director or by any agreement state pursuant to licensing requirements equivalent to those contained in §32.57(n) of 10 C.F.R. Part 32 or §70.39 of 10 C.F.R. Part 70.

6805.4 Any person who owns, receives, acquires, possesses, uses, or transfers one (1) or more calibration or reference sources pursuant to these general licenses shall store the source, except when the source is being used, in a closed container adequately designed and constructed to contain americium 241 or plutonium which might otherwise escape during storage.

6805.5 Any person who owns, receives, acquires, possesses, uses, or transfers one (1) or more calibration or reference sources pursuant to a general license shall not do the following:

(a) Possess at any one (1) time, at any one (1) location of storage or use, more than five (5) microcuries of americium 241 and five (5) microcuries of plutonium in the sources;

(b) Receive, possess, use, or transfer the source, unless the source of the storage container bears a label containing the information as may be required by the Director;

(c) Transfer, abandon, or dispose of the source, except by transfer to a person authorized to receive the source by a license from the Director, the NRC, or an agreement state; and

(d) Use the source for any purpose other than the calibration of the radiation detectors or the standardization of other sources.

6805.6 The general licenses provided by this section shall not authorize the manufacture of calibration or reference sources containing americium 241 or plutonium.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR § 8-2:10189(e); as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6806 MEDICAL DIAGNOSTIC USES

6806.1 A general license shall be issued to any physician to receive, possess, transfer, or use for any of the following diagnostic uses, in accordance with the provisions of §§6806.2 through 6806.6 of this section, the following radioactive materials in capsules, disposable syringes, or other forms of prepackaged individual doses:

(a) Iodine 131 as sodium iodide (NaI131) for measurement of thyroid uptake;

(b) Iodine 131 as iodinated human serum albumin (IHSA) for determinations of blood plasma volume;

(d) Cobalt 57, Cobalt 58, and Cobalt 60 for the measurement of intestinal absorption of cyanocobalamin; and

(e) Chromium 51 as sodium radiochromate for determinations of red blood cell volumes and studies of red blood cell survival time.

6806.2 No physician shall receive, possess, use, or transfer radioactive material pursuant to the general license established in §6806.1, except in accordance with the terms of a certificate issued by the Director.

6806.3 Application for the certification required in §6806.2 shall be filed on a form prescribed by the Director, and shall contain information as may be required by the Director.

6806.4 The physician shall report in writing any changes in the information furnished in the form within thirty (30) days of the change.

6806.5 A physician who receives, possesses, or uses a pharmaceutical containing radioactive material pursuant to the general license established in §6806.1 shall do the following:

(a) Store the pharmaceutical until administered in the original shipping container, or a container providing equivalent radiation protection; and

(b) Use the pharmaceutical only for the uses authorized by §6806.1.

6806.6 A physician who receives, possesses, or uses a pharmaceutical containing radioactive material pursuant to the general license established in §6806.1 shall not do the following

(a) Possess at any one (1) time, pursuant to the general license in §6806.1, more than the following substances:

(1) Two hundred (200) microcuries of iodine 131;

(2) Two hundred (200) microcuries of iodine 125;

(3) Five (5) microcuries of cobalt 57;

(4) Five (5) microcuries of cobalt 58;

(5) Five (5) microcuries of cobalt 60; or

(6) Two hundred (200) microcuries of chromium 51.

(b) Administer the pharmaceutical to a woman with a confirmed pregnancy or to a person under eighteen (18) years of age;

(c) Transfer the radioactive material to a person who is not authorized to receive it pursuant to a license issued by the Director, the AEC, or any agreement state; and

(d) Transfer the radioactive material in any manner other than in the unopened, labeled shipping container as received from the supplier, except by administering it to a patient.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR §8-2:1018(g); as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6807 ICE DETECTION DEVICES

6807.1 A general license shall be granted to own, receive, acquire, possess, use, and transfer strontium 90 contained in ice detection devices; Provided that the following requirements are met:

(a) Each device shall contain not more than fifty (50) microcuries of strontium 90;

(b) Each device shall have been manufactured or imported in accordance with a specific license issued by the NRC; and

(c) Each device shall have been manufactured in accordance with the specifications, contained in a specific license or equivalent licensing document issued by the Director or any agreement state to the manufacturer of the device pursuant to licensing requirements equivalent to those in §32.61 of 10 C.F.R. Part 32.

6807.2 Persons who own, receive, acquire, possess, use, or transfer strontium 90 contained in ice detection devices pursuant to the general license in §6807.1 shall do the following:

(a) Upon occurrence of visually observable damage to the device, such as a bend or crack or discoloration from overheating, discontinue use of the device until it has been inspected, tested for leakage, and repaired by a person holding a specific license or equivalent licensing document from the NRC or an agreement state to manufacture or service the devices, or dispose of the device pursuant to the provisions of these regulations; and

(b) Ensure that all labels affixed to the device at the time of receipt, and which bear a statement that prohibits removal of the labels are maintained on the device.

6807.3 The general license provided in this section shall not authorize the manufacture, assembly, disassembly, or repair of strontium 90 in ice detection devices.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR §8-2:1018(h); as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6808 RESERVED

History

SOURCE: Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6809 RESERVED

History

SOURCE: Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6810 EXEMPTIONS: SOURCE MATERIALS

6810.1 Any person who receives, possesses, uses, or transfers source material in any chemical mixture, compound, solution, or alloy in which the source material is by weight less than one twentieth of one percent (0.05%) of the mixture, compound, solution, or alloy shall be exempt from the provisions of chapters 67 through 69 of this title.

6810.2 Any person who receives, possesses, uses, or transfers unrefined and unprocessed ore containing source material shall be exempt from the provisions of chapters 67 through 69 of this title. Except as authorized in a specific license, the person shall not refine or process the ore.

6810.3 A person shall be exempt from chapters 67 through 69 if the person receives, possesses, uses, or transfers any quantities of thorium contained in the following:

(a) Incandescent gas mantles;

(b) Vacuum tubes;

(d) Electric lamps for illuminating purposes; Provided, that each lamp does not contain more than fifty (50) milligrams of thorium;

(e) Germicidal lamps, sunlamps, and lamps for outdoor or industrial lighting; Provided that each lamp does not contain more than two (2) grams of thorium; or

(f) Rare earth metals and compounds, mixtures, and products containing not more than twenty-five percent (25%) by weight of thorium, uranium, or any combination of thorium and uranium.

6810.4 A person shall be exempt from chapters 67 through 69 if the person receives, possesses, uses, or transfers any quantities of thorium contained in the following products:

(a) Glazed ceramic tableware; Provided, that the glaze contains not more than twenty percent (20%) by weight source material; and

(b) Glassware, glass enamel, and glass enamel frit containing not more than ten percent (10%) by weight source material; but not including commercially manufactured glass brick, pane glass, ceramic tile or other glass, glass enamel, or ceramic used in construction.

6810.5 A person shall be exempt from chapters 67 through 69 if the person receives, possesses, uses, or transfers any finished product or part fabricated of, or containing, tungsten or magnesium-thorium alloys; Provided, that the thorium content of the alloy does not exceed four percent (4%) by weight and that the exemption contained in this subsection shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any product or part.

6810.6 A person shall be exempt from chapters 67 through 69 if the person receives, possesses, uses, or transfers photographic film, negatives, and prints containing uranium or thorium.

6810.7 A person shall be exempt from chapters 67 through 69 if the person receives, possesses, uses, or transfers uranium contained in the detector heads for use in fire detection units; Provided, that each detector head contains not more than five one-thousandths (0.005) microcurie of uranium.

6810.8 A person shall be exempt from chapters 67 through 69 if the person receives, possesses uses, or transfers uranium contained in counterweights installed in aircraft, rockets, projectiles, or missiles, or stored or handled in connection with the installation or removal of the counterweights when the following requirements are met:

(a) The counterweights are manufactured in accordance with the specifications contained in a specific license or equivalent licensing document issued by the Director, the NRC, or any agreement state;

(b) Each counterweight has been impressed with the following legend clearly legible through any plating or other covering: "CAUTION" "RADIOACTIVE MATERIAL - URANIUM"; and

6810.9 A person shall be exempt from chapters 67 through 69 if the person receives, possesses, uses, or transfers uranium used as shielding constituting part of any shipping container that is conspicuously and legibly impressed with the legend "CAUTION RADIOACTIVE SHIELDING - URANIUM", and that meets the specifications for containers for radioactive materials prescribed by regulations published by the U.S. Department of Transportation at 49 C.F.R. § 172.403.

6810.10 A person shall be exempt from chapters 67 through 69 if the person receives, possesses, uses, or transfers thorium contained in finished optical lenses; Provided, that each lens shall not contain more than thirty percent (30%) by weight of thorium, and that the exemption contained in this subsection shall not be deemed to authorize either off following:

(a) The shaping, grinding, or polishing of the lens or manufacturing process other than the assembly of the lens into optical systems and devices without any alteration of the lens; or

(b) The receipt, possession, use, or transfer of thorium contained in contact lenses, or in spectacles, or in eyepieces in binoculars or other optical instruments.

6810.11 A person shall be exempt from chapters 67 through 69 if the person receives, possesses, uses, or transfers thorium in any finished aircraft engine part containing nickel-thoria alloy; Provided, that the following requirements are met:

(a) The thorium is dispersed in the nickel-thoria alloy in the form of finely divided thoria (thorium dioxide); and

(a) The thorium content in the nickel-thoria alloy does not exceed four percent (4%) by weight.

6810.12 The exemptions in this section shall not authorize the manufacture of any of the products described in this section.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR §8-2:1012; as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6811 EXEMPTIONS: RADIOACTIVE MATERIALS

6811.1 Except as provided in §6811.2, any person who receives, possesses, uses, transfers, owns, or acquires products or materials containing radioactive material in concentrations not in excess of those listed in standards issued by the Director, shall be exempt from chapters 67 through 69 of this title.

6811.2 No person shall introduce radioactive material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under §6811.1 or under equivalent regulations of the NRC or any agreement state; except in accordance with a license issued pursuant to §6915, or the general license set forth in §§6800 through 6807 of this chapter.

6811.3 Except for a person who applies tritium, promethium 147, or radium to, or a person who incorporates tritium, promethium 147, or radium into, the following products, a person shall be exempt from chapters 67 through 69 to the extent that the person receives, possesses, uses, transfers, owns, or acquires the following products:

(a) Twenty-five (25) millicuries of tritium per timepiece;

(b) Five (5) millicuries of tritium per hand;

(d) One hundred (100) microcuries of promethium 147 per watch or two hundred (200) microcuries of promethium 147 per any other timepiece;

(e) Twenty (20) mirocuries of promethium 147 per watch hand or forty (40) microcuries of promethium 147 per other timepiece hand; and

(f) Sixty (60) microcuries of promethium 147 per watch dial or one hundred twenty (120) microcuries of promethium 147 per other timepiece dial (bezels when used shall be considered as part of the dial).

6811.4 The levels of radiation from hands and dials containing radium or promethium 147 shall not exceed, when measured through fifty (50) milligrams per square centimeter of absorber as follows:

(a) For wrist watches - one-tenth (0.1) millirad per hour at ten (10) centimeters from any surface;

(b) For pocket watches - one-tenth (0.1) millirad per hour at one (1) centimeter from any surface; and

6811.5 Except for a person who applies tritium, promethium 147, or radium to, or a person who incorporates tritium, promethium 147, or radium into the following products, a person shall be exempt from chapters 67 through 69 to the extent that the person receives, possesses, uses, transfers, owns, or acquires the following products:

(a) Lock illuminators containing not more than fifteen (15) millicuries of tritium or not more than two (2) millicuries of promethium 147 installed in automobile locks. The levels of radiation from each lock illuminator containing promethium 147 shall not exceed one (1) millirad per hour at one (1) centimeter from any surface when measured through fifty (50) milligrams per square centimeter of absorber;

(b) Balances of precision containing not more than one (1) millicurie of tritium per balance, or not more that five-tenths (0.5) millicuries of tritium per balance part;

(d) Marine compasses containing not more that seven hundred fifty (750) millicuires of tritium gas and other marine navigational instruments containing not more than two hundred fifty (250) millicuries of tritium gas;

(e) Thermostat dials and pointers containing not more that twenty-five (25) millicuries of tritium per thermostat;

(f) Glow lamps containing not more than ten (10) microcuries of tritium per lamp; and

(g) Spark gap tubes containing not more than thirty (30) microcuries of promethium 147. The levels of radiation from each spark gap tube containing promethium 147 shall not exceed five-tenths (0.5) millirad per hour at one (1) centimeter from any surface when measured through seven (7) milligrams per square centimeter of absorber.

6811.6 Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing source, byproduct, or special nuclear material intended for use by the general public shall not be granted under chapters 67 through 69 of this title.

6811.7 Any person who receives, possesses, uses, transfers, owns, or acquires synthetic plastic resins containing scandium 46 which are designed for sand consolidation in oil wells shall be exempt from chapters 67 through 69 of this title.

6811.8 The resins specified in §6811.7 shall have been manufactured or imported in accordance with a specific license issued by the NRC, or shall have been manufactured in accordance with specifications contained in a specific license or equivalent licensing document issued by the Director or any agreement state to the manufacturer of the resins pursuant to licensing requirements equivalent to those in §§32.16 and 32.17 of 10 C.F.R. Part 32 of the regulations of the NCR.

6811.9 The exemption provided in §6811.7 shall not authorize the manufacture of any resins containing scandium 46.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR §8-2:1013; as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6812 EXEMPTIONS: CARRIERS AND CONTRACTORS

6812.1 Any Nuclear Regulatory Commission contractor or subcontractor of the following categories operating within the District shall be exempt from chapters 67 through 69 to the extent that the contractor or subcontractor under his or her contract receives, possesses, uses, transfers, owns, or acquires sources of radiation:

(a) Prime contractors performing work for the NRC at U.S. government-owned or

(b) Prime contractors performing research in or development, manufacture, storage, testing, or transportation of, atomic weapons or components of the weapons;

(c) Prime contractors using or operating nuclear reactors or other nuclear devices in a U.S. government-owned vehicle or vessel; and

(d) Any other prime contractor or subcontractor when the Director and the NRC jointly determine the following:

(1) That, under the terms of the contract or subcontract, there is adequate assurance that the work under the contract or subcontract can be accomplished without undue risk to the public health and safety; and

(2) That the exemption of the contractor or subcontractor is otherwise appropriate.

6812.2 Common and contract carriers operating within the District shall be exempt from the provisions of chapters 67 through 69 to the extent that they transport or store sources of radiation in the regular course of their carriage for another or storage incident to that carriage.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR §§8-2:1014 and 8-2:1015; as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6899 DEFINITIONS

6899.1 The meanings ascribed to the definitions appearing in §6799 of chapter 67 of this title shall apply to the terms in this chapter.

History

SOURCE: As amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B69 RADIATION: SPECIFIC LICENSE PROCEDURES

22-B DCMR § 6900 APPLICATION FOR SPECIFIC LICENSES

6900.1 Applications for specific licenses shall be filed with the Director on a form prescribed by the Director, and containing information that the Director may require.

6900.2 At any time after the filing of the original application, and before the expiration of the license, the Director may require further statements in order to determine whether the application should be granted or denied or whether a license should be modified or revoked.

6900.3 Each application shall be signed by the applicant or licensee or a person duly authorized to act for and on his or her behalf.

6900.4 In the application, the applicant may incorporate by reference information contained in previous applications, statements, or reports filed with the Director; Provided, that the references shall be clear and specific.

6900.5 An application may include a request for a license authorizing one (1) or more purposes.

6900.6 Applications and documents submitted to the Director may be made available for public inspection, except that the Director may withhold all or part of any document from public inspection if disclosure of its contents is not required in the public interest and would adversely affect the interest of a person concerned.

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is the Atomic Energy Act of 1946, as amended, 60 Stat. 755 (current version at 42 U.S.C. §§2011 et seq.); Commissioners’ Order No. 64-193 (February 11, 1964) (Organization Order No. 141); and Commissioners’ Order No. 70-83 (March 6, 1970).
SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR § 8-2:1019; as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006). EDITOR’S NOTE: This chapter was previously codified as Chapter 22 of Title 20 of the District of Columbia Municipal Regulations.

22-B DCMR § 6901 GENERAL REQUIREMENTS FOR ISSUANCE OF LICENSES

6901.1 A license application shall be approved if the Director determines that the requirements of this section have been satisfied.

6901.2 The applicant shall qualify by reason of training and experience to use the material in question for the purpose requested in accordance with these regulations in a manner that minimizes danger to public health, safety, and property.

6901.3 The applicant’s proposed equipment, facilities, and procedures shall be adequate to minimize danger to public health, safety, and property.

6901.4 The issuance of the license shall not be inimical to the health and safety of the public.

6901.5 The applicant shall satisfy the applicable special requirements for each specific license requested pursuant to §§6910 through 6916 of this chapter.

6901.6 Upon a determination that an application meets the requirements of these regulations, the Director shall issue a specific license authorizing the proposed activity. The license shall state the conditions of and the limitations on the license as are deemed appropriate or necessary.

6901.7 The Director may incorporate in any license at the time of its issuance, or after it is issued by appropriate rule or order, any additional requirements and conditions with respect to the licensee’s receipt, possession, use, and transfer of radioactive material, subject to the radiation provisions of this title, as are deemed appropriate or necessary in order to do the following:

(a) Minimize danger to public health and safety or property;

(b) Require any reports, the keeping of records and provide for inspections and activities under the license as may be appropriate or necessary; and

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR § 8-2:1020; as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6902 SPECIFIC TERMS AND CONDITIONS OF LICENSES

6902.1 Each license issued pursuant to the radiation provisions of this title shall be subject to all rules, regulations, orders, and standards of the Department.

6902.2 Each person licensed by the Director pursuant to the radiation provisions of this title shall confine his or her use and possession of the material licensed to the locations and purposes authorized in the license.

6902.3 Each licensee authorized under §6912 of this chapter to distribute certain devices to generally licensed persons shall report to the Director all transfers of the devices to persons generally licensed under §6803 of chapter 68 of this title.

6902.4 The report required by §6902.3 shall identify each general licensee by name and address, the type of device transferred, and the quantity and type of radioactive material contained in the device.

6902.5 The report required by §6902.3 shall be submitted within thirty (30) days after the end of each calendar quarter in which a device is transferred to a generally licensed person.

6902.6 Each licensee authorized under §6912 to distribute certain devices to generally licensed persons shall furnish to each general licensee in the District to whom he or she transfers a device a copy of the general license contained in §6803 of chapter 68 of this title.

6902.7 No license issued or granted under the radiation provisions of this title, and no right to possess or utilize radioactive material granted by any license issued pursuant to those provisions, shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, or through transfer of control of any license to any person unless the Director finds that the transfer is in accordance with the radiation provisions of this title and consents in writing to a transfer, assignment, or another means of disposal. The director shall base his or her finding on full information.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR §§ 8-2:1023 and 8-2:1027; as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6903 RENEWAL AND AMENDMENT OF LICENSES

6903.1 Each application for renewal of a specific license shall be filed in accordance with §6900 of this chapter.

6903.2 In any case in which a licensee has filed an application not less than thirty (30) days prior to the expiration of his or her existing license, and has filed the application in proper form for renewal or for a new license authorizing the same activities, the existing license shall not expire until a decision on the application has been made by the Director.

6903.3 Each application for an amendment of a license shall be filed in accordance with §6900 of this chapter, and shall specify the respects in which the licensee desires his or her license to be amended and the grounds for the amendment.

6903.4 In considering an application by a licensee to renew or amend his or her license, the Director shall apply the criteria set forth in §6901 and §§6910 through 6916 of this chapter as applicable.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR §§ 8-2:1024 through 8-2:1026; as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6904 MODIFICATION, REVOCATION, AND TERMINATION OF LICENSES

6904.1 The terms and conditions of all licenses shall be subject to amendment, revision, or modification, or the license may be suspended or revoked by reason of amendments to the radiation provisions of this title, or by requirements and orders issued by the Director.

6904.2 Any license may be revoked, suspended, or modified, in whole or in part, for any of the following reasons:

(a) Any material false statement in the application or any statement of fact required under the radiation provisions of this title;

(b) Because of conditions revealed by the application or statement of fact, or any report, record, or inspection or other means that would warrant the Director refusing to grant a license on an original application; or

(c) For violation of, or failure to observe, any of the terms and conditions of the license, or of the radiation provisions of this title, or order of the Director.

6904.3 Except in cases of willfulness, or in cases in which the public health, interest, or safety requires otherwise, no license shall be modified, suspended, or revoked unless, prior to the institution of proceedings for the action, facts or conduct that may warrant the action have been called to the attention of the licensee in writing; and the licensee has been accorded an opportunity to demonstrate or achieve compliance with all lawful requirements.

6904.4 The Director may terminate a specific license upon the written request of the licensee.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR § 8-2:1031; as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6905 TRANSFER OF RADIOACTIVE MATERIALS BY LICENSEES

6905.1 No licensee shall transfer radioactive material except as authorized pursuant to this section.

6905.2 With the advance approval of the receiver, any licensee may transfer radioactive material to the following:

(a) The Department;

(b) The Nuclear Regulatory Commission (NRC);

(d) Any person authorized to receive the material under terms of a general license or its equivalent, or a specific license or equivalent licensing document, issued by the Director, the NRC, or any agreement state, or to any person otherwise authorized to receive the material by the federal government or any federal government agency, the Director, or any agreement state.

6905.3 With advance approval of the receiver, a licensee may transfer radioactive material when authorized to do so by the Director in writing.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR § 8-2:1030; as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6906 [RESERVED]

22-B DCMR § 6907 [RESERVED]

22-B DCMR § 6908 [RESERVED]

22-B DCMR § 6909 [RESERVED]

22-B DCMR § 6910 HUMAN USE OF RADIOACTIVE MATERIALS

6910.1 A specific license for human use of radioactive material in institutions shall be issued only if the requirements of §§6910.2 through 6910.6 are satisfied.

6910.2 The applicant shall appoint and submit to the Director the names of the members of a medical radiation safety committee of at least three (3) members to evaluate all proposals for research, diagnostic, and therapeutic use of radioisotopes within that institution.

6910.3 Membership of the medical radiation safety committee required by §6910.1 shall include physicians expert in internal medicine, hematology, and therapeutic radiology, and a person experienced in testing of radioisotopes and protection against radiation.

6910.4 The applicant shall possess adequate facilities for the clinical care of patients.

6910.5 The physician designated on the application as the individual user shall have substantial experience in the handling and administration of radioisotopes and, where applicable, the clinical management of radioactive patients.

6910.6 If the application is for the license to use unspecified quantities or multiple types of radioactive material, the applicant’s staff shall have substantial experience in the use of radioactive materials for a variety of human uses.

6910.7 A specific license for the human use of radioactive materials shall be issued to an individual physician only if the applicant satisfies the following requirements:

(a) The applicant has access to a hospital possessing adequate facilities to hospitalize and monitor the applicant’s radioactive patients whenever it is advisable; and

(b) The applicant has extensive experience in the handling and administration of radioisotopes and, where applicable, the clinical management of radioactive patients.

6910.8 A specific license for human use of sealed sources shall be issued only if the applicant or, if the application is made by an institution, the individual user meets the following requirements:

(a) He or she has specialized training in the therapeutic use of the sealed source considered (such as a teletherapy unit, beta applicator, or similar device), or has experience equivalent to that training; and

(b) He or she is a physician.

6910.9 An application for a specific license pursuant to §§6910.1 through 6910.7 of this section for any diagnostic use of radioactive material in humans as specified in standards issued by the Director shall be approved for all of the diagnostic uses within the standards if the applicant satisfies the following requirements:

(a) The applicant satisfies the requirements of §§6910.1 through 6910.7;

(b) The applicant or the physician designated in the application as the individual user has adequate clinical experience in the performance of diagnostic procedures specified in the appropriate standards; and

(c) The applicant’s proposed radiation detection instrumentation is adequate for conducting the diagnostic procedures specified in the appropriate standards.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR §§ 8-2:1021 (a) - (d); as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6911 MANUFACTURE FOR MEDICAL DIAGNOSTIC USES

6911.1 A specific license authorizing the distribution of radioactive material for use by physicians under the general license in §6806 of chapter 68 of this title shall be issued only if the requirements of this section are met.

6911.2 The applicant for the license shall submit evidence that the radioactive material is to be manufactured, labeled, and packaged in accordance with the following:

(a) A new drug application which the Commissioner of Food and Drugs, of the Food and Drug Administration, has approved; or

(b) A license for a biologic product issued by the Secretary of Health and Human Services.

6911.3 A label or statement containing information as the Director may require shall be affixed to the container or shall appear in the leaflet or brochure that accompanies the package of radioactive material.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR § 8-2:1021(j); as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6912 RESEARCH AND DEVELOPMENT

6912.1 A specific license for multiple quantities or types of radioactive material for use in research and development shall be issued if the requirements of this section are met.

6912.2 The applicant’s staff shall have substantial experience in the use of a variety of radioisotopes for a variety of research and development uses.

6912.3 The applicant shall have established a radiation safety committee which will review and approve, in advance of purchase of radioisotopes, proposals for the radiological use.

6912.4 The committee required by §6912.3 shall be composed of persons such as a radiological safety officer, a representative of the business office, and one (1) or more persons trained or experienced in the safe use of radioactive materials.

6912.5 The applicant shall appoint a radiological safety officer who will advise and assist on radiological safety problems.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR § 8-2:1021(e); as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6913 MEASURING, GAUGING, AND CONTROLLING DEVICES

6913.1 A specific license to distribute certain devices of the types enumerated in §6803 of chapter 68 of this title to persons generally licensed under that section shall be issued only if the requirements of this section are met.

6913.2 The applicant shall submit sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling, proposed uses, and potential hazards of the device to reasonably ensure the following:

(a) The radioactive material contained in the device will not be lost;

(b) No individual will receive a radiation exposure to a major portion of his or her body in excess of five-tenths (0.5) rem in a year under ordinary circumstances of use;

(d) The radioactive material within the device will not be accessible to unauthorized individuals.

6913.3 In describing the label or labels and the label contents to be affixed to the device, the applicant shall separately indicate instructions and precautions that are necessary to assure safe operation of the device. The instructions and precautions shall be contained on labels bearing the statement, “REMOVAL OF THIS LABEL IS PROHIBITED.”

6913.4 If the applicant desires that the device be tested for proper operation of the on-off mechanism and indicator, if any, and for leakage of radioactive material, subsequent to the initial test required by §§6803.9 and 6803.10, at intervals longer than six (6) months, but not exceeding three (3) years, the applicant shall include in the application sufficient information to demonstrate that the longer interval is justified by performance characteristics of the device or similar devices, and by design features which have a significant bearing on the probability or consequences of leakage of radioactive material from the device.

6913.5 In determining the acceptable interval for tests of leakage of radioactive material, the Director shall consider information on particulars which includes, but is not necessarily limited to, the following:

(a) Primary containment (source capsule);

(b) Protection of primary containment;

(d) Containment construction materials;

(e) Form of contained radioactive material;

(f) Maximum temperature withstood during prototype tests;

(g) Maximum pressure withstood during prototype tests;

(h) Maximum quantity of contained radioactive material;

(i) Radiotoxicity of contained radioactive material; and

(j) Operating experience with identical devices or similarly designed and constructed devices.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR § 8-2:1021(f); as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6914 INDUSTRIAL RADIOGRAPHY

6914.1 A specific license for use of sealed sources in industrial radiography (that is, the examination of the structure of materials by nondestructive methods utilizing sealed sources of radioactive material) shall be issued if the requirements of this section are met.

6914.2 The applicant shall have an adequate program for training radiographers and radiographers’ assistants.

6914.3 The applicant shall submit to the Director a schedule or description of the program for training radiographers and radiographers’ assistants which specifies the following:

(a) Initial training;

(b) Periodic training;

(d) Means to be used by the licensee to determine the radiographer’s knowledge and understanding of and ability to comply with regulations and licensing requirements, and the operating and emergency procedures of the applicant; and

(e) Means to be used by the licensee to determine the radiographer’s assistant’s knowledge and understanding of and ability to comply with the operating and emergency procedures of the applicant.

6914.4 The applicant shall establish and submit to the Director operating and emergency procedures that comply with the standards issued by the Director.

6914.5 The applicant shall have an adequate internal inspection system, or another management control, to assure that license provisions, regulations, and the applicant’s operating and emergency procedures are followed by each radiographer and each radiographer’s assistant.

6914.6 The applicant shall submit to the Director a description of the applicant’s overall organizational structure pertaining to the industrial radiography program, including specified delegations of authority and responsibility for operation of the program.

6914.7 The applicant who desires to conduct his or her own leak tests shall establish adequate procedures to be followed in leak testing sealed sources for possible leakage and contamination, and shall submit to the Director a description of the procedures, including the following:

(a) Instrumentation to be used;

(b) Method of performing tests, such as the points on the equipment to be smeared and the method of taking a smear; and

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR § 8-2:1021(g); as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6915 PROCESSING FOR DISTRIBUTION

6915.1 A specific license for multiple quantities or types of radioactive material for use in processing for distribution to authorized persons shall be issued only if the requirements of this section are met.

6915.2 The applicant’s staff shall have substantial experience in the use of a variety of radioisotopes for processing and distribution.

6915.3 The applicant shall appoint a radiological safety officer who will advise and assist on radiological safety problems.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR § 8-2:1021(h); as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6916 USE OF EXEMPT CONCENTRATIONS IN PRODUCTS

6916.1 A specific license for the introduction of radioactive material into a product or material owned by or in the possession of the licensee or another to be transferred to persons exempt under §6811.1 shall be issued only if the requirements of this section are met.

6916.2 The applicant shall submit the following information:

(a) A description of the product or material into which the radioactive material will be introduced;

(b) The intended use of the radioactive material and the product or material into which it is introduced;

(d) The initial concentration of the radioactive material in the product or material;

(e) The control methods to ensure that no more than the specified concentration is introduced into the product or material;

(f) The estimated time interval between the introduction and the transfer of the product or material; and

(g) The radioactive material in the product or material at the time of transfer.

6916.3 The applicant shall provide reasonable assurance of the following:

(a) The concentrations of radioactive material at the time of transfer will not exceed the concentrations specified in standards issued by the Director;

(b) Reconcentration of the radioactive material in concentrations exceeding those in the standards issued by the Director is not likely;

(d) The product or material is not likely to be incorporated in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being.

6916.4 Each person licensed under this section shall file an annual report with the Director that provides the following information:

(a) A description of the type and quantity of each product or material into which radioactive material has been introduced during the reporting period;

(b) The name and address of the person who owns or possesses the product or material into which radioactive material has been introduced;

(d) The initial concentrations of radioactive material in the product or material at the time of the transfer of the radioactive material by the licensee.

6916.5 The report required by §6916.4 shall be submitted within thirty (30) days after the end of each calendar year in which the licensee introduces radioactive material into a product or material pursuant to a license granted under this section.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR § 8-2:1021(i); as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6917 [RESERVED]

22-B DCMR § 6918 [RESERVED]

22-B DCMR § 6919 [RESERVED]

22-B DCMR § 6920 REGISTRATION OF RADIATION MACHINES

6920.1 The owner or person having possession of any radiation machine, except those specifically exempted, shall register the machine with the Director.

6920.2 No person, in any advertisement, shall refer to the fact that a radiation machine is registered with the Director.

6920.3 No person shall state or imply that any activity conducted under his or her registration has been approved by the Director.

6920.4 The following machines and equipment are exempt from the radiation provisions of this title:

(a) Domestic television receivers manufactured after the effective date of these regulations and sold in the District that comply with the applicable federal requirements of 42 C.F.R. 78.210, “Performance Standard for Television Receivers”;

(b) Other electrical equipment that produces radiation incidental to its operation for other purposes; Providing, that the dose rate to the whole body at the point of nearest approach to the equipment when any external shielding is removed does not exceed five-tenths (0.5) rem per year. The production testing or factory servicing of the equipment shall not be exempt; and

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR §§ 8-2:1032(a), (b)(8) and 8-2:1032(c); as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6921 RADIATION MACHINES AND REGISTRATION PROCEDURES

6921.1 Registration shall be on forms furnished by the Director, and shall contain all information that the Director may require.

6921.2 The applicant shall designate an individual who will be responsible for radiation protection for the machine. This person shall:

(a) Be qualified by training and experience concerning all hazards and precautions involved in operating the machine for which he or she is responsible;

(b) Recommend a detailed program of radiation safety for effective compliance with the applicable requirements of the radiation provisions of this title;

(c) Give instructions concerning hazards and safety practices to individuals who may be exposed to radiation from the machine; and

(d) Make surveys and carry out other procedures as required by these regulations.

6921.3 When, in the opinion of the Director, the person designated to be responsible for radiation safety does not have qualifications sufficient to ensure safety of the machine for which the person is responsible, the Director may order the registrant to designate another individual who meets the qualifications.

6921.4 The Director shall issue a Notice of Registration to each applicant who has submitted the information required in §6921.1.

6921.5 The Notice of Registration shall state the period of registration and shall be retained by the registrant for the stated period.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR §§8-2:1032(b) (1) - (b)(3); as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6922 RADIATION MACHINES: RENEWAL AND MODIFICATION OF REGISTRATION

6922.1 The owner or person having possession of any registered radiation machine shall re-register the machine with the Director every two (2) years.

6922.2 The application for re-registration shall be submitted at least thirty (30) days prior to the expiration of the registrant’s current Notice of Registration.

6922.3 When a registrant has filed an application not less than thirty (30) days prior to the expiration of his or her existing registration, and when the application has been filed in the proper form for renewal or amendment of the application, the existing registration shall be valid until a final decision has been made on the application by the Director.

6922.4 The registrant shall notify the Director within thirty (30) days of any change that renders the information furnished by him or her no longer accurate.

6922.5 A change in the ownership, possession, or address where a radiation machine is located shall terminate a registration.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR §§ 8-2:1032(b) (5) - (b)(7); as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6923 SUPPLIERS OF MEDICAL AND DENTAL X-RAY MACHINES

6923.1 No person shall make, sell, lease, repair, transfer, lend, or install medical or dental x-ray equipment in the District unless authorized to do so by a license issued by the Director.

6923.2 Application to become a licensed supplier shall be filed on forms prescribed by the Director, and shall contain information as the Director may require.

6923.3 For the purposes of this section, a “licensed supplier” shall be a person who has been licensed by the Director to make, sell, lease, repair, lend, transfer, or install medical or dental x-ray equipment for use in the District.

6923.4 For the purposes of this section, “medical or dental x-ray equipment” shall mean any electronic device that produces x-rays by electrical means for the intentional exposure of humans.

6923.5 Any person licensed to supply medical or dental x-ray equipment in the District shall notify the Director on forms provided by the Director within fifteen (15) days following the sale, lease agreement, or decision to make available the equipment, or at least ten (10) days prior to the installation of the equipment, whichever occurs sooner.

6923.6 No medical or dental x-ray equipment shall be supplied in the District which, when properly placed in operation and properly used, does not meet the standards prescribed by the Director.

6923.7 Plans or blueprints of any medical or dental x-ray installation that is to receive x-ray equipment supplied by a licensed supplier shall be approved by the Director prior to the installation of the equipment.

6923.8 The Director may require information such as that required by §6923.7 to be furnished to him or her as the Director deems necessary to determine compliance with the requirements of the radiation provisions of this title.

6923.9 Licenses to supply medical and dental x-ray equipment in the District may be terminated for any of the following reasons:

(a) Failure to provide advance notification to the Director of the installation of medical or dental x-ray equipment sold, leased, loaned, transferred, or installed in the District;

(b) When information on the application is determined to be incorrect, or no longer current, and the licensee fails to submit an amended application containing the corrected information within thirty (30) days after the change takes place;

(d) Repeated failure to supply medical and dental x-ray equipment that meets the standards established by the Director.

6923.10 A temporary license may be granted by the Director for a specified period, not to exceed one (1) year, for those suppliers of x-ray equipment who wish to make a limited sale, lease, loan, transfer, or installation of medical or dental x-ray equipment, and who do not normally supply the equipment for profit.

History

SOURCE: Regulation No. 70-33 (July 10, 1970), 17 DCR 39 (July 27, 1970); 6A DCRR §8-2:1033; as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6924 FEE SCHEDULE

6924.1 Each owner or operator of an x-ray tube shall pay the following biennial registration fees:

(a) Dental X-Ray Tubes:

(i) Two hundred fifty dollars ($250.00) for the first tube; and

(ii) One hundred dollars ($100.00) for each additional tube.

(b) Medical X-Ray Tubes:

(i) Two hundred fifty dollars ($250.00) for the first tube; and

(ii) One hundred dollars ($100.00) for each additional tube.

6924.2 Each health physicist shall pay an annual registration fee of one hundred dollars ($100.00).

6924.3 Each x-ray supplier shall pay an annual registration fee of one hundred dollars ($100.00).

6924.4 Each radioactive material user shall pay an annual registration fee of five hundred dollars ($500.00).

6924.5 Each generator of low-level radioactive waste shall pay an annual registration fee of five thousand dollars ($5,000.00).

6924.6 All fees shall be due and payable upon filing an application for registration, or for renewal of registration, with the Department.

6924.7 The Director shall assess a late fee of fifty dollars ($50.00).

6924.8 A department, office, or agency of the District of Columbia Government shall not be required to pay a fee pursuant to this section, if the registration or services are required for a governmental purpose.

6924.9 All fees shall be paid by check or money order, made payable to the District of Columbia Treasurer.

History

SOURCE: Final Rulemaking published at 42 DCR 5016, 5017 (September 1, 1995); as amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B DCMR § 6999 DEFINITIONS

6999.1 The meanings ascribed to the definitions appearing in §6799 of chapter 67 of this title shall apply to the terms in this chapter.

History

SOURCE: As amended by Final Rulemaking published at 53 DCR 3721 (May 5, 2006).

22-B73 CHILDHOOD LEAD POISONING PREVENTION

22-B DCMR § 7300 GENERAL PROVISIONS

7300.1 Each health care provider or health care facility shall inform the parent or guardian of every child under the age of six (6) years residing in the District of Columbia, served by the provider or the facility, of the requirement for periodic blood lead level (BLL) screening tests, as required by this chapter. Each health care provider or health care facility shall document in the child's health record that the parent or guardian was informed of this requirement and understood the purpose of the tests.

7300.2 Each health care provider or health care facility offering care to pregnant women and breast feeding mothers shall inform the patient of the risks of lead poisoning, specifically the risks from lead-based paint hazards, including lead-contaminated dust, lead-contaminated soil, and lead-contaminated paint that is deteriorated or present in accessible surfaces; lead in drinking water; and lead in improperly prepared or unsafe foods, folk remedies, toys, and other consumer products.

History

AUTHORITY: Unless otherwise indicated, the authority for this chapter is the District of Columbia Newborn Screening Requirement Act of 1979 §§4 and 5, D.C. Code, 2001 Ed. §§7-833 and 7-834; and Mayor’s Order 99-88 (June 14, 1999).
SOURCE: Final Rulemaking published at 46 DCR 10170, 10171 (December 17, 1999); as amended by Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7301 UNIVERSAL CHILDHOOD LEAD SCREENING

7301.1 Each health care provider or health care facility that has obtained parental consent shall, as part of a well-child care visit, perform a blood lead level (BLL) screening test on every child who resides in the District of Columbia and who is served by the provider or facility, unless an identical test was performed not more than twelve (12) months before the well-child visit. Blood lead level screening tests shall be performed according to the following schedule:

(a) Once between the ages of six (6) months and fourteen (14) months;

(b) Once between the ages of twenty-two (22) and twenty-six (26) months; and

(c) At least twice if a child over the age of twenty-six (26) months has not previously been tested for BLL. The tests for children over the age of twenty-six (26) months shall be conducted before the child attains the age of six (6) years and shall be conducted at least twelve (12) months apart, or according to a schedule determined appropriate by the health care provider or health care facility.

7301.2 When a health care provider or health care facility required to provide testing pursuant to this chapter does not administer a BLL test during a well-child visit and according to the schedule provided in § 7301.1, the health care provider or health care facility shall document in the child's health record the reason for not performing the BLL test.

7301.3 Each health care provider and health care facility shall conduct additional BLL screening when any of the following circumstances are present:

(a) When a child is at risk for high-dose lead exposure based on the child's living conditions, a parent's occupational exposure to lead, a history of lead poisoning in siblings or playmates, or as indicated because of the child's behavior or development. In determining whether a child is at risk for high-dose lead exposure, each health care provider and health care facility shall determine, through the use of a personal-risk questionnaire or by other appropriate means, whether any of the following risk indicators are present:

(1) The child lives in, or frequently visits, deteriorated housing built before 1978;

(2) The child lives in, or frequently visits, housing built before 1978, with recent, ongoing, or planned renovation or remodeling;

(3) The child's siblings, housemates, or playmates have confirmed lead poisoning;

(4) The child's parent, guardian, or other household members participate in occupations or hobbies that may result in exposure to lead; or

(5) The child lives, or has lived, near industrial facilities or operations that may release atmospheric lead;

(b) The child exhibits pica, which consists of repeated ingestion of nonfood substances, or has frequent hand-to-mouth activity; or

(c) The child has unexplained seizures, neurological symptoms, abdominal pain, or other symptoms consistent with lead poisoning, including growth failure, developmental delay, attention deficit, hyperactivity, behavioral disorders, school problems, hearing loss, or anemia.

7301.4 Each health care provider or health care facility shall provide family lead education and appropriate referrals for social and environmental services to the family of a child with an elevated blood lead level.

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005); as amended by Final Rulemaking published at 60 DCR 10909 (July 26, 2013).

22-B DCMR § 7302 TESTING AND CASE MANAGEMENT

7302.1 This section establishes best practices for providing diagnostic testing, follow-up testing, and case management when a child under the age of six (6) has a BLL screening that indicates an elevated BLL.

7302.2 Each health care provider or health care facility should provide:

(a) Diagnostic and follow-up testing, treatment, and care for a child with an elevated BLL; and

(b) Case management for a lead-poisoned child, according to generally accepted medical standards and the guidelines established in this section. The guidelines in this section should be applied in conjunction with pertinent information regarding the child's medical condition and risk of exposure to lead hazards.

7302.3 Each health care provider or health care facility should give a child with an elevated blood level, based on the BLL in a screening test, a diagnostic test according to the following schedule:

(a) If the results of a BLL screening test are equal to ten (10) micrograms per deciliter (μ/dL), or between ten (10) and nineteen (19) micrograms per deciliter (μ/dL), the child should receive a diagnostic test within three (3) months after the screening test; and

(b) If the results of a BLL screening test are equal to or greater than twenty (20) micrograms per deciliter (μ/dL), the child should receive a diagnostic test according to the following schedule:

(1) Between one (1) week and one (1) month after the screening test when the BLL was between twenty (20) and forty-four (44) micrograms per deciliter (μ/dL);

(2) Not later than forty-eight (48) hours after the screening test when the BLL was between forty-five (45) and fifty-nine (59) micrograms per deciliter (μ/dL);

(3) Not later than twenty-four (24) hours after the screening test when the BLL was between sixty (60) and sixty-nine (69) micrograms per deciliter (μ/dL); or

(4) Immediately, as an emergency laboratory test, when the BLL was equal to or greater than seventy (70) micrograms per deciliter (μ/dL).

7302.4 If a child twelve (12) months of age or younger has an elevated BLL on a screening test, or the health care provider has reason to believe that the child's BLL is increasing rapidly, the health care provider may provide the diagnostic test sooner than indicated in subsection 7302.3. Generally, there is a direct correlation between the elevation of the BLL and the urgency for performing a diagnostic test.

7302.5 Each health care provider or health care facility should provide a child with an elevated BLL equal to or greater than ten (10) micrograms per deciliter (μ/dL), as indicated in a diagnostic test, with the following services:

(a) Case management; and

(b) Follow-up testing within two (2) months of the diagnostic test.

7302.6 A child receiving case management pursuant to this section should receive follow-up testing at not sooner than thirty (30) days and not more than sixty (60) day intervals until all of the following conditions are met:

(a) The child's BLL is less than ten (10) micrograms of lead per deciliter (μ/dL) for at least two (2) follow-up tests;

(b) The lead hazards that caused, or that are likely to have caused, the child's elevated BLL have been removed; and

7302.7 After all the conditions in § 7302.6 have been met, the child should be tested approximately once every three (3) months, until the child reaches thirty-six (36) months of age and typically no longer requires follow-up testing.

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7303 REPORTING

7303.1 Each time a health care provider or health care facility draws blood or orders a blood draw for a BLL test for a child residing in the District of Columbia, the health care provider or health care facility shall collect and record the information listed in § 7303.3. The provider or facility shall transmit the information to the laboratory performing the BLL analysis at the same time the provider or facility transmits the blood specimen to the laboratory.

7303.2 Each laboratory that analyzes a blood sample taken from a child residing in the District of Columbia shall, within a week after completion of the analysis, submit a report that meets the requirements in § 7303.3, as follows:

(a) The laboratory shall submit a written report to the health care provider or the health care facility where the sample was taken;

(b) The laboratory shall submit a report to the Childhood Lead Poisoning Prevention Program (Program), through the Program’s electronic reporting system; and

(c) The laboratory shall immediately notify the health care provider or the health care facility and the Program of the results by telephone or fax if the child's BLL equals or exceeds ten micrograms of lead per deciliter (10 μg/dL).

7303.3 The laboratory reports for BLL tests shall include the following information:

(a) Full name, date of birth, gender, and race of the child;

(b) Medicaid Identification Number of the child, if applicable;

(c) Complete home address of the child at the time the blood sample was drawn, including the house or apartment number, street, and zip code;

(d) Full name, address, and telephone number of the parent or guardian;

(e) Name, address, and telephone number of the health care provider or health care facility, including the name and telephone number of the physician ordering the test;

(f) Type of specimen (venous or capillary), and date on which the specimen was drawn;

(g) Draw site name, address, and telephone number, if different from the health care provider or health care facility;

(h) Clinical Laboratory Improvement Act (CLIA) number, name, address, and telephone number;

(i) Blood lead level, in micrograms per deciliter (μg/dL);

(j) Name, address, and telephone number of any insurance company that may provide coverage for the child, and the group number and member identification number of the primary insured; and

(k) Any other information that may be required in any reporting forms or instructions that the Program may issue.

7303.4 Immediately upon receipt of a laboratory report indicating an elevated BLL in a child, the health care provider or health care facility shall inform the child's parent or guardian of the results and the measures recommended for follow-up treatment and care. Upon request, the provider or facility shall furnish the parent or guardian with a copy of the laboratory report free of charge.

7303.5 Each health care provider or health care facility shall report a lead-poisoned child to the Program as follows:

(a) Report a lead-poisoned child by telephone within seventy-two (72) hours after receiving information of a lead-poisoned child from a laboratory or another health care provider or health care facility;

(b) Supply the child's name and address; and

7303.6 The health care provider or health care facility shall, upon a parent's or guardian's request, provide to the child's parent or guardian, a certificate of testing for lead poisoning that includes the date of the test, and the test results.

7303.7 Except as provided in this section, each health care provider, health care facility, laboratory, and the Program shall keep confidential the laboratory report prepared pursuant to this section and the underlying transmittal information from the health care provider or health care facility to the laboratory.

7303.8 An employee or agent of the District Government may disclose the following information concerning a child with an elevated BLL to the owner of the affected property and to the owner's attorney:

(a) The name of the child;

(b) The child's home address;

(d) Any other information contained in a laboratory report prepared pursuant to this section, except that the child's Social Security Number, if provided to the Program, shall not be disclosed to the owner of the affected property or the owner's attorney.

7303.9 An employee or agent of the District Government may disclose the address of an affected property, but not the name of a child who may have become lead-poisoned at the affected property, or any other information contained in a laboratory report prepared pursuant to this section concerning that child, to an individual or business entity retained to conduct lead-based paint activities at the affected property, provided the individual or business entity is certified pursuant to the Lead Hazard Prevention and Elimination Act of 2008, effective March 31, 2009 (D.C. Law 17-381; D.C. Official Code §§ 8-231.01 et seq.).

7303.10 An employee or agent of the District Government may, in a manner that is consistent with federal law and to the extent consistent with other provisions of District law, disclose information contained in a laboratory report prepared pursuant to this section to an agency or authority of the District or United States government, or a person or entity acting under a grant of authority from or contract with such authority or agency, if the disclosure is:

Required by District or federal law;

To a public health authority authorized by law to receive the information for the purpose of preventing or controlling disease, injury, or disability;

Required or authorized by statute or regulation relating to the reporting of abuse, neglect, or domestic violence, if the conditions for disclosure under 45 CFR § 164.512(c)(1) are met;

To a health oversight agency for oversight activities authorized by law;

For judicial and administrative proceedings, in response to an order of a court or administrative tribunal, and includes only the information expressly authorized by such order;

For law enforcement purposes, if the conditions for disclosure under 45 CFR § 164.512(f) are met;

For research purposes, if the conditions for disclosure under 45 CFR

§ 164.512(i) are met;

To prevent or lessen a serious and imminent threat to the health or safety of a person or the public, and is made to a person or persons reasonably able to prevent or lessen the threat, including the target of the threat; or

For any other purpose for which an entity subject to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), approved August 21, 1996 (110 Stat. 1936; 42 USC §§ 1320d et seq.), would be authorized to disclose health information without consent of the individual.

7303.11 Except as provided in this section, no person other than an employee or agent of the Department may disclose the name of the child or any other information contained in a laboratory report prepared pursuant to this section, to any other person without the express consent of the parent or guardian.

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005); as amended by Final Rulemaking published at 60 DCR 10909 (July 26, 2013); as amended by Final Rulemaking published at 65 DCR 9729 (September 21, 2018). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 7303

22-B DCMR § 7304 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7305 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7306 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7307 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7308 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7309 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7310 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7311 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7312 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7313 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7314 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7315 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7316 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7317 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7318 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7319 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7320 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7321 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7322 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7323 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7324 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7325 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7326 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7327 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7328 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7329 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7330 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7331 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7332 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7333 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7334 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7335 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7336 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7337 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7338 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7339 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7340 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7341 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7342 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7343 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7344 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7345 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7346 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7347 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7348 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7349 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7350 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7351 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7352 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7353 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7354 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7355 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7356 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7357 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7358 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7359 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7360 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7361 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7362 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7363 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7364 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7365 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7366 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7367 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7368 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7369 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7370 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7371 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7372 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7373 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7374 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7375 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7376 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7377 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7378 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7379 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7380 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7381 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7382 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7383 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7384 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7385 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7386 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7387 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7388 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7389 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7390 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7391 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7392 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7393 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7394 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7395 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7396 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7397 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7398 RESERVED

History

SOURCE: Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B DCMR § 7399 DEFINITIONS

7399.1 When used in this chapter, the following terms have the meanings ascribed:

Affected property - a residence where a child with an elevated blood lead level resides or regularly visits and which is a likely source of the lead contributing to the elevated blood lead level.

Blood lead level or BLL - the concentration of lead in a sample of whole blood expressed in micrograms per deciliter (μ/dL).

Case management - the interdisciplinary treatment and care of a child with an elevated blood lead level, consisting of coordinated medical, social, and environmental services. This term includes diagnostic testing and medical evaluation for complications of lead poisoning; pharmacological treatment, if appropriate; follow-up testing at appropriate intervals; family lead education, housekeeping, and nutritional intervention; appropriate referrals, including referral to the Childhood Lead Poisoning Prevention Program and referral for child development and social services; environmental investigation and assessment; and the elimination or reduction of lead hazards, including source control measures necessary to eliminate or control any lead-based paint hazard to which a lead-poisoned child is exposed.

Child - a person under six (6) years of age.

Childhood Lead Poisoning Prevention Program or Program - the office in the Department of Health or a successor program or agency responsible for receiving reports and results concerning a child's blood lead level.

Department - the Department of Health.

Diagnostic test - the first venous blood level test performed within six (6) months on a child with a previously elevated blood level of lead on a screening test. A test performed more than six (6) months after the original screening test is a new screening test, with decisions about further testing and treatment based on the new screening test.

Elevated blood lead level - the concentration of lead in a sample of whole blood equal to or greater than ten (10) micrograms of lead per deciliter (μ/dL).

Follow-up test - a venous blood lead level test used to monitor the status of a child with a prior diagnostic test indicating an elevated blood lead level.

Health care facility - a facility providing individual care or treatment of diseases or other medical, physiological, or psychological conditions, including hospitals, clinics, laboratories, nursing homes, or homes for the aged or chronically ill, but excluding private medical offices.

Health care provider - a physician, clinic, hospital, or neighborhood health center, licensed by the District of Columbia, that is responsible for providing primary care and coordinating referrals, when necessary, to other health care providers.

Lead-based paint activities - that term as used in § 2(9) of the Lead-Based Paint Abatement and Control Act of 1996, effective April 9, 1997 (D.C. Law 11-221; D.C. Official Code § 8-115.01(9)).

Lead-poisoned child - a child with a confirmed blood lead level equal to or greater than fifteen (15) micrograms per deciliter (μ/dL), or any other lower threshold that the United States Centers for Disease Control and Prevention may establish in written guidance or regulation.

Lead hazard - any source or pathway that results, or that may result, in exposure to lead, including lead-based paint; lead-contaminated dust or soil; sources related to occupations or work sites of parents, guardians, and caregivers (take-home exposure); airborne lead; and lead in water, food, ceramics, traditional remedies, cosmetics, and materials used in hobbies and other home activities.

Owner - a person who, alone or jointly or severally with others, meets either of the following criteria:

(a) Has legal title to any building arranged, designed, or used (in whole or in part) to house one or more dwelling or rooming units: or

(b) Has charge, care, or control of any building arranged, designed, or used (in whole or in part) to house one or more dwelling or rooming units, as owner or agent of the owner, as fiduciary of the estate of the owner, or as an officer appointed by the court.

Person - an individual, corporation, partnership, firm, conservator, receiver, trustee, executor, or legal representative.

Screening test - a laboratory test for lead poisoning that is performed on a blood sample from an asymptomatic child to determine the child's blood lead level.

History

SOURCE: Final Rulemaking published at 46 DCR 10170, 10171 (December 17, 1999); as amended by Final Rulemaking published at 52 DCR 9852 (November 4, 2005).

22-B75 NURSING HOMES AND COMMUNITY RESIDENCE FACILITIES: RECEIVERSHIP

22-B DCMR § 7500 CRITERIA FOR ESTABLISHMENT OF A LIST OF POTENTIAL RECEIVERS

7500.1 Pursuant to the Nursing Home and Community Residence Facility Residents’ Protection Act of 1985, D.C. Code, 2001 Ed. §§ 44-1001.01 to 44-1005.02, (the “Act”), the criteria in § 7501 shall govern the establishment of a list, to be given to the D.C. Superior Court, of potential candidates who may be appointed by the Court as a receiver for either a nursing home or a community residence facility (“CRF”).

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is the Nursing Home and Community Residence Facility Residents’ Protection Act of 1985, D.C. Code, 2001 Ed. § 44-1001.01 to 44-1005.02; and Mayor’s Order 87-47 (February 17, 1987).
SOURCE: Final Rulemaking published at 35 DCR 762 (February 5, 1988).

22-B DCMR § 7501 RECEIVERSHIP CRITERIA

7501.1 A person may only be placed on the list if the person meets the requirements of this section and § 205(b)(2) and (b)(3) of the Act, D.C. Code, 2001 Ed. § 44-1002.05(b)(2) and (b)(3).

7501.2 The following criteria shall be used by the Department of Consumer and Regulatory Affairs in the establishment of a list of potential receivers:

(a) The person shall have at least three (3) consecutive years of experience in operating a health care facility, preferably a nursing home or CRF;

(b) As a facility operator, the person shall have complied with all applicable laws and regulations that applied to the facility during the three (3) years of operating a health care facility.

(c) The person shall not be the subject of an adverse action by any government agency at any time after the date of application to be on the list;

(d) The person shall be financially solvent as evidenced by the absence of any bankruptcy court action, lien against property, or civil action for indebtedness; and

(e) The person shall not be a convicted felon.

7501.3 The term “person” as used in this chapter includes individual, organization, or firm.

History

SOURCE: Final Rulemaking published at 35 DCR 762 (February 5, 1988).

22-B80 PUBLIC HEALTH GRANTS

22-B DCMR § 8000 GENERAL PROVISIONS

8000.1 This chapter establishes uniform requirements for transferring money or other things of value to recipients outside the District government, where the Department is authorized to make grants.

8000.2 The Director of the Department of Human Services is authorized to make a grant where:

(a) A statute authorizes the Department to support or stimulate the activity of the recipient;

(b) The Department will not be substantially involved in the activity that is supported or stimulated; and

8000.3 The Department is authorized to make grants pursuant to:

(a) The Public Health Services Act, 42 U.S.C. §§ 201 et seq., as amended by the Ryan White Comprehensive AIDS Resources Emergency Act of 1990, Pub. L. No. 101-381, 104 Stat. 576;

(b) Section 301 of the Public Health Service Act, 42 U.S.C. §241--demonstration projects for community-based service for persons affected by HIV;

(d) Drug Free Schools and Communities Act of 1986, as amended, 20 U.S.C. §§3181 et seq.--grants for community-based alcohol and drug abuse education and prevention services to high risk youth;

(e) Sections 301(a), 311(B), and 317 of the Public Health Service Act, 42 U.S.C. §§ 241(a), 243(b), and 247(b)--grants to support a variety of community-based programs of HIV/AIDS prevention services and activities;

(f) Title XXIV of the Public Health Service Act, 42 U.S.C. §§300dd et seq.--community-based health services for persons with AIDS;

(g) Section 3521 of the Anti-Drug Abuse Act of 1988, 42 U.S.C. §11841--demonstration grants to encourage partnerships between government and community-based organizations which will establish and evaluate innovative alcohol and other drug abuse prevention services programs for youth;

(h) Section 317(k)(3) of the Public Health Service Act, 42 U.S.C. §247b (k)(3)--grants for monitoring the prevalence of major health behaviors and to implement a chronic disease prevention program among public housing residents;

(i) Drug Abuse Waiting Period Reduction Amendment Act of 1990, §509E of the Public Health Service Act, 42 U.S.C. §290aa-12--grants to expand treatment capacity of existing programs so as to decrease the waiting time necessary to access services;

(j) Sections 509F and G of the Public Health Service Act, 42 U.S.C. §§290aa-13 and 290aa-14--grants for treatment of pregnant women and their infants for substance abuse;

(k) Developmental Disabilities Assistance and Bill of Rights, 42 U.S.C. §6000--funds for a project which would give disabled consumers access to the transit system; and

(l) Part A, Title XIX of the Public Health Service Act, as amended, 42 U.S.C. §300w et seq.--preventive health services block grant to provide funds to support a variety of community and institutionally based programs that focus on health and disease prevention activities.

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is Mayor’s Order 91-29 (February 14, 1991); and the Public Health Service Act, 42 U.S.C. § 201 et seq., as amended by the Ryan White Comprehensive AIDS Resources Emergency Act of 1990, Pub. L. No. 101-381, 104 Stat. 576.
SOURCE: Final Rulemaking published at 38 DCR 4431 (July 19, 1991); as amended by Final Rulemaking published at 40 DCR 3168 (May 14, 1993).

22-B DCMR § 8001 GRANT AVAILABILITY ANNOUNCEMENTS AND APPLICATIONS

8001.1 Except where the grant authority specifies the grantee, the availability of a grant shall be announced by one (1) of the following methods:

(a) Publication in a newspaper of general circulation in the District of Columbia;

(b) Publication in the District of Columbia Register; or

8001.2 Each grant availability announcement shall include the following:

(a) A brief description of the project for which funds may be available;

(b) The estimated total funds available;

(d) The deadline for submission of applications;

(e) The review factors to be used in selecting grant recipients;

(f) Source of funds and estimated time of funds availability;

(g) An address within the Department where detailed information may be obtained and where the application may be filed; and

(h) The time and place of a pre-application information session for prospective applicants if such a session would be useful.

History

SOURCE: Final Rulemaking published at 38 DCR 4431, 4432 (July 19, 1991).

22-B DCMR § 8002 APPLICATION REVIEW

8002.1 A review panel shall review each application to determine if it meets the requirements that apply to the particular grant.

8002.2 The review panel shall advise the Director of all those applications which satisfy the applicable grant requirements and shall recommend awards based on the review factors and available funding.

History

SOURCE: Final Rulemaking published at 38 DCR 4431, 4432 (July 19, 1991).

22-B DCMR § 8003 REVIEW FACTORS

8003.1 The Director shall review applications and make awards based upon the following criteria:

(a) Feasibility of the project;

(b) Soundness of research design, statistical technique, and procedures and methodology, if appropriate; and

(c) Theoretical and technical soundness of the proposed plan of operation including consideration of the extent to which:

(1) The objectives of the proposed project are clearly defined and clearly stated;

(2) Proposed project activities appear likely to reach objectives;

(3) The proposed project would contribute to the achievement of the grant’s stated policy objectives; and

(4) Provisions are made for adequate evaluation of the effectiveness of the project and for determining the extent to which the objectives are accomplished.

History

SOURCE: Final Rulemaking published at 38 DCR 4431, 4433 (July 19, 1991).

22-B DCMR § 8004 DISPOSITION OF APPLICATIONS

8004.1 The Director shall make the final selection of the grant award.

8004.2 Based upon his or her review, the Director shall do one (1) of the following:

(a) Approve the application, in whole or in part, for such amount of funds and subject to such conditions as he or she considers necessary or desirable for the completion of the approved project;

(b) Disapprove the application; or

8004.3 A Grant Officer appointed by the Director shall notify the awardee in writing of the Director’s decision.

8004.4 The Director’s decision is final and shall not be appealed.

History

SOURCE: Final Rulemaking published at 38 DCR 4431, 4433 (July 19, 1991).

22-B DCMR § 8005 GRANT AGREEMENT

8005.1 Each grant award shall be in the form of a written grant agreement between the Director and the awardee that is consistent with those statutes and regulations that apply to the grant.

8005.2 The grant agreement shall include, but not be limited to, the following:

(a) A statement of the purpose of the grant;

(b) The amount of the grant award;

(e) The scope of work for the grant, a description of any services or products required to be delivered under the grant, and a schedule of expected performance;

(f) Reporting requirements, both program and financial;

(g) A payment schedule;

(h) The name, address and telephone number of the Grant Officer in the Department, and of the agent for the grantee;

(i) The address to which all written communications from the Department to the grantee may be sent, including the periodic payments due under the grant; and

(j) A provision that the grant may be modified by agreement of both parties.

History

SOURCE: Final Rulemaking published at 38 DCR 4431, 4434 (July 19, 1991).

22-B DCMR § 8006 CERTIFICATION OF A DRUG-FREE WORKPLACE

8006.1 By submission of its application, the grantee, if other than an individual, certifies and agrees that with respect to all its employees under the grant it shall, no later than thirty (30) calendar days after grant award (unless a longer period is agreed to in writing), for a grant of thirty (30) calendar days or more performance duration; or as soon as possible for a grant of less than thirty (30) calendar days performance duration, but in any case, by a date prior to when performance is expected to be completed:

(a) Publish a statement notifying such employees that the unlawful manufacture, distribution, dispensing, possession or use of a controlled substance is prohibited in the grantee’s workplace and specifying the actions that will be taken against employees for violations of such prohibition;

(b) Establish a drug-free awareness program to inform such employees about the following:

(1) The dangers of drug abuse in the workplace;

(2) The grantee’s policy of maintaining a drug-free workplace;

(3) Any available drug counseling, rehabilitation and employee assistance programs; and

(4) The penalties that may be imposed upon employees for drug abuse violations occurring in the workplace;

(d) Notify such employees in the statement required by § 8006.1(a) that as a condition of continued employment on the grant resulting from this solicitation, the employee shall do the following:

(1) Abide by the terms of the statement;

(2) Notify the employer of any criminal drug statute conviction for a violation occurring in the workplace no later than five (5) calendar days after such conviction;

(e) Notify the Grant Officer in writing within ten (10) days after receiving notice under § 8006.1(d)(2), from an employee or otherwise receiving actual notice of such conviction;

(f) Within thirty (30) calendar days after receiving notice under § 8006.1(d) of a conviction, take one (1) of the following actions with respect to any employee who is convicted of drug abuse violations occurring in the workplace:

(1) Take appropriate personnel action against such employee up to and including termination; or

(2) Require such employee to satisfactorily participate in a drug abuse assistance or rehabilitation program approved for such purposes by a Federal, State, or local health law enforcement, or other appropriate agency; and

(g) Make a good faith effort to maintain a drug-free workplace through implementation of § 8006.1(a) through (f).

8006.2 By submission of its application, the grantee, if an individual who is applying for a grant of any dollar value, certifies and agrees not to engage in the unlawful manufacture, distribution, dispensing, possession or use of a controlled substance in the performance of the grant.

8006.3 The grantee’s failure to comply with the requirements of §§ 8006.1 and 8006.2 may, pursuant to § 8013, render the grantee subject to suspension of grant payments, termination of the grant or other available legal remedies.

History

SOURCE: Final Rulemaking published at 38 DCR 4431, 4435 (July 19, 1991).

22-B DCMR § 8007 FINANCIAL MANAGEMENT BY GRANTEES

8007.1 Each grantee shall make accurate, current, and complete disclosure of the financial results of each project or program in accordance with the financial reporting requirements of the grant agreement.

8007.2 Each grantee shall maintain records which identify adequately the source and application of funds for grant supported activities.

8007.3 The grantee’s records shall contain information identifying the following:

(a) Grant awards;

(b) Any subgrant awards, if authorized by the grant agreement;

(d) Obligations;

(e) Unobligated balances;

(f) Assets;

(g) Outlays; and

(h) Income.

8007.4 Each grantee shall maintain effective control and accountability for all grant or subgrant assets, including cash and real personal property.

8007.5 Each grantee shall adequately safeguard all property and shall assure that it is used solely for authorized purposes.

8007.6 Each grantee’s records shall compare the actual and budgeted amounts of expenditures for each grant or subgrant.

8007.7 If required by the Grant Officer, the grantee shall relate financial information to performance or productivity data, including the production of unit cost information.

8007.8 The grantee shall establish procedures to minimize the time elapsing between the advance of District grant or subgrant funds and their disbursement by the grantee.

8007.9 Grantees advancing cash to subgrantees shall conform substantially to the same standards of timing and amount of advances as apply to advances by the District to grantees, including requirements for timely reporting of cash disbursements and balances.

8007.10 Each grantee shall establish procedures for determining the reasonableness, allowability, and allocability of costs in accordance with the applicable cost principles prescribed in OMB Circular A-122.

8007.11 Grantee accounting records shall be supported by source documentation such as canceled checks, paid bills, payrolls, contract and subgrant award documents.

8007.12 Each grantee shall follow a systematic method to assure timely and appropriate resolution of audit findings and recommendations.

History

SOURCE: Final Rulemaking published at 38 DCR 4431, 4437 (July 19, 1991).

22-B DCMR § 8008 MONITORING BY GRANTEES

8008.1 Each grantee shall monitor grant and subgrant supported activities by reviewing each program, function or activity to assure that adequate progress is being made towards achieving the goals of the grant or subgrant.

8008.2 Each grantee shall submit an annual performance report unless the grant agreement requires more frequent reports.

8008.3 The grantee’s final performance report shall be due ninety (90) days after the expiration or termination of grant support.

8008.4 The Grant Officer may waive the requirement for any performance report which is not needed, except the final report.

8008.5 The content of performance reports shall conform to any instructions issued by the Grant Officer including, to the extent appropriate to the particular grant, a brief presentation of the following for each program, function, or activity involved:

(a) A comparison of actual accomplishments to the goals established for the periods;

(b) A statement of reasons if established goals are not being met;

(d) Any other pertinent information.

History

SOURCE: Final Rulemaking published at 38 DCR 4431, 4438 (July 19, 1991).

22-B DCMR § 8009 AUDITS AND DISALLOWANCES

8009.1 Appropriate District or Federal personnel may conduct fiscal and program audits of the grantee.

8009.2 Each grantee shall have an annual audit performed by an auditor who is independent of the staff person who authorizes expenditure of project funds.

8009.3 Whenever an audit shows that an expenditure not allowable under the grant has been charged to the grant or that the grantee has otherwise failed to discharge its obligation to account for the expenditure of grant funds, the Grant Officer shall disallow the expenditure of the funds.

History

SOURCE: Final Rulemaking published at 38 DCR 4431, 4439 (July 19, 1991).

22-B DCMR § 8010 REPAYMENT OF FUNDS BY GRANTEE

8010.1 As a condition of each grant awarded, the grantee shall agree to do the following:

(a) Repay the District for final audit disallowances within thirty (30) days from receipt of notification by a disallowance letter; and

(b) Pay interest at the rate of twenty-four percent (24%) per annum from the date of the disallowance letter if the repayment is not complete within the thirty (30) day period.

8010.2 A grantee may request informal dispute resolution of any disallowance determination by a Grant Officer by requesting within thirty (30) days of the date of the disallowance notification letter, that the Director conduct a review.

8010.3 If the Director sustains the finding of the Grant Officer, interest shall be charged on the amount to be repaid as of the date of the disallowance letter.

History

SOURCE: Final Rulemaking published at 38 DCR 4431, 4439 (July 19, 1991).

22-B DCMR § 8011 CLOSE-OUT

8011.1 The Grant Officer shall close-out the grant when he or she determines that all applicable administrative actions and all required work of the grant have been completed.

8011.2 Upon termination or close-out of the grant, the Grant Officer shall promptly provide an accounting of funds expended, obligated, and remaining under the grant to the DHS Controller.

8011.3 Within ninety (90) days after the expiration or termination of the grant, the grantee shall submit all financial, performance, and other reports required as a condition of the grant. The Grant Officer may extend this deadline upon request by the grantee.

8011.4 The District shall make prompt payment to the grantee for allowable reimbursable costs.

8011.5 The grantee shall immediately refund to the District any balance of unobligated cash advanced that is not authorized to be retained for use on other grants.

8011.6 The close-out of a grant shall not affect the following:

(a) The Grant Officer’s authority to disallow costs and recover funds on the basis of a later audit or other review;

(b) The grantee’s obligation to return any funds due as a result of later refunds, correction or other transactions; or

History

SOURCE: Final Rulemaking published at 38 DCR 4431, 4440 (July 19, 1991).

22-B DCMR § 8012 RECORD RETENTION AND ACCESS

8012.1 The grantee shall retain all records for a period of at least three (3) years following final closeout of the grant, if no other period is specified in the grant agreement.

History

SOURCE: Final Rulemaking published at 38 DCR 4431, 4440 (July 19, 1991).

22-B DCMR § 8013 TERMINATION AND SUSPENSION PROCEDURES

8013.1 If a grantee has materially failed to comply with the terms of a grant agreement, the Grant Officer may, after giving reasonable written notice to the grantee, do the following:

(a) Suspend the grant in whole or in part;

(b) Terminate the grant for cause; or

8013.2 The notice of suspension shall state the reasons for the suspension, any corrective action required of the grantee and the effective date.

8013.3 The suspension may be made effective at once if a delayed effective date would be unreasonable considering the Grant Officer’s responsibilities to protect the District government’s interest.

8013.4 The Grant Officer may reinstate a suspended grant if the grantee has taken corrective action satisfactory to the Grant Officer, or given satisfactory evidence that corrective action will be taken.

8013.5 The Grant Officer may terminate the grant before the date of expiration if:

(a) The grantee has materially failed to comply with the terms of the grant agreement and appropriate corrective actions have not been taken during the period of suspension; of

(b) The failure to comply with the terms of the grant agreement is so serious that immediate termination is in the best interests of the District government.

8013.6 The notice of termination shall state, in writing, the reasons for the termination, together with the effective date.

8013.7 A grant may be terminated at the request of the grantee upon notification to the Grant Officer, in accordance with the provisions of the grant.

History

SOURCE: Final Rulemaking published at 38 DCR 4431, 4441 (July 19, 1991).

22-B DCMR § 8014 INFORMAL DISPUTE RESOLUTION

8014.1 The provisions contained in this section and in § 8015 shall establish an informal procedure for resolution of disputes between the grantee and the Director.

8014.2 The procedures shall apply to the following adverse determinations made by the Grant Officer:

(a) Suspension or termination of a grant in whole or in part or a refusal to reinstate a suspended grant;

(b) A disallowance of expenditures; and

(c) A denial of a noncompeting continuation of a grant award if the denial is for failure to comply with the terms of the award.

8014.3 The Grant Officer shall notify the grantee, in writing, of any adverse determination and shall state the reasons for the determination in sufficient detail to enable the grantee to respond, and shall give the grantee notice that the grantee may request a review of the adverse determination.

8014.4 A grantee may request a review of the adverse determination by submitting a written request for review to the Director no later than thirty (30) days after receipt of the notice of determination.

8014.5 The grantee’s request for a review of the adverse determination shall include the following:

(a) A copy of the Grant Officer’s determination;

(b) Identification of the issue in dispute;

(c) A full statement of the grantee’s position regarding the issue in dispute and the pertinent facts and reasons in support of the grantee’s position; and

(d) Copies of any documents supporting the grantee’s claim.

8014.6 If the grantee submits a request for review, the Director shall conduct an informal hearing in accordance with the requirements of this section or he or she shall appoint a hearing officer to conduct the hearing.

8014.7 The Director shall send by certified mail a written notice to the grantee of the time and place scheduled for the informal hearing within fifteen (15) calendar days from the receipt of the grantee’s request to the Department for a hearing.

8014.8 The grantee may be accompanied or represented at the informal hearing by legal counsel or other person chosen by the grantee.

8014.9 If a hearing officer conducts the hearing, he or she shall render a written recommendation to the Director regarding whether to sustain or overrule the adverse determination of the Grant Officer.

History

SOURCE: Final Rulemaking published at 38 DCR 4431, 4442 (July 19, 1991).

22-B DCMR § 8015 DECISION OF THE DIRECTOR

8015.1 The Director may require informal, non-binding mediation between the parties before issuing a final decision if, due to the nature of the dispute, the Director considers it to be in the best interests of the District.

8015.2 The Director shall appoint one (1) or more individuals who have not participated substantially in the matter in dispute to conduct the mediation described in § 8014.1.

8015.3 The Director shall make a final written decision based upon the grant file, other documents filed by the parties, and the testimony and evidence presented at the hearing, in accordance with applicable laws and regulations.

8015.4 The final decision of the Director shall include the following:

(a) A description of the dispute;

(b) Reference to the pertinent grant terms, regulations or statutes;

(d) A determination sustaining or overruling the determination of the Grant Officer, in whole or in part, with the reason for the determination;

(e) If all or any part of the Grant Officer’s determination has been determined to be valid, a determination of any monetary settlement, the grant adjustment to be made, or other relief to be granted; and

(f) A written notice that the grantee may appeal the final decision to the Board of Appeals and Review.

8015.5 The Director shall deliver or send by certified mail, a copy of the final decision to the grantee, and shall provide a copy to the Grant Officer for inclusion in the grant file.

History

SOURCE: Final Rulemaking published at 38 DCR 4431, 4443 (July 19, 1991).

22-B DCMR § 8099 DEFINITIONS

8099.1 When used in this chapter, the following terms shall have the meanings ascribed:

Controlled substance - a controlled substance in Schedules I through V or § 202 of the Controlled Substances Act (21 U.S.C. § 812) and as further defined, in regulation, at 21 C.F.R. §§ 1308.11 - 1308.15.

Conviction - a finding of guilt (including a plea of nolo contendere) or imposition of sentence, or both, by any judicial body charged with the responsibility to determine violations of the Federal, State or District criminal drug statutes (criminal statute involving the manufacture, distribution, dispensing, possession or use of any controlled substance).

Department - the D.C. Department of Human Services.

Drug-free workplace - a site for the performance of work done in connection with a specific grant at which employees of the grantee are prohibited from engaging in the unlawful manufacture, distribution, dispensing, possession, or use of a controlled substance.

Employee - an employee of a grantee directly engaged in the performance of work under a District government grant.

Grantee - the recipient of a grant from the District government.

Individual - a grantee that has no more than one (1) employee including the grantee.

Grant Officer - an employee of the Department of Human Services designated by the Director to manage the specified grant program in accordance with these regulations.

History

SOURCE: Final Rulemaking published at 38 DCR 4431, 4444 (July 19, 1991).

22-B81 PUBLIC BENEFIT CORPORATION PERSONNEL POLICIES: GENERAL PROVISIONS

22-B DCMR § 8100 AUTHORITY

8100.1 The D.C. Health and Hospitals Public Benefit Corporation shall be referred to as the “PBC” throughout the Human Resources Regulations Manual. These regulations establish policies, procedures, and guidelines relating to terms and conditions of employment in accordance with § 208(c) of the D.C. Health and Hospitals Public Benefit Corporation Act, D.C. Code, 2001 Ed. § 44-1102.08(c). The PBC Board is responsible for providing comprehensive community centered health care to residents of the District. To that end, the PBC Board will provide the resources to develop a multi-skilled and highly trained workforce to ensure the fulfillment of its mission.

8100.2 The PBC Board has ultimate responsibility for Human Resources Policies. Operating oversight of Human Resources policies adopted by the Board rests with the Chief Executive Officer, who may establish procedures as appropriate to carry out said policies.

8100.3 These personnel regulations are not intended to be, and they shall not constitute a contract of employment between the PBC Board and any of its employees.

8100.4 In order to retain necessary flexibility in the administration of policies and procedures, the PBC Board may alter these policies.

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is the Health and Hospitals Public Benefit Corporation Act of 1996, D.C. Code §§ 44-1101.01 to 44-1103.03.
SOURCE: Final Rulemaking published at 45 DCR 7353, 7354 (October 9, 1998).

22-B DCMR § 8101 EMPLOYMENT-AT-WILL

8101.1 The Human Resources Regulations constitute guidelines for managers to follow in dealing with Human Resources issues and are in no way to be interpreted as a contract or commitment between the PBC and any member of management, administration, or employee. The PBC expressly reserves the right to modify or delete any of the policies contained therein subject to District rulemaking requirements.

8101.2 Neither the Human Resources Regulations nor the Employee Handbook, nor any other communication (oral or written) by a management representative is intended to, nor does it in any way create a contract of employment.

8101.3 Nothing in this manual constitutes a promise or guarantee as to duration of employment. Both parties voluntarily enter into employment and an employee is free to resign at any time for any reason. Similarly, PBC shall have the absolute right to terminate an employment relationship at any time without prior action, for any reason, with or without cause consistent with current District of Columbia law. Positions which were At-Will prior to the implementation of the PBC (October 1, 1997) shall continue to be At-Will. Management or supervisory positions filled after October 1, 1997 shall be At-Will. Employees covered by collective bargaining agreements or other written employment contracts shall not be considered At-Will unless so specified in the collective bargaining agreement.

8101.4 All management and supervisory employees are exempt from representation in collective bargaining units for the purpose of at-will employment.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7354 (October 9, 1998); as amended by Final Rulemaking published at 45 DCR 7727 (October 30, 1998).

22-B DCMR § 8102 TRANSITION TO PBC

8102.1 Employees transferred to the PBC as of the effective date of the implementation of the PBC (October 1, 1997) shall retain their original date of hire and seniority, and shall lose no benefits held prior to the transfer. Those employees hired or transferred to the PBC after the date of implementation to the PBC are considered new hires, subject to seniority and benefits accruing to a new hire.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7355 (October 9, 1998).

22-B DCMR § 8103 HUMAN RESOURCES PHILOSOPHY

8103.1 The PBC supports the goals and objectives of the PBC through its most valuable resource - its employees. To that end, the PBC shall strive to maintain competent staff to provide high quality services while ensuring credibility in treating all employees in a fair, consistent, timely and appropriate manner.

8103.2 The PBC shall seek to do the following:

(a) Recruit the most capable people and place them in positions best suited to their abilities;

(b) Establish and promote policies and procedures that are fair and encourage issues and disputes to be resolved fairly, quickly, and credibly;

(d) Provide competitive and fair compensation programs that reward performance and comprehensive benefits;

(e) Provide, within budgetary constraints, educational opportunities to promote personal and professional growth;

(f) Communicate openly on issues affecting all employees;

(g) Recognize and reward excellence in individual and group performance related to patient care responsibilities and enhancement of the healthcare network; and

(h) Provide outstanding service and ensure courtesy and respectful treatment of patients and their families at all times.

8103.3 While the PBC establishes policies and provides essential services, it is the responsibility of all employees to become familiar with, adhere to, and comply with these policies, and the management staff to provide the administration necessary to ensure their compliance.

8103.4 The PBC Board of Directors has the ultimate responsibility for Human Resources policy. Operating oversight of Human Resources policies adopted by the Board rests with the Chief Executive Officer (CEO), who may establish procedures appropriate to carry out said policies. The organization shall ensure that Human Resources representatives are available to provide guidance to any and all employees as to policy interpretation and application.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7355 (October 9, 1998).

22-B DCMR § 8104 EQUAL EMPLOYMENT OPPORTUNITY

8104.1 The PBC shall not discriminate because of race, sex, religion, color, ancestry, national origin, age, disability, marital status, sexual preference, matriculation or obligation to the U.S. Armed Forces, or for any other reason prohibited by law.

8104.2 The PBC shall strive for the following:

(a) Recruit, hire, and promote employees on the basis of ability, experience, and qualifications;

(b) Respect the individual rights of each employee and to treat employees in a professional manner with dignity and respect, valuing the unique contribution of each individual employee;

(c) Make prompt and fair assessments and responses to employee concerns that may arise in the daily operation of the PBC;

(d) Maintain a diverse workforce; and

(e) The PBC shall comply with EEO procedures consistent with applicable federal and district law.

8104.3 Affirmative Action: PBC shall follow Affirmative Action policies consistent with Federal and District law.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7356 (October 9, 1998).

22-B DCMR § 8105 CONFIDENTIALITY

8105.1 Policy: The PBC shall protect the confidentiality of information relative to each patient and employee, including but not limited to patients, patient’s families, physicians, payors, and employees. No patient or employee information shall be released without a signed release except where disclosure is permitted by law.

8105.2 Confidentiality Procedures:

(a) The following information is relative to employees:

(1) The Human Resources Department shall be the official depository of employee records for the PBC. The Vice President of Human Resources shall be the custodian of Human Resources records. Any request for information regarding an employee must be directed, in writing, to the Vice President of Human Resources or his/her designee;

(2) Appropriate requests for employee information shall be released only with the written consent of the employee, or in accordance with applicable law; and

(3) An employee and/or his/her authorized representative shall have access to review and copy his/her personnel file. Such review must be scheduled in advance with Human Resources.

(b) The following information is relative to patients and others:

(1) The Medical Records Department is the official depository of patient records for the PBC. The Director of Medical Records shall be the custodian of all medical records;

(2) To protect patient privacy, employees must maintain the confidentiality of patient information, including medical records, at all times; and

(3) No patient information or other information not otherwise available pursuant to the Freedom of Information Act (FOIA) shall be given to or discussed with other patients, visitors, unauthorized employees, or any person unassociated with PBC.

(1) Requests for information from the press or other requests from the public or public agencies shall be honored only by the appropriate personnel; and

(2) No one will be permitted to address the media or any other forum on behalf of the PBC except Public Affairs Officers and others authorized by the CEO or the PBC Board of Directors.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7356 (October 9, 1998).

22-B DCMR § 8106 CONFLICT OF INTEREST

8106.1 Policy: Institutional decisions shall be made solely to promote the best interests of the PBC without favor or preference based on personal or political considerations or other external concerns. All employees shall exercise the highest ethical conduct and utmost faith in all matters relating to their duties, responsibilities, and business relationships, and shall act, at all times, in the best interest of PBC. Employees shall not use their positions or confidential information gained to advance a personal interest.

8106.2 The procedures are as follows:

(a) A conflict of interest is considered to be a situation, either isolated, occurring, or continuous, in which an employee’s decision on behalf of the PBC may be influenced by his/her own personal interest, financial or otherwise; and

(b) Employees shall be responsible for disclosing potential conflicts of interest in writing to the Chief Executive Officer. A review with appropriate consultation shall be made as to whether or not a conflict exists. If it is determined that a conflict exists, remedies may include prohibition of such activity, prohibition from institutional decisions related to such activity, and/or disciplinary action up to and including termination.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7357 (October 9, 1998).

22-B82 PUBLIC BENEFIT CORPORATION PERSONNEL POLICIES: EMPLOYEE STATUS

22-B DCMR § 8200 TYPES OF EMPLOYMENT

8200.1 An employee is a person who works in an authorized position and receives compensation from the PBC, except where otherwise defined in this manual.

8200.2 For the purpose of benefit determination, the following are examples of persons not considered employees:

(a) Students;

(b) Private duty nurses;

(d) Private temporaries;

(e) Employees of outside contractors;

(f) Youth corps trainees;

(g) Rehabilitation workshop employees; and

(h) Independent contractors.

8200.3 The following are categories the PBC uses to classify employees:

(a) A benefit-eligible employee is considered as follows:

(1) Full-time employee: An employee whose scheduled weekly hours are equal to the full-time hours of the job classification. For most employees, a forty (40) hour work week is considered full-time. Full-time employees are entitled to all the benefits of the job classification; and

(2) Part-time employee: An employee whose regularly scheduled weekly hours are less than forty (40) hours per week. Part-time employees are entitled to accrue benefits on a prorated basis.

(b) A non-benefit employee is an employee who is not scheduled on a regular basis, but who works on a day-to-day basis as needed by the employer.

8200.4 A temporary employee is an employee who is hired to work in an authorized position for a limited amount of time in relief of a regular employee or for a specific project. Temporary employees are not eligible for any benefits unless employed on a term appointment for thirteen (13) months or greater or otherwise provided in the collective bargaining agreements. The following are examples of temporary work:

(a) Employment in a temporarily authorized position;

(b) Employment in relief of a full or part-time employee out on a leave of absence.

8200.5 A grant-funded employee is an employee who is hired or who moves into a position that is supported by a grant. The following criteria apply to grant-funded employees:

(a) New hires that serve in grant funded positions are considered temporary employees; and

(b) Current benefit-eligible employees who move into grant-funded positions maintain their existing benefits while under the grant. If a grant can no longer support a position, a benefit-eligible employee shall be entitled to return to their former position, if available, with no loss of salary or benefits that would have accrued in that former position. Benefit-eligible employees may transfer to a vacant position that has the same salary and benefits requiring similar skills and qualifications.

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is the Health and Hospitals Public Benefit Corporation Act of 1996, D.C. Code §§ 44-1101.01 to 44-1103.03.
SOURCE: Final Rulemaking published at 45 DCR 7353, 7358 (October 9, 1998).

22-B DCMR § 8201 EMPLOYEE CLASSIFICATION

8201.1 Policy: All employees shall be classified in a particular job title according his/her duties and responsibilities.

8201.2 The following procedures shall apply:

(a) Upon hire and/or positional review, employees shall be classified within a particular job title;

(b) Employees shall receive, as part of the performance management process, a position description, which shall contain an overview of duties and responsibilities for the position;

(c) Each job classification shall be assigned a salary range and placed within the compensation system. For more information of classifying individual employees, see Compensation Section; and

(d) Requests to change an employee's job classification may be initiated by the employee, management, or the Human Resources Division. Such request should be submitted on the Position Reclassification/Salary Justification Form and include objective justification for the change. Such requests shall then be reviewed by Human Resources and a response given within thirty (30) days.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7359 (October 9, 1998).

22-B DCMR § 8202 DUAL EMPLOYMENT

8202.1 An employee shall not be permitted to accept two separate positions within the PBC that result in the employee working more than forty (40) regularly scheduled hours per week.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7360 (October 9, 1998).

22-B DCMR § 8203 PROBATIONARY PERIOD

8203.1 Policy: The PBC shall provide an appropriate period for employees to demonstrate their ability and potential to succeed in a new position. During this period, employees are subject to enhanced scrutiny as to their performance, attitude and ability to follow the rules and regulations of the organization. The following policy shall apply to the probation period:

(a) The probationary period is six (6) months for full-time employees and nine (9) months for part-time employees, exclusive of time lost for sickness and excused absences. Employees represented by a union should refer to their collective bargaining agreement for information regarding probationary periods;

(b) During the probationary period, employees are evaluated on their performance and behavior on the job;

(c) A manager shah complete a formal performance review no less than every two (2) months prior to the end of the probationary period. A final review shall be forwarded to Human Resources at the conclusion of the probationary period; and

(d) An extension by the manager of the probationary period for any employee shall be discussed with their divisional administrator and the Human Resources at least thirty (30) days prior to its completion. A written extension is provided to the employee prior to the end of the probationary period indicating the time frame for the extension, with a copy sent to Human Resources. Extensions may be made for up to three (3) additional months. An additional probationary period may be required for employees moving from a non-supervisory position to a supervisory position.

8203.2 Managers with employees covered by union contracts should review the portion of the applicable contract relating to probationary periods and ensure that a decision to retain or discharge a new employee is made prior to the end of that period. Human Resources must be consulted at the same time. The decision about whether to continue the employee shall be communicated to that employee and the union as required prior to the end of the probationary period.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7360 (October 9, 1998).

22-B DCMR § 8204 SENIORITY

8204.1 Seniority shall be applied when length of service is a factor, including layoff and scheduling of paid time off.

8204.2 Accrual shall be determined by the following factors:

(a) Seniority shall commence on an employee's date of hire, except as provided in item (d) below;

(b) There shall be two seniority lists maintained, one for full-time and one for part-time employees. Seniority for an employee going from full-time to part-time will maintain their original seniority date. Seniority for an employee going from part-time to full-time shall receive credit for one-half of the part-time work;

(d) A temporary employee shall not have seniority during the first six (6) months he/she occupies the status of temporary employee, but if employed longer than six (6) months or should any temporary employee become a regular employee, then his/her seniority shall be retroactive to the date of employment and calculated in accordance with (a) through (c) above.

8204.3 An employee's seniority shall be lost when the following occurs:

(a) Terminates voluntarily, except that seniority shall not be lost when an employee who has voluntarily terminated is rehired and returns to work within one (1) month of the date of voluntary termination; and

(b) Is discharged for cause.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7361 (October 9, 1998).

22-B DCMR § 8299 DEFINITIONS

8299.1 When used in this chapter, the following terms and phrases shall have the meanings ascribed:

Classification seniority - the length of time an employee has worked continuously in a specific job classification within a department.

Seniority - the length of time an employee has been continuously employed in any capacity in the D.C. Government except where otherwise defined in the Human Resources Manual or any other related personnel issuance.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7361 (October 9, 1998).

22-B83 PUBLIC BENEFIT CORPORATION PERSONNEL POLICIES: STAFFING

22-B DCMR § 8300 RECRUITMENT, SELECTION AND PLACEMENT

8300.1 Policy: Recruitment, selection and placement for approved vacant positions shall be handled in a fair manner and be filled by the most qualified candidates. Prospective candidates must meet the minimum qualifications for the position. Applicants must verify U.S. citizenship, and/or permission to work in the U.S. The following statements describe the resources, methods and guidelines utilized by the recruitment staff in attracting and selecting candidates.

8300.2 The following resources shall be applicable:

(a) Internal: Every effort is made to fill positions from within utilizing the following:

(1) Job postings; and

(2) In-house temporary assignments.

(b) Other employment sources: Human Resources shall make every effort to consider referrals from employees and arrange job orders with public agencies such as campus placement offices, community action groups, agencies for the disabled, etc. Should all qualifications be equal, priority shall be given to candidates from the Washington, D.C. area.

(c) Private employment agencies: Human Resources shall place job orders with private employment agencies when appropriate. The following guidelines shall apply:

(1) All contract arrangements with private agencies shall be managed through Human Resources;

(2) The determination to recruit using an outside agency rests with the Vice President for Human Resources after consulting with the department head, or his/her designee; and

(3) Agency selections are based on their ability to attract and screen qualified candidates, fee schedules, fee payment and refund arrangements.

(d) Employment advertising: Human Resources shall coordinate the planning and placement of employment advertisements, selection of media and development of advertising programs. An advertising request form must be completed and approved prior to the placement of employment advertisements; and

(e) Job fairs and conventions: The PBC shall make every effort to participates in job fairs and conventions to disseminate employment information and seek employment candidates.

8300.3 The following procedures apply:

(a) Application: All applicants shall complete an application. These applications are screened by Human Resources to identify candidates who meet the basic criteria for the position;

(b) Interview: The most promising candidates meeting the position criteria shall be screened by Human Resources;

(c) Testing: Applicants may receive basic skills tests as well as specialized tests germane to an operational department. Human Resources is responsible for ensuring that all test content conforms with Equal Employment Opportunity and other appropriate guidelines;

(d) Department interview: Qualified applicants who meet the position criteria shall be referred to the department. Departmental interviews focus on assessing specialized qualifications that are relevant to the position. Departmental interviewers shall relate the duties, responsibilities and conditions to the position to the applicant’s potential for meeting the same. Participation by both managers and staff in this process is encouraged, including post-interview collaboration. Questions concerning appropriate issues to be discussed during the interview should be directed to the Human Resources; and

(e) Selection and placement: The following shall apply:

(1) After the applicant is interviewed, the department manager shall confer with Human Resources to determine the applicant’s acceptability for the position if additional information is required and an appropriate salary; and

(2) An offer in writing shall be made to the applicant by Human Resources. Human Resources shall make every attempt to procure a minimum of two references for each applicant prior to employment. Verification of licensure, citizenship, certification, registration or other appropriate documents of qualification are also required as part of the preemployment process.

8300.4 Executive and management positions: The procedure and ultimate selection of applicants for executive and managerial positions shall be coordinated by the Vice President of Human Resources or designee with approval of the CEO.

8300.5 Job offers: Job offers shall only be made through Human Resources.

8300.6 Employment of relatives: An employee cannot supervise, hire, fire, discipline, reward, or evaluate the performance of a relative. A relative is defined as a parent, spouse, grandparent, sister, brother, child, grandchild, step parent, step child, step sister, step brother, aunt, uncle, niece, nephew, cousin, or in-law relative.

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is the Health and Hospitals Public Benefit Corporation Act of 1996, D.C. Code §§ 44-1101.01 to 44-1103.03.
SOURCE: Final Rulemaking published at 45 DCR 7353, 7362 (October 9, 1998).

22-B DCMR § 8301 POSITION CONTROL

8301.1 Policy: The PBC shall review and analyze every vacant position in order to determine its impact on the operations of the organization. Positions shall be approved based on their indirect and/or direct effect on the PBC’s ability to provide quality patient care and services.

8301.2 The following procedures shall apply:

(a) When a position becomes vacant within a department, the director shall assess its value to the operations of the area. If a determination is made that the position should be filled, the director shall then fill out the personnel requisition form (PRF) attaching justification for why the position should be filled. This documentation should then be forwarded to the appropriate Vice President/Administrator;

(b) The Vice President/Administrator shall review the documentation, address any questions and/or concerns with the Vice President, Human Resources and then approve or reject the request. Considerations should include budgetary constraints and operational requirements;

(c) A Committee consisting of the Vice President of Human Resources, the Director of Management Services/Internal Audit, and the Chief Financial Officer shall meet on a regular basis to review vacant positions. Department Directors or designees may be present to support their request. Positions shall be approved, disapproved, or held. Vacant positions requested for review overseen by Committee members must be approved by the CEO or designee; and

(d) The PRF shall then be forwarded to Human Resources for recruitment for the position. If a new or different position is to be created/filled, Human Resources shall discuss the position with the department for appropriateness. Should a new position be created Human Resources shall consult with the department to prepare job requirements, description and classification.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7364 (October 9, 1998).

22-B DCMR § 8302 STAFF REQUISITIONS

8302.1 Policy: Staff requisitions shall be processed to maintain current employee information and records through the appropriate preparation of personnel requisition forms.

8302.2 The following procedures apply:

(a) The manager for the department receiving the employee shall initiate and submit to Human Resources the personnel requisition form;

(b) Personnel requisition forms submitted to Human Resources must be typed and completed with the following information:

(1) Name;

(2) Address;

(3) Social Security Number;

(4) Initiation date;

(5) Effective date;

(6) Proposed action;

(7) Present status; and

(8) Proposed status.

(d) Every effort shall be made to prepare approve, and submit personnel requisition forms to Human Resources within five (5) days of status change;

(e) Salary adjustments and terminations must be reviewed and approved by the respective Vice President and Human Resources.

(f) Human Resources shall process and distribute the personnel requisition forms as follows:

(1) Employee’s file;

(2) Payroll Department; and

(3) Department Manager.

(g) A personnel requisition form shall be the only document by which an employee can be entered into payroll and effect a change in status. Department managers, Human Resources and Payroll shall ensure that submitted forms have the appropriate approvals and are completed correctly; and

(h) Employees shall be responsible for initiating name, address, and marital status changes by completing an employee change form submitted to their manager.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7364 (October 9, 1998).

22-B DCMR § 8303 JOB POSTING

8303.1 Policy: The PBC shall make every effort to use its existing workforce, if qualified, to fill vacant positions. As such, qualified employees may seek promotions and transfers within the PBC through the posting of vacancies.

8303.2 The following procedures shall apply:

(a) The personnel requisition form shall be received by Human Resources, completed and approved, prior to the posting of vacancies;

(b) Jobs shall be posted by the Human Resources at designated locations within all facilities;

(1) Job posting number;

(2) Date posted;

(3) Bidding date deadline;

(4) Job title;

(5) Classification;

(6) Department and unit;

(7) Special requirements (skills, licenses, certifications, regulations, registrations, education, funding source); and

(8) Salary.

(d) Job vacancies shall be posted for a minimum of five (5) workdays for internal applicants and a minimum of ten (10) workdays for outside applicants. Every effort shall be made to notify applicants regarding the status of their candidacy upon completion of the selection process;

(e) Employees who wish to be considered for posted jobs shall submit their request with Human Resources using a bid card. Candidates must submit separate bids for each posted job in which they are interested. Human Resources shall review the personnel records of all prospective candidates and conduct the screening process; and

(f) If operational needs determine a position must be filled immediately, the position may be filled before or during the posting process. The CEO must approve emergency appointments.

8303.3 Referrals: Human Resources shall refer the names of internal candidates meeting the job qualifications to the department where the vacancy exists. Human Resources shall not refer applicants from outside the PBC until it has been determined that there are no qualified internal candidates.

8303.4 Selection: The primary responsibility for selecting the most qualified person for the job rests with the department where the vacancy exists. Human Resources shall screen candidates to assure that potential candidates meet the criteria for positions, coordinate interviews and assist in the selection process.

8303.5 Collective bargaining agreements: Union contracts often contain specific rules concerning the posting and filling of vacancies within the group of positions covered by the contract. Department heads who have employees covered by a union contract shall consult with Human Resources regarding any special posting and vacancy filling requirements under such contracts.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7365 (October 9, 1998).

22-B DCMR § 8304 POSITIONAL MOVEMENT

8304.1 Policy: The PBC makes every effort to provide employees with promotional and career development opportunities. Employees qualified through education, on-the-job training, and/or experience shall be given the opportunity to apply for division, department, or unit vacancies where appropriate prior to consideration being given to outside candidates. Management maintains the prerogative to reassign employees based on operational need.

8304.2 Posting: Posting of job vacancies shall be done in accordance with the job posting policy, located in § 8303.

8304.3 Criteria: An employee is eligible to request consideration of a transfer to another position if he/she meets the following:

(a) Meets the minimum qualifications for the new job as stipulated in the position description;

(b) Has completed a minimum of six (6) months in his/her current position;

(c) In cases where two employees request a transfer to the same position, the position shall be awarded to the most qualified candidate subject to the PBC’s staffing needs; and

(d) The manager makes the final determination of which candidate is most qualified subject to the PBC’s needs.

8304.4 Effect on seniority and paid time off scheduling: Internally transferred employees shall retain their PBC seniority date. However, where departmental seniority for paid time off scheduling is affected, the employee’s date of transfer into the new position shall serve as the job seniority date.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7366 (October 9, 1998).

22-B DCMR § 8305 STAFF REALLOCATION/LAY-OFFS/SEVERANCE

8305.1 Policy: The PBC shall make every reasonable effort to provide preferential transfer options to employees who are displaced due to changes in departmental operations, services, and staffing needs. Should no such option be available, the PBC shall provide employees with a package of benefits to ease the transition and recognize the work he/she has provided.

8305.2 The following procedure applies:

(a) Department Directors shall identify the position(s) to be affected based on workload census levels, consolidation of services, productivity measures and other relevant factors. Recommendations are forwarded to the appropriate Vice President for approval;

(b) The Vice President shall review the recommendations of the Department Director and make a final determination based on the impact on the PBC’s ability to provide services on a continuous basis. The Vice President shall then advise the Department Director of the determination;

(d) Once a determination has been made to reallocate within existing units, restructure, or eliminate position(s), the Department Director shall take the following factors into consideration where two (2) or more employees shall be affected: matching criteria for the new position, ability to perform the work, previous work record and seniority;

(e) The Department Director shall give a minimum of twenty (20) workdays notice to full-time and twenty (20) calendar days notice to part-time employees selected for reallocation or layoff and, at the same time, tell them they shall be considered for any available reallocation or vacancies for which they are qualified. The PBC may, at its discretion, offer incentives to employees to voluntarily surrender their positions;

(f) Transfer/reassignment applicants shall be matched with open positions for which they qualify. Interviews shall be coordinated by Human Resources;

(g) Human Resources shall explain all applicable options, including separation benefits, if any, to employees not placed within the organization;

(h) If an employee is not reassigned within the notice period, the position shall be eliminated and the employee shall be laid off. Such employees shall be eligible for rehire; and

(i) Severance benefits may be provided to employees who are laid off due to the elimination or restructuring of their positions. Employees shall be required to sign a release of all claims in order to obtain such benefits. Complete details of the plan may be obtained by consulting the Summary Plan Description (SPD) the PBC’s Severance Plan.

8305.3 Collective bargaining agreements: Union contracts often contain specific provisions covering layoff and severance for employees covered by that agreement. Department heads who have employees covered by a union contract shall consult Human Resources regarding any layoff, reallocation, recall, or severance requirements under such contracts.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7367 (October 9, 1998).

22-B DCMR § 8306 SEPARATION FROM EMPLOYMENT

8306.1 Policy: Employment with the PBC is “at will” unless otherwise provided in an applicable union-management collective bargaining agreement. As set forth in the employment-at-will policy in this manual, employment-at-will means that the PBC and the employee have the absolute right to terminate the employment relationship at any time, without prior notice, for any reason, and with or without cause. Nothing in this manual constitutes a promise or guarantee as to the duration of anyone’s employment with the PBC or the terms and conditions of that employment. All employees shall be “at-will,” unless otherwise provided by an applicable collective bargaining agreement or a written employment agreement.

8306.2 The following procedures apply to separation from employment:

(a) The following criteria apply to the resignation of an employee:

(1) Employees who choose to terminate their employment relationship must provide written notice to their immediate supervisor. The notice period shall, at a minimum, be equivalent to their initial paid time off entitlement or twenty (20) work days, whichever is less;

(2) The department manager must notify Human Resources immediately upon notification of employee’s intent to terminate;

(3) Employees who give proper notification shall be paid for all accrued, unused paid time off in accordance with the paid time off policy; and

(4) The employee shall receive information regarding benefit continuation.

(b) Termination: Department managers shall consult with Human Resources prior to terminating an employee; and

(c) Exit Meeting: On or before the employee’s last day of work, the department manager shall conduct a meeting to complete the termination process. A list of supplies and equipment utilized by the employee shall be retrieved or accounted for at this meeting. The PBC may take actions necessary to retrieve these items. These items include but are not limited to; identification badge, beeper, cellular phones, keys, door access card, and laptop computer. An exit interview with Human Resources may also be conducted.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7368 (October 9, 1998).

22-B DCMR § 8307 TEMPORARY SERVICES

8307.l Policy: PBC shall make every effort to provide support to departments in need of temporary employment services due to specific unexpected staffing shortages or for a specific project.

8307.2 The following procedures apply for temporary services:

(a) Departments shall explore alternative ways to complete departmental workloads without utilizing temporary staff by utilizing the following methods:

(1) Cross-training current staff;

(2) Utilization of staff in immediate work area;

(3) Call forwarding of telephone lines;

(4) Prioritization of workloads; and

(5) Utilization of approved volunteers.

(b) When all alternatives to securing temporary help have been explored, requests shall be processed as follows:

(1) Requests for temporary staff must be submitted to Human Resources utilizing the temporary services request form. Completed requests must include approvals from the department head and appropriate Vice President. Requests must be for a minimum of three (3) days and with a maximum of three (3) months. Extensions shall be considered on an individual basis; and

(2) Human Resources shall process the request and seek an appropriate match in collaboration with the department manager.

(c) Human Resources shall confirm with the department the temporary employee’s name, position, duration of assignment, time, and rate of pay;

(d) Employees shall be required to sign a receipt acknowledging temporary employment;

(e) All costs shall be charged to the requesting departments; and

(f) If the temporary employee does not meet the required needs of the position, the department shall contact the Human Resources immediately to seek another staffing alternative.

8307.3 The following payment criteria apply:

(a) Time sheets shall be completed and signed by the manager, and returned to Human Resources by the close of business every Friday; and

(b) Upon completion of the assignment, the department manager must complete and return an evaluation form to Human Resources within five (5) days.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7369 (October 9, 1998).

22-B DCMR § 8308 AMERICANS WITH DISABILITIES ACT

8308.1 Policy: The PBC shall comply with the Americans with Disabilities Act of 1990 (“ADA”). The PBC shall make efforts to provide reasonable accommodation of qualified individuals with a disability, provided they can perform the essential functions of the job, whether or not an accommodation is necessary to enable them to do so.

8308.2 The following terms used under in the ADA provide guidance as to the PBC’s compliance with ADA:

(a) Persons Protected by ADA: Under the ADA, a “qualified individual with a disability” is as a person with a disability that, with or without reasonable accommodation, can perform the essential functions of the job. A “disability” is considered as follows:

(1) A physical or mental impairment that substantially limits one or more major life activities;

(2) A record of having such impairment; and

(3) Being regarded as having such impairment.

(b) Essential Functions: A factual determination of the essential functions of a particular position shall be made on a case by case basis. Essential functions of a job are considered to be the following:

(1) Duties that are fundamental to the position;

(2) Tasks which, if removed, would fundamentally alter the position;

(3) Adverse consequences that may result from failing to have the function performed; and

(4) Tasks which only a limited number of employees are available to perform.

(c) Reasonable Accommodation: The ADA requires employers to provide employees with a reasonable accommodation so that they can continue or obtain employment. Reasonable accommodation is determined on a case by case basis. Reasonable accommodation does not include action that constitutes an undue hardship to the employer that may require significant difficulty or expense. Reasonable accommodations include, but are not limited to the following:

(1) Making employee facilities accessible;

(2) Job restructuring;

(3) Part-time or modified work schedules;

(4) Reassignment to vacant position;

(5) Acquiring or modifying equipment;

(6) Modification of examinations;

(7) Modification of training materials;

(8) Modification of policies;

(9) Qualified interpreters or readers; and

(10) Other action.

8308.3 Procedure: Whenever an issue concerning an employee’s physical or mental ability to perform a job arises, Human Resources must be contacted. A department representative shall review the issue and, with the assistance of the department head and in consultation with the employee, where appropriate, determine the appropriate action.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7370 (October 9, 1998).

22-B DCMR § 8399 DEFINITIONS

8399.1 When used in this chapter, the following terms and phrases shall have the meanings ascribed:

Lateral transfer - the movement to a different job classification or department that has the same grade as the current job.

Promotion - a transfer of an employee to a higher job classification than his/her current job.

Shift change - the movement to a different shift within the same job classification.

Temporary transfer - the movement of an employee to a job classification for a limited/defined period of time.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7371 (October 9, 1998).

22-B84 PUBLIC BENEFIT CORPORATION PERSONNEL POLICIES: SCHEDULING

22-B DCMR § 8400 HOURS OF WORK

8400.1 The following policies apply:

(a) Excepted at designated sites, the PBC shall maintain a twenty-four (24) hours-a-day, seven (7) days-a-week, fifty-two (52) weeks-a-year operation in order to provide proper service to its patients and to the community, except at designated sites. Employees shall be assigned hours and shifts consistent with departmental needs, and whenever possible, with individual preferences. Every effort shall be made to change hours and/or schedules with two (2) weeks notice to affected employees; and

(b) Employees shall be in their assigned work areas during work hours. Employees leaving their work area can do so only with the approval of their manager.

8400.2 The following rules are applicable:

(a) A work week for all employees shall be considered from midnight Saturday to the following midnight Saturday;

(b) A non-exempt employee who is granted less than a full day’s time off, and who desires a full day’s pay, must make up the difference by using accrued paid time; and

(c) Two fifteen (15) minute breaks are allowed each full shift and are considered time worked. One fifteen (15) minute break is allowed each employee working a full half shift. Breaks and lunch periods shall be coordinated through the department manager.

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is the Health and Hospitals Public Benefit Corporation Act of 1996, D.C. Code §§ 44-1101.01 to 44-1103.03.
SOURCE: Final Rulemaking published at 45 DCR 7353, 7372 (October 9, 1998).

22-B DCMR § 8401 WORK SCHEDULES

8401.1 Policy: The PBC shall schedule employees to meet patient care and/or organizational needs. Every effort shall be made to collaborate with employees to develop schedules that balance both organizational and individual needs.

8401.2 The following rules apply to work schedules:

(a) The normal work schedule for regular full-time employees shall total forty (40) hours per week exclusive of a daily meal period;

(b) The work schedule for part-time employees shall be less than forty (40) hours per week, provided there is some form of regular scheduled duty;

(c) Managers shall discuss work schedules with their staff and make every effort to accommodate individual needs. Information regarding system staffing requirements shall be shared with affected employees. Should schedules be changed, every effort shall be made to give affected employees two (2) weeks notice;

(d) Maximum flexibility shall be encouraged to vary schedules to meet patient care needs and fluctuating census. Non-traditional schedules may be instituted, such as job sharing, telecommuting or peak-hour scheduling; and

(e) Department managers shall communicate the scheduled work hours to employees.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7372 (October 9, 1998).

22-B DCMR § 8402 LEAVE CATEGORIES

8402.1 Policy: The PBC shall provide paid time off to regular full-time and part-time employees to allow employees time away from work. Paid time off replaces traditional vacation, personal, and sick time and places joint responsibility on managers and employees to schedule time off.

8402.2 The following procedures are applicable when computing paid time off:

(a) The qualifying date for computing the employee’s entitlement to paid time off shall be the calendar year;

(b) An employee accrues hours of paid time off per pay period (per month) in accordance with the following categories:

(1) There shall be two (2) separate schedules; one for employees who have been employed prior to the October 1, 1997 date the PBC is instituted and another far employees (i.e., new hires) hired after October 1, 1997. The following procedures shall apply:

(A) For employees hired prior to October 1, 1997 leave shall be credited at the following rate:

(i) Annual Leave for full-time employees:

a. 0-3 years of service: 4 hours per pay period or 13 days per year;

b. 3-15 years of service: 6 hours per pay period or 20 days per year;

c. 15 or more years of service: 8 hours per pay period or 26 days per year.

(ii) Annual Leave for part-time employees:

a. 0-3 years of service: 1 hour for each 20 hours in a pay status;

b. 3-15 years of service: 1 hour for each 13 hours in a pay status;

c. 15 years of service: 1 hour for each 10 hours in a pay status.

(iii) Sick leave for full time employees is four (4) hours bi-weekly; and

(iv) Sick leave for part-time employees is one (1) hour for each 20 hours of duty.

(B) For employees hired after October 1, 1997 leave for paid time off, which includes annual and sick leave, shall be credited at the following rate:

(i) Eighteen (18) days for an employee with less than three (3) years of service;

(ii) Twenty-three (23) days for an employee with three (3) to ten (10) years of service;

(iii) Twenty-eight (28) days for an employee with ten (10) or more years of service; and

(iv) Part-time employees shall receive leave on a pro-rated basis.

(2) Paid time off can be taken only after it has been accrued.

(d) An employee shall maintain, but shall not accrue paid time off credit when in an unpaid status. Where an employee has been voluntarily absent, the paid time off shall be pro-rated on a percentage basis, i.e., the period of time actually worked as that period relates to the period of paid time off due; and

(e) If an approved holiday falls on an employee’s paid time off day, the holiday shall replace a paid time off day.

8402.3 The following procedures are applicable when scheduling paid time off:

(a) Paid time off schedules shall be established taking into account the wishes of the employee and the needs of the PBC. Where there is a conflict in choice of time off among employees, seniority shall prevail. Managers and employees shall collaborate on scheduling time off, including the sharing of information that would facilitate understanding of the need for coverage and the need for the time off;

(b) The manager shall respond to a request for time off within thirty (30) days after the deadline or deadlines established by the department for submission of requests;

(c) For new hires, the balance of paid time off that is unused in a calendar year may be transferred into the disability bank to be used to supplement bona fide disability payments. Up to ten (10) days of paid time off may be carried over into the next calendar year for new hires;

(d) If an employee is mandated to work and cannot use earned time off due to operational needs of the organization, special arrangements can be made for carry over into the new year. Leave carried over in this manner must be used in the first ninety (90) days of the new calendar year or it shall be lost;

(e) Those employees hired on or before October 1, 1997, prior to the implementation of the PBC, may carry over up to two hundred and forty (240) hours of annual leave and all accrued sick leave;

(f) Employees may donate paid time off to other employees, the value of which shall be converted for the employee who is the recipient. Human Resources should be contacted in such instances;

(g) Part-time employees shall be entitled to paid time off benefits on a pro-rated basis; and

(h) Temporary employees retained beyond six (6) months of continuous employment shall accrue paid time off from the first day of employment.

8402.4 Paid time off pay is considered as follows:

(a) Pay shall be based upon the employee’s regular pay and regularly scheduled hours prior to the start of the employee’s time off;

(b) Pay shall be computed on the basis of regular straight-time earnings. “on-call” pay and overtime pay are excluded from the paid time off rate;

(c) An employee who has resigned and has given proper notice of resignation, shall receive up to a maximum currently allowable annual leave upon termination; and

(d) An employee may opt to cash out paid time off of up to two (2) weeks at sixty (60%) value, payable in December.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7373 (October 9, 1998).

22-B DCMR § 8403 HOLIDAYS

8403.1 Policy: The PBC shall provide the following eleven (11) total paid holidays off during the calendar year:

(a) New Year’s Day;

(b) Martin Luther King Jr.’s Birthday;

(d) Memorial Day;

(e) Independence Day;

(f) Labor Day;

(g) Columbus Day;

(h) Veteran’s Day;

(i) Thanksgiving Day;

(j) Christmas Day; and

(k) Presidential Inaugural Day.

8403.2 Part-time employees shall be entitled to the above holidays, with pay, on a prorated basis.

8403.3 Holiday scheduling and pay:

(a) Recognizing that PBC operates every day of the year and that it is not possible for all employees to be off on the same day, the PBC shall have the right, at its sole discretion, to require any employee to work on any of the holidays herein specified; however, department heads shall distribute time off to observe holidays in an equitable manner;

(b) The day on which the holiday is legally celebrated shall be the day an which premium pay is paid to those employees who work on that day;

(c) If an employee is absent the scheduled work day before or the scheduled day after a paid holiday or day off for having worked a previous holiday, PBC shall require proof of illness. The employer may deny pay for such holiday if such proof is requested and not provided or satisfactory to the PBC;

(d) In the event the employee is required to work on any of the legal holidays named in § 403.1, the employee shall be paid at the rate of one and one-half (1 1/2) regular pay for all hours worked on the holiday, and shall receive an additional day off with regular pay within thirty (30) days of the holiday or an extra day’ regular pay in lieu thereof, as determined by the PBC. Every effort shall be made to collaborate with employees to develop schedules that balance both organizational and individual needs;

(e) Employees who are exempt from the overtime pay requirements or who are required to work on a legal holiday, shall receive regular pay plus an additional day off with pay;

(f) If any employee is scheduled to work on a paid holiday and fails to work his/her shift, the employee shall forfeit holiday pay;

(g) If a legal holiday falls on an employee’s regularly scheduled day off, the employee shall receive a day off with regular pay within thirty (30) days of the holiday or at the option of the PBC, an additional day’s regular pay in lieu thereof; and

(h) If a legal holiday falls during an employee’s paid time off, the employee shall have that day considered a holiday rather than a paid time off day.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7375 (October 9, 1998).

22-B DCMR § 8404 JURY DUTY

8401.1 Policy: The receipt of notice to report for jury duty must be immediately submitted to an employee’s department head or supervisor. The PBC with the employee’s consent may request exemption from jury duty if the employee’s services are essential at the time of proposed jury service.

8401.2 The following procedures apply:

(a) If an employee serves on jury duty, a copy of the subpoena or notice to report to jury duty shall be given to his/her manager as soon as possible;

(b) All employees who serve on jury duty after receipt of notice to report to jury duty shall be granted court leave of absence with pay for the entire period, (from the date stated in the summons on which he or she is required to report to the court to the time he or she is discharged by the court). Employees shall remit any jury stipend or jury pay received from the government to PBC. Employees shall submit jury pay allowance to Payroll;

(d) Employees who are “on-call” for jury duty must report to work. Employees who are scheduled to work weekends or other days when court is not in session must report to work.

(e) Witness service - Court leave for witness served in an official capacity at a judicial proceeding may be granted to the following:

(1) Full-time and part-time employees permanent employees; and

(2) Full-time and part-time employees, except for those employed as a substitute.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7377 (October 9, 1998).

22-B DCMR § 8405 BEREAVEMENT

8405.1 Policy: The PBC recognizes the need for employees to handle certain personal obligations during the loss of an immediate family member. The PBC shall help its employees with these obligations by granting time off. Bereavement time is intended to provide the full-time or part-time employee time off to make arrangements for and/or attend funeral/memorial services. PBC may request bereavement documentation. The following criteria applies:

(a) Employees shall receive up to three (3) working days off with pay immediately following the death of a spouse, child, step child, parent, parent-in-law, step parent, grandparent, brother, or sister;

(b) If a death or funeral in the family occurs during an employee’s normal day off, or scheduled paid time off, no substitution of paid bereavement leave shall be allowed; and

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7377 (October 9, 1998).

22-B DCMR § 8406 LEAVE OF ABSENCE

8406.1 Policy: The PBC shall grant specific types of paid or unpaid leave to employees, subject to the following provisions:

(a) An employee shall be on the PBC’s payroll for at least six (6) months (unless otherwise noted) to be eligible for a leave of absence. However, short-term disability leave, disability compensation leave and military leave are exempt from the length of service eligibility requirements; and

(b) A leave of absence represents time away from work granted by the PBC at the request of the employee. The leave is arranged for a specific time period and is either paid or an unpaid leave.

8406.2 The following procedures apply to leaves of absence:

(a) All requests for a leave of absence must be in writing (unless otherwise noted) using a leave of absence request form and directed to the employee’s manager for written approval. The request shall state the reason for the leave of absence and indicate the effective date and the anticipated date of return;

(b) Upon approval by the manager, the leave request and a signed requisition form must be submitted immediately to Human Resources;

(c) Personal or educational leaves may be granted up to thirty (30) days. Requests for extensions must be made in advance in writing prior to completion of the current thirty (30) days leave and directed to the manager for approval. The maximum number of times a leave can be extended is five (5);

(d) Leaves of absence that qualify under FMLA may be granted up to sixteen (16) weeks or the duration of the leave specified by the physician’s documentation, whichever is less. After the applicable period, requests for extensions must be made in advance in writing and directed to the manager for approval. Extended leaves shall be granted up to thirty (30) days and total leave, including the FMLA portion, may not exceed six (6) months; and

(e) PBC holidays that fall within a leave of absence shall be without pay unless otherwise noted.

8406.3 The following terms shall be used for types of leave:

(a) Short-term disability leave: Leave granted to eligible employees for non-job related illnesses or injuries. See § 8410 for disability benefits available during such leave;

(b) Disability compensation leave: Leave granted to eligible employees who are injured or become ill as a result of their employment. See § 8411 for workers’ compensation benefits available during such leave;

(c) Family and medical leave: Leave granted to eligible employees to provide care for a newly arrived child, a parent, spouse or child with a serious health condition or self-care for the employee’s own serious health condition as mandated by law and subject to limits set forth in the “family and medical leave” policy;

(d) The following criteria is to be used for military leave:

(1) Leave granted by law to non-temporary employees who serve in the uniformed services and require time off from work. Service in the uniformed services includes active duty, active duty for training, inactive duty training, full-time National Guard duty, and absence due to a fitness for training examination;

(2) Employees who serve in the uniformed services for a period of less than thirty-one (31) days shall be granted a leave of absence for the required period upon written or verbal notice;

(3) Employees returning from a period of service in the uniformed services of more than thirty (30) days may be reinstated to a position of employment as required by law, provided that advance written or verbal notice of service was given, such employees apply for reinstatement within the time frames established by applicable law of their day of honorable discharge from military service, the employee has not exceeded the established service limitations, and re-employment is not impossible or unreasonable due to a change in circumstances. PBC may request documentation to establish an employee’s entitlement for re-employment. Use of military leave of absence shall in no way reduce an employee’s seniority length of service credit; and

(4) Employees shall use accrued vacation time or paid leave time prior to the commencement of their service in the uniformed services.

(e) Personal or Educational Leaves: Leave maybe granted to eligible employees who have certain compelling personal reasons or educational needs that may require time off from work.

8406.4 Continuation of benefits: The employee shall be responsible while on leave of absence to pay the premiums in advance for all insurance programs of which the employee is a member. Failure to pay the employee’s portion shall result in loss of coverage. The insurance premiums are to be forwarded directly to Human Resources.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7378 (October 9, 1998).

22-B DCMR § 8407 FAMILY AND MEDICAL LEAVE

8407.1 Policy: The PBC shall comply with the Family and Medical Leave Act of 1993 (“FMLA”) and other applicable law.

8407.2 Eligibility:

(a) An eligible employee is one who has been employed for at least twelve (12) months and for at least one thousand (1,000) base hours of service during the previous twelve (12) months;

(b) Eligible employees have the right to take unpaid leave, or paid leave if it has been earned, for a period of up to sixteen (16) work weeks in a twelve (12) month period to provide care for a new arrived child, care for a parent, spouse or child with a serious health condition or self care for the employee who has a serious health condition; and

8407.3 Paid time off in conjunction with family and medical leave: Employees who take family and medical leave may use unpaid leave. Any paid leave provided that the employee elects to use for medical leave shall count against the sixteen (16) workweeks of allowable medical leave.

8407.4 Continuation of benefits: While on a family and medical leave, employees shall have health benefits maintained while on leave, provided they timely remit to Human Resources the required employee portion of the premium of the group health plan, if any.

8407.5 Leave restrictions: An employee’s FMLA leave for the birth, adoption, or foster care of a child must commence within twelve (12) months of the birth, adoption, or foster care of child.

8407.6 Intermittent or reduced leave schedules: Under certain conditions, PBC shall allow employees to take an intermittent leave or work on a reduced schedule.

8407.7 The following procedures shall apply to the Family and Medical Leave Act:

(a) Initial request: An employee shall give thirty (30) days advance notice to their manager in writing, where practical, when applying for an FMLA leave using the applicable forms of leave of absence request form or employee application for FMLA;

(1) In emergency circumstances, the employee may provide oral notice initially, if written notice impracticable. The employee must then submit written notice;

(2) When applicable, a Department of Labor form for medical certification may be required;

(3) Upon initial approval by the manager, the leave request and a signed requisition form must be submitted immediately to Human Resources for final designation as FMLA leave, if qualified; and

(4) An employee may opt to reveal their condition to Occupational Health Services in lieu of their manager or Human Resources if confidentiality is an issue.

(b) Designation of FMLA leave: Human Resources and/or Occupational Health Service shall determine whether the leave qualifies under FMLA. If the leave is determined to be an FMLA leave, a response letter designating the leave as an FMLA leave and explaining the employee’s rights shall be forwarded to the employee by Human Resources;

(c) Request for continuation or reinstatement: A request for reinstatement must be submitted to the department manager ten (10) days before the expiration of leave or prior to the date the employee intends to return to work; and

(d) An employee shall return to the same or similar position provided they return within or immediately following the sixteen week period as permitted by law.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7380 (October 9, 1998).

22-B DCMR § 8408 MANAGING ATTENDANCE

8408.1 The PBC shall seek to provide the highest quality of care to its patient population. This goal is accomplished, in part, through the maintenance of effective levels of staffing. Employees must maintain good attendance records by reporting to work regularly and as scheduled. Absenteeism is detrimental to the operations of the institution and may subject the employee to the disciplinary process.

8408.2 The following procedures apply for managing attendance:

(a) The manager shall evaluate the impact of an employee’s attendance on the operations of the department;

(b) Managers shall periodically review all time records to anticipate, identify and resolve potential attendance problems before disciplinary action is required. The definitions of excessive, unauthorized and patterned absence occurrence shall be considered in identifying problem records;

(c) Managers shall meet with employees and exercise reasonable efforts to assist them in maintaining good attendance records. Where appropriate, managers may refer employees to Occupational Health Services, the Employee Assistance Program, or Human Resources;

(d) Should absenteeism persist, employees may be disciplined as appropriate; and

(e) Employees shall receive no compensation for unauthorized absences.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7381 (October 9, 1998).

22-B DCMR § 8409 LATENESS

8409.1 Policy: Employees must be at their assigned work areas, prepared to work, promptly at the beginning of their assigned shift.

8409.2 Subject to Title V and Title XVII of the CMPA, the following procedures are applicable:

(a) Employees must contact their supervisor or departmental designee in the event that the employee will be late for his/her assigned shift;

(b) Managers shall periodically review of all time records to anticipate and resolve punctuality problems before disciplinary action is required. Managers shall determine whether a lateness is to be excused for valid reasons or not excused. Repeated lateness must be documented in detail and may lay the foundation for disciplinary action;

(c) Managers shall meet with employees and exercise reasonable effort to assist employees in maintaining good attendance records. Should lateness persist, the manager shall consult with Human Resources;

(d) Should lateness occur, deductions of the time late from the time record shall be made; and

(e) Should lateness persist, employees may be disciplined. Although any lateness is unacceptable, a guideline which triggers disciplinary action shall be if the employee has accumulated lateness of sixty (60) minutes or more, or is late five (5) times or more in any three (3) month period of time, or ten times in any twelve month period of time, whichever comes first.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7382 (October 9, 1998).

22-B DCMR § 8410 SHORT-TERM DISABILITY

8410.1 Policy: The PBC shall provide short-term disability benefits for non-job related illnesses or injuries as mandated by the law. Short-term disability policy begins after an employee has been disabled due to non-job related illness or injury and their regular paid time off has been exhausted. Employees may then supplement their short-term disability benefits with their supplemental paid time off bank. Employees may receive pay and/or benefits for a total of twenty-six (26) weeks.

8410.2 The following procedures are applicable:

(a) The employee shall contact the Human Resources department and complete and submit a disability claim form within thirty (30) days of the first day of disability to avoid disallowance of the claim;

(b) Employees shall be paid available paid time off for regularly scheduled work days during the disability until their accrued paid time runs out;

(c) Once paid time off runs out, all employees shall use available time in the supplemental bank to make up the difference between their regular wages and the disability benefit;

(d) Employees must be under a physician’s care to continue to be eligible for disability. Employees are responsible for providing continued proof of illness; and

(e) An employee may collect up to a maximum of twenty-six (26) weeks of benefits for each period of disability.

8410.3 The following additional practices are applicable:

(a) The manager shall place the employee on a short-term disability leave of absence using the requisition form. Upon return from disability, the manager shall process a requisition form to return the employee to work status; and

(b) Prior to returning to work after an absence for short-term disability, all employees shall be cleared by the Occupational Health Director or designee.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7382 (October 9, 1998).

22-B DCMR § 8411 WORKERS’ COMPENSATION

8411.1 Policy: The PBC shall provide benefits under workers’ compensation in accordance with the law for all employees who are injured or become ill as a result of their work, i.e., incur occupational injury or illness.

8411.2 The following procedures are applicable:

(a) Notice of any work-related injury for which compensation is payable shall be given within thirty (30) days after the date of such injury, or thirty (30) days after the employee is aware or in the exercise of reasonable diligence should have been aware of a relationship between the injury and the employment. Such notice shall be given to the Mayor and to the employer. An incident report shall be completed by the employee and signed by the supervisor. The employee, if on duty, may then receive medical treatment from Occupational Health and/or the Emergency Room. If any additional treatment is necessary, Occupational Health shall make appropriate referrals;

(b) The initial three (3) work days for claims shall be paid from the employee’s paid time off days;

(c) After an absence of three (3) work days, an employee who is continuously disabled shall be eligible to receive pay allowable by law. This shall be paid directly to the employee by the workers’ compensation insurance carrier. Employees may use available paid time supplemental bank to supplement the difference between regular wage and the workers compensation benefit;

(d) After three work days, a requisition form shall be prepared by the employee’s department putting the employee on workers’ compensation leave and the effective date of that leave. The form shall also indicate the expected date of return;

(e) The workers’ compensation provider shall pay for the hospital, medical and surgical expenses relating to the occupational injury or illness. Medical bills relating to the occupational injury or illness should be submitted to the Human Resources Department; and

(d) Workers’ compensation leave is exempt from length of service requirements. An employee returning to work following a workers’ compensation leave of up to one year’s duration will be reinstated to his/her former position or its equivalent. An employee from a workers’ compensation leave must receive medical clearance from Occupational Health before returning to work.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7383 (October 9, 1998).

22-B DCMR § 8499 DEFINITIONS

8499.1 In this chapter, the following terms and phrases shall have the definitions ascribed:

Absence occurrence - An employee is absent when he/she does not report to work as scheduled. An absence occurrence may be for one day or multiple consecutive days of absence. For example, an employee who has been absent for four days (Monday through Thursday) has incurred one absence occurrence. Absences separated only by an employee’s regular days off still count as one occurrence. For example, if an employee is absent on Friday and Monday, and Saturday and Sunday are the employee’s regular days off, the Friday and Monday absences count as one occurrence.

Excessive - Repeated unscheduled absence occurrences over a period of time including, but not limited to, two (2) or more absence occurrences in any month, five (5) or more absence occurrences in a six (6) month period, nine (9) or more absence occurrences in a year.

Patterned - Absences that are similar and repetitive in nature, including but not limited to, days taken in conjunction with scheduled days off, same day each week, day before or after pay-day or holiday.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7384 (October 9, 1998).

22-B85 PUBLIC BENEFIT CORPORATION PERSONNEL POLICIES: CONDUCT AND STANDARDS

22-B DCMR § 8500 COMMUNICATION

8500.1 Policy: PBC shall strive to communicate in a manner that is open, honest, and timely. Communication is one of the keys to promoting understanding and limiting conflict among employees. Dialogue between and among all levels of employees shall be encouraged to allow varying viewpoints to be aired.

8500.2 The following procedures are applicable:

(a) Regular communication shall occur on issues affecting PBC and its employees through written, verbal, and other methods;

(b) Management meetings shall be held monthly to discuss issues of importance to the organization;

(c) Managers shall hold staff meetings at least monthly. Items such as departmental procedures, quality improvement initiatives, current PBC-wide issues, and other pertinent issues are examples of discussion topics. Staff is encouraged to ask questions and provide feedback at that time; and

(d) Regular labor/management meetings shall be held to encourage dialogue between labor and management towards mutual resolution of issues and problems.

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is the Health and Hospitals Public Benefit Corporation Act of 1996, D.C. Code §§ 44-1101.01 to 44-1103.03.
SOURCE: Final Rulemaking published at 45 DCR 7353, 7385 (October 9, 1998).

22-B DCMR § 8501 STANDARDS OF CONDUCT

8501.1 The following policies are applicable:

(a) As set forth in the employment-at-will policy of this manual, employment-at-will means that an employee remains free to leave their employment at the PBC at any time for any reason. Similarly, the PBC shall have the absolute authority to terminate an individual’s employment at any time, without prior notice, and with or without cause. Nothing in this manual constitutes a promise or guarantee as to the duration of anyone’s employment with the PBC or the terms and conditions of employment. Regardless of what the manual states, there is no promise or guarantee that employees shall be terminated only for reasons listed in this manual. In addition, the PBC may change the terms and conditions at any time, without prior notice, and with or without cause;

(b) The PBC expects employees to maintain high standards of conduct that are necessary to ensure the well being of patients and to protect the rights and safety of all employees and other visitors that are part of the PBC community. Common sense, good judgement, and appropriate personal behavior are the essential responsibility of every employee;

(d) The following are examples that shall not limit the PBC’s right to take corrective action, discipline, or discharge employees in any way, but is solely intended to provide guidance to managers on the type of conduct for which they should discipline employees in the best interest of the PBC:

(1) Falsification of PBC documents;

(2) Failing to record one’s own time record, recording another employee’s time record, or permitting another employee to record one’s own time record;

(3) Unauthorized possession, disclosure, or other use of PBC financial or other confidential documents or information;

(4) Unauthorized absence from work or assigned work area;

(5) Excessive absenteeism or lateness;

(6) Failure to satisfactorily perform appropriate duties and/or assignments;

(7) Insubordination or refusal to accept a job assignment;

(8) Failure to render service to a patient;

(9) Inconsiderate or abusive treatment of patients, visitors, or other employees, or performing negligent acts adversely affecting a patient’s, visitor’s, or other employee’s welfare;

(10) Use of threatening, intimidating, obscene, or abusive acts or language, or other disorderly conduct towards patients, visitors, or other employees;

(11) Fighting, horseplay, or other physical confrontation towards patients, visitors, or other employees;

(12) Sleeping while on duty;

(13) Unauthorized possession, sale, or use of narcotics, alcohol, or other intoxicants on PBC premises, or reporting to work under the influence of such substances;

(14) Unauthorized solicitation of any kind, or accepting gifts, gratuities, or tips from patients or visitors;

(15) Destruction or misuse of equipment, facilities, or property belonging to the PBC, visitors, or other employees;

(16) Theft or misappropriation of assets, equipment, other property or resources belonging to the PBC, patients, visitors, and other employees;

(17) Possession of a weapon on PBC premises;

(18) Gambling on PBC premises;

(19) Smoking in unauthorized areas;

(20) Sexual or other harassment of patients, visitors, or other employees;

(21) Disregard for appearance, personal hygiene, or departmental dress code;

(22) Illegal or immoral conduct on or off duty; and

(23) Conduct detrimental to patient care or PBC operations.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7385 (October 9, 1998).

22-B DCMR § 8502 GUIDELINES FOR CORRECTIVE/DISCIPLINARY ACTION

8502.1 Policy: Employees shall perform their jobs in a competent and professional manner, adhering at all times to the rules of conduct of the institution. Managers are expected to counsel and appropriately discipline employees for failure to do so. This shall enable the PBC to ensure that its employees exhibit appropriate behavior. The Employee Relations Department shall be available to assist those affected by the disciplinary process. The disciplinary action taken should accomplish the following:

(a) Modify unacceptable behavior;

(b) Deter repeated violations;

(d) Be consistent with PBC and departmental procedures; and

(e) Safeguard patients, visitors, and employees from disruptive behavior.

8502.2 Guidelines: The following are guidelines provided to managers in situations where disciplinary action may be appropriate. They are not a promise at progressive discipline in any situation since PBC can terminate any manager or employee at will, with or without notice, for any reason or no reason, unless provided otherwise in and applicable union-management collective bargaining agreement. The following guidelines are intended solely to ensure that an adequate record of warning and disciplinary action exists in the event it becomes necessary to respond to a charge of discrimination or support a disciplinary action in some other legal proceeding. Managers are encouraged to discuss potential disciplinary actions with and Employee Relations Department representative. The guidelines are as follows:

(a) The immediate supervisor shall be responsible for initiating disciplinary action if an infraction has occurred;

(b) When the manager becomes aware of the infraction, an investigation shall take place. The manager shall gather all appropriate information, including all physical evidence and witness statements. The employee shall be spoken with to obtain their view of the incident. A review shall take place by the manager to assess the appropriateness and level of disciplinary action. The manager shall prepare a written record of the entire investigation;

(1) Counseling - a discussion between the employee and the manager that seeks to resolve the unsatisfactory performance. This is used for relatively minor infractions and may be reduced to writing;

(2) Written warning-when the infraction is more serious or has not been resolved through counseling, the warning should be reduced to writing and presented to the employee;

(3) Suspension - a written warning containing a day or days suspension without pay for serious infractions or when a written warning has not brought about appropriate behavior; and

(4) Discharge - used for major infractions or when prior discipline has not brought about appropriate behavior.

(d) Prior to taking action to suspend or discharge an employee, the manager must consult with an Employee Relations department representative;

(e) In determining the appropriate level of discipline, the manager shall at a minimum consider the following:

(1) Seriousness of the infraction;

(2) Employee’s work history;

(3) Time span of prior discipline;

(4) Extenuating circumstances; and

(5) Departmental disciplinary practices.

(f) For employees represented by a union, when a manager issues a warning, the employee shall have an opportunity to have a union representative present in accordance with the applicable collective bargaining agreement. If the employee waives the right to representation, it shall be noted on the disciplinary form. The manager shall also have a management witness present. The warning shall be read to the employee, and the employee asked to sign the notice. If that is refused, the witness shall sign the notice attesting to said fact. In all cases, the representative’s name shall be noted on the notice.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7386 (October 9, 1998); as amended by Final Rulemaking published at 45 DCR 7727 (October 30, 1998).

22-B DCMR § 8503 GRIEVANCE PROCEDURE

8503.1 Policy: PBC shall strive to settle disputes between managers and employees through the establishment of a grievance procedure.

(a) The grievance procedure should accomplish the following:

(1) Resolve the complaint expeditiously;

(2) Give all involved an opportunity to present all relevant information; and

(3) Encourage and promote fair and equitable treatment among employees and managers.

(b) The Employee Relations Department is available to assist those who desire to avail themselves of the grievance process.

8503.2 The following procedures are applicable:

(a) Step 1: The employee may submit a written, signed grievance and discuss the problem with his/her immediate supervisor. The grievance shall be submitted within a reasonable time frame of the incident or issue, not to exceed thirty (30) days from the occurrence. The specific complaint shall be specified, along with the remedy sought. The supervisor shall give a written answer to the employee within five (5) working days of the discussion of the incident and/or the receipt of the written grievance, whichever is later;

(b) Step 2: If the grievance is not settled in Step 1, the employee may, within five (5) working days of the answer in Step 1, present the written grievance to the department manager or his/her designee. As in Step 1, the employee shall receive a written answer within five (5) working days;

(c) Step 3: If the grievance is not settled in Step 2, the employee may, within five (5) working days of the answer in Step 2, present the written grievance to the Director of Employee Relations or designee. A third step hearing shall be scheduled. The employee shall receive a written answer from the Director of Employee Relations within ten (10) working days of the hearing;

(d) Step 4: If a grievance is not settled in Step 3, the employee within ten (10) working days of the answer in Step 3 may present the written grievance to the Grievance Review Committee. The Committee shall consist of no more than six (6) members, to include the Vice President of Human Resources, two (2) senior level administrators, two (2) union representatives, and one (1) non-union representative. The Committee shall meet twice per month to review grievances filed timely before it. After discussion, it shall render a written decision which shall recommend a resolution of the grievance; and

(e) Prior to the recommended solution, the following guidelines are applicable:

(1) Grievances filed at Steps 3 and 4 shall be conducted by a hearing. Statements shall be made by the parties and evidence presented. The manager of the department taking the action shall present the case, and the employee/union representative shall then present their case. Questions are permitted by both parties. The Hearing Officer at Step 3 or the Committee at Step 4 shall preside and ask questions as appropriate. Closing statements will then be made. The Hearing Officer/Committee shall take notes, and then present a written decision within the time limits specified above. Nothing precludes the parties from discussing a resolution at any time during the above process;

(2) Non-union employees may have another non-union employee from within the PBC appear with them at any of the grievance steps if they so desire. Union employees may attend with their representative. Employees must receive their manager’s approval to attend, which shall not be unreasonably denied. Outside counsel shall not be permitted in any internal PBC process, including the grievance procedure;

(3) The grievant shall be allowed time off without loss of pay to attend such hearings during working hours. (This should not be construed as a guarantee that the grievance shall be scheduled during working hours in all cases);

(4) Failure of the grieving employee to initially file the grievance or proceed to the next step in the grievance procedure, within the time specified above, shall constitute a full and final denial of the grievance;

(5) Time limits are exclusive of Saturdays, Sundays, and holidays; and

(6) Employees may file grievances over suspensions and terminations initially at Step 3 of the procedure.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7388 (October 9, 1998).

22-B DCMR § 8504 HARASSMENT AND SEXUAL HARASSMENT

8504.1 The creation of a hostile environment or the sexual harassment of any employee is unacceptable conduct and shall not be tolerated by the PBC.

8504.2 The following procedures are applicable: Any employee who believes that he or she has been or is being subjected to harassment or sexual harassment shall be encouraged to submit an immediate written complaint to Human Resources. Managers who observe incidents of harassment or sexual harassment or receive reports of such activity must report the matter to Human Resources. All complaints shall be promptly and fully investigated by Human Resources, with written documentation of any kind of retaliation for the good faith submission of a complaint alleging harassment or sexual harassment or for assisting in providing information relevant to any reported allegation of same.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7389 (October 9, 1998).

22-B DCMR § 8505 BARGAINING UNITS

8505.1 The PBC shall maintain collective bargaining relationships with unions elected to represent many of its employees.

8505.2 Employees in these bargaining units shall be subject to the terms and conditions of the applicable collective bargaining agreement. In the event of any inconsistency between the policies and procedures contained herein and the collective bargaining agreement, the collective bargaining agreement shall apply.

8505.3 PBC shall observe the letter and the spirit of the applicable laws and collective bargaining agreements that govern its labor relations. No employee shall be discriminated against or coerced as a result of his/her legally protected collective bargaining rights. Likewise, the rights of those who do not belong to established bargaining units shall be respected and protected from infringement.

8505.4 Employees desiring to attend collective bargaining related activities shall obtain the approval of their manager prior to attending such activity.

8505.5 Management and supervisory employees shall be exempt from being represented for the purposes of collective bargaining.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7390 (October 9, 1998).

22-B DCMR § 8506 FILE ACCESSABILITY

8506.1 Policy: Records and documents pertinent to an employee’s employment at PBC shall be maintained in Human Resources. All such records are confidential and shall not be viewed, entered or omitted without the consent of the Vice President of Human Resources or his/her designee, or in accordance with applicable law, or to comply with legal process or in defense of claims against the PBC. Pertinent records shall be maintained in the files for periods in accordance with applicable laws. Employees in professions requiring licensure or certification shall be responsible for ensuring that such documents are kept current and are on record in Human Resources.

8506.2 The following procedures are applicable:

(a) An employee wishing to review his/her personnel file shall make an appointment with Human Resources to review the file;

(b) A Human Resources representative must be present upon review of the file;

(d) Managers may view the file of one of their employees or potential employees only.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7390 (October 9, 1998).

22-B DCMR § 8507 DRESS CODE

8507.1 Policy: The PBC shall require its employees to present and maintain a personal appearance that is well-groomed and professional in nature. Employees’ uniform or personal dress must be in accordance with the work setting, safety requirements, contact with the public, and the job duties performed.

8507.2 The following procedures are applicable:

(a) All employees shall maintain and observe good personal hygiene and dress that presents a professional image;

(b) Clothing deemed inappropriate, including but not limited to: jeans, spandex pants, shorts, biker pants, halter tops, sandals, leotards, mini skirts, midriff tops, and tank tops, shall not be worn. Open shoes or high heels shall not be worn where they may cause safety problems. Hosiery/socks must be worn while on duty;

(c) Uniformed personnel shall wear a complete uniform that is clean and appropriate for their work setting. Employees shall remain in full uniform during the course of their shift. Hats or head coverings must be removed unless worn for religious purposes or are part of the work attire;

(d) PBC supplied scrub clothing worn in scrub designated areas must be covered with a lab coat if an employee is leaving their normal work area; and

(e) Employees who appear for work in a manner that is inappropriate shall be required to correct the situation. The period of absence from duty shall be treated as unpaid time.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7391 (October 9, 1998).

22-B DCMR § 8508 SOLICITATION AND DISTRIBUTION

8508.1 All requests for solicitation and distribution must comply with the following:

(a) Solicitation shall be prohibited by an employee or a non-employee in patient care areas at all times while either the person doing the soliciting or being solicited is on work time. Work time includes all time during which employees are assigned to work, and does not include break or meal periods;

(b) The PBC may solicit charitable contributions from employees for PBC related charities or activities with prior approval of the Chief Executive Officer;

(c) Distribution of literature or other written material shall be prohibited in patient care areas or while either the person doing the distributing or receiving the material is on work time;

(d) Non-employees shall not solicit or distribute literature on PBC property for any purpose, including but not limited to selling goods or services, seeking charitable contributions, or obtaining employee support for any particular cause or purpose; and

(e) Employees shall not solicit on PBC property for the purpose of selling goods or services.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7391 (October 9, 1998).

22-B DCMR § 8509 IDENTIFICATION BADGE

8509.1 Policy: The PBC shall require all employees to wear PBC identification badges while on PBC premises.

8509.2 The following procedures are applicable:

(a) PBC identification badges shall be prepared and issued by the Security Department;

(b) All new employees shall receive one identification badge that shall be issued on the first day of employment;

(c) Employees shall wear their identification badge in plain sight on PBC premises at all times. A temporary badge shall be issued when an employee fails to wear their identification badge; and

(d) Employees shall report lost or stolen badges to the Security Department. A fee of $10 shall be charged for replacement of lost badges.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7392 (October 9, 1998).

22-B DCMR § 8599 DEFINITIONS

8599.1 When used in this chapter, the following terms and phrases shall have the meaning ascribed:

Harassment - Conduct directed at an employee solely on the basis of his/her affectional preference, age, color, creed, disability, national origin, race, religion, sexual orientation or other basis prohibited by law which would lead an employee to reasonably believe that the conditions of employment are altered and that the work environment is hostile or abusive.

Sexual harassment - Unwelcome sexual advances, requests for sexual favors, and other verbal or physical contact of a sexual nature constitute sexual harassment when submission to such conduct is made either explicitly or implicitly a term or condition of an individual’s employment. Submission to, or rejection of, such conduct by an individual is used as the basis for employment decisions affecting such individual. Such conduct, or conduct directed against an employee because of his/her sex would lead an employee to reasonably believe that the conditions of employment are altered.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7392 (October 9, 1998).

22-B86 PUBLIC BENEFIT CORPORATION PERSONNEL POLICIES: PERFORMANCE MANAGEMENT PROGRAMS

22-B DCMR § 8600 PERFORMANCE MANAGEMENT PROGRAMS

8600.1 Policy: PBC shall maintain a performance management system to provide a systematic approach to employee development.

8600.2 The goals of the program are as follows:

(a) Provide an on-going opportunity for employees to review and understand their job responsibilities and needed competencies, plan for their performance and development, and establish dialogue and feedback as to their actual performance;

(b) Establish objective criteria on which to base performance measurement;

(c) Provide sound knowledge on which to base decisions regarding job qualification, compensation, transfers, promotions, and when applicable, termination; and

(d) Reward employees for performance.

8600.3 Position description preparation shall consist of the following:

(a) Each employee shall have a position description that shall include essential responsibilities and criteria for the position they hold;

(b) Each vice president and his/her designee shall prepare position descriptions. Human Resources shall provide guidance in preparation of descriptions according to established format; and

(c) Each manager shall review position descriptions at least annually. If the position description no longer reflects the current responsibilities, a revised description shall be prepared and submitted to Human Resources.

8600.4 Performance management process shall consist of the following:

(a) Managers shall initiate the performance management process. Upon hire, and at the beginning of the review period, the manager shall meet with the employee and provide them with a position description. He/she shall discuss needed competencies and collaborate on goals for the upcoming period, which shall then be written on the performance management form. A work plan shall also be developed outlining what the employee should be doing to meet the established goals. Particular attention shall be paid to ensuring criteria are objective and measurable;

(b) On a regular basis, no less than quarterly, managers shall meet with their employees to review performance. Coaching may be provided to help employees develop the needed skills for performance success;

(c) At the end of each review period, the manager shall solicit input from others who work with the employee to obtain multiple perspectives on the individual’s performance. Others may include colleagues within and outside the department, other managers, and customers. The employee shall also be asked for a self-assessment. Input shall be incorporated in the evaluation form and discussed with the employee; and

(d) Once completed, the employee shall receive and sign a copy of the evaluation. Completed evaluation forms shall then be forwarded to Human Resources.

8600.5 Dispute resolution shall consist of the following:

(a) Should an employee disagree with the performance evaluation made by his/her reviewing manager, he/she may appeal to his/her next highest level manager (the appealing manager) in writing, within thirty (30) days. A copy shall also be sent to Human Resources;

(b) An initial meeting shall be held between the employee and the appealing manager to discuss discrepancies in the evaluation. The focus shall be on providing objective justification for the appealed issues. The appealing manager shall investigate the contentions, including discussion with the reviewing manager;

(c) The appealing manager shall meet within ten (10) days with the employee and the reviewing manager to discuss the issues and render a written decision. The decision may include modification of the contested section. If so, that section shall be written to reflect the modified position; and

(d) Should the employee be dissatisfied with the decision, he/she may append written comments that shall be made part of the employee’s permanent record.

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is the Health and Hospitals Public Benefit Corporation Act of 1996, D.C. Code §§ 44-1101.01 to 44-1103.03.
SOURCE: Final Rulemaking published at 45 DCR 7353, 7393 (October 9, 1998).

22-B87 PUBLIC BENEFIT CORPORATION PERSONNEL POLICIES: STAFF DEVELOPMENT

22-B DCMR § 8700 STAFF DEVELOPMENT PROGRAMS

8700.1 Policy: The PBC recognizes the need for employees to continue to learn. To ensure appropriate competencies are present, the PBC shall provide staff development opportunities for all employees on all shifts that shall promote attainment of skills, knowledge, and abilities important for organizational and personal success.

8700.2 Staff development opportunities are as follows:

(a) The PBC shall offer courses that address acquisition of competencies to meet organizational needs. Coursework, such as customer service skills, computer skills, labor relations training and management development, shall be offered on an on-going basis. Managers shall encourage attendance and, to the extent possible, permit participation during work time;

(b) Opportunities for career development shall be provided, when applicable, through vehicles including mentoring programs, temporary assignments, and involvement in cross-functional teams;

(c) The PBC shall, within budgetary constraints, provide financial assistance to those employees taking job related courses and support credentialing/licensure for those employees required to possess such training;

(d) Recognizing the need for employees to remain healthy and the desire to enhance employees’ personal development, the PBC shall, within budgetary constraints, offer programs to promote wellness and personal growth. Efforts shall be made to partner with outside resources should the PBC not have the capabilities to provide the development opportunities; and

(e) Managers shall be responsible for providing training in specific job related/departmental competencies.

8700.3 Procedures which apply are as follows:

(a) Employees who desire to enroll for courses or participate in a program shall review the course catalog and program schedules. Human Resources shall coordinate enrollment. Managerial permission must be given if the course is taken on work time;

(b) Employees who request attendance at a job related seminar or training session shall complete an off-site training request form and submit it to their manager. The manager shall review the request. Approved requests shall be forwarded to Human Resources. Final approval by Human Resources shall be based on the relevance of the proposed course to current position and objectives subject to financial constraints. Requests shall be reviewed on a quarterly basis, and every effort shall be made to approve coursework equitably. Initial budgets shall reflect such support. Human Resources shall provide guidance for such requests; and

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is the Health and Hospitals Public Benefit Corporation Act of 1996, D.C. Code §§ 44-1101.01 to 44-1103.03.
SOURCE: Final Rulemaking published at 45 DCR 7353, 7395 (October 9, 1998).

22-B DCMR § 8701 ORIENTATION PROGRAM

8701.1 Policy: An orientation program shall be held on a regular basis, designed to introduce new employees to the goals, values and policies of PBC. The program’s objective is to enhance the employee’s assimilation into the work environment through a basic understanding of PBC and departmental policies, employee responsibilities, as well as specific training enabling them to perform their work assignments. Employees shall be encouraged to ask for instruction when necessary.

8701.2 Procedures which apply are as follows:

(a) Attendance shall be mandatory for all employees. Department directors and managers shall be advised of all new employees scheduled for orientation; and

(b) The orientation program shall at a minimum include the following:

(1) Welcome;

(2) Employee expectations;

(3) Employee recognition;

(4) Infection control;

(5) Hazard communications;

(6) Benefits review;

(7) Performance management program;

(8) Tour of the institution;

(9) Security, safety and fire procedures;

(10) Completion of evaluation;

(11) Patients’ rights;

(12) Customer service; and

(13) Organizational values.

(c) Each manager shall provide new employees with detailed explanations of their duties, office routines and schedules as well as specific rules and regulations. During the departmental orientation for a new employee, the manager shall review at least the following topics:

(1) Position descriptions;

(2) Supervisor’s expectations;

(3) Probationary period;

(4) Performance management process;

(5) Work schedule, hours, break and lunch periods;

(6) Time card or time sheet;

(7) Pay period;

(8) Dress code;

(9) Telephone system;

(10) Confidentiality;

(11) Description and overall function of the department;

(12) Relationship with other departments;

(13) Hazards communication; and

(14) Customer service.

(d) Each new employee shall sign documentation of departmental orientation and a copy forwarded to Human Resources.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7396 (October 9, 1998).

22-B DCMR § 8702 MANDATORY RETRAINING

8702.1 Policy: Mandatory retraining must be accomplished on a yearly basis for infection control, hazardous communications, and fire, electrical and security safety, and any other program required by code, JCAHO, or other governing body or law.

8702.2 Procedures which apply are as follows:

(a) All employees must have documented retraining annually for infection control, hazardous communications, and fire, electrical and security safety, and for any other hazards which employees are expected to encounter in their workplace;

(b) The department manager must ensure that every employee has yearly, mandatory retraining on the above topics; and

(c) Documentation of this annual training must be kept in the employees’ file and a copy sent to the appropriate administrator (e.g., if an infection control in-service was given, a copy of the attendees must be given to the Infection Control Director).

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7397 (October 9, 1998).

22-B DCMR § 8703 CUSTOMER SERVICE

8703.1 Policy: The PBC places the highest value on service to customers. To that end, the PBC shall offer a customer service program. Customers include all people who interact with the PBC during the course of the workday, whether they are patients, physicians, staff, visitors, and vendors of the public. The goal is to provide high quality care in a caring and respectful way, while enhancing cooperation and communication among customers.

8703.2 The program shall strive to accomplish the following:

(a) Improve employees’ skills for interacting with customers;

(b) Foster enhanced cooperation and communication;

(d) Recognize each employee’s self-worth.

8703.3 Attendance guidelines are as follows:

(a) The customer service program shall be mandatory. Continued failure to participate in the program may lead to disciplinary action;

(b) The management of each department shall ensure that all of their staff attend the PBC’s customer service program; and

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7397 (October 9, 1998).

22-B DCMR § 8704 TUITION REIMBURSEMENT

8704.1 Policy: The PBC shall encourage its regularly scheduled employees to seek professional advancement and individual improvement through educational opportunities in job-related fields. As resources permit, tuition shall be reimbursed.

8704.2 Eligibility for tuition reimbursement is as follows:

(a) Full-time employees shall be eligible to receive tuition reimbursement for previously approved college credit courses taken on their own time under the following conditions;

(b) Employees pursuing certificate, associate, bachelors, masters, or Ph.D. degree programs are eligible to be reimbursed if job-related; and

(c) An employee must be employed for at least twelve (12) months prior to registration for the course for which reimbursement is being sought.

8704.3 Procedure: Reimbursement shall be made for tuition only when the following procedures are followed:

(a) Prior to registration, an employee must submit a curriculum plan request form to Human Resources. Human Resources shall conduct a meeting with the employee and his/her manager to review and establish a formal curriculum plan; and

(b) For each course within the plan, the employee must submit a tuition reimbursement request form to the Human Resources. Courses shall be approved in accordance with the curriculum plan. Requests submitted after the semester begins shall not be considered.

8704.4 Reimbursement shall be made under the following conditions:

(a) Upon completion of the course(s), the employee must submit a transcript of grade(s) or certificate accompanied with a paid receipt indicating the tuition cost. A grade of “C” or better for undergraduate courses, and “B” or better for graduate courses, or “pass” when it applies in place of other grading, shall be required; and

(b) The employee shall be required to sign a tuition reimbursement loan agreement that shall be forgiven when and if the employee completes one (1) year of additional service.

(c) Employees shall receive reimbursement for tuition only up to a maximum of three thousand dollars ($3,000) per academic year (August to August). All other expenses, i.e., books, fees, etc., shall be excluded.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7398 (October 9, 1998).

22-B DCMR § 8705 EMPLOYEE RECOGNITION

8705.1 Policy: The PBC recognizes that employees’ performance is critical to success. Exemplary conduct or service shall be recognized through special programs.

8705.2 The Shining Star Program shall recognize employees for extraordinary service and performance. The employees nominated must have performed a noteworthy accomplishment within the PBC environment or community. The following rules apply:

(a) A selection committee shall be established. The committee is comprised of three non-exempt/professional and two management employees that shall meet as necessary to review Shining Star nominations. The Vice President for Human Resources shall direct the appointment process. Senior vice presidents shall recommend staff as appropriate;

(b) Selection committee members shall be appointed to the committee for a minimum of six (6) months. Appointments shall be rotated on a staggered basis to ensure both continuity and new membership. The committee shall select a chairperson who shall serve for a six (6) month period;

(d) An employee may nominate any other employee for consideration as a candidate for the Shining Star Award;

(e) The committee may establish specific criteria for selection beyond the performance of a noteworthy accomplishment. All employment records shall be reviewed by Human Resources prior to committee consideration. Nominations shall be presented to the committee without the individual’s name to prevent potential bias. The committee shall review all nominations prior to making final selections. Selected employees shall be notified by the Vice President for Human Resources. Receipt of award shall be by policy established by the committee;

(f) An employee may receive only one Shining Star Award per year; and

(g) A letter of acknowledgment shall be sent to those who submit candidates for nomination.

8705.3 Lunch with the Chief Executive Officer shall recognize employees who consistently perform at the highest level. The goal is to both reward outstanding employees and foster two-way communication on issues relevant to the PBC.

(a) Each group/department shall be invited to choose an employee from their department to have lunch with the Chief Executive Officer. Lunches shall be held once a month. Normally, each department shall send at least one (1) person during the course of the year;

(b) The department manager must notify Human Resources of the name of the employee by the first week of the month for which the lunch shall take place;

(d) The criteria for selection shall be as follows:

(1) The employee must have a satisfactory work record, i.e., no recent disciplinary actions, acceptable attendance, etc.;

(2) The employee must exemplify commitment to his/her department and to the PBC; and

(3) The employee shall be chosen by a consensus of his/her department.

8705.4 Other programs: A committee shall be established to recommend other employee recognition programs subject to financial constraints.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7399 (October 9, 1998).

22-B DCMR § 8706 TRAVEL/PROFESSIONAL MEETINGS

8706.1 Policy: The PBC shall encourage its employees to attend professional business meetings, seminars and workshops that shall aid in the development of professionalism and growth and excellence in patient care standards. The following guidelines are as follows:

(a) As specified by the guidelines of this policy, the PBC may reimburse reasonable expenses incurred by an employee as a result of participation in approved business trips directly related to the PBC business. Expenses must be necessary and related to the performance of the PBC-related business involved;

(b) The Executive Vice President and the Chief Executive Officer must approve all requests. Accessibility of pertinent meetings and seminars shall be considered in obtaining approval for a particular location (i.e., travel to a seminar in a distant location shall be disapproved when a similar conference is available in a closer location to the PBC);

(c) Expenses for a meeting or conference, where an employee is scheduled to make a presentation, shall not be authorized except when the meeting has a direct impact on the PBC. Other considerations shall include associated expenses, time required, location, institutional benefit and clinical service; and

(d) Funds must be available within departmental budgets for travel requests.

8706.2 Procedures which apply are as follows:

(a) Requests in writing must be made in advance and include the purpose and description of the travel, personnel involved, and details of travel and hotel arrangements. The employee must attach literature, i.e., brochures, relevant to the trip and meeting;

(b) Approval for all travel must be obtained from the designated person at least four (4) weeks in advance;

(c) Expenses must be submitted within five (5) days of completion of travel. Reasonable expenses incurred by the employee shall be reimbursed by the PBC provided the employee submits receipts for: room, rental car, air, rail, taxi, meals, etc. Cash advancement shall not be permitted;

(d) Where an automobile is selected for long trips normally traveled by air or rail, the PBC shall reimburse automobile travel cost only up to the currently accepted IRS mileage reimbursement rate up to an amount not to exceed the cost of air or rail travel; and

(e) Employees shall be responsible for presenting information to colleagues, as appropriate, whenever the knowledge gained or accomplishments achieved on a trip would be of interest or significant value to other PBC staff.

8706.3 Travel expenses allowable are as follows:

(a) Automobile - current IRS reimbursement per mile shall be given when a personal automobile is used. Tolls and parking directly associated with a business trips shall be reimbursable. The use of a rental car must be approved in advance and shall be reimbursable only if the location of the trip requires self-provided transportation;

(b) Taxi - fares for taxi and subway between hotels, airports, and business sites shall be reimbursable. Hotel limousine services shall be used whenever possible;

(d) Hotel - hotel accommodations shall be reimbursed up to $150 per day;

(e) Communications - business calls and reasonable personal calls shall be reimbursed;

(f) Entertainment - expenses for entertaining individuals not employed by PBC who have significant business with the PBC shall be reimbursed, although diligence should be exercised. The names of guest, business affiliation and PBC personnel included in the entertainment must be submitted with the expenses;

(g) Travel with spouse - Expenses attributed to travel by the spouse/significant other shall not be reimbursed;

(h) Conference and registration fees - the PBC shall reimburse fees associated with pre-approved business trips; and

(i) Miscellaneous allowance - registration, luncheon meetings shall be reimbursed. A reasonable amount for tips for all other purposes shall also be reimbursed.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7400 (October 9, 1998).

22-B88 PUBLIC BENEFIT CORPORATION PERSONNEL POLICIES: COMPENSATION

22-B DCMR § 8800 COMPENSATION POLICY

8800.1 Policy: The PBC shall maintain a market-based compensation program designed to attract and retain qualified employees that at the same time rewards performance. The goals of the program are to attract employees by the following:

(a) Motivate and reward results;

(b) Provide competitive total cash compensation opportunities;

(d) Provide reasonable and appropriate levels of income protection and replacement.

8800.2 Procedures which apply are as follows:

(a) Human Resources shall maintain the compensation system. Regular reviews shall be performed to ensure internal and external equity;

(b) Jobs shall be classified into pay ranges based on the market for that job, value to the organization, and objective content criteria;

(c) New hires shall be paid within the range for the job contingent upon criteria such as experience and education. No new employee shall be hired at greater than the 50th percentile unless approved by the CEO. Human Resources shall make all job offers;

(d) Employee rewards shall be earned each year and may include individual or group incentives based on achievement of goals, gain sharing plans, or lump sum bonuses for outstanding performance. The Chief Executive Officer shall approve the plan for the upcoming period in consultation with Human Resources;

(e) Individual employees may have their pay adjusted based on meeting objective and measurable criteria in conjunction with the performance management process. Requests for review shall be submitted to the Human Resources along with reasons the employee should be adjusted. Human Resources shall review the request and respond to the requestor within forty-five (45) days; and

(f) Any adjustment in compensation must be approved in advance by Human Resources.

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is the Health and Hospitals Public Benefit Corporation Act of 1996, D.C. Code §§ 44-1101.01 to 44-1103.03.
SOURCE: Final Rulemaking published at 45 DCR 7353, 7402 (October 9, 1998).

22-B DCMR § 8801 OVERTIME AND ON-CALL PAY

8801.1 Policy: The PBC must, of necessity, arrange the hours of work to ensure continuous service to patients while keeping overtime at a minimum.

8801.2 Subject to the CMPA-Title XII, D.C. Code, 2001 Ed. §§ 1-612.01 to 1-612.11, the following procedures which apply are as follows:

(a) In situations where overtime is necessary, PBC shall comply with the provisions of the Fair Labor Standards Act. Nonexempt employees must be paid overtime in accordance with Federal Wage and Hour Laws and applicable collective bargaining agreements;

(b) Overtime must be approved in advance by the department manager;

(c) The overtime rate of time one and one-half (1 1/2) shall be paid for all hours worked in excess of forty (40) hours in each week;

(d) Paid time off days shall not be considered as time worked for the purposes of computing overtime. Overtime shall not be scheduled on a paid time off day;

(e) Unpaid absence shall not be considered time worked; and

(f) There shall be no pyramiding of overtime pay. When two or more types of overtime compensation are applicable to the same hours of work, the greater amount shall be paid.

8801.3 On-call pay: The following procedures are applicable:

(a) Non-exempt employees required by the PBC to be on-call off PBC premises shall receive, during such time, a rate of pay equal to twenty-five percent (25%) of their regular pay. Full-time on-call employees called to work other than during their normal work hours shall receive time and one-half for all hours worked over forty (40) hours. When an employee is called to work more than once during a single on-call period, work performed in response to all calls shall be accumulated. Employees shall receive minimum pay of two (2) hours for any on-call period during which they are called to work at least one (1) time; and

(b) Exempt employees required to be on-call shall be reviewed on a case by case basis.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7403 (October 9, 1998).

22-B DCMR § 8802 DIFFERENTIALS

8802.1 Policy: The PBC may pay a differential to compensate any employee or group of employees in accordance with organizational need. Differentials may be temporary for the duration of the need as determined by the CEO.

8802.2 Procedures that apply are as follows:

(a) Any designated employee whose daily straight-time hours end after 7:00 p.m. or begin before 5:00 a.m. shall receive a shift differential;

(b) Exempt employees shall not be eligible for shift differential;

(c) Any designated employee who works beyond his her regular shift shall be paid a shift differential for all extra hours if at least one-half of the extra time falls between the hours of 7:00 p.m. and 5:00 a.m.; and

(d) The CEO shall designate other differentials according to organizational need.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7404 (October 9, 1998).

22-B DCMR § 8803 OUT OF TITLE PAY

8803.1 Policy: The PBC recognizes that an employee may temporarily work in a job classification that has a higher level of responsibility than the employee’s designated job. The PBC shall pay the difference between the regular job and the higher rated job or 10%, whichever is greater.

8803.2 Procedures which apply are as follows:

(a) To be paid for working out of title, an employee must work in that capacity for a continuous period of two (2) weeks;

(b) Prior to submission of payment for out of title pay, the department manager must notify Human Resources in writing of the reason(s) for the out of title pay. The notification must indicate the expected length of time for the out of title assignment;

(c) For assignments of between two (2) and four (4) weeks, Human Resources shall advise the department manager of approval to grant the out of title pay. A copy of this approval must be attached to the PRF;

(d) For out of title pay requests for four (4) weeks or more the Department Director shall obtain Human Resources and CEO approval for the out of title assignment;

(e) If approved, the form shall be forwarded to Payroll by Human Resources for payment of the out of title pay; and

(f) When the out of title assignment ends, the department manager shall prepare a new form removing the pay differential.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7404 (October 9, 1998).

22-B DCMR § 8804 PAYROLL DEDUCTIONS

8804.1 Policy: The PBC shall deduct from employees’ pay amounts legally required by law and voluntarily agreed to by the employee.

8804.2 Procedures which apply are as follows:

(a) The Payroll Department shall make the deductions as legally required by law without permission of the employee (i.e., federal and state withholdings, social security withholding, garnishments, liens);

(b) Voluntary payroll deduction will take effect with the written permission of the employee. Examples are as follows:

(1) Union dues and initiation fees;

(2) Premiums for insurance beyond that paid for by PBC;

(3) Tax sheltered annuity contributions;

(4) Charitable contributions;

(5) Supplemental life insurance; and

(6) US Savings Bonds.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7405 (October 9, 1998).

22-B DCMR § 8805 GARNISHMENTS AND WAGE ASSIGNMENTS

8805.1 Policy: Employees shall be notified by the Payroll Department that a garnishment, levy or tax lien shall be placed against their earnings. A garnishment execution is a judicial process whereby a creditor has a judgment to shall be forwarded to the Payroll Department for processing. The PBC is legally required to honor appropriately authorized garnishments. It is illegal to terminate an employee because of a garnishment.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7405 (October 9, 1998).

22-B89 PUBLIC BENEFIT CORPORATION PERSONNEL POLICIES: BENEFITS

22-B DCMR § 8900 BENEFITS POLICY

8900.1 For employees hired before October 1, 1997, the PBC shall provide a market competitive benefits package at least equal to or greater than that provided during their previous employment. The plan design shall provide various choices of coverage and encourages financial responsibility. Use of PBC facilities shall be encouraged. Tax-related advantages may be offered to the extent allowable by law.

8900.2 For employees hired after October 1, 1997, the PBC shall provide a market competitive benefits package for its employees. The plan design shall provide various choices of coverage and encourages financial responsibility. Use of PBC facilities shall be encouraged. Tax-related advantages may be offered to the extent allowable by law.

8900.3 Details regarding the benefits plan shall be contained in the appropriate plan documents and Summary Plan Description that are available through Human Resources.

8900.4 The PBC shall offer supplemental benefit programs to allow employees to individually purchase these options through payroll deductions at a favorable group rate.

8900.5 The benefit and retirement eligibility requirements and procedures for union represented employees shall be subject to the provisions of the collective bargaining agreements. Benefits or pension fund information and procedures are set forth in the plan documents issued by the trustees of those plans. Union employees covered by those plans shall be encouraged to consult the plan description issued by the trustees or call the administrator for more information.

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is the Health and Hospitals Public Benefit Corporation Act of 1996, D.C. Code §§ 44-1101.01 to 44-1103.03.
SOURCE: Final Rulemaking published at 45 DCR 7353, 7405 (October 9, 1998).

22-B DCMR § 8901 RETIREMENT

8901.1 Policy: The PBC shall maintain a retirement plan to ensure employees have income during the retirement years. Details of the plan shall be contained in the appropriate plan documents and the Summary Plan Description (SPD). Supplemental savings options shall be offered to provide additional self-funded income, using tax advantages where appropriate.

8901.1 The PBC shall make available to employees education regarding post retirement income strategies. It is noted that the PBC shall provide these programs as a service to employees and does not endorse nor take financial responsibility for the advice given.

8901.2 The following procedures are applicable:

(a) Employees planning to retire shall file written notice with their manager and Human Resources as soon as the decision is made but no later than ninety (90) days prior to retirement;

(b) Human Resources shall then meet with the employee and provide direction as to the process in accordance with the SPD; and

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7406 (October 9, 1998).

22-B DCMR § 8902 COBRA

8902.1 The PBC shall adhere to the Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA). The PBC shall offer employees and their eligible dependents the opportunity to continue certain coverages when a qualifying event occurs, as defined by law, for a limited amount of time determined by the event.

8902.2 Policies that apply are as follows:

(a) Eligibility: All regular employees who are scheduled to work at least 22.50 hours or more per week and are covered by PBC’s group health plan are eligible. Dependents of these employees are also covered.

(b) Reasons for Coverage: The PBC’s group health care plans coverage may be continued up to eighteen (18) or thirty-six (36) months (and, in some cases, twenty-nine (29) months) on behalf of a self (employee) paid basis for the following qualifying events:

(1) For covered employees (up to 18 months at continued coverage);

(2) Termination of employment (other than for gross misconduct); or

(3) Reduction of hours worked.

(1) The covered employee’s termination of employment or reduction of hours worked;

(2) The covered employee’s death;

(3) Divorce or legal separation of a spouse from a covered employee;

(4) A covered employee’s entitlement to Medicare; and

(5) A child’s loss of dependent status.

8902.3 Notification procedures which apply are as follows:

(a) Initial notification shall be forwarded to employees and dependents via first class mail upon eligibility for benefits and when an employee adds on a new dependent (spouse or child);

(b) Election notices shall be mailed certified (with a return receipt requested) to the employee, spouse and dependents when a qualifying event occurs. In the case of divorce, legal separation, or cessation of dependency, covered employees and qualified beneficiaries shall be responsible for notifying the plan administrator within sixty (60) days after the qualifying event;

(1) The employee shall have sixty (60) days from the termination date or the date of the letter, whichever is later, to make the election;

(2) Upon receipt of a signed election notice, the individual or individuals applying shall be processed for benefits. The first payment is due at the time of election, but must be made no later than due forty-five (45) days after receipt of the election notice. The amount of the first payment must include the premium from the date coverage ceased until the date payment is made;

(3) Subsequent payments shall be due by the 1st of the month for which the participant is covered. The participant has a thirty (30) day grace period to make payments;

(4) Open enrollment notification: COBRA participants shall be notified of open enrollments occurring during their period of coverage. This notification gives COBRA participants the opportunity to make changes to their coverage; and

(5) Notification of plan changes: A notification shall be sent to all COBRA participants when the plan offered to active employees is changed. This notice includes a description of change and rates.

8902.4 Termination of continuation: Coverage may be terminated for the following reasons:

(a) The eighteen (18), twenty-nine (29) or thirty-six (36) month period has been exhausted;

(b) PBC no longer provides group health coverage to any of its employees;

(d) The former employee or dependent becomes covered under another group health plan; unless that plan contains any exclusions or limitations with respect to any pre-existing conditions;

(e) Medicare entitlement, and

(f) If coverage is extended up to twenty-nine (29) months due to disability and there has been a determination that the former employee is no longer disabled.

8902.5 Termination notices shall be mailed via first class mail within one hundred and eighty (180) days prior to expected termination date.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7406 (October 9, 1998).

22-B DCMR § 8903 RELOCATION

8903.1 Policy: The PBC shall provide reasonable relocation expenses for individuals in positions of department manager and above and in difficult to recruit positions. The needs of the PBC shall be the primary factor in this determination. The determination shall be made by the Vice President for Human Resources, subject to the approval of the Chief Executive Officer.

8903.2 Procedures which are applicable are as follows:

(a) Requests for relocation benefits must have prior approval from the Vice President of Human Resources;

(b) Relocation must be completed within a reasonable time; the maximum time allotted is one year from the date of hire;

(c) Payment shall be made to cover the cost of transportation expenses for moving normal household goods, furnishings, and personal effects. In transit insurance covering the foregoing items and the packing/crating at origin and unpacking at destination shall also be covered;

(d) The employee must obtain three (3) bids from licensed movers and submit them to Human Resources. Human Resources in consultation with the employee shall select the moving company; and

(e) Payment shall be made to the selected mover by PBC.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7408 (October 9, 1998).

22-B90 PUBLIC BENEFIT CORPORATION PERSONNEL POLICIES: HEALTH AND SAFETY

22-B DCMR § 9000 HEALTH, SAFETY, AND SECURITY

9000.1 Safety: The PBC shall strive to provide a safe environment for its patients, visitors, and employees. The PBC shall adhere to guidelines established by regulatory agencies for health care institutions.

9000.2 Employees shall be responsible for maintaining a safe environment. Information on specific safety procedures is available in the Regulatory Affairs Department and the PBC safety manual. Guidelines shall be available to all employees.

9000.3 Employees shall be encouraged to bring to the attention of the Safety Officer any potential hazard or unsafe condition of which they become aware immediately. No employee shall be penalized in any manner or face any kind of retaliation for the good faith submission of a complaint regarding a health and safety issue or for providing information relevant to any reported health and safety issue.

9000.4 The PBC shall maintain a written hazardous communication program to provide policies for handling hazardous or potentially hazardous materials. Information is contained in the materials safety data sheets, which are available to all employees through the Infection Control Coordinator and the Safety Officer.

9000.5 Health: The nature of a healthcare institution dictates that employees shall be potentially exposed to various hazardous conditions that may affect their health. It is therefore mandated that universal precautions shall be used under the conditions in which employees may be exposed to blood and body fluids.

9000.6 Exposures to blood and potentially infectious materials shall be considered serious and reported immediately to Infection Control/Risk Management so that adequate and appropriate follow up is ensured.

9000.7 Security: The Security Department shall seek to maintain a secure campus. Specific security procedures are available through that department.

9000.8 The PBC shall not accept responsibility for any personal property lost or damaged on the premises. All valuables should be secured appropriately. Any missing property must be reported to the Security Department. The PBC shall reserve the right to inspect lockers and other employer provided storage space and packages and bags entering or leaving the premises.

History

AUTHORITY: Unless otherwise noted, the authority for this chapter is the Health and Hospitals Public Benefit Corporation Act of 1996, D.C. Code §44-1101.01 to 44-1103.03.
SOURCE: Final Rulemaking published at 45 DCR 7353, 7409 (October 9, 1998).

22-B DCMR § 9001 OCCUPATIONAL HEALTH SERVICE

9001.1 Policy: The PBC shall maintain an Occupational Health Service. The Occupational Health Service shall provide pre-employment and annual screening, drug and alcohol testing, return to work clearance, evaluation of on-the-job injury, first aid and minor palliative treatment to allow the employee to return to work.

9001.2 Procedures for pre-employment and health screening are as follows:

(a) All employees shall undergo a pre-employment examination and may not commence work until health clearance is given by Occupational Health Services;

(b) Human Resources shall schedule pre-employment health examination prior to desired start date. The pre-employment health examination shall require a minimum of three (3) days for completion; and

(c) Occupational Health Services may require additional information from the applicant’s private physician prior to employment clearance.

9001.3 Annual health assessments procedures are as follows:

(a) Employees shall complete the annual health assessment as a condition of continued employment;

(b) Managers shall release their employees for health assessments. Appointment schedules shall be forwarded to department managers. Employees shall consult with their department managers to arrange the health review appointment;

(c) Employees who fail to complete the health assessment during the assigned month shall be subject to suspension from duty and loss of pay. The suspension shall last until all requirements are met;

(d) Employees may elect to have their health assessment completed by a private physician at their own expense. A health assessment form must be obtained by the employee from Occupational Health Services. The completed form must be returned to Occupational Health Services by the end of the month in which the review is scheduled;

(e) In the event an employee is on a leave of absence, vacation, or sick leave during the month of the annual assessment, the employee must complete the health review within two weeks of their return. The employee shall contact Occupational Health Services prior to their return to schedule an appointment; and

(f) If an employee is injured while on duty, an occurrence report must be completed by the injured employee and signed by the employee’s supervisor. The completed report must be taken to Occupational Health Services by the injured employee at the time of the incident, if possible. Occupational Health Services shall provide an evaluation, treatment, and referral. Compliance with this referral is essential for eligibility to receive worker’s compensation benefits through the Human Resources. The employee must contact Occupational Health Services if unable to return to work after an on the job injury. Absence due to on the job injury must be authorized by Occupational Health Services.

9001.4 Procedures for on the job illness are as follows:

(a) In the event an employee becomes ill on duty, the employee must report the illness to the departmental supervisor, obtain a sick call slip, and present it to Occupational Health. Employees who are not on duty, shall not be seen by Occupational Health Services. Employees who come to work ill, shall not be seen, but sent home to follow-up with their private healthcare provider;

(b) Occupational Health Services shall provide first aid and minor treatment and emergency care to enable the employee to return to work. Continuing care is not available in Occupational Health Services. All other healthcare services shall be provided by the employee’s private healthcare provider; and

(c) Employees who sustain life threatening injuries or illness while on duty shall be escorted directly to the Emergency Room. The Emergency Room shall notify Occupational Health Services of the incident. Occupational Health Service shall notify the employee’s departmental supervisor of the situation.

9001.5 Return to work clearance procedures are as follows:

(a) In the event an employee is absent from work for three (3) or more consecutive days due to illness or injury, he/she must be cleared through Occupational Health Services to return to work;

(b) Upon returning to work, the employee must submit a physician’s certificate to Occupational Health Services indicating the following:

(1) Beginning and ending dates of disability;

(2) Clearance date to return to full duty; and

(3) Any limitations or restrictions on performing the essential functions of his/her job.

(d) Employees who returns to duty from an illness or injury on a Saturday and Sunday, holiday, or shift commencing after 3:00 p.m., must report to the Emergency Room for temporary clearance. Clearance must be obtained as indicated in this policy from Occupational Health Services during the next regular working day; and

(e) Employees must report for clearance no later than a half-hour prior to the commencement of their assigned shift schedule, or they may not be cleared for duty for an additional twenty (24) hours.

9001.6 Procedures for emergency room coverage for Occupational Health Services are as follows:

(a) The Emergency Room shall provide temporary clearance for employees who are returning to work from an illness and are reporting back to work during the non-operational hours (weekends, holidays, or after 3:00 p.m., Monday through Friday), of the Occupational Health Service; and

(b) The Emergency Room (ER) shall be available for assessment and treatment for on the job injury and illness during the non-operational hours of Occupational Health Services. All employees shall be referred back to the Occupational Health Services from the ER. Any employee seen in the ER for an on the job injury, must contact the Occupational Health Service during the next working day.

9001.7 Confidentiality procedures are as follows:

(a) Results of all services provided by Occupational Health Services and Emergency Room as provided for by this policy must be kept confidential and maintained in separate Occupational Health Services files; and

(b) Exceptions to this apply in instances where the implications of the disability disclosed require the PBC to take precautionary measures and in other circumstances prescribed by law. In such instances, information shall only be supplied to those with a need to know.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7410 (October 9, 1998).

22-B DCMR § 9002 EMPLOYEE ASSISTANCE PROGRAM

9002.1 Policy: The PBC shall maintain an Employee Assistance Program (EAP) addressing the needs of employees. The guidelines of the EAP program are as follows:

(a) PBC shall maintain an Employee Assistance Program to assist employees who develop emotional/behavioral/dependency problems that adversely affect their job performance;

(b) The purpose of the EAP is restoration of health with full recovery by motivating the employee to seek, accept, and benefit from the treatment provided by or through the Employee Assistance Program;

(c) An employee may at any time make a self-referral, however, when an employee’s job performance, attendance, or punctuality begins to suffer, the manager’s role is to identify the problem and utilize that performance as a motivator for the employee to seek help and treatment through the EAP; and

(d) The Employee Assistance Program shall not be a substitute for the disciplinary process.

9002.2 Procedures: The following actions shall be taken for managerial referral to the Employee Assistance Program:

(a) The manager shall ensure that each employee has a clear understanding of what is expected of him/her in terms of work performance and attendance by way of job description, skills evaluation, and previously documented counseling;

(b) The manager shall document, and discipline, if appropriate, all behavior, attendance, and job performance that fails to meet established standards;

(c) The manager shall meet with the employee to discuss job performance, attendance, etc. The employee shall be informed of the concern the manager has regarding his/her performance. The employee shall also be informed if improvement does not occur, that disciplinary action may be necessary. A plan for improvement whereby the employee is part of the solution, i.e., offers suggestions and partakes in problem-solving, may be discussed at this time. The manager may indicate that the Employee Assistance Program is available and the employee may elect to go at this time;

(d) Should job performance continue to deteriorate, and severe disciplinary action be warranted, the manager after consultation with Human Resources may impose a time frame as to when the employee must respond with an EAP appointment;

(e) After the employee has notified the manager of the appointment, the employee shall sign an EAP release form which may be either faxed to the attention of the counselor or brought to the EAP by the employee. The counselor and employee shall establish and work toward goals so that he/she may achieve working potential. The EAP counselor shall keep the manager abreast of the employee’s progress regarding the established working goals, while keeping all personal information such as diagnosis and treatment strictly confidential; and

(f) Any employee requiring time off for rehabilitation treatment, either self or EAP referred, shall notify his/her manager regarding the time out prior to admission. Documentation of successful completion of a rehabilitation program shall be presented to Occupational Health or the Human Resources prior to returning to work.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7412 (October 9, 1998).

22-B DCMR § 9003 DRUG AND ALCOHOL MISUSE

9003.1 Policy: The PBC shall comply with the Drug Free Workplace Act. The PBC shall strive to provide both our patients and employees with a safe drug free environment. This policy is designed to protect the health of employees and ensure the safety of our patients. This policy encompasses employee conduct and performance as it relates to legal and illegal drug and alcohol use.

9003.2 PBC shall prohibit the use, sale, dispensing, and possession of illegal drugs or alcohol in the workplace. PBC also prohibits employees from being under the influence of illegal drugs or alcohol in the workplace. This prohibition includes the presence of any legal or prescription drug which impairs the employee’s ability to perform his/her job properly and safely.

9003.3 Drug and alcohol screening shall be performed when an employee demonstrates a “reasonable suspicion” of being under the influence of alcohol and an illegal drug.

9003.4 The PBC shall encourage employees who are experiencing drug or alcohol problems to voluntarily seek appropriate assistance. To serve this need the services of the Employee Assistance Program shall be available to employees and anyone who lives with them. The employee shall notify his/her supervisor regarding absence from work due to inpatient treatment. It shall be treated as any short-term disability.

9003.5 Employee drug testing is done when an employee demonstrates a “reasonable suspicion” and should be handled as follows:

(a) The employee is observed for signs of being under the influence of drugs or alcohol with another supervisor or administrator present. A sample listing of such signs is available from the Human Resources;

(b) If the supervisors concur there is a “reasonable suspicion” that the employee appears to be under the influence of a substance, the employee shall be asked to a private area in the presence of another manager and notified of their suspicions;

(c) The employee shall be brought to the Occupational Health Department or the Emergency Room (when Occupational Health is closed) by his/her manager who shall remain with the employee until the specimen collection is completed;

(d) Failure to consent to drug testing may result in termination of employment;

(e) Employees taking any prescribed or over-the counter medications must list all medications on the informed consent. This information shall be considered a confidential medical record;

(f) Employees who deny any prescribed or over-the-counter medications shall sign the consent;

(g) Specimen collection shall be carried out maintaining chain of custody;

(h) The employee shall not be permitted to work while test results are pending;

(i) An employee who is believed to be impaired shall not be permitted to operate a motor vehicle. Arrangements shall be made through the employee’s department to be transported home by either a taxicab, coworker, or family member;

(j) Test results shall be provided by the Human Resources;

(k) Positive test results may result in termination. At the PBC’s discretion, measures short of termination may be considered;

(l) PBC shall be under no obligation to refer anyone for treatment; and

(m) Employees who have completed a treatment program must report to the Occupational Health Department with the appropriate documentation for clearance.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7414 (October 9, 1998).

22-B DCMR § 9004 WORKPLACE VIOLENCE

9004.1 Policy: The PBC is committed to provide a workplace free of recognized hazards which are likely to cause physical harm to employees. As such, the PBC shall take steps to identify and prevent violence in the workplace.

9004.2 Workplace violence is defined as any coercive behavior occurring in the work setting, such as physical violence, threatening behavior, or verbal abuse. This includes but is not limited to intimidation, threats, destruction of property, assaults, fighting, or rape.

9004.3 The PBC shall not tolerate violence of any kind. To prevent workplace violence the PBC shall follow these applicable procedures:

(a) Conduct appropriate background checks on new hires to screen out potential problem employees;

(b) Treat employees with dignity and respect;

(c) Conduct termination with empathy and compassion, focusing on the behavior or issues as opposed to the person, and providing outplacement assistance as appropriate;

(d) Provide training on identifying, controlling, and defusing aggressive behavior;

(e) Develop a crisis management team trained to respond to potentially violent situations; and

(f) Provide access to an Employee Assistance Program.

9004.4 Procedures which apply are as follows:

(a) Employees who engage in violent behavior shall be subject to severe disciplinary action, up to and including discharge; and

(b) Employees who observe or are subject to workplace violence must immediately report such activity to their manager, the Security Department, and Human Resources so that an investigation may take place. No employee shall be penalized in any manner or face any kind of retaliation for the good faith submission of a complaint alleging workplace violence or for assisting in providing information relevant to any reported violent incident.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7415 (October 9, 1998).

22-B DCMR § 9005 SMOKING

9005.1 Policy: The PBC shall provide a smoke-free environment for employees, patients, and visitors. As such, smoking shall be prohibited within all of PBC’s facilities.

9005.2 Procedures which apply are as follows:

(a) Smoking shall be prohibited in offices, patient rooms, waiting rooms, lobbies, restrooms, stairwells, elevators, cafeteria, and all other areas within the PBC facilities;

(b) Smoking shall be prohibited within fifteen (15) feet of the entrances of the facility. Employees may smoke only in designated areas; and

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7416 (October 9, 1998).

22-B DCMR § 9006 CONSCIENTIOUS OBJECTION TO MEDICAL PROCEDURES

9006.1 Department heads shall not discipline or in any way penalize an employee for refusing to participate in certain aspects of direct patient care that are in conflict with their religious, or ethical beliefs. If a patient’s safety is in jeopardy, the employee must provide for patient safety and avoid abandonment. Withdrawing from care/treatment of the patient is only acceptable when an alternative source of care has been made available.

9006.2. Procedures which are applicable are as follows:

(a) Pre-employment: If an applicant or new employee indicates during an interview that he/she has a religious or ethical belief that conflicts with a particular procedure, the department head must consult with Human Resources concerning whether a reasonable accommodation is warranted;

(b) Staff requests: If treatment modalities occur in an area or unit that may be sensitive to cultural or religious beliefs, the manager shall discuss such treatments with the staff and ascertain if staffing issues exist;

(c) An employee must notify his/her immediate supervisor in writing of any procedures which conflict with his/her religious or ethical beliefs. This request shall be received prior to any assignment. The suggested format is:

I hereby notify PBC that I am unwilling to take part in ______________ procedure since it is contrary to my conscience or religious beliefs. This is my official notification. (Signature and date.)

(d) The department manager shall send a copy of the request to Human Resources, which shall determine whether a reasonable accommodation is warranted;

(e) The department manager shall be ultimately responsible to assess and ensure appropriate staffing so that patient care needs are met;

(f) The department manager shall notify Human Resources of staffing issues related to departmental changes; and

(g) Staff shall be afforded every opportunity to bid on available positions for which they are credentialed/qualified.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7416 (October 9, 1998).

22-B DCMR § 9007 EMERGENCY CONDITIONS

9007.1 Policy: The PBC shall ensure that essential patient care services are provided and staffing is adequate in the event of an emergency, such as inclement weather, power failure, or other natural disaster.

9007.2 Employees scheduled to work must make every effort to support the patient care delivery system.

9007.3 Emergency transportation arrangements, if instituted, may be designed to transport employees essential to support patient care.

9007.4 Emergency conditions: activation of emergency conditions are as follows:

(a) After review of available information regarding a potential emergency, the administrator on-call shall determine whether an emergency condition as defined by this policy exists;

(b) If an “emergency condition” is called, the administrator on-call shall advise the nursing administrator on duty, the Security Department, the Communications Department, and each vice president that such condition exists;

(d) A hotline for emergency information shall be established and maintained by the Communications Department. A command center shall be established in the Nursing Department to coordinate essential services and staffing. Human Resources shall assist such effort;

(e) The Communications Department shall notify local radio stations to announce that an emergency condition has been activated;

(f) Staffing during emergency conditions is as follows:

(1) Departments providing essential services shall remain open;

(2) Department managers must not release employees until the next shift has arrived. Assessments on staff shall be made regularly by managers to ensure safe patient care;

(3) Scheduled employees who are late or prevented from arriving must contact the command center for instructions; and

(4) Each department shall maintain an employee list containing names, addresses, and phone numbers to be contacted in an emergency. A copy of such list shall be forwarded to the Communications Department.

(g) The following guidelines are applicable for emergency transportation:

(1) The command post shall coordinate the transportation effort, which shall include PBC owned vehicles equipped for emergency conditions; and

(2) Every effort shall be made to provide transportation to those employees considered essential who cannot arrive at the PBC on his/her own;

(h) Pay practices during emergency conditions, which apply, are as follows:

(1) Employees unable to leave shall be accommodated with food and lodging;

(2) Employees who are assigned to perform duties other than their regular assignments shall be compensated by their regular rate of pay;

(3) Overtime and shift differential shall be paid per policy;

(4) Employees unable to report to work due to emergency conditions shall normally not be paid. Alternate pay practices for severe conditions shall be reviewed on a case by case basis;

(5) Employees who are ill shall be marked absent without pay pending presentation of proof of illness; and

(6) Employees who arrive within two (2) hours of the start of their shift shall be paid for the entire shift. Those who arrive more than two hours after the start of their shift may be paid either from the time of arrival or the entire shift at the discretion of their manager. Normally, an employee to be paid for the entire shift must demonstrate effort to arrive on time (i.e., calling the command center or manager while in transit or requiring transportation).

9007.5 Termination of emergency conditions: The PBC administrator on-call in coordination with the CEO shall terminate the emergency condition after appropriate consultation; and

9007.6 The Communications Department and the command post must be notified immediately. The hotline shall be updated at that time.

History

SOURCE: Final Rulemaking published at 45 DCR 7353, 7417 (October 9, 1998).

22-B95 D.C. GENERAL HOSPITAL PROCUREMENT REGULATIONS

22-B DCMR § 9500 PURPOSE AND APPLICATION

9500.1 The District of Columbia General Hospital Procurement Regulations (the “Regulations”), issued by the District of Columbia General Hospital Commission (the “Commission”) establish policies, procedures, and guidelines relating to the procurement, management, control, and disposal of supplies, services, and construction, as applicable under the authority of D.C. Code, 2001 Ed. §44-1901 to 44-1957, and in accordance with the quality controls stated in §9811.

9500.2 The Executive Director of the Hospital, as delegated by the Commission, is vested with the authority to administer operating policies, procedures, and regulations adopted by the Commission in accordance with D.C. Code, 2001 Ed. §44-1901 to 44-1957.

9500.3 This chapter applies only to procurements solicited or entered into after the effective date of this chapter, unless the parties agree to its application to a contract solicited or entered into prior to the effective date.

9500.4 Where such statute or regulation is referred to in this chapter, the reference shall be to the most recent amendment or version of any statute or regulation.

9500.5 If any provision of this chapter is deemed invalid, void or unenforceable by a court of competent jurisdiction, this chapter shall be construed as though the provision does not appear herein. Any such finding by a court of competent jurisdiction shall not affect the validity of any other section, paragraph, or sentence of this chapter.

History

AUTHORITY: Unless otherwise noted, this chapter was enacted under the authority of the D.C. General Hospital Commission Act, D.C. Code, 2001 Ed. §44-1901 to 44-1957. The D.C. General Hospital Commission Act subsequently was repealed by the Health and Hospitals Public Benefit Corporation Act of 1996 §402, D.C. Law 11-212, 43 DCR 4962 (April 12, 1997). For current provisions regarding the Public Benefit Corporation, please refer to D.C. Code, 2001 Ed. §44-1101.01 to 44-1103.03.
SOURCE: Final Rulemaking published at 41 DCR 4508 (July 8, 1994).

22-B DCMR § 9501 AUTHORITY AND RESPONSIBILITY OF THE OFFICE OF MATERIELS MANAGEMENT

9501.1 The Executive Director shall designate the Contracting Officer (the “CO”). The CO shall be familiar with public procurement of supplies, services, and construction.

9501.2 The CO shall adopt operational procedures governing the internal functions of the offices which shall conform to this chapter.

9501.3 Any authority conferred on the CO by this chapter may be further delegated in writing by the CO, after consultation with the Executive Director or his designee, unless otherwise provided herein and shall include clear written actions on the limitations of the authority being delegated. The delegations shall remain in effect unless modified or until revoked in writing.

9501.4 In no instance shall a Hospital official designated as a contracting officer be delegated any greater contracting authority than that from whom it was delegated.

9501.5 Only an appointed contracting officer is authorized to enter into, administer, and terminate contracts. However, he/she may bind the Hospital only to the extent of the contracting authority set forth under §9501.3.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4509 (July 8, 1994).

22-B DCMR § 9502 SOURCES OF SUPPLIES AND SERVICES

9502.1 The Hospital may obtain supplies and services as described below:

(a) The Hospital may satisfy requirements for supplies and services from or through the sources and publications listed below without solicitation:

(1) General Service Administration (GSA)/Veteran Administration Federal Schedules (VA);

(2) Existing requirements contracts;

(3) District supply schedules; and

(4) D.C. Department of Corrections, Industries Division; or other District agencies; or

(b) The Hospital may satisfy requirements for supplies and services from other sources, including the open and LSDBE market.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4509 (July 8, 1994).

22-B DCMR § 9503 CONTRACTING FOR SERVICES

9503.1 The Hospital may obtain services from professional, non-professional, expert, and consulting personnel on an individual or organizational basis, when essential to the Hospital’s mission or when the services would achieve maximum effectiveness or economy of operations.

9503.2 The CO shall ensure that the applicable provisions of the Service Contract Act of 1965 (41 U.S.C. §§351 - 358) and any applicable wage determinations are incorporated in accordance with federal regulations into all solicitations.

9503.3 All contracts for professional and non-professional personnel, expert and consulting services must be executed in a manner that is consistent with Hospital personnel policy as promulgated in DCMR Chapter 85 - General Personnel Policy.

9503.4 Requirements for medical and human care services may be publicly announced. Medical and human care services shall use methods set forth in this section rather than the solicitation or source selection methods.

9503.5 Requirements for medical and human care services are services provided by professionals whose occupations are subject to licensure under the D.C. Health Occupation Revision Act of 1985, D.C. Code, 2001 Ed. §§3-1201.01 to 3-1213.01, or a health care institution and are not subject to any other solicitation process set forth in this regulation.

9503.6 The CO in conjunction with the appropriate Hospital Division Director shall negotiate contracts for the medical and human care services based on the demonstrated competence and qualifications of prospective contractors to perform the services required at fair and reasonable prices.

9503.7 No individual or institution shall be eligible for award of a medical and human care services contract during the period in which any of its principals or officers are participating as members of the awarding evaluation board, or when any member of the awarding evaluation board has a financial interest in the firm.

9503.8 Expert services may be procured when in the best interest of the Hospital and are not subject to the solicitation processes set forth in this regulation.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4510 (July 8, 1994).

22-B DCMR § 9504 LOCAL, SMALL AND DISADVANTAGED BUSINESS ENTERPRISE ACT

9504.1 Procurements made under this chapter shall be in accordance with the requirements of D.C. Act 9-223, as amended.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4511 (July 8, 1994). EDITOR’S NOTE: For current provisions regarding contracting with local, small, and disadvantaged businesses, please refer to D.C. Code, 2001 Ed. §§2-217.01 to 2-217.07.

22-B DCMR § 9505 PUBLICIZING PROCUREMENT ACTIONS

9505.1 A notice of availability for each solicitation for a proposed procurement may be published in a major newspaper of local circulation. Additional advertisements may be placed when it is considered appropriate.

9505.2 The time between the issuance of the solicitation and the date set for bid opening or receipt of initial proposals shall not be less than thirty (30) calendar days, except as provided by §9505.3.

9505.3 The requirements of solicitation advertising shall not apply to any of the following:

(a) Sole source procurement (§9600);

(b) Emergency procurement (§9601);

(d) Medical and human care services (§9503).

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4511 (July 8, 1994).

22-B DCMR § 9506 SOLICITATIONS

9506.1 After issuance of a solicitation, but before the date and time set for receipt of bids/proposals, changes may be made in the solicitation to reflect any of the following:

(a) Significant changes in quantity, specifications, or deliver schedules;

(b) The correction of defects or ambiguities;

(d) any other appropriate purpose affecting the procurement.

9506.2 Each amendment shall be distributed no later than three (3) business days prior to the bid opening or closing date to allow prospective bidders/offerors to consider the information in submitting their bid/offer.

9506.3 Amendments to the solicitation shall be identified as such and shall require the bidder/offeror to acknowledge its receipt.

9506.4 If the original time and date set in the solicitation for receipt of bids/offers does not permit preparation of the bid/offer, an increase in the time and for submission of the bids/offers may be allowed. The Hospital may increase the time for submission of the bids/offers by facsimile transmission, telegraph, or telephone. The extension of time shall be confirmed in a subsequent written amendment.

9506.5 Prior to the opening of bids/proposals or after the opening but before the award, a solicitation may be canceled if is determined to be in the best interest of the Hospital.

9506.6 When a solicitation is canceled, notice of cancellation shall be sent to all prospective bidders/offerors to whom the solicitation has been furnished.

9506.7 Any response to a solicitation received at the place designated in the solicitation after the exact time and date set for receipt of such shall be considered “late” unless either of the following applies:

(a) It was sent by registered or certified mail not later than five (5) calendar days before the solicitation receipt date specified;

(b) It was sent by mail and it is determined that the late receipt was due solely to mishandling by the Hospital after receipt at the location specified.

9506.8 Any request for withdrawal or request for modification received after the time and date set for opening of bids/offers shall be considered late.

9506.9 If a contract provides for the exercise of an option, the solicitation shall include appropriate option clauses, approved by the CO.

9506.10 Each solicitation containing an option provision shall state the basis of evaluation, either exclusive or inclusive of the option, and, when appropriate, shall inform bidders that the Hospital may exercise the option at the time of award.

9506.11 A solicitation may require that an option must be offered at prices no higher than those for the initial requirements in either of the following circumstances:

(a) When the option quantities will not be evaluated for award purposes, or

(b) When future competition for the option is not practical.

9506.12 A solicitation that requires the offering of an option at prices no higher than those for the initial requirement shall specify the following:

(a) That the Hospital will accept an offer containing an option price higher than the base price only if the acceptance does not prejudice any other offeror; and

(b) That option quantities for additional supplies will be limited to not more than fifty percent (50%) of the initial quantity of the same contract line item. However, in unusual circumstances, the CO may approve a greater percentage or quantity.

9506.13 Each solicitation and contract shall state the period within which an option may be exercised and the period shall be set in order to provide the contractor adequate lead time to ensure continuous production or services.

9506.14 A solicitation or contract may express options for increased quantities of supplies or services in terms of the following:

(a) A percentage of specific line items;

(b) An increase in specific line items; or

9506.15 In deciding which firms to notify of a change, the CO shall consider the following:

(a) If proposals are not yet due, the amendment shall be sent to all firms that have received a solicitation;

(b) If the time for receipt of proposals has passed but proposals have not yet been evaluated, the amendment shall be sent only to the responding offerors; and

(c) If the competitive range has been established, the amendment shall be sent only to those offerors within the competitive range.

9506.16 If a change is so substantial that it warrants complete revision, the original solicitation, shall be canceled and at the Hospital’s option a new one may be issued. The new solicitation shall have a new number and shall be issued to all firms originally solicited and to any firms added to the original list, and shall be advertised in accordance with the requirements of this title.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4511 (July 8, 1994).

22-B DCMR § 9507 SPECIFICATIONS, STATEMENT OF WORK, AND PURCHASE DESCRIPTIONS

9507.1 The Hospital shall provide specifications, statement of work, and purchase descriptions in a manner designed to promote competition to the maximum extent possible and shall include restrictive provisions or conditions only to the extent necessary to satisfy the minimum needs of the Hospital, or as required by law.

9507.2 Specifications, statement of work, and purchase descriptions shall reflect the minimum needs of the Hospital to meet those needs. Specifications and purchase descriptions may be stated in terms of the following:

(a) Function, so that a variety of products or services may qualify;

(b) Performance, including specifications of the range of acceptable characteristics or the minimum acceptable standards; or

9507.3 Items to be procured shall be described by citing the applicable specifications, statement of work, or by a description containing the necessary requirements.

9507.4 When authorized in accordance with this section, or when no applicable specification exists, a purchase description may be used. Each purchase description shall set forth the essential physical and functional characteristics of the materials or services required.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4514 (July 8, 1994).

22-B DCMR § 9508 COMPETITIVE SEALED BIDDING

9508.1 Competitive sealed bidding shall be the preferred procedure for the solicitation of bids for the procurement of supplies, services, or construction when the following conditions exist:

(a) Award will be made on the basis of conformance to the specifications and price-related factors;

(b) It is not necessary to conduct discussions with the responding bidders about their bids; and

9508.2 A pre-bid conference may be held to brief prospective bidders after a solicitation has been issued, but before bids are submitted. The conference shall be announced to all prospective offerors known to have received a solicitation.

9508.3 Determination provided at the pre-bid conference does not change the terms or amend the solicitation.

9508.4 To be considered for award, a bid shall be required to comply with all the provisions of the solicitation.

9508.5 Bids shall be submitted so that they will be received in the office designated in the solicitation not later than the exact time set for receipt of bids. Bids/offers are mailed at the risk of the bidder and the preferred method of delivery is hand-delivery.

9508.6 A bidder may modify or withdraw its bid by submitting a written notice. The notice shall be received in the office designated in the solicitation before the time set for receipt of bids.

9508.7 All bids, bid withdrawals, and bid modifications shall be opened publicly in the presence of one or more persons at the time, date, and place indicated in the solicitation. The name of each bidder, the bid price, and such other information as is deemed appropriate by the CO shall be read aloud or otherwise made available.

9508.8 For purposes of this section, a “minor informality or irregularity” is one that is merely a matter of form and not of substance. It also relates to some immaterial defect in an offer which can be corrected or waived without being prejudicial to other bidders.

9508.9 Minor informalities or irregularities in bids submitted to the Hospital may be waived if the waiver of the deficiency is in the best interest of the Hospital.

9508.10 After the opening of bids, the Hospital shall examine each bid for mistakes.

9508.11 In cases of mistakes or in cases where there is reason to believe that a mistake may have been made, the bidder shall request a verification of the bid and the suspected mistake.

9508.12 If the bidder alleges a mistake, the matter shall be processed before award in accordance with the following:

(a) If the bidder submits a written notice of the alleged mistake within five business days;

(b) The authority to permit corrections of bids is limited to bids that, as submitted, are responsive to the CSB and shall not be used to permit correction of bids to make them responsive;

(d) A bidder may be permitted to withdraw a low bid in either of the following circumstances:

(1) If a mistake is clearly evident on the face of the bid document but the intended bid is not similarly evident; or

(2) If the bidder submits evidence which clearly and convincingly demonstrates that a mistake was made.

9508.13 When a bid is corrected or withdrawn, or correction or withdrawal is denied, the CO shall prepare a determination showing that the relief was granted or denied.

9508.14 If a mistake in a bid is not discovered until after award, the mistake may be corrected by contract amendment if correcting the mistake would be favorable to the Hospital without changing the essential requirements of the specifications.

9508.15 In addition to the cases contemplated in this section, or as otherwise authorized by law, if a mistake in a bid is not discovered until after award, one (1) of the following determinations shall be made:

(a) To reform a contract to delete the items involved in the mistake or to reform a contract to increase the price if the contract price, as corrected, does not exceed that of the next lowest acceptable bid under the original CSD;

(b) That no changes shall be made in the contract as awarded; or

9508.16 Determinations under this section shall be made only on the basis of clear and convincing evidence that a mistake was made by the contractor, and was so apparent as to have given the CO notice of the probability of the mistake.

9508.17 The Hospital shall include in the contract file a record of each determination made in accordance with this section, the facts involved, and the action taken.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4514 (July 8, 1994).

22-B DCMR § 9509 COMPETITIVE SEALED PROPOSALS

9509.1 If competitive sealed bidding is not appropriate, offers shall be solicited through the competitive sealed proposals method.

9509.2 A pre-proposal conference may be held to brief prospective offerors after a solicitation has been issued but before offerors are submitted. The conference shall be announced to all prospective offerors known to have received a solicitation.

9509.3 Attendees shall be informed of the following:

(a) That remarks and explanations at the conference do not qualify or amend the terms of the solicitation; and

(b) That the solicitation and specification remain unchanged unless the solicitation is amended in writing.

9509.4 All proposals shall be received by the exact time and date set in the solicitation.

9509.5 To be considered for award, a CSP shall be required to comply with all the provisions of the solicitation.

9509.6 Each CSP shall include all of the evaluation factors, including price, and the relative importance of each factor. A statement shall be included in the CSP that the CO may conduct written or oral discussions with all offerors who submit proposals within a competitive range, but that initial proposals may be accepted without such discussions.

9509.7 The evaluation of each proposal shall be based on the evaluation factors established in the CSP. Numerical rating systems may be used by the Hospital, but are not required. Factors not specified in the CSP shall not be considered.

9509.8 For purposes of this section, a “minor informality or irregularity” is one that is merely a matter of form and not of substance. It also relates to some immaterial defect in an offer which can be corrected or waived without being prejudicial to other offerors.

9509.9 Minor informalities or irregularities in offers submitted to the Hospital may be waived if the waiver of the deficiency is in the best interests of the Hospital.

9509.10 After the closing of proposals, each shall be examined for mistakes.

9509.11 In cases of mistakes or in cases where there are reasons to believe that a mistake may have been made, a request shall be made from the offeror for a verification of the proposal and call attention to the suspected mistake.

9509.12 If the offeror alleges a mistake, the matter shall be processed before award.

(a) The authority to permit corrections of proposals is limited to proposals that, as submitted, are responsible to the CSP and shall not be used to permit correction of proposals to make them responsive;

(b) Corrections of an apparent clerical mistake may be permitted before award.

(1) If a mistake is clearly evident on the face of the proposal document but the intended proposal is not similarly evident; or

(2) If the offeror submits evidence which clearly and convincingly demonstrates that a mistake was made.

9509.13 When a proposal is corrected or withdrawn, or correction or withdrawal is denied, the CO shall prepare a determination showing that the relief was granted or denied.

9509.14 When a mistake in a proposal is discovered after award, the mistake may be corrected by contract amendment if correcting the mistake would be favorable to the Hospital without changing the essential requirements of the specifications.

9509.15 In addition to the cases contemplated in this section, or as otherwise authorized by law, when a mistake in a proposal is discovered after award, the CO shall make one (1) of the following determinations:

(a) To reform a contract to delete the items involved in the mistake or to reform a contract to increase the price if the contract price, as corrected;

(b) That no changes shall be made in the contract as awarded; or

9509.16 Determinations under this section shall be made only on the basis of clear and convincing evidence that a mistake was made by the contractor, and was so apparent as to have given the CO notice of the probability of the mistake.

9509.17 The Hospital shall include in the contract file a record of each determination made in accordance with this section, the facts involved, and the action taken.

9509.18 The Hospital has the right to reject all proposals in whole or in part when it is determined that such action is in the best interest of the Hospital.

9509.19 The competitive range shall be determined on the basis of price and other factors, in accordance with the evaluation criteria stated in the solicitation, and shall include all proposals that have a reasonable chance of being selected for award. If there is doubt as to whether a proposal is in the competitive range, the proposal shall be included.

9509.20 Oral presentation or written clarification of technical information may be requested of the offeror.

9509.21 Negotiations may be held with offerors determined to be in the competitive range.

9509.22 If negotiations are not held, the following requirements shall be met:

(a) All offerors must have been notified of the possibility that an award might be made without negotiation; and

(b) The award must be made without further written or oral communications with any offeror.

9509.23 Upon completion of negotiation, the CO shall issue to all offerors within the competitive range a request for best and final offers.

9509.24 After receipt of best and final offers, negotiations will only continue if in the best interests of the Hospital.

9509.25 Any offer submitted as best and final offer should be considered complete and not subject to additional negotiation.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4516 (July 8, 1994).

22-B DCMR § 9510 COST OR PRICING DATA

9510.1 Bidders/offerors maybe required to submit and certify cost or pricing data before award of contract.

9510.2 Certification and submission of actual cost or pricing data shall not be required when it is determined that prices are as follows:

(a) Based on adequate price competition;

(b) Based on established catalog or market prices of commercial items sold in substantial quantities to the general public; or

9510.3 Price competition exists if two (2) or more responsible offerors make a responsive offer to a solicitation issued by the Hospital, and they compete independently for a contract to be awarded.

9510.4 When cost or pricing data are required, each offeror submits a certificate that states that to the best of the contractor’s knowledge and belief, the cost and/or pricing data are accurate, complete and current as of a determined specified date.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4519 (July 8, 1994).

22-B DCMR § 9511 ANTI-COMPETITIVE PRACTICES AMONG OFFERORS

9511.1 For the purpose of this section, an “anti-competitive practice” is a practice among offerors or potential offerors that reduces or eliminates competition or restrains trade. An anti-competitive practice can result from an agreement or understanding among competitors to submit collusive offers.

9511.2 The CO shall be alert and sensitive to conditions to the market place and may conduct studies of past procurements such as, but not limited to, the following:

(a) A study of the history of a supply, service, or construction item over a period of time sufficient to determine any significant patterns of changes;

(b) A review of similar Hospital contract awards over a period of time; or

(c) Consultation with outside sources of information, such as offerors who have competed for similar Hospital business in the past but who are no longer competing for such business.

9511.3 When collusion or other anti-competitive practices are suspected among any offerors, a notice of the relevant facts shall be transmitted to the Corporation Counsel of the District of Columbia.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4519 (July 8, 1994).

22-B DCMR § 9512 ETHICS IN PUBLIC CONTRACTING

9512.1 To achieve the purpose of this section, it is essential that all persons doing business with the Hospital observe the ethical standards prescribed herein. The CO shall make available and disseminate to every person doing business with the Hospital, and to every Hospital managerial employee with procurement responsibilities, the requirements for this section.

9512.2 It shall be the policy of the Hospital to promote and balance the objective of protecting government integrity and that of facilitating the recruitment and retention of personnel needed by the Hospital. The policy shall be implemented by prescribing essential standards of ethical conduct without creating unnecessary obstacles to entering public service.

9512.3 It shall be a breach of ethical standards for any employee to participate directly or indirectly in a procurement when the employee knows that the employee or any member of the employee’s immediate family has a financial interest pertaining to the procurement.

9512.4 When a Hospital employee knows that he or she has an actual or potential conflict of interest, or when the CO has determined that an actual conflict of interest exists, such employee shall be disqualified from the procurement involved. The employee may apply to the Executive Director for a waiver of the conflict of interest prohibition.

9512.5 It shall be a breach of ethical standards for any person to offer, give, or agree to give any employee or former employee, or for any employee or former employee to solicit, demand, accept, or agree to accept from another person, a gratuity or an offer of employment in connection with any decision, approval, disapproval, recommendation, or preparation of any part of a procurement.

9512.6 It shall be a breach of ethical standards for any payment, gratuity, or offer of employment to be made by or on behalf of a subcontractor under a contract to the prime contractor, or higher tier subcontractor, as an inducement for the award of a subcontract or order.

9512.7 It shall be a breach of ethical standards for any employee, former employee or any other person knowingly to use confidential information for actual or anticipated personal gain.

9512.8 No employee, officer, or Commission member shall serve on the board of directors or other governing body (whether or not compensated) of any contractor with whom the Hospital has a current contractual relationship if the individual’s responsibilities with the Hospital entail the letting or management of the contract.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4520 (July 8, 1994).

22-B DCMR § 9513 FREEDOM OF INFORMATION AND PRIVACY

9513.1 The CO shall direct any request for records which specifically cites the D.C. Freedom of Information Act (the “FOIA”), D.C. Code, 2001 Ed. §§2-531 to 2- 539, to the Executive Director or to the information officer designated by the Executive Director.

9513.2 If a request for records contains no reference to the FOIA, and if the CO is unsure whether the requested records can be released, the CO shall forward the request to the Hospital information officer or Executive Director.

9513.3 No Hospital employee shall disclose proprietary or confidential information which has been properly designated as such, in accordance with the provisions of §9809, to any person other than Hospital employees who need access to the information as part of their duties in connection with the procurement process.

9513.4 If a contractor collects, retains, or has in its possession any document, record, or other information obtained in the performance of a Hospital contract, such document, record, or information may be exempt from disclosure under the FOIA. The contractor shall not disclose the document, record, or other information to any person other than an authorized Hospital employee or representative.

9513.5 If a contractor collects, retains, or has in its possession any document, record, or other information obtained in the performance of a Hospital contract, the disclosure of which is prohibited by any Hospital, District, or Federal law or regulation, the contractor shall not disclose the document, record, or other information to any person other than an authorized Hospital employee or agent.

9513.6 If a contractor is not sure whether a document, record, or other information may be disclosed, the contractor shall refer the matter to the CO for appropriate action.

9513.7 The CO shall include in each solicitation and contract, a clause that notifies the bidder, offeror, or contractor of the provisions of this section.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4521 (July 8, 1994).

22-B DCMR § 9599 DEFINITIONS

9599.1 The following terms as used in this chapter and Chapters 96, 97, and 98 shall have the meanings ascribed:

Allocable costs - a cost is considered allocable if the goods or services involved are chargeable or assignable to a particular cost objective (e.g., a specific function, project, or department) in accordance with relative benefits received or other equitable relationship.

Allowable costs - a cost is considered allowable if the charge is reasonable and allocable, given consistent treatment through application of generally accepted accounting principals, and conforms to the terms and conditions set forth in the contract.

Amendment - any change to a solicitation issued by the contracting officer.

Bid bond - a bid security in the form of a bond.

Bid security - a form of guarantee assuring that the bidder or offeror will not withdraw a bid or proposal within the period specified for acceptance and will execute a written contract and furnish required bonds or other security, including any necessary coinsurance or reinsurance agreements, within the time specified in the solicitation, unless a longer time is allowed, after receipt of the specified forms.

Bidder/Offeror - an individual, corporation, hospital, or other business entity which submits a bid or proposal to provide goods or services to the Hospital for a stated price in response to a procurement solicitation issued by the Hospital.

Bilateral contract modification - a contract modification that is signed by the contractor and the contracting officer.

Competitive range - range determined on the basis of cost or price and other factor that were stated in the solicitation and shall include all proposals that have a reasonable chance of being selected for award.

Competitive sealed bidding (CSB) - the solicitation vehicle for the procurement of supplies, equipment, services, or construction. The CSB method is used when the award can be made on the basis of specifications and price-related factors and it is not necessary to conduct discussions with bidders after bid opening. No alterations in the bid, including price, may be made after bid opening.

Competitive sealed proposals (CSP) - the solicitation vehicle for the procurement of goods or services when the CSP method is not appropriate. The CSP method is used when discussions with competing offerors and judgmental evaluations of offers are in the best interest of the Hospital. Alterations in the nature of a proposal to further clarify, and in prices, may be made after proposals are opened.

Contract Award - a documented and executed legal agreement between the Hospital and a contractor by which specific goods, supplies, equipment, and services are procured for a stated price, under specified terms and conditions.

Contracting Officer (CO) - an employee of the Hospital officially designated as a “contracting officer” and so authorized to enter into contract agreements with outside parties and sign purchase orders and other contract related documents on behalf of D.C. General Hospital. No other Hospital employee is authorized to do so.

Cost analysis - the review and evaluation of the separate cost elements and proposed profit of an offeror’s or contractor’s cost or pricing data and the judgmental factors applied in projecting from the data to the estimated costs, in order to form an opinion on the degree to which the proposed costs represent what the contract should cost, assuming reasonable economy and efficiency.

Cost or pricing data - all facts as of the time or price agreement that prudent buyers and sellers would reasonably expect to significantly affect price negotiations. Cost or pricing data is factual, not judgmental, and is therefore verifiable. While it does not indicate the accuracy of the prospective contractor’s judgment about estimated future costs or projections, it does include the data forming the basis for that judgment. Cost or pricing data is more than historical accounting data; it is all the facts that can be reasonably expected to contribute to the soundness of estimates of future costs and to the validity of determinations of costs already incurred. It also includes facts such as vendor quotations; nonrecurring costs; information on changes in production methods or purchasing volume; data supporting projections of business prospects and objectives and related operational costs; and unit cost trends, such as those associated with labor efficiency, make-or-buy decisions, estimated resources to attain business goals, and information on management decisions that could have a significant bearing on cost.

Cure notice - a notice in writing in which the contracting officer specifies a contractor’s failure to perform some provision of the contract or failure to make sufficient progress on contract performance so as to endanger performance of the contract. The notice includes a period of time in which the contractor will be allowed to cure the failure.

Debarment - action taken by the CO to exclude a contractor from Hospital contracting and Hospital approved subcontracting for a reasonable, specified period. A contractor so excluded is “debarred.”

Depreciation - a charge to current operations which distributes the cost of a tangible capital asset, less estimated residual value, over the estimated useful life of the asset in a systematic and logical manner. Useful life refers to the prospective period of economic usefulness in a particular contractor’s operations as distinguished from physical life, as evidenced by the actual or estimated retirement and replacement practice of the contractor.

Direct costs - direct costs are costs that can be identified specifically with a particular project, activity, or other cost objective related to the good or services required. Typical direct costs are the compensation of employees directly performing work specified in the contract, the cost of materials consumed or expended in performance of work or delivery of goods, and other items of direct expense incurred to satisfy the performance of work or delivery of goods specified in the contract.

Emergency procurement - an “emergency” procurement involves life, death, or disability, equipment damage or failure, including procurement of an item necessary to preserve or protect the health or safety of patients, employees, or visitors or to correct unforeseen damage to Hospital property.

Evaluation factors - technical and/or cost criteria used in evaluating whether a bid/offer is responsible and rating the capabilities and qualifications of the bidder/offeror’s response to the solicitation. Where there are multiple factors, they are assigned a relative weighing to produce an overall evaluation score for each bid/offer.

Expert - a person or company who is so qualified, either by actual experience or by careful study and known by contemporaries, as to enable him or it to form a definite opinion of his own respecting a division of science, branch of art, or department of trade about which persons has no particular training or special study or incapable of forming accurate opinions or of deducting correct conclusions.

Facilities - property used for production, maintenance, research, development, or testing. The term includes plant equipment and real property, but does not include material. When used in a facilities contract, the term includes all property provided under the contract.

Facilities contract - a contract under which Hospital facilities are provided to a contractor or subcontractor by the Hospital for use in connection with performing one (1) or more related contracts for supplies or services.

Field Work Authorization (FWA) - written directive issued to contractors to proceed with work not actually included in the original scope of work but reasonably related to the work set forth in the original contract.

Firm fixed price contract - a contract that establishes a price that is not subject to any adjustment on the basis of the contractor’s actual cost experience in performing the contract. This contract type places upon the contractor maximum incentive to control costs and perform effectively and imposes minimum administrative burden upon the contracting parties.

Fixed price contract with economic adjustments - a contract that provides for upward and downward revision of the stated contract price upon the occurrence of specific contingencies.

Fixed price incentive contract - a contract that provides for adjusting profit and establishing the final contract price by a formula based on the relationship of final negotiated total cost to total target cost. It specified a target cost, a target profit, a price ceiling, and a price adjustment formula negotiable at the outset. The price ceiling is the maximum that may be paid to the contractor, except for any adjustment under other contract clauses. This contract type provides a positive, calculable profit incentive for the contractor to control costs.

Hospital-furnished property - property in the possession of or directly acquired by the Hospital and subsequently made available to the contractor.

Hospital property - all property owned by or leased to the Hospital or acquired by the Hospital under the terms of the contract, including Hospital-furnishing property.

Indictment - an accusation in writing found and presented by a grand jury to the court charging that a named person has committed a criminal offense, including any information or other filing by a competent prosecuting authority charging a criminal offense.

Indirect costs - indirect costs are costs that are not readily identifiable with a particular contract cost objective, but nonetheless are necessary to the performance of the work or delivery of the goods specified in the contract. An example of indirect costs is general and administrative expenses.

Individual surety - a natural person, as distinguished from a business entity, who is liable for the entire penal amount of the bond.

Inspection - examining and testing supplies, services, or construction to determine whether they conform to contract requirements. This includes, when appropriate, examination and testing of raw materials, components, and intermediate assemblies.

Insurance - a contract which provides that, for a stipulated consideration, the insurer undertakes to indemnify the insured party against risk of loss, damage, or liability arising from an unknown or contingent event.

Insurance administration expenses - the contractor’s costs of administering an insurance program, which may include the cost of operating an insurance or risk management department, processing claims, actuarial fees, and service fees paid to insurance companies, trustees, or technical consultants.

Interested party - An actual or prospective bidder or offeror whose direct economic interest would be affected by the award of a contract or by the failure to award a contract.

Invention - any device, process, design, or other discovery that is or may be patentable or otherwise protectable under Title 35 of the U.S. Code.

Liquidated damages - a sum stipulated and agreed upon by the parties, at the time of entering into a contract, as being payable as compensation for loss in the event of a breach.

Material - property that may be incorporated into or attached to a deliverable end item or that may be consumed or expended in performing a contract. The term includes assemblies, components, parts, raw and processed materials, and small tools and supplies that may be consumed in normal use in performing a contract.

Material costs - costs of items such as raw materials, parts, sub-assemblies, components, and manufacturing supplies, whether purchased or manufactured by the contractor, which may include such collateral items as inbound transportation and in transit insurance.

Medical and human care services - services provided by professionals whose occupations are subject to licensure under the D.C. Health Occupations Revisions Act of 1985, D.C. Code, 2001 Ed. §§3-1201.01 to 3-1213.01.

Minor informality or irregularity - some immaterial defect in a bid or variation of a bid from the exact requirements of the CSB that can be corrected or waived without being prejudicial to other bidders. The defect or variation is immaterial when the effect on price, quantity, quality, or delivery is negligible when contrasted with the total cost or scope of the requirement.

Mistakes - mistakes are clearly evident errors such as typographical errors in extending unit prices, transposing errors, and arithmetical errors.

Multiyear contract - a contract for a period covering more than one (1) fiscal year but not more than five (5) fiscal years.

Nonrecurring costs - those production costs which are generally incurred on a tone-time basis and include costs such as plant or equipment relocation, plant rearrangement, pre-production engineering, initial spoilage and rework, and specialized work force training.

Notice of intent to award - a written notice to the apparent awardee advising of intent to award the contract contingent upon the executive of required bonds and the formal contract, and the obtaining of all necessary approvals.

Novation - although the transfer of a government contract is prohibited by law, the Government may, if it is in the best interest, recognize a third party as the successor in interest to a Government contract when the third party’s interest in the contract arises out of the transfer either of all the assets of the contractor or of all of that part of the contractor’s assets involved in the performance of the contract.

Option - a unilateral right in a contract under which, for a specified time, the Hospital may elect to purchase additional quantities or services called for by the contract, or may elect to extend the term of the contract.

Partial termination - the termination of a part, but not all, work that has not been completed and accepted under a contract.

Payment bond - a bond that ensures payment as required by law to all persons supplying labor or material in the performance of the work provided for in the contract.

Performance bond - a bond that secures performance and fulfillment of the contractor’s obligations under the contract.

Personal property - property of any kind or interest in property except real property and records of the Hospital.

Plant equipment - personal property of a capital nature (including equipment, machine tools, test equipment, furniture, vehicles, and accessory and auxiliary items) for use in manufacturing supplies, in performing services, or for any administrative or general plant purpose.

Plans and specifications - drawings, text, and other descriptions of the physical or functional characteristics required for and preliminary to the construction.

Preventative maintenance - maintenance performed on a regularly scheduled basis to prevent the occurrence of defects and to detect and correct minor defects before they result in serious consequences.

Price - cost plus any fee or profit applicable to the contract type.

Price analysis - the process of examining and evaluating a proposed price without evaluating its separate cost elements and proposed profit.

Project manager - the individual assigned by the CO responsible for the on-site management of a project after a contact is executed.

Proprietary information - information, including a formula, patterns, compilation, program, device, method, technique, or process that derives independent economic value, actual or potential, from not being generally known to, and not being readily ascertainable by proper means, by other persons who can obtain economic value from its disclosure or use and is the subject of efforts that are reasonable under the circumstances to maintain its secrecy.

Proprietary information - information, including trade secrets, data, formulas, patterns, compilations, programs, devices, methods, techniques, or processes, that has the following characteristics:

(a) It devices independent economic value, actual or potential, from not being generally known to, and not being readily ascertainable by proper means, by, other persons who can obtain economic value from its disclosure or use; or

(b) It is the subject of efforts that are reasonable under the circumstances to maintain its secrecy.

Purchase description - a description of the essential physical characteristics and functions required to meet the Hospital’s minimum needs.

Purchase order - the purchase order is the official document for all purchasing activities. The terms and conditions of the purchase order detailed descriptions of the goods or services being procured, and also give legal protection to the Hospital. It provides legal reference and backup in disputes arising from problems in shipping, quality, damage, etc.

Quotation - a citation of price and delivery terms or a period of performance by a contractor in response to a contracting officer’s request.

Real property - land and rights in land, group improvements, utility distribution systems, and buildings and other structures. The term does not include foundations and other work necessary for installing plant equipment.

Recurring cost - the production costs that vary with the quantity being produced, such as labor and materials.

Reinsurance - a transaction which provides that a surety, for a consideration, agrees to indemnify another surety against loss which the latter may sustain under a bond which it has issued.

Responsible bidder/offeror - a bidder/offeror that demonstrates the capability and qualifications to provide the goods or services requested in the Hospital’s solicitation, including meeting the specifications, scope of work, terms and conditions, and any other requirements.

Responsible offeror - respondent to a request for proposal (RFP) or an invitation for the bid (IFB) who has the qualifications to satisfying the required scope of work.

Responsive bid - a contractor who submits a bid/proposal that conforms in all material respects to the invitation for bids/request for proposals.

Responsive offer - respondent to an IFB who has the qualifications to satisfy the requirements of the IFB.

Settlement agreement - a written agreement in the form of a modification to a contract settling all or a severable portion of a settlement proposal.

Settlement proposal - a proposal for effecting settlement of a contract terminated, in whole or in part, submitted by a contractor or subcontractor.

Show cause notice - a notice in which the contracting officer notifies the contractor in writing of the possibility of a termination for default. The notice calls the contractor’s attention to the contractual liabilities if the contract is terminated for default, and requests the contractor to show cause why the contract should not be terminated for default.

Small purchase - a procurement of supplies, services, or other items in an aggregate amount not exceeding the small purchase authority limitations set forth in this section.

Solicitation - request for proposals (RFP), except as otherwise provided in this section.

Sole source procurement - an award for the procurement of goods, supplies, equipment, or services to the only known capable supplier, upon determination that the procurement is warranted due to the unique nature of the requirement, proposed supplier, or market conditions. This includes medical and human service and expert providers, where a high level of personal confidence is required and a high degree of professional skill and knowledge is required of the individuals providing the services.

Specification - a description of the technical requirements for a material, product, or service that includes the criteria for determining whether these requirements are met.

Standard - a document that establishes engineering and technical limitations and applications of items, materials, processes, methods, designs, and engineering practices. It includes any related criteria deemed essential to achieve the highest practical degree of uniformity in materials or products, or interchangeability of parts. Standards may be used in specifications, invitations for bids, requests for proposals, and contracts.

Stop-work order - a written document issued by the contracting officer advising a contractor to cease work.

Subcontractor - any supplier, distributor, vendor, or firm which furnishes supplies, services, or construction to or for a prime contractor or another subcontractor.

Supplemental agreement - a bilateral contract modification.

Surety - a party legally liable for the debt, default, or failure of a principal to satisfy a contractual obligation.

Suspension - action taken by the CO to disqualify a contractor temporarily from Hospital contracting and Hospital approved subcontracting. A contractor so disqualified is “suspended.”

Termination for convenience - the exercise of the Hospital’s right to terminate, completely or partially, a contract when it is in the best interest of the Hospital.

Termination for default - the exercise of the Hospital’s contractual right to terminate, completely or partially, a contract because of the contractor’s actual or anticipated failure to perform its contractual obligations.

Testing - the element of inspection that determines the properties or elements, including functional operation of supplies or their components, by the application of established scientific principles and procedures.

Unilateral contract modification - a contract modification that is signed only by the contracting officer.

Warranty - a promise or affirmation given by a contractor to the Hospital regarding the nature, usefulness, or condition of the supplies, services, or construction furnished under a contract.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4522 (July 8, 1994).

22-B96 D.C. GENERAL HOSPITAL SPECIAL PROCUREMENT PROVISIONS

22-B DCMR § 9600 SOLE SOURCE PROCUREMENT

9600.1 A sole source may be approved if it is in the best interest of the Hospital.

9600.2 Reasonable steps shall be taken to avoid using sole source procurement except in circumstances when it is both necessary and in the best interests of the Hospital.

9600.3 Whenever possible, procurement of the same supply, service, or construction without competition shall be avoided

9600.4 Any local, small and disadvantaged business enterprise sole source procurement shall be made in accordance with the requirements of D.C. Act 9-223 as amended.

History

AUTHORITY: Unless otherwise noted, this chapter was enacted under the authority of the D.C. General Hospital Commission Act, D.C. Code, 2001 Ed. §§44-1901 to 44-1957. The D.C. General Hospital Commission Act subsequently was repealed by the Health and Hospitals Public Benefit Corporation Act of 1996 §402, D.C. Law 11-212, 43 DCR 4962 (April 12, 1997). For current provisions regarding the Public Benefit Corporation, please refer to D.C. Code, 2001 Ed. §§44-1101.01 to 44-1103.03.
SOURCE: Final Rulemaking published at 41 DCR 4508, 4530 (July 8, 1994). EDITOR’S NOTE: For current provisions regarding contracting with local, small, and disadvantaged businesses, please refer to D.C. Code, 2001 Ed. §§2-217.01 to 2-217.07.

22-B DCMR § 9601 EMERGENCY PROCUREMENT

9601.1 A procurement may be approved on an emergency basis if such procurement is necessary to remedy an existing or inherent emergency condition.

9601.2 Documentation shall be made of the circumstances necessitating any such emergency purchases.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4530 (July 8, 1994).

22-B DCMR § 9602 SMALL PURCHASES

9602.1 The CO has the authority to use the small purchase procedures for the procurement of supplies, services, and other items when the total amount of the purchase does not exceed twenty-five thousand dollars ($25,000).

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4530 (July 8, 1994).

22-B DCMR § 9603 RATIFICATION OF UNAUTHORIZED PURCHASES

9603.1 Ratification of unauthorized purchases shall not be used in a manner that encourages such purchases being made by Hospital personnel.

9603.2 Ratification authority shall not be delegated below the level of the Executive Director.

9603.3 The CO may ratify an unauthorized purchase in the following circumstances:

(a) Supplies or services have been provided to and accepted by the Hospital, or the Hospital otherwise has obtained or will obtain a benefit resulting from performance of the unauthorized purchase;

(b) The resulting contract would otherwise have been proper if made by an appropriate CO;

(d) The Executive Director recommends payment.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4530 (July 8, 1994).

22-B97 D.C. GENERAL HOSPITAL CONSTRUCTION AND ARCHITECT - ENGINEER PROCUREMENT

22-B DCMR § 9700 SPECIAL PROVISIONS FOR CONSTRUCTION AND ARCHITECT - ENGINEER PROCUREMENT

9700.1 Procurement for construction and architect-engineer services shall be awarded in accordance with the provisions of this section. In instances where the provisions of this section are inconsistent with other sections, this section takes precedence for that award of a construction or architect-engineer contract.

9700.2 For all construction contracts estimated to exceed fifty thousand dollars ($50,000), the CO shall include a liquidated damages clause and shall determine appropriate, reasonable rates of liquidated damages. In addition to standard liquidated damages, the contractor shall be liable for the estimated cost of inspection and superintendence for each day of construction delay.

9700.3 Construction projects will be procured using firm, fixed-price contracts.

9700.4 A contract may be priced on a lump-sum basis (when a lump sum is paid for the total work or defined parts of the work), on a unit-price basis (when a unit price is paid for a specified quantity of work units), or a combination of both methods.

9700.5 Because of potential labor and administrative conflicts, contracts with cost variation or cost adjustment features shall not be permitted concurrently at the same work site with firm, fixed-price, or unit-price contracts without the prior written approval of the CO.

9700.6 The CO shall not award a contract for the construction of a project to the firm that designed the project or its subsidiaries or affiliates, unless the project is a turnkey project.

9700.7 The CO shall make appropriate arrangements for prospective bidders to inspect the work site and to have the opportunity to examine data available to the Hospital that may provide information concerning the performance of the work.

9700.8 The CO shall provide notice to the prospective contractor of the intent to award. Each notice of intent to award shall include the following:

(a) The identity of the competitive sealed bidding (CSB);

(b) The prospective contractor’s bid;

(d) A statement notifying the prospective contractor that all required performance and payment bonds must be properly executed by the prospective contractor and sureties and returned to the CO by the prospective contractor within the time period specified in the CSB, or, if no time period is specified in the CSB, within ten (10) days after the bond forms are presented by the Hospital to the prospective contractor for signature;

(e) A statement notifying the prospective contractor that the required contract form must be properly executed by the prospective contractor and returned to the CO by the prospective contractor within the time period specified in the CSB, or, if no time period is specified in the CSB, within ten (10) days after the Hospital contract form is presented by the Hospital to the prospective contractor for signature; and

(f) A statement that a notice to proceed will be issued, contingent upon the CO’s receipt of executed performance and payment bonds and executed contract form that are in compliance with the requirements of the CSB and this title.

9700.9 The Hospital may, without any liability upon the Hospital, rescind the notice of intent to award at any time prior to approval of a formal written contract signed by the prospective contractor and the CO.

9700.10 The architect-engineer firm shall be responsible for the professional quality, technical accuracy, and coordination of all services required under its contract. The firm shall be liable for costs to the Hospital resulting from errors, deficiencies, and omissions in designs furnished under its contract.

9700.11 When modification of a construction contract is required because of an error or deficiency in the services provided under an architect-engineer contract, the CO shall consider the extent to which the architect-engineer contractor may be liable.

9700.12 If the CO determines that the firm is liable, and the recoverable cost will exceed the administrative cost involved or collection is otherwise in the best interests of the Hospital, the CO shall initiate procedures to collect the amount due.

9700.13 The CO may enter into General Service requirement contracts with firms recommended by the evaluation board. The Hospital shall negotiate each project in an alternating rotation with each firm with which it has an existing General Service contract.

9700.14 The Hospital may require the architect-engineer contractor to design the project so that construction costs will not exceed a contractually specified dollar limit. The amount of the construction funding limitation shall be established during negotiations between the firm and the CO.

9700.15 If the price of construction proposed in response to a Hospital solicitation exceeds the construction specified dollar funding limit in the architect-engineer contract, the firm shall be solely responsible for redesigning the project within the funding limitation.

9700.16 Any redesign services required shall be performed at no increase in the price of the architect-engineer contract. However, if the cost of proposed construction is affected by events beyond the firm’s reasonable control (such as an increase in material cost which could not have been anticipated or an undue delay by the Hospital in issuing a construction solicitation), the Hospital may be obligated for any additional costs.

9700.17 If an architect-engineer firm’s design fails to meet the contractual limitation on construction cost and the Hospital determines that the firm should not redesign the project, the CO shall place a written statement of the reasons for that determination in the contract file.

9700.18 The architect-engineer firm shall make necessary corrections at no cost to the Hospital if the designs, drawings, specifications, or other items or services furnished by the firm contain any errors, deficiencies, or omissions.

9700.19 If the CO does not require a firm to correct errors, the CO shall include a written statement of the reasons for that decision in the contract file.

History

AUTHORITY: Unless otherwise noted, this chapter was enacted under the authority of the D.C. General Hospital Commission Act, D.C. Code, 2001 Ed. §§44-1901 to 44-1957. The D.C. General Hospital Commission Act subsequently was repealed by the Health and Hospitals Public Benefit Corporation Act of 1996 §402, D.C. Law 11-212, 43 DCR 4962 (April 12, 1997). For current provisions regarding the Public Benefit Corporation, please refer to D.C. Code, 2001 Ed. §§44-1101.01 to 44-1103.03.
SOURCE: Final Rulemaking published at 41 DCR 4508, 4532 (July 8, 1994).

22-B98 D.C. GENERAL HOSPITAL CONTRACT MANAGEMENT AND ADMINISTRATION

22-B DCMR § 9800 CONTRACT AWARD

9800.1 Contract award may be made as follows:

(a) Within the time specified for acceptance in the solicitation or an extension thereof;

(b) To the responsible and responsive bidder/offer, whose bid/offer meets the requirements and criteria provided in the solicitation; and

9800.2 Awards shall not be made until all necessary approvals have been obtained. A contract shall be deemed to have been awarded on the date signed by the CO.

9800.3 Following an award, a record showing the basis for determining the successful bidder/offeror shall be made a part of the contract file.

History

AUTHORITY: Unless otherwise noted, this chapter was enacted under the authority of the D.C. General Hospital Commission Act, D.C. Code, 2001 Ed. §§44-1901 to 44-1957. The D.C. General Hospital Commission Act subsequently was repealed by the Health and Hospitals Public Benefit Corporation Act of 1996 §402, D.C. Law 11-212, 43 DCR 4962 (April 12, 1997). For current provisions regarding the Public Benefit Corporation, please refer to D.C. Code, 2001 Ed. §§44-1101.01 to 44-1103.03.
SOURCE: Final Rulemaking published at 41 DCR 4508, 4535 (July 8, 1994).

22-B DCMR § 9801 PURCHASE ORDERS

9801.1 Purchase orders shall be approved and issued to buy supplies, services, equipment and construction by the Hospital, shall specify the quantity and quality of supplies or services ordered, any trade and prompt payment discounts offered, delivery date, and notification of applicable standard contract provisions.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4535 (July 8, 1994).

22-B DCMR § 9802 CONTRACT MODIFICATIONS

9802.1 Only a CO is authorized to execute a contract modification on behalf of the Hospital. Other Hospital personnel shall not do any of the following:

(a) Execute contract modifications, including change orders;

(b) Act in a manner that causes a contractor to believe that they have authority to bind the Hospital; or

9802.2 A contract modification, including a change issued unilaterally by the Hospital, shall be priced and a government estimate shall be prepared before signature by the parties, unless the interests of the Hospital would be adversely affected. If a significant cost increase could result from a contract modification, the CO shall negotiate a maximum contract price increase and include that price in the modification.

9802.3 The CO shall not execute a contract modification, including a change order, that causes or will cause an increase in the funding level of the contract without having first obtained a certification of the availability of funds. The certification shall be based on the negotiated price or the negotiated maximum price.

9802.4 A modification to a contract may be executed without having first obtained the certification required under this subsection if the modification includes a clause which conditions payment upon the availability of funds.

9802.5 The CO shall use a bilateral contract modification (also known as a “supplemental agreement”) to do the following:

(a) Make negotiated equitable adjustments resulting from the issuance of a change order;

(b) Formalize a letter contract; or

9802.6 The CO shall use a unilateral contract modification to do the following:

(a) Make administrative changes;

(b) Make changes authorized by a provision of the contract other than a changes clause, such as an option; or

9802.7 A contractor shall be bound by the terms of the written contract and written contract modifications signed by the CO.

9802.8 A contractor shall not rely upon any written or oral statements or directions of employees or agents of the Hospital other than the CO for authority to perform work, alter schedules or specifications, or any other action that would normally require a written contract modification.

9802.9 After the CO issues an unpriced change order, the CO and the contractor shall execute a separate bilateral modification reflecting the resulting equitable adjustment in contract terms.

9802.10 If the CO and the contractor agree in advance to an equitable adjustment in the contract price, delivery terms, or other contract terms, the CO shall issue a bilateral contract modification and shall not be required to issue a change order.

9802.11 Failure to agree to any adjustment shall be a dispute under the disputes clause in the contract and shall be resolved in accordance with the procedures set forth in the Provisions of Protest and Disputes Section of this regulation (§§9816, 9817). However, nothing in this section shall excuse the contractor from proceeding with the contract as changed, except as provided in the Provision of Termination set forth in this regulation (§9814).

9802.12 For a unilateral contract modification, the effective date shall be the date on which the CO executes the modification.

9802.13 For a bilateral modification (supplemental agreement), the effective date shall be the date on which the CO executes the modification.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4536 (July 8, 1994).

22-B DCMR § 9803 CONTRACT COST PRINCIPLES

9803.1 The CO shall incorporate the contract cost principles in contracts as the basis for:

(a) Determining reimbursable costs under cost-reimbursement contracts and cost-reimbursement subcontracts, and the cost-reimbursement portion of time-and-materials contracts, except when material is priced on a basis other than at cost;

(b) Negotiating indirect cost rates;

(d) Pricing changes and other contract modifications.

9803.2 The cost principles and procedures set forth in this section shall not apply to the following:

(a) The establishment of prices under contracts awarded on the basis of competitive sealed bidding;

(b) Prices fixed by law or regulations; or

9803.3 The CO may recommend, to the Executive Director, a deviation from the cost principles set forth in this section if the CO determines in writing that the deviation would be in the best interests of the Hospital.

9803.4 The factors to be considered in determining whether a cost is allowable include reasonableness, allocability, the terms of the contract, consistency with generally accepted accounting principles and practices appropriate to the particular circumstances, consistency with the limitations set forth in this section, and consistency with any applicable law.

9803.5 A cost is reasonable if, in its nature and amount, it does not exceed that which would be incurred by a prudent person in the conduct of competitive business.

9803.6 In determining reasonableness of a given cost, the CO shall consider the following factors:

(a) Whether the cost is of a type generally recognized as ordinary and necessary for the conduct of the contractor’s business or the performance of the contract;

(b) The restraints or requirements imposed by generally accepted sound business practices, arms length bargaining, and contract terms and specifications;

(c) The action that a prudent business person would take considering responsibilities to the owner of the business, employees, customers, the Hospital and the public at large;

(d) Any significant deviations from the established practices of the contractor that may unjustifiably increase the contract costs; and

(e) Any other relevant factors.

9803.7 For purposes of this section, a cost is allocable to a contract if it is assignable or chargeable to one or more cost objectives on the basis of relative benefits received or other equitable relationship.

9803.8 The CO shall consider a cost allocable to a Hospital contract if the cost meets one or more of the following criteria:

(a) The cost is incurred specifically for the contract;

(b) The cost benefits both the contract and other work, and can be distributed to both in reasonable proportion to the benefits received; or

(c) The cost is necessary to the overall operation of the business, although a direct relationship to any particular cost objective may not be evident.

9803.9 The CO shall identify and exclude from each invoice, claim, and proposal, costs that are expressly unallowable under this section or mutually agreed to be unallowable under an advance cost agreement.

9803.10 When costs are identified as unallowable or mutually agreed to be unallowable, all directly associated costs shall also be unallowable.

9803.11 Direct costs associated with Hospital contracts shall be segregated from other costs and recorded in accounts identifying them with the particular contract or cost objective to the maximum extent possible.

9803.12 Indirect costs shall not be allocated to a Hospital contract if other costs incurred for the same purpose in like circumstances have been included as a direct cost of that contract or any final cost objective not related to the Hospital contract.

9803.13 Indirect costs shall be accumulated in logical groupings known as “indirect cost pools” and allocated in a method in accordance with generally accepted accounting principles.

9803.14 The following is a treatment of certain specific cost categories:

(a) Bad debt, penalties and fines, and contingency costs shall not be allowable;

(b) Depreciation and use allowances made for fully depreciated assets shall not be allowable;

(d) Advertising costs shall not be allowable unless incurred as a direct result of compliance with specific provisions of the contract or written instructions of the CO;

(e) Per diem costs for services directly related to a contract and as provided for in the contract shall be allowable;

(f) Interest expense incurred by contractors shall not be an allowable cost unless stated otherwise in the terms and conditions of the solicitation;

(g) Costs of material shall be allowable;

(h) Bonding costs shall be allowable when required under the terms of the contract; and

(i) The cost of required or approved insurance that is maintained by the contractor pursuant to the contract shall be allowable.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4537 (July 8, 1994).

22-B DCMR § 9804 CONTRACT FINANCING AND FUNDING

9804.1 Contract financing in the form of progress payments may be to assist a contractor when private financing for a contract is either unavailable or insufficient.

9804.2 The CO shall not make progress payments or increase the contract price beyond the funds obligated under the contract, as amended.

9804.3 Bids conditioned on progress payments when the solicitation does not provide for progress payments shall be rejected as nonresponsive.

9804.4 The CO may provide for customary progress payments if the contractor will not be able to bill for delivery of products (or other performance milestones) for a substantial time (not less than four (4) months) after work must begin and, during the predelivery period, will make expenditures for contract performance that have a significant impact on the contractor’s working capital.

9804.5 The CO shall not provide for progress payments if the contract items are quick turnover types for which progress payments are not a customary commercial practice such as the following:

(a) Subsistence;

(b) Clothing;

(d) Standard commercial items not requiring a substantial accumulation of predelivery expenditures by the contractor.

9804.6 In each contract providing for progress payments, the CO shall include provisions giving the Hospital the right to conduct postpayment reviews or audits at the discretion of the CO.

9804.7 In each contract that provides for progress payments, the CO shall include provisions that assert the Hospital’s right to reduce or suspend progress payments.

9804.8 Progress payments shall be recouped by the Hospital through the deduction of liquidations from payments that would otherwise be due the contractor for completed contract items. To determine the amount of liquidation, the CO shall apply a liquidation rate to the contract price of contract items delivered and accepted.

9804.9 The CO shall include a provision with the progress payment provisions in the contract which provides that the Hospital shall receive title to all of the materials, work-in-process, finished goods, and other items of property under the contract.

9804.10 The CO shall require additional protective provisions, if deemed necessary, to establish and protect the Hospital’s title.

9804.11 The CO shall include a provision with the progress payment provisions of the contract which provides that, except for normal spoilage, the contractor shall bear the risk of loss, theft, destruction, or damage to property affected by the provision, unless the Hospital has expressly assumed that risk.

9804.12 The contractor shall be obligated to repay the Hospital the amount of unliquidated progress payments based on costs allocable to the property if the loss occurred after the contractor assumed the risk of loss.

9804.13 The contract shall not be obligated to pay for the loss of property for which the Hospital has assumed the risk of loss.

9804.14 Contractor may provide progress payments to subcontractors on terms.

9804.15 When determining the amount of any contract debt, the CO shall fairly consider both the Hospital’s claim and any contract claims by the contractor against the Hospital pursuant to the provisions for protest and disputes set forth in this regulation.

9804.16 The CO, or other official designated to administer the collection of contract debts and applicable interest, shall use all proper means available for collecting debts as rapidly as possible.

9804.17 Except in cases in which an agreement has been entered into for deferment of collections, or when bankruptcy proceedings against the contractor have been initiated, the contractor shall liquidate the debt by either of the following methods:

(a) Cash payment in a lump sum, on demand; or

(b) Credit against existing payments due to the contractor.

9804.18 The CO shall make a demand for payment as soon as the amount of contract debt due has been computed.

9804.19 The CO shall attempt to resolve expeditiously the amount of contract debt and refund through negotiations with the contractor. If the CO and contractor agree upon a refund to the Hospital, the CO shall promptly write a memorandum to document the agreement and the contract debt.

9804.20 In accordance with the Anti-Deficiency Act (31 U.S.C. §665), no CO or other Hospital employee shall make or authorize an encumbrance or expenditure in advance of appropriations or which exceeds the budget authority available under a current appropriation.

9804.21 Before executing any contract, the CO shall obtain certification from an official designated by the Hospital Budget Office that the amount of the contract does not exceed the amount of unencumbered budget authority as of the date on which the contract is executed.

9804.22 For purposes of this section, “unencumbered budget authority” shall mean that portion of an appropriation which has been allocated to the object of the procurement and which has not been reallocated to another purpose, committed to any other procurement, or expended.

9804.23 If the contract provides for expenditures in excess of the amount of unencumbered budget authority, the CO shall not sign the contract unless the contract contains a provision that expressly provides that the portion of the contract requiring payment of any amount in excess of available budget authority is conditioned upon the appropriation or allocation of additional budget authority.

9804.24 If the contract provides for expenditures in a future fiscal year, the CO shall not sign the contract unless the contract contains a provision, approved by the CO, that expressly provides that the portion of the contract requiring expenditures in a future fiscal year is conditioned upon the appropriation of budget authority for that fiscal year.

9804.25 Before execution of a contract, the CO shall ensure that the appropriate amount of allocated budget authority is encumbered to cover the cost of the contract.

9804.26 Budget authority shall be encumbered as follows:

(a) In an amount sufficient to cover the price or target price of a fixed-price contract, or the price of that portion of the contract to be performed in the current fiscal year; or

(b) In an amount sufficient to cover the estimated cost and any fee of a cost-reimbursement contract, or that portion of the estimated cost and fee applicable to the current fiscal year.

9804.27 Each encumbrance shall expire at the end of the fiscal year to which it applies. The portion of any contract not performed or delivered during the fiscal year shall be handled as follows:

(a) If the contract does not extend beyond the end of the fiscal year, that portion of the contract shall be canceled; or

(b) If the contract extends to the following fiscal year, that portion of the contract shall be encumbered against appropriated budget authority in the following fiscal year or canceled if budget authority is not available.

9804.28 A contractor shall not perform services or deliver supplies under a contract conditioned upon the availability of funds until the CO has given written notice to the contractor that funds are available. The CO shall not give notice to the contractor until the appropriate amount of budget authority has been encumbered.

9804.29 The Hospital shall not accept supplies or services under a contract conditioned upon the availability of funds until the CO has given written notice to the contractor that funds are available.

9804.30 Upon learning that a partially-funded contract will receive no further funds, the CO shall promptly give the contractor notice of the decision not to provide funds.

9804.31 Under a cost-reimbursement contract, the CO, upon learning that the contractor is approaching the estimated cost of the contract or the limit of the budget authority allocated and encumbered, shall promptly obtain information about funding and programming pertinent to the continuation of the contract and notify the contractor in writing of one (1) of the following:

(a) That additional funding is available or the estimated cost has been increased in a specified amount;

(b) That the contract will not be further funded, and that the contractor shall submit a proposal for an adjustment of fee, if any, based on the percentage of work completed in relation to the total work called for under the contract;

(d) That the Hospital is considering whether to allot additional funds or increase the estimated cost, that the contractor is entitled by the contract terms to stop work when the funding or cost limit is reached, and that any work beyond the funding or cost limit will be at the contractor’s risk.

9804.32 Under a cost-reimbursement contract, the CO may issue a change order, a direction to replace or repair defective items or work, or a termination notice without immediately increasing the funds available.

9804.33 Under a cost-reimbursement contract, because a contractor is not obligated to incur costs in excess of the estimated cost in the contract, the CO shall ensure availability of funds for directed actions.

9804.34 Under a cost-reimbursement contract, the CO may direct that any increase in the estimated cost or amount allotted to a contract be used for the sole purpose of funding termination or other specified expenses.

9804.35 A contractor may assign monies due or to become due under a contract if all the following conditions are met:

(a) The contract specifies payments aggregating one thousand dollars ($1,000) or more;

(b) The assignment is made to a bank, trust company, or other financing institution; and

9804.36 Unless otherwise expressly permitted in the contract, an assignment shall cover all unpaid amounts payable under the contract.

9804.37 Unless expressly permitted in the contract, an assignment may be made only to one (1) party, except that any assignment may be made to one (1) party as agent or trustee for two (2) or more parties participating in the financing of the contract.

9804.38 Unless expressly permitted in the contract, an assignment of contract payments shall not be subject to further assignment.

9804.39 The assignee shall be required to send written notice of assignment together with a true copy of the assignment instrument to the following:

(a) The CO;

(b) The surety on any bond applicable to the contract; and

9804.40 A contract may prohibit the assignment of contract payments if the CO determines that the prohibition is in the best interest of the Hospital.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4540 (July 8, 1994).

22-B DCMR § 9805 MULTIYEAR/OPTION CONTRACTS

9805.1 Multiyear contracting is a special method used to acquire known requirements extending over more than one (1) year but not to exceed five (5) years.

9805.2 Unless prohibited by the provisions of an appropriations act, a CO may issue the following types of contracts on a multiyear basis:

(a) Firm fixed-price contracts;

(b) Fixed-price contracts with economic adjustments; and

9805.3 If sufficient budget authority is not made available to fund any fiscal year after the first fiscal year of a multiyear contract, the contract shall be cancelled.

9805.4 For purpose of this section, an “option” is a unilateral right in a contract by which, for a specified time, the Hospital may elect to purchase additional supplies or services called for by the contract, or may elect to extend the term of the contract.

9805.5 The CO may include an option in a contract when the option is in the best interests of the Hospital.

9805.6 Contract provisions, setting forth the cost of the option may include, but are not limited to, the following:

(a) A specific dollar amount;

(b) An amount to be determined by applying provisions (or a formula) provided in the basic contract, but not including renegotiation of the price for work in a fixed-price type contract;

(c) In a cost-type contract, a stated fixed or maximum fee, or a fixed or maximum fee amount determinable by applying a formula contained in the basic contract;

(d) A specific price that is subject to an economic price adjustment provision; or

(e) A specific price that is subject to change as a result of changes to the prevailing labor rates provided by the U.S. Department of Labor.

9805.7 When awarding the basic contract, the CO shall evaluate offers for any options contained in a solicitation when it has been determined prior to soliciting offers that the Hospital is likely to exercise the options.

9805.8 The CO shall not evaluate offers for any option when it is determined that evaluation would not be in the best interests of the Hospital.

9805.9 The CO may determine not to evaluate options due to circumstances including, but not limited to, the following:

(a) There is not a reasonable certainty that sufficient budget authority will be available to permit the exercise of the option, and

(b) The option would not be exercisable at a price specified in, or reasonably determinable from, the terms of the basic contract.

9805.10 Except as provided in this section, in order to meet the requirements of this title for maximum competition, each option shall be evaluated as part of the initial competition and be exercisable at an amount specified from the terms of the basic contract.

9805.11 When exercising an option, the CO shall provide written notice to the contractor within the time period specified in the contract.

9805.12 When a contract provides for economic price adjustment and the contractor requests a revision of the price, the CO shall determine the effect of the adjustment on prices under the option before the option is exercised.

9805.13 The CO shall exercise an option only after determining the following:

(a) That sufficient budget authority is available;

(b) That the requirement covered by the option fulfills existing Hospital needs; and

(c) That the exercise of the option will be the most advantageous method of fulfilling the Hospital’s need when price and other factors are considered.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4544 (July 8, 1994).

22-B DCMR § 9806 TAXES

9806.1 The Government of the District of Columbia is exempt from, and will not pay, Federal Excise Taxes and D.C. Sales and Use Tax. Bidders must exclude such taxes, as well as state and city taxes, from their bids.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4546 (July 8, 1994).

22-B DCMR § 9807 BONDS, OTHER SECURITY, AND INSURANCE

9807.1 The CO may require any of the following types of security for any solicitation or contract, other than a small purchase, regardless of the estimated amount of the contract when determined to be in the best interest of the Hospital or when required by District law or regulation:

(a) Bid bonds;

(b) Other bid or proposal security;

(d) Insurance; and

(e) Performance or payment bonds or other security on non-construction contracts.

9807.2 A payment security shall be required only when a performance security is required and the use of the payment security is in the best interest of the Hospital, unless the CO determines, in writing, that either type of security would, by itself, protect the best interests of the Hospital.

9807.3 When a security is required by the CO, the CO may accept any of the following types of security:

(a) A bond provided by a surety;

(b) A certified check or irrevocable letter of credit issued by an insured financial institution in the equivalent amount of the security; or

(c) United States government securities that are assigned to the Hospital which pledge the full faith and credit of the United States.

9807.4 When the Hospital’s independent price estimate for a construction contract exceeds seventy-five thousand dollars ($75,000), the CO shall require a bid security for the invitation for bids or request for proposals. For a construction project less than seventy five thousand dollars ($75,000), the CO may require a bid security.

9807.5 The bid security for a construction contract shall be in an amount equal to at least five percent (5%) of the amount of the bid or price proposal. The bid security for non-construction contracts shall be in an amount set by the CO.

9807.6 When a bid security is required, the solicitation shall contain the following:

(a) A statement that bid security is required;

(b) Notice that the bid security will remain in effect for as long as the bid or proposal is required to remain effective; and

9807.7 No action shall be taken against the bid security of a bidder or offeror that is permitted to withdraw a bid or proposal prior to award due to a mistake in the bid or proposal.

9807.8 If a bid fails to comply with the bid security requirements set forth in the solicitation, the CO shall reject the bid. However, the CO may accept the bid if the CO determines that acceptance of the bid or proposal would be in the best interests of the Hospital and for one of the following reasons:

(a) When only one bid is received, that bid may be accepted and the CO shall require the furnishing of the bid security before the contract is signed;

(b) The amount of the bid security is less than required, but is equal to or greater than the difference between the bid price and the next higher acceptable bid;

(c) The amount of the bid security submitted, although less than that required by the solicitation for the maximum quantity bid upon, is sufficient for a quantity for which the bidder is otherwise eligible for award. Any award to the bidder or offeror shall not exceed the quantity covered by the bid security;

(d) The bid security becomes inadequate as a result of the correction of a mistake, if the bidder agrees to increase the bid security to the level required for the corrected bid; and

(e) The bid security is received late, and late receipt is waived by the CO for reasons determined to be in the best interests of the Hospital.

9807.9 The CO shall require a contractor to furnish performance and payment bonds or other security on any construction contract when the Hospital’s independent estimate of the cost of the contract exceeds seventy-five thousand dollars ($75,000). The CO may require a contractor to furnish a payment or performance bond or other security for any construction or non-construction contract, regardless of amount, when the CO determines that the security is necessary or advisable to protect the interests of the Hospital.

9807.10 The amount of the performance security shall be one hundred percent (100%) of the original contract price, unless the CO determines that a lesser amount or percentage would be adequate for the protection of the Hospital. The CO shall state the amount or percentage in the solicitation.

9807.11 The CO shall require additional performance security when a contract price is increased. The increase in performance security shall equal one hundred percent (100%) of the increase in the contract price, unless the CO determines that a lesser amount or percentage is adequate for the protection of the Hospital.

9807.12 The CO may require additional performance security by directing a contractor to increase the original sum of the existing security or to obtain an additional security.

9807.13 The payment security shall be in an amount of not less than fifty percent (50%) of the total amount of the contract price.

9807.14 When a contract price is increased, the Hospital may require additional payment security in an amount adequate to protect suppliers of labor and material. However, in no event shall the amount of payment security fall below fifty percent (50%) of the increased contract price.

9807.15 When performance or payment security is required, the solicitation shall contain the following:

(a) A statement that security is required;

(b) The amount of the security expressed as a fixed sum or percentage of the contract price; and

9807.16 If the CO uses a letter contract to allow the contractor to proceed with work before execution of the definitive contract, the letter contract shall contain a clause that no payments shall be made under the letter contract until the required payment and performance securities have been received.

9807.17 Security requirements shall be in accordance with Local Small Disadvantaged Business Enterprises (LSDBE) Act 9-223 as amended.

EDITOR’S NOTE: For current provisions regarding contracting with local, small, and disadvantaged businesses, please refer to D.C. Code, 2001 Ed. §§2-217.01 to 2-217.07.

9807.18 A new surety bond covering all or part of the obligation on a security previously approved may be substituted for the original security, if approved by the CO. The CO shall require the contractor to notify the principal and surety on the original bond of the effective date of the new bond.

9807.19 The CO shall, upon request, furnish the name and address of the surety or sureties to any subcontractor or supplier who has furnished or been requested to furnish labor or material for a contract. In addition, general information concerning the work progress, payments, and the estimated percentage of completion may be furnished to persons who have provided labor or material and have not been paid.

9807.20 During the performance of contracts requiring payment and performance security, the Hospital shall not withhold payments that are due to contractors or assignees because subcontractors or suppliers have not been paid.

9807.21 If, after completion of a contract requiring payment and performance security, the Hospital receives written notice from the surety regarding the contractor’s failure to meet its obligation to its subcontractors or suppliers, the CO shall withhold final payment. However, the surety shall agree to hold the Hospital harmless from any liability resulting from withholding the final payment. The CO shall authorize final payment upon agreement between the contractor and surety or upon a judicial or other binding determination of the rights of the parties.

9807.22 The Hospital shall obtain adequate security for bonds (including coinsurance and reinsurance agreements), required or used with a contractor for supplies or services, including construction. A bond security may be obtained from a corporate or individual surety; provided, that an individual surety shall not be used for any construction contract in excess of seventy-five thousand dollars ($75,000). At least two (2) individual sureties shall be required to execute a security. Each corporate surety shall be a company authorized to do business in the District of Columbia.

9807.23 The CO shall determine the acceptability of all individuals proposed as sureties.

9807.24 If a contract is modified, the CO shall obtain the consent of surety in the following circumstances:

(a) When an additional bond is obtained from another surety;

(b) When no additional bond is required and the modification is beyond the scope of the original contract; or

(c) When no additional bond is required and the modification does not change the scope of the contract but increases or decreases the contract price by more than twenty-five percent (25%) or fifty thousand dollars ($50,000).

9807.25 The CO shall obtain the consent of surety for a novation agreement.

9807.26 The CO shall obtain the consent of surety when a contract is to be awarded after the deadline set for contract award unless the written commitment of the surety extends to or beyond the date the contract is signed.

9807.27 The Hospital shall require each contractor to obtain insurance, by purchase, for the risks to which the contractor is exposed, except when the contract specifically relieves the contractor of liability for loss or damage suffered by Hospital personnel and property.

9807.28 When the Hospital requires a contractor to provide insurance coverage, the policies shall contain an endorsement that any cancellation or material change in the coverage or terms and conditions of the coverage shall not be effective unless the insurer or the contractor gives prior written notice of the cancellation or change to the Hospital in the manner required by the contract or the CO.

9807.29 The Hospital requires malpractice insurance to be carried by specific contractors performing under a Health Care Service contract. The insurance amount required is in accordance with the dollar minimum as stated in the contract. The liabilities arising from performance is the responsibility of the contractor.

9807.30 If reinsurance is contemplated, the CO may require reinsurance agreements to be executed and submitted with the securities before making a final determination on the securities.

9807.31 The CO shall require contractors to comply with applicable federal and Hospital workers’ compensation and occupational disease statutes. If occupational diseases are not compensable under those statutes, they shall be covered under the employer’s liability section of the insurance policy, except when contract operations are so commingled with a contractor’s commercial operations that it would not be practical to require the coverage.

9807.32 Each contractor shall be required to carry employer’s liability coverage of at least one hundred thousand dollars ($100,000).

9807.33 The CO shall require each contractor to have bodily injury liability insurance coverage written on the comprehensive form of policy of at least five hundred thousand dollars ($500,000) per occurrence.

9807.34 Property damage liability insurance shall be required only in special circumstances, as determined by the CO.

9807.35 The CO shall require automobile liability insurance written on the comprehensive form of policy. The policy shall provide for bodily injury and property damage liability covering the operation of all automobiles used in connection with performing the contract.

9807.36 Policies covering automobiles shall provide coverage of at least two hundred thousand dollars ($200,000) per person and five hundred thousand dollars ($500,000) per occurrence for bodily injury and twenty thousand dollars ($20,000) per occurrence for property damage.

9807.37 When an aircraft is used in connection with performing a contract, the CO shall require aircraft public and passenger liability insurance. Coverage shall be at least two hundred thousand dollars ($200,000) per person and five hundred thousand dollars ($500,000) per occurrence for bodily injury, other than passenger liability, and two hundred thousand dollars ($200,000) per occurrence for property damage. Coverage for passenger liability bodily injury shall be at least two hundred thousand dollars ($200,000) multiplied by the number of seats or passengers, whichever is greater.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4546 (July 8, 1994).

22-B DCMR § 9808 USE OF HOSPITAL PROPERTY AND SOURCES BY CONTRACTORS

9808.1 When it is in the best interest of the Hospital, and if supplies or services required in the performance of a Hospital contract are available from Hospital property or Hospital supply sources, COs may authorize contractors and subcontractors to use these sources in their performance.

9808.2 The CO may include in the authorization to use Hospital supply sources, any limitations or conditions deemed necessary.

9808.3 Facilities shall be provided to a contractor or subcontractor only under a facilities contract using appropriate contract clauses prescribed by the Executive Director. All facilities provided by the Hospital for use by a contractor at a single place or general location shall be governed by a single facilities contract, unless the Executive Director determines that it is impractical.

9808.4 No fee shall be allowed under a facilities contract.

9808.5 The contractor shall be directly responsible and accountable for all Hospital property in accordance with the provisions of the contract, including all Hospital property in the possession or control of a subcontractor. The contractor shall maintain and make available all property control records required under this section and account for all Hospital property until relieved of the responsibility by the CO under the terms of the contract or this section.

9808.6 Unless the contract or CO provides otherwise, the contractor shall be relieved of property control responsibility for Hospital property by the occurrence of any of the following:

(a) Reasonable and proper consumption of property in the performance of the contract as determined by the CO;

(b) Retention by the contractor, with the approval of the CO, of property for which the Hospital has received adequate consideration;

(d) Shipment from the contractor’s plant, under Hospital instructions, except when shipment is to a subcontractor or other location of the contractor; or

(e) A written determination by the CO of the contractor’s liability for any property that is lost, damaged, destroyed, or consumed in excess of that normally anticipated in a manufacturing or processing operation, which is followed by reimbursement of the Hospital of any amount required in the determination. If the property is rendered unserviceable by damage, the property shall be disposed of properly, and the determination shall refer to the documents evidencing disposal.

9808.7 The contractor shall establish and maintain a system to control, protect, preserve, and maintain all Hospital property.

9808.8 When Hospital property is found to be in the possession or control of the contractor, although not provided under any contract, the contractor shall promptly record the property and furnish to the CO all known circumstances and data pertaining to its receipt and a statement about whether it is needed for the performance of the contract.

9808.9 When unrecorded Hospital property is found in the possession or control of the contractor, both the cause of the discrepancy and actions taken or needed to prevent recurrence shall be determined and reported to the CO.

9808.10 The contractor shall promptly report to the CO all Hospital property it receives in excess of the amounts needed to complete full performance under the contracts providing the property or authorizing the use of such property. The contractor shall furnish written receipts for all or specified classes of Hospital property only when the CO deems it essential for maintaining acceptable property controls.

9808.11 When overages, shortages, or damages are discovered upon receipt of Hospital property, the contractor shall provide a statement of the condition and apparent causes to the CO. Only the quantity of property actually received shall be recorded on the official records.

9808.12 Contractors shall be responsible and liable for Hospital property in their possession, unless otherwise specified in the contract.

9808.13 A prime contractor that provides Hospital property to a subcontractor shall not be relieved of any responsibility to the Hospital that the prime contractor may have under the terms of the prime contract.

9808.14 Subject to the terms of the contract and the circumstances surrounding the particular case, the contractor shall be liable for shortages, loss, damages, or destruction of Hospital property. The contractor shall also be liable when the use or consumption of Hospital property unreasonably exceeds the allowances provided for by the contract.

9808.15 The contractor shall investigate and report to the CO all cases of loss, damage, or destruction of Hospital property in its possession or control as soon as the facts become known, or when requested by the CO. A report shall also be furnished when completed and accepted products or end items are lost, damaged, or destroyed while in the contractor’s possession or control.

9808.16 Immediately upon termination or completion of a contract providing for use of Hospital property by the contractor, the contractor shall perform a physical inventory that is adequate for disposal purposes of all Hospital property applicable to the contract.

9808.17 The contractor shall, at a minimum, submit the following to the CO promptly after completing the physical inventory:

(a) A listing that identifies all discrepancies disclosed by a physical inventory; and

(b) A signed statement that physical inventory of all or certain classes of Hospital property was completed on a given date, and that the official property records were found to be in agreement except for the discrepancies reported.

9808.18 The contractor shall be responsible for the proper care, maintenance, and use of Hospital property in its possession or control from the time of receipt until properly relieved of responsibility, in accordance with sound industrial practice and the terms of the contract and this section.

9808.19 The contractor shall be responsible for a preventive maintenance program.

9808.20 The contractor’s maintenance program shall provide for disclosing and reporting to the CO, the need for major repair, replacement, and other capital rehabilitation work for Hospital property in its possession or control.

9808.21 The contractor shall keep records of maintenance actions performed and any deficiencies in Hospital property discovered as a result of inspections.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4552 (July 8, 1994).

22-B DCMR § 9809 PATENTS, COPYRIGHTS, AND PROPRIETARY INFORMATION

9809.1 The Hospital shall honor rights in patents, copyrights, and proprietary information. The CO shall comply with the requirements of District laws and regulations, in addition to the requirements of this section, in acquiring or using these rights.

9809.2 A contractor shall obtain permission from the lawful owner(s) of copyrighted materials before including all or part of any copyrighted work in any item to be delivered under a contract, unless permission is not required under the fair use or other applicable provisions of District copyright statutes or regulations.

9809.3 The Hospital shall not unreasonably restrict the commercial use, outside of the performance of the contract with the Hospital, of inventions made while performing Hospital contracts.

9809.4 The CO shall not refuse to award a contract solely on the basis of a suspicion that the contractor may infringe a patent, unless the contracting officer determines that refusal is in the best interest of the Hospital.

9809.5 The Hospital shall limit its demands for rights in proprietary information resulting from private developments to those reasonable for present and future use by the Hospital.

9809.6 The contractor shall hold harmless and indemnify the Hospital, its officers, agents, servants and employees from liability of any nature or kind, including cost and expenses for or on account of any patented or unpatented invention, article, process or appliance manufactured or used in the performance of Hospital contracts, including their use, unless otherwise specifically stipulated in the contract.

9809.7 The CO shall prescribe standard contract provisions governing patent rights under Hospital contracts in accordance with the provisions of this section.

9809.8 If the contract permits the contractor to retain title and the contractor elects to retain title to an invention, the Hospital shall have at least a nonexclusive, non-transferable, irrevocable, paid-up license to use or have used, for or on behalf of the Hospital, any invention made in the performance of work under a Hospital contract. The Hospital may have additional rights to sublicense the invention if provided in the contract.

9809.9 If the contract gives a limited right to the contractor to acquire patent rights, the contractor may request greater rights to an invention within the period specified in the contract. The CO may grant a request for greater rights if the CO determines that the grant of greater rights is in the best interest of the Hospital. In making the determination, the CO shall consider the following objectives:

(a) Ensuring that inventions are used in a manner that will promote full and open competition and free enterprise; and

(b) Ensuring that the Hospital obtains sufficient rights in Hospital-supported inventions to meet the needs of the Hospital and protect the public against nonuse or unreasonable use of inventions.

9809.10 If the contract permits the contractor to retain title to an invention and the contractor elects not to retain title, the Hospital may, after consultation with the contractor, grant a request for retention of rights by the inventor.

9809.11 If a Hospital employee is a co-inventor of an invention made under a contract and the Hospital acquires all or part of the rights to the invention, the CO may take any of the following actions that is consistent with the best interests of the Hospital:

(a) Assign all or part of the Hospital’s rights to its employee while retaining for the Hospital any rights set forth herein;

(b) Assign all or part of the Hospital’s rights to the contractor for reasonable consideration, after negotiation by the CO of a reasonable consideration;

(c) If the contractor is a nonprofit organization or is a certified minority business, assign all or part of the Hospital’s rights without consideration; or

(d) Retain the Hospital’s rights.

9809.12 For purposes of this section, an invention is made in the performance of work under a Hospital contract if it is conceived or first actually produced to practice in the performance of work under a Hospital contract.

9809.13 The Hospital may acquire title to, or obtain or limited access to, copyrighted materials, materials subject to copyright protection, and proprietary information developed under or used in the performance of contracts.

9809.14 In accordance with §317(d) of the Procurement Practices Act of 1985 (the “Act”), D.C. Code, 2001 Ed. §2-303.17(d), a bidder or offeror shall designate information contained in a response to the invitation for bids or request for proposals as proprietary or confidential by specifically identifying that information in writing in the bid or proposal.

9809.15 A bidder or offeror including proprietary or confidential information in its bid or offer shall conspicuously display the following information on the first page of the bid or offer if the bidder or offeror does not want the proprietary or confidential information disclosed to the public for any purpose or used by the Hospital except for evaluation purposes:

(a) That the bid or offer includes proprietary or confidential information that shall not be disclosed outside the Hospital and shall not be duplicated, used, or disclosed, in whole or in part, for any purpose other than to evaluate the bid or proposal;

(b) That if a contract is awarded to the bidder or offeror, the Hospital shall have the right to duplicate, use, or disclose the proprietary or confidential information to the extent provided in the contract;

(c) That this restriction does not limit the Hospital’s right to use the proprietary or confidential information if it is obtained from another source without restriction; and

(d) That the bidder or offeror has specifically identified, by page number or otherwise, the proprietary or confidential information subject to the restriction.

9809.16 In addition, the bidder or offeror shall conspicuously mark each separate sheet containing proprietary or confidential information with a notation to the effect that use or disclosure of proprietary or confidential information contained on the sheet is subject to the restriction set forth on the first page of the bid or offer.

9809.17 The bidder or offeror shall not designate as confidential or proprietary the name of the bidder or offeror, the bid or proposal price, or any information that is not actually proprietary or confidential.

9809.18 If, after inspection of a bid or proposal, the CO determines that all or any part of the information designated as confidential or proprietary may be subject to disclosure under the D.C. Freedom of Information Act, D.C. Code, 2001 Ed. §§2-531 to 2-539, the CO shall notify the bidder or offeror of that determination and allow the contractor ten (10) days to respond.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4554 (July 8, 1994).

22-B DCMR § 9810 DELIVERY AND PERFORMANCE

9810.1 The Hospital shall ensure that a delivery or performance schedule is practical, given the need of the Hospital, and takes into account factors which impact the delivery or performance and meets the requirements of the procurement.

9810.2 A solicitation shall inform bidders or offerors of the basis on which their bids or proposals will be evaluated with respect to time of delivery or performance.

9810.3 If a contractor fails or refuses to perform the work or services or make delivery of the supplies or complete installation thereof to meet the requirements of the procurement, such contractor shall be liable to the Hospital for any excess cost the Hospital is reasonably expected to incur, except when non-delivery is due to unforeseen causes beyond the control and without the fault or negligence of the contractor.

9810.4 A contractor must specify reason in writing.

9810.5 A variation in the cost in a fixed-price contract, and supply contracts may be accepted by the Hospital if the variation is caused by conditions of loading, shipping, packing, or allowances in manufacturing processes, and shall not proceed plus or minus 10%, unless a different limitation is established by the CO.

9810.6 The overrun or underrun permitted in each contract shall be based upon the normal commercial practices of a particular industry for a particular item, and the permitted percentage shall be no larger than is necessary to afford a contractor reasonable protection.

9810.7 When the variation between the estimated quantity and the actual required quantity of a unit-priced item in a fixed price construction contract is more than plus or minus fifteen percent (15%), an equitable adjustment in the contract price shall be made upon demand of either the CO or the contractor. The CO shall base the adjustment on the increase or decrease in the contractor’s costs due to the variation in quantity.

9810.8 The contractor may request an extension of time if the quantity variation will increase the time necessary for completion of the contract. The contractor shall ensure that the CO receives the request no later than ten (10) days after the beginning of the period of delay.

9810.9 The CO may issue a stop work order, when appropriate, if work stoppage is required to protect the best interest of the Hospital in circumstances such as advancement in the state-of-the-art production, engineering breakthroughs, realignment of programs, or for any other reason determined to be in the best interest of the Hospital.

9810.10 The CO may issue a stop work order only if it is advisable to suspend work pending the CO’s decision regarding continuation of the work and a contract modification providing for the suspension is not feasible.

9810.11 Promptly after issuing the stop work order, the CO shall discuss the stop work order with the contractor and may, if necessary, modify the order based on the discussion.

9810.12 If the contractor believes that the stop work order is unreasonable the contractor may submit a written claim for increases in the cost of performance due to the stoppage, excluding profit.

9810.13 As soon as feasible after a stop work order is issued, but before its expiration, the CO shall take appropriate action to do one (1) of the following:

(a) Terminate the contract;

(b) Cancel the stop work order; or

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4557 (July 8, 1994).

22-B DCMR § 9811 QUALITY CONTROL

9811.1 A contractor and/or subcontractor may be required to provide and maintain an inspection system or program for the control of quality that is acceptable to the Hospital.

9811.2 The contractor shall be ultimately responsible for performing all inspections and tests required by the contract except those specifically reserved for performance by the Hospital.

9811.3 The type and extent of contract quality requirements needed in each solicitation or contract shall depend on the particular procurement and may range from inspection at time of acceptance to a requirement for the contractor’s implementation of a comprehensive program for controlling quality.

9811.4 The CO may authorize alternative quality control or inspection methods recommended by the contractor when in the best interest of the Hospital.

9811.5 Acceptance shall constitute acknowledgment that the supplies, services, or construction conform to the applicable contract quality and quantity requirements.

9811.6 Supplies, services, or construction shall not be accepted before completion of Hospital contract quality control actions.

9811.7 Acceptance shall be evidenced by execution of an acceptance certificate on an inspection or receiving report form or on a commercial shipping document or packing list.

9811.8 Acceptance of supplies, services, or construction shall be the responsibility of the CO. When the CO assigns the responsibility for acceptance to another Hospital employee, acceptance by that employee shall be binding on the Hospital.

9811.9 Contracts that provide for Hospital contract quality control at the source shall provide for acceptance at the source. Contracts that provide for Hospital contract quality assurance at destination shall provide for acceptance at destination.

9811.10 A certificate of conformance may be used instead of source inspection, whether the contract calls for acceptance at the source or at destination, at the discretion of the CO. Use of the certificate shall not prejudice the Hospital’s right to inspect supplies, services, and construction under the inspection provisions of the contract.

9811.11 Title to supplies and construction shall pass to the Hospital upon formal acceptance.

9811.12 Unless the contract specifically provides otherwise, risk of loss of or damage to supplies shall remain with the contractor until, and shall pass to the Hospital upon either of the following:

(a) Delivery of the supplies to a carrier if transportation is freight on board origin; or

(b) Acceptance by the Hospital or delivery of the supplies to the Hospital at the destination specified in the contract, whichever is later, if transportation is F.O.B. destination.

9811.13 The risk of loss or damage to construction shall remain with the contractor until formal acceptance of the construction by the Hospital. If any of a construction project is excepted from normal acceptance by the Hospital due to defects or failure to conform to the requirements and specifications of the contract, or is subject to contingent acceptance pending cure of defects, the risk of loss or damage to the construction shall remain with the contractor until the defects are cured and the contingency is removed or the construction is formally accepted by the Hospital.

9811.14 The CO shall ensure that each warranty in a Hospital contract clearly delineates the rights and obligations of the contractor and the Hospital for defective items and services and fosters quality performance.

9811.15 A warranty shall provide the following:

(a) A contractual right for the correction of defects, notwithstanding any other requirement of the contract pertaining to acceptance of the supplies or service by the Hospital; and

(b) A stated period of time or use, or the occurrence of a specified event, after acceptance by the Hospital within which the Hospital may assert a contractual right for the correction of defects.

9811.16 The CO shall ensure that the benefits to be derived from a warranty are commensurate with the cost of the warranty to the Hospital.

9811.17 A warranty clause shall not limit the Hospital’s rights under an inspection clause in relation to latent defects, fraud, or gross mistakes that amount to fraud. A warranty clause shall provide that the warranty applies notwithstanding inspection and acceptance, or other clauses or terms of the contract.

9811.18 When the CO determines that a warranty for the entire item is not in the best interests of the Hospital, the CO may require a warranty for a particular aspect of the item that may require special protection, such as installation, components, accessories, subassemblies, preservation, packaging, or packing.

9811.19 A warranty shall provide, at a minimum, that the Hospital may obtain an equitable adjustment of the contract or direct the contractor to repair or replace the defective item at the contractor’s expense.

9811.20 If it is not practical to require the contractor to make a repair or provide a replacement, or, because of the nature of the item, the repair or replacement does not afford an appropriate remedy to the Hospital, the warranty may provide an alternative such as allowing the Hospital to arrange for the repair or replacement of the defective item by the Hospital, or by another source, at the contractor’s expense.

9811.21 The CO shall clearly specify the duration of the warranty.

9811.22 The duration of the warranty shall not extend the contractor’s liability for patent defects beyond a reasonable time after acceptance by the Hospital.

9811.23 If the Hospital specifies the design of the end item and its measurements, tolerances, materials, tests, or inspection requirements, the contractor’s obligations for correction of defects shall be limited to defects in material and workmanship or failure to conform to specifications. If the Hospital does not specify the design, the warranty shall extend to the usefulness of the design.

9811.24 Each warranty shall specify a reasonable time for furnishing notice to the contractor regarding the discovery of defects.

9811.25 The packaging and preservation requirements of a contract shall require the contractor to stamp or mark the supplies delivered or otherwise furnish notice with the supplies of the existence of the warranty.

9811.26 The provisions of this section shall apply to contractor liability for loss of or damage to Hospital property that occurs after acceptance as a result of defects or deficiencies in the supplies delivered or services performed.

9811.27 Except as provided in this subsection, the Hospital shall act as a self-insurer by relieving contractors, as specified in this section, of liability for loss of or damage to property of the Hospital that occurs after acceptance of supplies delivered or services performed under a contract as a result of defects or deficiencies in the supplies or services. However, the Hospital shall not relieve the contractor of liability for loss of or damage to the contract end item itself, except for high-value items.

9811.28 Except as provided in this section, in contracts requiring delivery of high-value items, the Hospital shall relieve contractors of contractual liability for loss of or damage to those items. However, the relief shall not limit the Hospital’s rights arising under the contract to do the following:

(a) Have any defective item or its components corrected, repaired or replaced when the defect or deficiency is discovered before the loss of or damage to high-value items occurs; or

(b) Obtain equitable relief when the defect or deficiency is discovered after such loss or damage occurs.

9811.29 The Hospital shall not provide the contractual relief specified in this section when contractor liability can be preserved without increasing the contract price.

9811.30 Subject to the specific terms of the limitation of liability clause included in the contract, the relief provided under this section shall not apply, as follows:

(a) To the extent that contractor liability is expressly provided for under a contract clause;

(b) When a defect or deficiency in, or the Hospital’s acceptance of, the supplies, services, or construction results from willful misconduct or lack of good faith on the part of the contractor or its agent; or

(c) To the extent that any contractor insurance, or self-insurance reserve, covers liability for loss or damage suffered by the Hospital through purchase or use of the supplies delivered or services performed under the contract.

9811.31 For items being priced at or based on catalog or market prices, the CO shall not provide relief to contractors unless they can obtain a reduction from the catalog or market price which reflects the reduced contractor liability. The CO shall include a clause, to inform bidders and offerors of the provisions of this section.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4559 (July 8, 1994).

22-B DCMR § 9812 INSPECTIONS

9812.1 The Hospital may, in its sole discretion, enter a contractor’s or subcontractor’s plant or place of business in order to:

(a) Inspect for acceptance by the Hospital based on the terms of the contract;

(b) Audit cost or pricing data, or audit the books and records; or

(c) Investigate in connection with an action to debar or suspend an offeror or contractor from consideration for award of contracts.

9812.2 If inspections, are performed at the contractor’s or subcontractor’s plant or place of business, the inspections shall be performed in a manner so as not to delay the work unduly.

9812.3 No inspector or Hospital employee other than the CO may change any provision of the specifications or the contract without written authorization of the CO.

9812.4 Inspections by the Hospital shall not relieve the contractor of responsibility for defects or other failures to meet contract requirements discovered before acceptance. Acceptance shall be conclusive, except for latent defects, fraud, gross mistakes amounting to fraud, or as otherwise provided in the contract.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4562 (July 8, 1994).

22-B DCMR § 9813 AUDITS

9813.1 At reasonable times and places, the Hospital may audit the books and records of any contractor, subcontractor, prospective contractor, or prospective subcontractor which are related to any contract with the Hospital when one of the following circumstances exist:

(a) A question as to the adequacy of accounting policies or cost systems;

(b) A substantial change in the methods or levels of operation;

(d) A lack of cost experience due to the procurement of a new supply or service; or

(e) Other evidence that an audit is in the Hospital’s best interest as determined by the CO.

9813.2 Where the CO requires an audit of a Hospital contractor, the Hospital shall procure the services of an independent certified public accountant (“CPA”) firm or use the services of its internal audit staff to perform an audit or audit review. The audit or audit review shall be conducted in accordance with generally accepted accounting principles, and include such tests as are necessary to render an opinion on the fairness of the contractor’s financial presentation.

9813.3 Books or records shall be maintained by a contractor or subcontractor for a period of three (3) years from date of final payment.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4563 (July 8, 1994).

22-B DCMR § 9814 TERMINATION OF CONTRACTS

9814.1 The CO may terminate a contract for the convenience of the Hospital or default in whole or in part, if it is determined that the termination is in the best interest of the Hospital.

9814.2 The CO may effect a no-cost settlement instead of issuing a termination notice.

9814.3 A termination notice may be amended to accomplish the following:

(a) Correct nonsubstantive mistakes in the notice;

(b) Add supplemental data or instructions;

(c) Rescind or modify the notice if it is determined that items terminated had been shipped or completed before the contractor’s receipt of the notice; or

(d) Reinstate the terminated portion in whole or in part with written consent of the contractor.

9814.4 After issuing a notice of termination for convenience, the CO shall be responsible for negotiating any settlement with the contractor, and shall attempt to settle, in one agreement, all rights and liabilities of parties involved in the terminated contract, except those arising from any portion of the contract still in effect.

9814.5 If the contractor and the CO cannot agree on a termination settlement or if the contractor fails to submit a settlement proposal within the period required by the termination clause, the CO shall issue a determination of the amount due consistent with the termination clause.

9814.6 After execution of a settlement agreement, the contractor shall submit a voucher or invoice showing the amount agreed upon, less any portion previously paid.

9814.7 In the case of construction contracts, before forwarding the final payment voucher, the CO shall ascertain whether there are any outstanding labor violations. If any violations are outstanding, the CO shall determine the amount to be withheld from the final payment.

9814.8 The Hospital shall not pay interest on the amount due under a settlement agreement or a settlement by determination.

9814.9 The total amount payable to the contractor under a settlement, before deducting disposal or other credits, exclusive of settlement costs, shall not exceed the contract price less payments otherwise made or to be made under the contract.

9814.10 Upon termination of a prime contract, the prime contractor and each subcontractor shall be responsible for the prompt settlement with their immediate subcontractors. A subcontractor shall have no contractual rights against the Hospital upon termination of the prime contract.

9814.11 The failure of a prime contractor to include an appropriate termination clause in any subcontract or the failure of the contractor to exercise the rights of the termination clause shall not affect the Hospital’s right to require the termination of the subcontract and shall not increase the obligation of the Hospital in any way whatsoever.

9814.12 Under a termination for default, the Hospital shall not be liable for the contractor’s costs on undelivered work and shall be entitled to the repayment of advance or progress payments, if any, applicable to that work.

9814.13 The default clause shall include a statement that the CO may require the contractor to transfer title and deliver to the Hospital completed supplies. However, the CO shall not use the default clause as authority to acquire any completed supplies unless it has been ascertained that the Hospital does not already have title under some other provision of the contract.

9814.14 When termination for default appears appropriate, the CO may, if it is in the best interest of the Hospital, notify the contractor in writing of the possibility of the termination. The show cause notice shall call the contractor’s attention to the contractual liabilities if the contract is terminated for default, and request the contractor to show cause why the contract should not be terminated for default.

9814.15 The show cause notice shall give the contractor seven (7) days after receipt of the notice to present, in writing, any facts bearing on the case. The notice shall be hand-delivered or sent by certified mail, return receipt requested.

9814.16 The notice may further state that failure of the contractor to present an explanation may be taken as an admission that no valid explanation exists. When appropriate, the notice may invite the contractor to discuss the matter at a conference.

9814.17 If, after consideration of all facts and circumstances, and after compliance with the provisions of this section, the CO determines that a termination for default is proper, the CO shall issue a notice of termination.

9814.18 The CO shall furnish a copy to the contractor’s surety, if any, when the notice is furnished to the contractor. The CO shall request the surety to advise the CO if it desires to arrange for completion of the work.

9814.19 If the CO determines, before issuing the termination notice, that the failure to perform is excusable, the contract shall not be terminated for default. If termination is in the best interest of the Hospital, the CO may terminate the contract for the convenience of the Hospital.

9814.20 If the CO has not been able to determine, before issuance of the notice of termination, whether the contractor’s failure to perform is excusable, the CO shall make a written decision on that point as soon as practicable after issuance of the notice of termination.

9814.21 When the CO determines that some action other than a termination for default is in the best interest of the Hospital, the CO may take any one of the following actions:

(a) The CO may permit the contractor, the surety, or the guarantor, to continue performance of the contract under a revised delivery schedule;

(b) The CO may permit the contractor to continue performance of the contract by means of a subcontract or other business arrangement with an acceptable third party; provided that the rights of the Hospital shall be adequately preserved;

(c) If the requirement for the supplies and services in the contract no longer exists, and the contractor is not liable to the Hospital for damages, the CO may execute a no-cost settlement; or

(d) The CO may, with the written consent of the contractor, reinstate the terminated contract by amending the notice of termination, after the CO makes a written determination that the supplies or services are still required and reinstatement is in the best interest of the Hospital.

9814.22 The termination clause of a cost-reimbursement type contract shall require the CO to provide the contractor with at least seven (7) days notice before issuance of a notice of termination for default.

9814.23 Settlement of a cost-reimbursement contract terminated for default shall be in accordance with the provisions under termination for convenience clause, except as follows:

(a) The costs of preparing the contractor’s settlement proposal shall not be allowable; and

(b) The contractor shall be reimbursed for all allowable costs, and an appropriate reduction shall be made in the total fee, if any.

9814.24 When the supplies or services under a terminated contract are still required after termination for default, the CO shall repurchase the same or similar supplies or services against the contractor’s accounts as soon as practicable. The CO shall repurchase similar supplies and services at as reasonable a price as practicable, considering the quality and delivery requirements.

9814.25 The CO may repurchase a quantity in excess of the quantity terminated for default when the excess quantity is needed. However, the costs of any items in excess of the undelivered quantity terminated for default shall not be charged against the defaulting contractor.

9814.26 If repurchase is made at a price greater than the price of the supplies or services terminated, the CO shall, after completion and final payment of the repurchase contract, make a written demand on the contractor for the total amount of the excess, giving consideration to any increases or decreases in other costs, such as transportation or discounts.

9814.27 If the surety offers to complete the contract work, the CO shall accept the offer, unless the CO has reason to believe that the persons or firms proposed by the surety to complete the work are not competent or qualified and the interests of the Hospital would be substantially prejudiced.

9814.28 If the surety conditions its offer of completion upon the execution by the Hospital of a “takeover” agreement, fixing the surety’s rights to payment from unpaid prior earnings (retained percentage and unpaid progress estimates), the CO may, at any time after the effective date of the termination, enter into a written agreement with the surety.

9814.29 The takeover agreement shall provide for the surety to complete the work according to all the terms and conditions of the contract and for the Hospital to pay the surety the balance of the contract price, less any setoffs or assessed damages, but not in excess of the surety’s costs and expenses, in the manner provided by the contract subject to the following conditions set forth in this section.

9814.30 Under a takeover agreement, any unpaid earnings of the defaulting contractor, including retained percentages and progress estimates for work accomplished before termination, shall be subject to debts and assessed damages due the Hospital by the contractor.

9814.31 The takeover agreement shall not waive or release the Hospital’s right to liquidated damages for delays in completion of the work, except to the extent that they are excusable under the contract.

9814.32 If the contract proceeds have been assigned to a financing institution, the surety may not be paid from unpaid earnings under a takeover agreement, unless the assignee consents to the payment in writing.

9814.33 Under a takeover agreement, the surety shall not be paid any amount in excess of its total expenditures necessarily made in completing the work and discharging its liabilities under the payment bond of the defaulting contractor.

9814.34 The CO shall make payments to the surety to reimburse it for discharging its liabilities under the payment bond of the defaulting contractor only on the basis of one (1) of the following:

(a) Mutual agreement between the Hospital, the defaulting contractor, and the surety; or

(b) Order of a court of competent jurisdiction.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4563 (July 8, 1994).

22-B DCMR § 9815 DEBARMENT OR SUSPENSION

9815.1 A contractor shall be debarred or suspended from being awarded any Hospital contracts if the principal, or in the case of a corporation, any of its officers, directors, or shareholders holding a substantial interest, or in the case of a partnership, any partner is:

(a) Convicted for commission of a criminal offense arising from or incident to obtaining or attempting to obtain a private contract;

(b) Convicted under District or Federal statutes of embezzlement, theft, forgery, bribery, falsification or destruction of records, receiving stolen property, or any other offense indicating a lack of business integrity or business honesty which directly affects the present responsibility as a Hospital contractor;

(d) Found to be in violation of contract provisions of a character which is regarded by the CO to be so serious as to justify debarment action;

(e) Engaging in business activities which are contrary to the laws, rules, or regulations of the Government of the District of Columbia;

(f) In violation of the ethical standards stated in §9512; or

(g) Determined by the CO in writing to have committed a breach in professional ethical conduct of such a serious and compelling nature so as to affect responsibility as a Hospital contractor.

9815.2 A contractor or prospective contractor who has been notified of a proposed debarment or suspension action may request in writing that a hearing be held. The contractor’s or prospective contractor’s written request shall be delivered by certified mail to the CO within ten (10) days of receipt by the contractor or prospective contractor of notice of the proposed action.

9815.3 The CO shall prepare a summary report of the proposed debarment or suspension action for the review of the Hospital’s Procurement Review Committee (PRC). The PRC shall hold a hearing after receipt of the contractor’s or prospective contractor’s request for hearing.

9815.4 The PRC shall issue a final decision after the hearing.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4568 (July 8, 1994).

22-B DCMR § 9816 PROTESTS

9816.1 Any aggrieved person or person thought to be aggrieved may protest a solicitation, award or proposed award. The protest shall be filed in writing within ten (10) days after the basis of the protest is known (or should have been known) with the contracting officer.

9816.2 When a protest against the making of an award is received and award will be withheld pending disposition of the protest, the CO shall notify bidders/offerors whose bids/offers might become eligible for award after the protest.

9816.3 If appropriate, those offerors shall be requested, before expiration of the time for acceptance of their offer, to extend the time for acceptance to avoid the need for resolicitation.

9816.4 In the event of failure to obtain extensions of offers, the CO shall give consideration and have authority to proceed with the award.

9816.5 The protestor may appeal the CO’s decision only to the District of Columbia Contract Appeals Board (CAB) within ten (10) calendar days after the protestor receives a determination from the CO.

9816.6 The CAB shall have exclusive jurisdiction to hear and decide appeals from final decisions of the CO; provided, however, that no appeal may be taken to the CAB unless and until all administrative review procedures have first been fully and properly complied with and exhausted.

9816.7 The CAB shall hear and decide appeals from final decisions of the CO and grant relief in accordance with D.C. Code, 2001 Ed. §2-309.08(c)-(e) and regulations promulgated thereunder and such other statutory provisions, regulations and independent agreements as are applicable to the Hospital.

9816.8 The proceeding before the CAB shall be final, subject to judicial review in accordance with D.C. Code, 2001 Ed. §2-309.05.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4569 (July 8, 1994).

22-B DCMR § 9817 DISPUTES

9817.1 The Hospital shall attempt to resolve all disputes arising under or relating to contracts by mutual agreement after informal discussions between the contractor and the CO.

9817.2 Any dispute arising under or relating to a contract which is not resolved by informal discussions shall be resolved in accordance with this section. Each Hospital contract shall contain a disputes clause that provides for resolution of disputes in accordance with the provisions of this section.

9817.3 A claim by the contractor shall be made in writing and submitted initially to the CO for a written decision. The CO shall hold informal discussions with the contractor and appropriate Hospital staff to resolve contract disputes. A claim by the contractor against the Hospital shall be subject to a written decision by the CO.

9817.4 In the event a claim by or against a contractor cannot be satisfied or settled by mutual agreement and a decision on the claim is necessary, the CO shall prepare a written decision upon receipt of the contractor’s claim. The CO’s written decision shall do the following:

(a) Grant or deny the contractor’s claim, in whole or in part;

(b) Give the reasons for the CO’s decision;

(c) Inform the contractor of the right to seek further redress by requesting reconsideration from the Contract Appeals Board; and

(d) Specifically indicate that the written document is the CO’s final decision.

9817.5 Any failure of the CO to issue a decision shall be deemed a decision by the CO denying the claim and authorizing the contractor to file an appeal with the Contracts Appeals Board.

9817.6 The contractor may use the same procedures as outlined in Appeal of the Contracting Officer’s Final Decision, under the Provision of Protest.

9817.7 Pending final resolution of a dispute or claim, the contractor shall comply with any decision of the Hospital and proceed diligently with performance of the contract, except to the extent such work has been terminated. Failure to proceed shall be grounds for termination for default.

History

SOURCE: Final Rulemaking published at 41 DCR 4508, 4569 (July 8, 1994).

22-B99 HOME SUPPORT AGENCIES

22-B DCMR § 9900 GENERAL PROVISIONS

9900.1 These regulations are implemented pursuant to Sections 2(b) and 5 of the Health Care and Community Residence Facility, Hospice and Home Care Licensure Act of 1983 ("Act"), effective February 24, 1984 (D.C. Law 5-48; D.C. Official Code §§ 44-501(b) and 44-504(a)).

9900.2 Each home support agency serving one or more clients in the District of Columbia shall be licensed and shall comply with the requirements in this chapter and, except as otherwise provided herein, with the regulations in Chapter 31 (Licensing of Health Care and Community Residence Facilities) of Title 22-B of the District of Columbia Municipal Regulations (“DCMR”), which contains provisions on inspections, licensing and enforcement actions pertaining to facilities authorized under the Act.

9900.3 Each home support agency shall comply with all other applicable federal and District laws and regulations.

History

SOURCE: Final Rulemaking published at 67 DCR 9476 (August 7, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 9900

22-B DCMR § 9901 OPERATING OFFICE

9901.1 Each home support agency shall maintain an operating office within the District of Columbia. This office shall be staffed at least eight (8) hours per business day.

9901.2 The business hours of the operating office shall be posted publicly so that they are visible from the outside of the office. The home support agency shall maintain a public website that provides, at a minimum, the home support agency’s business hours, services provided, ownership information, key personnel, and contact information that includes a phone number and email address.

9901.3 A separate license shall be required for each operating office maintained by a home support agency.

9901.4 Each operating office shall either store at the office in paper form or have immediately available electronically the following records:

(a) Client records for all clients served within the District of Columbia;

(b) Personnel records for all employees;

(d) Incident reports and investigations; and

(e) Complaint reports and investigations.

9901.5 All other records and documents required under this chapter and other applicable laws and regulations that are not maintained within the operating office shall be produced for inspection within two (2) hours after a request by the Department, or within a shorter time if the Department so specifies.

9901.6 Each home support agency shall post its license in a conspicuous place within the operating office.

9901.7 Prior to any change in office location, a home support agency shall:

(a) Notify the Department in writing at least sixty (60) days prior to the change;

(b) Provide the following documentation to the Department:

The new address;

A copy of the lease agreement for the new office location, if applicable;

A certificate of insurance reflecting the new address;

A certificate of occupancy reflecting the new address;

A Clean hands certificate in accordance with the D.C. Official Code §§ 47-2861 et seq.; and

A Certificate of Good Standing for a corporation to be obtained from the Office of the Registrar of Corporations at the Department of Consumer and Regulatory Affairs; and

9901.8 The operating office shall be open to employees, clients, client representatives, and prospective clients and their representatives during business hours.

History

SOURCE: Final Rulemaking published at 67 DCR 9476 (August 7, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 9901

22-B DCMR § 9902 APPLICATION FOR LICENSURE

9902.1 Applications for licensure shall be processed in accordance with this section and Chapter 31 of Title 22-B DCMR.

9902.2 The submission of an application does not guarantee that the Department will issue a license.

9902.3 Applicants for licensure shall submit the following information to the Department as part of the application:

The names, addresses, and types of all entities owned or managed by the applicant;

A copy of the applicant’s operating policies and procedures manual for the home support agency;

The identity of each officer and director of the corporation, if the entity is organized as a corporation, including name, address, phone number, and email;

A copy of the Articles of Incorporation and Bylaws, if the entity is organized as a corporation;

A copy of the Partnership Agreement and the identity of each partner if the entity is organized as a partnership, including name, address, phone, number, and email;

A copy of the Articles of Formation and Operating Agreement, if the entity is organized as a limited liability company;

The identity of the members of the governing body, including name, address, phone number, and email;

The identity of any officers, directors, partners, managing members or members of the governing body who have a financial interest of five percent (5%) or more in an applicant’s operation or related businesses, including name, address, phone number, and email;

Disclosure of whether any officer, director, partner, employee, or member of the governing body has a felony criminal record;

The name of the Director who is responsible for the management of the home support agency and the name of the Client Service Coordinator, if applicable;

A list of management personnel, including their credentials; and

Any other information required by the Department.

9902.4 Each applicant shall be responsible for submitting a complete application, including all information required pursuant to § 9902.3. The Department reserves the right to return an incomplete application to the applicant: The return of an incomplete application to the applicant shall not be considered a denial of the application.

9902.5 If the Department returns the application with identified deficiencies:

(a) The applicant shall have thirty (30) days to correct the identified deficiencies and return the application to the Department; and

(b) If the applicant resubmits the application to the Department and has not corrected all the deficiencies, the application shall be deemed incomplete and returned the applicant. The applicant shall have the option of filing a new application along with a new processing fee.

9902.6 As part of its review of a home support agency’s application, the Department shall conduct an on-site walk through of the business location to verify that the office is capable of operating.

History

SOURCE: Final Rulemaking published at 67 DCR 9476 (August 7, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 9902

22-B DCMR § 9903 LICENSURE

9903.1 At the beginning of a home support agency’s license year, the Department shall issue a provisional license for a period of ninety (90) days to each home support agency that has completed the application process consistent with these regulations, has passed the on-site walk through by the Department, and whose policies and procedures demonstrate compliance with the rules and regulations pertaining to home support agency licensure.

9903.2 A provisional license shall permit a home support agency to hire staff and establish a client caseload;

9903.3 To be eligible for a permanent license, the home support agency shall:

(a) Obtain and demonstrate that the home support agency has a client census equal to or greater than five (5) clients by the end of the ninety (90) day provisional license period;

(b) Notify the Department that is has a client census of at least five (5) clients;

(c) Complete an on-site survey during the provisional license period, provided they have a demonstrated client census of five (5) or more clients; and

(d) Demonstrate during the on-site survey, that it meets the definition of a home support agency in these regulations, complies with these regulations, and is in operation and caring for clients.

9903.4 The Department may, at its discretion, renew a provisional license for up to an additional ninety (90) days in order for the licensee to meet the definition of a home support agency, have a demonstrated client census of five (5) or more clients, and come into substantial compliance with these regulations:

The Department shall designate the conditions and the time period for the renewal of a provisional license;

An initial provisional license issued to a home support agency that is not in substantial compliance with these regulations following an on-site survey by the Department shall not be renewed unless the Department approves a corrective action plan for the home support agency; and

If a home support agency is not in substantial compliance with these regulations after two (2) provisional license periods, the home support agency shall be denied a permanent license.

9903.5 The Department shall grant a permanent license for a period of twelve (12) months, including the provisional license period, to a home support agency that the Department has determined meets the definition of a home support agency, complies with these regulations, and has a demonstrated client census of five (5) or more clients.

9903.6 An existing licensed home support agency shall apply for renewal of its license at least ninety (90) days prior to its expiration.

9903.7 A renewal license shall not be issued to a home support agency that at the time of renewal:

(a) Does not meet the definition of a home support agency as contained within these regulations;

(b) Is not in substantial compliance with these regulations as determined by the Department;

Does not have a demonstrated client census of five (5) or more clients; or

(d) Has one or more deficient practice which presents an immediate threat to the health and safety of its clients.

9903.8 A home support agency that undergoes a modification of ownership or control is required to re-apply for licensure as a new home support agency.

9903.9 The Department shall issue each license only for the premises and the person or persons named as applicant(s) in the license application. The license shall not be valid for use by any other person or at any place other than that designated in the license. Any transfer of the home support agency to a new person or place without the approval of the Department shall result in the immediate forfeiture of the license.

9903.10 A home support agency licensed pursuant to this chapter shall not use the word “health” in its title.

History

SOURCE: Final Rulemaking published at 67 DCR 9476 (August 7, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 9903

22-B DCMR § 9904 LICENSE FEES

9904.1 License fees for home support agencies shall be based upon a census of clients served in the District of Columbia at the time of applying for the issuance or renewal of a license. The fees shall be as follows:

Initial Application Processing Fee $1200

License Fee $400

1 – 50 Clients

Annual Renewal Processing Fee $800

51 – 150 Clients

Annual Renewal Processing Fee $1400

151 – 350 Clients

Annual Renewal Processing Fee $2200

351 or more Clients

Annual Renewal Processing Fee $2600

Duplicate of License $100

Late Fee for Renewal Application $100

History

SOURCE: Final Rulemaking published at 67 DCR 9476 (August 7, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 9904

22-B DCMR § 9905 INSURANCE

9905.1 Each home support agency shall maintain the following minimum amounts of insurance coverage:

Blanket malpractice insurance for all professional employees in the amount of at least one million dollars ($1,000,000) per incident; and

Comprehensive general liability insurance covering personal property damages, bodily injury, libel and slander in the amount of at least one million dollars ($1,000,000) per incident or occurrence and two million dollars ($2,000,000) aggregate.

History

SOURCE: Final Rulemaking published at 67 DCR 9476 (August 7, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 9905

22-B DCMR § 9906 GOVERNING BODY

9906.1 Each home support agency shall have a governing body that shall be responsible for the operation of the home support agency.

9906.2 The governing body shall:

(a) Establish and adopt by-laws, policies, and procedures governing the operation of the home support agency;

(b) Designate a full-time Director who is qualified in accordance with Section 9907 of this chapter;

(c) Review and evaluate, on an annual basis, all policies and procedures governing the operation of the home support agency to ensure that services promote client care that is appropriate, adequate, effective and efficient. This review and evaluation shall include the following:

A review of feedback from a representative sample consisting of either ten percent (10%) of total District of Columbia clients or forty (40) District of Columbia clients, whichever is less, regarding services provided to those clients; and

A review of all complaints and incidents involving the home support agency, including the nature of each complaint or incident, the home support agency's response, and the resolution;

(d) A written report of the results of the evaluation shall be prepared and shall include recommendations for modifications of the home support agency's overall policies or practices, if appropriate; and

(e) The evaluation report shall be acted upon by the governing body at least annually. The results of the action taken by the governing body shall be documented, maintained, and available for review by the Department.

History

SOURCE: Final Rulemaking published at 67 DCR 9476 (August 7, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 9906

22-B DCMR § 9907 DIRECTOR

9907.1 The Director shall be responsible for managing and directing the home support agency's operations, serving as a liaison between the governing body and staff, employing qualified personnel, and ensuring that staff members are adequately and appropriately trained.

9907.2 The Director shall be available at all times during the business hours of the home support agency.

9907.3 The Director shall designate, in writing, a similarly qualified person to act in the absence of the Director.

9907.4 The home support agency shall advise the Department in writing within fifteen (15) days following any change in the designation of the Director.

9907.5 The Director shall:

(a) Be a registered nurse licensed in the District of Columbia; or

(b) Have training and experience in health services administration, including at least one (1) year of supervisory or administrative experience in health services or related health programs.

9907.6 If the Director is not a registered nurse, the home support agency shall also have a full-time Client Service Coordinator appointed by the Director who is a registered nurse licensed in the District of Columbia.

9907.7 The Client Service Coordinator, or the Director if the Director is a registered nurse, shall:

(a) Be responsible for implementing, coordinating and assuring the quality of client services;

(b) Be available at all times during the business hours of the home support agency;

(c) Participate in all aspects of services provided, including the development of clients’ service plans and the assignment of qualified personnel; and

(d) Provide general supervision and direction of the services offered by the home support agency.

9907.8 The Director, Client Service Coordinator, or an individual designated by the Director in writing, must be on-call outside of the home support agency’s business hours.

History

SOURCE: Final Rulemaking published at 67 DCR 9476 (August 7, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 9907

22-B DCMR § 9908 POLICIES AND PROCEDURES

9908.1 Each home support agency shall develop and implement written operational policies and procedures that govern the day-to-day operations of the home support agency. These policies and procedures shall be approved by the governing body and shall be available for review by the Department.

9908.2 The home support agency’s written policies and procedures shall govern the following topics, at a minimum:

(a) Personnel;

(b) Admission and denials of admission;

(d) Coordination of services;

(e) Records retention and disposal;

(f) Client rights and responsibilities;

(g) Complaint process;

(h) Each service offered;

(i) Billing for services;

(j) Supervision of services;

(k) Infection control; and

(l) Management of incidents.

9908.3 Staff shall be oriented towards the written policies and procedures. The written policies and procedures shall be readily available for use by staff at all times.

9908.4 Written policies and procedures shall be available to clients, prospective clients, and client representatives, upon request.

History

SOURCE: Final Rulemaking published at 67 DCR 9476 (August 7, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 9908

22-B DCMR § 9909 PERSONNEL

9909.1 Each home support agency shall have written personnel policies that shall be available to each staff member and shall include the following:

(a) The terms and conditions of employment, including but not limited to wage scales, hours of work, personal and medical leave, insurance, and benefits;

(b) Provisions for an annual evaluation of each employee's performance by appropriate supervisors;

(c) Provisions pertaining to probationary periods, promotions, disciplinary actions, termination and grievance procedures;

(d) A position description for each category of employee; and

(e) Provisions for orientation, periodic training or continuing education, and periodic competency evaluation.

9909.2 Each home support agency shall maintain accurate personnel records, which shall include the following information for each employee:

(a) Name, address and social security number;

(b) Current professional license, registration, or certification, if any;

(c) Resume of education, training certificates, skills checklist, and prior employment, and evidence of attendance at orientation and in-service training, workshops or seminars;

(d) Documentation of current CPR certification, if required;

(e) Health certification as required by Subsection 9909.7 of this chapter;

(f) Verification of previous employment;

(g) Documentation of reference checks;

(h) Copies of completed annual evaluations;

(i) Documentation of any required criminal background check;

(j) Documentation of all personnel actions;

(k) A position description signed by the employee;

(l) Results of any competency testing;

(m) Documentation of acceptance or declination of the Hepatitis Vaccine; and

(n) Documentation of insurance, if applicable.

9909.3 Each home support agency shall comply with the Health-Care Facility Unlicensed Personnel Criminal Background Check Act of 1998, effective April 20, 1999 (D.C. Law 12-238; D.C. Official Code §§ 44-551 et seq.), for its employees who are not licensed, certified or registered in accordance with the District of Columbia Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq.) (“HORA”), and shall ensure that employees who are licensed, registered, or certified in accordance with the HORA are in compliance with the criminal background check requirements of D.C. Official Code § 3-1205.22.

9909.4 Each home support agency shall maintain its personnel records for all personnel serving clients within the District of Columbia in its operating office in paper form or have these records immediately available electronically.

9909.5 Each employee shall have a right to review his or her personnel records.

9909.6 At the time of initial employment, the home support agency shall verify that the employee, within the six months immediately preceding the date of hire, has been screened for and is free of all communicable diseases.

9909.7 Each employee shall be screened for communicable diseases according to the guidelines issued by the federal Centers for Disease Control and Prevention, and shall be certified free of communicable diseases.

9909.8 No employee may provide personal care services, and no home support agency may knowingly permit an employee to provide personal care services, if an employee:

(a) Is under the influence of alcohol, any mind-altering drug or combination thereof; or

(b) Has a communicable disease which poses a confirmed health risk to clients.

9909.9 Each employee who is required to be licensed, certified or registered to provide services in the District of Columbia shall be licensed, certified or registered under the laws and rules of the District of Columbia.

9909.10 Each home support agency shall document the professional qualifications of each employee to ensure that the applicable licenses, certifications, accreditations or registrations are valid.

9909.11 Each home support agency shall ensure that each employee presents a valid home support agency identification prior to entering the home of a client.

History

SOURCE: Final Rulemaking published at 67 DCR 9476 (August 7, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 9909

22-B DCMR § 9910 ADMISSIONS

9910.1 Each home support agency shall develop and implement written policies on admissions, which shall include, at a minimum, the following:

(a) Admission criteria and procedures;

(b) A description of the services provided;

(d) Policies governing fees, payments and refunds;

(e) Execution and location of client advance directives (living will and durable power of attorney for health care), as applicable;

(f) Execution and location of client Medical Orders for Scope of Treatment (“MOST”), as applicable;

(g) Communication with the client representative, if applicable;

(h) Client service agreements; and

(i) Client consent for interagency sharing of information.

9910.2 A written summary of the home support agency's admissions policies, including all of the items specified at Subsection 9909.1 of this chapter, shall be made available to each prospective client upon request, and shall be given to each client upon admission.

9910.3 The home support agency shall only admit those individuals whose needs can be met by the home support agency.

9910.4 Each home support agency shall conduct an initial assessment by a registered nurse to ensure that the client does not require services outside of the scope of personal care services. The assessment shall include a home visit and a review of information provided by the prospective client or the client representative and any other pertinent data and shall take place prior to the time that personal care services are initially provided to the client. The assessment must determine whether the home support agency has the ability to provide the necessary services in a safe and consistent manner.

9910.5 The home support agency shall notify each individual requesting services from the home support agency of the availability or unavailability of service, and the reason(s) therefor, within forty-eight (48) hours after the referral or request for services.

9910.6 A home support agency shall maintain records on each person requesting services whose request is not accepted. The records shall be maintained for at least one (1) year from the date of non-acceptance and shall include the nature of the request for services and the reasons for not accepting the client.

History

SOURCE: Final Rulemaking published at 67 DCR 9476 (August 7, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 9910

22-B DCMR § 9911 CLIENT SERVICE AGREEMENT

9911.1 There shall be a written service agreement between each client and the home support agency. The agreement shall:

Specify the services to be provided by the home support agency, including but not limited to:

Frequency of visits including scheduled days and hours;

Accompaniment and/or transportation agreements as appropriate;

Procedures for emergency medical response; and

Conditions for discharge and appeal;

Specify the procedure to be followed when the home support agency is not able to keep a scheduled client visit;

Specify financial arrangements, which shall minimally include:

A description of services purchased and the associated cost;

An acceptable method of payment(s) for services;

An outline of the billing procedures, including any required deposits, if applicable;

A requirement that all payments by the client for services rendered shall be made directly to the home support agency or its billing representative and no payments shall be made to or in the name of individual employees of the home support agency; and

The home support agency’s policies for non-payment;

Identify the client representative, if applicable;

Specify the home support agency’s emergency contact information during both business and non-business hours;

Specify the number for the Department of Health’s Complaint Hotline;

Be signed by the client or client representative, if applicable, and the representative of the home support agency prior to the initiation of services;

Be given to the client or client representative, if applicable, and a copy shall be kept in the client record; and

Be reviewed and updated as necessary to reflect any change in the services or the financial arrangements.

History

SOURCE: Final Rulemaking published at 67 DCR 9476 (August 7, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 9911

22-B DCMR § 9912 DISCHARGES, TRANSFERS, AND REFERRALS

9912.1 Each home support agency shall develop and implement written policies that describe discharge, transfer, and referral criteria and procedures, including timeframe for discharge, transfer, or referral if a need for services beyond personal care services is identified.

9912.2 Each client shall receive written notice of discharge or referral no less than seven (7) days prior to the action. The seven (7) day written notice shall not be required, and oral notice may be given at any time, if the transfer, referral or discharge is the result of:

(a) A medical or social emergency;

(b) A physician's order to admit the client to an in-patient facility;

(c) A determination by the home support agency that the referral or discharge is necessary to protect the health, safety, or welfare of the home support agency’s staff; or

(d) The refusal of further services by the client or the client representative.

9912.3 Each home support agency shall document activities related to discharge, transfer, or referral planning for each client in the client's record.

History

SOURCE: Final Rulemaking published at 67 DCR 9476 (August 7, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 9912

22-B DCMR § 9913 CLIENT SERVICE PLAN

9913.1 The home support agency shall provide services in accordance with a written client service plan in agreement with the client or client representative, if applicable.

9913.2 A registered nurse shall develop a service plan on admission based upon the initial assessment of the client and in accordance with Subsection 9917.4.

9913.3 The service plan shall include at least the following:

The scope and types of services, frequency and duration of services to be provided, including any diet, equipment, and transportation required;

Parameters related to services provided pursuant to Subsections 9917.4(e)-(f) of this chapter;

Functional limitations of the client;

Activities permitted; and

Safety measures required to protect the client from injury.

9913.4 A registered nurse shall review and evaluate the service plan at least every ninety (90) days.

9913.5 A copy of the service plan shall be available to the client or client representative upon request.

9913.6 The personnel assigned to each client shall be oriented to the service plan.

History

SOURCE: Final Rulemaking published at 67 DCR 9476 (August 7, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 9913

22-B DCMR § 9914 CLIENT RECORDS

9914.1 Each home support agency shall establish and maintain a complete and accurate client record of the services provided to each client in accordance with this chapter and accepted professional standards and practices.

9914.2 Each client record shall include the following information related to the client:

(a) Admission data, including name, address, date of service inquiry, date of birth, sex, next of kin, name and contact information of the client representative (if applicable), date accepted by the home support agency to receive services, and source of payment;

(b) Source of referral;

(d) Signed client services agreement;

(e) Advance directives (living will and durable power of attorney for health care), if applicable;

General Power of Attorney or Guardianship, if applicable;

MOST, if applicable;

Service plan;

History of sensitivities and allergies;

(j) Medication list;

(k) Service delivery notes signed and dated as appropriate by staff;

(l) Documentation of supervision of personal care services;

(m) Documentation of discharge planning, if appropriate;

(n) Discharge summary, including the reason for termination of services and the effective date of discharge;

(o) Documentation of coordination of services, if applicable;

(p) Communications between the home support agency and all health care professionals involved in the client's care; and

(q) Documentation of training and education given to the client and the client’s caregivers.

History

SOURCE: Final Rulemaking published at 67 DCR 9476 (August 7, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 9914

22-B DCMR § 9915 RECORDS RETENTION AND DISPOSAL

9915.1 Each home support agency shall maintain a records system that shall include the following:

(a) Written policies that provide for the protection, confidentiality, retention, storage, and maintenance of home support agency records; and

(b) Written procedures that address the transfer or disposition of home support agency records in the event of dissolution of the home support agency.

9915.2 If a home support agency is dissolved and there is no identified new owner, the home support agency records shall be retained either electronically or in paper form so as to be retrievable upon request by the client or the client representative for a period of five (5) years following the date of dissolution. The records shall be produced to the client or client representative within thirty (30) days of receipt of a request and at no cost to the client or the client representative.

9915.3 Each home support agency shall inform the Department and each client in writing, within thirty (30) days of dissolution of the home support agency, of the location of the client records and how each client may obtain his or her records.

9915.4 A home support agency shall maintain client records for at least five (5) years after the date of discharge of the client.

9915.5 A home support agency shall maintain records of complaints and incidents for a minimum of five (5) years.

9915.6 A home support agency shall maintain the personnel records of each staff member for at least five (5) years after the date of termination or separation.

9915.7 Department authorities shall have access to home support agency records at all times.

History

SOURCE: Final Rulemaking published at 67 DCR 9476 (August 7, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 9915

22-B DCMR § 9916 CLIENT RIGHTS AND RESPONSIBILITIES

9916.1 Each home support agency shall develop a written statement of client rights and responsibilities that shall be given, upon admission, to each client who receives personal care services or the client representative, if applicable.

9916.2 Each home support agency shall develop policies to ensure that each client who receives personal care services has the following rights:

(a) To be treated with courtesy, dignity, and respect;

(b) To control his or her own household and life style;

(1) Services to be provided by the home support agency, including any limits on service availability;

(2) The amount charged for each service, and procedures for billing and non-payment;

(3) Prompt notification of acceptance, denial or reduction of services;

(4) Complaint process; and

(5) The telephone number of the Complaint Hotline maintained by the Department;

(d) To receive services consistent with the service agreement and with the client's service plan;

(e) To participate in the planning and implementation of his or her personal care services;

(f) To receive services by competent personnel who can communicate with the client;

(g) To refuse all or part of any service and to be informed of the consequences of refusal;

(h) To be free from mental and physical abuse, neglect, and exploitation by home support agency employees;

(i) To be assured confidential handling of client records as provided by law;

(j) To be educated about and trained in matters related to the services to be provided;

(k) To voice a complaint or other feedback to the Department or the home support agency in confidence and without fear of reprisal from the home support agency or any home support agency personnel, in writing or orally, including an in-person conference if desired, and to receive a timely response to a complaint as provided in these rules; and

(l) To have access to his or her own client records.

9916.3 Each home support agency shall inform all clients that they have the right to make complaints and to provide feedback concerning the services rendered by the home support agency to the Department, in confidence and without fear of reprisal from the home support agency or any home support agency personnel, in writing or orally, including an in person conference if desired.

9916.4 Each home support agency shall develop a statement of client responsibilities regarding the following:

Treating home support agency personnel with respect and dignity;

Providing accurate information when requested;

Informing the home support agency when instructions are not understood or cannot be followed;

Cooperating in making a safe environment for care within the home; and

Providing prompt payment for services.

9916.5 Written policies on client rights and responsibilities shall be made available to the general public.

9916.6 The home support agency shall take appropriate steps to ensure that all information is conveyed, pursuant to these rules, to any client who cannot read or who otherwise needs accommodations in an alternative language or communication method. The home support agency shall document in the client's records the steps taken to ensure that the client has been provided effectively with all required information.

History

SOURCE: Final Rulemaking published at 67 DCR 9476 (August 7, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 9916

22-B DCMR § 9917 MANAGEMENT OF COMPLAINTS AND INCIDENTS

9917.1 Each home support agency shall develop and implement policies and procedures for receiving, processing, documenting, and investigating complaints and incidents.

9917.2 A complaint may be presented to the home support agency orally or in writing.

9917.3 A written summary of the complaint process shall be given to the client or client representative upon acceptance or denial of services.

9917.4 The telephone number of the Complaint Hotline maintained by the Department shall be posted in the home support agency's operating office in a place where it is visible to all staff and visitors.

9917.5 Each home support agency shall respond to each complaint received by it within fourteen (14) days of receipt, shall investigate the complaint as soon as reasonably possible, and shall, upon completion of the investigation, provide the complainant with the results of the investigation.

9917.6 If the client indicates that he or she is not satisfied with the response, the home support agency shall respond in writing within thirty (30) days from the client’s expression of dissatisfaction. The response shall include the telephone number and address of all District government agencies with which a complaint may be filed and the telephone number of the Complaint Hotline maintained by the Department.

9917.7 The home support agency shall report all incidents involving a client occurring in the presence of staff to the Department within forty-eight (48) hours in addition to other reporting requirements prescribed by law.

9917.8 The home support agency shall investigate all incidents. The home support agency shall forward a complete investigation report to the Department within thirty (30) days of the occurrence or of the date that the home support agency first became aware of the incident.

9917.9 Each home support agency shall develop and implement a system of documenting complaints and incidents, which shall reflect all complaint, incident, and investigative activity for each year, and which shall include, for each complaint or incident:

(a) The name, address and phone number of the complainant or client involved in the incident, if known;

(b) If the complaint is anonymous, a statement so indicating;

(d) A description of the complaint or incident, including the names of any staff involved;

(e) The date on which the investigation is completed;

(f) Whether the complaint is substantiated; and

(g) Any subsequent action taken as a result of the complaint or incident, and the date on which the action was taken.

9917.10 Each home support agency shall report any action taken by, or any condition affecting the fitness to practice of, a registered nurse or home health aide that might be grounds for enforcement or disciplinary action under HORA or Home Health Aide Regulations of Chapter 93 of Title 17 DCMR to the Department within five (5) business days of the home support agency’s receipt of the relevant information.

9917.11 The Department may receive and investigate a complaint alleging violation of any provision of this chapter and may investigate any incident.

9917.12 Based on a licensee’s or applicant’s violation of any provision of this chapter, the Department may initiate an enforcement action which may include license denial, license suspension, license summary suspension, or license revocation.

9917.13 As an alternative to denial, suspension, or revocation of a license when a home support agency has numerous deficiencies or a serious single deficiency with respect to the standards established under this chapter, the Director may:

Issue a provisional license if the home support agency is taking appropriate ameliorative action in accordance with a mutually agreed upon timetable; or

Issue a restricted license that prohibits the home support agency from accepting new clients or delivering certain specified services that it would otherwise be authorized to deliver, if appropriate ameliorative action is not forthcoming.

9917.14 A provisional or restricted issued under this section may be granted for a period not exceeding ninety (90) days, and may be renewed no more than once.

9917.15 When a provisional or restricted license has expired the Department may choose to initiate enforcement action in accordance with this section.

History

SOURCE: Final Rulemaking published at 67 DCR 9476 (August 7, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 9917

22-B DCMR § 9918 PERSONAL CARE SERVICES

9918.1 A home support agency may offer personal care services and shall employ qualified home health aides pursuant to 17 DCMR §§ 9300 et seq. to perform those services.

9918.2 Each home health aide shall be supervised by a registered nurse. On-site supervision of personal care services shall take place at least once every ninety (90) days.

9918.3 The home support agency shall have an adequate number of registered nurses to supervise the implementation of personal care services.

9918.4 Personal care services may include the following:

(a) Basic personal care including bathing, grooming, dressing, and assistance with toileting;

(b) Assisting with incontinence, including bed pan use, changing urinary drainage bags, protective underwear, and monitoring urine input and output;

(d) Assisting the client with self-administration of medication;

(e) Reading and recording temperature, pulse, and respiration;

(f) Measuring and recording blood pressure, height, and weight;

(g) Observing, recording, and reporting the client's physical condition, behavior, or appearance;

(h) Meal preparation in accordance with dietary guidelines, and assistance with eating;

(i) Implementation of universal precautions to ensure infection control;

(j) Tasks related to keeping the client’s living area in a condition that promotes the client's health and comfort;

(k) Accompanying or transporting the client to medical and medically-related appointments, to the client's place of employment, and to recreational activities;

(l) Assisting the client at his or her place of employment;

(m) Shopping for items related to promoting the client's nutritional status and other health needs; and

(n) Providing companion services.

History

SOURCE: Final Rulemaking published at 67 DCR 9476 (August 7, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 9918

22-B DCMR § 9919 COORDINATION OF SERVICES

9919.1 A home support agency shall develop and implement policies and procedures relating to:

The delineation of services provided by the home support agency when the home support agency coordinates services within the home support agency or with another provider; and

Notification to the client or client representative of the home support agency’s responsibilities to coordinate services when appropriate.

9919.2 Personnel providing services shall communicate with each other to assure their efforts effectively complement one another and support the objectives outlined in the client service plan.

9919.3 The client record or minutes of case conferences shall establish that effective interchange, reporting, and coordinated client evaluation and planning occurs.

History

SOURCE: Final Rulemaking published at 67 DCR 9476 (August 7, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 9919

22-B DCMR § 9999 DEFINITIONS

9999.1 For the purposes of this chapter, the following terms shall have the meanings ascribed below:

Admission - A home support agency’s acceptance of client to provide personal care services.

Business day - Monday through Friday between the hours of 8:00 am and 6:00 pm, excluding public holidays.

Business hours - The hours during the day in which business operations are commonly conducted in the operating office by the licensee.

Client - The individual receiving home support agency services as defined in this chapter.

Client record - A written account of all services provided to a client by the home support agency, as well as other pertinent information necessary to provide care.

Client representative - A person designated in writing by the client in the service agreement or a person acting in a representative capacity under a durable power of attorney, durable power of attorney for health care, or guardianship pursuant to District law, or other legal representative arrangement.

Client Service Coordinator - A registered nurse who is sufficiently qualified to provide general supervision and direction of the services offered by the home support agency and who has at least one (1) year administrative or supervisory experience in personal care, home health care, or related health programs.

Client service plan - A written plan developed by the registered nurse in agreement with the client or client representative, if applicable, that specifies the tasks that are to be performed by the aide primarily in the client’s residence. The written plan specifies scope, frequency, and duration of services.

Companion services - Non-healthcare related services, such as cooking, housekeeping, errands, and social interaction.

Complaint - Any occurrence or grievance reported by a client or client representative related to the nature of the services provided by the home support agency.

Department - The District of Columbia Department of Health.

Director - The individual appointed by the governing body to act on its behalf in the overall management of the home support agency.

Full-time - Employment period by the home support agency, at minimum, during each of the home support agency’s established business days.

Governing body - The individual, partnership, group, or corporation designated to assume full legal responsibility for the policy determination, management, operation, and financial liability of the home support agency.

Home health aide - A person who performs home health and personal care services, and who is qualified to perform such services pursuant to Chapter 93 (Home Health Aides) of Title 17 (Business, Occupations, and Professionals) of the District of Columbia Municipal Regulations.

Home support agency - An entity licensed in accordance with this chapter that employs home health aides to provide personal care services to clients.

HORA – Health Occupations Revision Act.

Incident - Any occurrence that results in significant harm, or the potential for significant harm, to a client’s health, welfare, or well-being. Incidents include an accident resulting in significant injury to a client, death, misappropriation of a client’s property or funds, or an occurrence requiring or resulting in intervention from law enforcement or emergency response personnel.

License - Formal permission granted by the Department to act as a home support agency in accordance with law.

Licensee - The individual or entity to whom the Department has granted formal permission to act as a home support agency in accordance with law.

Modification of ownership and control - The sale, purchase, transfer or re-organization of ownership rights.

Medical Orders for Scope of Treatment (MOST) Form - A set of portable, medical orders on a form issued by the Department that results from a client’s or a client representative's informed decision-making with a health care professional pursuant to D.C Official Code §§ 21-2221 et seq.

Operating Office - The physical location at which the business of the home support agency is conducted and at which the records of personnel, clients, incidents, and complaints of the home support agency are stored either electronically or physically.

Personal care services - Services that are limited to individual assistance with or supervision of activities of daily living, companion services, homemaker services, reporting changes in client’s condition, and completing reports. Personal care services do not include skilled services.

Registered nurse - An individual who is currently licensed to practice nursing under the District of Columbia Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq.)

Service delivery notes - Documentation of the duties or tasks completed per shift by a home health aide, nursing supervision, and any other pertinent information related to the provision of services.

History

SOURCE: Final Rulemaking published at 67 DCR 9476 (August 7, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 9999

22-B101 ASSISTED LIVING RESIDENCES

22-B DCMR § 10100 General Provisions

10100.1 These rules are implemented pursuant to and in accordance with the Assisted Living Residence Regulatory Act of 2000, effective June 24, 2000 (D.C. Law 13-127; D.C. Official Code §§ 44-101.01 et seq. (2012 Repl.), as amended from time to time (hereinafter, the Act).

10100.2 The provisions set forth in this chapter have been issued to supplement provisions of the Act. Accordingly, each assisted living residence (“ALR”) licensed pursuant to the Act must comply with the Act and with this chapter, which together constitute standards for licensing and operation of ALRs within the District of Columbia.

10100.3 Nothing in this chapter shall be construed to violate the provisions of the Act or the residents’ rights provided therein.

10100.4 Nothing in this chapter shall be construed to authorize conduct that is in violation of any other District or federal law or rules issued thereto, including, where applicable, the D.C. Human Rights Act of 1977 (D.C. Law 2-38; D.C. Official Code §§ 2-1401.01 et seq. (2016 Repl.)), the Americans With Disabilities Act of 1990 (42 USC §§ 12101 et seq.), the Fair Housing Act (42 USC §§ 3601 et seq.); and the Health Insurance Portability and Accountability Act of 1996 (42 USC §§ 1320d et seq.).

10100.5 An ALR that participates in the Medicaid Home Community-Based Services Waiver program for the Elderly and Persons with Physical Disabilities, as approved by the Council of the District of Columbia and the Centers for Medicare and Medicaid Services, shall maintain compliance with Chapter 42 (Home and Community-Based Services Waiver for Persons Who Are Elderly and Individuals with Physical Disabilities) of Title 29 of the District of Columbia Municipal Regulations (DCMR) in addition to the Act and this chapter.

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10100

22-B DCMR § 10101 Purpose

10101.1 The purpose of this chapter is to supplement provisions of the Act, which sets minimum, reasonable standards for licensure of ALRs in the District of Columbia. This chapter is intended to promote the principles of the Act, and establish additional minimum standards as necessary to protect assisted living residents’ health, safety, and welfare.

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10101

22-B DCMR § 10102 Authority to operate an assisted living residence (ALR) in the District of Columbia

10102.1 A separate license shall be required to operate each ALR, regardless of whether multiple ALRs are operated by the same person, or whether the ALR is on premises shared with another ALR or facility. Each ALR license shall be specific to the location of the ALR.

10102.2 The provision of housing under a landlord-tenant arrangement does not, in and of itself, exclude a person from the requirements to be licensed and in compliance with the provisions of the Act and this chapter.

10102.3 An ALR shall post its license to operate on its premises in a manner conspicuous to residents and visitors.

10102.4 A Licensee shall be responsible for the health, safety, and welfare of the ALR’s residents.

10102.5 A Licensee shall be responsible for the operation of the ALR, including personnel and the ALR’s compliance with the Act, this chapter, or any other applicable District or federal laws or regulations.

10102.6 An ALR’s failure to comply with the Act, this chapter, or any other applicable District or federal laws or regulations may be grounds for sanctions or penalties, including suspension or revocation of licensure, as specified in the Act and in § 10126 of this chapter.

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10102

22-B DCMR § 10103 Restrictions

10103.1 An ALR shall not provide services beyond the scope of its license.

10103.2 An entity may not use the term "assisted living" to advertise its services unless the entity is licensed under the Act to operate as an ALR.

10103.3 A person may not advertise, represent, or imply to the public that an ALR is authorized to provide a service that the service provider is not licensed, certified, or otherwise authorized to provide.

10103.4 A person may not advertise the facilities or services provided by the ALR in a manner that is false, misleading, or fraudulent. Facilities or services that are provided at an additional cost to an ALR resident shall be identified in a manner that indicates such.

10103.5 The Director shall issue each license only for the premises and person or persons named as applicants in the application. The license shall not be valid for use by any other person or persons or at any place other than that designated on the license. Any transfer as to person or place shall cause the immediate forfeiture of the license.

10103.6 Each license to operate an ALR that is in the Licensee's possession shall be the property of the District Government and shall be returned to the Director immediately upon any of the following events:

(a) Suspension, or revocation of the license;

(b) Denial of an application to renew the license;

(d) The ALR’s operation is discontinued by voluntary action of the Licensee.

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10103

22-B DCMR § 10104 Qualification and Eligibility

10104.1 The Director may conduct background checks on an applicant for licensure or for renewal of licensure in order to determine the applicant’s suitability or capability to operate or to continue operating an ALR. If applicant is a partnership or non-corporation business entity, the background checks may be conducted on the owners. If applicant is a corporation, the background checks may be conducted on the directors, officers, and any person owning or controlling ten percent (10%) or more of common stock in the corporation.

10104.2 Applicant background checks may consist of, but not be limited to, investigating the following:

Whether the applicant, or the individual identified on the application to serve as assisted living administrator (ALA) for the ALR, holds a current, valid license to practice assisted living administration in the District of Columbia;

Applicant’s history of compliance with the District of Columbia or any other jurisdiction’s licensing requirements and with any federal certification requirements, including any license revocation or denial; and

The arrest and criminal records of the applicant, including, but not limited to, the following:

(1) Crimes or acts involving abuse, neglect or mistreatment of a person or misappropriation of property of the person;

(2) Crimes or acts related to the manufacture, distribution, prescription, use, or dispensing of a controlled substance;

(3) Fraud, or substantial or repeated violations of applicable laws and rules in the operation of any health care facility or in the care of dependent persons;

(4) A conviction or pending criminal charge which substantially relates to the care of adults or minors, to the funds or property of adults or minors, or to the operation of a residential or health care facility; or

(5) Current investigations by enforcement agencies to include, but not be limited to, the District of Columbia Departments of Health, Health Care Finance, and Consumer and Regulatory Affairs, the Federal Bureau of Investigation, the Office of Inspector General of the United States Department of Health and Human Services, and law enforcement agencies.

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10104

22-B DCMR § 10105 Fees

10105.1 As provided in § 302(b) of the Act (D.C. Official Code § 44-103.02(b)), each assisted living residence facility seeking an initial license shall pay a base fee of one hundred dollars ($100.00), plus a fee of six dollars ($6.00) per resident based on license capacity. These fees shall be paid at the time of the facility's application for the initial license.

10105.2 As provided in § 304(d) of the Act (D.C. Official Code § 44-103.04(d)), each assisted living residence facility seeking a renewal of its license shall pay a base fee of one hundred dollars ($100.00), plus a fee of six dollars ($6.00) per resident based on license capacity. These fees shall be paid at the time of the facility's application for the renewal license.

10105.3 Each assisted living residence facility seeking an initial license or renewal license which fails to submit its application timely, as provided in §§ 302(a) and 304(b) of the Act (D.C. Official Code §§ 44-103.02(a), 44-103.04(b)), shall pay, in addition to the base fee and per-resident fee specified herein, a late fee of one hundred dollars ($100.00). This fee shall be paid at the time of the facility's application for the license.

10105.4 As provided in § 305 of the Act (D.C. Official Code § 44-103.05), each assisted living residence facility seeking a revised license as required due to changes within the facility shall pay the following fees, as applicable, which fees shall be paid at the time of the facility's request for revision of the license:

For a revision based on changes any of which require re-inspection of the facility, a base fee of one hundred dollars ($100.00), plus a fee of six dollars ($6.00) per resident based on license capacity; or

(b) For a revision based on changes which do not require re-inspection of the facility, a fee of one hundred dollars ($100.00).

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10105

22-B DCMR § 10106 Initial ALR licensure

10106.1 To obtain and maintain a license, an applicant shall meet all the requirements of the Act and this chapter, and other applicable federal and local laws and regulations.

10106.2 An application for an initial license to operate an ALR shall be made as prescribed by this section and § 302(a)-(e) of the Act (D.C. Official Code §§ 44-103.02(a)-(e)), or as prescribed by § 304 of the Act (D.C. Official Code § 44-103.04) if an application for renewal.

10106.3 The application shall be submitted to the Director for review and shall not be approved for licensure unless determined by the Director to meet the requirements of the Act and this chapter. The Director shall consider the entirety of the application record when determining whether to approve or deny an application, including the results of a background check conducted pursuant to § 10104 of this chapter and any documents required under this section.

10106.4 In addition to the requirements in § 302(d)(2) of the Act (D.C. Official Code § 44-103.02(d)(2)), an application for an ALR license shall include evidence of a current, valid license issued by the District of Columbia to the assisted living administrator (ALA) named in the application.

10106.5 In addition to the information required under § 302(e)(2) of the Act (D.C. Official Code § 44-103.02(e)(2)), an applicant for licensure shall provide the following information:

The policies and procedures required by §§ 10110.2 and 10110.3 of this chapter;

A floor plan specifying dimensions of the ALR, exits and planned room usage;

Proof that the ALR’s proposed location has passed an inspection for compliance with fire codes conducted by the District of Columbia Fire & EMS Department’s Fire Prevention Division or a successor entity that becomes responsible for conducting such inspections on behalf of the District; and

Any additional information requested by the Director.

10106.6 The documentation required under § 302(e)(2) of the Act (D.C. Official Code § 44-103.02(e)(2)) and § 10106.05 of this chapter shall be provided to the Director during the pre-licensure inspection period, after on-site inspection of the applicant’s ALR has been conducted.

10106.7 An applicant for an ALR license shall pay the licensure fees set forth in § 10105 of this chapter.

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10106

22-B DCMR § 10107 Inspections BEFORE AND AFTER LICENSURE

10107.1 The Director is authorized to conduct inspections:

At the time of an ALR’s application for initial licensure;

Six (6) months after an ALR’s initial licensure;

At the time of an ALR’s application for each annual renewal of licensure;

To investigate complaints alleging a violation of the Act or this chapter; and

To ensure an ALR or suspected ALR’s compliance with the Act and this chapter, at the discretion of the Director.

10107.2 The inspections set forth in § 10107.1 shall be conducted in accordance with the procedures set forth by § 306 of the Act (D.C. Official Code § 44-103.06) and D.C. Official Code § 44-505, and pursuant to the rules set forth in 22-B DCMR § 3101.

10107.3 In addition to the procedures and rules described in § 10107.2, inspections for the purpose of investigating a complaint alleging a violation of the Act or this chapter shall be guided as follows:

The Director shall investigate complaint allegations of a life-threatening nature or those that represent immediate danger within twenty-four (24) hours of receipt of the complaint by the Department. All other complaints shall be investigated by the Director no later than thirty (30) days from their receipt or as deemed appropriate.

The Director shall conduct complaint investigations during time periods and staff shifts consistent with the allegations in the complaint, when deemed appropriate.

The Director shall communicate the findings of the complaint investigation directly to the ALR or suspected ALR, and the complainant, if the complaint is received directly by the Department. If the complaint is referred by another governmental agency, the Director shall send its findings to the referring agency. The referring agency shall be responsible for communicating the findings to the complainant.

10107.4 An ALR or prospective ALR that seeks to accept the Director’s suggested remedy to a deficiency or propose its own remedy, pursuant to § 306(e) of the Act (D.C. Official Code § 44-103.06(e)), shall do so by submitting the remedy to the Director in a written, signed and dated plan of corrective action to abate the cited deficiencies. The ALR shall include the plan of corrective action in its response to the Director that is required by § 306(e) of the Act (D.C. Official Code § 44-103.06(e)).

10107.5 The Director, after having conducted an inspection described in paragraphs (b) through (e) of § 10107.1, shall require an ALR it has determined to be in violation of the Act and the rules, but whose deficiencies are not life threatening or seriously endangering to the public's health, safety, and welfare, to correct the deficiencies within thirty (30) days from receipt of the written notice of violations provided by the Director pursuant to § 306(d) of the Act (D.C. Official Code § 44-103.06(d)).

10107.6 An ALR shall be subject to the sanctions provided under § 401 of the Act (D.C. Official Code § 44-104.01) if it fails to correct within thirty (30) days the deficiencies indicated in the written notice of violations provided by the Director pursuant to § 306(d) of the Act (D.C. Official Code § 44-103.06(d)) after the conclusion of any inspection conducted under § 10107.1. The Director may extend this time as he or she determines is appropriate under the circumstances.

10107.7 The Director shall, after having conducted any inspection under § 10107.1, deny, suspend, or revoke an ALR’s licensure pursuant to § 10126 of this chapter if the ALR is found to have life threatening deficiencies or deficiencies which seriously endanger the public's health and safety, but which do not pose an immediate threat to warrant an emergency suspension described by § 404 of the Act (D.C. Official Code § 44-104.04).

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10107

22-B DCMR § 10108 Admissions

10108.1 No ALR may have more residents, including respite care residents, than the maximum bed capacity on its license.

10108.2 An ALR shall deny admission to an individual if the individualized service plan (ISP) that is developed prior to the individual’s admission, pursuant to section 604(a)(1) of the Act (D.C. Official Code § 44-106.04(a)(1)), does not indicate that the individual requires at least the minimal level of assistance with activities of daily living or instrumental activities of daily living provided by the ALR.

10108.3 For the purpose of § 601(d)(1) of the Act, physical or mental abuse of others or destruction of property shall be considered behavior that significantly and negatively impacts the lives of others. An ALR shall not admit an individual who at the time of initial admission, and as established by the initial assessment, exhibits such behavior where the ALR would be unable to eliminate it through the use of appropriate treatment modalities.

10108.4 An ALR shall consider the availability of mental health treatments offered by the District’s network of core service agencies and the Department of Behavioral Health prior to determining whether it can provide, or arrange for a third party service to provide, appropriate services for an individual requiring mental health treatment.

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10108

22-B DCMR § 10109 Resident’s Rights and Quality of Life

10109.1 The ALR shall promote and facilitate resident self-determination through support of resident choice and all the rights specified in the Act and this chapter.

10109.2 The ALR shall support the resident (or surrogate) in exercising the resident’s rights under this chapter without interference, coercion, discrimination, or threat of retaliation.

10109.3 An ALR shall not discriminate against a resident in treatment or access to services based on reasons prohibited by the District of Columbia Human Rights Act of 1977, effective December 13, 1977 (D.C. Law 2-38; D.C. Official Code §§ 2-1401.01 et seq. (2016 Repl.)) or any other applicable anti-discrimination law, or rule issued pursuant thereto.

10109.4 An ALR shall honor a duly-executed supported decision-making agreement provided to it by a resident with a disability or a prospective resident with a disability, in accordance with Title III of the Disability Services Reform Amendment Act of 2018 (D.C. Law 22-93; D.C. Official Code §§ 7-2131.01 et seq. (2018 Repl.)). An ALR that has received a supported decision-making agreement from a resident shall be advised that all notices required to be sent to that resident under the Act or this chapter must also be sent to the resident’s supported decision maker as designated in the resident’s supported decision-making agreement, pursuant to § 303(c) of Title III of the Disability Services Reform Amendment Act of 2018 (D.C. Official Code § 7-2133(c)). For the purpose of this subsection, “supported decision-making agreement” and “disability” shall have the meanings prescribed to them by Title III of the Disability Services Reform Amendment Act of 2018 (D.C. Official Code §§ 7-2131.01 et seq.).

10109.5 An ALR shall allow notices of upcoming resident group meetings to be posted prominently and conspicuously in designated areas. The ALR shall also include the date, time, and location of upcoming resident group meetings in the calendars or schedules of activities that are published by the ALR for residents on a regular basis, provided that the resident group submits the pertinent information to the ALR prior to the date of the calendar or schedule’s publication.

10109.6 By the rights granted under § 505(a)(7) of the Act (D.C. Official Code § 44-105.05(a)(7)):

A resident shall have the right to organize and participate in resident groups in the ALR;

A resident shall have the right to invite staff or visitors, including family members and other individuals interested in the resident’s wellbeing, to resident group meetings in the ALR;

The ALR shall provide meeting space of appropriate size and with appropriate seating to accommodate the resident group meeting’s attendees; and

The ALR shall designate an employee or employees who shall assist with resident group meetings, and through whom the resident group may submit its written requests to the ALR and shall receive the ALR’s response to those requests.

10109.7 An ALR shall consider the written requests and grievances submitted by a resident or resident group and respond within fifteen (15) days, in writing, indicating its intended action or inaction in response to the issues of resident care and life in the ALR raised by the resident or resident group. The ALR shall act promptly to complete the actions indicated in its response within a reasonable amount of time. This subsection shall not be construed to imply that the ALR must implement the requests of a resident or resident group in the exact manner recommended by that resident or resident group.

10109.8 An ALR shall maintain complete written records of the filing and disposition of all requests, grievances, and appeals.

10109.9 An ALR shall permit a resident group meeting to have in attendance family members, visitors, and other guests invited by the resident group’s members. ALR staff may attend a resident group meeting only at a resident group member’s invitation. This subsection shall not prevent a resident’s surrogate from attending a resident group meeting with, or instead of, the resident he or she represents.

10109.10 For the purpose of § 506(a)(1) of the Act (D.C. Official Code § 44-105.06(a)(1)) “the ALA and healthcare records” to which a resident shall have access on demand shall mean the aggregate of the following records maintained by the ALR with respect to a particular resident:

Signed resident agreements written pursuant to § 602 of the Act (D.C. Official Code § 44-106.02), including the financial provisions required by § 603 of the Act (D.C. Official Code § 44-106.03);

Healthcare records, including healthcare notes and progress reports written by ALR staff, the record of prescription medication stored by the ALR pursuant to § 904 of the Act (D.C. Official Code § 44-109.04) to administer to the resident, and the record of prescription and non-prescription medication and dietary supplements stored by a resident in his or her living unit pursuant to § 10123.3 of this chapter;

Individualized service plans (ISPs), including all SRAs pertaining thereto;

Medication administration records, including records of drug errors and adverse drug reactions; and

Medication and treatment orders.

10109.11 A resident (or surrogate, to the extent that disclosure of the resident’s health information of is not prohibited by applicable laws) shall be entitled to access, on demand, the following documents from the ALR, and to obtain a copy at a fee not to exceed that which is reasonable to cover the cost of its reproduction:

The resident’s ALA and healthcare records, as described in § 10109.10;

The resident’s financial records pertaining to the funds and personal property deposited or managed by an ALR for the benefit of the resident described in § 603(a)(2) of the Act (D.C. Official Code § 44-106.03(a)(2)); and

The results of investigations conducted by the ALR that were prompted by the resident’s submission of a complaint.

10109.12 An ALR shall provide a space with adequate privacy for a resident (or surrogate) to review the document or documents he or she requested to access pursuant to § 10109.11. The space shall have the means to view the document in the format in which the ALR presented it. This subsection is not intended to accommodate copies of documents made at a resident’s request pursuant to § 10109.11.

10109.13 An ALR shall not name a group, council, meeting, or other gathering of individuals a “resident group,” “resident council,” “family group,” “family council,” or combination thereof if the ALR conducts or otherwise controls that gathering beyond providing its resident’s the support and services specified in the Act and this chapter.

10109.14 A copy of all signed agreements between an ALR and a resident (or surrogate), and all notifications required under the Act or this chapter, shall be retained in the resident’s record. An ALR shall provide its residents (or surrogates) with a copy of signed documents within three (3) business days of signing the document.

10109.15 An ALR shall maintain each resident’s record for no less than three (3) years after transfer, discharge, or death.

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10109

22-B DCMR § 10110 Required Policies and Procedures

10110.1 An ALR shall develop and implement dated, written policies and procedures concerning its operation which shall be consistent with the Act, this chapter, and all other applicable District or federal law.

10110.2 Policies developed and implemented pursuant to § 10110.01 shall include, but not be limited to the following, which shall meet the approval of the Director:

Medication management, administration of medication, medication administration errors, and medication storage;

Developing, reviewing, and revising a resident’s ISP, including policies on addressing a resident’s (or surrogate’s) disagreement with an ISP in part or whole and using a shared responsibility agreement (SRA) to resolve remaining discrepancies between the individual resident’s right to independence and the ALR’s concerns for the safety and wellbeing of the resident and others;

Private duty nurses, aides, and other healthcare professionals;

Companions;

Admission, transfer, and discharge, including guidelines on accommodating a resident’s needs prior to an admission, transfer, or discharge;

Complaints and grievances, including policies for use of the mechanism through which a resident may have complaints and grievances addressed, and for review of submitted complaints and grievances;

Protecting residents from the threat of retaliation for expressing complaints and grievances;

Preventing, investigating, reporting, and remediating abuse, neglect, and exploitation of residents;

Criteria to determine the care needs required by each resident upon initial assessment and throughout the duration of the resident’s stay, including how staffing, emergency triage, and fees assessed to residents are impacted by the level of care needs assigned to a resident;

Alcohol, tobacco, and marijuana use;

Infection control, sanitation, and universal precautions;

Emergency preparedness, which shall meet the same standards for emergency preparedness as those set for long term care facilities by the Centers for Medicare and Medicaid Services, at 42 CFR § 483.73;

Use of audio-visual monitoring systems to monitor the non-private areas of the ALR’s internal and external premises, including length of retention and the destruction of recordings;

Resident's right to visitation, and visitor conduct;

Monitoring of independent contractors performing work on the ALR’s premises on behalf of the ALR or resident;

Availability of the ALA to the ALR staff;

Contacting the ALR’s registered nurse;

Determining when an ambulance or emergency medical services are contacted during a health emergency;

Resident falls; and

Notification system to inform residents in the event of emergencies such as utility outages, environmental hazards, and other events that pose a substantial threat to the safety of the general ALR community.

10110.3 Procedures developed and implemented in connection with the policies in § 10110.2 shall meet the approval of the Director.

10110.4 An ALR shall train its staff in the proper implementation of its procedures.

10110.5 A resident shall be permitted to view a copy of any policy required under § 10110.2 at his or her request.

10110.6 A resident shall be permitted, at his or her request, to view a copy of the ALR procedures developed in connection with the policies identified in paragraphs (b) and (f) of § 10110.2.

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10110

22-B DCMR § 10111 Disclosure

10111.1 An ALR shall not provide any billable service or item that will be at a cost additional to the resident’s existing balance for the billing cycle unless the ALR has first:

Provided the resident (or surrogate) with:

Oral and written notice of all fees, rates, and charges he or she will incur for the provision of the service or item; and

The dollar amount, frequency, and number of recurring charges that will occur for the provision of that service or item; and

Obtained the resident’s (or surrogate’s) signature acknowledging receipt of the advance disclosures required by paragraph (a) of this subsection.

10111.2 An ALR shall keep a copy of the written notice and signed acknowledgment required by this subsection in the resident’s record.

10111.3 An ALR shall be excused from the requirements of § 10111.01 if emergency circumstances necessitate the immediate provision of an item or service that would otherwise have required advance disclosure of the fees, rates, and charges. An ALR shall provide the disclosures described in § 10111.01(a) and obtain the signature confirmation described in § 10111.01(b) upon concluding its assessment of the resident following the emergency.

10111.4 If an ALR is unable to obtain a resident’s (or surrogate’s) signed acknowledgement required by § 10111.1 after diligent efforts, the ALR may make note of its inability to obtain the signature on the signature line, which shall include a brief description of the method and number of attempts made to obtain the signature, the dates the attempts were made, and the name of the employee who made the attempts.

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10111

22-B DCMR § 10112 Financial Agreements

10112.1 The complete terms of all financial provisions in a resident’s agreement shall be made available for the resident (or surrogate) to review prior to admission.

10112.2 Funds deposited with or managed by an ALR for the benefit of the resident that total more than two hundred dollars ($200) shall be deposited in an interest-bearing account in the resident's name in a savings institution. Funds deposited or managed by an ALR for the benefit of the resident that total two hundred dollars ($200) or less may be deposited in an interest-bearing or non-interest-bearing account or secured on-site for the resident’s use as petty cash.

10112.3 An ALR shall not commingle residents' funds or personal property with the funds or property of the ALR, the licensee, employees, or any other entity or individual other than another resident. The ALR must maintain a system that assures a complete and separate accounting, according to generally accepted accounting principles, of each resident's funds and personal property entrusted to the ALR on the resident's behalf.

10112.4 The resident’s financial records pertaining to the funds and personal property described in § 603(a)(2) of the Act (D.C. Official Code § 44-106.03(a)(2)) shall be made available to the resident (or surrogate) upon request. The ALR shall provide a report of the resident's financial records to the resident (or surrogate) on a quarterly basis.

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10112

22-B DCMR § 10113 Individualized Service Plans (ISPs)

10113.1 An ISP shall be developed for each resident not more than thirty (30) days prior to admission.

10113.2 An ALR shall support the involvement of family and friends selected by the resident to participate in the development, review, and renegotiation of his or her ISP under the Act and this chapter, provided that the involvement of the selected family and friends is conducive to the resident’s participation in the ISP development, review, or renegotiation. This subsection shall not apply to a resident’s surrogate acting in his or her capacity as the resident’s surrogate pursuant to law.

10113.3 An ALR shall ensure that the assessments conducted prior to a resident’s admission, pursuant to §§ 802 and 803 of the Act (D.C. Official Code §§ 44-108.02 and 44-108.03), are performed by a registered nurse who is licensed to practice in the District, and any other healthcare professional necessary to perform the assessments as required who shall also be licensed or otherwise authorized to practice in the District.

10113.4 In accordance with § 604 of the Act (D.C. Official Code § 44-106.04), the ISP developed following the completion of the “post move-in” assessment shall be based on the following factors:

The medical, rehabilitation, and psychosocial assessment of the resident, conducted by or on behalf of the ALR and in accordance with § 802 of the Act (D.C. Official Code § 44-108.02);

The functional assessment of the resident, conducted by or on behalf of the ALR and in accordance with § 803 of the Act (D.C. Official Code § 44-108.03); and

The reasonable accommodation of the resident’s (or surrogate’s) preferences.

10113.5 A “post move-in” assessment required by § 604 of the Act (D.C. Official Code § 44-106.04) shall be conducted by or on behalf of the ALR within seventy-two (72) hours of a resident’s admission.

10113.6 An ALR shall ensure that the update of a resident’s ISP conducted pursuant to § 604(d) of the Act (D.C. Official Code § 44-106.04(d)) shall include the involvement of the following personnel on its behalf:

A registered nurse licensed to practice in the District of Columbia;

The ALA or Acting Administrator responsible for the ALR, if the health or safety of the resident is at risk; and

Any additional healthcare professional licensed in the District whose expertise is necessary for the ALR to perform a full and competent review of the services provided in the ISP prior.

10113.7 At or around the time of an ISP review conducted pursuant to § 604(d) of the Act (D.C. Official Code § 44-106.04(d)), the ALR shall:

Obtain from the resident (or surrogate) a signed statement confirming that the resident (or surrogate):

Was invited to participate in the review of the ISP; and

Did or did not participate in the review of the ISP; or,

If the resident has refused to give signed confirmation regarding the same ISP review on two (2) separate occasions, document in the resident’s record the date, time, and method of each attempt to obtain the resident’s signed confirmations and the name of the ALR personnel who made each attempt.

10113.8 An ALR shall provide the resident (or surrogate) no less than seven (7) days’ notice prior to the review of a resident’s ISP conducted pursuant to § 604(d) of the Act (D.C. Official Code § 44-106.04(d)), unless seven days’ (7) notice is made impractical due to a significant change in the resident’s condition that necessitates review of the resident’s ISP at a sooner date. The notice shall:

Include the date, time, and location at which the ALR proposes to conduct the ISP review, and advise the resident (or surrogate) that he or she may request to reschedule the ISP review to another date or time that is mutually agreeable;

Include an outline of the topics to be discussed during the ISP review and no less than a summary of the ALR’s proposed changes to the ISP, if any, in order to facilitate the resident’s (or surrogate’s) informed decision-making;

Encourage the resident (or surrogate) to participate in the ISP review with the involvement of family and friends of the resident’s choice in accordance with § 10113.2;

Be delivered to the resident (or surrogate) in writing; and

Be followed by no less than one (1) written reminder encouraging the resident (or surrogate) to participate in the review.

10113.9 An ALR shall permit a resident (or surrogate) to reschedule the review of his or her ISP conducted pursuant to § 604(d) of the Act (D.C. Official Code § 44-106.04(d)) to a date and time that is mutually agreeable.

10113.10 If a resident (or surrogate) disagrees with an ISP that is updated pursuant to § 604(d) of the Act (D.C. Official Code § 44-106.04(d)), the ALR shall:

Attempt to resolve the disagreement according to its written policy and procedure for addressing a resident’s disagreement with his or her updated ISP, which shall be implemented consistent with this subsection and in accordance with all applicable provisions of the Act and this chapter;

Indicate within the ISP the portions that are in dispute;

Document the disagreement in the resident’s record;

Record in the resident’s record the date, time, and summary of each effort by the parties to discuss and resolve the disputed portions of the ISP, including, if applicable, the resident’s (or surrogate’s) uncoerced, written, informed consent to implement the portions of the ISP that are not in dispute, pursuant to §§ 10113.11 and 10113.12; and

If attempts to resolve the dispute pursuant to paragraph (a) are unsuccessful, attempt to negotiate a shared responsibility agreement (“SRA”) with the resident (or surrogate) according to the ALR’s written policy and procedures, which shall be in accordance with § 605 of the Act (D.C. Official Code § 44-106.05) and § 10114 of this chapter.

10113.11 A resident’s (or surrogate’s) disagreement with an ISP that is updated pursuant to § 604(d) of the Act (D.C. Official Code § 44-106.04(d)) and in accordance with the Act and this chapter shall not, in and of itself, prevent the ALR from attempting to implement the ISP, provided that the individuals charged with implementing the ISP do not administer medications or treatments to the resident’s person without the resident’s (or surrogate’s) consent. This subsection shall not be construed to prevent a resident (or surrogate) from engaging in negotiations to reach a SRA in accordance with § 605 of the Act (D.C. Official Code § 44-106.05) and § 10114 of this chapter, for reasons including, but not limited to, resolving a disagreement with respect to that resident’s ISP, or exercising that resident’s right to refuse participation in a service as provided by § 504(5) of the Act (D.C. Official Code § 44-105.04(5)).

10113.12 Consistent with § 10113.11, an ALR shall be permitted to implement an ISP that has been disputed by the resident (or surrogate) as follows:

Implementation is limited to the portions of the ISP that are not in dispute, and in accordance with the resident’s (or surrogate’s) uncoerced, written, informed consent. For the purposes of this paragraph, informed consent requires that, prior to giving consent, the resident (or surrogate) has been provided, in writing, the specific ISP services that will not be implemented at that time, and an opportunity to have the ALR explain the consequences of accepting and forgoing the disputed portions of the ISP;

Implementation is in accordance with an SRA that has been reached in order to resolve the resident’s (or surrogate’s) disagreement with the ISP, pursuant to the ALR’s written policy and procedures and in accordance with the Act and § 10114 of this chapter; or

Implementation of a disputed portion of the ISP is necessitated by a health emergency or by the resident’s urgent medical needs as explicitly delineated in the signed, written orders of an attending healthcare practitioner or registered nurse.

10113.13 The ALR shall periodically monitor a resident who foregoes an ISP service in order to ascertain whether the resident can continue to forego the service safely.

10113.14 Nothing in this section shall compel an ALR to enter into a SRA that is inconsistent with § 605 of the Act (D.C. Official Code § 44-106.05), § 10114 of this chapter, or other applicable District or federal requirement.

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10113

22-B DCMR § 10114 Shared responsibility agreements (SRAs)

10114.1 Shared responsibility agreements (SRAs) may be developed and entered into between an ALR and a prospective or admitted resident (or surrogate), at any time prior to or subsequent to the resident’s admittance to the ALR.

10114.2 An ALR shall not enter into a SRA with a prospective or admitted resident (or surrogate) that:

Seeks to directly or indirectly waive the ALR’s obligations to the resident, in whole or in part, beyond the scope necessary to accommodate the resident’s (or surrogate’s) reasonable, requested arrangement or course of action;

Relieves the ALR of its obligation ensure that it makes available for a resident’s use all prescription and non-prescription medications and dietary supplements required to be provided to that resident according to his or her ISP developed or updated pursuant to § 604(d) of the Act (D.C. Official Code § 44-106.04(d)), or applicable law;

Violates any applicable District or federal criminal law; or

Violates or will cause the violation of any provision of the Act or this chapter.

10114.3 An SRA shall not have the effect of absolving a party from responsibility for negligent conduct.

10114.4 An ALR may decline to enter into a SRA if satisfaction of the SRA will result in an adverse risk to the health, welfare, or safety of other residents or ALR staff. The ALR shall identify the adverse risks for which it declined to enter the SRA in writing to the resident (or surrogate), and include a copy of that correspondence in the resident’s record.

10114.5 Attempts to develop a SRA shall be conducted in good-faith. For purposes of this section, a good-faith attempt to negotiate a SRA shall mean a two-way negotiation between the ALR and the resident (or surrogate), where both parties have equal opportunity to propose and decline terms of the SRA, and suggest reasonable alternatives to accommodate the course of action the resident wishes to pursue.

10114.6 In the event that a good-faith attempt to negotiate a SRA is unsuccessful, the ALR:

Shall document in the resident record the ALR’s consultations with the resident (or surrogate) to dissuade the course of action, including but not limited to:

The date and time each consultation was held;

The content of the consultations;

The alternative courses of action proposed by the resident (or surrogate) and ALR, and why the proposed alternatives were not acceptable to the resident (or surrogate) or ALR;

Shall notify the resident (or surrogate) that harm to the resident’s person or others as a result of the persisted course of action may result in discharge;

Shall not obstruct the resident from pursuing the course of action sought after, provided that the course of action does not pose a clear and present risk of harm to the health, welfare, or safety of other residents or staff, or otherwise warrant intervention by the ALR in order to maintain an environment that is safe and compliant with the ALR’s obligations under the Act and this chapter. This paragraph shall not be construed to authorize either party to violate the terms of the resident agreement entered into between the ALR and resident pursuant to §§ 602 and 603 of the Act (D.C. Official Code §§ 44-106.02 and 44-106.03) as it pertains to resident conduct, or to prohibit an ALR from enforcing the provisions of its resident agreement in accordance with the Act, this chapter, all applicable law; and

Shall monitor the resident as necessary to ascertain whether the resident’s chosen course of action places the resident or others in danger, or other conduct for which subsequent action by the ALR is necessary to maintain an environment that is safe and compliant with the ALR’s obligations under the Act and this chapter.

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10114

22-B DCMR § 10115 TRANSFER, DISCHARGE, and Relocation

10115.1 The ALA or Acting Administrator shall determine if the care needs of a resident exceed the resources that can be marshalled by the ALR or third-party services in order to safely support the resident, making transfer to another facility necessary. This determination shall only be made after having consulted with the resident (or surrogate) to identify if the ALR can continue to support the resident safely. An ISP review shall satisfy the requirement for this consultation.

10115.2 Except as provided in § 10115.13, an ALR shall conform to the notices and procedures applicable to involuntary relocation, transfer, or discharge provided by subchapter 3 of Chapter 10 of Title 44 of the District of Columbia Official Code (D.C. Official Code §§ 44-1003.02 – 1003.13), and shall conduct the involuntary relocation, transfer, or discharge in accordance with this chapter and § 608(d)-(f) of the Act (D.C. Official Code § 44-106.08(d)-(f)).

10115.3 Prior to transferring a resident to another facility for reasons other than an emergency described in § 608(b) of the Act (D.C. Official Code § 44-106.08(b)), or prior to a discharge, the ALR shall complete and transmit to the receiving facility or, if no receiving facility has been identified, to the resident (or surrogate) any information related to the resident that is necessary to ensure continuity of care and services, including at a minimum, the:

Contact information of the healthcare practitioner or practitioners responsible for the primary care of the resident;

Current medication and treatment orders from the resident’s healthcare practitioner or practitioners;

Dosage and date of each medication last administered to the resident;

Resident’s most recent ISP, which shall include the resident’s assessments;

Resident’s name, date of birth, and a personal identifier number, such as a social security number or health insurance information, for purposes of continuing medical care services;

Primary medical diagnoses and allergies;

Name and contact information for the resident’s surrogate, if applicable; and

Resident’s Advanced Directive information.

10115.4 An ALR shall not transmit the information prescribed in § 10115.3 to the receiving facility without the prior, written, uncoerced consent of the resident (or surrogate). In the event that consent is withheld, an ALR shall transmit the information prescribed in § 10115.3 directly to the resident (or surrogate) prior to transfer or discharge.

10115.5 Although an ALR shall make every effort to avoid discharge, grounds for involuntary discharge may include the following:

Failure to pay all fees and costs as specified in the contract;

Inability of the ALR to meet the care needs of the resident as provided in the ISP, as amended by an SRA when applicable;

Engaging in sexual harassment, exploitation, or other degrading conduct to the detriment of another residents’ dignity, in violation of the victim’s rights provided under the Act and this chapter;

Resident presents a risk of physical self-harm, or harm to one or more other residents or staff, for which no other reasonable means of mitigation are available;

Discharge is essential to meet the ALR’s reasonable administrative needs and no practicable alternative is available;

The ALR is ceasing to operate;

The licensed capacity of the ALR is being reduced by the District; or

The license to operate the ALR is suspended or revoked.

10115.6 A resident’s return to an ALR after transfer to, and subsequent discharge from, an acute care facility pursuant to § 608 (c) of the Act (D.C. Official Code § 44-106.08(c)) shall be guided by the following provisions:

Pursuant to § 608(c) of the Act (D.C. Official Code § 44-106.08(c)), a resident’s return to his or her ALR from an acute care facility pursuant to an attending healthcare practitioner’s written approval shall be a provisional return pending renegotiation of the resident’s ISP and the ALA’s determination concerning whether the resident can continue to reside safely at the ALR in accordance with § 10115.1;

It shall be considered an involuntary discharge for the purposes of the Act and this chapter for an ALR to refuse or obstruct a resident’s return to the ALR from an acute care facility pursuant to his or her attending healthcare practitioner’s written approval. An involuntary discharge described in this paragraph shall be afforded the same notices, procedures, and provisions applicable to involuntary discharges described in the Act, this chapter, and D.C. Official Code §§ 44-1003.02- 44-1003.13;

If the attending healthcare practitioner’s written approval to return to an ALR indicates that the resident requires additional supports in order to do so safely, those additional supports shall be arranged consistent with the resident agreement’s financial provisions for coordinating and contracting services not covered by the resident agreement;

Except for under the circumstances set forth in D.C. Official Code § 44-1003.02(b)(1) and (2) or the occurrence of a separate event for which a resident may be lawfully discharged under the Act or this chapter, a resident who has returned to the ALR pursuant to an attending healthcare practitioner’s written approval shall be permitted to remain in the ALR:

Throughout the ISP renegotiation performed under § 608(c) of the Act (D.C. Official Code § 44-106.08(c));

Throughout the ALA’s determination of whether the resident can continue to safely reside in the ALR in accordance with § 10115.1; and

If the ALA determines that the resident must be transferred or discharged because of the ALR’s inability to continue supporting the resident safely, throughout the transfer or discharge notice period, and hearing period if applicable, provided by the Act, this chapter, and D.C. Official Code §§ 44-1003.02 and 44-1003.03.

10115.7 As provided for by D.C. Official Code § 44-1003.02(d), the written notice due to a resident prior to an involuntary discharge, transfer, or relocation shall be on a form prescribed by the Director and shall, at a minimum, contain:

The specific reason(s), stated in detail and not in conclusory language, for the proposed discharge, transfer, or relocation;

The proposed effective date of the discharge, transfer, or relocation;

A statement in not less than twelve (12)-point type that reads:

“You have a right to challenge this facility’s decision to discharge, transfer, or relocate you. If the decision is to discharge you from the facility or to transfer you to another facility and you think you should not have to leave, you or your representative have 7 days from the day you receive this notice to inform the Administrator or a member of the staff that you are requesting a hearing and to complete the enclosed hearing request form and mail it in the preaddressed envelope provided. If you are mailing the hearing request form from the facility, the day you place it in the facility’s outgoing mail or give it to a member of the staff for mailing shall be considered the date of mailing for purposes of the time limit. In all other cases, the postmark date shall be considered the date of mailing. If, instead, the decision is to relocate you within the facility and you think you should not have to move to another room, you or your representative have only 5 days to do the above.

“If you or your representative request a hearing, it will be held no later than 5 days after the request is received in the mail, and, in the absence of emergency or other compelling circumstances, you will not be moved before a hearing decision is rendered. If the decision is against you, in the absence of an emergency or other compelling circumstances you will have at least 5 days to prepare for your move if you are being discharged or transferred to another facility, and at least 3 days to prepare for your move if you are being relocated to another room within the facility.

“To help you in your move, you will be offered counseling services by the staff, assistance by the District government if you are being discharged or transferred from the facility, and, at your request, additional support from the Long-Term Care Ombudsman program. If you have any questions at all, please do not hesitate to call one of the phone numbers listed below for assistance.”;

(d) A hearing request form, together with a postage paid envelope preaddressed to the appropriate District official or agency;

(e) The name, address, and telephone number of the person charged with the responsibility of supervising the discharge, transfer, or relocation;

(f) The names, addresses, and telephone numbers of the Long-Term Care Ombudsman program and local legal services organizations; and

(g) The location to which the resident will be transferred.

10115.8 If the tribunal adjudicating a contested transfer, discharge, or relocation finds that the existence of a ground for transfer, discharge, or relocation, respectively, has been proven at a hearing requested by the resident pursuant to D.C. Official Code § 44-1003.03, the resident shall not be:

Discharged or transferred from the facility before the 31st calendar day following his or her receipt of the transfer or discharge notice required under the Act and § 10115.7, or the 5th calendar day following his or her notification of the hearing decision, whichever is later, unless a condition set forth in D.C. Official Code §§ 44-1003.02(b)(1) and (2) develops in the interim; or

Relocated within the facility before the 8th calendar day following his or her receipt of the relocation notice required under the Act and § 10115.7, or the 3rd calendar day following his or her notification of the hearing decision, whichever is later, unless a condition set forth in D.C. Official Code §§ 44-1003.02(b)(1) and (2) develops in the interim.

10115.9 The involuntary transfer or discharge of a resident shall be canceled, and the resident shall be entitled to remain in the ALR, upon remediation of the ground or grounds for transfer or discharge. Remediation may be, when applicable, the payment of all monies owed at any time prior to discharge, or the negotiation of a new ISP, and SRA if applicable, that meets the care needs of the resident prior to transfer or discharge.

10115.10 The ALR shall return all funds and personal property that have been deposited with or managed by the ALR for the benefit of the resident no later than the time of discharge.

10115.11 Within thirty (30) days after the date of the discharge or death of a resident, the ALR shall:

Provide a final accounting of funds and personal property that have been deposited with or managed by the ALR for the benefit of the resident, which shall be delivered to the resident (or surrogate) in the event of discharge, or to the resident’s legal representative in the event of the resident’s death; and

Return any refunds due to the resident (or surrogate) in the event of discharge, or to the resident’s legal representative in the event of the resident’s death.

10115.12 An ALR may temporarily relocate a resident to another living unit within the ALR on an involuntary basis if:

Temporary relocation is necessary to protect the resident from an imminent and physical harm present in, or threatening to enter, the living unit;

The imminent and physical harm is due to a curable condition of the living unit; and

The temporary relocation lasts no longer than necessary to cure the threat to physical harm posed by the condition and return the living unit to its habitable condition.

10115.13 An involuntary, temporary relocation that is necessitated by the conditions set forth in § 10115.12 shall conform to the notices and procedures for involuntary relocation provided by subchapter 3 of Chapter 10 of Title 44 of the District of Columbia Official Code (D.C. Official Code §§ 44-1003.02 – 1003.13), except when an exigent threat to the resident’s physical safety demands an abbreviated notice period.

10115.14 An ALR shall document in the resident’s records any relocation, transfer, or discharge of a resident, and the basis for the action taken.

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10115

22-B DCMR § 10116 Staffing standards

10116.1 An ALR shall be supervised by an assisted living administrator (ALA) who shall be responsible for all personnel and services within the ALR, including, but not limited to, resident care and services, personnel, finances, adherence to the ALR’s own policies and procedures, and the ALR’s physical premises.

10116.2 A Licensee may designate a person to serve as ALA to supervise the ALR provided that the designee holds a current, valid license to practice assisted living administration issued by the District of Columbia’s Board of Long-Term Care Administration. The Licensee shall submit the name of the person designated to be ALA to the Director on a form approved by the Director not more than ten (10) days after the designation is made or the designee has begun employment as the ALA, whichever occurs first.

10116.3 In addition to the staffing standards for ALAs set forth by § 701 of the Act (D.C. Official Code § 44-107.01), an ALA shall meet all requirements to practice assisted living administration prescribed by the District of Columbia Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code § 3-1203.02(14) (2016 Repl.)), and all requirements to practice assisted living administration set forth by the Director by rulemaking.

10116.4 At all times one (1) or more residents are on the premises of an ALR, an ALA or Acting Administrator shall also be on the premises. At all times an ALA is not on the premises, an ALA shall:

Ensure that an Acting Administrator is designated and assumes the responsibilities of the ALA required by the Act and this chapter, and that the Acting Administrator is a staff member who is at least eighteen (18) years of age, meets the staffing standards for an ALA required by § 701 of the Act (D.C. Official Code § 44-107.01), and is authorized to temporarily practice as an Acting Administrator without an ALA license by rulemaking promulgated by the Director to regulate the practice of assisted living administration; and

Be available to the ALR staff by telephone, at a minimum, and shall respond to the ALR staff’s attempts to contact him or her by telephone within 1 hour of the staff’s initial attempt, except as provided for in § 10116.6.

10116.5 The Licensee or ALA may, during an ALA’s leave of absence, designate a staff member who meets the requirements in paragraph (a) of § 10116.4 to serve as Acting Administrator for the ALR and perform the duties of the ALA for up to six (6) cumulative weeks in a twelve (12) month period. For purposes of this section, a “leave of absence” shall mean an ALA’s scheduled or unscheduled absence from his or her supervision of the ALR for more than one (1) work day during which the ALA would normally have been expected to oversee the ALR’s day-to-day operations.

10116.6 An ALA shall not be subject to § 10116.4(b) during a leave of absence described in § 10116.5.

10116.7 An Acting Administrator who is designated pursuant to § 10116.5 shall be held responsible for all duties prescribed to an ALA under the Act and this chapter for the duration of the ALA’s leave of absence, or until relieved from duty as the Acting Administrator.

10116.8 An Acting Administrator who is designated pursuant to § 10116.5 shall, at all times one (1) or more residents are on the ALR’s premises and he or she is not, comply with paragraphs (a) and (b) of § 10116.4.

10116.9 An ALR shall not be administrated by any person other than a licensed ALA for more than six (6) cumulative weeks in a twelve (12) month period without prior, written approval by the Director. A request for written authorization under this subsection shall be submitted to the Director in writing, and shall contain all information deemed necessary by the Director to determine the qualifications of the individual or individuals who will be serving as an Acting Administrator beyond the sixth (6th) cumulative week of the ALA’s leave of absence.

10116.10 An ALR shall not permit any person or persons, other than a licensed ALA, to administrate the ALR for more than a total of twelve (12) cumulative weeks in a twelve (12) month period.

10116.11 An ALR shall give to the Director prior written notice if an ALA’s leave of absence will be for a period longer than three (3) consecutive weeks in duration. The notice shall include the name or names of the staff member or members designated to serve as Acting Administrator during the ALA’s leave of absence, as well as the telephone number by which the Acting Administrators are to be contacted pursuant to § 10116.4(b).

10116.12 An ALR shall be responsible for maintaining accurate record of the ALA’s leaves of absence from the ALR. Record of the ALA’s leaves of absence shall be made available to the Director or the Director’s designee upon request during an inspection of an ALR authorized by this chapter or the Act.

10116.13 An ALR shall cause no less than one (1) registered nurse to be available to the ALA and the ALR’s staff members twenty-four (24) hours a day, seven (7) days a week. For the purpose of this subsection, “available” means the registered nurse is required to:

Be accessible to the ALA and ALR staff members in-person or by real-time communication methods, such as telephone, text message, or video call; and

Respond to the ALA or ALR staff members’ attempts to contact him or her within 1 hour; and

Be able to present him or herself, in person, to the ALR’s premises to respond to a significant change in a resident’s health status if the nurse determines, in his or her professional opinion, that the change in health status necessitates his or her presence.

10116.14 The contact information for the available registered nurse shall be posted conspicuously for, and shall be easily accessible to, the ALR staff.

10116.15 Personnel records maintained by the ALA for each employee pursuant to § 701(d)(11) of the Act (D.C. Official Code § 44-107.01(d)(11)) shall be accurate and current and shall contain documentation including, but not limited to, the following:

(a) A description of the employment, signed and dated by the employee, that includes the employee’s duties and responsibilities, and the qualifications required for the position;

(b) Initial date of hire;

(c) Proof of license, registration, certificate, or other authority for the employee to practice his or her profession in the District, if applicable;

(d) A completed criminal background check, performed as required by the District laws and regulations applicable to each individual;

(e) Employee training required by the Act or this chapter, or the individual’s exemption therefrom; and

(f) A healthcare practitioner’s written statement as to whether the employee bears any communicable diseases, including communicable tuberculosis.

10116.16 Employee records shall be made available for review by the Department of Health upon request during any inspection of an ALR that is authorized by the Act or this chapter.

10116.17 All employees, including the ALA, shall be required on an annual basis to document freedom from tuberculosis in a communicable form. Documentation shall be provided by the employee’s licensed healthcare practitioner.

10116.18 All employees shall wear identification badges on their persons, which shall not be obscured, but shall always remain visible while the employee is on the ALR premises. The identification badge shall prominently and conspicuously display the employee’s full name and job title.

10116.19 The first name, last name, and job title of the ALA, or Acting Administrator, on duty shall be posted in a manner conspicuous to residents and visitors.

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10116

22-B DCMR § 10117 Assisted Living Administrators (ALAs)

10117.1 The ALA shall maintain a current, valid license to practice assisted living administration in the District at all times he or she is responsible for the administration of an ALR. For purposes of this subsection, an ALA shall not be considered responsible for the administration of an ALR for the period of time he or she is on a leave of absence described in § 10116.5 of this chapter.

10117.2 The ALA shall ensure that the ALR complies with the Act and this chapter.

10117.3 An ALA shall be subject to action by the District of Columbia Board of Long-Term Care Administration for failure to comply with the requirements of this section, or other applicable requirements of the Act or this chapter.

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10117

22-B DCMR § 10118 Private Duty Healthcare Professionals

10118.1 Pursuant to § 701(a) of the Act (D.C. Official Code § 44-107.01(a)), the ALA shall be responsible for all personnel and services within the ALR, and shall cause all private duty healthcare professionals that provide healthcare related services on the ALR’s premises to comply with the requirements of this section as a condition of providing service on the ALR’s premises.

10118.2 An ALR shall require that private duty healthcare professionals arranged by a resident, surrogate, or party other than the ALR to provide healthcare-related services to the resident on the ALR’s premises on a recurring basis:

Be certified, registered, licensed, or otherwise authorized by the District of Columbia to render the healthcare-related service they will provide to the resident;

Maintain an accurate and current personnel record with the ALR that includes, but is not limited to, the following:

A signed and dated description of the services to be rendered to the resident;

A copy of the registration, certification, license, or other authorization required for the nurse, aide, or other healthcare professional to lawfully practice the healthcare-related services being rendered in the District of Columbia;

Initial date and final date, if known, of providing service to resident on the ALR’s premises;

A healthcare practitioner’s written statement as to whether the nurse, aide, or other healthcare professional bears any communicable diseases, including communicable tuberculosis; and

If the nurse, aide, or other healthcare professional is providing care to the resident under the employ of an agency:

The name, address, telephone number of the agency;

The name and telephone number of the private nurse, aide, or other healthcare professional’s immediate supervisor; and

A copy of the agency’s license or other authorization to operate in the District;

Administer prescription medication to only the resident for whom the medication was prescribed, or assist in the self-administering of prescription medication for only the resident to whom the medication was prescribed; and

Be subject to immediate removal from the premises upon determination by the ALA or designee that the nurse, aide, or other healthcare professional has, or is suspected to have, a communicable disease, is mentally or physically incapable of performing his or her duties, or otherwise presents a risk to the health and safety of one (1) or more residents in the ALR.

10118.3 An ALR shall inform a resident (or surrogate) promptly if a private duty healthcare professional he or she has contracted has been removed for the premises under § 10118.2(d). The ALR shall include the reason for the removal and its intended duration, and provide the resident (or surrogate) with an opportunity to appeal its decision in accordance with the ALR’s internal grievance procedures required by § 10110.2 of this chapter.

10118.4 An ALR shall have a written agreement with each private duty healthcare professional providing healthcare services on the ALR’s premises, or the agency that employs him or her, if applicable, requiring the private duty healthcare professional to report the following events to the ALR and describing the procedure by which such reporting shall occur:

Medication errors and adverse drug reactions;

Abuse, neglect, exploitation, or unusual incidents, such as changes in the resident’s condition; and

Any restriction of, suspension, revocation, or failure to renew the healthcare professional’s license or other authorization to practice his or her healthcare profession in the District.

10118.5 Pursuant to § 607(a)(1) of the Act (D.C. Official Code § 44-106.07(a)(1)), the ALR shall be responsible for the safety and well-being of its residents, including residents receiving services from private duty healthcare professionals on the ALR’s premises.

10118.6 An ALR shall have the duty to ensure that all services and supports identified in a resident’s ISP are received by the resident. Services provided by a private duty healthcare professional shall not be presumed to have satisfied the ALR’s obligation to ensure that the resident receives all services and supports due, pursuant to his or her ISP. An ALR must provide or arrange for the provision of any service or support identified in a resident’s ISP that is left unsatisfied by the resident’s private duty healthcare professional.

10118.7 Nothing in this section authorizes a private duty healthcare professional to practice outside the scope of their authority to practice their profession in the District.

10118.8 The requirements for a private duty nurse, aide, or other healthcare professional under this section shall not apply to companions of a resident.

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10118

22-B DCMR § 10119 Companions

10119.1 Pursuant to § 701(a) of the Act (D.C. Official Code § 44-107.01(a)), the ALA shall be responsible for all personnel and services within the ALR, and shall cause all companions that provide companion services on the ALR’s premises to comply with the requirements of this section as a condition of providing service on the ALR’s premises.

10119.2 A companion shall not be permitted to provide any healthcare services to a resident or perform any services that constitute hands-on care of the resident.

10119.3 A companion may provide companion services, including but not limited to cooking, housekeeping, errands, and providing social interaction with a resident. The ALR shall obtain a written description of the type and frequency of services to be delivered to the resident, review the information to determine if the services are acceptable based on the resident’s care needs, and notify the companion if the services to be provided are unacceptable.

10119.4 An ALR shall require that, prior to performing companion services for a resident, any companion with direct resident access must provide to the ALR:

A completed criminal background check for unlicensed professionals performed in accordance with D.C. Official Code §§ 44-551 et seq. and 22-B DCMR §§ 4700 et seq., which shall be free from conviction of an offense listed in 22-B DCMR § 4705.1, or their equivalents, within seven (7) years prior to the criminal background check unless permitted under § 22-B DCMR § 4705.2;

A healthcare practitioner’s written statement as to whether the companion bears any communicable diseases, including communicable tuberculosis; and

A signed and dated description of the type and frequency of services to be delivered to the resident, approved pursuant to § 10119.3.

10119.5 A companion shall be subject to immediate removal from the ALR premises upon determination by the ALA or designee that he or she has, or is suspected to have, a communicable disease presents a risk to the health and safety of the residents, is mentally or physically incapable of performing his or her duties, or otherwise presents a risk to the health and safety of the residents. An ALR shall permit a resident (or surrogate) to appeal the removal of his or her companion in accordance with the ALR’s internal grievance procedures required by § 10110.2 of this chapter.

10119.6 An ALR shall have a written agreement with each companion providing companion services on the ALR’s premises, or the agency that employs him or her, if applicable, requiring the companion to report abuse, neglect, exploitation, or unusual incidents, such as changes in the resident’s condition, to the ALR and describing the procedure by which such reporting shall occur.

10119.7 Pursuant to § 607(a)(1) of the Act (D.C. Official Code § 44-106.07(a)(1)), the ALR shall be responsible for the safety and well-being of its residents, including residents receiving companion services from companions on the ALR’s premises.

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10119

22-B DCMR § 10120 Unlicensed Personnel Criminal Background Check

10120.1 No ALR shall employ or contract an unlicensed person for work on the ALR’s premises until a criminal background check has been conducted for that person.

10120.2 An ALR shall implement and comply with the criminal background check standards and requirements for unlicensed personnel prescribed by D.C. Official Code §§ 44-551 et seq. and 22-B DCMR §§ 4700 et seq.

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10120

22-B DCMR § 10121 Pre-admission Medication Management Assessment

10121.1 In addition to the consultations required by § 902 of the Act (D.C. Official Code § 44-109.02), the ALR shall consult with the prospective resident’s healthcare practitioner regarding the prospective resident’s ability to self-administer medication within thirty (30) days prior to admission.

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10121

22-B DCMR § 10122 On-site Medication Review

10122.1 The on-site medication review by a registered nurse that is arranged to occur every forty-five (45) days, pursuant to § 903 of the Act (D.C. Official Code § 44-109.03), shall include documentation of any changes to the resident’s medication profile, including changes in dosing and any medications that have been added or discontinued.

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10122

22-B DCMR § 10123 Medication storage

10123.1 Medication that is entrusted to the ALR for storage shall be stored in accordance with the requirements of § 904 of the Act (D.C. Official Code § 44-109.04) and the following:

Each medication shall be stored under proper conditions of light and temperature as indicated on its label; and

Medication requiring refrigeration shall be maintained in a refrigerator that is secured and used exclusively for the storage of medication. The key to the refrigerator shall be kept on the person of the employee on duty who is responsible for administering the medications within.

10123.2 Medication taken from the ALR’s storage space for delivery to a resident or elsewhere shall not leave the immediate control of the employee delivering it unless the medication is secured with a locking mechanism or the delivery has been completed. The key to the lock must be kept on the person of the employee who is responsible for delivering the medication for the duration of the delivery.

10123.3 An ALR shall keep a current record of each prescription and non-prescription medication and dietary supplement kept by a resident in his or her living unit pursuant to § 904(e)(8) of the Act (D.C. Official Code § 44-109.04(e)(8)), which shall be retained in the resident’s healthcare record and include:

Name of the medication;

Strength of medication and quantity;

Lot number; and

If a prescribed medication:

Name of prescriber;

Name and phone number of the pharmacy that filled the prescription;

Date the prescription was filled; and

The frequency and directions for use provided by the prescriber.

10123.4 In the event of voluntary or involuntary discharge, the ALR shall notify and attempt to return all medications to the resident (or surrogate) or a caregiver at the time of discharge, unless return of the medication is prohibited by federal or other District law. If the resident's medications can't be returned or remains unclaimed for more than thirty (30) days after the resident has been discharged, the medication shall be considered abandoned and destroyed. Witness and documentation of the destruction shall be in accordance with the § 904 of the Act (D.C. Official Code § 44-109.04) and applicable District law.

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10123

22-B DCMR § 10124 Medication administration

10124.1 A resident shall be permitted to self-administer his or her medications, provided that the resident has been determined capable of self-administering his or her own medication as defined in paragraphs (a) or (b) of § 10124.2 by the most recent on-site medication review required under the Act or, if he or she is a new resident, by the initial assessment conducted during the ALR’s admission process.

10124.2 The initial assessment and periodic medication review performed pursuant to §§ 901 and 903 of the Act (D.C. Official Code §§ 44-109.01 and 44-109.03) for the purpose of determining whether a resident is capable of self-administering medication shall make one the following findings based on an assessment of the associated tasks below:

A resident is capable of self-administering his or her own medication, provided that the resident can:

Correctly read the label on the medication’s container;

Correctly interpret the label;

Correctly follow instructions as to route, dosage, and frequency of administration;

Correctly ingest, inject, or otherwise apply the medication;

Correctly measure or prepare the medication, including mixing, shaking, and filling syringes;

Safely store the medication;

Correctly follow instructions as to the time the medication must be administered; and

Open the medication container, remove the medication from the container, and close the container;

A resident is capable of self-administering his or her own medication, but requires a reminder to take medications or requires physical assistance with opening and removing medications from the container, or both, provided that the resident can:

Correctly read the label on the medication’s container;

Correctly interpret the label;

Correctly follow instructions as to route, dosage, and frequency of administration;

Correctly ingest, inject, or otherwise apply the medication;

Correctly measure or prepare the medication, including mixing, shaking, and filling syringes; and

Safely store the medication; or

A resident is not capable of self-administering his or her own medication, provided that the resident needs the assistance of another person to properly carry out one or more of the tasks enumerated in paragraph (b) of this subsection.

10124.3 A resident who has been determined not capable of self-administering medication pursuant to paragraph (c) of § 10124.2, or has elected not to self-administer his or her own medications, or his or her surrogate, may arrange with a third-party for a licensed practical nurse, registered nurse, advanced practice registered nurse, physician, physician assistant, or certified medication aide to administer medication to the resident or assist the resident with taking his or her medications to the extent of the healthcare professional’s authority to do so under District and federal laws or regulations. A healthcare professional arranged to administer or assist in the self-administering of medication to a resident in accordance with this subsection shall be required to conform to the requirements of private duty healthcare professionals provided in § 10118 of this chapter.

10124.4 A resident who has been determined to be capable of self-administering his or her own medication but requires a reminder or physical assistance as defined in paragraph (b) of § 10124.02, shall be permitted to utilize a device or a third-party other than those who are listed in § 10124.3 in order to be reminded to take a medication, to open a medication container, or to remove a medication from its container, only. Under no circumstance shall this subsection be construed to authorize a person, other than a healthcare professional employed as described in § 10124.3, to assist a resident with an activity related to the administration of medication other than reminding that resident to take a medication, opening a medication container at the explicit direction of that resident, or removing a medication from its container at the explicit direction of that resident; nor shall any activity other than reminding a resident to take a medication, opening a medication container at the explicit direction of the resident, or removing a medication from its container at the explicit direction of the resident be construed as permissible for the purpose of this subsection. Activities that are not authorized by this subsection include, but are not limited to, the following: administering a medication, preparing a medication for administration or self-administration, advising or assisting in the administration of a medication, sorting medications, relabeling a medication, transferring medications from one container to another, removing a medication from its container for a purpose other than for the resident to self-administer independently promptly thereafter, or any other activity not expressly authorized by this subsection.

10124.5 An ALR shall provide or arrange for a licensed practical nurse, registered nurse, advanced practice registered nurse, physician, physician assistant, trained medication employee (“TME”), or certified medication aide to administer, or assist in the self-administering of, medication to a resident, provided that:

The resident has been determined not capable of self-administering medication pursuant to paragraph (c) of § 10124.2 or has elected not to self-administer his or her own medications, and he or she has not arranged with a third-party to administer, or assist in the self-administering of, his or her medication in accordance with § 10124.3;

The healthcare professional holds the requisite certificate, registration, or license to practice issued by the District;

The healthcare professional does not exceed his or her authority to administer or assist in the administration of medication to the resident under District and federal laws or regulations;

The ALR discloses, orally and in writing, any fees, rates, or charges associated with providing assistance with or the administration of a medication that are additional to the resident’s existing bill, in accordance with § 10111 of this chapter;

Prior to the provision of the medication administration or assistance, the resident (or surrogate) provides in writing:

Acceptance of the medication administration or assistance offered by the ALR; and

Acknowledgment of receiving the ALR's medication administration policy and the disclosure of fees required in paragraph (c) of this subsection; and

The ALR has in place education, remediation, and discipline procedures by which to address recurring medication errors perpetrated by the licensed practical nurse, registered nurse, advanced practice registered nurse, physician, physician assistant, TME, or certified medication aide.

10124.6 An ALR shall require that administration or assistance in the administration of medication to a resident by a healthcare professional pursuant to §§ 10124.3 and 10124.5 be in accordance with the prevailing standard of acceptable medication administration rights in the healthcare professional’s field.

10124.7 An ALR shall ensure that all medication administered to a resident by licensed practical nurse, registered nurse, advanced practice registered nurse, physician, physician assistant, TME, or certified medication aide on its premises shall be recorded on a written or electronic medication administration record that is kept as part of the resident’s healthcare records.

10124.8 An ALR shall ensure that all employees and all licensed practical nurses, registered nurses, advanced practice registered nurses, physicians, physician assistants, or certified medication aides responsible for administering or assisting in the administration of medication to a resident while on the ALR’s premises, immediately report any medication error or adverse drug reactions to the ALR’s available registered nurse and ALA upon discovery. The ALR shall require the ALA or Acting Administrator to report the medication error or adverse drug reaction, to the resident’s healthcare practitioner, prescriber, pharmacist, and the resident (or surrogate), as appropriate.

10124.9 An ALR shall require all medication errors and adverse drug reactions be documented in the resident’s record.

10124.10 An ALR shall initiate an investigation of any reported medication error or adverse drug reaction within twenty-four (24) hours of discovery. Upon the completion of the investigation, the ALR shall compose a report documenting the findings and conclusion of the investigation, which shall be kept as part of the ALR’s records for no less than five (5) years. A report required under this subsection shall also be made available to the Director or the Director’s designee upon request during an inspection authorized by the Act or this chapter.

10124.11 An ALR shall submit to the Director a copy of any report of an adverse drug reaction required by § 10124.10 within thirty (30) days of the discovery of the adverse drug reaction, in addition to the requirements of § 10124.10 and the notification requirements of § 10125.4(a) of this chapter.

10124.12 Nothing in this section authorizes a healthcare professional to practice outside the scope of their authority to practice their profession in the District.

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10124

22-B DCMR § 10125 REPORTING COMPLAINTS TO THE DIRECTOR; REPORTING ABUSE, NEGLECT, EXPLOITATION, AND UNUSUAL INCIDENTS

10125.1 Notwithstanding a resident’s right to address grievances and complaints to representatives of the Office of the Long-Term Care Ombudsman provided by § 505(a)(5) of the Act (D.C. Official Code § 44-105.05(a)(5)), the Director may receive any complaint alleging violations of the Act and this chapter from any person and may conduct an inspection to determine the validity of the complaint pursuant to § 10107.3 of this chapter.

10125.2 An ALR shall immediately notify the Department of Health, the District’s Adult Protective Services program, and the District of Columbia Long-Term Care Ombudsman of all suspected or alleged incidents of abuse, neglect, or exploitation. The Department of Health shall be notified by phone immediately, and the ALR shall follow up by written notification to the Department within twenty-four (24) hours or the next business day.

10125.3 The results of an ALR’s investigation into allegations of abuse, neglect, or exploitation of a resident pursuant to § 509(b)(3) of the Act (D.C. Official Code 44-105.09(b)(3)) shall be reported to the Director within thirty (30) days of the complaint or fifteen (15) days of the conclusion of the investigation, whichever occurs first.

10125.4 In addition to the requirements to report abuse, neglect, and exploitation of a resident provided in § 509 of the Act (D.C. Official Code § 44-105.09):

An ALR shall notify the Director of any unusual incident that substantially affects a resident. Notifications of unusual incidents shall be made by contacting the Department of Health by phone promptly, and shall be followed up by written notification to the same within twenty-four (24) hours or the next business day; and

An ALR shall notify the Metropolitan Police Department of abuse or any unusual incident involving death or criminal activity at an ALR before notifying the Director pursuant to paragraph (a) of this subsection. Instances of sexual abuse, specifically, shall be directed to the Metropolitan Police Department’s Sexual Assault Unit.

10125.5 For purposes of § 10125.4, an “unusual incident” shall mean any occurrence involving a resident or the ALR’s physical plant that results in significant harm, or the potential for significant harm, to any resident’s health, welfare, or wellbeing. Unusual incidents include, but are not limited to: an accident resulting in significant injury to a resident, unexpected death, a sustained utility outage, environmental hazards, misappropriation of a resident’s property or funds, or an occurrence requiring or resulting in intervention from law enforcement or emergency response personnel.

10125.6 An ALR shall keep record of all instances of unusual incidents for no less than three (3) years after the date of occurrence.

10125.7 An ALR shall, upon request, provide an affected resident (or surrogate) with a copy of the results of the ALR’s investigation into suspected abuse, neglect, or exploitation of that resident, and any actions taken by the ALR, that are reported to the Department pursuant to § 509(b)(3) of the Act (D.C. Official Code § 44-105.09(b)(3)).

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10125

22-B DCMR § 10126 DENIAL, RESTRICTION, SUSPENSION, OR REVOCATION OF A LICENSE

10126.1 The Director may take the following actions with respect to a license issued pursuant to the Act and § 10106 of this chapter:

Refuse to issue, renew, or restore a license;

Issue a provisional license pursuant to § 304(e)(2) of the Act (D.C. Official Code § 44-103.04(e)(2));

Restrict a license for one of the reasons listed in § 401 of the Act (D.C. Official Code § 44-104.01) or § 10127 of this chapter; or

Suspend or revoke the license of an ALR that:

Fails to meet all applicable requirements for renewal, as provided by § 304(e) of the Act (D.C. Official Code § 44-103.04(e));

Violates a condition or requirement of an imposed sanction, as provided by § 401(c) of the Act (D.C. Official Code § 44-104.01(c)); or

Is determined by the Director, after an inspection, to have life threatening deficiencies or deficiencies which seriously endanger the public's health and safety, as provided by § 306(d) of the Act (D.C. Official Code § 44-103.06(d)).

10126.2 Except for an emergency suspension undertaken pursuant to § 404 of the Act (D.C. Official Code § 44-104.14), every applicant for or holder of a license, or applicant for reinstatement after revocation, shall be afforded notice and an opportunity to be heard prior to the action of the Director, if the effect of which would be one of the following:

To deny an initial license for cause which raised an issue of fact;

To suspend a license;

To revoke a license;

To refuse to restore a license;

To issue a provisional renewal license; or

To refuse to issue a renewal license for any cause other than failure to pay the prescribed fees.

10126.3 When the Director contemplates taking any action of the type specified in § 10126.2(a), the Director shall give to the applicant a written notice containing the following statements:

That the applicant has failed to satisfy the Director as to the applicant's qualifications;

The respect in which the applicant has failed to satisfy the Director; and

That the denial shall become final unless the applicant files a request for a hearing with the Director within fifteen (15) days of receipt of the notice.

10126.4 When the Director contemplates taking any action of the type specified in paragraphs (b), (c), (d), (e), and (f) of § 10126.2, the Director shall give the licensee a written notice containing the following statements:

That the Director has sufficient evidence (setting forth the nature of the evidence), which if not rebutted or explained, justifies taking the proposed action; and

That the Director shall take the proposed action unless within fifteen (15) days of the receipt of the notice the ALR files with the Director a written request for a hearing or in the alternative submits documentary evidence for the Director's consideration before the Director takes final action.

10126.5 If the ALR does not respond to a notice required under §§ 10126.3 or 10126.4 within the time specified, the Director may, without a hearing, take the action contemplated in the notice. The Director shall inform the applicant or licensee, in writing, of the action taken.

10126.6 If the ALR chooses to submit documentary evidence but does not request a hearing, the Director shall consider the material submitted and take such action as is appropriate without a hearing. The Director shall notify the ALR in writing of the action taken.

10126.7 Service of any notice required by this section shall be in accordance with the rules provided in 22-B DCMR § 3109.

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10126

22-B DCMR § 10127 SANCTIONS

10127.1 Failure of a Licensee to comply with the requirements of this chapter shall be grounds for sanctions, which shall be imposed in accordance with the Act and this chapter.

10127.2 On determining that a Licensee has violated this chapter, the Director may impose, or cause to be imposed, the sanctions set forth in § 401 of the Act (D.C. Official Code § 44-104.01).

10127.3 If the Director determines that the Licensee has violated a condition or requirement of a sanction imposed under the authority of this chapter, the Director may suspend or revoke the license.

10127.4 Appeals under this section may be taken pursuant to § 1201 of the Act (D.C. Official Code § 44-1012.01).

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10127

22-B DCMR § 10128 CIVIL PENALTIES

10128.1 The Director may impose, or cause to be imposed, one or more of the civil penalties authorized under § 402 of the Act (D.C. Official Code § 44-104.02) against persons who:

Maintain or operate an unlicensed ALR; or

Otherwise violate provisions of this chapter.

10128.2 Notwithstanding any other provision of law, penalties authorized under § 10128.1 shall not be imposed by the Director unless a violation cited during an inspection:

Is within the control of the ALR; and

Poses an immediate or serious and continuing danger to the health, safety, welfare, or rights of resident.

10128.3 If, during a follow-up inspection, the Director determines that violations of this chapter which are within the control of the ALR and were cited in an immediately prior inspection have not been corrected or have recurred, the Director may impose the penalties authorized under § 402 of the Act (D.C. Official Code § 44-104.02).

10128.4 Appeals under this section may be taken as provided by § 402(d) of the Act (D.C. Official Code § 44-104.02(d)).

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10128

22-B DCMR § 10129 CRIMINAL PENALTIES

10129.1 The criminal penalties authorized by § 403 of the Act (D.C. Official Code § 44-104.03) of the Act shall apply to an ALR.

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10129

22-B DCMR § 10130 REFERRALS TO REGULATORY ENTITIES

10130.1 The Director may refer an ALA who is alleged to have engaged in conduct prohibited by the Act, this chapter, or other District or federal law or rules issued pursuant thereto, to the District of Columbia Board of Long-Term Care Administration for review of the conduct.

10130.2 The Director may refer any healthcare professional who practices his or her healthcare profession on the premises of an ALR and who is alleged to have engaged in conduct prohibited by the Act, this chapter, or other District of federal law or rules issued pursuant thereto, to the appropriate regulatory entity with jurisdiction over the healthcare professional for review of the conduct.

10130.3 Nothing in this section shall prohibit any person, including the Director, from referring any individual suspected of conduct prohibited by District or federal law or regulation to the appropriate District or federal regulatory entities.

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10130

22-B DCMR § 10131 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10132 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10133 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10134 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10135 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10136 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10137 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10138 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10139 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10140 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10141 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10142 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10143 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10144 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10145 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10146 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10147 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10148 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10149 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10150 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10151 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10152 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10153 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10154 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10155 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10156 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10157 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10158 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10159 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10160 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10161 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10162 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10163 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10164 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10165 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10166 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10167 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10168 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10169 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10170 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10171 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10172 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10173 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10174 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10175 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10176 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10177 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10178 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10179 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10180 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10181 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10182 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10183 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10184 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10185 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10186 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10187 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10188 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10189 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10190 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10191 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10192 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10193 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10194 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10195 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10196 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10197 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10198 RESERVED

History

SOURCE: Final Rulemaking published at 54 DCR 005591 (June 8, 2007).

22-B DCMR § 10199 DEFINITIONS

10199.1 The definitions of terms provided in the Act (at D.C. Official Code § 44-102.01) shall apply to this chapter, unless provided another definition under § 10199.2.

10199.2 When used in this chapter, the following terms and phrases shall have the meanings ascribed:

“Act” or “the Act” – means the Assisted Living Residence Regulatory Act of 2000, effective June 24, 2000, (D.C. Law 13-127; D.C. Official Code §§ 44-101.01 et seq.).

Acting Administrator – means a member of the ALR staff who is designated by the Licensee or Assisted Living Administrator to assume the responsibilities of the Assisted Living Administrator for a temporary period of time.

“Administer” or “Administration” – means, with respect to medication, the direct application of a medication to the body of a person by injection, inhalation, ingestion, or any other means.

ALA – means “Assisted Living Administrator,” as defined by the Act (D.C. Official Code § 44-102.01).

ALR – means “Assisted Living Residence,” as defined by the Act (D.C. Official Code § 44-102.01).

Audio-Visual Monitoring – means the surveillance of the ALR facility, its employees, or its residents by audio, visual, or audio-visual means.

Certified Medication Aide – means a person certified to practice as a medication aide by the District of Columbia Board of Nursing, who shall not practice independently, but shall work under the supervision of a registered nurse of licensed practical nurse.

Companion – means an individual who is employed, for pay or not-for-pay, to provide companion services to a resident at the discretion of the companion’s client, the companion’s employer, or the resident. For purposes of this chapter, the definition of a companion shall not include the resident’s social guest, unless that social guest is performing companion services on the ALR’s premises at the discretion of anyone other than himself or herself.

Companion services – means non-healthcare related services, such as cooking, housekeeping, errands, and social interaction, performed for a resident on the ALR’s premises.

Department – means the District of Columbia Department of Health.

Direct Resident Access – means access to a resident that involves, or may foreseeably involve, presence in a room occupied by the resident while not under the immediate and contemporaneous supervision of a licensed health care professional employed by the ALR.

Director – means the Director of the District of Columbia Department of Health.

Employee – means any person who works under the employ of an ALR or a separate entity that is owned or operated or a subsidiary of the ALR; or any person who is contracted through an entity independent of an ALR for the purpose of working under the direction and supervision of the ALR.

Healthcare Professional – means the practitioner of a healthcare occupation, the practice of which requires authorization pursuant to the District of Columbia Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99; D.C. Official Code §§ 3-1201.01 et seq.), as amended from time to time.

ISP- means “Individualized Service Plan,” as defined by the Act (at D.C. Official Code § 44-102.01).

Medication Error – means any error in the prescribing, dispensing, or administration of a drug, irrespective of whether such errors lead to adverse consequences or not.

Private Duty Healthcare Professional – means a nurse, home health aide, nurse aide, or any other healthcare professional arranged by a resident, surrogate, or party other than the ALR to provide healthcare-related services to the resident on the ALR’s premises.

SRA – means “Shared Responsibility Agreement,” as defined by the Act (at D.C. Official Code § 44-102.01).

“Staff” or “Staff member” – means “Employee,” as defined by this subsection.

Unlicensed Person – means a person who is not licensed pursuant to the Health Occupations Revision Act of 1985, effective March 25, 1986 (D.C. Law 6-99, D.C. Official Code §§ 3-1201.01 et seq.) and who functions in a complementary or assistance role to licensed health care professionals in providing direct patient care or carrying out common nursing tasks, such as nurse aides, orderlies, assistant technicians, attendants, home health aides, personal care aides, medication aides, geriatric aides, or other health aides. “Unlicensed person” also includes housekeeping, maintenance, and administrative staff for whom it is foreseeable that the person will come in direct contact with patients.

History

SOURCE: Final Rulemaking published at 54 DCR 5591 (June 8, 2007); as amended by Final Rulemaking published at 67 DCR 3717 (April 3, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10199

22-B102 LICENSING OF MEDICAL DEVICES - DISTRIBUTORS, MANUFACTURERS, INITIAL IMPORTERS, AND VENDORS

22-B DCMR § 10200 GENERAL PROVISIONS

10200.1 These sections provide for the minimum licensing standards necessary to ensure the safety and efficacy of medical devices placed in the stream of commerce by distributors, manufacturers, initial importers, and vendors.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013); as amended by Final Rulemaking published at 63 DCR 13491 (October 28, 2016). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10200

22-B DCMR § 10201 APPLICABLE LAWS AND REGULATIONS

10201.1 The Department of Health (Department or DOH) adopts by reference the following laws and regulations:

(a) Federal Food, Drug, and Cosmetic Act, approve June 25, 1938, 21 U.S.C. § 301, et seq. (“act”) as amended;

(b) 21 Code of Federal Regulations (C.F.R.), part 801, Labeling, as amended;

(d) 21 C.F.R., part 807, Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices, as amended;

(e) 21 C.F.R., part 814, Premarket Approval of Medical Devices, as amended;

(f) 21 C.F.R., part 820, Quality System Regulation, as amended; and

(g) 21 C.F.R., Subchapter J--Radiological Health, as amended.

10201.2 Copies of these laws and regulations are indexed and filed at the Department, 899 North Capitol Street, N.E., Washington, D.C. 20002 and are available for inspection during normal working hours. Electronic copies of these laws and regulations are available online at www.hpla.doh.dc.gov.

10201.3 Nothing in these sections shall relieve any person of the responsibility for compliance with other applicable District of Columbia and federal laws and regulations.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10201

22-B DCMR § 10202 EXEMPTIONS

10202.1 A person is exempt from licensing under these sections if the person engages only in the following types of device distribution:

(a) Intra-company sales; or

(b) The sale, purchase, or trade of a distressed or reconditioned device by a salvage operator.

10202.2 An exemption from the licensing requirements under these sections does not constitute an exemption from other applicable provisions of federal and District of Columbia laws and regulations.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10202

22-B DCMR § 10203 LICENSURE REQUIREMENTS FOR DISTRIBUTORS,

MANUFACTURERS, INITIAL IMPORTERS, AND VENDORS

10203.1 Except as provided by § 10202, a person may not engage in distributing, manufacturing, importing, or vending medical devices in the District of Columbia unless the person has a valid license from the Department of Health.

10203.2 The license shall be displayed in an open public area at each place of business.

10203.3 Each person engaged in distributing, manufacturing, importing, or vending of medical devices in the District of Columbia on the effective date of these sections shall apply for a medical device distributor, manufacturer, initial importer, or vendor license no later than sixty (60) days following the effective date of these regulations.

10203.4 Each person acquiring or establishing a place of business for the purpose of medical device distribution, manufacturing, importation, or vending after the effective date of these subsections shall apply to the Department for a license prior to beginning operation.

10203.5 If the medical device distributor, manufacturer, initial importer, or vendor operates more than one place of business, the medical device distributor, manufacturer, initial importer, or vendor shall obtain a license for each place of business.

10203.6 The Department may license a distributor, manufacturer, initial importer, or vendor of medical devices who meets the requirements of these sections and pays all fees.

10203.7 Licenses shall not be transferable from one (1) person to another or from one (1) place of business to another.

10203.8 Unless a license is amended pursuant to this section or revoked or suspended as provided in § 10207 (relating to Refusal, Cancellation, Suspension, or Revocation of a License), the license shall be valid for one (1) year.

10203.9 The license application as outlined in § 10204.2 of this chapter (relating to Licensing Procedures) and non-refundable licensing fees for each place of business shall be submitted to the department prior to the expiration date of the current license. A person who files a renewal application after the expiration date must pay an additional one hundred dollars ($100) as a delinquency fee.

10203.10 A licensee who fails to submit a renewal application prior to the current license expiration date and continues operations may be subject to the enforcement and penalty provision in § 10210 (relating to Enforcement and Penalties), or the revocation and suspension provisions in § 10207.

10203.11 A renewal license shall only be issued when all past due fees and delinquency fees are paid.

10203.12 A license that is amended, including a change of name, ownership, or a notification of a change in the location of a licensed place of business, shall require submission of an application as outlined in § 10204 (relating to Licensing Procedures) and submission of fees.

10203.13 Not fewer than thirty (30) days in advance of the change, a licensee shall notify the Director or the Director’s designee in writing of the licensee’s intent to change the location of a licensed place of business. The notice shall include the address of the new location, and the name and residence address of the individual in charge of the business at the new location. Not more than ten (10) days after the completion of the change of location, the licensee shall notify the Director or the Director’s designee in writing to verify the change of location, the specific date of change, the new location, the address of the new location, and the name and residence address of the individual in charge of the business at the new address. Notice shall be deemed adequate if the licensee provides the intent and verification notices to the Director or the Director’s designee by certified mail, return receipt requested, mailed to the Department, 899 North Capitol Street, N.E., Washington, D.C. 20002.

10203.14 If the United States Food and Drug Administration (FDA) determines, with respect to a product that is a combination of a drug and a medical device, that the primary mode of action of the product is as a device, a distributor, manufacturer, initial importer, or vendor of the product is subject to licensure as described in this section.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013); as amended by Final Rulemaking published at 63 DCR 13491 (October 28, 2016); as amended by Final Rulemaking published at 65 DCR 3648 (April 6, 2018). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10203

22-B DCMR § 10204 LICENSING PROCEDURES FOR DISTRIBUTORS, MANUFACTURERS, INITIAL IMPORTERS AND VENDORS

10204.1 License application forms may be obtained from the Department at 899 North Capitol Street, N.E., Washington, D.C., or online at www.hpla.doh.dc.gov.

10204.2 The application for licensure as a medical device distributor, manufacturer, initial importer, or vendor shall be signed and verified, and submitted on a license application form furnished by the Department.

10204.3 If the legal entity is a proprietorship, partnership, corporation, or association, the application shall contain the following:

(a) The name and residence address of the applicant, and the date and place of incorporation (if applicable);

(b) The name and address of the corporation’s registered agent and corporation charter number, or if any other type of association;

(d) The name of the legal entity to be licensed, including the name under which the business is conducted;

(e) The address of each place of business that is licensed;

(f) If a proprietorship, the name and residence address of the proprietorship;

(g) If a corporation, the date and place of incorporation and name and address of its registered agent in the state and corporation charter number; or

(h) If any other type of association, the names of the principals of such association;

(i) The name, residence address, and valid driver’s license number of each individual in an actual administrative capacity which, in the case of proprietorship, shall be the managing proprietor; partnership, the managing partner; corporation, the officers and directors; or those in a managerial capacity in any other type of association; and

(j) For each place of business, the residence address of the individual in charge;

10204.4 A completed application shall entitle a medical device distributor, manufacturer, initial importer, or vendor to a license, except as provided in § 10207.

10204.5 The renewal application for licensure as a medical device distributor, manufacturer, initial importer, or vendor shall be made on a license application form furnished by the Department.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013); as amended by Final Rulemaking published at 63 DCR 13491 (October 28, 2016). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10204

22-B DCMR § 10205 REPORT OF CHANGES

10205.1 The license holder shall notify the department in writing no later than ten (10) days after any change which would render the information contained in the application for the license, reported pursuant to § 10204 (relating to Licensing Procedures), no longer accurate. Failure to inform the department no later than ten (10) days after a change in the information required in the application for a license may result in a suspension or revocation of the license following a hearing.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10205

22-B DCMR § 10207 REFUSAL, CANCELLATION, SUSPENSION, OR REVOCATION OF LICENSE

10207.1 The Director may refuse an application or may refuse to license an applicant, or, suspend or revoke a license , after providing the applicant or licensee with an opportunity for a hearing, if the applicant or licensee:

(a) Has been convicted of a felony or misdemeanor that involves moral turpitude;

(b) Is an association, partnership, or corporation whose managing officer has been convicted of a felony or misdemeanor that involves moral turpitude;

(c) Has been convicted in a District of Columbia or federal court of the illegal use, sale, or transportation of intoxicating liquors, narcotic drugs, barbiturates, amphetamines, desoxyephedrine, their compounds or derivatives, or any other dangerous or habit-forming drugs;

(d) Is an association, partnership, or corporation whose managing officer has been convicted in the District of Columbia Superior Court or federal court of the illegal use, sale or transportation of intoxicating liquors, narcotic drugs, barbiturates, amphetamines, desoxyephedrine, their compounds or derivatives, or any other dangerous or habit-forming drugs;

(e) Has violated any of the provisions of D.C. Official Code §§ 48-904.01, et seq. (2009 Repl.);

(f) Has failed to pay a license fee or a renewal fee for a license; or

(g) Has obtained or attempted to obtain a license by fraud or deception.

10207.2 The Director may refuse to license an applicant, or, suspend or revoke a license if the Director determines from evidence presented during a hearing that the applicant or licensee:

(a) Has violated any provisions of the District of Columbia Official Code, §§ 22-901, et seq. concerning the counterfeiting of a drug or the sale or holding for sale of a counterfeit drug;

(b) Has violated D.C. Official Code §§ 48-904.01, et seq.; or

(c) Has violated any of these regulations, including being responsible for a significant discrepancy in the records that District law requires the applicant or licensee to maintain.

10207.3 The Department may, after providing opportunity for a hearing, refuse to license a distributor, manufacturer, initial importer, or vendor of medical devices, or may suspend or revoke a license, for any violation of the federal-law requirements incorporated into these regulations pursuant to § 10201.

10207.4 A license issued under this chapter shall be returned to the Department if the medical device distributor, manufacturer, initial importer, or vendor’s place of business:

Ceases business or otherwise ceases operation on a permanent basis;

Relocates; or

Is deemed, as a corporation, to have undergone an ownership change as determined by a transfer of five percent (5%) or more of the share of stock from one person to another.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013); as amended by Final Rulemaking published at 63 DCR 13491 (October 28, 2016). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10207

22-B DCMR § 10208 MINIMUM STANDARDS FOR LICENSURE

10208.1 All medical device distributors, manufacturers, initial importers, or vendors engaged in the design, manufacture, packaging, labeling, storage, installation, servicing, and vending of medical devices shall comply with the minimum standards of this section.

10208.2 For the purpose of this section, the policies described in the FDA’s Compliance Policy Guides as they apply to devices shall be the policies of the Department.

10208.3 [REPEALED].

10208.4 [REPEALED].

10208.5 All manufacturing, assembling, packaging, packing, holding, testing, or labeling of devices by manufacturers shall take place in buildings and facilities described in §§ 10718 “Handling,” 10719 “Storage,” 10720 “Distribution,” and 10720 “Installation.”

10208.6 No manufacturing, assembling, packaging, packing, holding, testing, or labeling operations of medical devices by distributors, manufacturers, initial importers, or vendors shall be conducted in any personal residence.

10208.7 Any place of business used by a distributor to store, warehouse, hold, offer, transport, or display devices shall:

(a) Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;

(b) Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, and space;

(d) Be maintained in a clean and order condition; and

(e) Be free from infestation by insects, rodents, birds, or vermin of any kind.

10208.8 All medical devices stored by distributors, manufacturers, initial importers, or vendors shall be held at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the label of such medical devices.

10208.9 Medical devices distributed by device distributors, manufacturers, initial importers, or vendors shall meet the labeling requirements of Chapter 103 of this subtitle.

10208.10 Where District regulations conflict with device labeling or packaging exemptions adopted under the Federal Food, Drug, and Cosmetic Act, as amended, federal law or regulations shall preempt District regulations.

10208.11 Reconditioned devices shall comply with the provisions of this chapter.

10208.12 Medical device distributors, manufacturers, initial importers, or vendors shall meet the applicable medical device reporting requirements of Chapter 104 of this subtitle.

10208.13 Devices which emit electronic product radiation and are distributed by device distributors or manufacturers shall meet the applicable requirements of Chapter 108 entitled of this subtitle.

10208.14 [RESERVED]

10208.15 Each medical device distributor, manufacturer, initial importer, or vendor who distributes prescription medical devices shall maintain a record for every prescription medical device, showing the identity and quantity received or manufactured and the disposition of each device.

10208.16 Each medical device distributor, manufacturer, initial importer, or vendor who delivers a prescription medical device to the ultimate user shall maintain a record of any prescription or other order lawfully issued by a practitioner in connection with the device.

10208.17 All types of contact lenses are medical devices which may be sold and dispensed only by an individual or a business authorized by law to dispense contact lenses.

10208.18 All types of contact lenses must be dispensed according to a prescription from the physician or optometrist who examined and fitted the contact lenses to the person’s eyes.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013); as amended by Final Rulemaking published at 63 DCR 13491 (October 28, 2016). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10208

22-B DCMR § 10209 ADVERTISING

10209.1 An advertisement of a device shall be deemed to be false if it is misleading in any particular.

10209.2 An advertisement of a device is false if the advertisement represents that the device affects:

Infectious and parasitic diseases;

Neoplasms;

Endocrine, nutritional, and metabolic diseases and immunity disorders;

Diseases of blood and blood-forming organs;

Mental disorders;

Diseases of the nervous system and sense organs;

Diseases of the circulatory system;

Diseases of the respiratory system;

Diseases of the digestive system;

Diseases of the genitourinary system;

Complications of pregnancy, childbirth, and the puerperium;

Diseases of the skin and subcutaneous tissue;

Diseases of the musculoskeletal system and connective tissue;

Congenital anomalies;

Certain conditions originating in the perinatal period;

Symptoms, signs, and ill-defined conditions; or

Injury and poisoning.

10209.3 Subsection 10209.2 shall not apply to an advertisement of a device if the advertisement does not violate the Act and is disseminated:

To the public for self-medication and is consistent with the FDA’s labeling claims;

Only to members of the medical, dental, and veterinary professions and appears only in the scientific periodicals of those professions; or

Only for the purpose of public health education by a person not commercially interested, directly or indirectly, in the sale of the device.

10209.4 Nothing in this section shall be construed as establishing any official policy of the Department concerning self-medication for a disease, other than a disease listed under § 10209.2, including any official policy that such self-medication is safe and effective.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10209

22-B DCMR § 10210 ENFORCEMENT AND PENALTIES

10210.1 To enforce the provisions of this chapter, the Department, an authorized agent, or a health authority may, on presenting appropriate credentials to the owner, operator, or agent in charge of a place of business:

(a) Enter at reasonable times a place of business, including factory or warehouse, in which a device is manufactured, assembled, packed, or held for introduction into commerce or held after the introduction;

(b) Enter a vehicle being used to transport or hold a device in commerce; or

(c) Inspect at reasonable times, within reasonable limits, and in a reasonable manner, the place of business or vehicles and all equipment, finished and unfinished materials, containers, and labeling of any medical device and obtain samples.

10210.2 The inspection of a place of business, including a factory, warehouse, or consulting laboratory, in which a restricted device is manufactured, assembled, packed, or held for introduction into commerce extends to any place or thing, including a record, file, paper, process, control, or facility, in order to determine whether the device:

Is adulterated or misbranded;

May not be manufactured, introduced into commerce, sold or offered for sale under the Act; or

Is otherwise in violation of the Act.

10210.3 An inspection under § 10210.2 may not extend to:

Financial data;

Sales data other than shipment data;

Pricing data;

Personnel data other than data relating to the qualifications of technical and professional personnel performing functions under this chapter; or

Research data other than data:

Relating to devices; and

Subject to reporting and inspection under regulations issued under 21 U.S.C. §§ 360i or 360j of the act, as amended.

10210.4 An inspection under § 10210.2 shall be started and completed with reasonable promptness.

10210.5 An authorized agent or health authority who makes an inspection of a place of business, including a factory or warehouse, and obtains a sample during or on completion of the inspection and before leaving the place of business, shall give to the owner, operator, or the owner’s or operator’s agent a receipt describing the sample.

10210.6 A person who is required to maintain records under 21 U.S.C. §§ 360i or 360j or a person who is in charge of or has custody of those records shall, at the request of an authorized agent or health authority, permit the authorized agent or health authority at all reasonable times access to the records, and to copy and verify the records.

10210.7 A person who is subject to licensure shall, at the request of an authorized agent or health authority, permit the authorized agent or health authority at all reasonable times, access to all records, as well as to copy and verify all records showing:

The movement in commerce of any device;

The holding of any device after movement in commerce; and

The quantity, shipper, and consignee of any device.

10210.8 Records shall be maintained at the place of business or other location that is reasonably accessible for a period of at two (2) years following disposition of the device unless a greater period is required by laws and regulations adopted in § 10201 of this subtitle (relating to Applicable Laws and Regulations).

10210.9 If the Department of Health identifies an adulterated or misbranded device, the Department may take or seek enforcement actions including, but not limited to:

Detention;

Emergency order;

Recall;

Condemnation;

Destruction;

Injunction;

Civil penalties;

Criminal penalties; or

Administrative penalties.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10210

22-B DCMR § 10299 DEFINITIONS

10299.1 As used in this chapter, the following terms shall have the meanings ascribed:

Initial importer – any person who furthers the marketing of a medical device from a foreign manufacturer to the person who makes the final delivery or sale of the medical device to the ultimate consumer or user, but does not repackage or otherwise change the container, wrapper, or labeling of the medical device or medical device package. The term “initial importer” does not include a common carrier, a delivery agent, or an agent or sales representative of a licensed manufacturer or distributor.

Vendor – any person, with the exception of any agent or sale representative of a licensed manufacturer or distributor, engaged in selling medical devices for the immediate delivery upon purchase.

History

SOURCE: Final Rulemaking published at 63 DCR 13491 (October 28, 2016). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10299

22-B103 LABELING OF MEDICAL DEVICES

22-B DCMR § 10300 MEDICAL DEVICES: NAME AND PLACE OF BUSINESS OF MANUFACTURER, OR DISTRIBUTOR

10300.1 The label of a device in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.

10300.2 The requirement for declaration of the name of the manufacturer, packer, or distributor shall be deemed to be satisfied, in the case of a corporation, only by the actual corporate name which may be preceded or followed by the name of the particular division of the corporation. Abbreviations for “Company” and “Incorporated” may be used, and “The” may be omitted. In the case of a proprietorship, partnership, or association, the name under which the business is conducted shall be used.

10300.3 Where a device is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection the person has with the device such as “Manufactured for …,” “Distributed by …,” or any other wording that expresses the facts.

10300.4 The statement of the place of business shall include the street address, city, state, and zip code; however, the street address may be omitted if it is shown in a current city directory or telephone directory. The requirement for inclusion of the zip code shall apply only to consumer commodity labels developed or revised after the effective date of these regulations. In the case of non-consumer packages, the zip code shall appear on either the label or the labeling (including the invoice).

10300.5 If a person manufactures, packs, or distributes a device at a place other than his principal place of business, the label may state the principal place of business in lieu of the actual place where the device was manufactured or packed or is to be distributed, unless the statement would be misleading.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10300

22-B DCMR § 10301 MEANING OF “INTENDED USES”

10301.1 The words “intended uses” or words of similar import in §§ 10302, 10312, and 10314 of this chapter refer to the objective intent of the persons legally responsible for the labeling of devices. The intent is determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the medical device.

10301.2 The objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised. The intended uses of a medical device may change after it has been introduced into interstate commerce by its manufacturer.

10301.3 If, for example, a packer, distributor, or seller intends a medical device for different uses than those intended by the person from whom he received the devices, the packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses.

10301.4 If a manufacturer knows, or has knowledge of facts that would give him or her notice that a device introduced into interstate commerce by him or her is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a device which accords with the other uses to which the medical device is to be put.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10301

22-B DCMR § 10302 RESERVED

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10302

22-B DCMR § 10303 MEDICAL DEVICES: MISLEADING STATEMENTS

10303.1 Among representations in the labeling of a device which render the device misbranded is a false or misleading representation with respect to another device, drug, food, or cosmetic.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10303

22-B DCMR § 10304 MEDICAL DEVICES: PROMINENCE OF REQUIRED LABEL STATEMENTS

10304.1 A word, statement, or other information required by or under the authority of the Act to appear on the label may lack prominence and conspicuousness, for the following:

Such word, statement, or information fails to appear on the part or panel of the label which is presented or displayed under customary conditions of purchase;

Such word, statement, or information fails to appear on two (2) or more parts or panels of the label, each of which has sufficient space therefore, and each of which is so designed as to render it likely to be, under customary conditions of purchase, the part or panel displayed;

The label fails to extend over the area of the container or package available for such extension, so as to provide sufficient label space for the prominent placing of such word, statement, or information;

The label space is insufficient for the prominent placing of such word, statement, or information, resulting from the use of label space for any other word, statement, design, or device that is not required by or under authority of the Act to appear on the label;

Label space is insufficient for the placing of such word, statement, or information, resulting from the use of label space to give materially greater conspicuousness to any other word, statement, or information, or to any design or device; or

Type style in which such word, statement, or information appears is small, there is insufficient background contrast or obscuring designs or vignettes, or the label is crowded with other written, printed, or graphic matter.

10304.2 No exemption depending on insufficiency of label space, as prescribed in regulations promulgated under 21 USC § 352(b) of the act, shall apply if such insufficiency is caused by:

The use of label space for any word, statement, design, or device which is not required by or under authority of the Act to appear on the label;

The use of label space to give greater conspicuousness to any word, statement, or other information than is required by 21 USC § 352(c); or

The use of label space for any representation in a foreign language.

10304.3 All words, statements, and other information required by or under authority of the Act to appear on the label or labeling shall appear thereon in the English language; provided, however, that in case of articles distributed solely in the Commonwealth of Puerto Rico or in a territory where the predominant language is one other than English, the predominant language may be substituted for English.

10304.4 If the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label shall appear thereon in the foreign language.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10304

22-B DCMR § 10305 MEDICAL DEVICES: SPANISH LANGUAGE VERSION OF CERTAIN REQUIRED STATEMENTS

10305.1 If devices restricted to prescription use only are labeled solely in Spanish for distribution in the Commonwealth of Puerto Rico where Spanish is the predominant language, the labeling is authorized under §§ 10304.3 through 10304.4 of this chapter.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10305

22-B DCMR § 10306 PRINCIPAL DISPLAY PANEL

10306.1 The term “principal display panel” as it applies to over-the-counter devices in package form and as used in this part means the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale.

10306.2 The principal display panel shall be large enough to accommodate all of the mandatory label information required to be placed thereon by this part with clarity and conspicuousness and without obscuring designs, vignettes, or crowding.

10306.3 Where packages bear alternate principal display panels, information required to be placed on the principal display panel shall be duplicated on each principal display panel. For the purpose of obtaining uniform type size in declaring the quantity of contents for all packages of substantially the same size, the term “area of the principal display panel” means the area of the side or surface that bears the principal display panel, which area shall be:

(a) In the case of a rectangular package where one (1) entire side properly can be considered to be the principal display panel side, the product of the height times the width of that side;

(b) In the case of a cylindrical or nearly cylindrical container, forty percent (40%) of the product of the height of the container times the circumference; and

(c) In the case of any other shape of container, forty percent (40%) of the total surface of the container; provided however, that where the container presents an obvious “principal display panel” such as the top of a triangular or circular package, the area shall consist of the entire top surface.

10306.4 In determining the area of the principal display panel, exclude tops, bottoms, flanges at the tops and bottoms of cans, and shoulders and necks of bottles or jars. In the case of cylindrical or nearly cylindrical containers, information required by this part to appear on the principal display panel shall appear within that forty percent (40%) of the circumference which is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10306

22-B DCMR § 10307 STATEMENT OF IDENTITY

10307.1 The principal display panel of an over-the-counter device in package form shall bear as one (1) of its principal features a statement of the identity of the commodity.

10307.2 The statement of identity shall be in terms of the common name of the device followed by an accurate statement of the principal intended action(s) of the device. The statement shall be placed in direct conjunction with the most prominent display of the name and shall employ terms descriptive of the principal intended action(s). The indications for use shall be included in the directions for use of the device, as required by 21 U.S.C. § 352(f)(1) and by the regulations in this section.

10307.3 The statement of identity shall be presented in bold face type on the principal display panel, shall be in a size reasonably related to the most prominent printed matter on the panel, and shall be in lines generally parallel to the base on which the package rests as it is designed to be displayed.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10307

22-B DCMR § 10308 DECLARATION OF NET QUANTITY OF CONTENTS

10308.1 The label of an over-the-counter device in package form shall bear a declaration of the net quantity of contents. This shall be expressed in terms of weight, measure, numerical count, or a combination of numerical count and weight, measure, or size, provided that:

(a) In the case of a firmly established general consumer usage and trade custom of declaring the quantity of a device in terms of linear measure or measure of area, the respective term may be used. The term shall be augmented when necessary for accuracy of information by a statement of the weight, measure, or size of the individual units or of the entire device; or

(b) If the declaration of contents for a device by numerical count does not give accurate information as to the quantity of the device in the package, it shall be augmented by such statement of weight, measure, or size of the individual units or of the total weight, measure, or size of the device as will give such information. For example, “one hundred (100) tongue depressors, adult size,” and “one (1) rectal syringe, adult size.” Whenever the Director determines for a specified packaged device that an existing practice of declaring net quantity of contents by weight, measure, numerical count, or a combination of these does not facilitate value comparisons by consumers, he or she shall, by regulation, designate the appropriate term or terms to be used for the medical device.

10308.2 Statements of weight of the contents shall be expressed in terms of avoirdupois pound and ounce. Statements of liquid measure of the contents shall be expressed in terms of the U.S. gallon of two hundred thirty-one cubic inches (231 cu. in.) and quart, pint, and fluid-ounce subdivisions thereof, and shall express the volume at sixty-eight degrees Fahrenheit (68 °F) (twenty degrees Celsius (20 °C)).

10308.3 The declaration may contain common or decimal fractions. A common fraction shall be in terms of halves, quarters, eighths, sixteenths, or thirty-seconds, except that if there exists a firmly established general consumer usage and trade custom of employing different common fractions in the net quantity declaration of a particular commodity, they may be employed. A common fraction shall be reduced to its lowest terms; a decimal fraction shall not be carried out to more than two (2) places. A statement that includes small fractions of an ounce shall be deemed to permit smaller variations than one which does not include such fractions.

10308.4 The declaration shall be located on the principal display panel of the label, and with respect to packages bearing alternate principal panels it shall be duplicated on each principal display panel.

10308.5 The declaration shall appear as a distinct item on the principal display panel, and shall be separated from other printed label information appearing to the left or right of the declaration by a space at least equal to the height of the lettering used in the declaration. It shall not include any term qualifying a unit of weight, measure, or count, such as “giant pint” or “full quart,” that tends to exaggerate. It shall be placed on the principal display panel within the bottom thirty percent (30%) of the area of the label panel in lines generally parallel to the base on which the package rests as it is designed to be displayed, provided, that:

On packages having a principal display panel of five square inches (5 sq. in.) or less the requirement for placement within the bottom thirty percent (30%) of the area of the label panel shall not apply when the declaration of net quantity of contents meets the other requirements of this part;

In the case of a device that is marketed with both outer and inner retail containers bearing the mandatory label information required by this part and the inner container is not intended to be sold separately, the net quantity of contents placement requirement of this section applicable to such inner container is waived; and

The principal display panel of a device marketed on a display card to which the immediate container is affixed may be considered to be the display panel of the card, and the type size of the net quantity of contents statement is governed by the dimensions of the display card.

10308.6 The declaration shall accurately state the quantity of device in the package exclusive of wrappers and other material packed therewith.

10308.7 The declaration shall appear in conspicuous and easily legible bold face print or type in distinct contrast (by typography, layout, color, embossing, or molding) to other matter on the package; except that a declaration of net quantity blown, embossed, or molded on a glass or plastic surface is permissible when all label information is so formed on the surface.

10308.8 Requirements of conspicuousness and legibility shall include the specifications that:

(a) The ratio of height to width of the letter shall not exceed a differential of three (3) units to one (1) unit, in other words, no more than three (3) times as high as it is wide;

(b) Letter heights pertain to upper case or capital letters. When upper and lower case or all lower case letters are used, it is the lower case letter “o” or its equivalent that shall meet the minimum standards; and

10308.9 The declaration shall be in letters and numerals in a type size established in relationship to the area of the principal display panel of the package and shall be uniform for all packages of substantially the same size by complying with the following type specifications:

(a) Not less than one-sixteenth inch (1/16 in.) in height on packages the principal display panel of which has an area of five square inches (5 sq. in.) or less;

(b) Not less than one-eighth inch (1/8 in.) in height on packages the principal display panel of which has an area of more than five (5) but not more than twenty-five square inches (25 sq. in.);

(c) Not less than three-sixteenths inch (3/16 in.) in height on packages the principal display panel of which has an area of more than twenty-five (25) but not more than one hundred square inches (100 sq. in.); and

(d) Not less than one-quarter inch (1/4 in.) in height on packages the principal display panel of which has an area of more than one hundred square inches (100 sq. in.), except not less than one-half inch (1/2 in.) in height if the area is more than four hundred square inches (400 sq. in.).

10308.10 Where the declaration is blown, embossed, or molded on a glass or plastic surface rather than by printing, typing, or coloring, the lettering sizes specified in § 10308.9(a) - (d) shall be increased by one-sixteenth inch (1/16 in.).

10308.11 On packages containing less than four pounds (4 lbs.) or one gallon (1 gal.) and labeled in terms of weight or fluid measure, the declaration shall be expressed both in ounces, with identification by weight or by liquid measure and, if applicable (one pound (1 lb.) or one pint (1 pt.) or more) followed in parentheses by a declaration in pounds for weight units, with, with any remainder in terms of ounces or common or decimal fractions of the pound, or in the case of liquid measure, in the largest whole units (quarts, quarts and pints, or pints, as appropriate) with any remainder in terms of fluid ounces or common or decimal fractions of the pint or quart. If the net weight of the package is less than one ounce (1 oz.) avoirdupois or the net fluid measure is less than one fluid ounce (1 fl. oz.), the declaration shall be in terms of common or decimal fractions of the respective ounce and not in terms of drams;

10308.12 Pursuant to § 10308.11, the declaration may appear in more than one line. The term “net weight” shall be used when stating the net quantity of contents in terms of weight. Use of the terms “net” or “net contents” in terms of fluid measure or numerical count is optional. It is sufficient to distinguish avoirdupois ounce from fluid ounce through association of terms: for example, “Net wt. six (6) oz.” or “six (6) oz. net wt.,” and “six (6) fl. oz.” or “net contents six (6) fl. oz.”

10308.13 On packages containing four pounds (4 lbs.) or one gallon (1 gal.) or more and labeled in terms of weight or fluid measure, the declaration shall be expressed in pounds for weight units with any remainder in terms of ounces or common or decimal fractions of the pound. In the case of fluid measure, it shall be expressed in the largest whole unit (such as gallons) followed by common or decimal fractions or a gallon or by the next smaller whole unit or units (quarts or quarts and pints), with any remainder in terms of fluid ounces or common or decimal fractions of the pint or quart.

10308.14 Pursuant to § 10308.13, examples are:

(a) A declaration of one and one half pounds (1-1/2 lbs.) weight shall be expressed as “net wt. 24 oz. (1 lb. 8 oz.),” or “Net wt. 24 oz. (1-1/2 lb.)” or “Net wt. 24 oz. (1.5 lb.);”

(b) A declaration of three-fourths pound (3/4 lb.) avoirdupois weight shall be expressed as “Net wt. 12. oz.;”

A declaration of one and three fourths quarts (1-3/4 qts.) liquid measure shall be expressed as “Net contents 56 fl. oz. (1 qt. 1.5 pt.),” but not in terms of quart and ounce such as “Net contents 56 fl. oz. (1 qt. 24 oz.);” or

(e) A declaration of two and one half gallons (2-1/2 gals.) liquid measure shall be expressed as “Net contents 2 gal. 2 qt.,” “Net contents 2.5 gallons,” or “Net contents 2-1/2 gal.” but not as “2 gal. 4 pt.”

10308.15 Pursuant to § 10308.14, for quantities, the following abbreviations and none other may be employed. Periods and plural forms are optional:

gallon – gal. liter – l

milliliter – ml cubic centimeter – cc

quart – qt. yard – yd.

pint – pt. feet or foot – ft.

ounce – oz. inch – in.

pound – lb. meter – m

grain – gr. centimeter – cm

kilogram – kg millimeter – mm

gram – g fluid – fl.

milligram – mg square – sq.

microgram – mcg weight – wt.

10308.16 On packages labeled in terms of linear measure, the declaration shall be expressed both in terms of inches and, if applicable (one foot (1 ft.)) or more), the largest whole units (yards, yards and feet, feet). The declaration in terms of the largest whole units shall be in parentheses following the declaration in terms of inches and any remainder shall be in terms of inches or common or decimal fractions of the foot or yard; if applicable, as in the case of adhesive tape, the initial declaration in linear inches shall be preceded by a statement of the width. Examples of linear measure are “86 inches (2yd, 1 ft. 2 in.)”, “90 inches (2-1/2 yd.),” “30 inches (2.5 ft.),” and “3/4 inch by 36 in. (1 yd.).”

10308.17 On packages labeled in terms of area measure, the declaration shall be expressed both in terms of square inches and, if applicable one square foot (1 sq. ft.) or more, the largest whole square unit (square yards, square yards and square feet, square feet). The declaration in terms of the largest whole units shall be in parentheses following the declaration in terms of square inches and any remainder shall be in terms of square inches or common or decimal fractions of the square foot or square yard; for example, "158 sq. inches (1 sq. ft. 14 sq. in.)."

10308.18 Nothing in this section shall prohibit supplemental statements at locations other than the principal display panel(s) describing in non-deceptive terms the net quantity of contents, provided that such supplemental statements of net quantity of contents shall not include any term qualifying a unit of weight, measure, or count that tends to exaggerate the amount of the device contained in the package; for example, "giant pint" or "full quart." Dual or combination declarations of net quantity of contents are not regarded as supplemental net quantity statements and shall be located on the principal display panel.

10308.19 A separate statement of net quantity of contents in terms of the metric system of weight or measure is not regarded as a supplemental statement and an accurate statement of the net quantity of contents in terms of the metric system of weight or measure may also appear on the principal display panel or on other panels.

10308.20 The declaration of net quantity of contents shall express an accurate statement of the quantity of contents of the package. Reasonable variations caused by loss or gain of moisture during the course of good distribution practice or by unavoidable deviations in good manufacturing practice will be recognized. Variations from stated quantity of contents shall not be unreasonably large.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10308

22-B DCMR § 10309 MEDICAL DEVICES: WARNING STATEMENTS FOR DEVICES CONTAINING OR MANUFACTURED WITH CHLOROFLUOROCARBONS AND OTHER CLASS I OZONE-DEPLETING SUBSTANCES

10309.1 All over-the-counter devices containing or manufactured with chlorofluorocarbons, halons, carbon tetrachloride, methyl chloride, or any other class I substance designated by the Environmental Protection Agency (EPA) shall carry one (1) of the following warnings:

(a) The EPA warning statement:

Warning: Contains [or Manufactured with, if applicable] [insert name of substance], a substance which harms public health and environment by destroying ozone in the upper atmosphere; or

(b) The alternative statement, which is as follows:

Warning: Contains [or Manufactured with, if applicable] [insert name of substance], a substance which harms public health and environment by destroying ozone in the upper atmosphere.

CONSULT WITH YOUR PHYSICIAN, HEALTH PROFESSIONAL, OR SUPPLIER IF YOU HAVE ANY QUESTION ABOUT THE USE OF THIS PRODUCT.

History

Note: The indented statement above is required by the Federal government's Clean Air Act for all products containing or manufactured with chlorofluorocarbons (CFCs) [or other class I substance, if applicable]. 10309.2 The warning statement shall be clearly legible and conspicuous on the product, its immediate container, its outer packaging, or other labeling in accordance with the requirements and appear with such prominence and conspicuousness as to render it likely to be read and understood by consumers under normal conditions of purchase.
SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10309

22-B DCMR § 10310 PRESCRIPTION DEVICES

10310.1 A device which, because of any potential for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which "adequate directions for use" cannot be prepared, shall be exempt from 21 U.S.C. § 352(f)(1) if all the following conditions are met:

(a) The device is:

(1) In the possession of a person, or his agents or employees, regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device; or

(2) In the possession of a practitioner, such as a physician, dentist, or veterinarian, licensed by law to use or order the use of such device; and

(3) Is to be sold only to or on the prescription or other order of such practitioner for use in the course of his or her professional practice.

(b) The label of the device, other than surgical instruments, bears:

(1) The statement "Caution: Federal law restricts this device to sale by or on the order of a ----------", the blank to be filled with the word "physician," "dentist," or "veterinarian," or with the descriptive designation of any other practitioner licensed by the law of the state in which he practices to use or order the use of the device; and

(2) The method of its application or use;

(c) Labeling on or within the package from which the device is to be dispensed bears information for use, including indications, effects, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which practitioners licensed by law to administer the device can use the device safely and for the purpose for which it is intended, including all purposes for which it is advertised or represented; provided, however, that such information may be omitted from the dispensing package if, but only if, the article is a device for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device. Upon written request, stating reasonable grounds therefore, the Department will offer an opinion on a proposal to omit such information from the dispensing package under this provision;

(d) Any labeling, as defined in 21 U.S.C. § 321(m) of the act, whether or not it is on or within a package from which the device is to be dispensed, distributed by or on behalf of the manufacturer, packer, or distributor of the device, that furnishes or purports to furnish information for use of the device contains adequate information for such use, including indications, effects, routes, methods, and frequency and duration of administration and any relevant hazards, contraindications, side effects, and precautions, under which practitioners licensed by law to employ the device can use the device safely and for the purposes for which it is intended, including all purposes for which it is advertised or represented; and

(e) All labeling, except labels and cartons, bearing information for use of the device also bears the date of the issuance or the date of the latest revision of such labeling.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10310

22-B DCMR § 10311 RETAIL EXEMPTION FOR PRESCRIPTION DEVICES

10311.1 A device subject to § 10310.1 shall be exempt at the time of delivery to the ultimate purchaser or user from 21 U.S.C. § 352(f)(1) if it is delivered by a licensed practitioner in the course of his or her professional practice or upon a prescription or other order lawfully issued in the course of his or her professional practice, with labeling bearing the name and address of such licensed practitioner and the directions for use and cautionary statements, if any, contained in such order.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10311

22-B DCMR § 10312 MEDICAL DEVICES HAVING COMMONLY KNOWN DIRECTIONS

10312.1 A device shall be exempt from 21 U.S.C. § 352(f)(1) insofar as adequate directions for common uses thereof are known to the ordinary individual.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10312

22-B DCMR § 10313 IN VITRO DIAGNOSTIC PRODUCTS

10313.1 A product intended for use in the diagnosis of disease and which is an in vitro diagnostic product shall be deemed to be in compliance with the requirements of this section if it meets the requirements of 21 C.F.R. § 809.10.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10313

22-B DCMR § 10314 DEVICES FOR PROCESSING, REPACKING, OR MANUFACTURING

10314.1 A device intended for processing, repacking, or use in the manufacture of another drug or device shall be exempt if its label bears the statement "Caution: For manufacturing, processing, or repacking."

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10314

22-B DCMR § 10315 MEDICAL DEVICES FOR USE IN TEACHING, LAW ENFORCEMENT, RESEARCH, AND ANALYSIS

10315.1 A device subject to § 10310 of this chapter shall be exempt from 21 U.S.C. § 352(f)(1) if shipped or sold to, or in the possession of, persons regularly and lawfully engaged in instruction in pharmacy, chemistry, or medicine not involving clinical use, or engaged in law enforcement, or in research not involving clinical use, or in chemical analysis, or physical testing, and is to be used only for such instruction, law enforcement, research, analysis, or testing.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10315

22-B DCMR § 10316 MEDICAL DEVICES: EXPIRATION OF EXEMPTIONS

10316.1 If a shipment or delivery, or any part thereof, of a device which is exempt under the regulations in this section is made to a person in whose possession the article is not exempt, or is made for any purpose other than those specified, such exemption shall expire, with respect to such shipment or delivery or part thereof, at the beginning of that shipment or delivery. The causing of an exemption to expire shall be considered an act which results in such device being misbranded unless it is disposed of under circumstances in which it ceases to be a drug or device.

10316.2 The exemptions conferred by §§ 10313 through 10315 of this chapter shall continue until the devices are used for the purposes for which they are exempted, or until they are relabeled to comply with 21 U.S.C. § 352(f)(1). If, however, the device is converted, or manufactured into a form limited to prescription dispensing, no exemption shall thereafter apply to the article unless the device is labeled as required by § 10310 of this chapter.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10316

22-B DCMR § 10317 OTHER EXEMPTIONS - MEDICAL DEVICES: PROCESSING, LABELING, OR REPACKING

10317.1 Except as provided by §§ 10317.2 and 10317.3, a shipment or other delivery of a device which is, in accordance with the practice of the trade, to be processed, labeled, or repacked, in substantial quantity at an establishment other than that where originally processed or packed, shall be exempt, during the time of introduction into and movement in interstate commerce and the time of holding in such establishment, from compliance with the labeling and packaging requirements of 21 U.S.C. §§ 352(b) and (f) if:

(a) The person who introduced such shipment or delivery into interstate commerce is the operator of the establishment where such device is to be processed, labeled, or repacked; or

(b) In case such person is not such operator, such shipment or delivery is made to such establishment under a written agreement, signed by and containing the post office addresses of such person and such operator, and containing such specifications for the processing, labeling, or repacking, as the case may be, of such device in such establishment as will ensure, if such specifications are followed, that such device will not be adulterated or misbranded within the meaning of the Act upon completion of such processing, labeling, or repacking. Such person and such operator shall each keep a copy of such agreement until two (2) years after the final shipment or delivery of such device from such establishment, and shall make such copies available for inspection at any reasonable hour to any officer or employee of the Department who requests them.

10317.2 An exemption of a shipment or other delivery of a device under § 10317.1(a) shall not apply if, at the beginning of the act of removing such shipment or delivery, or any part thereof, from such establishment, the device comprising such shipment, delivery, or part is adulterated or misbranded within the meaning of the Act when so removed.

10317.3 An exemption of a shipment or other delivery of a device under § 10317.1(b) shall not apply with respect to the person who introduced such shipment or delivery into interstate commerce upon refusal by such person to make available for inspection a copy of the agreement, as required by § 10317.1(b).

10317.4 An exemption of a shipment or other delivery of a device under § 10317.1(b) shall expire:

(a) At the beginning of the act of removing such shipment or delivery, or any part thereof, from such establishment if the device comprising such shipment, delivery, or part is adulterated or misbranded within the meaning of the Act when so removed; or

(b) Upon refusal by the operator of the establishment where such device is to be processed, labeled, or repacked, to make available for inspection a copy of the agreement, as required by § 10317.1(b).

10317.5 Because of common industry practice to manufacture or assemble, package, and fully label a device as sterile at one (1) establishment and then ship such device in interstate commerce to another establishment or to a contract sterilizer for sterilization, the Department of Health will initiate no regulatory action against the device as misbranded or adulterated when the non-sterile device is labeled sterile, provided all the following conditions are met:

(a) There is in effect a written agreement which:

(1) Contains the names and post office addresses of the firms involved and is signed by the person authorizing such shipment and the operator or person in charge of the establishment receiving the devices for sterilization;

(2) Provides instructions for maintaining proper records or otherwise accounting for the number of units in each shipment to ensure that the number of units shipped is the same as the number received and sterilized;

(3) Acknowledges that the device is non-sterile and is being shipped for further processing; and

(4) States in detail the sterilization process, the gaseous mixture or other media, the equipment, and the testing method or quality controls to be used by the contract sterilizer to assure that the device will be brought into full compliance; and

(b) Each pallet, carton, or other designated unit is conspicuously marked to show its non-sterile nature when it is introduced into and is moving in interstate commerce, and while it is being held prior to sterilization. Following sterilization, and until such time as it is established that the device is sterile and can be released from quarantine, each pallet, carton, or other designated unit is conspicuously marked to show that it has not been released from quarantine (for example, "sterilized--awaiting test results" or an equivalent designation).

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10317

22-B DCMR § 10318 SPECIAL REQUIREMENTS FOR SPECIFIC DEVICES - LABELING OF ARTICLES INTENDED FOR LAY USE IN THE REPAIRING OR REFITTING OF DENTURES

10318.1 The American Dental Association and leading dental authorities have advised the FDA of their concern regarding the safety of denture reliners, repair kits, pads, cushions, and other articles marketed and labeled for lay use in repairing, refitting, or cushioning of ill-fitting, broken, or irritating dentures. It is the opinion of dental authorities and the FDA that to properly repair and properly refit dentures a person must have professional knowledge and specialized technical skill. Laymen cannot be expected to maintain the original vertical dimension of occlusion and the centric relation essential in the proper repairing or refitting of dentures. The continued wearing of improperly repaired or refitted dentures may cause acceleration of bone resorption, soft tissue hyperplasia, and other irreparable damage to the oral cavity. Such articles designed for lay use should be limited to emergency or temporary situations pending the services of a licensed dentist.

10318.2 The FDA and the Department therefore regard such articles as unsafe and misbranded under the Federal Food, Drug, and Cosmetic Act unless the labeling:

(a) Limits directions for use for denture repair kits to emergency repairing pending unavoidable delay in obtaining professional reconstruction of the denture;

(b) Limits directions for use for denture reliners, pads, and cushions to temporary refitting pending unavoidable delay in obtaining professional reconstruction of the denture;

(c) Contains in a conspicuous manner the word "emergency" preceding and modifying each indication-for-use statement for denture repair kits and the word "temporary" preceding and modifying each indication-for-use statement for reliners, pads, and cushions; and

(d) Includes a conspicuous warning statement to the effect:

(1) For denture repair kits: "Warning--For emergency repairs only. Long term use of home-repaired dentures may cause faster bone loss, continuing irritation, sores, and tumors. This kit is for emergency use only. See Dentist Without Delay;"

(2) For denture reliners, pads, and cushions: "Warning--For temporary use only. Long-term use of this product may lead to faster bone loss, continuing irritation, sores, and tumors. For Use Only Until a Dentist Can Be Seen."

10318.3 Adequate directions for use require full information of the temporary and emergency use recommended in order for the layman to understand the limitations of usefulness, the reasons therefore, and the importance of adhering to the warnings. Accordingly, the labeling should contain the following information:

(a) For denture repair kits:

(1) Special training and tools are needed to repair dentures to fit properly. Home-repaired dentures may cause irritation to the gums and discomfort and tiredness while eating. Long term use may lead to more troubles, even permanent changes in bones, teeth, and gums, which may make it impossible to wear dentures in the future. For these reasons, dentures repaired with this kit should be used only in an emergency until a dentist can be seen. Dentures that don't fit properly cause irritation and injury to the gums and faster bone loss, which is permanent. Dentures that don't fit properly cause gum changes that may require surgery for correction. Continuing irritation and injury may lead to cancer in the mouth. You must see your dentist as soon as possible;

(b) For denture reliners, pads, and cushions:

(1) Use of these preparations or devices may temporarily decrease the discomfort; however, their use will not make the denture fit properly. Special training and tools are needed to repair a denture to fit properly. Dentures that do not fit properly cause irritation and injury to the gums and faster bone loss, which is permanent and may require a completely new denture. Changes in the gums caused by dentures that do not fit properly may require surgery for correction. Continuing irritation and injury may lead to cancer in the mouth. You must see your dentist as soon as possible;

(2) If the denture relining or repairing material forms a permanent bond with the denture, a warning statement to the following effect should be included: "This reliner becomes fixed to the denture and a completely new denture may be required because of its use."

10318.4 Labeling claims exaggerating the usefulness or the safety of the material or failing to disclose all facts relevant to the claims of usefulness will be regarded as false and misleading under 21 U.S.C. §§ 321(n) and 352(a).

10318.5 Regulatory action may be initiated with respect to any article found within the jurisdiction of the Act contrary to the provisions of this policy statement after ninety (90) days following the date of publication of these rules in the D.C. Register.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10318

22-B DCMR § 10319 USE OF IMPACT-RESISTANT LENSES IN EYEGLASSES AND SUNGLASSES

10319.1 Examination of data available on the frequency of eye injuries resulting from the shattering of ordinary crown glass lenses indicates that the use of such lenses constitutes an avoidable hazard to the eye of the wearer.

10319.2 The consensus of the ophthalmic community is that the number of eye injuries would be substantially reduced by the use in eyeglasses and sunglasses of impact-resistant lenses.

10319.3 To protect the public more adequately from potential eye injury, eyeglasses and sunglasses must be fitted with impact-resistant lenses, except in those cases where the physician or optometrist finds that such lenses will not fulfill the visual requirements of the particular patient, directs in writing the use of other lenses, and gives written notification thereof to the patient.

10319.4 The physician or optometrist shall have the option of ordering glass lenses, plastic lenses, or laminated glass lenses made impact resistant by any method; however, all such lenses shall be capable of withstanding the impact test described in § 10319.7.

10319.5 Each finished impact-resistant glass lens for prescription use shall be individually tested for impact resistance and shall be capable of withstanding the impact test described in § 10319.7. Raised multifocal lenses shall be impact resistant but need not be tested beyond initial design testing. Prism segment multifocal, slab-off prism, lenticular cataract, iseikonic, depressed segment one (1) piece multifocal, bioconcave, myodisc and minus lenticular, custom laminate, and cemented assembly lenses shall be impact resistant but need not be subjected to impact testing. To demonstrate that all other types of impact-resistant laminated glass lenses (such as lenses other than those described in the three (3) sentences of this paragraph), are capable of withstanding the impact test described in this regulation, the manufacturer of these lenses shall subject to an impact test a statistically significant sampling of lenses from each production batch, and the lenses so tested shall be representative of the finished forms as worn by the wearer, including finished forms that are of minimal lens thickness and have been subjected to any treatment used to impart impact resistance. All nonprescription lenses and plastic prescription lenses tested on the basis of statistical significance shall be tested in uncut-finished or finished form.

10319.6 For the purpose of this regulation, the impact test described in § 10319.7 shall be the "referee test," defined as "one which will be utilized to determine compliance with a regulation." The referee test provides the Department of Health with the means of examining a medical device for performance and does not inhibit the manufacturer from using equal or superior test methods. A lens manufacturer shall conduct tests of lenses using the impact test or any equal or superior test. Whatever test is used, the lenses shall be capable of withstanding the impact test if the Department of Health examines them for performance.

10319.7 In the impact test, a five-eighths inch (5/8 in.) steel ball weighing approximately 0.56 ounce is dropped from a height of fifty inches (50 in.) upon the horizontal upper surface of the lens. The ball shall strike within a five-eighths inch (5/8 in.) diameter circle located at the geometric center of the lens. The ball may be guided but not restricted in its fall by being dropped through a tube extending to within approximately four inches (4 in.) of the lens. To pass the test, the lens must not fracture; for the purpose of this section, a lens will be considered to have fractured if it cracks through its entire thickness, including a laminar layer, if any, and across a complete diameter into two (2) or more separate pieces, or if any lens material visible to the naked eyes becomes detached from the ocular surface. The test shall be conducted with the lens supported by a tube one inch (1 in.) inside diameter, one and one quarter inch (1-1/4 in.) outside diameter, and approximately one inch (1 in.) high affixed to a rigid iron or steel base plate. The total weight of the base plate and its rigidly attached fixtures shall be not less than twenty-seven pounds (27 lbs.). For lenses of small minimum diameter, a support tube having an outside diameter of less than one and one-fourth inches (1-1/4 in.) may be used. The support tube shall be made of rigid acrylic plastic, steel, or other suitable substance and shall have securely bonded on the top edge a one-eighth inch by one-eighth inch (1/8 in. x 1/8 in.) neoprene gasket having a hardness of 40 [+/-] 5, as determined by ASTM Method D 1415-88, Standard Test Method for Rubber Property -- International Hardness; a minimum tensile strength of one thousand two hundred pounds (1,200 lbs.), as determined by ASTM Method D 412-98A, "Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension;" and a minimum ultimate elongation of four hundred percent (400 %), as determined by ASTM Method D 412-68. (Both methods are incorporated by reference and are from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428, or available for inspection at the Center for Devices and Radiological Health's Library, 9200 Corporate Blvd., Rockville, MD 20850, or at the Office of the Federal Register, 800 North Capitol St. NW., Suite 700, Washington, DC.) The diameter or contour of the lens support may be modified as necessary so that the one-eighth inch by one-eighth inch (1/8 in. x 1/8 in.) neoprene gasket supports the lens at its periphery.

10319.8 Copies of invoice(s), shipping document(s), and records of sale or distribution of all impact-resistant lenses, including finished eyeglasses and sunglasses, shall be kept and maintained for a period of three (3) years; however, the names and addresses of individuals purchasing nonprescription eyeglasses and sunglasses at the retail level need not be kept and maintained by the retailer. The records kept in compliance with this section shall be made available upon request at all reasonable hours to any officer or employee of the Department of Health and such officer or employee shall be permitted to inspect and copy such records, to make such inventories of stock as he or she deems necessary, and otherwise to check the correctness of such inventories.

10319.9 In addition, those persons conducting tests in accordance with §§ 10319.6 and 10319.7 shall maintain the results thereof and a description of the test method and of the test apparatus for a period of three (3) years. These records shall be made available upon request at any reasonable hour by any officer or employee acting on behalf of the Department. The persons conducting tests shall permit the officer or employee to inspect and copy the records, to make such inventories of stock as the officer or employee deems necessary, and otherwise to check the correctness of the inventories.

10319.10 For the purpose of this section, the term "manufacturer" includes an importer for resale. Such importer may have the tests conducted in the country of origin but must make the results thereof available, upon request, to the Department, as soon as practicable.

10319.11 All lenses shall be impact-resistant except when the physician or optometrist finds that impact-resistant lenses will not fulfill the visual requirements for a particular patient.

10319.12 This statement of policy shall not apply to contact lenses.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10319

22-B DCMR § 10320 MAXIMUM ACCEPTABLE LEVEL OF OZONE

10320.1 Ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy. In order for ozone to be effective as a germicide, it must be present in a concentration far greater than that which can be safely tolerated by man and animals.

10320.2 Although undesirable physiological effects on the central nervous system, heart, and vision have been reported, the predominant physiological effect of ozone is primary irritation of the mucous membranes. Inhalation of ozone can cause sufficient irritation to the lungs, resulting in pulmonary edema. The onset of pulmonary edema is usually delayed for some hours after exposure. Thus, symptomatic response is not a reliable warning of exposure to toxic concentrations of ozone. Since olfactory fatigue develops readily, the odor of ozone is not a reliable index of atmospheric ozone concentration.

10320.3 A number of devices currently on the market generate ozone by design or as a byproduct. Since exposure to ozone above a certain concentration can be injurious to health, any such device will be considered adulterated or misbranded if it is used or intended for use under the following conditions:

(a) In such a manner that it generates ozone at a level in excess of five hundredths (0.05) parts per million by volume of air circulating through the device or causes an accumulation of ozone in excess of five hundredths (0.05) parts per million by volume of air (when measured under standard conditions at twenty-five degrees Celsius (25 ºC), seventy-seven degrees Fahrenheit (77 ºF), and seven hundred sixty millimeters (760 mm.) of mercury in the atmosphere of enclosed space intended to be occupied by people for extended periods of time, e.g., houses, apartments, hospitals, and offices. This applies to any such device, whether portable or permanent or part of any system, which generates ozone by design or as an inadvertent or incidental product;

(b) To generate ozone and release it into the atmosphere in hospitals or other establishments occupied by the ill or infirm;

(c) To generate ozone and release it into the atmosphere and does not indicate in its labeling the maximum acceptable concentration of ozone which may be generated (not to exceed five-hundredths (0.05) parts per million by volume of air circulating through the device) as established herein and the smallest area in which such device can be used so as not to produce an ozone accumulation in excess of five-hundredths (0.05) parts per million;

(d) In any medical condition for which there is no proof of safety and effectiveness; or

(e) To generate ozone at a level less than five-hundredths (0.05) parts per million by volume of air circulating through the device and it is labeled for use as a germicide or deodorizer.

10320.4 This section does not affect the present threshold limit value of one tenth (0.10) part per million (two tenths of a milligram per cubic meter (0.2 mg./m.3)) of ozone exposure for an eight (8)-hour-day exposure of industrial workers as the American Conference of Governmental Industrial Hygienists recommend.

10320.5 The method and apparatus specified in 40 C.F.R., part 50, or any other equally sensitive and accurate method, may be employed in measuring ozone pursuant to this section.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10320

22-B DCMR § 10321 CHLOROFLUOROCARBON PROPELLANTS

10321.1 The use of chlorofluorocarbon in devices as propellants in self-pressurized containers is generally prohibited except as provided in 21 C.F.R. § 2.125.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10321

22-B DCMR § 10322 HEARING AID DEVICES: PROFESSIONAL AND PATIENT LABELING

10322.1 Hearing aids shall be clearly and permanently marked with:

(a) The name of the manufacturer or distributor, the model name or number, the serial number, and the year of manufacture; and

(b) A "+" symbol to indicate the positive connection for battery insertion, unless it is physically impossible to insert the battery in the reversed position.

10322.2 All labeling information required by this section shall be included in a User Instructional Brochure that the manufacturer or distributor develops, shall accompany the hearing aid, and shall be provided to the prospective user by the dispenser of the hearing aid in accordance with 21 C.F.R. § 801.421(c). The User Instructional Brochure accompanying each hearing aid shall contain the following information and instructions for use, to the extent applicable to the particular requirements and characteristics of the hearing aid:

(a) An illustration(s) of the hearing aid, indicating operating controls, user adjustments, and battery compartment;

(b) Information on the function of all controls intended for user adjustment;

(c) A description of any accessory that may accompany the hearing aid (for example, accessories for use with a television or telephone);

(d) Specific instructions for:

(1) Use of the hearing aid;

(2) Maintenance and care of the hearing aid, including the procedure to follow in washing the earmold, when replacing tubing on those hearing aids that use tubing, and in storing the hearing aid when it will not be used for an extended period of time; and

(3) Replacing or recharging the batteries, including a generic designation of replacement batteries;

(e) Information on how and where to obtain repair service, including at least one specific address where the user can go, or send the hearing aid to, to obtain such repair service;

(f) A description of commonly occurring avoidable conditions that could adversely affect or damage the hearing aid, such as dropping, immersing in liquid, or exposing the hearing aid to excessive heat;

(g) Identification of any known side effects associated with the use of hearing aid that may warrant consultation with a physician, e.g., skin irritation and accelerated accumulation of cerumen (ear wax);

(h) A statement that a hearing aid will not restore normal hearing and will not prevent or improve a hearing impairment resulting from organic conditions;

(i) A statement that in most cases infrequent use of a hearing aid does not permit a user to attain full benefit from it;

(j) A statement that the use of a hearing aid is only part of hearing habilitation and may need to be supplemented by auditory training and instruction in lip-reading;

(k) The warning statement required by § 10322.3;

(l) The notice for prospective hearing aid users required by § 10322.4; and

(m) The technical data required by § 10322.5, unless such data is provided in separate labeling accompanying the device.

10322.3 The User Instructional Brochure shall contain the following warning statement:

WARNING TO HEARING AID DISPENSERS

A hearing aid dispenser should advise a prospective hearing aid user to consult promptly with a licensed physician (preferably an ear specialist) before dispensing a hearing aid if the hearing aid dispenser determines through inquiry, actual observation, or review of any other available information concerning the following conditions:

(a) Visible congenital or traumatic deformity of the ear;

(b) History of active drainage from the ear within the previous ninety (90) days;

(d) Acute or chronic dizziness;

(e) Unilateral hearing loss of sudden or recent onset within the previous ninety (90) days;

(f) Audiometric air-bone gap equal to or greater than fifteen decibels (15 dB) at five hundred hertz (500 Hz), one thousand hertz (1,000 Hz), and two thousand hertz (2,000 Hz);

(g) Visible evidence of significant cerumen accumulation or a foreign body in the ear canal; or

(h) Pain or discomfort in the ear.

Special care should be exercised in selecting and fitting a hearing aid whose maximum sound pressure level exceeds one hundred thirty-two decibels (132 dB) because there may be risk of impairing the remaining hearing of the hearing aid user. (This provision is required only for those hearing aids with a maximum sound pressure capability greater than one hundred thirty-two decibels (132 dB).”

10322.4 The User Instructional Brochure shall contain the following notice:

IMPORTANT NOTICE FOR PROSPECTIVE HEARING AID USERS

Good health practice requires that a person with a hearing loss have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before purchasing a hearing aid. Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists, otologists, or otorhinolaryngologists. The purpose of medical evaluation is to assure that all medically treatable conditions that may affect hearing are identified and treated before the hearing aid is purchased.

CHILDREN WITH HEARING LOSS

In addition to seeing a physician for a medical evaluation, a child with hearing loss should be directed to an audiologist for evaluation and rehabilitation since hearing loss may cause problems in language development and the educational and social growth of a child. An audiologist is qualified by training and experience to assist in the evaluation and rehabilitation of a child with a hearing loss.

10322.5 Technical data useful in selecting, fitting, and checking the performance of a hearing aid shall be provided in the User Instructional Brochure or in separate labeling that accompanies the device. The determination of technical data values for the hearing aid labeling shall be conducted in accordance with the test procedures of the American National Standard "Specification of Hearing Aid Characteristics," ANSI S3.22-2003 (Revision of ANSI S3.22-19106) (includes April 2007 Erratum). At a minimum, the User Instructional Brochure or such other labeling shall include the appropriate values or information for the following technical data elements as these elements are defined or used in such standard:

(a) Saturation output curve (SSPL 90 curve);

(b) Frequency response curve;

(d) Average full-on gain (HF-Average full-on gain);

(e) Reference test gain;

(f) Frequency range;

(g) Total harmonic distortion;

(h) Equivalent input noise;

(i) Battery current drain;

(j) Induction coil sensitivity (telephone coil aids only);

(k) Input-output curve (automatic gain control aids only); or

(l) Attack and release times (ACG aids only).

10322.6 If a hearing aid has been used or rebuilt, this fact shall be declared on the container in which the hearing aid is packaged and on a tag that is physically attached to the hearing aid. Such fact may also be stated in the User Instructional Brochure.

10322.7 A User Instructional Brochure may contain statements or illustrations in addition to those required by § 10322.2 if the additional statements:

(a) Are not false or misleading in any particular (for example, diminishing the impact of the required statements); and

(b) Are not prohibited by this chapter or by regulations.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10322

22-B DCMR § 10323 HEARING AID DEVICES: CONDITIONS FOR SALE

10323.1 Except as provided in § 10323.2, a hearing aid dispenser shall not sell a hearing aid unless the prospective user has presented to the hearing aid dispenser a written statement signed by a licensed physician that states that the patient's hearing loss has been medically evaluated and the patient may be considered a candidate for a hearing aid. The medical evaluation must have taken place within the preceding six (6) months.

10323.2 If the prospective hearing aid user is eighteen (18) years of age or older, the hearing aid dispenser may afford the prospective user an opportunity to waive the medical evaluation requirement of § 10323.1 of this section provided that the hearing aid dispenser:

(a) Informs the prospective user that the exercise of the waiver is not in the user's best health interest;

(b) Does not in any way actively encourage the prospective user to waive such a medical evaluation; and

“I have been advised by (Hearing aid dispenser's name) that the Department of Health has determined that my best health interest would be served if I had a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before purchasing a hearing aid. I do not wish to have a medical evaluation before purchasing a hearing aid.”

10323.3 Before signing any statement under § 10323.2(c) of this section and before the sale of a hearing aid to a prospective user, the hearing aid dispenser shall:

(a) Provide the prospective user a copy of the User Instructional Brochure for a hearing aid that has been, or may be, selected for the prospective user;

(b) Review the content of the User Instructional Brochure with the prospective user orally, or in the predominate method of communication used during the sale; and

10323.4 Upon request by an individual who is considering the purchase of a hearing aid, a dispenser shall, with respect to any hearing aid that he dispenses, provide a copy of the User Instructional Brochure for the hearing aid or the name and address of the manufacturer or distributor from whom a User Instructional Brochure for the hearing aid may be obtained.

10323.5 In addition to ensuring that a User Instructional Brochure accompanies each hearing aid, a manufacturer or distributor shall, with respect to any hearing aid that he manufactures or distributes:

(a) Provide sufficient copies of the User Instructional Brochure to sellers for distribution to users and prospective users; and

(b) Provide a copy of the User Instructional Brochure to any hearing aid professional, user, or prospective user who requests a copy in writing.

10323.6 The dispenser shall retain for three (3) years after the dispensing of a hearing aid a copy of any written statement required under § 10323.1 of this section from a physician or any written statement waiving a medical evaluation required under § 10323.2(c).

10323.7 Group auditory trainers, defined as a group amplification system, that a qualified school or institution purchases for the purpose of communicating with and educating individuals with hearing impairments, are exempt from the requirements in this section.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10323

22-B DCMR § 10324 USER LABELING FOR MENSTRUAL TAMPON

10324.1 This section applies to scented or scented deodorized menstrual tampons as identified in 21 C.F.R. § 884.5460 and unscented menstrual tampons as identified in 21 C.F.R. § 884.5470.

10324.2 Data show that Toxic Shock Syndrome (TSS), a rare but serious and sometimes fatal disease, is associated with the use of menstrual tampons. To protect the public and to minimize the serious adverse effects of TSS, menstrual tampons shall be labeled as set forth in §§ 10324.3 through 10324.5 of this section and tested for absorbency as set forth in § 10324.6.

10324.3 If the information specified in § 10324.4 is to be included as a package insert, the following alert statement shall appear prominently and legibly on the package label:

“ATTENTION: Tampons are associated with Toxic Shock Syndrome (TSS). TSS is a rare but serious disease that may cause death. Read and save the enclosed information.”

10324.4 The labeling of menstrual tampons shall contain the following consumer information prominently and legibly, in such terms as to render the information likely to be read and understood by the ordinary individual under customary conditions of purchase and use:

(a) Warning signs of TSS (for example, sudden fever (usually one hundred two degrees Fahrenheit (102 ºF)) or more) and vomiting, diarrhea, fainting or near fainting when standing up, dizziness, or a rash that looks like a sunburn);

(b) What to do if these or other signs of TSS appear, including the need to remove the tampon at once and seek medical attention immediately;

(c) The risk of TSS to all women using tampons during their menstrual period, especially the reported higher risks to women under thirty (30) years of age and teenage girls, the estimated incidence of TSS of one (1) to seventeen (17) per one hundred thousand (100,000) menstruating women and girls per year, and the risk of death from contracting TSS;

(d) The advisability of using tampons with the minimum absorbency needed to control menstrual flow in order to reduce the risk of contracting TSS; and

(e) The need to seek medical attention before resuming use of tampons if TSS warning signs have occurred in the past, or if women have any questions about TSS or tampon use.

10324.5 The statements required by § 10324.4 shall be prominently and legibly placed on the package label of menstrual tampons (unless the menstrual tampons are exempt).

10324.6 Menstrual tampon package labels shall bear one (1) of the following absorbency terms representing the absorbency of the production run, lot, or batch;

Ranges of absorbency in grams

Corresponding term of absorbency

6 and under

Junior absorbency

6 to 9

Regular absorbency

9 to 12

Super absorbency

12 to 15

Super plus absorbency

15 to 18

Ultra absorbency

Above 18

No term

10324.7 The package label shall include an explanation of the ranges of absorbency and a description of how consumers can use a range of absorbency, and its corresponding absorbency term, to make comparisons of absorbency of tampons to allow selection of the tampons with the minimum absorbency needed to control menstrual flow in order to reduce the risk of contracting TSS.

103324.8 A manufacturer shall measure the absorbency of individual tampons using the test method specified in § 10324.10 and calculate the mean absorbency of a production run, lot, or batch by rounding to the nearest one tenth of a gram (0.1 g).

10324.9 A manufacturer shall design and implement a sampling plan that includes collection of probability samples of adequate size to yield consistent tolerance intervals such that the probability is ninety percent (90%) that at least ninety percent (90%) of the absorbencies of individual tampons within a brand and type are within the range of absorbency stated on the package label.

10324.10 In the absorbency test, an unlubricated condom, with tensile strength between seventeen Mega Pascals (17 MPa) and thirty Mega Pascals (30 MPa), as measured according to the procedure in the American Society for Testing and Materials (ASTM) D 3492-97, "Standard Specification for Rubber Contraceptives (Male Condoms)" for determining tensile strength is attached to the large end of a glass chamber (or a chamber made from hard transparent plastic) with a rubber band (see Figure 1) and pushed through the small end of the chamber using a smooth, finished rod. The condom is pulled through until all slack is removed. The tip of the condom is cut off and the remaining end of the condom is stretched over the end of the tube and secured with a rubber band. A pre-weighed (to the nearest one-tenth gram (0.1 g) tampon is placed within the condom membrane so that the center of gravity of the tampon is at the center of the chamber. An infusion needle fourteen gauge (14 ga.) is inserted through the septum created by the condom tip until it contacts the end of the tampon. The outer chamber is filled with water pumped from a temperature-controlled water bath to maintain the average temperature at twenty-seven, plus or minus one, degrees Celsius (27 +/- 1 ºC). The water returns to the water bath as shown in Figure 2. Syngyna fluid ten grams (10 g) sodium chloride, five tenths gram (0.5 g) Certified Reagent Acid Fuchsin, one thousand milliliters (1,000 ml) distilled water is then pumped through the infusion needle at a rate of fifty milliliters (50 ml) per hour. The test shall be terminated when the tampon is saturated and the first drop of fluid exits the apparatus. (The test result shall be discarded if fluid is detected in the folds of the condom before the tampon is saturated). The water is then drained and the tampon is removed and immediately weighed to the nearest one hundredths gram, (0.01 g). The absorbency of the tampon is determined by subtracting its dry weight from this value. The condom shall be replaced after ten (10) tests or at the end of the day during which the condom is used in testing, whichever occurs first.

FIG 1

FIG 2

10324.11 The FDA and the Department may permit the use of an absorbency test method different from the test method specified in this section if each of the following conditions is met:

(a) The manufacturer presents evidence, in the form of a citizen petition submitted in accordance with the requirements of 21 C.F.R. § 10.30, demonstrating that the alternative test method will yield results that are equivalent to the results yielded by the test method specified in this section; and

(b) The FDA or the Department approves the method and has published notice of its approval of the alternative test method in the Federal Register.

10324.12 Any menstrual tampon intended to be dispensed by a vending machine is exempt from the requirements of this section.

10324.13 Any menstrual tampon that is not labeled as required by §§ 10324.3 through 10324.5 and that is initially introduced or initially delivered for introduction into commerce after March 1, 1990, is misbranded under 21 U.S.C. §§ 321(m) and, 352(a) and (f).

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). These ranges are defined, respectively, as follows: Less than or equal to six grams (6 g); greater than six grams (6 g) up to and including nine grams (9 g); greater than nine grams (9 g) up to and including twelve grams (12 g); greater than twelve grams (12 g) up to and including fifteen grams (15 g); greater than fifteen grams (15 g) up to and including eighteen grams (18 g); and greater than eighteen grams (18 g). Copies of the standard are available from the American Society for Testing and Materials, 100 Barr Harbor Dr., West Conshohocken, PA 19428, or available for inspection at the Center for Devices and Radiological Health's Library, 9200 Corporate Blvd., Rockville, MD 20850, or at the Office of the Federal Register, 800 North Capitol St., NW, Suite 700, Washington, DC 20002. District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10324

22-B DCMR § 10325 WARNING STATEMENTS FOR PRESCRIPTION AND RESTRICTED DEVICE PRODUCTS CONTAINING OR MANUFACTURED WITH CHLOROFLUOROCARBONS OR OTHER OZONE-DEPLETING SUBSTANCES

10325.1 All prescription and restricted device products containing or manufactured with chlorofluorocarbons, halons, carbon tetrachloride, methyl chloride, or any other class I substance designated by the Environmental Protection Agency (EPA) shall, except as provided in § 10325.3, bear the following warning statement:

“Warning: Contains [or Manufactured with, if applicable] [insert name of substance], a substance which harms public health and the environment by destroying ozone in the upper atmosphere.”

10325.2 The warning statement shall be clearly legible and conspicuous on the product, its immediate container, its outer packaging, or other labeling in accordance with the requirements of 40 C.F.R. part 82 and appear with such prominence and conspicuousness as to render it likely to be read and understood by consumers under normal conditions of purchase.

10325.3 For prescription and restricted device products, the following alternative warning statement may be used:

“Note: The indented statement below is required by the District of Columbia for all products containing or manufactured with chlorofluorocarbons (CFCs) [or name of other class I substance, if applicable]:

This product contains [or is manufactured with, if applicable] [insert name of substance], a substance which harms the environment by destroying ozone in the upper atmosphere.

Your physician has determined that this product is likely to help your personal health. USE THIS PRODUCT AS DIRECTED, UNLESS INSTRUCTED TO DO OTHERWISE BY YOUR PHYSICIAN. If you have any questions about alternatives, consult your physician.”

10325.4 The warning statement shall be clearly legible and conspicuous on the product, its immediate container, its outer packaging, or other labeling and appear with such prominence and conspicuousness so that it is likely to be read and understood by consumers under normal conditions of purchase.

10325.5 If the warning statement in Paragraph § 10325.3 is used, the following warning statement must be placed on the package labeling intended to be read by the physician (physician package insert) after the "How supplied" section, which describes special handling and storage conditions on the physician labeling:

Warning: Contains [or Manufactured with, if applicable] [insert name of substance], a substance which harms public health and environment by destroying ozone in the upper atmosphere.

A notice similar to the above WARNING has been placed in the information for the patient [or patient information leaflet, if applicable] of this product under Environmental Protection Agency (EPA) regulations. The patient's warning states that the patient should consult his or her physician if there are questions about alternatives.”

10325.6 This section does not replace or relieve a person from any requirements imposed under 40 C.F.R., part 82.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10325

22-B DCMR § 10326 USER LABELING FOR LATEX CONDOMS

10326.1 This section applies to the subset of condoms as identified in 21 C.F.R. § 884.5300, and condoms with spermicidal lubricant identified in 21 C.F.R. § 884.5310, whose products are formed from latex films.

10326.2 Data show that the material integrity of latex condoms degrades over time. To protect the public health and minimize the risk of device failure, latex condoms must bear an expiration date.

10326.3 The expiration date, as demonstrated by testing procedures required by §§ 10326.4 and 10326.8, must be displayed prominently and legibly on the primary packaging (such as individual package), and higher levels of packaging (such as boxes of condoms), in order to ensure visibility of the expiration date by consumers.

10326.4 Except as provided under § 10326.6, the expiration date must be supported by data demonstrating physical and mechanical integrity of the product after three (3) discrete and representative lots of the product have been subjected to each of the following conditions:

(a) Storage of unpackaged bulk product for the maximum amount of time the manufacturer allows the product to remain unpackaged, followed by storage of the packaged product at seventy degrees Celsius (70 °C) (plus or minus two degrees Celsius (2 ºC) for seven (7) days;

(b) Storage of unpackaged bulk product for the maximum amount of time the manufacturer allows the product to remain unpackaged, followed by storage of the packaged product at a selected temperature between forty degrees Celsius (40 ºC) and fifty degrees (50 ºC) (plus or minus two degrees Celsius (+/- 2 ºC) for ninety (90) days; and

(c) Storage of unpackaged bulk product for the maximum amount of time the manufacturer allows the product to remain unpackaged, followed by storage of the packaged product at a monitored or controlled temperature between fifteen degrees Celsius (15º C) and thirty degrees Celsius (30º C) for the lifetime of the product (real time storage).

10326.5 If a product fails the physical and mechanical integrity tests commonly used by industry after the completion of the accelerated storage tests described in §§ 10326.4(a) and(b), the product expiration date must be demonstrated by real time storage conditions described in § 10326.4(c). If all of the products tested after storage at temperatures pass the manufacturer's physical and mechanical integrity tests, the manufacturer may label the product with an expiration date of up to five (5) years from the date of product packaging. If the extrapolated expiration date under §§ 10326.4(a) and(b) of this section is used, the labeled expiration date must be confirmed by physical and mechanical integrity tests performed at the end of the stated expiration period as described in section § 10326.4(c). If the data from tests following real time storage described in § 10326.4(c) of this section fail to confirm the extrapolated expiration date, the manufacturer must, at that time, re-label the product to reflect the actual shelf life.

10326.6 Products that already have established shelf life data based upon real time storage and testing and have such storage and testing data available for inspection are not required to confirm such data using accelerated and intermediate aging data described in §§10326.4(a) and (b). If, however, such real time expiration dates were based upon testing of products that were not first left unpackaged for the maximum amount of time as described in § 10326.4(c), the real time testing must be confirmed by testing products consistent with the requirements of § 10326.4(c). Until the confirmation testing in accordance with § 10326.4(c) is completed, the product may remain on the market labeled with the expiration date based upon previous real time testing.

10326.7 If a manufacturer uses testing data from one (1) product to support expiration on any variation of that product, the manufacturer must document and provide, upon request, an appropriate justification for the application of the testing data to the variation of the tested product.

10326.8 If a latex condom contains a spermicide, and the expiration date based on spermicidal stability testing is different from the expiration date based upon latex integrity testing, the product shall bear only the earlier expiration date.

10326.9 The time period upon which the expiration date is based shall start with the date of packaging.

10326.10 As provided in Chapter 107 of this subtitle, all testing data must be retained in each company's files, and shall be made available upon request for inspection by the FDA of the Department.

10326.11 Any latex condom not labeled with an expiration date as required by § 10326.3 and initially delivered for introduction into interstate commerce after the effective date of this regulation is misbranded under 21 U.S.C. §§ 321(n) and 352(a) and (f).

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10326

22-B DCMR § 10327 USER LABELING FOR DEVICES THAT CONTAIN NATURAL RUBBER

10327.1 Data in the Medical Device Reporting System and the scientific literature indicate that some individuals are at risk of severe anaphylactic reactions to natural latex proteins. This labeling regulation is intended to minimize the risk to individuals sensitive to natural latex proteins and to protect the public health.

10327.2 This section applies to all devices composed of or containing, or having packaging or components that are composed of or contain, natural rubber that contacts humans.

10327.3 For purposes of this section, the term "natural rubber" includes natural rubber latex, dry natural rubber, and synthetic latex or synthetic rubber that contains natural rubber in its formulation.

10327.4 For purposes of this section, the term "natural rubber latex" means rubber that is produced by the natural rubber latex process that involves the use of natural latex in a concentrated colloidal suspension. Products are formed from natural rubber latex by dipping, extruding, or coating.

10327.5 For purposes of this section, the term "dry natural rubber" means rubber that is produced by the dry natural rubber process that involves the use of coagulated natural latex in the form of dried or milled sheets. Products are formed from dry natural rubber by compression molding, extrusion, or converting the sheets into a solution for dipping.

10327.6 For purposes of this section, the term "contacts humans" means that the natural rubber contained in a device is intended to contact or is likely to contact the user or patient. This includes contact when the device that contains natural rubber is connected to the patient by a liquid path or an enclosed gas path; or the device containing the natural rubber is fully or partially coated with a powder, and such powder may carry natural rubber proteins that may contaminate the environment of the user or patient.

10327.7 Devices containing natural rubber shall be labeled as set forth in §§ 10327.5 through 10327.9. Each required labeling statement shall be prominently and legibly displayed in accordance with 21 U.S.C. § 352(c).

10327.8 Devices containing natural rubber latex that contacts humans, as described in § 10327.2, shall bear the following statement in bold print on the device labeling:

"Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."

This statement shall appear on all device labels, and other labeling, and shall appear on the principal display panel of the device packaging; the outside package, container, or wrapper; and the immediate device package, container, or wrapper.

10327.9 Devices containing dry natural rubber that contacts humans, as described in § 10327.2, shall bear the following statement in bold print on the device labeling:

"This Product Contains Dry Natural Rubber."

10327.10 Devices that have packaging containing natural rubber latex that contacts humans shall bear the following statement in bold print on the device labeling:

"Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions."

This statement shall appear on the packaging that contains the natural rubber, and the outside package, container, or wrapper.

10327.11 Devices that have packaging containing dry natural rubber that contacts as described in § 10327.2, shall bear the following statement in bold print on the device labeling:

"The Packaging of This Product Contains Dry Natural Rubber."

This statement shall appear on the packaging that contains the natural rubber and the outside package, container, or wrapper.

10237.12 Devices that contain natural rubber that contacts humans shall not contain the term "hypoallergenic" on their labeling.

10327.13 Any affected person may request an exemption or variance from the requirements of this section by submitting a citizen petition in accordance with 21 C.F.R. § 10.30.

10327.14 Any device subject to this section that is not labeled in accordance with §§ 10327.4 through 10327.8 and that is initially introduced or initially delivered for introduction into interstate commerce after the effective date of this regulation is misbranded under 21 U.S.C. §§ 321(n) and 352(a), (c), and (f).

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10327

22-B DCMR § 10399 DEFINITIONS

10399.1 As used in this chapter, the following terms and phrases shall have the meanings ascribed:

Adequate directions for use - directions under which the layman can use a device safely and for the purposes for which it is intended. Directions for use may be inadequate because, among other reasons, of omission in whole or in part or incorrect specification of:

Statements of all conditions, purposes, or uses for which the device is intended, including conditions, purposes, or uses for which it is prescribed, recommended, or suggested in its oral, written, printed, or graphic advertising, and conditions, purposes, or uses for which the device is commonly used; except that such statements shall not refer to conditions, uses, or purposes for which the device can be safely used only under the supervision of a practitioner licensed by law and for which it is advertised solely to such practitioner;

Quantity of dose, including usual quantities for each of the uses for which it is intended and usual quantities for persons of different ages and different physical conditions;

Frequency of administration and application;

Duration of administration or application;

Time of administration or application, in relation to time of meals, time of onset of symptoms, or other factors;

Route or method of administration or application; and

Preparation for use (for example, adjustment of temperature or other manipulation or process).

Chlorofluorocarbon - means any fully halogenated chlorofluoroalkane.

Principal display panel – the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale, as it applies to over-the-counter devices in package form and as used in this chapter.

Propellant - means a liquefied or compressed gas that is used in whole or in part to expel from the same self-pressurized container or from a separate container a liquid or solid material different from the propellant, but the term does not include the use of a chlorofluorocarbon as an aerating agent for foamed or sprayed food products.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10399

22-B104 MEDICAL DEVICE REPORTING

22-B DCMR § 10400 GENERAL

10400.1 This section establishes the requirements for medical device reporting for device user facilities, manufacturers, importers, and distributors. A device user facility shall report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, and submit summary annual reports. A manufacturer or importer shall report deaths and serious injuries that its device has or may have caused or contributed to, shall report certain device malfunctions, and shall establish and maintain adverse event files. A manufacturer shall also submit specified follow-up. These reports help the Department to protect the public health by helping to ensure that devices are not adulterated or misbranded and are safe and effective for their intended use. A medical device distributor shall maintain records (files) of incidents, but is not required to report these incidents.

10400.2 This part supplements and does not supersede other provisions of this chapter, including the provisions of Chapter 107.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10400

22-B DCMR § 10401 PUBLIC AVAILABILITY OF REPORTS

10401.1 The Department may disclose to the public any report, including any record of a telephone report, submitted under this part.

10401.2 Before the Department discloses a report to the public, the Department shall delete the following:

(a) Any information that constitutes trade secret or confidential commercial or financial information under 21 C.F.R. § 20.61;

(b) Any personal, medical, and similar information, including the serial number of implanted devices, which would constitute an invasion of personal privacy under 21 C.F.R. § 20.63. However, if a patient requests a report, the Department shall disclose to that patient all the information in the report concerning that patient; and

10401.3 The Department shall not disclose the identity of a device user facility that makes a report under this part except in connection with:

(a) An action brought to enforce 21 U.S.C. § 331(q), including the failure of refusal to furnish material or information required by 21 U.S.C. § 360i;

(b) A communication to a manufacturer of a device that is the subject of a report required to be submitted by a user facility under § 10415 of this chapter; or

(c) A disclosure to employees of the Department of Health and Human Services, the Department of Justice, the District of Columbia Department of Health, or to the duly authorized committees and subcommittees of the Congress.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10401

22-B DCMR § 10402 GENERAL DESCRIPTION OF REPORTS REQUIRED FROM USER FACILITIES, IMPORTERS, AND MANUFACTURERS

10402.1 A device user facility must submit the following reports:

(a) Reports of individual adverse events no later than ten (10) work days after the day that the facility becomes aware of a reportable event, which shall include:

(1) Reports of device-related deaths to the Department and to the manufacturer, if known; or

(2) Reports of device-related serious injuries to the manufacturers or, if the manufacturer is unknown, to the Department; and

(b) Annual reports described in § 10417 to the Department.

10402.2 A device importer must submit the following reports:

(a) Reports of individual adverse events no later than thirty (30) calendar days after the day that the importer becomes aware of a reportable event, which shall include:

(1) Reports of device-related deaths or serious injuries to the Department and to the manufacturer; or

(2) Reports of device-related malfunctions to the manufacturer.

10402.3 If you are a manufacturer must submit the following reports:

(a) Reports of individual adverse events no later than thirty (30) days after the day that you become aware of a reportable death, serious injury, or malfunction;

(b) Reports of individual adverse events no later than five (5) work days after the day that you become aware of:

(1) A reportable event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health; or

(2) A reportable event for which we made a written request.

10402.4 Supplemental reports shall be filed if information is obtained that was not submitted as part of any initial report required by this section.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10402

22-B DCMR § 10403 RESERVED

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10403

22-B DCMR § 10404 WHERE TO SUBMIT REPORTS

10404.1 You must submit any written report or additional information required under this part to the DC Department of Health, 899 North Capitol Street, N.E., 2nd Floor, Washington, D.C. 20002.

10404.2 You must specifically identify each report (for example, "User Facility Report," "Annual Report," "Importer Report," "Manufacturer Report," "10-Day Report").

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10404

22-B DCMR § 10405 ENGLISH REPORTING REQUIREMENT

10405.1 All written or electronic equivalent reports must be in English.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10405

22-B DCMR § 10406 ELECTRONIC REPORTING

10406.1 You may electronically submit any report required by this part if you have our prior written consent. We may revoke this consent at anytime. Electronic report submissions include alternative reporting media (magnetic tape, and disc) and computer-to-computer communication.

10406.2 If your electronic report meets electronic reporting standards, guidance documents, or other medical device report (MDR) reporting procedures that we have developed, you may submit the report electronically without receiving our prior written consent.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10406

22-B DCMR § 10407 REQUESTS FOR ADDITIONAL INFORMATION

10407.1 The Department will notify you in writing if we require additional information and will tell you what information we need. The Department will require additional information if the Department determines that protection of the public health requires additional or clarifying information for medical device reports submitted to the Department and in cases when the additional information is beyond the scope of the Department’s reporting forms or is not readily accessible to the Department.

10407.2 In any request under this section, the Department will state the reason or purpose for the information request, specify the due date for submitting the information, and clearly identify the reported event(s) related to our request. The Department shall confirm in writing any requests for additional information that it makes verbally.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10407

22-B DCMR § 10408 DISCLAIMERS

10408.1 A report or other information submitted by you, and the Department’s release of report or information, is not necessarily an admission that the device, or you or your employees, caused or contributed to the reportable event. You do not have to admit and may deny that the report or information submitted under this part constitutes an admission that the device, you, or your employees, caused or contributed to a reportable event.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10408

22-B DCMR § 10409 WRITTEN MEDICAL DEVICE REPORT PROCEDURES

10409.1 If you are a user facility, importer, or manufacturer, you must develop, maintain, and implement written MDR procedures for the following:

(a) Internal systems that provide for:

(1) Timely and effective identification, communication, and evaluation of events that may be subject to Medical Device Report (MDR) requirements;

(2) A standardized review process or procedure for determining when an event meets the criteria for reporting under this part; and

(3) Timely transmission of complete medical device reports to manufacturers or to the Department, or to both if required; and

(b) Documentation and recordkeeping requirements for:

(1) Information that was evaluated to determine if an event was reportable;

(2) All medical device reports and information submitted to manufacturers or the Department;

(3) Any information that was evaluated for the purpose of preparing the submission of annual reports; and

(4) Systems that ensure access to information that facilitates timely follow-up and inspection by the Department.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10409

22-B DCMR § 10410 FILES AND DISTRIBUTOR RECORDS

10410.1 A user facility, importer, or manufacturer shall establish and maintain MDR event files. The user shall clearly identify all MDR event files, and maintain them to facilitate timely access.

10410.2 For purposes of this section, "MDR event files" are written or electronic files maintained by user facilities, importers, and manufacturers. MDR event files may incorporate references to other information (e.g., medical records, patient files, and engineering reports), in lieu of copying and maintaining duplicates in this file. MDR event files must contain:

(a) Information in your possession or references to information related to the adverse event, including all documentation of your deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable under this section; and

(b) Copies of all MDR forms, as required by this section, and other information related to the event that you submitted to us and other entities such as an importer, distributor, or manufacturer.

10410.3 If you are a user facility, importer, or manufacturer, you must permit any authorized DOH employee, at all reasonable times, to access, copy, and verify the records required by this section.

10410.4 A user facility shall retain an MDR event file relating to an adverse event for a period of two (2) years from the date of the event. If you are a manufacturer or importer, you must retain an MDR event file relating to an adverse event for a period of two (2) years from the date of the event or a period of time equivalent to the expected life of the device, whichever is greater. If the device is no longer distributed, you still must maintain MDR event files for the time periods described in this section.

10410.5 If you are a device distributor, you must establish and maintain device complaint records (files). Your records must contain any incident information, including any written, electronic, or oral communication, either received or generated by you, that alleges deficiencies related to the identity (e.g., labeling), quality, durability, reliability, safety, effectiveness, or performance of a device. You must also maintain information about your evaluation of the allegations, if any, in the incident record. You must clearly identify the records as device incident records and file these records by device name. You may maintain these records in written or electronic format. You must back up any file maintained in electronic format.

10410.6 A device distributor shall retain copies of the required device incident records for a period of two (2) years from the date of inclusion of the record in the file or for a period of time equivalent to the expected life of the device, whichever is greater. Copies of these records shall be maintained even if a device is no longer distributed.

10410.7 A device distributor shall maintain the device complaint files established under this section at the principal business establishment. A manufacturer shall maintain the file at the same location where a complaint file is maintained under Chapter 107. Any authorized DOH employee shall, at all reasonable times, have access to copy or verify the records required by this section.

10410.8 A manufacturer shall maintain MDR event files as part of your complaint file, under Chapter 107, if you prominently identify these records as MDR reportable events. We will not consider your submitted MDR report to comply with this part unless you evaluate an event in accordance with the quality system requirements described in Chapter 107. You must document and maintain in your MDR event files an explanation of why you did not submit or could not obtain any information required by this part, as well as the results of your evaluation of each event.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10410

22-B DCMR § 10411 EXEMPTIONS, VARIANCES, AND ALTERNATIVE REPORTING REQUIREMENTS

10411.1 The following persons are exempt from the adverse event reporting requirements of this section:

(a) A licensed practitioner who prescribes or administers devices intended for use in humans and manufactures or imports devices solely for use in diagnosing and treating persons with whom the practitioner has a "physician-patient" relationship;

(b) An individual who manufactures devices intended for use in humans solely for the individual’s use in research or teaching and not for sale. This includes any person who is subject to alternative reporting requirements under the investigational device exemption regulations, which require reporting of all adverse device effects; and

10411.2 If you are a manufacturer, importer, or user facility, you may request an exemption or variance from any or all of the reporting requirements in this section. You must submit the request to the Department in writing. Your request must include information necessary to identify you and the device; a complete statement of the request for exemption, variance, or alternative reporting; and an explanation why your request is justified.

10411.3 The Department may grant, in writing, to a manufacturer, importer, or user facility, an exemption or variance from, or alternative to, any or all of the reporting requirements in this section and may change the frequency of reporting to quarterly, semiannually, annually, or any other appropriate time period. The Department may grant these modifications in response to a request made pursuant to § 10411.2, or at the Department’s discretion. When the Department grants modifications to the reporting requirements, we may impose other reporting requirements to ensure the protection of public health.

10411.4 The Department may revoke or modify in writing an exemption, variance, or alternative reporting requirement if the Department determines that revocation or modification is necessary to protect the public health.

10411.5 If the Department grants your request for a reporting modification, you must submit any reports or information required in our approval of the modification. The conditions of the approval will replace and supersede the regular reporting requirement specified in this part until such time that the Department revokes or modifies the alternative reporting requirements in accordance with § 10411.4.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10411

22-B DCMR § 10412 HOW TO REPORT ADVERSE EVENTS

10412.1 If you are a user facility, you must submit MDR reports to:

(a) The manufacturer and to the Department no later than ten (10) business days after the day that you become aware of information that reasonably suggests that a device has or may have caused or contributed to a death; or

(b) The manufacturer no later than ten (10) business days after the day that you become aware of information that reasonably suggests that a device has or may have caused or contributed to a serious injury. If the manufacturer is not known, you must submit this report to the Department.

10412.2 An importer shall submit MDR reports to:

(a) The manufacturer and to the Department, no later than thirty (30) calendar days after the day that the importer becomes aware of information that reasonably suggests that a device has or may have caused or contributed to a death or serious injury; or

(b) The manufacturer, no later than thirty (30) days calendar after receiving information that a device the importer marketed has malfunctioned and that this device or a similar device that the importer marketed would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

10412.3 If you are a manufacturer, you must submit MDR reports to the Department:

(a) No later than thirty (30) calendar days after the day that you become aware of information that reasonably suggests that a device may have caused or contributed to a death or serious injury; or

(b) No later than thirty (30) calendar days after the day that you become aware of information that reasonably suggests a device has malfunctioned and that this device or a similar device that you market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur; or

10412.4 Any information, including professional, scientific, or medical facts, observations, or opinions, may reasonably suggest that a device has caused or may have caused or contributed to an MDR reportable event. An MDR reportable event is a death, a serious injury, or, if you are a manufacturer or importer, a malfunction that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

10412.5 If you are a user facility, importer, or manufacturer, you do not have to report an adverse event if you have information that would lead a person who is qualified to make a medical judgment reasonably to conclude that a device did not cause or contribute to a death or serious injury, or that a malfunction would not be likely to cause or contribute to a death or serious injury if it were to recur. Persons qualified to make a medical judgment include physicians, nurses, risk managers, and biomedical engineers. You must keep in your MDR event files the information that the qualified person used to determine whether or not a device-related event was reportable.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10412

22-B DCMR § 10413 WHERE TO FIND REPORTING CODES USED WITH MEDICAL DEVICE REPORTS

10413.1 The Department shall publish adverse events on its website.

10413.2 The Department may sometimes use additional coding of information on the reporting forms or modify the existing codes. If the Department does make modifications, it shall make the new coding information available to all reporters.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10413

22-B DCMR § 10414 WHEN NOT TO FILE A REPORT

10414.1 If you become aware of information from multiple sources regarding the same patient and same reportable event, you may submit one (1) medical device report.

10414.2 You are not required to submit a medical device report if:

(a) You are a user facility, importer, or manufacturer, and you determine that the information received is erroneous in that a device-related adverse event did not occur. You must retain documentation of these reports in your MDR files for the time periods specified in § 10410; or

(b) You are a manufacturer or importer and you did not manufacture or import the device about which you have adverse event information. When you receive reportable event information in error, you must forward this information to us with a cover letter explaining that you did not manufacture or import the device in question.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10414

22-B DCMR § 10415 INDIVIDUAL ADVERSE EVENT REPORTS: USER FACILITIES

10415.1 If you are a user facility, you must submit reports to the manufacturer or to the Department or both, as specified below:

(a) When reporting a death, you must submit a report to the Department as soon as practicable but no more than ten (10) work days after the day that you become aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to the death of a patient of your facility. You must also submit the report to the device manufacturer, if known; or

(b) When reporting a serious injury, you must submit a report to the manufacturer of the device no later than ten (10) work days after the day you become aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to a serious injury to a patient of your facility. If the manufacturer is not known, you must submit the report to the Department.

10415.2 You must submit all information required in § 10416 that is reasonably known to you. This information includes information found in documents that you possess and any information that becomes available as a result of reasonable follow-up within your facility. You are not required evaluate or investigate the event by obtaining or evaluating information that you do not reasonably know.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10415

22-B DCMR § 10416 INDIVIDUAL ADVERSE EVENT REPORT DATA ELEMENTS FOR USER FACILITIES

10416.1 A user facility shall include the following information in its report, if reasonably known:

(a) For patient information, the user facility shall submit the following:

(1) The patient’s name or other identifier;

(2) The patient’s age at the time of event, or date of birth;

(3) The patient’s sex; and

(4) The patient’s weight;

(b) For an adverse event or product problem, the user facility shall submit the following:

(1) Identification of the adverse event or product problem;

(2) Outcomes attributed to the adverse event (for example, death or serious injury). An outcome is considered a serious injury if it is:

(A) A life-threatening injury or illness;

(B) A disability resulting in permanent impairment of a body function or permanent damage to a body structure; or

(3) The date of the event;

(4) The date of report by the initial reporter;

(5) A description of event or problem, including a discussion of how the device was involved, nature of the problem, patient follow-up or required treatment, and any environmental conditions that may have influenced the event;

(6) A description of relevant tests, including dates and laboratory data; and

(7) A description of other relevant history, including preexisting medical conditions;

(1) The brand name;

(2) The type of device;

(3) The manufacturer’s name and address;

(4) The operator of the device (health professional, patient, lay user, other);

(5) The expiration date;

(6) The model, catalog, serial, lot, or other identifying number;

(7) The date of device implantation (month, day, and year);

(8) The date of device expiration (month, day, and year);

(9) Whether the device was available for evaluation and whether the device was returned to the manufacturer; if so, the date it was returned to the manufacturer; and

(10) Concomitant medical products and therapy dates;

(d) For initial reporter information, you must submit the following:

(1) Name, address, and telephone number of the reporter who initially provided information to you, or to the manufacturer or distributor;

(2) Whether the initial reporter is a health professional;

(3) Occupation; and

(4) Whether the initial reporter also sent a copy of the report to the Department, if known; and

(e) For user facility information, you must submit the following:

(1) An indication that this is a user facility report (by marking the user facility box on the form);

(2) Your user facility number;

(3) Your address;

(4) Your contact person;

(5) Your contact person's telephone number;

(6) The date that you became aware of the event (month, day, year);

(7) The type of report (initial or follow-up);

(8) The report number of the initial report, if a follow-up report;

(9) The date of the report (month, day, and year);

(10) The approximate age of device;

(11) The event problem codes--patient code and device code (refer to the "MEDWATCH Medical Device Reporting Code Instructions");

(12) Whether a report was sent to the Department and the date it was sent (month, day, and year);

(13) The location where the event occurred;

(14) Whether the report was sent to the manufacturer and the date it was sent (month, day, year); and

(15) The manufacturer’s name and address, if available.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10416

22-B DCMR § 10417 ANNUAL REPORTS

10417.1 You must submit to the Department an annual report on in writing or electronic equivalent. You must submit an annual report by January 1 of each year. You must clearly identify your annual report as such. Your annual report must include:

(a) Your Centers for Medicare & Medicaid (CMS) provider number used for medical device reports, or the number that the Department assigns for reporting purposes;

(b) Reporting year;

(d) The total number of reports attached or summarized;

(e) The date of the annual report and report numbers identifying the range of medical device reports that you submitted during the report period;

(f) The name, position title, and complete address of the individual designated as your contact person responsible for reporting to the Department and whether that person is a new contact for you; and

(g) Information for each reportable event that occurred during the annual reporting period including:

(1) The report number;

(2) The name and address of the device manufacturer;

(3) The device brand name and common name;

(4) The product model, catalog, serial and lot numbers;

(5) A brief description of the event reported to the manufacturer or the Department; and

(6) Where the report was submitted (for example, to the manufacturer, importer, or the Department).

10417.2 If you did not submit any medical device reports to manufacturers or us during the time period, you do not need to submit an annual report.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10417

22-B DCMR § 10418 INDIVIDUAL ADVERSE EVENT REPORTING REQUIREMENTS FOR IMPORTERS

10418.1 When reporting deaths or serious injuries, an importer shall submit a report to the Department, and a copy of this report to the manufacturer, as soon as practicable but no later than thirty (30) calendar days after the day that the importer receives or otherwise becomes aware of information from any source, including user facilities, individuals, or medical or scientific literature, whether published or unpublished, that reasonably suggests that one (1) of the importer’s marketed devices may have caused or contributed to a death or serious injury.

10418.2 When reporting malfunctions, an importer shall submit a report to the manufacturer as soon as practicable but no later than thirty (30) calendar days after the day that you receive or otherwise become aware of information from any source, including user facilities, individuals, or through the importer’s own research, testing, evaluation, servicing, or maintenance of one of the importer’s devices, that reasonably suggests that one (1) of the devices has malfunctioned and that this device or a similar device that you market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10418

22-B DCMR § 10419 INDIVIDUAL ADVERSE EVENT REPORT DATA ELEMENTS FOR IMPORTERS

10419.1 You must include the following information in your report, if the information is known or should be known to you:

(a) For patient information, you must submit the following:

The patient’s name or other identifier;

The patient’s age at the time of event, or date of birth;

The patient’s sex; and

The patient’s weight;

(b) For adverse event or product problem, you must submit the following:

(1) Identification of the adverse event or product problem;

(2) Outcomes attributed to the adverse event (for example, death or serious injury). An outcome is considered a serious injury if it is:

(A) A life-threatening injury or illness;

(B) A disability resulting in permanent impairment of a body function or permanent damage to a body structure; or

(3) The date of the event;

(4) The date of report by the initial reporter;

(5) The description of the event or problem, including a discussion of how the device was involved, nature of the problem, patient follow-up or required treatment, and any environmental conditions that may have influenced the event;

(6) A description of relevant tests, including dates and laboratory data; and

(7) A description of other relevant patient history, including preexisting medical conditions;

The brand name;

(2) The type of device;

(3) The manufacturer’s name and address;

(4) The operator of the device (health professional, patient, lay user, other);

The expiration date;

(6) The model, catalog, serial, lot, or other identifying numbers;

(7) The date of device implantation (month, day, and year);

(8) The date of device expiration (month, day, and year);

(9) Whether the device was available for evaluation, and whether the device was returned to the manufacturer, and if so, the date it was returned to the manufacturer; and

(10) Concomitant medical products and therapy dates;

(d) For initial reporter information, you must submit the following:

(1) The name, address, and telephone number of the reporter who initially provided information to the manufacturer, user facility, or distributor;

(2) Whether the initial reporter is a health professional;

(3) Occupation; and

(4) Whether the initial reporter also sent a copy of the report to the Department, if known; and

(e) For importer information, you must submit the following:

(1) An indication that this is an importer report (by marking the importer box on the form);

(2) Your importer report number;

(3) Your address;

(4) Your contact person;

(5) Your contact person's telephone number;

(6) The date that you became aware of the event (month, day, and year);

(7) Type of report (initial or follow-up);

(8) The report number of the initial report, if a follow-up report;

(9) The date of the report (month, day, and year);

(10) The approximate age of the device;

(11) The event problem codes;

(12) Whether a report was sent to the Department and the date it was sent (month, day, and year);

(13) The location where event occurred;

(14) Whether a report was sent to the manufacturer and the date it was sent (month, day, and year); and

(15) The manufacturer’s name and address, if available.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10419

22-B DCMR § 10420 INDIVIDUAL ADVERSE EVENT REPORTS REQUIREMENTS FOR MANUFACTURERS

10420.1 A manufacturer shall report to the Department no later than thirty (30) calendar days after the day that it receives or otherwise becomes aware of information, from any source, that reasonably suggests that a device that it markets:

(a) May have caused or contributed to a death or serious injury; or

(b) Has malfunctioned and the device or a similar device that it markets would likely cause or contribute to a death or serious injury, if the malfunction were to recur.

10420.2 The manufacturer shall submit all information required that is reasonably known to it. The following information is considered to be reasonably known:

Any information that can be obtained by contacting a user facility, importer, or other initial reporter;

Any information in the manufacturer’s possession; or

Any information that the manufacturer can obtain by analysis, testing, or other evaluation of the device.

10420.3 The manufacturer is responsible for obtaining and submitting to the Department information that is incomplete or missing from reports submitted by user facilities, importers, and other initial reporters.

10420.4 The manufacturer is also responsible for investigating each event and evaluating the cause of the event. If the manufacturer cannot submit complete information in a report, it shall provide a statement explaining why this information is incomplete and the steps it took to obtain the information. If the manufacturer later obtains any required information that was not available at the time it filed the initial report, it shall submit this information in a supplemental report.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10420

22-B DCMR § 10421 INDIVIDUAL ADVERSE EVENT REPORT DATA ELEMENTS FOR MANUFACTURERS

10421.1 You must include the following information in your reports, if known or reasonably known to your patient information, you must submit the following:

The patient’s name or other identifier;

The patient’s age at the time of event, or date of birth;

The patient’s sex; and

(d) The patient’s weight;

10421.2 For an adverse event or product problem, you must submit the following:

Identification of the adverse event or product problem;

(b) The outcomes attributed to the adverse event (for example, death or serious injury). An outcome is considered a serious injury if it is:

(1) Life-threatening injury or illness;

(2) A disability resulting in permanent impairment of a body function or permanent damage to a body structure; or

(3) Injury or illness that requires intervention to prevent permanent impairment of a body structure or function;

(4) The date of the event;

(5) The date of report by the initial reporter;

(6) A description of the event or problem, including a discussion of how the device was involved, nature of the problem, patient follow-up or required treatment, and any environmental conditions that may have influenced the event;

(7) A description of relevant tests, including dates and laboratory data; and

(8) Any other relevant patient history including preexisting medical conditions.

10421.3 For device information, you must submit the following:

The brand name;

The type of device;

Your name and address;

(d) The operator of the device (health professional, patient, lay user, other);

(e) The expiration date;

(f) The model, catalog, serial, lot, or other identifying numbers;

(g) The date of device implantation (month, day, and year);

(h) The date of device explanation (month, day, and year);

Whether the device was available for evaluation, and whether the device was returned to you, and if so, the date it was returned to you; and

(j) Concomitant medical products and therapy dates.

10421.4 For initial reporter information, you must submit the following:

(a) Name, address, and phone number of the reporter who initially provided information to you, or to the user facility or importer;

Whether the initial reporter is a health professional;

Whether the initial reporter also sent a copy of the report to the Department, if known.

10421.5 When reporting information for all manufacturers, you must submit the following:

Your reporting office's contact name and address and device manufacturing site;

Your telephone number;

Your report sources;

(d) The date received by you (month, day, and year);

(e) The type of report being submitted (for example, five (5) day, initial, or follow-up); and

(f) Your report number.

10421.6 For device manufacturer information, you must submit the following:

(a) The type of reportable event (death, serious injury, or malfunction);

(b) The type of follow-up report, if applicable (such as, correction or a response to the Department’s request);

If the device was returned to you and evaluated by you, you must include a summary of the evaluation. If you did not perform an evaluation, you must explain why you did not perform an evaluation;

The device manufacture date (month, day, and year);

Whether the device was labeled for single use;

The evaluation codes (including event codes, method of evaluation, result, and conclusion codes);

Whether remedial action was taken and the type of action;

Whether the use of the device was initial, reuse, or unknown;

Whether remedial action was reported as a removal or correction, and if it was, provide the correction or removal report number; and

Your additional narrative; or

Corrected data, including:

(1) Any information missing on the user facility report or importer report, including any event codes that were not reported or information corrected on these forms after your verification;

(2) For each event code provided by the user facility, under § 10416.1(e)(10) or the importer under § 10419.1(e)(10), you must include a statement of whether the type of the event represented by the code is addressed in the device labeling; and

(3) If your report omits any required information, you must explain why this information was not provided and the steps taken to obtain this information.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10421

22-B DCMR § 10422 FIVE (5)-DAY REPORTS FOR MANUFACTURERS

10422.1 You must submit a five (5)-day report to us no later than five (5) work days after the day that you become aware of:

An MDR reportable event that necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health. The manufacturer may become aware of the need for remedial action from any information, including any trend analysis; or

(b) A written request by the Department for the submission of a five (5)-day report. If you receive such a written request from the Department, you must submit, without further request, a five (5)-day report for all subsequent events of the same nature that involve substantially similar devices for the time period specified in the written request. We may extend the time period stated in the original written request if we determine it is in the interest of the public health.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10422

22-B DCMR § 10423 SUPPLEMENTAL REPORTS

10423.1 If you are a manufacturer, when you obtain information that you did not provide because it was not known or was not available when you submitted the initial report, you must submit the supplemental information to the Department within one (1) month of the day that you receive this information. On a supplemental or follow-up report, you must:

Indicate on the envelope and in the report that the report being submitted is a supplemental or follow-up report;

(b) Submit the appropriate identification numbers of the report that you are updating with the supplemental information (for example, your original manufacturer report number and the user facility or importer report number of any report on which your report was based), if applicable; and

(c) Include only the new, changed, or corrected information in the appropriate portion(s) of the respective form(s) for reports that cross reference previous reports.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10423

22-B DCMR § 10424 FOREIGN MANUFACTURERS

10424.1 Every foreign manufacturer whose devices are distributed in the United States shall designate a U.S. agent to be responsible for reporting in accordance with § 10510 of this subtitle. The designated agent accepts responsibility for the duties that such designation entails. Upon the effective date of these regulations, foreign manufacturers shall inform the Department, by letter, of the name and address of the agent designated under this section and § 10510 of this subtitle, and shall update this information as necessary. Such updated information shall be submitted to the Department, within five (5) days of a change in the designated agent information.

10424.2 Designated agents of foreign manufacturers are required to:

(a) Report to the Department in accordance with §§ 10420, 10421, 10422, and 10423;

(b) Conduct or obtain from the foreign manufacturer the necessary information regarding the investigation and evaluation of the event to comport with the requirements of § 10420;

(e) Maintain complaint files in accordance with § 10410; and

(f) Register, list, and submit premarket notifications in accordance with Chapter 105.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10424

22-B DCMR § 10499 DEFINITIONS

10499.1 As used in this chapter, the following terms and phrases shall have the meanings ascribed:

Ambulatory surgical facility (ASF) –a distinct entity that operates for the primary purpose of furnishing same-day outpatient surgical services to patients. An ASF may be either an independent entity (for example, not a part of a provider of services or any other facility) or operated by another medical entity (such as under the common ownership, licensure, or control of an entity). An ASF is subject to this regulation regardless of whether it is licensed by a Federal, state, municipal, or local government or regardless of whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the ASF must report that event regardless of the nature or location of the medical service provided by the ASF.

Become aware – an employee of the entity required to report has acquired information reasonably suggesting a reportable adverse event has occurred in the following situations:

(a) Device user facilities are considered to have “become aware” when medical personnel as defined under the term “medical personnel” who are employed by or otherwise formally affiliated with the facility acquire such information about a reportable event;

(b) Manufacturers are considered to have become aware of an event when:

Any employee becomes aware of a reportable event that is required to be reported within thirty (30) days or that is required; or to be reported within five (5) days under a written request; and

(2) Any employee, who is a person with management or supervisory responsibilities over persons with regulatory, scientific, or technical responsibilities, or a person whose duties relate to the collection and reporting of adverse events, becomes aware that a reportable MDR event or events, from any information, including any trend analysis, necessitate remedial action to prevent an unreasonable risk of substantial harm to the public health; and

Caused or contributed – a death or serious injury was or may have been attributed to a medical device, or that a medical device was or may have been a factor in a death or serious injury, including events occurring as a result of:

(a) Failure;

(b) Malfunction;

(d) Manufacture;

(e) Labeling; or

(f) User error.

Device family - a group of one (1) or more devices manufactured by or for the same manufacturer and having the same:

(a) Basic design and performance characteristics related to device safety and effectiveness;

(b) Intended use and function;

(d) Devices that differ only in minor ways not related to safety or effectiveness can be considered to be in the same device family. Factors such as brand name and common name of the device and whether the devices were introduced into commercial distribution under 21 U.S.C. § 351(k) or premarket approval application (PMA), may be considered in grouping products into device families.

Device user facility – a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility which is not a “physician's office.” School nurse offices and employee health units are not device user facilities.

Distributor – any natural or legal person who, on his or her own behalf, sells

chiefly to vendors. The term “distributor” does not include a common carrier, a delivery agent, or sales representative, who does not have legal title to a medical device.

Expected life of a device –means the time that a device is expected to remain functional after it is placed into use. Certain implanted devices have specified “end of life” (EOL) dates. Other devices are not labeled as to their respective EOL, but are expected to remain operational through maintenance, repair, and upgrades for an estimated period of time.

Five (5)-day report – a medical device report that must be submitted by a manufacturer within five (5) business days.

Hospital – a distinct entity that operates for the primary purpose of providing diagnostic, therapeutic (medical, occupational, speech, physical), surgical, and other patient services for specific and general medical conditions. Hospitals include general, chronic disease, rehabilitative, psychiatric, and other special-purpose facilities. A hospital may be either independent (that is, not a part of a provider of services or any other facility) or may be operated by another medical entity (such as under the common ownership, licensure, or control of another entity). A hospital is covered by this regulation regardless of whether it is licensed by the District and regardless of whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the hospital must report that event regardless of the nature or location of the medical service provided by the hospital.

Importer – any person who imports a device into the District of Columbia and who furthers the marketing of a device from the original place of manufacture to the person who makes final delivery or sale to the ultimate user, but who does not repackage or otherwise change the container, wrapper, or labeling of the device or device package.

Malfunction – the failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. The intended performance of a device refers to the intended use for which the device is labeled or marketed.

Manufacturer – any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure. The term includes any person who:

(a) Repackages or otherwise changes the container, wrapper, or labeling of a device in furtherance of the distribution of the device from the original place of manufacture;

(b) Initiates specifications for devices that are manufactured by a second party for subsequent distribution by the person initiating the specifications;

(c) Manufactures components or accessories which are devices that are ready to be used and are intended to be commercially distributed and intended to be used as is, or are processed by a licensed practitioner or other qualified person to meet the needs of a particular patient; or

(d) Is the U.S. agent of a foreign manufacturer.

MDR – medical device report.

MDR reportable event (or reportable event) – an event about which user facilities:

(a) Become aware of information that reasonably suggests that a device has or may have caused or contributed to a death or serious injury; or

(b) An event about which manufacturers or importers have received or become aware of information that reasonably suggests that one (1) of their marketed devices:

(1) May have caused or contributed to a death or serious injury; or

(2) Has malfunctioned and that the device or a similar device marketed by the manufacturer or importer would be likely to cause a death or serious injury if the malfunction were to recur.

Medical personnel – an individual who:

(a) Is licensed, registered, or certified by a State, territory, or other governing body to administer health care;

(b) Has received a diploma or a degree in a professional or scientific discipline;

(d) Is a supervisor of such persons.

Nursing home – an independent entity (that is, not a part of a provider of services or any other facility) or one operated by another medical entity (such as under the common ownership, licensure, or control of an entity) that operates for the primary purpose of providing:

(a) Skilled nursing care and related services for persons who require medical or nursing care;

(b) Hospice care to the terminally ill; or

A nursing home is subject to this regulation regardless of whether it is licensed by a Federal, State, municipal, or local government or whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the nursing home must report that event regardless of the nature or location of the medical service provided by the nursing home.

Outpatient diagnostic facility – a distinct entity that:

(a) Operates for the primary purpose of conducting medical diagnostic tests on patients;

(b) Does not assume ongoing responsibility for patient care; and

(d) Examples include diagnostic radiography, mammography, ultrasonography, electrocardiography, magnetic resonance imaging, computerized axial tomography, and in-vitro testing. An outpatient diagnostic facility may be either independent (that is, not a part of a provider of services or any other facility) or operated by another medical entity (such as under the common ownership, licensure, or control of an entity). An outpatient diagnostic facility is covered by this regulation regardless of whether it is licensed by a Federal, State, municipal, or local government or whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the outpatient diagnostic facility must report that event regardless of the nature or location of the medical service provided by the outpatient diagnostic facility.

Outpatient treatment facility – a distinct entity that operates for the primary purpose of providing nonsurgical therapeutic (medical, occupational, or physical) care on an outpatient basis or home health care setting.

(a) Outpatient treatment facilities include ambulance providers, rescue services, and home health care groups. Examples of services provided by outpatient treatment facilities include:

(1) Cardiac defibrillation;

(2) Chemotherapy;

(3) Radiotherapy;

(4) Pain control;

(5) Dialysis;

(6) Speech or physical therapy; and

(7) Treatment for substance abuse;

(b) An outpatient treatment facility may be either independent (that is, not a part of a provider of services or any other facility) or operated by another medical entity (such as under the common ownership, licensure, or control of an entity). An outpatient treatment facility is covered by this regulation regardless of whether it is licensed by a Federal, state, municipal, or local government or whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the outpatient treatment facility must report that event regardless of the nature or location of the medical service provided by the outpatient treatment facility.

Patient of the facility – any individual who is being diagnosed or treated, or receiving medical care at or under the control or authority of the facility. For the purposes of this chapter, the definition encompasses employees of the facility or individuals affiliated with the facility, who in the course of their duties suffer a device-related death or serious injury that has or may have been caused or contributed to by a device used at the facility.

Physician's office – a facility that operates as the office of a physician or other health care professional (such as, dentist, chiropractor, optometrist, nurse practitioner, school nurse offices, school clinics, employee health clinics, or free-standing care units) for the primary purpose of examination, evaluation, and treatment or referral of patients. A physician's office may be independent, a group practice, or part of a Health Maintenance Organization.

Permanent – impairment or damage to a body structure or function, excluding trivial impairment or damage.

Remedial action – any action other than routine maintenance or servicing of a device where such action is necessary to prevent recurrence of a reportable event.

Serious injury – an injury or illness that:

(a) Is life-threatening;

(b) Results in permanent impairment of a body function or permanent damage to body structure; or

(c) Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

Shelf life – as required on the manufacturer's baseline report, means the maximum time a device will remain functional from the date of manufacture until it is used in patient care. Some devices have an expiration date on their labeling indicating the maximum time they can be stored before losing their ability to perform their intended function.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013); as amended by Final Rulemaking published at 65 DCR 3648 (April 6, 2018). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10499

22-B105 ESTABLISHMENT, REGISTRATION, AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

22-B DCMR § 10500 WHO MUST REGISTER AND SUBMIT A DEVICE LIST

10500.1 An owner or operator of an establishment not exempt under Section 510(g) of the Act or § 10512 of this chapter who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for human use shall register and submit listing information for those devices in commercial distribution, except that registration and listing information may be submitted by the parent, subsidiary, or affiliate company for all the domestic or foreign establishments under the control of one (1) of these organizations when operations are conducted at more than one (1) establishment and there exists joint ownership and control among all the establishments. The term “device" includes all in vitro diagnostic products and in vitro diagnostic biological products not subject to licensing under the Public Health Service Act, 42 U.S.C. § 262.

10500.2 An owner or operator of an establishment located in the District shall register its name, place of business, and all establishments, and list the devices whether or not the output of the establishments or any particular device so listed enters interstate commerce. The registration and listing requirements shall pertain to any person who:

(a) Initiates or develops specifications for a device that is to be manufactured by a second party for commercial distribution by the person initiating specifications;

(b) Manufactures for commercial distribution a device either for itself or for another person. However, a person who only manufactures devices according to another person's specifications, for commercial distribution by the person initiating specifications, is not required to list those devices;

(d) Acts as an initial importer; or

(e) Manufactures components or accessories which are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose (for example, blood filters, hemodialysis tubing) or devices which of necessity must be further processed by a licensed practitioner or other qualified person to meet the needs of a particular patient (such as, a manufacturer of ophthalmic lens blanks).

10500.3 Registration or listing does not constitute an admission or agreement or determination that a product is a device within the meaning of Section 201(h) of the Act.

10500.4 Registration and listing requirements shall not pertain to any person who:

Manufacturers devices for another party who both initiated the specifications and commercially distributes the device;

Sterilizes devices on a contract basis for other registered facilities who commercially distributes the devices; or

Acts as a wholesale distributor and who does not manufacture, repackage, process, or re-label a device.

10500.5 Owners and operators of establishments or persons engaged in the recovery, screening, testing, processing, storage, or distribution of human cells, tissues, and cellular and tissue-based products that are regulated under the Federal Food, Drug, and Cosmetic Act must register and list those human cells, tissues, and cellular and tissue-based products following the procedures set out in this chapter, instead of the procedures for registration and listing contained in this section, except that the additional listing information requirements in § 10506 remain applicable.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10500

22-B DCMR § 10501 TIME FOR ESTABLISHMENT REGISTRATION AND DEVICE LISTING

10501.1 An owner or operator of an establishment who has not previously entered into an operation shall register within thirty (30) days after entering into such an operation and submit device listing information at that time. An owner or operator of an establishment shall update its registration information annually within thirty (30) days after receiving registration forms. The Department of Health shall mail forms to the owners or operators of registered establishments according to a schedule based on the first letter of the name of the owner or operator. The schedule is as follows:

First letter of owner or operator name

Date DOH will mail forms

A, B, C, D, E

March

F, G, H, I, J, K, L, M

June

N, O, P, Q, R

August

S, T, U, V, W, X, Y, Z

November

10501.2 Owners or operators of all registered establishments shall update their device listing information every June and December or, at their discretion, at the time the change occurs.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10501

22-B DCMR § 10502 HOW AND WHERE TO REGISTER ESTABLISHMENTS AND LIST DEVICES

10502.1 The first registration of a device establishment shall be on Form FDA-2891 (Initial Registration of Device Establishment) or a similar form supplied by the Department. Subsequent annual registration shall be accomplished on Form FDA-2891a (Annual Registration of Device Establishment), furnished by the FDA, or a similar form furnished by the Department to establishments whose registration for that year was validated under § 10507.1. The forms shall be mailed to the owner or operators of all establishments via the official correspondent in accordance with the schedule as described in § 10501.1. The completed form shall be mailed no later than thirty (30) days after receipt from DOH.

10502.2 The initial listing of devices and subsequent June and December updates shall be on form FDA-2892 (Medical Device Listing) or similar form furnished by the Department. A separate form FDA-2892 or similar Department form shall be submitted for each device or device class listed with the Department. Devices having variations in physical characteristics such as size, packaging, shape, color, or composition should be considered to be one (1) device; provided, the variation does not change the function or intended use of the device.

10502.3 The listing obligations of the initial importer are satisfied as follows:

The initial importer is not required to submit a form FDA-2892 or its Department equivalent for those devices for which such initial importer did not initiate or develop the specifications for the device or repackage or re-label the device. However, the initial importer shall submit, for each device, the name and address of the manufacturer. Initial importers shall also be prepared to submit, when the Department requests, the proprietary name, if any, and the common or usual name of each device for which they are the initial importers; and

(b) The initial importer shall update the information at the intervals specified in § 10505.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10502

22-B DCMR § 10503 INFORMATION REQUIRED OR REQUESTED FOR ESTABLISHMENT REGISTRATION AND DEVICE LISTING

10503.1 Form FDA-2891 and Form FDA-2891a or their Department equivalents are the approved forms for initially providing the information required by the Act and for providing annual registration, respectively. The required information includes the name and street address of the device establishment, including zip code, all trade names that the establishment uses, and the business trading name of the owner or operator of such establishment.

10503.2 The owner or operator shall identify the device activities of the establishment such as manufacturing, repackaging, or distributing devices.

10503.3 Each owner or operator is required to maintain a listing of all officers, directors, and partners for each establishment the owner or operator registers and to furnish this information to the Department upon request.

10503.4 Each owner or operator shall provide the name of an official correspondent who will serve as a point of contact between the Department and the establishment for matters relating to the registration of device establishments and the listing of device products. All correspondence relating to registration, including requests for the names of partners, officers, and directors, will be directed to the official correspondent. In the event no person is designated by the owner or operator, the owner or operator of the establishment shall be the official correspondent.

10503.5 The designation of an official correspondent does not in any manner affect the liability of the owner or operator of the establishment or any other individual under 21 U.S.C. §§ 331(p) or any other provision of the Act.

10503.6 Form FDA-2892 or its Department equivalent is the approved form for providing the device listing information required by the Act. This required information includes the following:

(a) The identification by classification name and number, proprietary name, and common or usual name of each device being manufactured, prepared, propagated, compounded, or processed for commercial distribution that has not been included in any list of devices previously submitted on form FDA-2892 or its Department equivalent;

(b) The Code of Federal Regulations citation for any applicable standard for the device under 21 U.S.C. § 360d or 42 U.S.C. §§ 263f;

(c) The Code of Federal Regulations or DOH citation for any applicable standard for the device under 21 U.S.C. §§ 360d or 42 U.S.C. §§ 263f;

(d) The assigned FDA number or DOH number of the approved application for each device listed that is subject to 21 U.S.C. §§ 355 or 360e;

(e) The name, registration number, and establishment type of every domestic or foreign device establishment under joint ownership and control of the owner or operator at which the device is manufactured, repackaged, or relabeled;

(f) Whether the device, as labeled, is intended for distribution to and use by the general public;

(g) Other general information requested on form FDA-2892 or its Department equivalent, such as:

If the submission refers to a previously listed device, as in the case of an update, the document number from the initial listing document for the device;

The reason for submission;

The date on which the reason for submission occurred;

The date that the form FDA-2892 or its Department equivalent, was completed; and

(5) The owner's or operator's name and identification number; and

(h) Labeling or other descriptive information (for example, specification sheets or catalogs) adequate to describe the intended use of a device when the owner or operator is unable to find an appropriate Department classification name for the device.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10503

22-B DCMR § 10504 AMENDMENTS TO ESTABLISHMENT REGISTRATION

10504.1 Changes in individual ownership, corporate or partnership structure, or location of an operation shall be submitted on Form FDA-2891a or its Department equivalent at the time of annual registration, or by letter if the changes occur at other times. This information shall be submitted within thirty (30) days of such changes. Changes in the names of officers or directors of the corporation(s) shall be filed with the establishment's official correspondent and shall be provided to the Department upon receipt of a written request for this information.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10504

22-B DCMR § 10505 UPDATING DEVICE LISTING INFORMATION

10505.1 Form FDA-2892 or its Department equivalent shall be used to update device listing information. The preprinted original document number of each form FDA-2892 or its Department equivalent on which the device was initially listed shall appear on the form subsequently used to update the listing information for the device and on any correspondence related to the device.

10505.2 An owner or operator shall update the device listing information during each June and December or, at its discretion, at the time the change occurs. Conditions that require updating and information to be submitted for each of these updates are as follows:

(a) If an owner or operator introduces into commercial distribution a device identified with a classification name not currently listed by the owner or operator, then the owner or operator must submit form FDA-2892 or its Department equivalent containing all the information required by § 10503.6;

(b) If an owner or operator discontinues commercial distribution of all devices in the same device class (for example, with the same classification name), the owner or operator must submit a form containing the original document number on which the device class was initially listed, the reason for submission, the date of discontinuance, the owner or operator's name and identification number, the classification name and number, the proprietary name, and the common or usual name of the discontinued device.

(c) If commercial distribution of a discontinued device identified on a form filed under this section is resumed, the owner or operator must submit a notice of resumption containing:

The original document number of the form initially used to list that device class;

The reason for submission;

The date of resumption; and

All other information required.

(d) If one (1) or more classification names for a previously listed device with multiple classification names has been added or deleted, the owner or operator must supply the original document number on which the device was initially listed and a supplemental sheet identifying the names of any new or deleted classification names.

(e) Other changes to information will be updated as follows:

(1) Whenever a change occurs only in the owner or operator name or number (for example, whenever one company's device line is purchased by another owner or operator) it will not be necessary to supply a separate form for each device. In such cases, the new owner or operator must submit a letter informing the Department of the original document number on which device was initially listed for those devices affected by the change in ownership;

(2) The owner or operator must also submit update information whenever establishment registration numbers, establishment names, or activities are added to or deleted. The owner or operator must supply the original document number on which the device was initially listed, the reason for submission, and all other information required.

(f) Updating is not required if the above information has not changed since the previously submitted list. Also, updating is not required if changes occur in proprietary names, in common or usual names, or to supplemental lists of unclassified components or accessories.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10505

22-B DCMR § 10506 ADDITIONAL LISTING INFORMATION

10506.1 Each owner or operator shall maintain a historical file containing the labeling and advertisements in use on the date of initial listing, and in use after October 10, 1978, but before the date of initial listing, as follows:

For each device subject to 21 U.S.C. §§ 360d or 360e of the act that is not a restricted device, a copy of all labeling for the device;

(b) For each restricted device, a copy of all labeling and advertisements for the device; and

(c) For each device that is neither restricted nor subject to 21 U.S.C. §§ 360d or 360e of the act, a copy of all labels, package inserts, and a representative sampling of any other labeling.

10506.2 In addition to the requirements set forth in this section, each owner or operator shall maintain in the historical file any labeling or advertisements in which a material change has been made any time after initial listing.

10506.3 Each owner or operator may discard labeling and advertisements from the historical file three (3) years after the date of the last shipment of a discontinued device by an owner or operator.

10506.4 Location of the file:

Currently existing systems for maintenance of labeling and advertising may be used for the purpose of maintaining the historical file as long as the information included in the systems fulfills the requirements of this section, but only if the labeling and advertisements are retrievable in a timely manner;

The contents of the historical file may be physically located in more than one (1) place in the establishment or in more than one (1) establishment provided there exists joint ownership and control among all the establishments maintaining the historical file. If no joint ownership and control exists, the registered establishment must provide the Department with a letter authorizing the establishment outside its control to maintain the historical file; and

A copy of the certification and disclosure statements as required by this chapter shall be retained and physically located at the establishment maintaining the historical file.

10506.5 Each owner or operator shall be prepared to submit to the Department, only upon specific request, the following information:

(a) For a device subject to 21 U.S.C. §§ 360d or 360e of the act, that is not a

restricted device, a copy of all labeling for the device;

(b) For a device that is a restricted device, a copy of all labeling for the device, a representative sampling of advertisements for the device, and for good cause, a copy of all advertisements for a particular device. A request for all advertisements will, where feasible, be accompanied by an explanation of the basis for such request;

(c) For a device that is not a restricted device, the label and package insert for the device and a representative sampling of any other labeling for the device;

(d) For a particular device, a statement of the basis upon which the registrant has determined the device is not a restricted device pursuant to 21 U.S.C. §§ 360d or 360e;

For a particular device, a statement of the basis for determining that the product is a device rather than a drug; or

(f) For a device that the owner or operator has manufactured for distribution under a label other than its own, the names of all distributors for whom it has been manufactured.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10506

22-B DCMR § 10507 NOTIFICATION OF REGISTRANT

10507.1 The Department will provide to the official correspondent, at the address listed on the form, a validated copy of Form FDA-2891 or Form FDA-2891a (whichever is applicable) or their Department equivalent as evidence of registration. A permanent registration number will be assigned to each device establishment registered in accordance with these regulations.

10507.2 Owners and operators of device establishments who also manufacture or process blood or drug products at the same establishment shall also register with the Department.

10507.3 Although establishment registration and device listing are required to engage in the device activities described in § 10500, validation of registration and the assignment of a device listing number in itself does not establish that the holder of the registration is legally qualified to deal in such devices and does not represent a determination by the Department of Health as to the status of any device.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10507

22-B DCMR § 10508 INSPECTION OF ESTABLISHMENT REGISTRATION AND DEVICE LISTING

10508.1 A copy of the forms FDA-2891 that the registrant files shall be available for inspection at the Department. Upon request, verification of registration number or location of a registered establishment shall be provided.

10508.2 The following information filed under the device listing requirements will be available for public disclosure:

(a) Each form FDA-2892 or its Department equivalent submitted;

(b) All labels submitted;

(d) All advertisements submitted; and

(e) All data or information that has already become a matter of public knowledge.

10508.3 Requests for device listing information identified in § 10508.2 of this section shall be directed to the Department.

10508.4 Requests for device listing information not identified in § 10508.2 shall be submitted and handled as specified in these regulations.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10508

22-B DCMR § 10509 MISBRANDING BY REFERENCE TO ESTABLISHMENT REGISTRATION OR TO REGISTRATION NUMBER

10509.1 Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products. Any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10509

22-B DCMR § 10510 ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR U.S. AGENTS OF FOREIGN MANUFACTURERS OF DEVICES

10510.1 Any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a device that is imported or offered for import into the United States shall register and list such devices in conformance with the requirements in 21 C.F.R. § 807.20, et seq., unless the device enters a foreign trade zone and is re-exported from that foreign trade zone without having entered U. S. commerce. The official correspondent for the foreign establishment shall facilitate communication between the foreign establishment's management and representatives of the Department of Health for matters relating to the registration of device establishments and the listing of device products.

10510.2 Each foreign establishment required to register under § 10510.1 of this section shall submit the name, address, and phone number of its United States agent as part of its initial and updated registration information in accordance with 21 C.F.R. § 807.20, et seq. Each foreign establishment shall designate only one United States agent and may designate the United States agent to act as its official correspondent.

10510.3 The United States agent shall reside or maintain a place of business in the United States.

10510.4 Upon request from the Department, the United States agent shall assist DOH in communications with the foreign establishment, respond to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and assist the Department in scheduling inspections of the foreign establishment. If the agency is unable to contact the foreign establishment directly or expeditiously, the Department may provide information or documents to the United States agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.

10510.5 The foreign establishment or the United States agent shall report changes in the United States agent's name, address, or phone number to the Department within ten (10) business days of the change.

10510.6 No device may be imported or offered for import into the United States unless it is the subject of a device listing as required under 21 C.F.R. § 807.20, et seq. and is manufactured, prepared, propagated, compounded, or processed at a registered foreign establishment; however, this restriction does not apply to devices imported or offered for import under the investigational use provisions of this chapter or to a component, part, or accessory of a device or other article of a device imported under the Act. The establishment registration and device listing information shall be in the English language.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10510

22-B DCMR § 10511 EXEMPTIONS FOR DEVICE ESTABLISHMENTS

10511.1 The following classes of persons are exempt from registration in accordance with § 10500 in accordance with the provisions of 21 U.S.C. § 360 (g)(1), (g)(2), and g(3) because such registration is not necessary for the protection of the public health. The exemptions are limited to those classes of persons located in the District as defined in the Act:

A manufacturer of raw materials or components to be used in the manufacture or assembly of a device who would otherwise not be required to register under the provisions of 21 C.F.R. § 807.65;

(b) A manufacturer of devices to be used solely for veterinary purposes;

(c) A manufacturer of general purpose articles such as chemical reagents or laboratory equipment whose uses are generally known by persons trained in their use and which are not labeled or promoted for medical uses;

(d) Licensed practitioners, including physicians, dentists, and optometrists, who manufacture or otherwise alter devices solely for use in their practice;

(e) Pharmacies, surgical supply outlets, or other similar retail establishments making final delivery or sale to the ultimate user. This exemption also applies to a pharmacy or other similar retail establishment that purchases a device for subsequent distribution under its own name (for example, a properly labeled health aid such as an elastic bandage or crutch) indicating "distributed by" or "manufactured for" followed by the name of the pharmacy;

(f) Persons who manufacture, prepare, propagate, compound, or process devices solely for use in research, teaching, or analysis and do not

introduce such devices into commercial distribution;

(g) Carriers by reason of their receipt, carriage, holding, or delivery of devices in the usual course of business as carriers; or

(h) Persons who dispense devices to the ultimate consumer or whose major responsibility is to render a service necessary to provide the consumer (for example, patient, physician, and layman) with a device or the benefits to be derived from the use of a device; for example, a hearing aid dispenser, optician, clinical laboratory, assembler of diagnostic X-ray systems, and personnel from a hospital, clinic, dental laboratory, orthotic or prosthetic retail facility, whose primary responsibility to the ultimate consumer is to dispense or provide a service through the use of a previously manufactured device.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10511

22-B DCMR § 10512 WHEN A PREMARKET NOTIFICATION SUBMISSION IS REQUIRED

10512.1 Except as provided otherwise, each person who is required to register his or her establishment pursuant to § 10500 must submit a premarket notification submission to the Department at least ninety (90) days before he proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use which meets any of the following criteria:

(a) The device is being introduced into commercial distribution for the first time; that is, the device is not of the same type as, or is not substantially equivalent to:

(1) A device in commercial distribution before May 28, 1976, or;

(2) A device introduced for commercial distribution after May 28, 1976, that has subsequently been reclassified into class I or II.

(b) The device is being introduced into commercial distribution for the first time by a person required to register, whether or not the device meets the criteria in Paragraph (a) of this subsection; or

(c) The device is one that the person currently has in commercial distribution or is reintroducing into commercial distribution, but that is about to be significantly changed or modified in design, components, method of manufacture, or intended use. The following constitutes significant changes or modifications that require a premarket notification:

A change or modification in the device that could significantly affect the safety or effectiveness of the device (such as, a significant change or modification in design, material, chemical composition, energy source, or manufacturing process); or

(2) A major change or modification in the intended use of the device.

10512.2 A premarket notification under 21 C.F.R. § 807.81 is not required for a device for which a premarket approval application under Section 515 of the Act, or for which a petition to reclassify under Section 513 of the Act, is pending before the Department of Health.

10512.3 The appropriate Department employee may determine that the submission and grant of a written request for an exception or alternative satisfies the requirement in § 10512.1(c).

10512.4 In addition to complying with the requirements of this part, owners or operators of device establishments that manufacture radiation-emitting electronic products, as defined in the Act, shall comply with the reporting requirements of this chapter.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10512

22-B DCMR § 10513 EXEMPTION FROM PREMARKET NOTIFICATION

10513.1 A device is exempt from the premarket notification requirements of 21 C.F.R. § 807.85 if the device intended for introduction into commercial distribution is not generally available in finished form for purchase and is not offered through labeling or advertising by the manufacturer, importer, or distributor thereof for commercial distribution, and the device meets one (1) of the following conditions:

It is intended for use by a patient named in the order of the physician or dentist (or other specially qualified person); or

It is intended solely for use by a physician or dentist (or other specially qualified person) and is not generally available to, or generally used by, other physicians or dentists (or other specially qualified persons).

10513.2 A distributor who places a device into commercial distribution for the time under his own name and a re-packager who places his or her own name on a device and does not change any other labeling or otherwise affect the device shall be exempt from the premarket notification requirements of 21 C.F.R. § 807.85 if:

The device was in commercial distribution before May 28, 1976; or

(b) Another person filed the premarket notification on submission.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10513

22-B DCMR § 10514 INFORMATION REQUIRED IN A PREMARKET MODIFICATION SUBMISSION

10514.1 Each premarket notification submission shall contain the following information:

(a) The device name, including both the trade or proprietary name and the common or usual name or classification name of the device;

(b) The establishment registration number, if applicable, of the owner or operator submitting the premarket notification submission;

(c) The class in which the device has been put under 21 U.S.C. § 360c and, if known, its appropriate panel; or, if the owner or operator determines that the device has not been classified under such section, a statement of that determination and the basis for the person's determination that the device is not so classified;

(d) Action taken by the person required to register to comply with the requirements under 21 U.S.C. § 360d for performance standards;

(e) Proposed labels, labeling, and advertisements sufficient to describe the device, its intended use, and the directions for its use. Where applicable, photographs or engineering drawings should be supplied;

(f) A statement indicating the device is similar to or different from other products of comparable type in commercial distribution, accompanied by data to support the statement. This information may include an identification of similar products, materials, design considerations, energy expected to be used or delivered by the device, and a description of the operational principles of the device;

(g) Where a person required to register intends to introduce into commercial distribution a device that has undergone a significant change or modification that could significantly affect the safety or effectiveness of the device, or the device is to be marketed for a new or different indication for use, the premarket notification submission must include appropriate supporting data to show that the manufacturer has considered what consequences and effects the change or modification or new use might have on the safety and effectiveness of the device;

(h) A 21 U.S.C. § 360(k) summary as described in § 10517 or a 21 U.S.C. § 360(k) statement as described in § 10518;

A financial certification or disclosure statement or both;

(j) For submissions claiming substantial equivalence to a device which has been classified into class III under the Act:

(1) Which was introduced or delivered for introduction into interstate commerce for commercial distribution before December 1, 1990; and

(2) For which no final regulation requiring premarket approval has been issued under 21 U.S.C. § 360e(b), a summary of the types of safety and effectiveness problems associated with the type of devices being compared and a citation to the information upon which the summary is based (class III summary). The 21 U.S.C. § 360(k) submitter shall also certify that a reasonable search of all information known or otherwise available about the class III device and other similar legally marketed devices has been conducted (class III certification), as described in § 10518. This information does not refer to information that already has been submitted to the Department under the Act. Department may require the submission of the adverse safety and effectiveness data described in the class III summary or citation;

(k) A statement that the submitter believes, to the best of his or her knowledge, that all data and information submitted in the premarket notification is truthful and accurate and that no material fact has been omitted; and

(l) Any additional information regarding the device requested by the DOH that is necessary for the Department to make a finding as to whether or not the device is substantially equivalent to a device in commercial distribution. A request for additional information will advise the owner or operator that there is insufficient information contained in the original premarket notification submission for the Department to make this determination and that the owner or operator may either submit the requested data or a new premarket notification containing the requested information at least ninety (90) days before the owner or operator intends to market the device, or submit a premarket approval application in accordance with21 U.S.C. § 360e. If the additional information is not submitted within thirty (30) days following the date of the request, the Department will consider the premarket notification to be withdrawn.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10514

22-B DCMR § 10515 FORMAT OF A PREMARKET NOTIFICATION SUBMISSION

10515.1 Each premarket notification submission pursuant to this chapter shall be submitted in accordance with this section. Each submission shall:

Be addressed to the Department of Health, 899 North Capitol Street, NE, Washington, DC 20002; and

Be in writing and sent to the addresses above if it is an inquiry regarding a premarket notification submission.

10515.2 The premarket notification submission shall be:

Bound into a volume or volumes, where necessary;

Submitted in duplicate on standard size paper, including the original and two copies of the cover letter;

(d) Designated "21 U.S.C. § 360(k) Notification" in the cover letter.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10515

22-B DCMR § 10516 CONTENT AND FORMAT OF A 21 U.S.C. § 360(k) SUMMARY

10516.1 A 21 U.S.C. § 360(k) summary shall be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence. The Department will accept summaries as well as amendments thereto until such time as the Department issues a determination of substantial equivalence. All 21 U.S.C. § 360(k) summaries shall contain the following information:

The submitter's name, address, telephone number, a contact person, and the date the summary was prepared;

(b) The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known;

(c) An identification of the legally marketed device to which the submitter claims equivalence. A legally marketed device to which a new device may be compared for a determination regarding substantial equivalence is a device that was legally marketed prior to May 28, 1976, or a device which has been reclassified from class III to class II or I (the predicate), or a device which has been found to be substantially equivalent through the 21 U.S.C. § 360(k) premarket notification process;

(d) A description of the device that is the subject of the premarket notification submission, such as might be found in the labeling or promotional material for the device, including an explanation of how the device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device, such as device design, material used, and physical properties;

(e) A statement of the intended use of the device that is the subject of the premarket notification submission, including a general description of the diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate, including a description, where appropriate, of the patient population for which the device is intended. If the indication statements are different from those of the legally marketed device identified in Paragraph (c) in this subsection, the 21 U.S.C. § 360(k) summary shall contain an explanation as to why the differences are not critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device, and why the differences do not affect the safety and effectiveness of the device when used as labeled; and

(f) If the device has the same technological characteristics (for example, design, material, chemical composition, and energy source) as the predicate device identified in this section, a summary of the technological characteristics of the new device in comparison to those of the predicate device. If the device has different technological characteristics from the predicate device, a summary of how the technological characteristics of the device compare to a legally marketed device identified in this section.

10516.2 21 U.S.C. § 360(k) summaries for those premarket submissions in which a determination of substantial equivalence is also based on an assessment performance data shall contain the following information:

A brief discussion of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence;

A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence. This discussion shall include, where applicable, a description of the subjects upon whom the device was tested, a discussion of the safety or effectiveness data obtained from the testing, with specific reference to adverse effects and complications, and any other information from the clinical testing relevant to a determination of substantial equivalence; and

(c) The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in § 10516.1(c) of this section.

10516.3 The summary should be in a separate section of the submission, beginning on a new page and ending on a page not shared with any other section of the premarket notification submission, and should be clearly identified as a "21 U.S.C. § 360(k) summary."

10516.4 The summary shall contain any other information that the Department reasonably deems necessary.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10516

22-B DCMR § 10517 CONTENT AND FORMAT OF A 21 U.S.C. § 360(k) STATEMENT

10517.1 A 21 U.S.C. § 360(k) statement submitted as part of a premarket notification shall state as follows:

“I certify that, in my capacity as (the position held in company by person required to submit the premarket notification, preferably the official correspondent in the firm), of (company name), I will make available all information included in this premarket notification on safety and effectiveness within thirty (30) days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent. The information I agree to make available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret and confidential commercial information.”

10517.2 The statement in § 10517.1 should be signed by the certifier, made on a separate page of the premarket notification submission, and be clearly identified as the "21 U.S.C. § 360(k) statement."

10517.3 If information is requested by the public regarding the premarket notification § 10517.1, the request shall be made in writing to the certifier, whose name will be published by Department on the list of premarket notification submissions for which substantial equivalence determinations have been made.

10517.4 Information provided to requestors will be a duplicate of the premarket notification submission, including any adverse information, but excluding all patient identifiers, trade secrets and confidential commercial information as defined in this chapter.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10517

22-B DCMR § 10518 FORMAT OF A CLASS III CERTIFICATION

10518.1 A class III certification submitted as part of a premarket notification shall state as follows:

“I certify, in my capacity as (position held in company), of (company name), that I have conducted a reasonable search of all information known or otherwise available about the types and causes of safety or effectiveness problems that have been reported for the (type of device). I further certify that I am aware of the types of problems to which the (type of device) is susceptible and that, to the best of my knowledge, the following summary of the types and causes of safety or effectiveness problems about the (type of device) is complete and accurate.”

10518.2 The statement in § 10518.1 should be signed by the certifier, clearly identified as "class III certification," and included at the beginning of the section of the premarket notification submission that sets forth the class III summary.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10518

22-B DCMR § 10519 CONFIDENTIALITY OF INFORMATION

10519.1 The Department will disclose publicly whether there exists a premarket notification submission under this part:

(a) Where the device is on the market (such as, introduced or delivered for introduction into interstate commerce for commercial distribution);

(b) Where the person submitting the premarket notification submission discloses, through advertising or any other manner, his or her intent to market the device to scientists, market analysts, exporters, or other individuals who are not employees of, or paid consultants to, the establishment and who are not in an advertising or law firm pursuant to commercial arrangements with appropriate safeguards for secrecy; or

(c) Where the device is not on the market and the intent to market the device has not been so disclosed, except where the submission is subject to an exception under this section.

10519.2 The Department will not disclose publicly the existence of a premarket notification submission for a device that is not on the market and where the intent to market the device has not been disclosed for ninety (90) days from the date of receipt of the submission, if:

The person submitting the premarket notification submission requests in the submission that the Department holds as confidential commercial information the intent to market the device, and submits a written certification to the Department:

That the person considers his intent to market the device to be confidential commercial information;

That neither the person nor, to the best of his or her knowledge, anyone else, has disclosed through advertising or any other manner, his intent to market the device to scientists, market analysts, exporters, or other individuals, except employees of, or paid consultants to, the establishment or individuals in an advertising or law firm pursuant to commercial arrangements with appropriate safeguards for secrecy;

That the person will immediately notify the Department if he or she discloses the intent to market the device to anyone, except employees of, or paid consultants to, the establishment or individuals in an advertising or law firm pursuant to commercial arrangements with appropriate safeguards for secrecy;

That the person has taken precautions to protect the confidentiality of the intent to market the device; and

That the person understands that the submission to the government of false information is prohibited; and

The Department agrees that the intent to market the device is confidential commercial information.

10519.3 Where the Department determines that the person has complied with the procedures described in § 10519.2 with respect to a device that is not on the market and where the intent to market the device has not been disclosed, and the Department agrees that the intent to market the device is confidential commercial information, the Department will not disclose the existence of the submission for ninety (90) days from the date of its receipt by the agency. In addition, the Department will continue not to disclose the existence of such a submission for the device for an additional time when any of the following occurs:

(a) The Department requests in writing additional information regarding the device pursuant to § 10514(h), in which case the Department will not disclose the existence of the submission until ninety (90) days after Department’s receipt of a complete premarket notification submission; or

(b) The Department determines that the device intended to be introduced is a class III device and cannot be marketed without premarket approval or reclassification, in which case the Department will not disclose the existence of the submission unless a petition for reclassification is submitted under the Act and its existence can be disclosed under this chapter.

10519.4 The Department will make a 21 U.S.C. § 360(k) summary of the safety and effectiveness data available to the public within thirty (30) days of the issuance of a determination that the device is substantially equivalent to another device. Accordingly, even when a 21 U.S.C. § 360(k) submitter has complied with the conditions set forth in § 10519.2 and 10519.3, confidentiality for a premarket notification submission cannot be granted beyond thirty (30) days after the Department issues a determination of equivalency.

10519.5 Data or information submitted with, or incorporated by reference in, a premarket notification submission (other than safety and effectiveness data that have not been disclosed to the public) shall be available for disclosure by the Department when the intent to market the device is no longer confidential in accordance with this section, unless exempt from public disclosure. Upon final classification, data and information relating to safety and effectiveness of a device classified in class I (general controls) or class II (performance standards) shall be available for public disclosure. Data and information relating to safety and effectiveness of a device classified in class III (premarket approval) that have not been released to the public shall be retained as confidential unless such data and information become available for release to the public.

10519.6 The Department may not disclose, or use as the basis for reclassification of a device from class III to class II, any information reported to or otherwise obtained by the Department that falls within the exemption described for trade secrets and confidential commercial information. The exemption does not apply to data or information contained in a petition for reclassification submitted that has been determined to contain no deficiencies that prevent the Department from making a decision on it. Accordingly, all data and information contained in such petitions may be disclosed by the Department and used as the basis for reclassification of a device from class III to class II.

10519.7 For purposes of this section, safety and effectiveness data include data and results derived from all studies and tests of a device on animals and humans and from all studies and tests of the device itself intended to establish or determine its safety and effectiveness.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10519

22-B DCMR § 10520 MISBRANDING BY REFERENCE TO PREMARKET NOTIFICATION

10520.1 Submission of a premarket notification in accordance with this subsection, and a subsequent determination by the Department that the device intended for introduction into commercial distribution is substantially equivalent to a device in commercial distribution before May 28, 1976, or is substantially equivalent to a device introduced into commercial distribution after May 28, 1976, that has subsequently been reclassified into class I or II, does not in any way denote official approval of the device. Any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10520

22-B DCMR § 10521 DEPARTMENT OF HEALTH ACTION ON A PREMARKET NOTIFICATION

10521.1 After review of a premarket notification, the Department will:

Issue an order declaring the device to be substantially equivalent to a legally marketed predicate device;

Issue an order declaring the device to be not substantially equivalent to any legally marketed predicate device;

Request additional information;

Withhold the decision until a certification or disclosure statement is submitted to the Department; or

Advise the applicant that the premarket notification is not required. Until the applicant receives an order declaring a device substantially equivalent, the applicant may not proceed to market the device.

10521.2 The Department will determine that a device is substantially equivalent to a predicate device using the following criteria:

(a) The device has the same intended use as the predicate device; and

(b) The device:

(1) Has the same technological characteristics as the predicate device; or

(2) The device:

(A) Has different technological characteristics, such as a significant change in the materials, design, energy source, or other features of the device from those of the predicate device;

(B) The data submitted establishes that the device is substantially equivalent to the predicate device and contains information, including clinical data if deemed necessary by the DOH, that demonstrates that the device is as safe and as effective as a legally marketed device; and

(3) The predicate device has not been removed from the market at the initiative of the DOH or has not been determined to be misbranded or adulterated by a judicial order.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10521

22-B DCMR § 10599 DEFINITIONS

10599.1 As used in this chapter, the following terms shall have the meanings ascribed:

21 U.S.C. § 360(k) summary – a summary of any information respecting safety and effectiveness. A summary of the safety and effectiveness information contained in a premarket notification submission upon which a determination of substantial equivalence can be based. Safety and effectiveness information refers to safety and effectiveness data and information supporting a finding of substantial equivalence, including all adverse safety and effectiveness information.

21 U.S.C. § 360(k) statement – a statement asserting that all information in a premarket notification submission regarding safety and effectiveness will be made available within thirty (30) days of a request by any person if the device described in the premarket notification submission is determined to be substantially equivalent. The information to be made available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret or confidential commercial information.

Act – the Federal Food, Drug, and Cosmetic Act, approved June 25, 1938, 21 U.S.C. § 301, et seq.

Class III certification – a certification that the submitter as described in 21 U.S.C. § 360(k) has conducted a reasonable search of all known information about the class III device and other similar, legally marketed devices.

Class III summary–a summary of the types of safety and effectiveness problems associated with the type of device being compared and a citation to the information upon which the summary is based. The summary must be comprehensive and describe the problems to which the type of device is susceptible and the causes of such problems.

Classification – the term used by the Department and its classification panels to describe a device or class of devices for purposes of classifying devices.

Commercial distribution – any distribution of a device intended for human use which is held or offered for sale but does not include the following:

(a) Internal or interplant transfer of a device between establishments within the same parent, subsidiary, or affiliate company;

(b) Any distribution of a device intended for human use which has in effect an approved exemption for investigational use under 21 U.S.C. § 360j; or

(c) Any distribution of a device that was not introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, and that is classified into class III under 21 U.S.C. § 360c; provided that the device is intended solely for investigational use and is not required to have an approved premarket approval application.

Establishment – a place of business under one (1) management at one (1) general physical location at which a device is manufactured, assembled, or otherwise processed.

Initial importer – any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.

Manufacture, preparation, propagation, compounding, assembly, or processing of a device – the making by chemical, physical, biological, or other procedures of any article that meets the definition of device in 21 U.S.C. § 321(h). These terms include the following activities:

(a) Repackaging or otherwise changing the container, wrapper, or labeling of any device package in furtherance of the distribution of the device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer;

(b) Initial importation of devices manufactured in foreign establishments;

(c) Initiation of specifications for devices that are manufactured by a second party for subsequent commercial distribution by the person initiating specifications; or

(d) Initiation of specifications for devices that are manufactured by a second party for subsequent commercial distribution by the person initiating specifications

Material changes – any change or modification in the labeling or advertisements that affects the identity or safety and effectiveness of the device. These changes may include, but are not limited to, changes in the common or usual or proprietary name, declared ingredients or components, intended use, contraindications, warnings, or instructions for use. Changes that are not material may include graphic layouts, grammar, or correction of typographical errors which do not change the content of the labeling of, changes in lot number, and, for devices where the biological activity or known composition differs with each lot produced, the labeling containing the actual values for each lot.

Official correspondent – person designated by the owner or operator of an establishment who is responsible for the following:

(a) The annual registration of the establishment;

(b) Contact with the Department of Health for device listing;

(d) The receipt of pertinent correspondence from the Department directed to and involving the owner or operator or any of the firm’s establishments; and

(e) The annual certification of medical device reports or forwarding the certification form to the person designated by that the firm designates as responsible for the certification.

Owner or operator – the corporation, subsidiary, affiliated company, partnership, or proprietor directly responsible for the activities of the registering establishment.

Representative sampling of advertisements – typical advertising material that gives the promotional claims made for the device.

Restricted device – a device for which the Department, by regulation under § 10310 of this subtitle, or otherwise under 21 U.S.C. § 360j(e), has restricted sale, distribution, or use only upon the written or oral authorization of a practitioner licensed by law to administer or use the device or upon such other conditions as the Department may prescribe.

U.S.-designated agent – the person, residing in the United States, designated and authorized by the owner or operator of a foreign manufacturer who exports devices into the United States and is responsible for:

(a) Submitting medical device reporting (MDR ) reports;

(b) Submitting annual certifications;

(d) Submitting registration information;

(e) Submitting device listing information; and

(f) Submitting premarket notifications on behalf of the foreign manufacturer.

Wholesale distributor – any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10599

22-B106 PREMARKET APPROVAL OF MEDICAL DEVICES

22-B DCMR § 10600 SCOPE

10600.1 This section provides procedures for the premarket approval of medical devices intended for human use.

10600.2 This section applies to any class III medical device, unless exempt under 21 U.S.C. § 360j, that:

Was not on the market (introduced or delivered for introduction into commerce for commercial distribution) before May 28, 1976, and is not substantially equivalent to a device on the market before May 28, 1976, or to a device first marketed on, or after that date, which has been classified into class I or class II;

Is required to have an approved premarket approval application (PMA) or a declared completed product development protocol under a regulation issued under 21 U.S.C. § 360e(b); or

(c) Was regulated by the Department as a new drug or antibiotic drug before May 28, 1976, and therefore is governed by 21 U.S.C. § 360j(1).

10600.3 This part amends the conditions to approval for any premarket approval (PMA) approved before the effective date of this part. Any condition to approval for an approved PMA that is inconsistent with this part is revoked. Any condition to approval for an approved PMA that is consistent with this part remains in effect.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10600

22-B DCMR § 10601 PURPOSE

10601.1 The purpose of this part is to establish an efficient and thorough device review process that will:

Facilitate the approval of PMAs for devices that have been shown to be safe and effective and that otherwise meet the statutory criteria for approval; and

(b) Ensure the disapproval of PMAs for devices that have not been shown to be safe and effective or that do not otherwise meet the statutory criteria for approval.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10601

22-B DCMR § 10602 CONFIDENTIALITY OF DATA AND INFORMATION IN A PREMARKET APPROVAL APPLICATION (PMA) FILE

10602.1 A premarket approval application file (PMA file) includes all data and information submitted with or incorporated by reference in the PMA, any investigational device exemption (IDE) incorporated into the PMA, any PMA supplement, any report under § 10616, any master file, or any other related submission. Any record in the PMA file will be available for public disclosure in accordance with the provisions of this section. The confidentiality of information in a color additive petition submitted as part of a PMA is governed by § 10629.5.

10602.2 The existence of a PMA file may not be disclosed by the Department before an approval order is issued to the applicant unless it was previously publicly disclosed or acknowledged.

10602.3 If the existence of a PMA file has not been publicly disclosed or acknowledged, data or information in the PMA file are not available for public disclosure.

10602.4 If the existence of a PMA file has been publicly disclosed or acknowledged before an order approving, or an order denying approval of the PMA is issued, data or information contained in the file are not available for public disclosure before such order issues. DOH may, however, disclose a summary of portions of the safety and effectiveness data before an approval order or an order denying approval of the PMA issues if disclosure is relevant to public consideration of a specific pending issue.

10602.5 Notwithstanding § 10602.4, the Department will make available to the public upon request the information in the IDE that was required to be filed for investigations involving an exception from informed consent in § 10602.6. Persons wishing to request this information shall submit a request under the Freedom of Information Act of 1976, effective March 25, 1977 (D.C. Law 1-96, D.C. Official Code § 2-531, et seq. (2011 Repl. and 2012 Supp.)).

10602.6 The Institutional Research Board (IRB) responsible for the review, approval, and continuing review of the clinical investigation described in this section may approve that investigation without requiring that informed consent of all research subjects be obtained if the IRB (with the concurrence of a licensed physician who is a member of or consultant to the IRB and who is not otherwise participating in the clinical investigation) finds and documents each of the following:

(a) The human subjects are in a life-threatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized placebo-controlled investigations, is necessary to determine the safety and effectiveness of particular interventions;

(1) Obtaining informed consent is not feasible because:

(A) The subjects will not be able to give their informed consent as a result of their medical condition;

(B) The intervention under investigation must be administered before consent from the subjects' legally authorized representatives is feasible; and

(C) There is no reasonable way to identify prospectively the individuals likely to become eligible for participation in the clinical investigation;

(2) Participation in the research holds out the prospect of direct benefit to the subjects because:

(A) Subjects are facing a life-threatening situation that necessitates intervention;

(B) Appropriate animal and other preclinical studies have been conducted, and the information derived from those studies and related evidence support the potential for the intervention to provide a direct benefit to the individual subjects;

(C) Risks associated with the investigation are reasonable in relation to what is known about the medical condition of the potential class of subjects, the risks and benefits of standard therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity;

(D) The clinical investigation could not practicably be carried out without the waiver;

(E) The proposed investigational plan defines the length of the potential therapeutic window based on scientific evidence, and the investigator has committed to attempting to contact a legally authorized representative for each subject within that window of time and, if feasible, to asking the legally authorized representative contacted for consent within that window rather than proceeding without consent. The investigator will summarize efforts made to contact legally authorized representatives and make this information available to the IRB at the time of continuing review; and

(F) The IRB has reviewed and approved informed consent procedures and an informed consent document consistent with 21 C.F.R § 50.25. These procedures and the informed consent document are to be used with subjects or their legally authorized representatives in situations where use of such procedures and documents is feasible. The IRB has reviewed and approved procedures and information to be used when providing an opportunity for a family member to object to a subject's participation in the clinical investigation consistent with Paragraph (3)(E) of this subsection; and

(3) Additional protections of the rights and welfare of the subjects will be provided, including, at least:

(A) Consultation (including, where appropriate, consultation carried out by the IRB) with representatives of the communities in which the clinical investigation will be conducted and from which the subjects will be drawn;

(B) Public disclosure to the communities in which the clinical investigation will be conducted and from which the subjects will be drawn, prior to initiation of the clinical investigation, of plans for the investigation and its risks and expected benefits;

(C) Public disclosure of sufficient information following completion of the clinical investigation to apprise the community and researchers of the study, including the demographic characteristics of the research population, and its results;

(D) Establishment of an independent data monitoring committee to exercise oversight of the clinical investigation; and

(E) If obtaining informed consent is not feasible and a legally authorized representative is not reasonably available, the investigator has committed, if feasible, to attempting to contact within the therapeutic window the subject's family member who is not a legally authorized representative, and asking whether he or she objects to the subject's participation in the clinical investigation. The investigator will summarize efforts made to contact family members and make this information available to the IRB at the time of continuing review.

10602.7 The IRB is responsible for ensuring that procedures are in place to inform, at the earliest feasible opportunity, each subject, or if the subject remains incapacitated, a legally authorized representative of the subject, or if such a representative is not reasonably available, a family member, of the subject's inclusion in the clinical investigation, the details of the investigation and other information contained in the informed consent document. The IRB shall also ensure that there is a procedure to inform the subject, or if the subject remains incapacitated, a legally authorized representative of the subject, or if such a representative is not reasonably available, a family member, that he or she may discontinue the subject's participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. If a legally authorized representative or family member is told about the clinical investigation and the subject's condition improves, the subject is also to be informed as soon as feasible. If a subject is entered into a clinical investigation with waived consent and the subject dies before a legally authorized representative or family member can be contacted, information about the clinical investigation is to be provided to the subject's legally authorized representative or family member, if feasible.

10602.8 The IRB determinations required by § 10602.6 and the documentation required by § 10602.10 are to be retained by the IRB for at least three (3) years after completion of the clinical investigation, and the records shall be accessible for inspection and copying by the Department.

10602.9 Protocols involving an exception to the informed consent requirement under this section must be performed under a separate IND application or IDE that clearly identifies such protocols as protocols that may include subjects who are unable to consent. The submission of those protocols in a separate IND or IDE is required even if an IND for the same drug product or an IDE for the same device already exists. Applications for investigations under this section may not be submitted as amendments.

10602.10 If an IRB determines that it cannot approve a clinical investigation because the investigation does not meet the criteria in the exception provided under § 10602.6 or because of other relevant ethical concerns, the IRB shall document its findings and provide these findings promptly in writing to the clinical investigator and to the sponsor of the clinical investigation. The sponsor of the clinical investigation must promptly disclose this information to the Department and to the sponsor's clinical investigators who are participating or are asked to participate in this or a substantially equivalent clinical investigation of the sponsor, and to other IRBs that have been, or are, asked to review this or a substantially equivalent investigation by that sponsor.

10602.11 Upon issuance of an order approving, or an order denying approval of any PMA, the Department will make available to the public the fact of the existence of the PMA and a detailed summary of information submitted to the Department respecting the safety and effectiveness of the device that is the subject of the PMA and that is the basis for the order.

10602.12 After the Department issues an order approving, or an order denying approval of any PMA, the following data and information in the PMA file are immediately made available for public disclosure:

All safety and effectiveness data and information previously disclosed to the public, as such disclosure is defined in 21 C.F.R. § 20.81;

(b) Any protocol for a test or study unless the protocol is shown to constitute trade secret or confidential commercial or financial information under 21 C.F.R. § 20.61;

(c) Any adverse reaction report, product experience report, consumer complaint, and other similar data and information, after deletion of:

(1) Any information that constitutes trade secret or confidential commercial or financial information under 21 C.F.R. § 20.61; and

(2) Any personnel, medical, and similar information disclosure of which would constitute a clearly unwarranted invasion of personal privacy under 21 C.F.R. § 20.63; provided, however, that except for the information that constitutes trade secret or confidential commercial or financial information under 21 C.F.R. § 20.61, DOH will disclose to a patient who requests a report all the information in the report concerning that patient;

(d) A list of components previously disclosed to the public, as defined in 21 C.F.R. § 20.81;

(e) An assay method or other analytical method, unless it does not serve any regulatory purpose and is shown to fall within the exemption in 21 C.F.R. § 20.61 for trade secrets or confidential commercial or financial information; and

(f) All correspondence and written summaries of oral discussions relating to the PMA file.

10602.13 All safety and effectiveness data and other information not previously disclosed to the public are available for public disclosure if any one of the following events occurs and the data and information do not constitute trade secret or confidential commercial or financial information under 21 C.F.R. § 20.61:

The PMA has been abandoned. The Department will consider a PMA abandoned if:

The applicant fails to respond to a request for additional information within one hundred eighty (180) days after the date the Department issues the request; or

Other circumstances indicate that further work is not being undertaken with respect to it, and

The applicant fails to communicate with the Department within seven (7) days after the date on which the Department notifies the applicant that the PMA appears to have been abandoned.

An order denying approval of the PMA was issued and all legal appeals have been exhausted;

An order withdrawing approval of the PMA has issued, and all legal appeals have been exhausted;

The device has been reclassified;

The device has been found to be substantially equivalent to a class I or class II device; or

(f) The PMA is considered voluntarily withdrawn under § 10611 of this chapter.

10602.14 The following data and information in a PMA file are not available for public disclosure unless they have been previously disclosed to the public, or they relate to a device for which a PMA has been abandoned and they no longer represent a trade secret or confidential commercial or financial information as defined in 21 C.F.R. § 20.61:

(a) Manufacturing methods or processes, including quality control procedures;

(b) Production, sales, distribution, and similar data and information, except that any compilation of such data and information aggregated and prepared in a way that does not reveal data or information which are not available for public disclosure under this provision is available for public disclosure; or

10602.15 The procedure for trade secrets and commercial or financial information which is privileged or confidential shall be as follows:

(a) A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationship between the trade secret and the productive process;

(b) Commercial or financial information that is privileged or confidential means valuable data or information which is used in one's business and is of a type customarily held in strict confidence or regarded as privileged and not disclosed to any member of the public by the person to whom it belongs;

(c) Data and information submitted or divulged to the Department which falls within the definitions of a trade secret or confidential commercial or financial information are not available for public disclosure;

(d) A person who submits records to the Department may designate part or all of the information in such records as exempt from disclosure under exemption 4 of the Freedom of Information Act. The person may make this designation either at the time the records are submitted to the government or within a reasonable time thereafter. The designation must be in writing. Where a legend is required by a request for proposals or request for quotations, pursuant to 48 C.F.R. § 352.215-12, then that legend is necessary for this purpose. Any such designation will expire ten (10) years after the records are submitted to the Department;

(e) The procedures in this paragraph apply to records on which the submitter has designated information as provided in Paragraph (d) of this subsection. These procedures also apply to records that were submitted to the Department when the agency has substantial reason to believe that information in the records could reasonably be considered exempt under exemption 4 of the Freedom of Information Act. Certain exceptions to these procedures are set forth in Paragraph (f) of this subsection. In addition:

(1) When the Department receives a request for such records and determines that disclosure may be required, the Department will make reasonable efforts to notify the submitter about these facts. The notice will include a copy of the request, and it will inform the submitter about the procedures and time limits for submission and consideration of objections to disclosure. If the Department must notify a large number of submitters, notification may be done by posting or publishing a notice in a place where the submitters are reasonably likely to become aware of it;

(2) The submitter has five (5) working days from receipt of the notice to object to disclosure of any part of the records and to state all bases for its objections;

(3) The Department will give consideration to all bases that have been stated in a timely manner by the submitter. If the Department decides to disclose the records, the Department will notify the submitter in writing. This notice will briefly explain why the agency did not sustain the submitter's objections. The Department will include with the notice a copy of the records about which the submitter objected, as the agency proposes to disclose them. The notice will state that the Department intends to disclose the records five (5) working days after the submitter receives the notice unless a court orders the agency not to release them;

(4) If a requester files suit under the Freedom of Information Act to obtain records covered by this paragraph, the Department will promptly notify the submitter; and

(5) Whenever the Department sends a notice to a submitter under Paragraph (e)(1) of this subsection, the Department will notify the requester that the Department is giving the submitter a notice and an opportunity to object. Whenever the DOH sends a notice to a submitter under Paragraph (e)(3) of this subsection, the Department will notify the requester of this fact; and

(f) The notice requirements in Paragraph (e) of this subsection shall not apply in the following situations:

(1) The Department decided not to disclose the records;

(2) The information was published previously or made generally available;

(3) Disclosure is required by a regulation issued after notice and opportunity for public comment that specifies narrow categories of records that are to be disclosed under the Freedom of Information Act. In this case, however, a submitter may still designate records as described in Paragraph (d) of this subsection, and in exceptional cases, the Department may, at its discretion, follow the notice procedures in Paragraph (e) of this subsection;

(4) The submitter did not designate the information requested as exempt from disclosure when the submitter had an opportunity to do so at the time of submission of the information or within a reasonable time thereafter, unless the Department has substantial reason to believe that disclosure of the information would result in competitive harm; or

(5) The designation appears to be frivolous, but in this case the Department will still give the submitter the written notice required by Subsection (e)(3) (although this notice need not explain the Department’s decision or include a copy of the records), and the Department will notify the requester as described in Subsection (e)(5).

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10602

22-B DCMR § 10603 RESEARCH CONDUCTED OUTSIDE OF THE UNITED STATES

10603.1 A study conducted outside of the United States (U.S.) submitted in support of a PMA and conducted under an IDE shall comply with 21 C.F.R. § 812. A study conducted outside of the U.S. submitted in support of a PMA and not conducted under an IDE shall comply with the provisions in § 10424, as applicable.

10603.2 The Department will accept studies submitted in support of a PMA which have been conducted outside of the U.S. and begun on or after November 19, 1986, if the data are valid and the investigator conducted the studies in conformance with the "Declaration of Helsinki" or the laws and regulations of the country in which the research is conducted, whichever affords greater protection to the human subjects. If the standards of the country are used, the applicant shall state in detail any differences between those standards and the "Declaration of Helsinki" and explain why they offer greater protection to the human subjects.

10603.3 The Department will accept studies submitted in support of a PMA which have been conducted outside of the United States and begun before November 19, 1986, if the Department is satisfied that the data is scientifically valid and that the rights, safety, and welfare of human subjects have not been violated.

10603.4 A PMA based solely on foreign clinical data and otherwise meeting the criteria for approval under 21 C.F.R. § 812 may be approved if:

(a) The foreign data are applicable to the U.S. population and U.S. medical practice;

(b) The studies were performed by clinical investigators of recognized competence; and

(c) The data may be considered valid without the need for an on-site inspection by the Department or, if the Department considers such an inspection to be necessary, the Department can validate the data through an on-site inspection or other appropriate means.

10603.5 Applicants are encouraged to meet with the Department officials in a "pre-submission" meeting when approval based solely on foreign data will be sought.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10603

22-B DCMR § 10604 SERVICE OF ORDERS

10604.1 Orders issued under this subsection will be served in person by a designated officer or employee of the Department on, or by registered mail to, the applicant or the designated agent at the applicant's or designated agent's last known address in the Department's records.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10604

22-B DCMR § 10605 PRODUCT DEVELOPMENT PROTOCOL (PDP)

10605.1 A class III device for which a product development protocol (PDP) has been declared completed by the Department under this chapter will be considered to have an approved PMA.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10605

22-B DCMR § 10606 APPLICATION

10606.1 The applicant or an authorized representative shall sign the PMA. If the applicant does not reside or have a place of business within the United States, the PMA shall be countersigned by an authorized representative residing or maintaining a place of business in the United States and shall identify the representative's name and address.

10606.2 Unless the applicant justifies an omission in accordance with § 10606.4, a PMA shall include:

The name and address of the applicant;

A table of contents that specifies the volume and page number for each item referred to in the table. A PMA shall include separate sections on nonclinical laboratory studies and on clinical investigations involving human subjects. A PMA shall be submitted in six (6) copies each bound in one (1) or more numbered volumes of reasonable size. The applicant shall include information that it believes to be a trade secret or confidential commercial or financial information in all copies of the PMA and identify in at least one (1) copy the information that it believes to be trade secret or confidential commercial or financial information;

A summary in sufficient detail that the reader may gain a general understanding of the data and information in the application. The summary shall contain the following information:

(1) A general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended;

(2) An explanation of how the device functions, the basic scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device. A brief description of the manufacturing process should be included if it will significantly enhance the reader's understanding of the device. The generic name of the device as well as any proprietary name or trade name should be included;

(3) A description of existing alternative practices or procedures for diagnosing, treating, preventing, curing, or mitigating the disease or condition for which the device is intended;

(4) A brief description of the foreign and U.S. marketing history, if any, of the device, including a list of all countries in which the device has been marketed and a list of all countries in which the device has been withdrawn from marketing for any reason related to the safety or effectiveness of the device. The description shall include the history of the marketing of the device by the applicant and, if known, the history of the marketing of the device by any other person;

(5) An abstract of any information or report described in the PMA and a summary of the results of technical data. Such summary shall include a description of the objective of the study, a description of the experimental design of the study, a brief description of how the data was collected and analyzed, and a brief description of the results, whether positive, negative, or inconclusive. This section shall include the following:

A summary of the nonclinical laboratory studies submitted in the application; and

(B) A summary of the clinical investigations involving human subjects submitted in the application including a discussion of subject selection and exclusion criteria, study population, study period, safety and effectiveness data, adverse reactions and complications, patient discontinuation, patient complaints, device failures and replacements, results of statistical analyses of the clinical investigations, contraindications and precautions for use of the device, and other information from the clinical investigations as appropriate (any investigation conducted under an IDE shall be identified as such); and

(6) A discussion demonstrating that the data and information in the application constitute valid scientific evidence and provide reasonable assurance that the device is safe and effective for its intended use. A concluding discussion shall present benefit and risk considerations related to the device including a discussion of any adverse effects of the device on health and any proposed additional studies or surveillance the applicant intends to conduct following approval of the PMA;

A complete description of:

The device, including pictorial representations;

(2) Each of the functional components or ingredients of the device if the device consists of more than one (1) physical component or ingredient;

(3) The properties of the device relevant to the diagnosis, treatment, prevention, cure, or mitigation of a disease or condition;

(4) The principles of operation of the device; and

(5) The methods used in, and the facilities and controls used for, the manufacture, processing, packing, storage, and, where appropriate, installation of the device, in sufficient detail so that a person generally familiar with current good manufacturing practice can make a knowledgeable judgment about the quality control used in the manufacture of the device;

Reference to any performance standard under 21 U.S.C. § 360d or under 21 U.S.C. § 360hh in effect or proposed at the time of the submission and to any voluntary standard that is relevant to any aspect of the safety or effectiveness of the device and that is known to or that should reasonably be known to the applicant. The applicant shall:

(1) Provide adequate information to demonstrate how the device meets, or justify any deviation from, any performance standard established under 21 U.S.C. § 360d or under 21 U.S.C. § 360kk; and

Explain any deviation from a voluntary standard;

The following technical sections which shall contain data and information in sufficient detail to permit the Department to determine whether to approve or deny approval of the application:

(1) A section containing results of the nonclinical laboratory studies with the device including microbiological, toxicological, immunological, biocompatibility, stress, wear, shelf life, and other laboratory or animal tests as appropriate. Information on nonclinical laboratory studies shall include a statement that each such study was conducted in compliance with 21 C.F.R. part 58, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance;

(2) A section containing results of the clinical investigations involving human subjects with the device including clinical protocols, number of investigators and subjects per investigator, subject selection and exclusion criteria, study population, study period, safety and effectiveness data, adverse reactions and complications, patient discontinuation, patient complaints, device failures and replacements, tabulations of data from all individual subject report forms and copies of such forms for each subject who died during a clinical investigation or who did not complete the investigation, results of statistical analyses of the clinical investigations, device failures and replacements, contraindications and precautions for use of the device, and any other appropriate information from the clinical investigations. Any investigation conducted under an IDE shall be identified as such. Information on clinical following:

(A) A statement with respect to each study that it either was conducted in compliance with the institutional review board regulations in 21 C.F.R. part 56, or was not subject to the regulations under 21 C.F.R. § 56.104 or 21 C.F.R. § 56.105, and that it was conducted in compliance with the informed consent regulations in 21 C.F.R., part 50; or if the study was not conducted in compliance with those regulations, a brief statement of the reason for the noncompliance; or

A statement that each study was conducted in compliance with Chapter 109 of this subtitle concerning sponsors of clinical investigations and clinical investigators, or if the study was not conducted in compliance, a brief statement of the reason for the noncompliance.

For a PMA supported solely by data from one (1) investigation, a justification showing that data and other information from a single investigator are sufficient to demonstrate the safety and effectiveness of the device and to ensure reproducibility of test results;

(h) A bibliography of all published reports not submitted under § 10606.2(f), whether adverse or supportive, known to or that should reasonably be known to the applicant and that concern the safety or effectiveness of the device;

(i) An identification, discussion, and analysis of any other data, information, or report relevant to an evaluation of the safety and effectiveness of the device known to or that should reasonably be known to the applicant from any source, foreign or domestic, including information derived from investigations other than those proposed in the application and from commercial marketing experience;

(j) Copies of such published reports or unpublished information in the possession of or reasonably obtainable by the applicant if a Department advisory committee or the Department requests;

(k) One or more samples of the device and its components, if requested by the Department. If it is impractical to submit a requested sample of the device, the applicant shall name the location at which the Department may examine and test one or more devices;

(l) Copies of all proposed labeling for the device. Such labeling may include (for example, instructions for installation and any information, literature, or advertising that constitutes labeling under 21 U.S.C. § 321(m);

(m) An environmental assessment prepared in the applicable format in § 10606.2(m)(1), unless the action qualifies for exclusion under § 10606.2(m)(2). If the applicant believes that the action qualifies for exclusion, the PMA shall provide information that establishes to the Department's satisfaction that the action requested is included within the excluded category and meets the criteria for the applicable exclusion;

(1) The following shall apply to environmental assessments:

(A) An environmental assessment (EA) is a concise public document that serves to provide sufficient evidence and analysis for an agency to determine whether to prepare an environmental impact statement (EIS) or a finding of no significant impact (FONSI). The EA shall include brief discussions of the need for the proposal, of alternatives, of the environmental impacts of the proposed action and alternatives, and a listing of agencies and persons consulted. An EA shall be prepared for each action not categorically excluded. The EA shall focus on relevant environmental issues relating to the use and disposal from use of Department-regulated articles and shall be a concise, objective, and well-balanced document that allows the public to understand the agency's decision. If potentially adverse environmental impacts are identified for an action or a group of related actions, the EA shall discuss any reasonable alternative course of action that offers less environmental risk or that is environmentally preferable to the proposed action. The use of a scientifically justified tiered testing approach, in which testing may be stopped when the results suggest that no significant impact will occur, is an acceptable approach;

(B) Generally, the Department requires an applicant to prepare an EA and make necessary corrections to it. Ultimately, the Department is responsible for the scope and content of EAs and may include additional information in environmental documents when warranted;

(C) Information concerning the nature and scope of information that an applicant or petitioner shall submit in an EA may be obtained from the center or other office of the agency having responsibility for the action that is the subject of the environmental evaluation. Applicants and petitioners are encouraged to submit proposed protocols for environmental studies for technical review by agency staff. Applicants and petitioners also are encouraged to consult applicable Department EA guidance documents, which provide additional advice on how to comply with Department regulations;

(D) EAs may incorporate by reference information presented in other documents that are available to the Department and to the public; and

(E) The Department evaluates the information contained in an EA and any public input to determine whether it is accurate and objective, whether the proposed action may significantly affect the quality of the human environment, and whether an EIS or a FONSI will be prepared. The Department examines the environmental risks of the proposed action and the alternative courses of action, selects a course of action, and ensures that any necessary mitigating measures are implemented as a condition for approving the selected course of action; and

(2) The classes of actions listed below are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or EIS:

(A) Action on a device premarket notification submission under Chapter 105 of this subtitle;

(B) Classifications or reclassifications of a device;

(C) Issuance, amendment, or repeal of a standard for a class II medical device or an electronic product, and issuance of exemptions or variances from such a standard;

(D) Approval of a PMA or a notice of completion of a PDP or amended or supplemental applications or notices for a class III medical device if the device is of the same type and for the same use as a previously approved device;

(E) Changes in the PMA or a notice of completion of a PDP for a class III medical device that do not require submission of an amended or supplemental application or notice;

(F) Issuance of a restricted device regulation if it will not result in increases in the existing levels of use or changes in the intended uses of the product or its substitutes;

(G) Action on an application for an IDE or an authorization to commence a clinical investigation under an approved PDP; and

(H) Issuance of a regulation exempting from preemption a requirement of a State or political subdivision concerning a device, or a denial of an application for such exemption.

(n) A financial certification, disclosure statement, or both; and

(o) If necessary, the Department will obtain the concurrence of the appropriate Department advisory committee before requesting additional information.

10606.3 Pertinent information in Department files specifically referred to by an applicant may be incorporated into a PMA by reference. Information in a master file or other information submitted to the Department by a person other than the applicant will not be considered part of a PMA unless such reference is authorized in writing by the person who submitted the information or the master file. If a master file is not referenced within five (5) years after the date that it is submitted to the Department, the Department will return the master file to the person who submitted it.

10606.4 If the applicant believes that certain information required under § 10606.2(m) of this section to be in a PMA is not applicable to the device that is the subject of the PMA, and omits any such information from its PMA, the applicant shall submit a statement that identifies the omitted information and justifies the omission. The statement shall be submitted as a separate section in the PMA and identified in the table of contents. The Department will notify the applicant if it does not accept their justification for omission.

10606.5 The applicant shall periodically update its pending application with new safety and effectiveness information learned about the device from ongoing or completed studies that may reasonably affect an evaluation of the safety or effectiveness of the device or that may reasonably affect the statement of contraindications, warnings, precautions, and adverse reactions in the draft labeling. The update report shall be consistent with the data reporting provisions of the protocol. The applicant shall submit three (3) copies of any update report and shall include in the report that number that the Department assigns to the PMA. These updates are considered to be amendments to the PMA. The timeframe for reviewing the PMA will not be extended due to the submission of an update report unless the update is a major amendment under 21 C.F.R. § 814.37(c)(1). The applicant shall submit these reports:

Three (3) months after the filing date;

Following receipt of an approvable letter; and

At any other time as requested by the Department.

10606.6 If a color additive subject to Section 721 of the Act is used in or on the device and has not previously been listed for such use, then, submitting a color additive petition under 21 CFR, part 71, at the option of the applicant, the information may be submitted under 21 CFR, part 71 as part of the PMA. When submitted as part of the PMA, the information shall be submitted in three (3) copies each bound in one or more numbered volumes of reasonable size. A PMA for a device that contains a color additive that is subject to Section 721 of the Act will not be approved until the color additive is listed for use in or on the device.

10606.7 If you are sending a PMA, PMA amendment, PMA supplement, or correspondence with respect to a PMA, you must send the submission to the Department.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10606

22-B DCMR § 10607 PREMARKET APPROVAL APPLICATION AMENDMENTS AND RESUBMITTED PREMARKET APPROVAL APPLICATION

10607.1 An applicant may amend a pending PMA or PMA supplement to revise existing information or provide additional information.

10607.2 The Department may request the applicant to amend a PMA or PMA supplement with any information regarding the device that is necessary for the Department or the appropriate advisory committee to complete the review of the PMA or PMA supplement.

10607.3 A PMA amendment submitted to DOH shall include the PMA or PMA supplement number assigned to the original submission and, if submitted on the applicant's own initiative, the reason for submitting the amendment. The Department may extend the time required for its review of the PMA, or PMA supplement, as follows:

If the applicant on its own initiative or at the Department's request submits a major PMA amendment (for example, an amendment that contains significant new data from a previously unreported study, significant updated data from a previously reported study, detailed new analyses of previously submitted data, or significant required information previously omitted), the review period may be extended up to one hundred eighty (180) days; or

(b) If an applicant declines to submit a major amendment that the Department requests, the review period may be extended for the number of days that elapse between the date of such request and the date that DOH receives the written response declining to submit the requested amendment.

10607.4 An applicant may on its own initiative withdraw a PMA or PMA supplement. If the Department requests an applicant to submit a PMA amendment and a written response to the Department's request is not received within one hundred eighty (180) days of the date of the request, the Department will consider the pending PMA or PMA supplement to be withdrawn voluntarily by the applicant.

10607.5 An applicant may resubmit a PMA or PMA supplement after withdrawing it or after it is considered withdrawn under § 10607.4, or after the Department has refused to accept it for filing, or has denied approval of the PMA or PMA supplement. A resubmitted PMA or PMA supplement shall comply with the requirements of § 10606 or § 10608, respectively, and shall include the PMA number assigned to the original submission and the applicant's reasons for resubmission of the PMA or PMA supplement.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10607

22-B DCMR § 10608 PREMARKET APPROVAL APPLICATION SUPPLEMENTS

10608.1 After the Department's approval of a PMA, an applicant shall submit a PMA supplement for review and approval by the Department before making a change affecting the safety or effectiveness of the device for which the applicant has an approved PMA, unless the change is of a type for which the Department, under § 10608.6 of this section, has advised that an alternate submission is permitted or is of a type which, under 21 U.S.C. § 360e(d)(6)(A) and § 10608.7, do not require a PMA supplement under this paragraph. While the burden for determining whether a supplement is required is primarily on the PMA holder, changes for which an applicant shall submit a PMA supplement include, but are not limited to, the following types of changes if they affect the safety or effectiveness of the device:

New indications for use of the device;

Labeling changes;

The use of a different facility or establishment to manufacture, process, or package the device;

Changes in sterilization procedures;

Changes in packaging;

(f) Changes in the performance or design specifications, circuits, components, ingredients, principle of operation, or physical layout of the device; and

(g) Extension of the expiration date of the device based on data obtained under a new or revised stability or sterility testing protocol that the Department has not approved. If the protocol has been approved, the change shall be reported to the Department under § 10608.2.

10608.2 An applicant may make a change in a device after the Department's approval of a PMA for the device without submitting a PMA supplement if the change does not affect the device's safety or effectiveness and the change is reported to the Department in post-approval periodic reports required as a condition to approval of the device (for example, an editorial change in labeling which does not affect the safety or effectiveness of the device).

10608.3 All procedures and actions that apply to an application under § 10606 also apply to PMA supplements except that the information required in a supplement is limited to that needed to support the change. A summary under 21 C.F.R. § 814.20(b)(3) is required for only a supplement submitted for new indications for use of the device, significant changes in the performance or design specifications, circuits, components, ingredients, principles of operation, or physical layout of the device, or when otherwise required by the Department. The applicant shall submit three copies of a PMA supplement and shall include information relevant to the proposed changes in the device. A PMA supplement shall include a separate section that identifies each change for which approval is being requested and explains the reason for each such change. The applicant shall submit additional copies and additional information if requested by the Department. The time frames for review of, and Department action on, a PMA supplement are the same as those provided in § 10609 for a PMA.

10608.4 After the Department approves a PMA, any change described in § 10608.5 of this section to reflect newly acquired information that enhances the safety of the device or the safety in the use of the device may be placed into effect by the applicant prior to the receipt under § 10604 of a written Department order approving the PMA supplement provided that:

The PMA supplement and its mailing cover are plainly marked "Special PMA Supplement -- Changes Being Effected;"

(b) The PMA supplement provides a full explanation of the basis for the changes;

(d) The PMA supplement specifically identifies the date that such changes are being effected.

10608.5 The following changes are permitted by § 10608.4:

Labeling changes that add or strengthen a contraindication, warning, precaution, or information about an adverse reaction for which there is reasonable evidence of a causal association;

Labeling changes that add or strengthen an instruction that is intended to enhance the safe use of the device;

(d) Changes in quality controls or manufacturing process that add a new specification or test method, or otherwise provide additional assurance of purity, identity, strength, or reliability of the device.

10608.6 The Department will identify a change to a device for which an applicant has an approved PMA and for which a PMA supplement under § 10608.1 is not required. The Department will identify such a change in an advisory opinion under 21 C.F.R. § 10.85, if the change applies to a generic type of device, or in correspondence to the applicant, if the change applies only to the applicant's device. The Department will require that a change for which a PMA supplement under § 10608 is not required be reported to DOH in:

A periodic report under § 10617; or

A thirty (30)-day PMA supplement.

10608.7 The Department will identify, in the advisory opinion or correspondence, the type of information that is to be included in the report or thirty (30)-day PMA supplement. If the change is required to be reported to the Department in a periodic report, the change may be made before it is reported to the Department. If the change is required to be reported in a thirty (30)-day PMA supplement, the change may be made thirty (30) days after DOH files the thirty (30)-day PMA supplement unless the Department requires the PMA holder to provide additional information, informs the PMA holder that the supplement is not approvable, or disapproves the supplement. The thirty (30)-day PMA supplement shall follow the instructions in the correspondence or advisory opinion. Any thirty (30)-day PMA supplement that does not meet the requirements of the correspondence or advisory opinion will not be filed and, therefore, will not be deemed approved thirty (30) days after receipt.

10608.8 Under 21 U.S.C. § 360e(d) of the act, modifications to manufacturing procedures or methods of manufacture that affect the safety and effectiveness of a device subject to an approved PMA do not require submission of a PMA supplement his section and are eligible to be the subject of a thirty (30) day notice. A thirty (30) day notice shall describe in detail the change, summarize the data or information supporting the change, and state that the change has been made in accordance with the requirements of Chapter 107 of this subtitle. The manufacturer may distribute the device thirty (30) days after the date on which DOH receives the thirty (30) day notice, unless DOH notifies the applicant within thirty (30) days from receipt of the notice that the notice is not adequate. If the notice is not adequate, the Department will inform the applicant in writing that a one hundred thirty five (135) day PMA supplement is needed and shall describe what further information or action is required for acceptance of such change. The number of days under review as a thirty (30) day notice shall be deducted from the one hundred thirty five (135) day PMA supplement review period if the notice meets appropriate content requirements for a PMA supplement.

10608.9 The submission and grant of a written request for an exception or alternative under § 10313 or 21 C.F.R. § 809.11 satisfies the requirement in § 10608.1.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10608

22-B DCMR § 10609 TIME FRAME FOR REVIEWING A PREMARKET APPROVAL APPLICATION

10609.1 Within one hundred eighty (180) days after receipt of an application that is accepted for filing and to which the applicant does not submit a major amendment, the Department will review the PMA and, after receiving the appropriate Department advisory committee’s report and recommendations, send the applicant an approval order under 21 C.F.R. § 814.44(d)(1), an approvable letter under 21 C.F.R. § 814.44(e), a not approvable letter under 21 C.F.R. § 814.44(f)(1) or (2), or an order denying approval under 21 C.F.R. § 814.45. The approvable letter and the not approvable letter will provide an opportunity for the applicant to amend or withdraw the application, or to consider the letter to be a denial of approval of the PMA under 21 C.F.R. § 814.45 and to request administrative review under Sections 21 U.S.C. §§ 360e(d)(3) and (g).

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10609

22-B DCMR § 10610 FILING A PREMARKET APPROVAL APPLICATION

10610.1 The filing of an application means that the Department has made a threshold determination that the application is sufficiently complete to permit a substantive review. Within forty five (45) days the Department receives a PMA, the agency will notify the applicant whether the application has been filed.

10610.2 If the Department does not find that any of the reasons in § 10610.5 for refusing to file the PMA application, the agency will file the PMA and will notify the applicant in writing of the filing. The notice will include the PMA reference number and the date the Department filed the PMA. The date of filing is the date that DOH receives a PMA. The one hundred eighty (180) day period for review of a PMA starts on the date of filing.

10610.3 If the Department refuses to file a PMA, the agency will notify the applicant of the reasons for the refusal. This notice will identify the deficiencies in the application that prevent filing and will include the PMA reference number.

10610.4 If the Department refuses to file the PMA, the applicant may:

(a) Resubmit the PMA with additional information necessary to comply with § 10606. A resubmitted PMA shall include the PMA reference number of the original submission. If the resubmitted PMA is accepted for filing, the date of filing is the date the Department receives the resubmission; or

(b) Request in writing within ten (10) working days of the date of receipt of the notice refusing to file the PMA, an informal conference with the Department to review the Department's decision not to file the PMA. The Department will hold the informal conference within ten (10) working days of its receipt of the request and will render its decision on filing within five (5) working days after the informal conference. If, after the informal conference, the Department accepts the PMA for filing, the date of filing will be the date of the decision to accept the PMA for filing. If the Department does not reverse its decision not to file the PMA, the applicant may request reconsideration of the decision from the Department. The Department’s decision will constitute final administrative action for the purpose of judicial review.

10610.5 The Department may refuse to file a PMA if any of the following applies:

The application is incomplete because it does not on its face contain all the information required;

The PMA does not contain each of the items required under § 10606 and justification for omission of any item is inadequate;

(c) The applicant has a pending premarket notification with respect to the same device, and the Department has not determined whether the device falls within the scope of 21 C.F.R. § 814.1(c)(1)-(3);

The PMA contains a false statement of material fact; or

(e) The PMA is not accompanied by a statement of either certification or disclosure.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10610

22-B DCMR § 10611 PROCEDURES FOR REVIEW OF A PREMARKET APPROVAL APPLICATION

10611.1 The Department will begin substantive review of a PMA after the PMA is accepted for filing under § 10610. The Department may refer the PMA to a panel on its own initiative, and will do so upon request of an applicant, unless the Department determines that the application substantially duplicates information previously reviewed by a panel. If the Department refers an application to a panel, the Department will forward the PMA, or relevant portions thereof, to each member of the appropriate Department panel for review. During the review process, the Department may communicate with the applicant as set forth under 21 C.F.R. § 814.37(b), or with a panel to respond to questions that may be posed by panel members or to provide additional information to the panel. The Department shall maintain a record of all communications with the applicant and with the panel.

10611.2 The advisory committee shall submit a report to the Department which includes the committee's recommendation and the basis for such recommendation on the PMA. Before submission of this report, the committee shall hold a public meeting to review the PMA. This meeting may be held by a telephone conference under 21 C.F.R. § 14.22(g). The advisory committee report and recommendation may be in the form of a meeting transcript signed by the chairperson of the committee.

10611.3 The Department will complete its review of the PMA and the advisory committee report and recommendation and, within the later of one hundred eighty (180) days from the date of filing of the PMA under 21 C.F.R. § 814.42 or the number of days after the date of filing as determined under 21 C.F.R. § 814.37(c)(1)-(2), issue an approval order under 21 C.F.R. § 814.44(d), an approvable letter under 21 C.F.R. § 814.44(e), a not approvable letter under 21 C.F.R. § 814.44(f), or an order denying approval of the application under 21 C.F.R. § 814.45(a)(1)-(5).

10611.4 The Department will issue to the applicant an order approving a PMA if none of the reasons in 21 C.F.R. § 814.45(a) for denying approval of the application applies. The Department will approve an application on the basis of draft final labeling if the only deficiencies in the application concern editorial or similar minor deficiencies in the draft final labeling. Such approval will be conditioned upon the applicant incorporating the specified labeling changes exactly as directed and upon the applicant submitting to the Department a copy of the final printed labeling before marketing. The Department will also give the public notice of the order, including notice of and opportunity for any interested persons to request review under 21 U.S.C. § 360e(d)(3).

10611.5 The notice of approval will be placed on the Department's website and it will state that a detailed summary of information respecting the safety and effectiveness of the device, which was the basis for the order approving the PMA, including information about any adverse effects of the device on health, is available on the Internet and has been placed on public display, and that copies are available upon request. The Department will publish after each quarter a list of the approvals announced in that quarter. When a notice of approval is published, data and information in the PMA file will be available for public disclosure in accordance with § 10602.

10611.6 A request for copies of the current PMA approvals and denials document and for copies of summaries of safety and effectiveness shall be sent in writing to the Department.

10611.7 The Department will send the applicant an approvable letter if the application substantially meets the requirements of this section and the agency believes it can approve the application if specific additional information is submitted or specific conditions are agreed to by the applicant.

10611.8 The approvable letter will describe the information the Department requires to be provided by the applicant or the conditions the applicant is required to meet to obtain approval. For example, the Department may require, as a condition to approval:

The submission of certain information identified in the approvable letter (for example, final labeling);

A Department inspection that finds the manufacturing facilities, methods, and controls in compliance with Chapter 107 and, if applicable, that verifies records pertinent to the PMA;

Restrictions imposed on the device; or

Post-approval requirements as described in 21 C.F.R. § 814.80, et seq.

10611.9 In response to an approvable letter the applicant may:

Amend the PMA as requested in the approvable letter;

Consider the approvable letter to be a denial of approval of the PMA under § 10612 and request administrative review under 21 U.S.C. § 360e(d)(3) by filing a petition in the form of a petition for reconsideration; or

Withdraw the PMA.

10611.10 The Department will send the applicant a not approvable letter if the agency believes that the application may not be approved for one or more of the reasons given in 21 C.F.R. § 814.45(a)(1)-(5). The not approvable letter will describe the deficiencies in the application, including each applicable ground for denial, and, where practical, will identify measures required to place the PMA in approvable form. In response to a not approvable letter, the applicant may:

Amend the PMA as requested in the not approvable letter (such an amendment will be considered a major amendment under 21 C.F.R. § 814.37(c)(1)-(2); or

Consider the not approvable letter to be a denial of approval of the PMA under § 10612 and request administrative review by filing a petition in the form of a petition for reconsideration; or

Withdraw the PMA.

10611.11 DOH will consider a PMA to have been withdrawn voluntarily if:

The applicant fails to respond in writing to a written request for an amendment within one hundred eighty (180) days after the date the Department issues such request;

The applicant fails to respond in writing to an approvable or not approvable letter within one hundred eighty (180) days after the date the Department issues such letter; or

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10611

22-B DCMR § 10612 DENIAL OF APPROVAL OF A PREMARKET APPROVAL APPLICATION

10612.1 The Department may issue an order denying approval of a PMA if the applicant fails to follow the requirements of this section or if, upon the basis of the information submitted in the PMA or any other information before the agency, the Department determines that any of the grounds for denying approval of a PMA specified in 21 U.S.C. §§ 360e(d)(2)(A)-(E) of the act, apply. In addition, the Department may deny approval of a PMA for any of the following reasons:

The PMA contains a false statement of material fact;

The device's proposed labeling does not comply with the requirements in Chapter 103 of this subtitle;

The applicant does not permit an authorized Department employee an opportunity to inspect at a reasonable time and in a reasonable manner the facilities, controls, and to have access to and to copy and verify all records pertinent to the application;

(d) A nonclinical laboratory study that is described in the PMA and that is essential to show that the device is safe for use under the conditions prescribed, recommended, or suggested in its proposed labeling, was not conducted in compliance with the good laboratory practice regulations and no reason for the noncompliance is provided or, if it is, the differences between the practices used in conducting the study and the good laboratory practice regulations do not support the validity of the study; or

(e) Any clinical investigation involving human subjects described in the PMA, subject to the institutional review board regulations or informed consent regulations, was not conducted in compliance with those regulations such that the rights or safety of human subjects were not adequately protected.

10612.2 The Department will issue any order denying approval of the PMA in accordance with § 10604. The order will inform the applicant of the deficiencies in the PMA, including each applicable ground for denial under 21 U.S.C. § 360e(d)(2) and the regulations under this section, and, where practical, will identify measures required to place the PMA in approvable form. The order will include a notice of an opportunity to request review under 21 U.S.C. § 360e(d)(4).

10612.3 The Department will determine the safety and effectiveness of a device in deciding whether to approve or deny approval of a PMA. DOH may use information other than that submitted by the applicant in making such determination.

10612.4 The Department will give the public notice of an order denying approval of the PMA. The notice will be placed on the Department's website and it will state that a detailed summary of information respecting the safety and effectiveness of the device, including information about any adverse effects of the device on health, is available on the website and has been placed on public display and that copies are available upon request. The Department will publish after each quarter a list of the denials announced in that quarter. When a notice of denial of approval is made publicly available, data and information in the PMA file will be available for public disclosure under § 10602.

10612.5 A request for copies of the current PMA approvals and denials document and copies of summaries of safety and effectiveness shall be sent in writing to the Department.

10612.6 The Department will issue an order denying approval of a PMA after an approvable or not approvable letter has been sent and the applicant:

Submits a requested amendment but any ground for denying approval of the application under 21 U.S.C. § 360e(d)(2) still applies; or

Notifies the Department in writing that the requested amendment will not be submitted; or

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10612

22-B DCMR § 10613 WITHDRAWAL OF APPROVAL OF A PREMARKET APPROVAL APPLICATION

10613.1 The Department may issue an order withdrawing approval of a PMA if, from any information available to the agency, the Department determines that:

Any of the grounds under 21 U.S.C. §§ 360e(e)(1) (A)-(G) applies;

Any post-approval requirement imposed by the PMA approval order or by regulation has not been met;

(c) A nonclinical laboratory study that is described in the PMA and that is essential to show that the device is safe for use under the conditions prescribed, recommended, or suggested in its proposed labeling, was not conducted in compliance with the good laboratory practice regulations and no reason for the noncompliance is provided or, if it is, the differences between the practices used in conducting the study and the good laboratory practice regulations do not support the validity of the study; or

(d) Any clinical investigation involving human subjects described in the PMA, subject to the institutional review board regulations in § 10630 or informed consent regulations, was not conducted in compliance with those regulations such that the rights or safety of human subjects were not adequately protected.

10613.2 The Department may seek advice on scientific matters from any appropriate Department advisory committee in deciding whether to withdraw approval of a PMA.

10613.3 The Department may use information other than that submitted by the applicant in deciding whether to withdraw approval of a PMA.

10613.4 Before issuing an order withdrawing approval of a PMA, the Department will issue the holder of the approved application a notice of opportunity for an informal hearing under 21 C.F.R., part 16.

10613.5 If the applicant does not request a hearing or if after the hearing is held the agency decides to proceed with the withdrawal, the Department will issue to the holder of the approved application an order withdrawing approval of the application. The order will be issued under § 10604, will state each ground for withdrawing approval, and will include a notice of an opportunity for administrative review under 21 U.S.C. § 360e (e)(2).

10613.6 The Department will give the public notice of an order withdrawing approval of a PMA. The notice will be published and will state that a detailed summary of information respecting the safety and effectiveness of the device, including information about any adverse effects of the device on health, has been placed on public display and that copies are available upon request. When a notice of withdrawal of approval is published, data and information in the PMA file will be available for public disclosure in accordance with § 10602.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10613

22-B DCMR § 10614 TEMPORARY SUSPENSION OF APPROVAL OF A PREMARKET APPROVAL APPLICATION

10614.1 This section describes the procedures that the Department will follow in exercising its authority under 21 U.S.C. § 360c(e)(3). This authority applies to the original PMA, as well as any PMA supplement(s), for a medical device.

10614.2 The Department will issue an order temporarily suspending approval of a PMA if the Department determines that there is a reasonable probability that continued distribution of the device would cause serious, adverse health consequences or death.

10614.3 If the Department believes that there is a reasonable probability that the continued distribution of a device subject to an approved PMA would cause serious, adverse health consequences or death, the Department may initiate and conduct a regulatory hearing to determine whether to issue an order temporarily suspending approval of the PMA.

10614.4 Pursuant to 21 C.F.R. part 16, the Department will initiate and conduct any regulatory hearing necessary for determining whether to issue an order temporarily supporting approval of a PMA. If the Department believes that immediate action to remove a dangerous device from the market is necessary to protect the public health, the agency may, in accordance with 21 C.F.R. § 16.60(h), waive, suspend, or modify any 21 C.F.R. part 16 procedure, pursuant to 21 CFR § 10.19.

10614.5 The Department will deem the PMA holder's failure to request a hearing within the timeframe specified by DOH in the notice of opportunity for hearing to be a waiver.

10614.6 If the PMA holder does not request a regulatory hearing or if, after the hearing, and after consideration of the administrative record of the hearing, the Department determines that there is a reasonable probability that the continued distribution of a device under an approved PMA would cause serious, adverse health consequences or death, the agency shall, under the authority of 21 U.S.C. § 360e(e)(3) of the act, issue an order to the PMA holder temporarily suspending approval of the PMA.

10614.7 Permanent withdrawal of approval of the PMA. If the Department issues an order temporarily suspending approval of a PMA, the agency shall proceed expeditiously, but within sixty (60) days, to hold a hearing on whether to permanently withdraw approval of the PMA in accordance with 21 U.S.C. § 360e(e)(1) and procedures set out in § 10613.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10614

22-B DCMR § 10615 GENERAL

10615.1 A device may not be manufactured, packaged, stored, labeled, distributed, or advertised in a manner that is inconsistent with any conditions to approval specified in the PMA approval order for the device.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10615

22-B DCMR § 10616 POST-APPROVAL REQUIREMENTS

10616.1 The Department may impose post-approval requirements in a PMA approval order or regulation at the time of approval of the PMA or by regulation subsequent to approval. Post-approval requirements may include as a condition to approval of the device:

Restriction of the sale, distribution, or use of the device as provided by 21 U.S.C. §§ 360e(d)(1)(B)(ii) or 360j(e);

Continuing evaluation and periodic reporting on the safety, effectiveness, and reliability of the device for its intended use. The Department will state in the PMA approval order the reason or purpose for such requirement and the number of patients to be evaluated and the reports required to be submitted;

(c) Prominently display on the labeling of a device and in the advertising of any restricted device of warnings, hazards, or precautions important for the device's safe and effective use, including patient information (for example, information provided to the patient on alternative modes of therapy and on risks and benefits associated with the use of the device);

(d) Inclusion of identification codes on the device or its labeling, or in the case of an implant, on cards given to patients if necessary to protect the public health;

(e) Maintenance of records that will enable the applicant to submit to the Department information needed to trace patients if such information is necessary to protect the public health. The Department will require that the identity of any patient be disclosed in records maintained under this paragraph only to the extent required for the medical welfare of the individual, to determine the safety or effectiveness of the device, or to verify a record, report, or information submitted to the agency;

(f) Maintenance of records for specified periods of time and organization and indexing of records into identifiable files to enable DOH to determine whether there is reasonable assurance of the continued safety and effectiveness of the device;

(g) Submission to the Department at intervals specified in the approval order of periodic reports containing the information required by § 10617.2;

(h) Batch testing of the device; or

Such other requirements as the Department determines are necessary to provide reasonable assurance, or continued reasonable assurance, of the safety and effectiveness of the device.

10616.2 An applicant shall grant to the Department access to any records and reports required under the provisions of this chapter, and shall permit authorized Department employees to copy and verify such records and reports and to inspect at a reasonable time and in a reasonable manner all manufacturing facilities to verify that the device is being manufactured, stored, labeled, and shipped under approved conditions.

10616.3 Failure to comply with any post-approval requirement constitutes a ground for withdrawal of approval of a PMA.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10616

22-B DCMR § 10617 REPORTS

10617.1 The holder of an approved PMA shall comply with the requirements in Chapter 104 and with any other requirements applicable to the device by other regulations in this section or by order approving the device.

10617.2 Unless the Department specifies otherwise, any periodic report shall:

Identify changes described in § 10608.1 and changes required to be reported to the Department under § 10608.2; and

Contain a summary and bibliography of the following information not previously submitted as part of the PMA:

(1) Unpublished reports of data from any clinical investigations or nonclinical laboratory studies involving the device or related devices and known to or that reasonably should be known to the applicant;

(2) Reports in the scientific literature concerning the device and known to or that reasonably should be known to the applicant. If, after reviewing the summary and bibliography, the Department concludes that the agency needs a copy of the unpublished or published reports, the Department will notify the applicant that copies of such reports shall be submitted; or

(3) Identify changes made pursuant to an exception or alternative under 21 C.F.R. § 801.128 or 21 C.F.R. § 809.11.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10617

22-B DCMR § 10618 PURPOSE AND SCOPE

10618.1 The purpose of this section is, to the extent consistent with the protection of the public health and safety and with ethical standards, to encourage the discovery and use of devices intended to benefit patients in the treatment or diagnosis of diseases or conditions that affect or are manifested in fewer than four thousand (4,000) individuals in the United States per year. This section provides procedures for obtaining:

Humanitarian use device (HUD) designation of a medical device; and

(b) Marketing approval for the HUD notwithstanding the absence of reasonable assurance of effectiveness that would otherwise be required.

10618.2 Although a HUD may also have uses that differ from the humanitarian use, applicants seeking approval of any non-HUD use shall submit a PMA as required in § 10606 or a premarket notification as required in Chapter 105.

10618.3 Obtaining marketing approval for a HUD involves two (2) steps:

Obtaining designation of the device as a HUD from DOH, and

Submitting a humanitarian device exemption (HDE) to the Department.

10618.4 A person granted an exemption shall submit periodic reports as described in § 10632.1.

10618.5 The Department may suspend or withdraw approval of an HDE after providing notice and an opportunity for an informal hearing.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10618

22-B DCMR § 10619 DESIGNATION OF HUMANITARIAN USE DEVICES STATUS

10619.1 Prior to submitting an HDE application, the applicant shall submit a request for humanitarian use devices (HUD) designation to the Department. The request shall contain the following:

A statement that the applicant requests HUD designation for a rare disease or condition or a valid subset of a disease or condition which shall be identified with specificity;

(b) The name and address of the applicant, the name of the applicant's primary contact person or resident agent, including title, address, and telephone number;

(c) A description of the rare disease or condition for which the device is to be used, the proposed indication or indications for use of the device, and the reasons why such therapy is needed. If the device is proposed for an indication that represents a subset of a common disease or condition, a demonstration that the subset is medically plausible should be included;

(d) A description of the device and a discussion of the scientific rationale for the use of the device for the rare disease or condition; and

(e) Documentation, with appended authoritative references, to demonstrate that the device is designed to treat or diagnose a disease or condition that affects or is manifested in fewer than four thousand (4,000) people in the United States per year. If the device is for diagnostic purposes, the documentation must demonstrate that fewer than four thousand (4,000) patients per year would be subjected to diagnosis by the device in the United States. Authoritative references include literature citations in specialized medical journals, textbooks, specialized medical society proceedings, or governmental statistics publications. When no such studies or literature citations exist, the applicant may be able to demonstrate the prevalence of the disease or condition in the United States by providing credible conclusions from appropriate research or surveys.

10619.2 Within forty-five (45) days of receipt of a request for HUD designation, the Department will take one (1) of the following actions:

Approve the request and notify the applicant that the device has been designated as a HUD based on the information submitted;

Return the request to the applicant pending further review upon submission of additional information. This action will ensue if the request is incomplete because it does not on its face contain all of the information required under § 10619.1(a). Upon receipt of this additional information, the review period may be extended up to forty five (45) days; or

Disapprove the request for HUD designation based on a substantive review of the information submitted. The Department may disapprove a request for HUD designation if:

There is insufficient evidence to support the estimate that the disease or condition for which the device is designed to treat or diagnose affects or is manifested in fewer than four thousand (4,000) people in the U.S. per year;

The Department determines that, for a diagnostic device, four thousand (4,000) or more patients in the United States would be subjected to diagnosis using the device per year; or

(3) The Department determines that the patient population defined in the request is not a medically plausible subset of a larger population.

10619.3 The Department may revoke a HUD designation if the agency finds that:

The request for designation contained an untrue statement of material fact or omitted material information; or

(b) Based on the evidence available, the device is not eligible for HUD designation.

10619.4 The applicant shall submit two (2) copies of a completed, dated, and signed request for HUD designation to the Department.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10619

22-B DCMR § 10620 ORIGINAL APPLICATIONS

10620.1 The applicant or an authorized representative shall sign the HDE. If the applicant does not reside or have a place of business within the U.S., the HDE shall be countersigned by an authorized representative residing or maintaining a place of business in the U.S. and shall identify the representative's name and address.

10620.2 Unless the applicant justifies an omission in accordance with § 10620.4, an HDE shall include:

A copy of or reference to the Department’s determination (in accordance with § 10619) that the device qualifies as a HUD;

An explanation of why the device would not be available unless an HDE were granted and a statement that no comparable device (other than another HUD approved under this section or a device under an approved IDE) is available to treat or diagnose the disease or condition. The application also shall contain a discussion of the risks and benefits of currently available devices or alternative forms of treatment in the United States; and

An explanation of why the probable benefit to health from the use of the device outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. Such explanation shall include a description, explanation, or theory of the underlying disease process or condition, and known or postulated mechanism(s) of action of the device in relation to the disease process or condition.

10620.3 All of the information required to be submitted under § 10606.2(b), except that:

In lieu of the summaries, conclusions, and results from clinical investigations required under §§ 10606.2(c)(5)(B), (c)(6), and (f)(2), the applicant shall include the summaries, conclusions, and results of all clinical experience or investigations (whether adverse or supportive) reasonably obtainable by the applicant that are relevant to an assessment of the risks and probable benefits of the device; and

(b) In addition to the proposed labeling requirement set forth in § 10606.2(l) the labeling shall bear the following statement:

“Humanitarian Device. Authorized by District of Columbia law for use in the [treatment or diagnosis] of [specify disease or condition]. The effectiveness of this device for this use has not been demonstrated.”; and

(c) The amount to be charged for the device and, if the amount is more than two hundred fifty dollars ($250), a report by an independent certified public accountant, made in accordance with the Statement on Standards for Attestation established by the American Institute of Certified Public Accountants, or in lieu of such a report, an attestation by a responsible individual of the organization, verifying that the amount charged does not exceed the costs of the device's research, development, fabrication, and distribution. If the amount charged is two hundred fifty dollars ($250) or less, the requirement for a report by an independent certified public accountant or an attestation by a responsible individual of the organization is waived.

10620.4 If the applicant believes that certain information required under § 10620.2 is not applicable to the device that is the subject of the HDE, and omits any such information from its HDE, the applicant shall submit a statement that identifies and justifies the omission. The statement shall be submitted as a separate section in the HDE and identified in the table of contents. If the justification for the omission is not accepted by the agency, the Department will so notify the applicant.

10620.5 Copies of all original HDE amendments and supplements, as well as any correspondence relating to an HDE, must be sent or delivered to the Department.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10620

22-B DCMR § 10621 HUMANITARIAN DEVICE EXEMPTION AMENDMENTS AND RESUBMITTED HUMANITARIAN DEVICE EXEMPTIONS

10621.1 An HDE or HDE supplement may be amended or resubmitted upon an applicant's own initiative, or at the request of DOH, for the same reasons and in the same manner as prescribed for PMAs in § 10607, except that the timeframes set forth in § 10607.3(a) and § 10607.4 do not apply.

10621.2 If the Department requests an HDE applicant to submit an HDE amendment, and a written response to the Department's request is not received within seventy-five (75) days of the date of the request, the Department will consider the pending HDE or HDE supplement to be withdrawn voluntarily by the applicant. Furthermore, if the HDE applicant, on its own initiative or at the Department’s request, submits a major amendment as described in § 10607.3(a), the review period may be extended up to seventy-five (75) days.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10621

22-B DCMR § 10622 SUPPLEMENTAL APPLICATIONS

10622.1 After the Department’s approval of an original HDE, an applicant shall submit supplements in accordance with the requirements for PMAs under § 10608, except that a request for a new indication for use of a HUD shall comply with requirements set forth in § 10623. The timeframes for review of, and the Department’s action on, an HDE supplement are the same as those provided in § 10625 for an HDE.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10622

22-B DCMR § 10623 NEW INDICATIONS FOR USE

10623.1 An applicant seeking a new indication for use of a HUD approved under this section shall obtain a new designation of HUD status in accordance with § 10619 and shall submit an original HDE in accordance with § 10620.

10623.2 An application for a new indication for use made under § 10620 may incorporate by reference any information or data previously submitted to the Department under an HDE.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10623

22-B DCMR § 10624 FILING A HUMANITARIAN DEVICE EXEMPTION

10624.1 The filing of an HDE means that the Department has made a threshold determination that the application is sufficiently complete to permit substantive review. Within thirty (30) days from the date an HDE is received by the Department, the agency will notify the applicant whether the application has been filed. The Department may refuse to file an HDE if any of the following applies:

The application is incomplete because it does not on its face contain all the information required under § 10620.2;

The Department determines that there is a comparable device available (other than another HUD approved under this section or a device under an approved IDE) to treat or diagnose the disease or condition for which approval of the HUD is being sought;

The application contains an untrue statement of material fact or omits material information; or

The HDE is not accompanied by a statement of either certification or disclosure, or both, as required by 21 C.F.R., part 54.

10624.2 The provisions contained in §§ 10610.2, 10610.3, and 10610.4 regarding notification of filing decisions, filing dates, the start of the seventy-five (75) day review period, and applicant's options in response to the Department’s refusal to file decisions shall apply to HDEs.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10624

22-B DCMR § 10625 TIME FRAMES FOR REVIEWING A HUMANITARIAN DEVICE EXEMPTION

10625.1 Within seventy-five (75) days after receipt of an HDE that is accepted for filing and to which the applicant does not submit a major amendment, the Department will send the applicant an approval order, an approvable letter, a not approvable letter (under § 10626), or an order denying approval (under § 10627).

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10625

22-B DCMR § 10626 PROCEDURES FOR REVIEW OF A HUMANITARIAN DEVICE EXEMPTION

10626.1 The Department will begin substantive review of an HDE after the HDE is accepted for filing under § 10624. The Department may refer an original HDE application to a panel on its own initiative, and shall do so upon the request of an applicant, unless the Department determines that the application substantially duplicates information previously reviewed by a panel. If the HDE is referred to a panel, the agency shall follow the procedures set forth under § 10611, with the exception that the Department will complete its review of the HDE and the advisory committee report and recommendations within seventy-five (75) days from receipt of an HDE that is accepted for filing under § 10624 or the date of filing as determined under § 10621, whichever is later. Within the later of these two timeframes, the Department will issue an approval order under § 10626.2, an approvable letter under § 10626.3, a not approvable letter under § 10626.4, or an order denying approval of the application under § 10627.1.

10626.2 The Department will issue to the applicant an order approving an HDE if none of the reasons in § 10627 for denying approval of the application applies. The Department will approve an application on the basis of draft final labeling if the only deficiencies in the application concern editorial or similar minor efficiencies in the draft final labeling. Such approval will be conditioned upon the applicant incorporating the specified labeling changes exactly as directed and upon the applicant submitting to the Department a copy of the final printed labeling before marketing. The notice of approval of an HDE will be published by the Department in accordance with the rules and policies applicable to PMAs submitted under § 10606. Following the issuance of an approval order, data and information in the HDE file will be available for public disclosure in accordance with § 10602.2 through § 10602.10, as applicable.

10626.3 The Department will send the applicant an approvable letter if the application substantially meets the requirements of this section and the agency believes it can approve the application if specific additional information is submitted or specific conditions are agreed to by the applicant. The approvable letter will describe the information the Department requires to be provided by the applicant or the conditions the applicant is required to meet in order to obtain approval. For example, the Department may require as a condition to approval:

The submission of certain information identified in the approvable letter (such as, final labeling);

Restrictions imposed on the device under 21 U.S.C. § 360j(e);

Post-approval requirements; and

A Department inspection that finds the manufacturing facilities, methods, and controls in compliance with Chapter 106 and, if applicable, that verifies records pertinent to the HDE.

10626.4 The Department will send the applicant a not approvable letter if the agency believes that the application may not be approved for one (1) or more of the reasons given in § 10627. The not approvable letter will describe the deficiencies in the application and, where practical, will identify measures required to place the HDE in approvable form. The applicant may respond to the not approvable letter in the same manner as permitted for not approvable letters for PMAs under § 10611.9, with the exception that if a major HDE amendment is submitted, the review period may be extended up to seventy-five (75) days.

10626.5 The Department will consider an HDE to have been withdrawn voluntarily if:

(a) The applicant fails to respond in writing to a written request for an amendment within seventy-five (75) days after the date DOH issues such request;

(b) The applicant fails to respond in writing to an approvable or not approvable letter within seventy-five (75) days after the date the Department issues such letter; or

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10626

22-B DCMR § 10627 DENIAL OF APPROVAL OR WITHDRAWAL OF APPROVAL OF A HUMANITARIAN DEVICE EXEMPTION

10627.1 The Department may deny approval or withdraw approval of an application if the applicant fails to meet the requirements of 21 U.S.C. § 360j(m) or of any condition of approval imposed by an IRB or by the Department, or any post-approval requirements imposed under § 10631. In addition, the Department may deny approval or withdraw approval of an application if, upon the basis of the information submitted in the HDE or any other before the agency, the Department determines that:

There is a lack of a showing of reasonable assurance that the device is safe under the conditions of use prescribed, recommended, or suggested in the labeling thereof;

The device is ineffective under the conditions of use prescribed, recommended, or suggested in the labeling thereof;

The applicant has not demonstrated that there is a reasonable basis from which to conclude that the probable benefit to health from the use of the device outweighs the risk of injury or illness, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment;

(d) The application or a report submitted by or on behalf of the applicant contains an untrue statement of material fact, or omits material information;

(e) The device's labeling does not comply with the requirements in Chapter 103;

(f) A nonclinical laboratory study that is described in the HDE and that is essential to show that the device is safe for use under the conditions prescribed, recommended, or suggested in its proposed labeling, was not conducted in compliance with the good laboratory practice regulations and no reason for the noncompliance is provided or, if it is, the differences between the practices used in conducting the study and the good laboratory practice regulations do not support the validity of the study;

(g) Any clinical investigation involving human subjects described in the HDE, subject to the institutional review board regulations in § 10631 or the informed consent regulations in 21 C.F.R., part 50, was not conducted in compliance with those regulations such that the rights or safety of human subjects were not adequately protected;

(h) The applicant does not permit an authorized Department employee an opportunity to inspect at a reasonable time and in a reasonable manner the facilities and controls, and to have access to and to copy and verify all records pertinent to the application; or

(i) The device's HUD designation should be revoked in accordance with § 10619.3.

10627.2 If the Department issues an order denying approval of an application, the agency will comply with the same notice and disclosure provisions required for PMAs under §§ 10612.2 and 10612.4, as applicable.

10627.3 The Department will issue an order denying approval of an HDE after an approvable or not approvable letter has been sent and the applicant. The following also applies:

Submits a requested amendment but any ground for denying approval of the application under § 10627.1 still applies;

Notifies the Department in writing that the requested amendment will not be submitted; or

(c) Petitions for review under 21 U.S.C. § 360e(d)(3) by filing a petition in the form of a petition for reconsideration under 21 C.F.R. § 10.33.

10627.4 Before issuing an order withdrawing approval of an HDE, the Department will provide the applicant with notice and an opportunity for a hearing as required for PMAs under §§ 10613.3 and 10613.4, and will provide the public with notice in accordance with § 10613.5, as applicable.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10627

22-B DCMR § 10628 TEMPORARY SUSPENSION OF APPROVAL OF A HUMANITARIAN DEVICE EXEMPTION

10628.1 An HDE or HDE supplement may be temporarily suspended for the same reasons and in the same manner as prescribed for PMAs in § 10614.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10628

22-B DCMR § 10629 CONFIDENTIALITY OF DATA AND INFORMATION

10629.1 The "HDE file" includes all data and information submitted with or referenced in the HDE, any IDE incorporated into the HDE, any HDE amendment or supplement, any report submitted under § 10631, any master file, or any other related submission. Any record in the HDE file will be available for public disclosure in accordance with the provisions of this section.

10629.2 Disclosure by the Department of the existence and contents of an HDE file shall be subject to the same rules that pertain to PMA's under § 10602.2 through 10602.10, as applicable.

10629.3 The HDE holder is responsible for ensuring that a HUD approved under this section is administered only in facilities having an IRB constituted and acting pursuant to § 10631, including continuing review of use of the device. In addition, a HUD may be administered only if the IRB approves such use located at the facility or by a similarly constituted IRB that has agreed to oversee such use and to which the local IRB has deferred in a letter to the HDE holder, signed by the IRB chair or an authorized designee. If, however, a physician in an emergency situation determines that approval from an IRB cannot be obtained in time to prevent serious harm or death to a patient, a HUD may be administered without prior approval by the IRB located at the facility or by a similarly constituted IRB that has agreed to oversee such use. In such an emergency situation, the physician shall, within five (5) days after the use of the device, provide written notification to the chairman of the IRB of such use. Such written notification shall include the identification of the patient involved, the date on which the device was used, and the reason for the use.

10629.4 A holder of an approved HDE shall notify the Department of any withdrawal of approval for the use of a HUD by a reviewing IRB within five (5) working days after being notified of the withdrawal of approval.

10629.5 In regards to the confidentiality of data and information in color additive petitions: the following data and information in a color additive petition are available for public disclosure, unless extraordinary circumstances are shown, after the notice of filing of the petition is published or, if the petition is not promptly filed because of deficiencies in it, after the petitioner is informed that it will not be filed because of the deficiencies involved:

(a) All safety and functionality data and information submitted with or incorporated by reference in the petition;

(b) A protocol for a test or study, unless it is shown to fall within the exemption established for trade secrets and confidential commercial information;

(c) Adverse reaction reports, product experience reports, consumer complaints, and other similar data and information, after deletion of:

(1) Names and any information that would identify the person using the product;

(2) Names and any information that would identify any third party involved with the report, such as a physician, hospital, or other institution;

(3) A list of all ingredients contained in a color additive, whether or not it is in descending order of predominance. A particular ingredient or group of ingredients shall be deleted from any such list prior to public disclosure if it is shown to fall within an exemption and a notation shall be made that any such ingredient list is incomplete;

(4) An assay method or other analytical method, unless it serves no regulatory or compliance purpose and is shown to fall within an exemption; and

(5) All records showing the Department's testing of or action on a particular lot of a certifiable color additive.

10629.6 The following data and information in a color additive petition are not available for public disclosure unless they have been previously disclosed to the public or they relate to a product or ingredient that has been abandoned and they no longer represent a trade secret or confidential commercial or financial information:

(a) Manufacturing methods or processes, including quality control procedures;

(b) Production, sales, distribution, and similar data and information, except that any compilation of such data and information aggregated and prepared in a way that does not reveal data or information which is not available for public disclosure under this provision is available for public disclosure; and

10629.7 All correspondence and written summaries of oral discussions relating to a color additive petition are available for public disclosure when the color additive regulation is published by the Department.

10629.8 For purposes of this regulation, safety and functionality data include all studies and tests of a color additive on animals and humans and all studies and tests on a color additive for identity, stability, purity, potency, performance, and usefulness.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10629

22-B DCMR § 10630 [RESERVED]

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10630

22-B DCMR § 10631 INSTITUTIONAL REVIEW BOARD REQUIREMENTS

10631.1 The HDE holder is responsible for ensuring that a HUD approved under this section is administered only in facilities having an IRB constituted and acting pursuant to these regulations, including continuing review of use of the device. In addition, a HUD may be administered only if such use has been approved by the IRB located at the facility or by a similarly constituted IRB that has agreed to oversee such use and to which the local IRB has deferred in a letter to the HDE holder, signed by the IRB chair or an authorized designee. If, however, a physician in an emergency situation determines that approval from an IRB cannot be obtained in time to prevent serious harm or death to a patient, a HUD may be administered without prior approval by the IRB located at the facility or by a similarly constituted IRB that has agreed to oversee such use. In such an emergency situation, the physician shall, within five (5) days after the use of the device, provide written notification to the chairman of the IRB of such use. Such written notification shall include the identification of the patient involved, the date on which the device was used, and the reason for the use.

10631.2 A holder of an approved HDE shall notify the Department of any withdrawal of approval for the use of a HUD by a reviewing IRB within five (5) working days after being notified of the withdrawal of approval.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10631

22-B DCMR § 10632 POST-APPROVAL REQUIREMENTS AND REPORTS

10632.1 An HDE approved under this section shall be subject to the post-approval requirements and reports set forth under 21 C.F.R. § 1.83, et seq., as applicable, with the exception of § 10616.1(g). In addition, medical device reports submitted to the Department in compliance with the requirements of Chapter 104 shall also be submitted to the IRB of record.

10632.2 In addition to the reports identified in § 10632.1, the holder of an approved HDE shall prepare and submit the following complete, accurate, and timely reports:

An HDE applicant is required to submit reports in accordance with the approval order. Unless the Department specifies otherwise, any periodic report shall include:

An update of the information required under § 10619.1 in a separately bound volume;

(2) An update of the information required under § 10620.2(b), (c), and (e);

(3) The number of devices that have been shipped or sold since initial marketing approval under this section and, if the number shipped or sold exceeds four thousand (4,000), an explanation and estimate of the number of devices used per patient. If a single device is used on multiple patients, the applicant shall submit an estimate of the number of patients treated or diagnosed using the device together with an explanation of the basis for the estimate;

(4) Information describing the applicant's clinical experience with the device since the HDE was initially approved. This information shall include safety information that is known or reasonably should be known to the applicant, medical device reports made under Chapter 104, any data generated from the post-marketing studies, and information (whether published or unpublished) that is known or reasonably expected to be known by the applicant that may affect an evaluation of the safety of the device or that may affect the statement of contraindications, warnings, precautions, and adverse reactions in the device's labeling; and

(5) A summary of any changes made to the device in accordance with supplements submitted under § 10622. If information provided in the periodic reports, or any other information in the possession of the Department, gives the agency reason to believe that a device raises public health concerns or that the criteria for exemption are no longer met, the agency may require the HDE holder to submit additional information to demonstrate continued compliance with the HDE requirements.

10632.3 An HDE holder shall maintain records of the names and addresses of the facilities to which the HUD has been shipped, correspondence with reviewing IRB's, as well as any other information that the IRB or the Department requests. Such records shall be maintained in accordance with the HDE approval order.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10632

22-B DCMR § 10699 DEFINITIONS

10699.1 As used in this chapter, the following terms shall have the meanings ascribed:

Act – the Federal Food, Drug, and Cosmetic Act, approved June 25, 1938, (31 U.S.C. § 301, et seq.)

Humanitarian Device Exemption (HDE) – an application that is similar to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of 21 U.S.C. §§ 360d and 360e of the Food, Drug, and Cosmetic Act.

Humanitarian Use Device (HUD) –a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than four thousand (4,000) individuals in the U. S. per year.

Investigational Device – a device, including a transitional device, that is the object of an investigation.

Investigational Device Exemption (IDE) – a process whereby an investigational device is allowed to be used in a clinical study in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification (21 U.S.C. § 360(k)) submission to FDA.

Master File – a reference source that a person submits to the Department of Health master file may contain detailed information on a specific manufacturing facility, process, methodology, or component used in the manufacture, processing, or packaging of a medical device.

Person – any individual, partnership, corporation, association, scientific or academic establishment, Government agency, or organizational unit thereof, or any other legal entity.

PMA – any premarket approval application for a class III medical device, including all information submitted with or incorporated by reference therein. ``PMA'' includes a new drug application for a device.

PMA amendment – information an applicant submits to the Department of Health to modify a pending PMA or a pending PMA supplement.

PMA supplement – a supplemental application to an approved PMA for approval of a change or modification in a class III medical device, including all information submitted with or incorporated by reference therein.

Reasonable probability – it is more likely than not that an event will occur.

Statement of material fact – a representation that tends to show that the safety or effectiveness of a device is more probable than it would be in the absence of such a representation. A false affirmation or silence or an omission that would lead a reasonable person to draw a particular conclusion as to the safety or effectiveness of a device also may be a false statement of material fact, even if the statement was not intended by the person making it to be misleading or to have any probative effect.

Serious, adverse health consequences – any significant adverse experience, including those which may be either life-threatening or involve permanent or long term injuries, but excluding injuries that are nonlife-threatening and that are temporary and reasonably reversible.

Thirty (30) - day PMA supplement – a supplemental application to an approved PMA in accordance with § 10608.

Transitional device – a device subject to 21 U.S.C. § 360j(1) of the act, that is, a device that the FDA considered to be a new drug or an antibiotic drug before May 28, 1976.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10699

22-B107 QUALITY SYSTEM REGULATION

22-B DCMR § 10700 SCOPE

10700.1 Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this chapter govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this chapter are intended to ensure that finished devices will be safe and effective and otherwise in compliance with District regulations. This chapter establishes basic requirements applicable to manufacturers of finished medical devices. If a manufacturer engages in only some operations subject to the requirements in this chapter, and not in others, that manufacturer need only comply with those requirements applicable to the operations in which it is engaged. With respect to class I devices, design controls apply only to those devices listed in § 10705(a)(2). This regulation does not apply to manufacturers of components or parts of finished devices, but such manufacturers are encouraged to use appropriate provisions of this regulation as guidance. Manufacturers of human blood and blood components are not subject to 21 C.F.R., part 606 or its Department of Health equivalent. Manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps), as defined in 21 C.F.R. § 1271.3(d), that are medical devices (subject to premarket review or notification, or exempt from notification, under an application submitted under the device provisions or under a biological product license application under the federal Public Health Service Act, 42 U.S.C. § 262 are subject to this chapter and are also subject to the donor-eligibility procedures set forth in 21 C.F.R., part 1271, subpart C and applicable current good tissue practice procedures in 21 C.F.R., part 1271, subpart D. In the event of a conflict between applicable regulations, the regulation specifically applicable to the device in question shall supersede the more general.

10700.2 The provisions of this chapter shall be applicable to any finished device as defined in this chapter, intended for human use, that is manufactured, imported, or offered for import in any State or Territory of the U.S., the District of Columbia, or the Commonwealth of Puerto Rico.

10700.3 In this regulation the term "where appropriate" is used several times. When a requirement is qualified by "where appropriate," it is deemed to be "appropriate" unless the manufacturer can document justification otherwise. A requirement is "appropriate" if non-implementation could reasonably be expected to result in the product not meeting its specified requirements or the manufacturer not being able to carry out any necessary corrective action.

10700.4 The quality system regulation in this chapter supplements regulations in other sections in this chapter except where explicitly stated otherwise. In the event of a conflict between applicable regulations in this chapter and in other sections in this chapter, the regulations specifically applicable to the device in question shall supersede any other generally applicable requirements.

10700.5 The failure to comply with any applicable provision in this chapter renders a device adulterated under 21 U.S.C. § 351. Such a device, as well as any person responsible for the failure to comply, is subject to regulatory action.

10700.6 If a manufacturer who offers devices for import into the U.S. refuses to permit or allow the completion of a Department inspection of the foreign facility for the purpose of determining compliance with this chapter, it shall appear for purposes of Chapter 103, that the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, or servicing of any devices produced at such facility that are offered for import into the U.S. do not conform to the requirements of 21 U.S.C. § 351j(f) and this section and that the devices manufactured at that facility are adulterated under 21 U.S.C. § 351(h).

10700.7 Any person who wishes to petition for an exemption or variance from any device quality system requirement must submit a petition for an exemption or variance according to the Department’s administrative procedures.

10700.8 The Department may initiate and grant a variance from any device quality system requirement when the agency determines that such variance is in the best interest of the public health. Such variance will remain in effect only so long as there remains a public health need for the device and the device would not likely be made sufficiently available without the variance.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10700

22-B DCMR § 10701 QUALITY SYSTEM

10701.1 Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this chapter.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10701

22-B DCMR § 10702 MANAGEMENT RESPONSIBILITY

10702.1 Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization.

10702.2 Each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this chapter.

10702.3 Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.

10702.4 Each manufacturer shall provide adequate resources, including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, to meet the requirements of this chapter.

10702.5 Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for:

Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this chapter; and

Reporting on the performance of the quality system to management with executive responsibility for review.

10702.6 Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this chapter and the manufacturer's established quality policy and objectives. The dates and results of quality system reviews shall be documented.

10702.7 Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met.

10702.8 Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10702

22-B DCMR § 10703 QUALITY AUDIT: TRAINED PERSONNEL

10703.1 Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a re-audit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and re-audit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and re-audits shall be documented.

10703.2 Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this chapter are correctly performed.

10703.3 Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.

10703.4 As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs.

10703.5 Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10703

22-B DCMR § 10704 RESERVED

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10704

22-B DCMR § 10705 DESIGN CONTROLS

10705.1 Each manufacturer of any class III or class II device, and the class I devices listed in § 10705.2, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.

10705.2 The following class I devices are subject to design controls:

Devices automated with computer software; and

(b) The devices listed in the following chart:

Device

Catheter, Tracheobronchial Suction.

Glove, Surgeon's.

Restraint, Protective.

System, Applicator, Radionuclide, Manual.

Source, Radionuclide Teletherapy.

10705.3 Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves.

10705.4 Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. A designated person(s) shall review and approve the documented design input requirements. The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.

10705.5 Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified. Design output shall be documented, reviewed, and approved before release. The approval, including the date and signature of the individual(s) approving the output, shall be documented.

10705.6 Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development. The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the DHF).

10705.7 Each manufacturer shall establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the design input requirements. The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the DHF.

10705.8 Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF.

10705.9 Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.

10705.10 Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.

10705.11 Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this chapter.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10705

22-B DCMR § 10706 DOCUMENT CONTROLS

10706.1 Each manufacturer shall establish and maintain procedures to control all documents that are required by this chapter.

10706.2 Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this chapter. The approval, including the date and signature of the individual(s) approving the document, shall be documented. Documents established to meet the requirements of this chapter shall be available at all locations for which they are designated, used, or otherwise necessary, and all obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use.

10706.3 Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise. Approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10706

22-B DCMR § 10707 PURCHASING CONTROLS

10707.1 Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.

10707.2 Each manufacturer shall establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants.

Each manufacturer shall:

Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented;

Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results; and

10707.3 Each manufacturer shall establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services. Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device. Purchasing data shall be approved in accordance with § 10706.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10707

22-B DCMR § 10708 IDENTIFICATION

10708.1 Each manufacturer shall establish and maintain procedures for identifying products during all stages of receipt, production, distribution, and installation to prevent mix-ups.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10708

22-B DCMR § 10709 TRACEABILITY

10709.1 Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user shall establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components. The procedures shall facilitate corrective action. Such identification shall be documented in the device history record (DHR).

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10709

22-B DCMR § 10710 PRODUCTION AND PROCESS CONTROLS

10710.1 Each manufacturer shall develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. Where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications. Where process controls are needed they shall include:

Documented instructions, standard operating procedures (SOPs), and methods that define and control the manner of production;

Monitoring and control of process parameters and component and device characteristics during production;

Compliance with specified reference standards or codes;

The approval of processes and process equipment; and

(e) Criteria for workmanship which shall be expressed in documented standards or by means of identified and approved representative samples.

10710.2 Each manufacturer shall establish and maintain procedures for changes to a specification, method, process, or procedure. Such changes shall be verified or where appropriate validated according to § 10713, before implementation and these activities shall be documented. Changes shall be approved in accordance with § 10706.

10710.3 Where environmental conditions could reasonably be expected to have an adverse effect on product quality, the manufacturer shall establish and maintain procedures to adequately control these environmental conditions. Environmental control system(s) shall be periodically inspected to verify that the system, including necessary equipment, is adequate and functioning properly. These activities shall be documented and reviewed.

10710.4 Each manufacturer shall establish and maintain requirements for the health, cleanliness, personal practices, and clothing of personnel if contact between such personnel and product or environment could reasonably be expected to have an adverse effect on product quality. The manufacturer shall ensure that maintenance and other personnel who are required to work temporarily under special environmental conditions are appropriately trained or supervised by a trained individual.

10710.5 Each manufacturer shall establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality.

10710.6 Buildings shall be of suitable design and contain sufficient space to perform necessary operations, prevent mix-ups, and assure orderly handling.

10710.7 Each manufacturer shall ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use.

10710.8 Each manufacturer shall establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met. Maintenance activities, including the date and individual(s) performing the maintenance activities, shall be documented.

10710.9 Each manufacturer shall conduct periodic inspections in accordance with established procedures to ensure adherence to applicable equipment maintenance schedules. The inspections, including the date and individual(s) conducting the inspections, shall be documented.

10710.10 Each manufacturer shall ensure that any inherent limitations or allowable tolerances are visibly posted on or near equipment requiring periodic adjustments or are readily available to personnel performing these adjustments.

10710.11 Where a manufacturing material could reasonably be expected to have an adverse effect on product quality, the manufacturer shall establish and maintain procedures for the use and removal of such manufacturing material to ensure that it is removed or limited to an amount that does not adversely affect the device's quality. The removal or reduction of such manufacturing material shall be documented.

10710.12 When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10710

22-B DCMR § 10711 INSPECTION, MEASURING, AND TEST EQUIPMENT

10711.1 Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results. Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. The procedures shall include provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness for use are maintained. These activities shall be documented.

10711.2 Calibration procedures shall include specific directions and limits for accuracy and precision. When accuracy and precision limits are not met, there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device's quality. These activities shall be documented.

10711.3 Calibration standards used for inspection, measuring, and test equipment shall be traceable to national or international standards. If national or international standards are not practical or available, the manufacturer shall use an independent reproducible standard. If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard.

10711.4 The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented. These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10711

22-B DCMR § 10712 PROCESS VALIDATION

10712.1 Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented.

10712.2 Each manufacturer shall establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met.

10712.3 Each manufacturer shall ensure that validated processes are performed by qualified individual(s).

10712.4 For validated processes, the monitoring and control methods and data, the date performed, and, where appropriate, the individual(s) performing the process or the major equipment used shall be documented.

10712.5 When changes or process deviations occur, the manufacturer shall review and evaluate the process and perform revalidation where appropriate. These activities shall be documented.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10712

22-B DCMR § 10713 RECEIVING, IN-PROCESS, AND FINISHED DEVICE ACCEPTANCE

10713.1 Each manufacturer shall establish and maintain procedures for acceptance activities. Acceptance activities include inspections, tests, or other verification activities.

10713.2 Each manufacturer shall establish and maintain procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented.

10713.3 Each manufacturer shall establish and maintain acceptance procedures, where appropriate, to ensure that specified requirements for in-process product are met. Such procedures shall ensure that in-process product is controlled until the required inspection and tests or other verification activities have been completed, or necessary approvals are received, and are documented.

10713.4 Each manufacturer shall establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria. Finished devices shall be held in quarantine or otherwise adequately controlled until released. Finished devices shall not be released for distribution until:

(a) The activities required in the device master record (DMR) are completed;

(b) The associated data and documentation is reviewed;

(d) The authorization is dated.

10713.5 Each manufacturer shall document acceptance activities required by this chapter. These records shall include:

(a) The acceptance activities performed;

(b) The dates on which acceptance activities are performed;

(d) The signature of the individual(s) conducting the acceptance activities; and

(e) Where appropriate, the equipment used. These records shall be part of the DHR.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10713

22-B DCMR § 10714 ACCEPTANCE STATUS

10714.1 Each manufacturer shall identify by suitable means the acceptance status of the product, to indicate the conformance or nonconformance of the product with acceptance criteria. The identification of acceptance status shall be maintained throughout manufacturing, packaging, labeling, installation, and servicing of the product to ensure that only products which have passed the required acceptance activities is distributed, used, or installed.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10714

22-B DCMR § 10715 NON-CONFORMING PRODUCT

10715.1 Each manufacturer shall establish and maintain procedures to control products that do not conform to specified requirements. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming products. The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation shall be documented.

10715.2 Each manufacturer shall establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming products. The procedures shall set forth the review and disposition process. Disposition of nonconforming product shall be documented. Documentation shall include the justification for use of nonconforming products and the signature of the individual(s) authorizing the use.

10715.3 Each manufacturer shall establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications. Rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, shall be documented in the DHR.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10715

22-B DCMR § 10716 CORRECTIVE AND PREVENTIVE ACTION

10716.1 Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for:

Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems;

Investigating the cause of nonconformities relating to product, processes, and the quality system;

Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;

Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device;

Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;

Ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; and

Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.

10716.2 All activities required under this section, and their results, shall be documented.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10716

22-B DCMR § 10717 DEVICE LABELING

10717.1 Each manufacturer shall establish and maintain procedures to control labeling activities.

10717.2 Labels shall be printed and applied so as to remain legible and affixed during the customary conditions of processing, storage, handling, distribution, and where appropriate, use.

10717.3 Labeling shall not be released for storage or use until a designated individual(s) has examined the labeling for accuracy including, where applicable, the correct expiration date, control number, storage instructions, handling instructions, and any additional processing instructions. The release, including the date and signature of the individual(s) performing the examination, shall be documented in the DHR.

10717.4 Each manufacturer shall store labeling in a manner that provides proper identification and is designed to prevent mix-ups.

10717.5 Each manufacturer shall control labeling and packaging operations to prevent labeling mix-ups. The label and labeling used for each production unit, lot, or batch shall be documented in the DHR.

10717.6 Where a control number is required by § 10709, that control number shall be on or shall accompany the device through distribution.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10717

22-B DCMR § 10718 DEVICE PACKAGING

10718.1 Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10718

22-B DCMR § 10719 HANDLING

10719.1 Each manufacturer shall establish and maintain procedures to ensure that mix-ups, damage, deterioration, contamination, or other adverse effects to products do not occur during handling.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10719

22-B DCMR § 10720 STORAGE

10720.1 Each manufacturer shall establish and maintain procedures for the control of storage areas and stock rooms for product to prevent mix-ups, damage, deterioration, contamination, or other adverse effects pending use or distribution and to ensure that no obsolete, rejected, or deteriorated product is used or distributed. When the quality of product deteriorates over time, it shall be stored in a manner to facilitate proper stock rotation, and its condition shall be assessed as appropriate.

10720.2 Each manufacturer shall establish and maintain procedures that describe the methods for authorizing receipt from and dispatch to storage areas and stock rooms.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10720

22-B DCMR § 10721 DISTRIBUTION

10721.1 Each manufacturer shall establish and maintain procedures for control and distribution of finished devices to ensure that only those devices approved for release are distributed and that purchase orders are reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution. Where a device's fitness for use or quality deteriorates over time, the procedures shall ensure that expired devices or devices deteriorated beyond acceptable fitness for use are not distributed.

10721.2 Each manufacturer shall maintain distribution records which include or refer to the location of:

The name and address of the initial consignee;

The identification and quantity of devices shipped;

The date shipped; and

(d) Any control number(s) used.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10721

22-B DCMR § 10722 INSTALLATION

10722.1 Each manufacturer of a device requiring installation shall establish and maintain adequate installation and inspection instructions, and where appropriate test procedures. Instructions and procedures shall include directions for ensuring proper installation so that the device will perform as intended after installation. The manufacturer shall distribute the instructions and procedures with the device or otherwise make them available to the person(s) installing the device.

10722.2 The person installing the device shall ensure that the installation, inspection, and any required testing are performed in accordance with the manufacturer's instructions and procedures and shall document the inspection and any test results to demonstrate proper installation.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10722

22-B DCMR § 10723 GENERAL REQUIREMENTS

10723.1 All records required by this chapter shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of the Department designated to perform inspections. Such records, including those not stored at the inspected establishment, shall be made readily available for review and copying by Department employee(s). Such records shall be legible and shall be stored to minimize deterioration and to prevent loss. Those records stored in automated data processing systems shall be backed up.

10723.2 Records that the manufacturer deems confidential may be marked to aid the Department in determining whether information may be disclosed as public information.

10723.3 All records required by this chapter shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than two (2) years from the date of release for commercial distribution by the manufacturer.

10723.4 This section does not apply to the reports required by § 10702.3 Management review, § 10703 Quality audits, and supplier audit reports used to meet the requirements of § 10707.1 Evaluation of suppliers, contractors, and consultants, but does apply to procedures established under these provisions. Upon request of a designated employee of the Department, an employee in management with executive responsibility shall certify in writing that the management reviews and quality audits required in this chapter, and supplier audits where applicable, have been performed and documented, the dates on which they were performed, and that any required corrective action has been undertaken.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10723

22-B DCMR § 10724 DEVICE MASTER RECORD

10724.1 Each manufacturer shall maintain device master records (DMR). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with § 10706. The DMR for each type of device shall include, or refer to the location of, the following information:

(a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;

(b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;

(c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;

(d) Packaging and labeling specifications, including methods and processes used; and

(e) Installation, maintenance, and servicing procedures and methods.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10724

22-B DCMR § 10725 DEVICE HISTORY RECORD

10725.1 Each manufacturer shall maintain Device History Records (DHRs). Each manufacturer shall establish and maintain procedures to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this chapter. The DHR shall include, or refer to the location of, the following information:

The dates of manufacture;

The quantity manufactured;

The quantity released for distribution;

The acceptance records which demonstrate the device is manufactured in accordance with the DMR;

The primary identification label and labeling used for each production unit; and

(f) Any device identification(s) and control number(s) used.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10725

22-B DCMR § 10726 QUALITY SYSTEM RECORD

10726.1 Each manufacturer shall maintain a quality system record (QSR). The QSR shall include, or refer to the location of, procedures and the documentation of activities required by this chapter that are not specific to a particular type of device(s), including, but not limited to, the records required by § 10702. Each manufacturer shall ensure that the QSR is prepared and approved in accordance with § 10706.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10726

22-B DCMR § 10727 COMPLAINT FILES

10727.1 Each manufacturer shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Such procedures shall ensure that:

All complaints are processed in a uniform and timely manner;

Oral complaints are documented upon receipt; and

Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to the Department under Chapter 104, Medical Device Reporting.

10727.2 Each manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate.

10727.3 Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary.

10727.4 Any complaint that represents an event which must be reported to the Department under Chapter 104 shall be promptly reviewed, evaluated, and investigated by a designated individual(s) and shall be maintained in a separate portion of the complaint files or otherwise clearly identified. In addition to the information required by § 10726.5, records of investigation within this section shall include a determination of:

Whether the device failed to meet specifications;

Whether the device was being used for treatment or diagnosis; and

10727.5 When an investigation is made under this section, a record of the investigation shall be maintained by the formally designated unit identified in §10726.1. The record of investigation shall include:

The name of the device;

The date the complaint was received;

Any device identification(s) and control number(s) used;

The name, address, and phone number of the complainant;

The nature and details of the complaint;

The dates and results of the investigation;

Any corrective action taken; and

Any reply to the complainant.

10727.6 When the manufacturer's formally designated complaint unit is located at a site separate from the manufacturing establishment, the investigated complaint(s) and the record(s) of investigation shall be reasonably accessible to the manufacturing establishment.

10727.7 If a manufacturer's formally designated complaint unit is located outside of the

U. S., records required by this section shall be reasonably accessible in the U.S. at either:

(a) A location in the U.S. where the manufacturer's records are regularly kept; or

(b) The location of the initial distributor.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10727

22-B DCMR § 10728 SERVICING

10728.1 Where servicing is a specified requirement, each manufacturer shall establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements.

10728.2 Each manufacturer shall analyze service reports with appropriate statistical methodology in accordance with § 10716.

10728.3 Each manufacturer who receives a service report that represents an event which must be reported to the Department under Chapter 104 shall automatically consider the report a complaint and shall process it in accordance with the requirements of § 10728.

10728.4 Service reports shall be documented and shall include:

The name of the device serviced;

Any device identification(s) and control number(s) used;

The date of service;

The individual(s) servicing the device;

The service performed; and

(f) The test and inspection data.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10728

22-B DCMR § 10729 STATISTICAL TECHNIQUES

10729.1 Where appropriate, each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics.

10729.2 Sampling plans, when used, shall be written and based on a valid statistical rationale. Each manufacturer shall establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed. These activities shall be documented.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10729

22-B DCMR § 10799 DEFINITIONS

10799.1 As used in this chapter, the following terms shall have the meanings ascribed:

Act – the Federal Food, Drug, and Cosmetic Act, approved June 25, 1938 (21 U.S.C. § 301, et seq.)

Complaint - any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.

Component - any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.

Control number - any distinctive symbols, such as a distinctive combination of letters or numbers, or both, from which the history of the manufacturing, packaging, labeling, and distribution of a unit, lot, or batch of finished devices can be determined.

Design history file (DHF) - a compilation of records which describes the design history of a finished device.

Design input – the physical and performance requirements of a device that are used as a basis for device design.

Design output – the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record.

Design review – a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.

Design validation – establishing by objective evidence that device specifications conform to users’ needs and intended use(s).

Device history record (DHR) – a compilation of records containing the production history of a finished device.

Device master record (DMR) – a compilation of records containing the procedures and specifications for a finished device.

Establish – define, document (in writing or electronically), and implement.

Finished device – any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.

Lot or batch – one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.

Management with executive responsibility – those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system.

Manufacturer – any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.

Manufacturing material – any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent, or a byproduct constituent produced during the manufacturing process, which is present in or on the finished device as a residue or impurity not by design or intent of the manufacturer.

Nonconformity – the non-fulfillment of a specified requirement.

Process validation – establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.

Product – components, manufacturing materials, in-process devices, finished devices, and returned devices.

Quality – the totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance.

Quality audit – a systematic, independent examination of a manufacturer's quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives.

Quality policy - the overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility.

Quality system - the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.

Remanufacturer – any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use.

Rework – action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution.

Specification – any requirement with which a product, process, service, or other activity must conform.

Validation – confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.

Verification – confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10799

22-B108 PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS (GENERAL), IONIZING RADIATION EMITTING PRODUCTS, LIGHT-EMITTING PRODUCTS, AND SONIC, INFRASONIC, AND ULTRASONIC RADIATION EMITTING PRODUCTS

22-B DCMR § 10800 EXAMPLES OF ELECTRONIC PRODUCTS SUBJECT TO THE RADIATION CONTROL FOR HEALTH AND SAFETY ACT OF 1968

10800.1 The following listed electronic products are intended to serve as illustrative examples of sources of electronic product radiation to which these regulations apply:

Examples of electronic products which may emit X-rays and other ionizing electromagnetic radiation, electrons, neutrons, and other particulate radiation include:

(1) Ionizing electromagnetic radiation:

Television receivers;

Accelerations; and

(2) Particulate radiation and ionizing electromagnetic radiation:

(A) Electron microscope; and

Neutron generators;

(b) Examples of electronic products which may emit ultraviolet, visible, infrared, microwaves, radio, and low frequency electromagnetic radiation include:

(1) Ultraviolet:

(A) Biochemical and medical analyzers;

(B) Tanning and therapeutic lamps;

Sanitizing and sterilizing devices;

Black light sources; and

Welding equipment;

(2) Visible:

(A) White light devices;

(3) Infrared:

(A) Alarm systems;

(B) Diathermy units; and

Dryers, ovens, and heaters;

(4) Microwave:

(A) Alarm systems;

(B) Diathermy units;

Medico-biological heaters;

Microwave power generating devices;

Radar devices;

Remote control devices; and

Signal generators;

(5) Radio and low frequency:

(A) Cauterizers;

(B) Diathermy units;

(D) Signal generators; and

Electro-medical equipment;

Examples of electronic products which may emit coherent electromagnetic radiation produced by stimulated emission include:

(1) Laser:

(A) Art-form, experimental, and educational devices;

(B) Biomedical analyzers;

(D) Cutting and drilling devices;

(E) Communications transmitters; and

Range-finding devices;

(2) Maser:

(A) Communication transmitters; and

(d) Examples of electronic products which may emit infrasonic, sonic, and ultrasonic vibrations resulting from operation of an electronic circuit include:

(1) Infrasonic:

(A) Vibrators;

(2) Sonic:

(A) Electronic oscillators; and

(B) Sound amplification equipment; and

(3) Ultrasonic:

(A) Cauterizers;

(B) Cell and tissue disintegrators;

(D) Diagnostic and non-destructive testing equipment; and

(E) Ranging and detection equipment.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10800

22-B DCMR § 10801 RECOMMENDATIONS FOR THE USE OF SPECIFIC AREA GONAD SHIELDING ON PATIENTS DURING MEDICAL DIAGNOSIS X-RAY PROCEDURES

10801.1 Specific area gonad shielding covers an area slightly larger than the region of the gonads. It may therefore be used without interfering with the objectives of the examination to protect the germinal tissue of patients from radiation exposure that may cause genetic mutations during many medical x-ray procedures in which the gonads lie within or are in close proximity to the x-ray field. Such shielding should be provided when the following conditions exist:

The gonads will lie within the primary x-ray field, or within close proximity (about five centimeters (5 cm)), despite proper beam limitation. Except as provided in §§ 10801.2 or 10801.3. The following applies to specific area gonads:

(1) Specific area testicular shielding should always be used during those examinations in which the testes usually are in the primary x-ray field, such as examinations of the pelvis, hip, and upper femur;

(2) Specific area testicular shielding may also be warranted during other examinations of the abdominal region in which the testes may lie within or in close proximity to the primary x-ray field, depending upon the size of the patient and the examination techniques and equipment employed. Some examples of these are: Abdominal, lumbar spine and lumbosacral spine examinations, intravenous pyelograms, and abdominal scout film for barium enemas and upper GI series. Each x-ray facility should evaluate its procedures, techniques, and equipment and compile a list of such examinations for which specific area testicular shielding should be routinely considered for use. As a basis for judgment, specific area testicular shielding should be considered for all examinations of male patients in which the pubic symphysis will be visualized on the film;

(3) Specific area gonad shielding should never be used as a substitute for careful patient positioning, the use of correct technique factors and film processing, or proper beam limitation (confinement of the x-ray field to the area of diagnostic interest), because this could result in unnecessary doses to other sensitive tissues and could adversely affect the quality of the radiograph; and

(4) Specific area gonad shielding should provide attenuation of x-rays at least equivalent to that afforded by twenty-five hundredths of a millimeter (0.25 mm) of lead.

(b) The clinical objectives of the examination will not be compromised:

(1) Specific area testicular shielding usually does not obscure needed information except in a few cases such as oblique views of the hip, retrograde urethrograms and voiding cystourethrograms, visualization of the rectum and, occasionally, the pubic symphysis. Consequently, specific area testicular shielding should be considered for use in the majority of x-ray examinations of male patients in which the testes will lie within the primary beam or within five centimeters (5 cm) of its edge. It is not always possible to position shields on male patients so that no bone is obscured. Therefore, if all bone structure of the pelvic area must be visualized for a particular patient, the use of shielding should be carefully evaluated. The decision concerning the applicability of shielding for an individual patient is dependent upon consideration of the patient's unique anthropometric characteristics and the diagnostic information needs of the examination; or

(2) The use of specific area ovarian shielding is frequently impractical at present because the exact location of the ovaries is difficult to estimate, and the shield may obscure visualization of portions of adjacent structures such as the spine, ureters, and small and large bowels. However, it may be possible for practitioners to use specific area ovarian shielding during selected views in some examinations; and

The patient has a reasonable reproductive potential.

Specific area shielding need not be used on patients who cannot or are not likely to have children in the future.

10801.2 The following table of statistical data regarding the average number of children expected by potential parents in various age categories during their remaining lifetimes is provided for x-ray facilities that wish to use it as a basis for judging reproductive potential:

Expected Number of Future Children Versus Age of Potential Parent

Age

Male parent

Female parent

Fetus

2.6

0 to 4

2.6

2.5

5 to 9

2.7

2.5

10 to 14

2.7

2.6

15 to 19

2.7

2.6

20 to 24

2.6

2.2

25 to 29

2.0

1.4

30 to 34

1.1

35 to 39

40 to 44

.04

45 to 49

.07

50 to 54

.03

55 to 64

.01

Over 65

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). Derived from data published by the National Center for Health Statistics, “Final Natality Statistics 11070,” HRA 74-1120. vol. 22, No. 12, Mar. 20, 1974. District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10801

22-B DCMR § 10802 RECOMMENDATION FOR QUALITY ASSURANCE PROGRAMS IN DIAGNOSTIC RADIOLOGY FACILITIES

10802.1 Quality assurance programs are recommended for all diagnostic radiology facilities.

10802.2 A quality assurance program should contain the elements listed in § 10802.3 through 10802.23. The extent to which each element of the quality assurance program is implemented should be determined by an analysis of the facility's objectives and resources conducted by its qualified staff or by qualified outside consultants. The extent of implementation should be determined on the basis of whether the expected benefits in radiation exposure reduction, improved image quality, or financial savings will compensate for the resources required for the program.

10802.3 Responsibility and authority for the overall quality assurance program as well as for monitoring, evaluation, and corrective measures should be specified and recorded in a quality assurance manual.

10802.4 The owner or practitioner in charge of the facility has primary responsibility for implementing and maintaining the quality assurance program.

10802.5 Staff technologists will generally be delegated a basic quality assurance role by the practitioner in charge. Responsibility for specific quality control monitoring and maintenance techniques or quality administration procedures may be assigned, provided that the staff technologists are qualified by training or experience for these duties. The staff technologists should also be responsible for identifying problems or potential problems requiring actions beyond the level of their training. They should bring these problems to the attention of the practitioner in charge, or his or her representative, so that assistance in solving the problems may be obtained from inside or outside the facility.

10802.6 In facilities where they are available, physicists, supervisory technologists, or quality control technologists should have a major role in the quality assurance program. Such specialized personnel may be assigned responsibility for day-to-day administration of the program, may carry out monitoring duties beyond the level of training of the staff technologist or, if desired by the facility, may relieve the staff technologists of some or all of their basic monitoring duties. Staff service engineers may also be assigned responsibility for certain preventive or corrective maintenance actions.

10802.7 Responsibility for certain quality control techniques and corrective measures may be assigned to personnel qualified by training or experience, such as consultants or industrial representatives, from outside of the facility, provided there is a written agreement clearly specifying these services.

10802.8 In large facilities, responsibility for long-range planning of quality assurance goals and activities should be assigned to a quality assurance committee as described in § 10802.22.

10802.9 Before purchasing new equipment, the staff of the diagnostic radiology facility should determine the desired performance specifications for the equipment. Initially, these specifications may be stated in terms of the desired performance of the equipment, or prospective vendors may be informed solely of the functions the equipment should be able to perform and asked to provide the performance specifications of items from their equipment line that can perform these functions. In either case, the responses of the prospective vendors should serve as the basis for negotiations to establish the final purchase specifications, taking into account the state of the art and balancing the need for the specified performance levels with the cost of the equipment to meet them. The final purchase specifications should be in writing and should include performance specifications. The availability of experienced service personnel should also be taken into consideration in making the final purchase decisions. Any understandings with respect to service personnel should be incorporated into the purchase specifications. After the equipment is installed, the facility should conduct a testing program, as defined in its purchase specifications, to ensure that the equipment meets the agreed upon specifications, including applicable Federal and State specifications and the records of the acceptance testing should be retained throughout the life of the equipment for comparison with monitoring results in order to assess continued acceptability of performance.

10802.10 A routine quality control monitoring and maintenance system incorporating state-of-the-art procedures should be established and conducted on a regular schedule. The purpose of monitoring is to permit evaluation of the performance of the facility's x-ray system(s) in terms of the standards for image quality established by the facility (as described in § 10802.17) and compliance with applicable Federal and State regulatory requirements. The maintenance program should include corrective maintenance to eliminate problems revealed by monitoring or other means before they have a serious deleterious impact on patient care. To the extent permitted by the training of the facility staff, the maintenance program should also include preventive maintenance, which could prevent unexpected breakdowns of equipment and disruption of departmental routine.

10802.11 The parameters to be monitored in a facility should be determined by that facility on the basis of an analysis of expected benefits and cost. Such factors as the size and resources of the facility, the type of examinations conducted, and the quality assurance problems that have occurred in that or similar facilities should be taken into account in establishing the monitoring system. The monitoring frequency should also be based upon need and can be different for different parameters.

10802.12 Although the parameters to be monitored will vary somewhat from facility to facility, every diagnostic radiology facility should consider monitoring the following five (5) key components of the x-ray system:

Film processing;

Basic performance characteristics of the x-ray unit;

Cassettes and grids;

View boxes; and

(e) Darkroom.

10802.13 Examples of parameters of the above-named components and of more specialized equipment that may be monitored are as follows:

For film processing:

An index of speed;

An index of contrast;

Base plus fog;

Solution temperatures; and

Film artifact identification;

For basic performance characteristics of the x-ray unit:

(1) For fluoroscopic x-ray units:

Table-top exposure rates;

Centering alignment;

(D) kVp accuracy and reproducibility;

(E) mA accuracy and reproducibility;

(F) Exposure time accuracy and reproducibility;

(G) Reproducibility of x-ray output;

(H) Focal spot size consistency;

Half-value layer; and

(J) Representative entrance skin exposures;

(2) For image-intensified systems:

(A) Resolution;

(B) Focusing;

(D) Glare;

(E) Low contrast performance; and

(F) Physical alignment of camera and collimating lens;

(3) For radiographic x-ray units:

Reproducibility of x-ray output;

Linearity and reproducibility of mA stations;

Reproducibility and accuracy of timer stations;

Reproducibility and accuracy of kVp stations;

Accuracy of source-to-film distance indicators;

Light or x-ray field congruence;

Half-value layer;

Focal spot size consistency; and

Representative entrance skin exposures;

(4) For automatic exposure control devices:

(A) Reproducibility;

(B) kVp compensation;

Field sensitivity matching;

Minimum response time; and

Backup timer verification;

For cassettes and grids:

For cassettes:

Film or screen contact;

Screen condition;

Light leaks; and

Artifact identification;

For grids:

Alignment and focal distance; and

Artifact identification;

For view boxes:

Consistency of light output with time;

Consistency of light output from one (1) box to another; and

View box surface conditions;

For darkrooms:

Darkroom integrity; and

Safe light conditions;

For specialized equipment:

For tomographic systems:

Accuracy of depth and cut indicator;

Thickness of cut plane;

Exposure angle;

Completeness of tomographic motion;

Flatness of tomographic field;

(F) Resolution;

(G) Continuity of exposure;

(H) Flatness of cassette; and

Representative entrance skin exposures; and

For computerized tomography:

Precision (noise);

Contrast scale;

High and low contrast resolution;

Alignment; and

Representative entrance skin exposures.

10802.14 The maintenance program should include both preventive and corrective aspects.

10802.15 Preventive maintenance should be performed on a regularly scheduled basis with the goal of preventing breakdowns due to equipment failing without warning signs detectable by monitoring. Such actions have been found cost effective if responsibility is assigned to facility staff members. Possible preventive maintenance procedures are visual inspection of the mechanical and electrical characteristics of the x-ray system (covering such things as checking conditions of cables, watching the tomographic unit for smoothness of motion, assuring cleanliness with respect to spilling of contaminants in the examination room or the darkroom, and listening for unusual noises in the moving parts of the system), following the manufacturer's recommended procedures for cleaning and maintenance of the equipment, and regular inspection and replacement of switches and parts that routinely wear out or fail. The procedures included would depend upon the background of the staff members available. Obviously, a large facility with its own service engineers can do more than an individual practitioner's office.

10802.16 For maximum effectiveness, the quality assurance program should make provisions, as described in § 10802.18 for ascertaining whether potential problems are developing. If potential or actual problems are detected, corrective maintenance should be carried out to eliminate them before they cause a major impact on patient care.

10802.17 Standards of acceptable image quality should be established. Ideally, these should be objective. Acceptability limits for the variations of parameter values, but they may be subjective (for example, the opinions of professional personnel, in cases where adequate objective standards cannot be defined). These standards should be routinely reviewed and redefined as needed, as described in § 10802.23 of this chapter.

10802.18 The facility's quality assurance program should include means for two (2) levels of evaluation:

(a) On the first level, the results of the monitoring procedures should be used to evaluate the performance of the x-ray system(s) to determine whether corrective actions are needed to adjust the equipment so that the image quality consistently meets the standards for image quality. This evaluation should include analysis of trends in the monitoring data as well as the use of the data to determine the need for corrective actions on a day-by-day basis. Comparison of monitoring data with the purchase specifications and acceptance testing results for the equipment in question is also useful; and

(b) On the second level, the facility quality assurance program should also include means for evaluating the effectiveness of the program itself. Possible means include ongoing studies of the retake rate and the causes of the repeated radiographs, examination of equipment repair and replacement costs, subjective evaluation of the radiographs being produced, occurrence and reasons for complaints by radiologists, and analysis of trends in the results of monitoring procedures such as sensitometric studies. Of these, ongoing studies of the retake rate (reject rate) and its causes are often the most useful and may also provide information of value in the first level of evaluation. Such studies can be used to evaluate potential for improvement, to make corrections, and to determine whether the corrective actions were effective. The number of rejects should be recorded daily or weekly, depending on the facility's analysis of its needs. Ideally, the reasons for the rejection should also be determined and recorded. Should determining these reasons be impossible on a regular basis with the available staff, the analysis should be done for a two (2)-week period after major changes have occurred in diagnostic procedures or the x-ray system and at least semi-annually.

10802.19 The program should include provisions for the keeping of records on the results of the monitoring techniques, any difficulties detected, the corrective measures applied to these difficulties, and the effectiveness of these measures. The extent and form of these records should be determined by the facility on the basis of its needs. The facility should view these records as a tool for maintaining an effective quality assurance program and not view the data in them as an end in itself but rather as a beginning. For example, the records should be made available to vendors to help them provide better service. More importantly, the data should be the basis for the evaluation and the reviews suggested in §§ 10802.18 and 10802.23.

10802.20 A quality assurance manual should be written in a format permitting convenient revision as needed and should be made readily available to all personnel. The content of the manual should be determined by the facility staff, but the following items are suggested as providing essential information:

(a) A list of the individuals responsible for monitoring and maintenance techniques;

(b) A list of the parameters to be monitored and the frequency of monitoring;

(c) A description of the standards, criteria of quality, or limits of acceptability that have been established for each of the parameters monitored;

(d) A brief description of the procedures to be used for monitoring each parameter;

(e) A description of procedures to be followed when difficulties are detected to call these difficulties to the attention of those responsible for correcting them;

(f) A list of the publications in which detailed instructions for monitoring and maintenance procedures can be found. Copies of these publications should also be readily available to the entire staff, but they should be separate from the manual. (Publications providing these instructions can usually be obtained from the Department or private sources, although the facility may wish to make some modifications to meet its needs more effectively);

(g) A list of the records, with sample forms, that the facility staff has decided should be kept. The facility staff should also determine and note in the manual the length of time each type of record should be kept before discarding; and

(h) A copy of each set of purchase specifications developed for new equipment and the results of the acceptance testing for that equipment.

10802.21 The program should include provisions for appropriate training for all personnel with quality assurance responsibilities. This should include both training provided before the quality assurance responsibilities are assumed and continuing education to keep the personnel up-to-date. Practical experience with the techniques conducted under the supervision of experienced instructors, either in the facility or in a special program, is the most desirable type of training. The use of self-teaching materials can be an adequate substitute for supervised instruction, especially in continuing education programs, if supervised instruction is not available.

10802.22 A facility whose size would make it impractical for all staff members to meet for planning purposes should consider the establishment of a quality assurance committee whose primary function would be to maintain lines of communication among all groups with quality assurance or image production or interpretation responsibilities. For maximum communication, all departments of the facility with x-ray equipment should be represented. The committee may also be assigned policy-making duties such as some or all of the following:

(a) Assign quality assurance responsibilities;

(b) Maintain acceptable standards of quality; and

(c) Periodically review program effectiveness. Alternatively, the duties of this committee could be assigned to an already-existing committee such as the Radiation Safety Committee. In smaller facilities, all staff members should participate in the committee's tasks. The Quality Assurance Committee should report directly to the head of the radiology department, or, in facilities where more than one (1) department operates x-ray equipment, to the chief medical officer of the facility. The committee should meet on a regular basis.

10802.23 The facility's quality assurance program should be reviewed by the Quality Assurance Committee or the practitioner in charge to determine whether its effectiveness could be improved. Items suggested for inclusion in the review include:

The reports of the monitoring and maintenance techniques to ensure that they are being performed on schedule and effectively. These reports should be reviewed at least quarterly;

(b) The monitoring and maintenance techniques and their schedules to ensure that they continue to be appropriate and in step with the latest developments in quality assurance. They should be made current at least annually;

(c) The standards for image quality to ensure that they are consistent with the state-of-the-art and the needs and resources of the facility. These standards should be evaluated at least annually;

(d) The results of the evaluations of the effectiveness of the quality assurance actions to determine whether changes need to be made. This determination should be made at least annually; and

The quality assurance manual should also be reviewed at least annually to determine whether revisions are needed.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10802

22-B DCMR § 10803 RECOMMENDATION ON ADMINISTRATIVELY REQUIRED DENTAL X-RAY EXAMINATIONS

10803.1 The Department recommends that dental x-ray examinations be performed only after careful consideration of the dental or other health needs of the patient, that is, when the patient's dentist or physician judges them to be necessary for diagnosis, treatment, or prevention of disease. Administratively required dental x-ray examinations are those required by a remote third party for reasons not related to the patient's immediate dental needs. These x-ray examinations are usually a source of unnecessary radiation exposure to the patient. Because any unnecessary radiation exposure should be avoided, third parties should not require dental x-ray examinations unless they can demonstrate that such examinations provide a direct clinical benefit to the patient, and the patient's dentist or physician agrees with that assessment.

10803.2 Some examples of administrative x-ray examinations that should not be required by third parties are those intended solely:

To monitor insurance claims or detect fraud;

To satisfy a prerequisite for reimbursement;

To provide training or experience; or

To certify qualifications or competence.

10803.3 This recommendation is not intended to preclude dental x-ray examinations ordered by the attending practitioner, based on the patient's history or physical examination, or those performed on selected populations shown to have significant yields of previously undiagnosed disease. This recommendation is also not intended to preclude the administrative use by third parties of dental radiographs that are taken on the order of the patient's dentist or physician as a necessary part of the patient's clinical care.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10803

22-B DCMR § 10804 APPLICABILITY

10804.1 The provisions of this chapter are applicable as follows:

All manufacturers of electronic products are subject to § 10815;

Manufacturers, dealers, and distributors of electronic products are subject to the provisions set forth in table 1 of this section, unless excluded by Paragraph (c) or an exemption has been granted under § 10818 or 10819; and

(1) Manufacturers of electronic products intended solely for export if such product is labeled or tagged to show that the product meets all the applicable requirements of the country to which such product is intended for export;

(2) Manufacturers of electronic products listed in table 1of this section if such product is sold exclusively to other manufacturers for use as components of electronic products to be sold to purchasers, with the exception that the provisions are applicable to those manufacturers certifying components of diagnostic x-ray systems pursuant to provisions of § 10853.5 of this chapter;

(3) Manufacturers of electronic products that are intended for use by the U.S. Government and whose function or design cannot be divulged by the manufacturer for reasons of national security, as evidenced by government security classification; or

(4) Assemblers of diagnostic x-ray equipment subject to the provisions of § 10853.6 of this chapter, provided the assembler has submitted the report required by § 10853.7 or 10853.8 of this chapter and retains a copy of such report for a period of five (5) years from its date.

Table 1. -- Record and Reporting Requirements By Product

Manufacturer

Products

Product reports § 10808

Supplemental reports § 10809

Abbreviated reports § 10810

Annual reports § 10811

DIAGNOSTIC X-RAY

(10853, 10854, 10855)

Computed tomography

X-ray system

Tube housing assembly

X-ray control

X-ray high voltage generator

X-ray table or cradle

X-ray film changer

Vertical cassette holders mounted in a fixed location and cassette holders with front panels

Beam-limiting devices

Spot-film devices and image intensifiers manufactured after April 26, 1977

Cephalometric devices manufactured after February 25, 1978

Image receptor support devices for mammographic X-ray systems manufactured after September 5, 1978

CABINET X RAY

Baggage inspection

Other

Products intended to produce particulate radiation or x-rays other than diagnostic or cabinet diagnostic x-ray

Medical

Analytical

Industrial

TELEVISION PRODUCTS

<25 kilovolt (kV) and <0.1

X fn6

milliroentgen per hour (mR/hr.)

IRLC,

(gteqt) 25kV and <0.1mR/hr IRLC

(gteqt) 0.1mR/hr IRLC

MICROWAVE/RF

MW ovens

MW diathermy

MW heating, drying, security systems

RF sealers, electromagnetic induction and heating equipment, dielectric heaters (2-500 megahertz)

OPTICAL

Phototherapy products

Laser products

Class I lasers and products containing such lasers

Class I laser products containing class IIa, II, IIIa, lasers

Class IIa, II, IIIa lasers and products other than class I products containing such lasers

Class IIIb and IV lasers and products containing such lasers

Sunlamp products

Lamps only

Sunlamp products

Mercury vapor lamps

T lamps

R lamps

ACOUSTIC

Ultrasonic therapy

Diagnostic ultrasound

Medical ultrasound other than therapy or diagnostic

Nonmedical ultrasound

Table 1. -- Record and Reporting Requirements By Product

Manufacturer

Dealer & Distributor

Products

Test records

Distribution

§ 10816.1(a)

records

§ 10816.1(b)

§§ 10812

and 10813

DIAGNOSTIC X-RAY (10853, 10854, 10855)

Computed tomography

X-ray system

Tube housing assembly

X-ray control

X-ray high voltage generator

X-ray table or cradle

X-ray film changer

Vertical cassette holders mounted in a fixed location and cassette holders with front panels

Beam-limiting devices

Spot-film devices and image intensifiers manufactured after intensifiers manufactured after April 26, 1977

Cephalometric devices manufactured after February 25, 1978

Image receptor support devices for mammographic X-ray systems manufactured after September 5, 1978

CABINET X RAY

Baggage inspection

Other

PRODUCTS INTENDED TO PRODUCE PARTICULATE RADIATION OR X-RAYS OTHER THAN DIAGNOSTIC OR CABINET DIAGNOSTIC X-RAY

Medical

Analytical

Industrial

TELEVISION PRODUCTS (§ 10851)

1t25 kilovolt (kV) and 1t0.1 milliroentgen per hour (mR/hr.) IRLC,

1t25 kV and 1t0.1 mR/hr. IRLC

t]25kV and 1t0.

MICROWAVE/RF

MW ovens

MW diathermy

MW heating, drying, security

systems

RF sealers, electromagnetic induction and heating equipment, dielectric heaters (2-500 megahertz)

OPTICAL

Phototherapy products

Laser products

Class I lasers and products containing such lasers

Class I laser products containing class IIa, II, IIIa, lasers

Class IIa, II, IIIa lasers and products other than class I products containing such lasers

Class IIIb and IV lasers and products containing such lasers

Sunlamp products

Lamps only

Sunlamp products

Mercury vapor lamps

T lamps

R lamps

ACOUSTIC

Ultrasonic therapy

Diagnostic ultrasound

Medical ultrasound other than

therapy or diagnostic

Nonmedical ultrasound

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). Report of Assembly (Form FDA 2579) is required for diagnostic x-ray components; see 21 C.F.R. § 1020.30(d)(1) through (d)(3). Systems records and reports are required if a manufacturer exercises the option and certifies the system as permitted in 21 C.F.R. § 1020.30(c). Determined using the isoexposure rate limit curve (IRLC) under phase III test conditions (21 C.F.R. § 1020.10(c)(3)(iii)). Annual report is for production status information only. Determination of the applicable reporting category for a laser product shall be based on the worst-case hazard present within the laser product. Id. Id. Id. However, authority to inspect all appropriate documents supporting the adequacy of a manufacturer’s compliance testing program is retained. The requirement includes §§ 10817 and 10814, if applicable. Report of Assembly is required for diagnostic x-ray components; see § 10853.7 through 10853.9. Systems records and reports are required if a manufacturer exercises the option and certifies the system as permitted in § 10853.6. Determined using the isexposure rate limit curve (IRLC) under phase III test conditions (§ 10851.4(c)). Annual report is for production status information only. Determination of the applicable reporting category for a laser product shall be based on the worst-case hazard present within the laser product. Id. Id. Id. District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10804

22-B DCMR § 10805 NOTIFICATION TO USER OF PERFORMANCE AND TECHNICAL DATA

10805.1 The Director and Deputy Director of the Center for Devices and Radiological Health, as authorized under delegated authority, may require a manufacturer of a radiation emitting electronic product to provide to the ultimate purchaser, at the time of original purchase, such performance data and other technical data related to safety of the product as the Director or Deputy Director finds necessary.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10805

22-B DCMR § 10806 CONFIDENTIALITY OF INFORMATION

10806.1 The Secretary or his or her representative shall not disclose any information reported to or otherwise obtained by him or her, pursuant to this chapter, which concerns or relates to a trade secret or other matter referred to in Section 1905 of Title 18 of the United States Code, except that such information may be disclosed to other officers or employees of the Department and of the other agencies concerned with carrying out the requirements of the Act. Nothing in this section shall authorize the withholding of information by the Secretary, or by any officers or employees under his or her control, from the duly authorized committees of the Congress.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10806

22-B DCMR § 10807 SUBMISSION OF DATA AND REPORTS

10807.1 All submissions such as reports, test data, product descriptions, and other information required by this chapter, or voluntarily submitted to the Department, shall be filed with the number of copies prescribed by the Department and shall be signed by the person making the submission.

10807.2 [Reserved]

10807.3 Where the Department issues guides or instructions have been for the submission of material required by this chapter, such as test data, product reports, abbreviated reports, supplemental reports, and annual reports, the material submitted shall conform to the applicable reporting guides or instructions. Where it is not feasible or where it would not be appropriate to conform to any portion of a prescribed reporting guide or instruction, an alternate format for providing the information requested by that portion of the guide or instruction may be used provided the submitter of such information submits adequate explanation and justification for use of an alternate format. If the Department determines that such justification is inadequate and that it is feasible or appropriate to conform to the prescribed reporting guide or instruction, the agency may require resubmission of the information in conformance with the reporting guide or instruction.

10807.4 Where the submission of quality control and testing information is common to more than one (1) model, or model family of the same product category, a "common aspects report" consolidating similar information may be provided, if applicable.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10807

22-B DCMR § 10808 PRODUCT REPORTS

10808.1 Every manufacturer of a product or component requiring a product report as set forth in Table 1 of § 10804 shall submit a product report to the Department, prior to the introduction of such product into commerce. The report shall be distinctly marked "Radiation Safety Product Report of (name of manufacturer)" and shall:

Identify which listed product is being reported;

Identify each model of the listed product together with sufficient information concerning the manufacturer's code or other system of labeling to enable the Director to determine the place of manufacture;

Include information on all components and accessories provided in, on, or with the listed product that may affect the quantity, quality, or direction of the radiation emissions;

(d) Describe the function, operational characteristics affecting radiation emissions, and intended and known uses of each model of the listed product;

(e) State the standard or design specifications, if any, for each model with respect to electronic product radiation safety. Reference may be made to a District standard, if applicable;

(f) For each model, describe the physical or electrical characteristics, such as shielding or electronic circuitry, incorporated into the product in order to meet the standards or specifications reported pursuant to Paragraph (e);

(g) Describe the methods and procedures employed, if any, in testing and measuring each model with respect to electronic product radiation safety, including the control of unnecessary, secondary, or leakage electronic product radiation, the applicable quality control procedures used for each model, and the basis for selecting such testing and quality control procedures;

(h) For those products which may produce increased radiation with aging, describe the methods and procedures used, and frequency of testing of each model for durability and stability with respect to electronic product radiation safety. Include the basis for selecting such methods and procedures, or for determining that such testing and quality control procedures are not necessary;

(i) Provide sufficient results of the testing, measuring, and quality control procedures described in accordance with Paragraphs (g) and (h) to enable the Department to determine the effectiveness of those test methods and procedures;

(j) Report for each model all warning signs, labels, and instructions for installation, operation, and use that relate to electronic product radiation safety; and

(k) Provide, upon request, such other information as the Department may reasonably require to enable it to determine whether the manufacturer has acted or is acting in compliance with the Act and any standards prescribed thereunder, and to enable the Department to carry out the purposes of the Act.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10808

22-B DCMR § 10809 SUPPLEMENTAL REPORTS

10809.1 Prior to the introduction into commerce of a new or modified model within a model or chassis family of a product listed in Table 1 of § 10804 for which a report under § 10808 is required, each manufacturer shall submit a report with respect to such new or modified model describing any changes in the information previously submitted in the product report. Reports will be required for changes that:

Affect actual or potential radiation emission; and

(b) Affect the manner of compliance with a standard or manner of testing for radiation safety.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10809

22-B DCMR § 10810 ABBREVIATED REPORTS

10810.1 Manufacturers of products requiring abbreviated reports as specified in Table 1 of § 10804 shall submit, prior to the introduction of such product, a report distinctly marked "Radiation Safety Abbreviated Report" which shall include:

(a) Firm and model identification;

(b) A brief description of operational characteristics that affect radiation emissions, transmission, leakage, or that control exposure;

(d) Radiation emission, transmission, or leakage levels; and

(e) If necessary, additional information as may be requested to determine compliance with the Act and this chapter.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10810

22-B DCMR § 10811 ANNUAL REPORTS

10811.1 Every manufacturer of products requiring an annual report as specified in Table 1 of § 10804 shall submit an annual report summarizing the contents of the records required to be maintained by § 10816.1 and providing the volume of products produced, sold, or installed.

10811.2 Reports are due annually by September 1. Such reports shall cover the twelve (12) month period ending on June 30 preceding the due date of the report.

10811.3 New models of a model family that do not involve changes in radiation emission or requirements of a performance standard do not require supplemental reports prior to introduction into commerce. These model numbers should be reported in quarterly updates to the annual report.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10811

22-B DCMR § 10812 RECORDS TO BE OBTAINED BY DEALERS AND DISTRUBUTORS

10812.1 Dealers and distributors of electronic products for which there are performance standards and for which the retail price is fifty dollars ($50) or more shall obtain such information as is necessary to identify and locate first purchasers if the product is subject to this section by virtue of Table 1 of § 10804.

10812.2 Such information shall include:

The name and mailing address of the distributor, dealer, or purchaser to whom the product was transferred;

Identification and brand name of the product;

(d) Date of sale, award, or lease.

10812.3 The information obtained pursuant to this section shall be forwarded immediately to the appropriate manufacturer of the electronic product, or preserved as prescribed in § 10813.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10812

22-B DCMR § 10813 DISPOSITION OF RECORDS OBTAINED BY DEALERS AND DISTRIBUTORS

10813.1 Information obtained by dealers and distributors pursuant to § 10812 shall immediately be forwarded to the appropriate manufacturer unless:

The dealer or distributor elects to hold and preserve such information and to immediately furnish it to the manufacturer when advised by the manufacturer or the Department of Health, that such information is required; and

The dealer or distributor, upon making the election under § 10813.1(a) of this section, promptly notifies the manufacturer of such election. Such notification shall be in writing and shall identify the dealer or distributor and the electronic product or products for which the information is being accumulated and preserved.

10813.2 Every dealer or distributor who elects to hold and preserve information required pursuant to § 10812 shall preserve the information for a period of five (5) years from the date of the sale, award, or lease of the product, or until the dealer or distributor discontinues dealing in, or distributing the product, whichever is sooner. If the dealer or distributor discontinues dealing in, or distributing the product, such information as obtained pursuant to § 10812 shall be furnished at that time, or before, to the manufacturer of the product.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10813

22-B DCMR § 10814 CONFIDENTIALITY OF RECORDS FURNISHED BY DEALERS AND DISTRIBUTORS

10814.1 All information furnished to manufacturers by dealers and distributors pursuant to this chapter shall be treated by such manufacturers as confidential information which may be used only as necessary to notify persons pursuant to Section 535 of the Act.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10814

22-B DCMR § 10815 REPORTING OF ACCIDENTAL RADIATION OCCURRENCES

10815.1 Manufacturers of electronic products shall, where reasonable grounds for suspecting that such an incident has occurred, immediately report to the Department all accidental radiation occurrences reported to or otherwise known to the manufacturer and arising from the manufacturing, testing, or use of any product introduced or intended to be introduced into commerce by such manufacturer. Reasonable grounds include, but are not necessarily limited to, professional, scientific, or medical facts or opinions documented or otherwise, that concludes or leads to the conclusion that such an incident has occurred.

10815.2 Such reports shall be addressed to the Department, and the reports and their envelopes shall be distinctly marked "Report on 10815" and shall contain all of the following information where known to the manufacturer:

The nature of the accidental radiation occurrence;

The location at which the accidental radiation occurrence occurred;

The manufacturer, type, and model number of the electronic product or products involved;

The circumstances surrounding the accidental radiation occurrence, including causes;

The number of persons involved, adversely affected, or exposed during the accidental radiation occurrence, the nature and magnitude of their exposure or injuries and, if requested by the Department, the names of the persons involved;

(f) The actions, if any, which may have been taken by the manufacturer, to control, correct, or eliminate the causes and to prevent reoccurrence; and

(g) Any other pertinent information with respect to the accidental radiation occurrence.

10815.3 If a manufacturer is required to report to the Director under § 10815.1 and also is required to report under Chapter 104, the manufacturer shall report in accordance with Chapter 104. If a manufacturer is required to report to the Director under § 10815.1 and is not required to report under Chapter 104, the manufacturer shall report in accordance with § 10815.1 of this section. A manufacturer need not file a separate report under this section if an incident involving an accidental radiation occurrence is associated with a defect or noncompliance and is reported pursuant to § 10823.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10815

22-B DCMR § 10816 RECORDS TO BE MAINTAINED BY MANUFACTURERS

10816.1 Manufacturers of products listed under Table 1 of § 10804 shall establish and maintain the following records with respect to such products:

Description of the quality control procedures with respect to electronic product radiation safety;

Records of the results of tests for electronic product radiation safety, including the control of unnecessary, secondary or leakage electronic product radiation, the methods, devices, and procedures used in such tests, and the basis for selecting such methods, devices, and procedures;

(c) For those products displaying aging effects which may increase electronic product radiation emission, records of the results of tests for durability and stability of the product, and the basis for selecting these tests;

Copies of all written communications between the manufacturer and dealers, distributors, and purchasers concerning radiation safety including complaints, investigations, instructions, or explanations affecting the use, repair, adjustment, maintenance, or testing of the listed product; and

(e) Data on production and sales volume levels if available.

10816.2 In addition to the records required by § 10816.1, manufacturers of products listed in § 10816.3 shall establish and maintain the following records with respect to such products:

A record of the manufacturer's distribution of products in a form which will enable the tracing of specific products or production lots to distributors or to dealers in those instances in which the manufacturer distributes directly to dealers; and

(b) Records received from dealers or distributors pursuant to § 10813.

10816.3 Manufacturers shall maintain reports for the following radiation-emitting products:

(a) Ultrasonic products;

(b) Microwave heating equipment;

(d) Rectifier tubes;

(e) Shunt regulator tubes;

(f) Cathode ray tubes intended to be operated at voltages greater than five thousand volts (5000 V) but less than fifteen thousand volts (15,000 V);

(g) Ultraviolet lamps and products containing such lamps intended for irradiation of any part of the human body by light of wavelength in air less than three hundred twenty nanometers (320 nm) to perform a diagnostic or therapeutic function;

(h) Television receivers that meet the District standard, provided the voltage of the cathode ray tube cannot exceed fifteen thousand volts (15,000 V);

(i) High voltage vacuum switches, rectifier tubes, shunt regulator tubes, and cathode ray tubes intended to be operated at voltages of fifteen thousand (15,000) or greater;

(j) Products in addition to television receivers that are subject to radiation standards; and

(k) Diagnostic x-ray, cabinet x-ray, microwave ovens, laser products, and sunlamp.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10816

22-B DCMR § 10817 PRESERVATION AND INSPECTION OF RECORDS

10817.1 Every manufacturer required to maintain records pursuant to this part, including records received pursuant to § 10813, shall preserve such records for a period of five (5) years from the date of the record.

10817.2 Upon reasonable notice by an officer or employee duly designated by the Department, manufacturers shall permit such officer or employee to inspect appropriate books, records, papers, and documents as are relevant to determining whether the manufacturer has acted or is acting in compliance with Federal standards.

10817.3 Upon request of the Department of Health, a manufacturer of products listed in Table 1 of § 10804 shall submit to the Director, copies of the records required to be maintained by § 10816.2.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10817

22-B DCMR § 10818 SPECIAL EXEMPTIONS

10818.1 Manufacturers of electronic products may submit to the Director a request, together with accompanying justification, for exemption from any requirements listed in Table 1 of § 10804. The request must specify each requirement from which an exemption is requested. In addition to other information that is required, the justification must contain documented evidence showing that the product or product type for which the exemption is requested does not pose a public health risk and meets at least one (1) of the following criteria:

The products cannot emit electronic product radiation in sufficient intensity or of such quality, under any conditions of operation, maintenance, service, or product failure, to be hazardous;

The products are produced in small quantities;

The products are used by trained individuals and are to be used by the same manufacturing corporation or for research, investigation, or training;

The products are custom designed and used by trained individuals knowledgeable of the hazards; or

The products are produced in such a way that the requirements are inappropriate or unnecessary.

10818.2 The Director may, subject to any conditions that the Director deems necessary to protect the public health, exempt manufacturers from all or part of the record and reporting requirements of this part on the basis of information submitted in accordance with § 10818.1 of this section or such other information which the Department may possess if the Department determines that such exemption is in keeping with the purposes of the Act.

10818.3 The Department will provide written notification of the reason for any denial. If the exemption is granted, the Department will provide written notification of:

(a) The electronic product or products for which the exemption has been granted;

(b) The requirements from which the product is exempted; and

(c) Such conditions as are deemed necessary to protect the public health and safety. Copies of exemptions shall be available upon request from the Department.

10818.4 The Department may exempt certain classes of products from the reporting requirements listed in Table 1 of § 10804, provided that the Department finds that such exemption is in keeping with the purposes of the Act.

10818.5 Manufacturers of products for which there is no applicable performance standard and for which an investigational device exemption has been approved or for which a premarket approval application has been approved in accordance with § 10611.4 of this chapter are exempt from submitting all reports listed in Table 1 of § 10804.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10818

22-B DCMR § 10819 EXEMPTIONS FOR MANUFACTURERS OF PRODUCTS INTENDED FOR THE DISTRICT OF COLUMBIA

10819.1 Upon application therefore by the manufacturer, the Department may exempt from the provisions of this chapter a manufacturer of any electronic product intended for use by departments or agencies of the District of Columbia provided such department or agency has prescribed procurement specifications governing emissions of electronic product radiation and provided further that such product is of a type used solely or predominantly by departments or agencies of the District of Columbia.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10819

22-B DCMR § 10820 APPLICABILITY

10820.1 The provisions of this chapter are applicable to electronic products which were manufactured after October 18, 1968.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10820

22-B DCMR § 10821 DEFECT IN ELECTRONIC PRODUCTS

10821.1 For the purpose of this chapter, an electronic product shall be considered to have a defect which relates to the safety of use by reason of the emission of electronic product radiation if:

(a) It is a product which does not utilize the emission of electronic product radiation in order to accomplish its purpose, and from which such emissions are unintended, and as a result of its design, production or assembly;

(b) It emits electronic product radiation which creates a risk of injury, including genetic injury, to any person;

(d) It is a product which utilizes electronic product radiation to accomplish its primary purpose and from which such emissions are intended, and as a result of its design, production, or assembly;

(e) Fails to conform to its design specifications relating to the emission of electronic product radiation;

(f) Without regard to the design specifications of the product, emits electronic product radiation unnecessary to the accomplishment of its primary purpose which creates a risk of injury, including genetic injury to any person; or

(g) Fails to accomplish the intended purpose.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10821

22-B DCMR § 10822 EFFECT OF REGULATION ON OTHER LAWS

10822.1 The remedies provided for in this chapter shall be in addition to and not in substitution for any other remedies provided by law and shall not relieve any person from liability at common law or under statutory law.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10822

22-B DCMR § 10823 DISCOVERY OF DEFECT OR FAILURE OF COMPLIANCE BY MANUFACTURER – NOTICE REQUIREMENTS

10823.1 Any manufacturer who discovers that any electronic product produced, assembled, or imported by him or her, which product has left its place of manufacture, has a defect or fails to comply with an applicable District standard shall:

(a) Immediately notify the Department in accordance with § 10825; and

(b) Except as authorized by § 10828, furnish notification with reasonable promptness to the following persons:

The dealers or distributors to whom such product was delivered by the manufacturer; and

The purchaser of such product and any subsequent transferee of such product (where known to the manufacturer or where the manufacturer upon reasonable inquiry to dealers, distributors, or purchasers can identify the present user).

10823.2 If a manufacturer is required to notify the Department under Chapter 104, the manufacturer shall report in accordance with Chapter 104.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10823

22-B DCMR § 10824 DETERMINATION BY THE DEPARTMENT OF HEALTH THAT PRODUCT FAILS TO COMPLY OR HAS A DEFECT

10824.1 If, the Department through testing, inspection, research, or examination of reports or other data, determines that any electronic product does not comply with an applicable standard issued pursuant to the Act or has a defect, he or she shall immediately notify the manufacturer of the product in writing specifying:

The defect in the product or the manner in which the product fails to comply with the applicable standard;

(b) The Department's findings, with references to the tests, inspections, studies, or reports upon which such findings are based; and

(c) A reasonable period of time during which the manufacturer may present his views and evidence to establish that there is no failure of compliance or that the alleged defect does not exist or does not relate to safety of use of the product by reason of the emission of electronic product radiation.

10824.2 The manufacturer shall have an opportunity for a regulatory hearing before the Department.

10824.3 Every manufacturer who receives a notice under § 10824.1 shall immediately advise the Department in writing of the total number of such product units produced and the approximate number of such product units which left the place of manufacture.

10824.4 If, after the expiration of the period of time specified in the notice, the Department determines that the product has a defect or does not comply with an applicable standard and the manufacturer has not applied for an exemption, he or she shall direct the manufacturer to furnish the notification to the persons specified in § 10823.1(b) in the manner specified in § 10826. The manufacturer shall within fourteen (14) days from the date of receipt of such directive furnish the required notification.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10824

22-B DCMR § 10825 NOTIFICATION BY THE MANUFACTURER TO THE DEPARTMENT OF HEALTH

10825.1 The notification to the Department required by § 10823.1(a) shall be confirmed in writing and, in addition to other relevant information which the Department may require, shall include the following:

Identification of the product or products involved;

The total number of such product units so produced, and the approximate number of such product units which have left the place of manufacture;

The expected usage for the product if known to the manufacturer;

A description of the defect in the product or the manner in which the product fails to comply with an applicable standard;

An evaluation of the hazards reasonably related to defect or the failure to comply with the standard;

A statement of the measures to be taken to repair such defect or to bring the product into compliance with the standard;

(g) The date and circumstances under which the defect was discovered; and

(h) The identification of any trade secret information which the manufacturer desires be kept confidential.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10825

22-B DCMR § 10826 NOTIFICATION BY THE MANUFACTURER TO AFFECTED PERSONS

10826.1 The notification to the persons specified in § 10823.1(b) shall be in writing and, in addition to other relevant information which the Department may require, shall include:

The information prescribed by § 10825.1(a) and (d), as well as instructions with respect to the use of the product pending the correction of the defect;

A clear evaluation in nontechnical terms of the hazards reasonably related to any defect or failure to comply;

The following statement:

“The manufacturer will, without charge, remedy the defect or bring the product into compliance with each applicable District of Columbia standard in accordance with a plan to be approved by the Department of Health, the details of which will be included in a subsequent communication to you.”; and

Provided, that if at the time the notification is sent, the Department has approved a plan for the repair, replacement, or refund of the product, the notification may include the details of the approved plan in lieu of the above statement.

10826.2 The envelope containing the notice shall not contain advertising or other extraneous material, and such mailings will be made in accordance with this section.

10826.3 Number 10 white envelopes shall be used, and the name and address of the manufacturer shall appear in the upper left corner of the envelope.

10826.4 The following statement is to appear in the far left third of the envelope in the type and size indicated and in reverse printing, centered in a red rectangle three and three-fourths inches (3 ¾ in.) wide and two and one-quarter inches (2 ¼ in.) high:

“Important--Electronic Product Radiation Warning”

10826.5 The statement shall be in three (3) lines, all capitals, and centered. "Important" shall be in thirty six (36) point Gothic Bold type. "Electronic Product" and "Radiation Warning" shall be in thirty six (36) point Gothic Condensed type.

10826.6 Envelopes with markings similar to those prescribed in this section shall not be used by manufacturers for mailings other than those required by this chapter.

10826.7 The notification shall be sent:

(a) By certified mail to purchasers of the product and to subsequent transferees;

(b) By certified mail or other more expeditious means to dealers and distributors; and

(c) Where products were sold under a name other than that of the manufacturer of the product, the name of the individual or company under whose name the product was sold may be used in the notification required by this section.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10826

22-B DCMR § 10827 COPIES OF COMMUNICATIONS SENT TO PURCHASERS, DEALERS, OR DISTRIBUTORS

10827.1 Every manufacturer of electronic products shall furnish to the Department a copy of all notices, bulletins, or other communications sent to the dealers or distributors of such manufacturers or to purchasers (or subsequent transferees) of electronic products of such manufacturer regarding any defect in such product or any failure of such product to comply with an applicable District standard.

10827.2 In the event the Department deems the content of such notices to be insufficient to protect the public health and safety, the Department may require additional notice to such recipients, or may elect to make or cause to be made such notification by whatever means it deems appropriate.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10827

22-B DCMR § 10828 APPLICATION FOR EXEMPTION FROM NOTIFICATION REQUIREMENTS

10828.1 A manufacturer may at the time of giving the written confirmation required by § 10825 or within fifteen (15) days of the receipt of any notice from the Secretary pursuant to § 10824.1(a), apply for an exemption from the requirement of notice to the persons specified in § 10823.1(b).

10828.2 The application for exemption shall contain the information required by § 10825 and in addition shall set forth in detail the grounds upon which the exemption is sought.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10828

22-B DCMR § 10829 GRANTING THE EXEMPTION

10829.1 If, in the judgment of the Department, the application filed pursuant to § 10828 states reasonable grounds for an exemption from the requirement of notice, the Department shall give the manufacturer written notice specifying a reasonable period of time during which he or she may present his or her views and evidence in support of the application.

10829.2 Such views and evidence shall be confined to matters relevant to whether the defect in the product or its failure to comply with an applicable District standard is such as to create a significant risk of injury, including genetic injury, to any person and shall be presented in writing unless the Department determines that an oral presentation is desirable. Where such evidence includes nonclinical laboratory studies, the data submitted shall include, with respect to each such study, either a statement that the study was conducted in compliance with the requirements set forth in 21 C.F.R., part 58, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance. When such evidence includes clinical investigations involving human subjects, the data submitted shall include, with respect to each clinical investigation either a statement that each investigation was conducted in compliance with the requirements set forth in 21 C.F.R., part 56 or a statement that the investigation is not subject to such requirements in accordance with 21 C.F.R., § 56.104 or 21 C.F.R. § 56.105, and a statement that each investigation was conducted in compliance with the requirements set forth in 21 C.F.R., part 50.

10829.3 If, during the period of time afforded the manufacturer to present his views and evidence, the manufacturer proves to the Department's satisfaction that the defect or failure to comply does not create a significant risk of injury, including genetic injury, to any person, the Department shall issue an exemption from the requirement of notification to the manufacturer and shall notify the manufacturer in writing specifying:

The electronic product or products for which the exemption has been issued; and

Such conditions as the Department deems necessary to protect the public health and safety.

10829.4 Any person who contests denial of an exemption shall have an opportunity for a regulatory hearing before the Department.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10829

22-B DCMR § 10830 MANUFACTURER’S OBLIGATION TO REPAIR, REPLACE, OR REFUND COST OF ELECTRONIC PRODUCTS

10830.1 If any electronic product fails to comply with an applicable District standard or has a defect and the notification specified in § 10823.1(b) is required to be furnished, the manufacturer of such product shall:

Without charge, bring such product into conformity with such standard or remedy such defect and provide reimbursement for any expenses for transportation of such product incurred in connection with having such product brought into conformity or having such defect remedied;

Replace such product with a like or equivalent product which complies with each applicable District standard and which has no defect relating to the safety of its use; or

Refund the product’s cost to the purchaser.

10830.2 The manufacturer shall take the action required by this section in accordance with a Department-approved plan pursuant to § 10834.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10830

22-B DCMR § 10831 PLANS FOR THE REPAIR OF ELECTRONIC PRODUCTS

10831.1 Every plan for bringing an electronic product into conformity with applicable District standards or for remedying any defect in such product shall be submitted to the Department in writing, and in addition to other relevant information which the Department may require, shall include:

Identification of the product involved;

The approximate number of defective product units which have left the place of manufacture;

The specific modifications, alterations, changes, repairs, corrections, or adjustments to be made to bring the product into conformity or remedy any defect;

(d) The manner in which the operations described in § 10831.1(c) will be accomplished, including the procedure for obtaining access to, or possession of, the products and the location where such operations will be performed;

(e) The technical data, test results or studies demonstrating the effectiveness of the proposed remedial action;

(f) A time limit, reasonable in light of the circumstances, for completion of the operations;

(g) The system by which the manufacturer will provide reimbursement for any transportation expenses incurred in connection with having such product brought into conformity or having any defect remedied; and

(h) The text of the statement which the manufacturer will send to the persons specified in § 10823.1(b) informing such persons:

That the manufacturer, at his or her expense, will repair the electronic product involved;

(2) Of the method by which the manufacturer will obtain access to or possession of the product to make such repairs;

That the manufacturer will reimburse such persons for any transportation expenses incurred in connection with making such repairs: and

(4) Of the manner in which such reimbursement will be effected.

10831.2 An assurance that the manufacturer will provide the Department with progress reports on the effectiveness of the plan, including the number of electronic products repaired.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10831

22-B DCMR § 10832 PLANS FOR THE REPLACEMENT OF ELECTRONIC PRODUCTS

10832.1 Every plan for replacing an electronic product with a like or equivalent product shall be submitted to the Department in writing, and in addition to other relevant information which the Department may require, shall include:

Identification of the product to be replaced;

(b) A description of the replacement product in sufficient detail to support the manufacturer's contention that the replacement product is like or equivalent to the product being replaced;

(d) The manner in which the replacement operation will be effected including the procedure for obtaining possession of the product to be replaced;

(e) A time limit, reasonable, in light of the circumstances for completion of the replacement;

(f) The steps which the manufacturer will take to insure that the defective product will not be reintroduced into commerce, until it complies with each applicable District standard and has no defect relating to the safety of its use;

(g) The system by which the manufacturer will provide reimbursement for any expenses for transportation of such product incurred in connection with effecting the replacement; and

(h) The text of the statement which the manufacturer will send to the persons specified in § 10823.1(b) of this chapter informing such persons:

That the manufacturer, at its expense, will replace the electronic product involved;

(2) Of the method by which the manufacturer will obtain possession of the product and effect the replacement;

(3) That the manufacturer will reimburse such persons for any transportation expenses incurred in connection with effecting such replacement; and

(4) Of the manner in which such reimbursement will be made.

10832.2 An assurance that the manufacturer will provide the Department with progress reports on the effectiveness of the plan, including the number of electronic products replaced.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10832

22-B DCMR § 10833 PLANS FOR REFUNDING THE COST OF ELECTRONIC PRODUCTS

10833.1 Every plan for refunding the cost of an electronic product shall be submitted to the Department in writing, and in addition to other relevant information which the Department may require, shall include:

Identification of the product involved;

The approximate number of defective product units which have left the place of manufacture;

The manner in which the refund operation will be effected including the procedure for obtaining possession of the product for which the refund is to be made;

The steps which the manufacturer will take to ensure that the defective products will not be reintroduced into commerce until it complies with each applicable District standard and has no defect relating to the safety of its use;

A time limit, reasonable in light of the circumstances, for obtaining the product and making the refund;

(f) A statement that the manufacturer will refund the cost of such product together with the information the manufacturer has used to determine the amount of the refund; and

The text of the statement which the manufacturer will send to the persons specified in § 10823.1(b) informing such persons:

That the manufacturer, at his or her expense, will refund the cost of the electronic product plus any transportation costs;

(2) Of the amount to be refunded exclusive of transportation costs; and

(3) Of the method by which the manufacturer will obtain possession of the product and make the refund.

10833.2 An assurance that the manufacturer will provide the Secretary with progress reports on the effectiveness of the plan, including the number of refunds made.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10833

22-B DCMR § 10834 APPROVAL OF PLAN

10834.1 If, after review of any plan submitted pursuant to this chapter, the Department determines that the action to be taken by the manufacturer will expeditiously and effectively fulfill the manufacturer's obligation under § 10830 in a manner designed to encourage the public to respond to the proposal, the Department will send written notice of approval of such plan to the manufacturer. Such approval may be conditioned upon such additional terms as the Department deems necessary to protect the public health and safety. Any person who contests denial of a plan shall have an opportunity for a regulatory hearing before the Department.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10834

22-B DCMR § 10844 SCOPE

10844.1 The standards listed in this chapter are applicable to electronic products as specified herein, to control electronic product radiation from such products. Standards so prescribed are subject to amendment or revocation and additional standards may be prescribed as are determined necessary for the protection of the public health and safety.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10844

22-B DCMR § 10845 CERTIFICATION

10845.1 Every manufacturer of an electronic product for which an applicable standard is in effect under this chapter shall furnish to the dealer or distributor, at the time of delivery of such product, the certification that such product conforms to all applicable standards under this chapter.

10845.2 The certification shall be in the form of a label or tag permanently affixed to or inscribed on such product so as to be legible and readily accessible to view when the product is fully assembled for use, unless the applicable standard prescribes some other manner of certification. All such labels or tags shall be in English.

10845.3 Such certification shall be based upon a test, in accordance with the standard, of the individual article to which it is attached or upon a testing program which is in accordance with good manufacturing practices. The Department may disapprove such a testing program on the grounds that it does not assure the adequacy of safeguards against hazardous electronic product radiation or that it does not assure that electronic products comply with the standards prescribed under this chapter.

10845.4 In the case of products for which it is not feasible to certify in accordance with § 10845.2, upon application by the manufacturer, the Department may approve an alternate means by which such certification may be provided.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10845

22-B DCMR § 10846 IDENTIFICATION

10846.1 Every manufacturer of an electronic product to which a standard under this chapter is applicable shall set forth the information specified in § 10846.2 and § 10846.3. This information shall be provided in the form of a tag or label permanently affixed or inscribed on such products so as to be legible and readily accessible to view when the product is fully assembled for use or in such other manner as may be prescribed in the applicable standard. Except for foreign equivalent abbreviations all such labels or tags shall be in English.

10846.2 The full name and address of the manufacturer of the product; abbreviations such as "Co.," "Inc.," or their foreign equivalents and the first and middle initials of individuals may be used. Where products are sold under a name other than that of the manufacturer of the product, the full name and address of the individual or company under whose name the product was sold may be set forth, provided such individual or company has previously supplied the Department with sufficient information to identify the manufacturer of the product.

10846.3 The place of manufacture may be expressed in code provided the manufacturer has previously supplied the Department with the key to such code.

10846.4 The month and year of manufacture shall be provided clearly and legibly, without abbreviation, and with the year shown as a four (4) digit number as follows:

Manufactured: (Insert Month and Year of Manufacture.)

10846.5 Every manufacturer of an electronic product to which a standard under this chapter is applicable shall provide to the Department a list identifying each brand name which is applied to the product together with the full name and address of the individual or company for whom each product so branded is manufactured.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10846

22-B DCMR § 10847 VARIANCES

10847.1 Upon application by a manufacturer (including an assembler), the Department may grant a variance from one (1) or more provisions of any performance standard for an electronic product subject to such standard when the Director determines that granting such a variance is in keeping with the purposes of the act, and:

The scope of the requested variance is so limited in its applicability as not to justify an amendment to the standard; or

(b) There is not sufficient time for the promulgation of an amendment to the standard.

10847.2 The issuance of the variance shall be based upon a determination that:

The product utilizes an alternate means for providing radiation safety or protection equal to or greater than that provided by products meeting all requirements of the applicable standard;

The product performs a function or is intended for a purpose which could not be performed or accomplished if required to meet the applicable standards, and suitable means for assuring radiation safety or protection are provided; or

One (1) or more requirements of the applicable standard are not appropriate, and suitable means for assuring radiation safety or protection are provided.

10847.3 If you are submitting an application for variances or for amendments or extensions thereof, you must submit an original and two (2) copies to the Department.

10847.4 The application for variance shall include the following information:

A description of the product and its intended use;

An explanation of how compliance with the applicable standard would restrict or be inappropriate for this intended use;

A description of the manner in which it is proposed to deviate from the requirements of the applicable standard;

(d) A description of the advantages to be derived from such deviation;

(e) An explanation of how alternate or suitable means of radiation protection will be provided;

(f) The period of time it is desired that the variance be in effect, and, if appropriate, the number of units the applicant wishes to manufacture;

(g) In the case of prototype or experimental equipment, the proposed location of each unit;

(h) Such other information required by regulation or by the Department, to evaluate and act on the application;

With respect to each nonclinical laboratory study contained in the application, either a statement that the study was conducted in compliance with the good laboratory practice regulations or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance; and

(j) If the electronic product is used in a clinical investigation involving human subjects, is subject to the requirements for institutional review set forth in 21 C.F.R., part 56, and is subject to the requirements for informed consent set forth in 12 C.F.R., part 50, the investigation shall be conducted in compliance with such requirements.

10847.5 The application for amendment or extension of a variance shall include the following information:

The variance number and expiration date;

(b) The amendment or extension requested and basis for the amendment or extension;

(d) An explanation of how alternate or suitable means of protection will be provided.

10847.6 The Department may approve or deny, in whole or in part, a requested variance or any amendment or extension thereof, and the Director shall inform the applicant in writing of this action on a requested variance, amendment, or extension. The written notice will state the manner in which the variance differs from the standard, the effective date and the termination date of the variance, a summary of the requirements and conditions attached to the variance, any other information that may be relevant to the application or variance, and, if appropriate, the number of units or other similar limitations for which the variance is approved. Each variance will be assigned an identifying number.

10847.7 The Department shall amend or withdraw a variance whenever the Department determines that this action is necessary to protect the public health or otherwise is justified by this chapter. Such action will become effective on the date specified in the written notice of the action sent to the applicant, except that it will become effective immediately upon notification to the applicant when the Department determines that such action is necessary to prevent an imminent health hazard.

10847.8 All applications for variances and for amendments and extensions thereof and all correspondence (including written notices of approval) on these applications will be available to the public except for information regarded as confidential under Section 537 of the Act.

10847.9 The manufacturer of any product for which a variance is granted shall modify the tag, label, or other certification required by § 10845 to state:

That the product is in conformity with the applicable standard, except with respect to those characteristics covered by the variance;

(b) That the product is in conformity with the provisions of the variance; and

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10847

22-B DCMR § 10848 EXEMPTIONS FOR PRODUCTS INTENDED FOR UNITED STATES GOVERNMENT USE

10848.1 Upon application by a manufacturer (including the assembler), the Department may grant an exemption from any performance standard for an electronic product, or class of products, otherwise subject to such standard when the Department determines that such electronic product or class is intended for use by departments or agencies of the U.S. and meets the criteria set forth in § 10848.2 or § 10848.3.

10848.2 The procuring agency shall prescribe procurement specifications for the product or class of products governing emissions of electronic product radiation, and the product or class shall be of a type used solely or predominantly by a department or agency of the U.S.

10848.3 The product or class of products is intended for research, investigations, studies, demonstration, training, or for reasons of national security.

10848.4 The U.S. department or agency that intends to procure or manufacture a product or class of products subject to electronic product radiation safety standards contained in this chapter should consult with the Department whenever it is anticipated that the specifications for the product or class must deviate from, or be in conflict with, such applicable standards. Such consultation should occur as early as possible during development of such specifications. The department or agency should include in the specifications all requirements of such standards that are not in conflict with, or are not inappropriate for, the special or unique uses for which the product is intended. The procuring agency should indicate to the Department if it desires to be notified of the approval, amendment, or withdrawal of the exemption.

10848.5 If you are submitting an application for exemption, or for amendment or extension thereof, you must submit an original and two copies to the Department. For an exemption under the criteria prescribed in § 10848.2 of this section, the application shall include the information prescribed in § 10848.6(a) through (m) of this section. For an exemption under the criteria prescribed in § 10848.3 of this section, the application shall include the information prescribed in § 10848.6(c) through (m). An application for exemption, or for amendment or extension thereof, and correspondence relating to such application shall be made available for public disclosure, except for confidential or proprietary information.

10848.6 Information classified for reasons of national security shall not be included in the application. Except as indicated in this section, the application for exemption shall include the following:

The procurement specifications for the product or class of products that govern emissions of electronic product radiation;

Evidence that the product or class of products is of a type used solely or predominantly by departments or agencies of the U.S.;

Evidence that such product or class of products is intended for use by a department or agency of the U.S.;

A description of the product or class of products and its intended use;

An explanation of how compliance with the applicable standard would restrict or be inappropriate for this intended use;

(f) A description of the manner in which it is proposed that the product or class of products shall deviate from the requirements of the applicable standard;

(g) An explanation of the advantages to be derived from such deviation;

(h) An explanation of how means of radiation protection will be provided where the product or class of products deviates from the requirements of the applicable standard;

(i) The period of time it is desired that the exemption be in effect, and, if appropriate, the number of units to be manufactured under the exemption;

(j) The name, address, and telephone number of the manufacturer or his agent;

(k) The name, address, and telephone number of the appropriate office of the U.S. department or agency purchasing the product or class of products;

(l) Such other information required by regulation or by the Department, to evaluate and act on the application. Where such information includes nonclinical laboratory studies, the information shall include, with respect to each nonclinical study, either a statement that each study was conducted in compliance with the requirements set forth in 21 C.F.R., part 58, or, if the study was not conducted in compliance, a statement that describes in detail all differences between the practices used in the study and those required in the regulations. When such information includes clinical investigations involving human subjects, the information shall include, with respect to each clinical investigation, a statement that each investigation was conducted in compliance with the requirements set forth in 21 C.F.R., part 56, or a statement that the investigation is not subject to such requirements in accordance with 21 C.F.R. §§ 56.104 or 56.105 and a statement that each investigation was conducted in compliance with the requirements set forth in 21 C.F.R., part 50; and

(m) With respect to each nonclinical laboratory study contained in the application, either a statement that the study was conducted in compliance, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.

10848.7 An exemption is granted on the basis of the information contained in the original application. Therefore, if changes are needed in the radiation safety specifications for the product, or its use, or related radiation control procedures such that the information in the original application would no longer be correct with respect to radiation safety, the applicant shall submit in advance of such changes a request for an amendment to the exemption. He or she also shall submit a request for extension of the exemption, if needed, at least sixty (60) days before the expiration date. The application for amendment or extension of an exemption shall include the following information:

The exemption number and expiration date; and

(b) The amendment or extension requested and basis for the amendment or extension.

10848.8 If the radiation safety specifications for the product or class of products or the product's or class of products' use or related radiation control procedures differ from the description provided in the original application, a description of such changes.

10848.9 The Department may grant an exemption including in the written notice of exemption such conditions or terms as may be necessary to protect the public health and safety and shall notify the applicant in writing of his or her action. The conditions or terms of the exemption may include specifications concerning the manufacture, use, control, and disposal of the excess or surplus exempted product of class of products as provided in the Code of Federal Regulations, Title 41, Subtitle C. Each exemption will be assigned an identifying number.

10848.10 The Department shall amend or withdraw an exemption whenever the Department determines that such action is necessary to protect the public health or otherwise is justified by provisions of the act or this chapter. Such action shall become effective on the date specified in the written notice of the action sent to the applicant, except that it shall become effective immediately when the Director determines that it is necessary to prevent an imminent health hazard.

10848.11 The manufacturer of any product for which an exemption is granted shall provide the following identification in the form of a tag or label permanently affixed or inscribed on such product so as to be legible and readily accessible to view when the product is fully assembled for use or in such other manner as may be prescribed in the exemption:

CAUTION

This electronic product has been exempted from Department of Health radiation safety performance standards prescribed in Chapter 108 (Radiological Health), pursuant to Exemption No.______, granted on ________.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10848

22-B DCMR § 10849 SPECIAL TEST PROCEDURE

10849.1 The Department may, on the basis of a written application by a manufacturer, authorize test programs other than those set forth in the standards under this chapter for an electronic product if he or she determines that such products are not susceptible to satisfactory testing by the procedures set forth in the standard and that the alternative test procedures assure compliance with the standard.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10849

22-B DCMR § 10850 ELECTRONIC PRODUCTS INTENDED FOR EXPORT

10850.1 The performance standards prescribed in this chapter shall not apply to any electronic product which is intended solely for export if:

Such product and the outside of any shipping container used in the export of such product are labeled or tagged to show that such product is intended for export; and

(b) Such product meets all the applicable requirements of the country to which such product is intended for export.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10850

22-B DCMR § 10851 TELEVISION RECEIVERS

10851.1 The provisions of this section are applicable to television receivers manufactured subsequent to January 15, 1970.

10851.2 Radiation exposure rates produced by a television receiver shall not exceed one half milliroentgens per hour (0.5 mR/hr.) at a distance of five centimeters (5 cm) from any point on the external surface of the receiver, as measured in accordance with this section.

10851.3 Compliance with the exposure rate limit defined in § 10851.2 shall be determined by measurements made with an instrument, the radiation sensitive volume of which shall have a cross section parallel to the external surface of the receiver with an area of ten square centimeters (10 cm2) and no dimension larger than five centimeters (5 cm). Measurements made with instruments having other areas must be corrected for spatial non-uniformity of the radiation field to obtain the exposure rate average over a ten square centimeter (10 cm2) area.

10851.4 All measurements shall be made with the receiver displaying a usable picture and with the power source operated at supply voltages up to the maximum test voltage of the receiver and, as applicable, under the following specific conditions:

On television receivers manufactured subsequent to January 15, 1970, measurements shall be made with all user controls adjusted so as to produce maximum x-radiation emissions from the receiver;

On television receivers manufactured subsequent to June 1, 1970, measurements shall be made with all user controls and all service controls adjusted to combinations which result in the production of maximum x-radiation emissions; and

(c) On television receivers manufactured subsequent to June 1, 1971, measurements shall be made under the conditions described in § 10851.4 (b), together with conditions identical to those which result from that component or circuit failure which maximizes x-radiation emissions.

10851.5 The manufacturer shall permanently affix or inscribe a warning label, clearly legible under conditions of service, on all television receivers which could produce radiation exposure rates in excess of the requirements of this section as a result of failure or improper adjustment or improper replacement of a circuit or shield component. The warning label shall include the specification of operating high voltage and an instruction for adjusting the high voltage to the specified value.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10851

22-B DCMR § 10852 COLD-CATHODE GAS DISCHARGE TUBES

10852.1 The provisions of this section are applicable to cold-cathode gas discharge tubes designed to demonstrate the effects of a flow of electrons or the production of x-radiation as specified herein.

10852.2 Radiation exposure rates produced by cold-cathode gas discharge tubes shall not exceed ten milliroentgens per hour (10 mR/hr.) at a distance of thirty centimeters (30 cm.) from any point on the external surface of the tube, as measured in accordance with this section.

10852.3 The divergence of the exit beam from tubes designed primarily to demonstrate the effects of x-radiation, with the beam blocking device in the open position, shall not exceed Pi steradians.

10852.4 Compliance with the exposure rate limit defined in § 10852.2 shall be determined by measurements averaged over an area of one hundred square centimeters (100 cm2) with no linear dimension greater than twenty centimeters (20 cm).

10852.5 Measurements of exposure rates from tubes in enclosures from which the tubes cannot be removed without destroying the function of the tube may be made at a distance of thirty centimeters (30 cm) from any point on the external surface of the enclosure, provided:

In the case of enclosures containing tubes designed primarily to demonstrate the production of x-radiation, measurements shall be made with any beam blocking device in the beam blocking position; or

In the case of enclosures containing tubes designed primarily to demonstrate the effects of a flow of electrons, measurements shall be made with all movable or removable parts of such enclosure in the position which would maximize external exposure levels.

10852.6 Measurements shall be made under the conditions of use specified in instructions provided by the manufacturer.

10852.7 Measurements shall be made with the tube operated under forward and reverse polarity.

10852.8 Manufacturers shall provide, or cause to be provided, with each tube to which this section is applicable, appropriate safety instructions, together with instructions for the use of such tube, including the specification of a power source for use with the tube.

10852.9 Each enclosure or tube shall have inscribed on or permanently affixed to it, tags or labels, which identify the intended polarity of the terminals and:

(a) In the case of tubes designed primarily to demonstrate the heat effect, fluorescence effect, or magnetic effect, a warning that application of power in excess of that specified may result in the production of x-rays in excess of allowable limits; and

In the case of tubes designed primarily to demonstrate the production of x-radiation, a warning that this device produces x-rays when energized.

10852.10 The tag or label required by this section shall be located on the tube or enclosure so as to be readily visible and legible when the product is fully assembled for use.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10852

22-B DCMR § 10853 DIAGNOSTIC X-RAY SYSTEMS AND THEIR MAJOR COMPONENTS

10853.1 The provisions of this section are applicable to:

The following components of diagnostic x-ray systems:

(1) Tube housing assemblies, x-ray controls, x-ray high-voltage generators, x-ray tables, cradles, film changers, vertical cassette holders mounted in a fixed location and cassette holders with front panels, and beam-limiting devices manufactured after August 1, 1974;

(2) Fluoroscopic imaging assemblies manufactured after August 1, 1974, and before April 26, 1977, or after June 10, 2006;

(3) Spot-film devices and image intensifiers manufactured after April 26, 1977;

(4) Cephalometric devices manufactured after February 25, 1978;

(5) Image receptor support devices for mammographic x-ray systems manufactured after September 5, 1978;

(6) Image receptors that are electrically powered or connected with the x-ray system manufactured on or after June 10, 2006; and

(7) Fluoroscopic air kerma display devices manufactured on or after June 10, 2006;

Diagnostic x-ray systems, except computed tomography x-ray systems, incorporating one (1) or more of such components. However, such x-ray systems shall be required to comply only with those provisions of this section and §§ 10854 and 10855, which relate to the components certified in accordance with § 10853.5 and installed into the systems;

Computed tomography (CT) x-ray systems manufactured before November 29, 1984; and

CT gantries manufactured after September 3, 1985.

10853.2 The following provisions of this section are applicable to CT x-ray systems manufactured or remanufactured on or after November 29, 1984:

Subsection 10853.1;

Subsection 10853.4(r) "CT";

(d) Subsection 10853.4(jjj) "Scan";

Subsection 10853.4(kkk) "Scan Time";

Subsection 10853.4(rrr) "Technique Factors";

Subsection 10853.4(sss) "Tomogram";

(h) Subsection 10853.17(f) through (h); and

Subsection 10853.28.

10853.3 The provisions of this section, including those provisions in 21 C.F.R. § 1020.33, are applicable to CT x-ray systems manufactured or remanufactured on or after September 3, 1985. The date of manufacture of the CT system is the date of manufacture of the CT gantry.

10853.4 As used in this section and §§ 10854 and 10855 the following definitions apply:

Accessible surface - the external surface of the enclosure or housing provided by the manufacturer;

(b) Accessory component -

(1) A component used with diagnostic x-ray systems, such as a cradle or film changer, that is not necessary for the compliance of the system with applicable provisions of this chapter but which requires an initial determination of compatibility with the system;

(2) A component necessary for compliance of the system with applicable provisions of this chapter but which may be interchanged with similar compatible components without affecting the system's compliance, such as one (1) of a set of interchangeable beam-limiting devices; or

(3) A component compatible with all x-ray systems with which it may be used and that does not require compatibility or installation instructions, such as a tabletop cassette holder;

Air kerma rate (AKR) - the air kerma per unit time;

Aluminum equivalent - the thickness of aluminum (type 1100 alloy) n1 affording the same attenuation, under specified conditions, as the material in question;

Articulated joint - a joint between two (2) separate sections of a tabletop in which a joint provides the capacity for one (1) of the sections to pivot on the line segment along which the sections join;

Assembler - any person engaged in the business of assembling, replacing, or installing one (1) or more components into a diagnostic x-ray system or subsystem. The term includes the owner of an x-ray system or his or her employee or agent who assembles components into an x-ray system that is subsequently used to provide professional or commercial services;

(h) Attenuation block - a block or stack of type 1100 aluminum alloy, or aluminum alloy having equivalent attenuation, with dimensions twenty centimeters (20 cm) or larger by twenty centimeters (20 cm) or larger by three and eight tenths centimeters (3.8 cm), that is large enough to intercept the entire x-ray beam;

Automatic exposure control (AEC) - a device which automatically controls one or more technique factors in order to obtain at a preselected location(s) a required quantity of radiation;

Automatic exposure rate control (AERC) -a device which automatically controls one (1) or more technique factors in order to obtain at a preselected location(s) a required quantity of radiation per unit time;

Beam axis -a line from the source through the centers of the x-ray fields;

Beam-limiting device -a device which provides a means to restrict the dimensions of the x-ray field;

(m) C-arm fluoroscope -a fluoroscopic x-ray system in which the image receptor and the x-ray tube housing assembly are connected or coordinated to maintain a spatial relationship. Such a system allows a change in the direction of the beam axis with respect to the patient without moving the patient;

(n) Cantilevered tabletop -a tabletop designed such that the unsupported portion can be extended at least one hundred centimeters (100 cm) beyond the support;

(o) Cassette holder -a device, other than a spot-film device, that supports or fixes the position of an x-ray film cassette during an x-ray exposure;

(p) Cephalometric device -a device intended for the radiographic visualization and measurement of the dimensions of the human head;

(q) Coefficient of variation -the ratio of the standard deviation to the mean value of a population of observations. It is estimated using the following equation:

where:

s = Estimated standard deviation of the population.

X = Mean value of observations in sample.

X[i] = ith observation sampled.

n = Number of observations sampled.

(r) Computed tomography (CT) -the production of a tomogram by the acquisition and computer processing of x-ray transmission data;

(s) Control panel -that part of the x-ray control upon which are mounted the switches, knobs, pushbuttons, and other hardware necessary for manually setting the technique factors;

(t) Cooling curve -the graphical relationship between heat units stored and cooling time;

(u) Cradle means:

(1) A removable device which supports and may restrain a patient above an x-ray table; or

(2) A device:

(A) Whose patient support structure is interposed between the patient and the image receptor during normal use;

(B) Which is equipped with means for patient restraint; and

(v) CT gantry -tube housing assemblies, beam-limiting devices, detectors, and the supporting structures, frames, and covers which hold or enclose these components;

(w) Cumulative air kerma -the total air kerma accrued from the beginning of an examination or procedure and includes all contributions from fluoroscopic and radiographic irradiation;

(x) Diagnostic source assembly -the tube housing assembly with a beam-limiting device attached;

(y) Diagnostic x-ray system -an x-ray system designed for irradiation of any part of the human body for the purpose of diagnosis or visualization;

(z) Dose -the absorbed dose as defined by the International Commission on Radiation Units and Measurements. The absorbed dose(D) is the energy deposited per unit mass of medium (D=de/dm), in units of joules per kilogram (J/kg), where the special name for the unit of absorbed dose is gray (Gy);

(aa) Equipment -x-ray equipment;

(bb) Exposure (X) -the quotient of dQ divided by dm (X=dQ/dm) where dQ is the absolute value of the total charge of the ions of one sign produced in air when all the electrons and positrons liberated or created by photons in air of mass, dm are completely stopped in air in units of coulomb per kilogram (C/kg). A second meaning of exposure is the process or condition during which the x-ray tube produces x-ray radiation;

(cc) Field emission equipment -equipment which uses an x-ray tube in which electron emission from the cathode is due solely to action of an electric field;

(dd) Fluoroscopic air kerma display device -a device, subsystem, or component that provides the display of AKR and cumulative air kerma required by § 10855.31. It includes radiation detectors, if any, electronic and computer components, associated software, and data displays;

(ee) Fluoroscopic imaging assembly -a subsystem in which x-ray photons produce a set of fluoroscopic images or radiographic images recorded from the fluoroscopic image receptor. It includes the image receptor(s), electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly;

(ff) Fluoroscopic irradiation time -the cumulative duration during an examination or procedure of operator-applied continuous pressure to the device, enabling x-ray tube activation in any fluoroscopic mode of operation;

(gg) Fluoroscopy -a technique for generating x-ray images and presenting them simultaneously and continuously as visible images. This term has the same meaning as the term "radioscopy" in the standards of the International Electrotechnical Commission;

(hh) General purpose radiographic x-ray system -any radiographic x-ray system which, by design, is not limited to radiographic examination of specific anatomical regions;

(ii) Half-value layer (HVL) -the thickness of specified material which attenuates the beam of radiation to an extent such that the AKR is reduced to one-half (1/2) of its original value. In this definition the contribution of all scattered radiation, other than any which might be present initially in the beam concerned, is deemed to be excluded;

(jj) Image intensifier -a device, installed in its housing, which instantaneously converts an x-ray pattern into a corresponding light image of higher energy density;

(kk) Image receptor -any device, such as a fluorescent screen, radiographic film, x-ray image intensifier tube, solid-state detector, or gaseous detector, which transforms incident x-ray photons either into a visible image or into another form which can be made into a visible image by further transformations. In those cases where means are provided to preselect a portion of the image receptor, the term "image receptor" shall mean the preselected portion of the device;

(ll) Image receptor support device -for mammography x-ray systems, that part of the system designed to support the image receptor during a mammographic examination and to provide a primary protective barrier;

(mm) Isocenter -the center of the smallest sphere through which the beam axis passes when the equipment moves through a full range of rotations about its common center;

(nn) Kerma - the quantity as defined by the International Commission on Radiation Units and Measurements. The kerma (K)is the quotient of dE[tr] by dm, where dE[tr] is the sum of the initial kinetic energies of all the charged particles liberated by uncharged particles in a mass dm of material; thus K=dE[tr]/dm, in units of J/kg, where the special name for the unit of kerma is gray (Gy). When the material is air, the quantity is referred to as "air kerma;"

(oo) Last-image-hold (LIH) radiograph -an image obtained either by retaining one (1) or more fluoroscopic images, which may be temporally integrated, at the end of a fluoroscopic exposure or by initiating a separate and distinct radiographic exposure automatically and immediately in conjunction with termination of the fluoroscopic exposure;

(pp) Lateral fluoroscope -the x-ray tube and image receptor combination in a biplane system dedicated to the lateral projection. It consists of the lateral x-ray tube housing assembly and the lateral image receptor that are fixed in position relative to the table with the x-ray beam axis parallel to the plane of the table;

(qq) Leakage radiation -radiation emanating from the diagnostic source assembly except for:

(1) The useful beam; and

(2) Radiation produced when the exposure switch or timer is not activated.

(rr) Leakage technique factors -the technique factors associated with the diagnostic source assembly which are used in measuring leakage radiation. They are defined as follows:

For diagnostic source assemblies intended for capacitor energy storage equipment, the maximum-rated peak tube potential and the maximum-rated number of exposures in an hour for operation at the maximum-rated peak tube potential with the quantity of charge per exposure being ten millicoulombs (10 mC) or the minimum obtainable from the unit, whichever is larger;

(2) For diagnostic source assemblies intended for field emission equipment rated for pulsed operation, the maximum-rated peak tube potential and the maximum-rated number of x-ray pulses in an hour for operation at the maximum-rated peak tube potential; and

(3) For all other diagnostic source assemblies, the maximum-rated peak tube potential and the maximum-rated continuous tube current for the maximum-rated peak tube potential;

(ss) Light field -that area of the intersection of the light beam from the beam-limiting device and one (1) of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the illuminance is one-fourth of the maximum in the intersection;

(tt) Line-voltage regulation -the difference between the no-load and the load line potentials expressed as a percent of the load line potential; that is,

Percent line-voltage regulation = 100(V[n] - V[i])/V[i]

where:

V[n] = No-load line potential and

V[i] = Load line potential.

(uu) Maximum line current -the root mean square current in the supply line of an x-ray machine operating at its maximum rating;

(vv) Mode of operation - for fluoroscopic systems, a distinct method of fluoroscopy or radiography provided by the manufacturer and selected with a set of several technique factors or other control settings uniquely associated with the mode. The set of distinct technique factors and control settings for the mode may be selected by the operation of a single control. Examples of distinct modes of operation include normal fluoroscopy (analog or digital), high-level control fluoroscopy, cineradiography (analog or digital), digital subtraction angiography, electronic radiography using the fluoroscopic image receptor, and photospot recording. In a specific mode of operation, certain system variables affecting air kerma, AKR, or image quality, such as image magnification, x-ray field size, pulse rate, pulse duration, number of pulses, source-image receptor distance (SID), or optical aperture, may be adjustable or may vary; their variation per se does not comprise a mode of operation different from the one that has been selected;

(ww) Movable tabletop -a tabletop which, when assembled for use, is capable of movement with respect to its supporting structure within the plane of the tabletop;

(xx) Non-image-intensified fluoroscopy -fluoroscopy using only a fluorescent screen;

(yy) Peak tube potential -the maximum value of the potential difference across the x-ray tube during an exposure;

(zz) Primary protective barrier -the material, excluding filters, placed in the useful beam to reduce the radiation exposure for protection purposes;

(aaa) Pulsed mode -operation of the x-ray system such that the x-ray tube current is pulsed by the x-ray control to produce one (1) or more exposure intervals of duration less than one-half (1/2) second;

(bbb) Quick change x-ray tube -an x-ray tube designed for use in its associated tube housing such that:

(1) The tube cannot be inserted in its housing in a manner that would result in noncompliance of the system with the requirements of § 10853.23 and 10853.25;

(2) The focal spot position will not cause noncompliance with the provisions of this section or § 10854 or § 10855;

(3) The shielding within the tube housing cannot be displaced; and

(4) Any removal and subsequent replacement of a beam-limiting device during reloading of the tube in the tube housing will not result in noncompliance of the x-ray system with the applicable field limitation and alignment requirements of §§ 10854 and 10855;

(ccc) Radiation therapy simulation system -a radiographic or fluoroscopic x-ray system intended for localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field;

(ddd) Radiography -a technique for generating and recording an x-ray pattern for the purpose of providing the user with an image(s) after termination of the exposure;

(eee) Rated line voltage -the range of potentials, in volts, of the supply line specified by the manufacturer at which the x-ray machine is designed to operate;

(fff) Rated output current -the maximum allowable load current of the x-ray high-voltage generator;

(ggg) Rated output voltage -the allowable peak potential, in volts, at the output terminals of the x-ray high-voltage generator;

(hhh) Rating -the operating limits specified by the manufacturer;

(iii) Recording -producing a retrievable form of an image resulting from x-ray photons;

(jjj) Scan -the complete process of collecting x-ray transmission data for the production of a tomogram. Data may be collected simultaneously during a single scan for the production of one (1) or more tomograms;

(kkk) Scan time -the period of time between the beginning and end of x-ray transmission data accumulation for a single scan;

(lll) Solid state x-ray imaging device -an assembly, typically in a rectangular panel configuration, that intercepts x-ray photons and converts the photon energy into a modulated electronic signal representative of the x-ray intensity over the area of the imaging device. The electronic signal is then used to create an image for display or storage;

(mmm) Source -the focal spot of the x-ray tube;

(nnn) Source-image receptor distance (SID) -the distance from the source to the center of the input surface of the image receptor;

(ooo) Source-skin distance (SSD) -the distance from the source to the center of the entrant x-ray field in the plane tangent to the patient skin surface;

(ppp) Spot-film device -a device intended to transport or position a radiographic image receptor between the x-ray source and fluoroscopic image receptor. It includes a device intended to hold a cassette over the input end of the fluoroscopic image receptor for the purpose of producing a radiograph;

(qqq) Stationary tabletop -a tabletop which, when assembled for use, is incapable of movement with respect to its supporting structure within the plane of the tabletop;

(rrr) Technique factors -the following conditions of operation:

(1) For capacitor energy storage equipment, peak tube potential in kilovolts (kV) and quantity of charge in milliampere-seconds (mAs);

(2) For field emission equipment rated for pulsed operation, peak tube potential in kV and number of x-ray pulses;

(3) For CT equipment designed for pulsed operation, peak tube potential in kV, scan time in seconds, and either tube current in milliamperes (mA), x-ray pulse width in seconds, and the number of x-ray pulses per scan, or the product of the tube current, x-ray pulse width, and the number of x-ray pulses in mAs;

(4) For CT equipment not designed for pulsed operation, peak tube potential in kV, and either tube current in mA and scan time in seconds, or the product of tube current and exposure time in mAs and the scan time when the scan time and exposure time are equivalent; and

(5) For all other equipment, peak tube potential in kV, and either tube current in mA and exposure time in seconds, or the product of tube current and exposure time in mAs;

(sss) Tomogram -the depiction of the x-ray attenuation properties of a section through a body;

(ttt) Tube -an x-ray tube, unless otherwise specified;

(uuu) Tube housing assembly -the tube housing with tube installed. It includes high-voltage or filament transformers and other appropriate elements when they are contained within the tube housing;

(vvv) Tube rating chart -the set of curves which specify the rated limits of operation of the tube in terms of the technique factors;

(www) Useful beam -the radiation which passes through the tube housing port and the aperture of the beam-limiting device when the exposure switch or timer is activated;

(xxx) Variable-aperture beam-limiting device -a beam-limiting device which has the capacity for stepless adjustment of the x-ray field size at a given SID;

(yyy) Visible area -the portion of the input surface of the image receptor over which incident x-ray photons are producing a visible image;

(zzz) X-ray control -a device which controls input power to the x- ray high-voltage generator or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices, which control the technique factors of an x-ray exposure;

(aaaa) X-ray equipment -an x-ray system, subsystem, or component thereof which include:

(1) Mobile, mounted on a permanent base with wheels or casters for moving while completely assembled;

(2) Portable, designed to be hand-carried; and

(3) Stationary, which is installed in a fixed location.

(bbbb) X-ray field -that area of the intersection of the useful beam and any one (1) of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the AKR is one-fourth (1/4) of the maximum in the intersection;

(cccc) X-ray high-voltage generator -a device which transforms electrical energy from the potential supplied by the x-ray control to the tube operating potential. The device may also include means for transforming alternating current to direct current, filament transformers for the x-ray tube(s), high-voltage switches, electrical protective devices, and other appropriate elements;

(dddd) X-ray subsystem -any combination of two (2) or more components of an x-ray system for which there are requirements specified in this section and §§ 10854 and 10855;

(eeee) X-ray system -an assemblage of components for the controlled production of x-rays. It includes minimally an x-ray high-voltage generator, an x-ray control, a tube housing assembly, a beam-limiting device, and the necessary supporting structures. Additional components which function with the system are considered integral parts of the system;

(ffff) X-ray table -a patient support device with its patient support structure (tabletop) interposed between the patient and the image receptor during radiography or fluoroscopy. This includes, but is not limited to, any stretcher equipped with a radiolucent panel and any table equipped with a cassette tray (or bucky), cassette tunnel, fluoroscopic image receptor, or spot-film device beneath the tabletop; and

(gggg) X-ray tube -any electron tube which is designed for the conversion of electrical energy into x-ray energy;

10853.5 Manufacturers of products subject to §§ 10853, 10854, and 10855 shall certify that each of their products meet all applicable requirements when installed into a diagnostic x-ray system according to instructions. This certification shall be made under the format specified in § 10845. Manufacturers may certify a combination of two (2) or more components if they obtain prior authorization in writing from the Department. Manufacturers shall not be held responsible for noncompliance of their products if that noncompliance is due solely to the improper installation or assembly of that product by another person; however, manufacturers are responsible for providing assembly instructions adequate to assure compliance of their components with the applicable provisions of §§ 10853, 10854, and 10855.

10853.6 An assembler who installs one (1) or more components certified as required by § 10853.5 shall install certified components that are of the type required by § 10854 or § 10855 and shall assemble, install, adjust, and test the certified components according to the instructions of their respective manufacturers. Assemblers shall not be liable for noncompliance of a certified component if the assembly of that component was according to the component manufacturer's instruction.

10853.7 All assemblers who install certified components shall file a report of assembly, except as specified in § 10853.8(a) through (d). The report will be construed as the assembler's certification and identification under §§ 10845 and 10846. The assembler shall affirm in the report that the manufacturer's instructions were followed in the assembly or that the certified components as assembled into the system meet all applicable requirements of §§ 10853 through 10855. All assembler reports must be on a form that the Department prescribes. Completed reports must be submitted to the Department and the purchaser within fifteen (15) days following completion of the assembly.

10853.8 Reports of assembly need not be submitted for any of the following:

(a) Reloaded or replacement tube housing assemblies that are reinstalled in or newly assembled into an existing x-ray system;

(b) Certified accessory components that have been identified as such to the Department in the report required under § 10808 of this chapter;

(c) Repaired components, whether or not removed from the system and reinstalled during the course of repair, provided the original installation into the system was reported; or

(d) Components installed temporarily in an x-ray system in place of components removed temporarily for repair, provided the temporarily installed component is identified by a tag or label bearing the following information:

Temporarily Installed Component

This certified component has been assembled, installed, adjusted, and tested by me according to the instructions provided by the manufacturer.

Signature

Company Name

Street Address, P.O. Box

City, State, Zip Code

Date of Installation.

10853.9 The replacement of the temporarily installed component by a component other than the component originally removed for repair shall be reported as specified in § 10853.6.

10853.10 In addition to the identification requirements specified in § 10846 of this chapter, manufacturers of components subject to this section and §§ 10854 and 10855, except high-voltage generators contained within tube housings and beam-limiting devices that are integral parts of tube housings, shall permanently inscribe or affix thereon the model number and serial number of the product so that they are legible and accessible to view. The word "model" or "type" shall appear as part of the manufacturer's required identification of certified x-ray components. Where the certification of a system or subsystem, consisting of two or more components, has been authorized under §10853.5, a single inscription, tag, or label bearing the model number and serial number may be used to identify the product.

10853.11 In a similar manner, manufacturers of tube housing assemblies shall also inscribe or affix thereon the name of the manufacturer, model number, and serial number of the x-ray tube which the tube housing assembly incorporates.

10853.12 Except as specified in § 10853.13, the replacement of an x-ray tube in a previously manufactured tube housing assembly certified under § 10853.5 constitutes manufacture of a new tube housing assembly, and the manufacturer is subject to the provisions of § 10853.10. The manufacturer shall remove, cover, or deface any previously affixed inscriptions, tags, or labels that are no longer applicable.

10853.13 The requirements of § 10853.12 shall not apply to tube housing assemblies designed and designated by their original manufacturer to contain quick change x-ray tubes. The manufacturer of quick-change x-ray tubes shall include with each replacement tube a label with the tube manufacturer's name, the model, and serial number of the x-ray tube. The manufacturer of the tube shall instruct the assembler who installs the new tube to attach the label to the tube housing assembly and to remove, cover, or deface the previously affixed inscriptions, tags, or labels that are described by the tube manufacturer as no longer applicable.

10853.14 Manufacturers of components listed in § 10853.1 shall provide to assemblers subject to § 10853.6 and, upon request, to others at a cost not to exceed the cost of publication and distribution, instructions for assembly, installation, adjustment, and testing of such components adequate to assure that the products will comply with applicable provisions of this section and §§ 10854 and 10855, when assembled, installed, adjusted, and tested as directed. Such instructions shall include specifications of other components compatible with that to be installed when compliance of the system or subsystem depends on their compatibility. Such specifications may describe pertinent physical characteristics of the components or may list by manufacturer model number the components which are compatible. For x-ray controls and generators manufactured after May 3, 1994, manufacturers shall provide:

(a) A statement of the rated line voltage and the range of line-voltage regulation for operation at maximum line current;

(b) A statement of the maximum line current of the x-ray system based on the maximum input voltage and current characteristics of the tube housing assembly compatible with rated output voltage and rated output current characteristics of the x-ray control and associated high-voltage generator. If the rated input voltage and current characteristics of the tube housing assembly are not known by the manufacturer of the x-ray control and associated high-voltage generator, the manufacturer shall provide information necessary to allow the assembler to determine the maximum line current for the particular tube housing assembly(ies); and

10853.15 Manufacturers of x-ray equipment shall provide to purchasers and, upon request, to others at a cost not to exceed the cost of publication and distribution, manuals or instruction sheets which shall include the following technical and safety information:

(a) For x-ray equipment to which this section and §§ 10854 and 10855 are applicable, there shall be provided:

(1) Adequate instructions concerning any radiological safety procedures and precautions which may be necessary because of unique features of the equipment; and

(2) A schedule of the maintenance necessary to keep the equipment in compliance with this section and §§ 10854 and 10855.

10853.16 For each tube housing assembly, there shall be provided:

(a) Statements of the leakage technique factors for all combinations of tube housing assemblies and beam-limiting devices for which the tube housing assembly manufacturer states compatibility, the minimum filtration permanently in the useful beam expressed as millimeters (mm) of aluminum equivalent, and the peak tube potential at which the aluminum equivalent was obtained;

(b) Cooling curves for the anode and tube housing; and

(c) If the tube is designed to operate from different types of x-ray high-voltage generators (such as single-phase self-rectified, single-phase half-wave rectified, single-phase full-wave rectified, 3-phase 6-pulse, 3-phase 12-pulse, constant potential, capacitor energy storage) or under modes of operation such as alternate focal spot sizes or speeds of anode rotation which affect its rating, specific identification of the difference in ratings shall be noted.

10853.17 For the x-ray control and associated x-ray high-voltage generator, there shall be provided:

(a) A statement of the rated line voltage and the range of line-voltage regulation for operation at maximum line current;

(b) A statement of the maximum line current of the x-ray system based on the maximum input voltage and output current characteristics of the tube housing assembly compatible with rated output voltage and rated current characteristics of the x-ray control and associated high-voltage generator. If the rated input voltage and current characteristics of the tube housing assembly are not known by the manufacturer of the x-ray control and associated high-voltage generator, the manufacturer shall provide necessary information to allow the purchaser to determine the maximum line current for his particular tube housing assembly(ies);

(c) A statement of the technique factors that constitute the maximum line current condition described in § 10853.17(b) of this section;

(d) In the case of battery-powered generators, a specification of the minimum stated of charge necessary for proper operation;

(e) Generator rating and duty cycle;

(f) A statement of the maximum deviation from the pre-indication given by labeled technique factor control settings or indicators during any radiographic or CT exposure where the equipment is connected to a power supply as described in accordance with this paragraph. In the case of fixed technique factors, the maximum deviation from the nominal fixed value of each factor shall be stated;

(g) A statement of the maximum deviation from the continuous indication of x-ray tube potential and current during any fluoroscopic exposure when the equipment is connected to a power supply as described in accordance with this paragraph; and

(h) A statement describing the measurement criteria for all technique factors used in § 10853.17(c), (f), and (g); for example, the beginning and endpoints of exposure time measured with respect to a certain percentage of the voltage waveform.

10853.18 For each variable-aperture beam-limiting device, there shall be provided:

(a) Leakage technique factors for all combinations of tube housing assemblies and beam-limiting devices for which the beam-limiting device manufacturer states compatibility; and

(b) A statement including the minimum aluminum equivalent of that part of the device through which the useful beam passes and including the x-ray tube potential at which the aluminum equivalent was obtained. When two (2) or more filters are provided as part of the device, the statement shall include the aluminum equivalent of each filter.

10853.19 For x-ray systems manufactured on or after June 10, 2006, that produce images using the fluoroscopic image receptor, the following information shall be provided in a separate, single section of the user's instruction manual or in a separate manual devoted to this information:

(a) For each mode of operation, a description of the mode and detailed instructions on how the mode is engaged and disengaged. The description of the mode shall identify those technique factors and system controls that are fixed or automatically adjusted by selection of the mode of operation, including the manner in which the automatic adjustment is controlled. This information shall include how the operator can recognize which mode of operation has been selected prior to initiation of x-ray production; and

(b) For each mode of operation, a descriptive example(s) of any specific clinical procedure(s) or imaging task(s) for which the mode is recommended or designed and how each mode should be used. Such recommendations do not preclude other clinical uses.

10853.20 For fluoroscopic x-ray systems manufactured on or after June 10, 2006, the following shall be provided:

(a) A schedule of maintenance for any system instrumentation associated with the display of air kerma information necessary to maintain the displays of AKR and cumulative air kerma within the limits of allowed uncertainty specified by § 10855.35 and, if the capability for user calibration of the display is provided, adequate instructions for such calibration;

(b) Identification of the distances along the beam axis:

(1) From the focal spot to the isocenter, and

(2) From the focal spot to the reference location to which displayed values of AKR and cumulative air kerma refer according to § 10855.31(d).

(c) A rationale for specification of a reference irradiation location alternative to fifteen centimeters (15 cm.) from the isocenter toward the x-ray source along the beam axis when such alternative specification is made according to § 10855.33.

10853.21 RESERVED

10853.22 The control panel containing the main power switch shall bear the following warning statement, legible and accessible to view:

"Warning: This x-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions and maintenance schedules are observed."

10853.23 The leakage radiation from the diagnostic source assembly measured at a distance of one meter (1 m) in any direction from the source shall not exceed eighty-eight hundredths milligray (0.88 mGy) air kerma (vice one hundred milliroentgen (100 mR) exposure) in one (1) hour when the x-ray tube is operated at the leakage technique factors. If the maximum rated peak tube potential of the tube housing assembly is greater than the maximum rated peak tube potential for the diagnostic source assembly, positive means shall be provided to limit the maximum x-ray tube potential to that of the diagnostic source assembly. Compliance shall be determined by measurements averaged over an area of one hundred square centimeters (100 cm2) with no linear dimension greater than twenty centimeters (20 cm).

10853.24 The radiation emitted by a component other than the diagnostic source assembly shall not exceed an air kerma of eighteen microGy (18 microGy) (vice two milliroentgen (2 mR) exposure) in one (1) hour at five centimeters (5 cm) from any accessible surface of the component when it is operated in an assembled x-ray system under any conditions for which it was designed. Compliance shall be determined by measurements averaged over an area of one hundred square centimeters (100 cm2) with no linear dimension greater than twenty centimeters (20 cm.).

10853.25 The HVL of the useful beam for a given x-ray tube potential shall not be less than the appropriate value shown in Table 1 in this section under the heading "Specified Dental Systems," for any dental x-ray system designed for use with intraoral image receptors and manufactured after December 1, 1980; under the heading "I -- Other X-Ray Systems," for any dental x-ray system designed for use with intraoral image receptors and manufactured before December 1, 1980, and all other x-ray systems subject to this section and manufactured before June 10, 2006; and under the heading "II -- Other X-Ray Systems," for all x-ray systems, except dental x-ray systems designed for use with intraoral image receptors, subject to this section and manufactured on or after June 10, 2006. If it is necessary to determine such HVL at an x-ray tube potential which is not listed in table 1 in this subsection, linear interpolation or extrapolation may be made. Positive means shall be provided to ensure that at least the minimum filtration needed to achieve the above beam quality requirements is in the useful beam during each exposure. Table 1 follows:

Table 1.

X-Ray Tube Voltage

Minimum HVL

(kilovolt peak)

(mm of aluminum)

Designed

Measured

Specified

I -- Other X-

II -- Other X-

Operating

Dental

Ray Systems

Range

Potential

Systems

Below 51

1.5

0.3

1.5

0.4

1.5

0.5

51 to 70

1.5

1.2

1.3

1.5

1.3

1.5

1.8

Above 70

2.1

2.5

2.3

2.9

2.5

3.2

100

2.7

3.6

110

3.0

3.9

120

3.2

4.3

130

3.5

4.7

140

3.8

5.0

150

4.1

5.4

10853.26 Fluoroscopic systems manufactured on or after June 10, 2006, incorporating an x-ray tube(s) with a continuous output of one kilowatt (1 kW) or more and an anode heat storage capacity of one million (1,000,000) heat units or more shall provide the option of adding x-ray filtration to the diagnostic source assembly in addition to the amount needed to meet the HVL provisions of § 10853.25. The selection of this additional x-ray filtration shall be either at the option of the user or automatic as part of the selected mode of operation. A means of indicating which combination of additional filtration is in the x-ray beam shall be provided.

10853.27 For capacitor energy storage equipment, compliance shall be determined with the maximum selectable quantity of charge per exposure.

10853.28 Except when used in a CT x-ray system, the aluminum equivalent of each of the items listed in Table 2 in Paragraph (n) of this section, which are used between the patient and image receptor, may not exceed the indicated limits. Compliance shall be determined by x-ray measurements made at a potential of 100 kilovolts peak and with an x-ray beam that has an HVL specified in table 1 in § 10853.25 for the potential. This requirement applies to front panel(s) of cassette holders and film changers provided by the manufacturer for patient support or for prevention of foreign object intrusions. It does not apply to screens and their associated mechanical support panels or grids. Table 2 follows:

Table 2.

Item

Maximum Aluminum

Equivalent (millimeters)

Front panel(s) of cassette holders (total of all)

1.2

Front panel(s) of film changer (total of all)

1.2

Cradle

2.3

Tabletop, stationary, without articulated joints

1.2

Tabletop, movable, without articulated joint(s) (including stationary subtop)

1.7

Tabletop, with radiolucent panel having one articulated joint

1.7

Tabletop, with radiolucent panel having two or more articulated joints

2.3

Tabletop, cantilevered

2.3

Tabletop, radiation therapy simulator

5.0

10853.29 On battery-powered generators, visual means shall be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation.

10853.30 RESERVED

10853.31 Diagnostic x-ray components and systems certified in accordance with § 10845 of this chapter shall not be modified such that the component or system fails to comply with any applicable provision of this chapter unless a variance in accordance with § 10847 of this chapter or an exemption under 21 U.S.C. §§ 360kk(a)(5) or 360oo(b) of the act, has been granted.

10853.32 The owner of a diagnostic x-ray system who uses the system in a professional or commercial capacity may modify the system, provided the modification does not result in the failure of the system or component to comply with the applicable requirements of this section or of §§ 10854 and 10855. The owner who causes such modification need not submit the report, provided the owner records the date and the details of the modification in the system records and maintains this information, and provided the modification of the x-ray system does not result in a failure to comply with §§ 10854 and 10855.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). n1 The nominal chemical composition of type 1100 aluminum alloy is ninety-nine percent (99 %) minimum aluminum, twelve hundredths percent (0.12%) of copper, as given in "Aluminum Standards and Data" (§ 11069). Copies may be obtained from The Aluminum Association, New York, NY. In the case of a system, which is to be operated with more than one (1) thickness of filtration, this requirement can be met by a filter interlocked with the kilovoltage selector which will prevent x-ray emissions if the minimum required filtration is not in place. Dental x-ray systems designed for use with intraoral image receptors and manufactured before or on December 1, 1980, and all other x-ray systems subject to this section and manufactured before June 10, 2006. All x-ray systems, except dental x-ray systems designed for use with intraoral image receptors, subject to this section and manufactured on or after June 10, 2006. Dental x-ray systems designed for use with intraoral image receptors and manufactured after December 1, 1980. District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10853

22-B DCMR § 10854 RADIOGRAPHIC EQUIPMENT

10854.1 The provisions of this section apply to equipment for radiography, except equipment for fluoroscopic imaging or for recording images from the fluoroscopic image receptor, or computed tomography x-ray systems manufactured on or after November 29, 1984.

10854.2 The technique factors to be used during an exposure shall be indicated before the exposure begins, except when automatic exposure controls are used, in which case the technique factors which are set prior to the exposure shall be indicated. On equipment having fixed technique factors, this requirement may be met by permanent markings. Indication of technique factors shall be visible from the operator's position except in the case of spot films made by the fluoroscopist.

10854.3 Means shall be provided to terminate the exposure at a preset time interval, a preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor.

10854.4 Except during serial radiography, the operator shall be able to terminate the exposure at any time during an exposure of greater than one-half (1/2) second. Except during panoramic dental radiography, termination of exposure shall cause automatic resetting of the timer to its initial setting or to zero (0). It shall not be possible to make an exposure when the timer is set to a zero (0) or off position if either position is provided.

10854.5 During serial radiography, the operator shall be able to terminate the x-ray exposure(s) at any time, but means may be provided to permit completion of any single exposure of the series in process.

10854.6 When an automatic exposure control is provided:

Indication shall be made on the control panel when this mode of operation is selected;

When the x-ray tube potential is equal to or greater than fifty-one kilovolts peak (51 kVp), the minimum exposure time for field emission equipment rated for pulsed operation shall be equal to or less than a time interval equivalent to two (2) pulses and the minimum exposure time for all other equipment shall be equal to or less than one sixtieth (1/60) second or a time interval required to deliver five milliampere-seconds (5 mAs), whichever is greater;

Either the product of peak x-ray tube potential, current, and exposure time shall be limited to not more than sixty kilowatt-seconds (60 kWs) per exposure or the product of x-ray tube current and exposure time shall be limited to not more than six hundred milliampereseconds (600 mAs) per exposure, except when the x-ray tube potential is less than fifty-one kilovolts peak (51 kVp), in which case the product of x-ray tube current and exposure time shall be limited to not more than two milliampere-seconds (2,000 mAs) per exposure; and

(d) A visible signal shall indicate when an exposure has been terminated at the limits described in § 10854.6 and manual resetting shall be required before further automatically timed exposures can be made.

10854.7 Deviation of technique factors from indicated values shall not exceed the limits given in the information provided in accordance with § 10853.17.

10854.8 The following requirements shall apply when the equipment is operated on an adequate power supply as specified by the manufacturer in accordance with the requirements of § 10853.17.

10854.9 For any specific combination of selected technique factors, the estimated coefficient of variation of the air kerma shall be no greater than five hundredths (0.05).

10854.10 Determination of compliance shall be based on ten (10) consecutive measurements taken within a time period of one (1) hour. Equipment manufactured after September 5, 1978, shall be subject to the additional requirement that all variable controls for technique factors shall be adjusted to alternate settings and reset to the test setting after each measurement. The percent line-voltage regulation shall be determined for each measurement. All values for percent line-voltage regulation shall be within plus or minus one (+/- 1) of the mean value for all measurements. For equipment having automatic exposure controls, compliance shall be determined with a sufficient thickness of attenuating material in the useful beam such that the technique factors can be adjusted to provide individual exposures of a minimum of twelve (12) pulses on field emission equipment rated for pulsed operation or no less than one-tenth (0.10) second per exposure on all other equipment.

10854.11 The following requirements apply when the equipment is operated on a power supply as specified by the manufacturer in accordance with the requirements of § 10853.17 for any fixed x-ray tube potential within the range of forty percent (40%) to one hundred percent (100%) of the maximum rated.

10854.12 The average ratios of air kerma to the indicated milliampere-seconds product (mGy/mAs) obtained at any two consecutive tube current settings shall not differ by more than one tenth (0.10) times their sum. This is: X[1] - X[2] </= 0.10(X[1] + X[2]); where X[1] and X[2] are the average mGy/mAs values obtained at each of two (2) consecutive milliampere-seconds selector settings or at two (2) settings differing by no more than a factor of two (2) where the milliampere-seconds selector provides continuous selection.

10854.13 For equipment manufactured after May 3, 1994, the average ratios of air kerma to the indicated milliampere-seconds product (mGy/mAs) obtained at any two (2) consecutive mAs selector settings shall not differ by more than one tenth (0.10) times their sum. This is: X[1] - X[2] </= 0.10 (X[1] + X[2]); where X[1] and X[2] are the average mGy/mAs values obtained at each of two (2) consecutive milliampere-seconds elector settings or at two (2) settings differing by no more than a factor of two (2) where the milliampere seconds selector provides continuous selection.

10854.14 Determination of compliance will be based on ten (10) exposures, made within one (1) hour, at each of the two (2) settings. These two (2) settings may include any two (2) focal spot sizes except where one (1) is equal to or less than forty-five hundredths millimeter (0.45 mm) and the other is greater than forty-five hundredths millimeter (0.45 mm). For purposes of this requirement, focal spot size is the focal spot size specified by the x-ray tube manufacturer. The percent line-voltage regulation shall be determined for each measurement. All values for percent line-voltage regulation at any one (10) combination of technique factors shall be within plus or minus one (1) of the mean value for all measurements at these technique factors.

10854.15 Except when spot-film devices are in service, mobile, portable, and stationary general purpose radiographic x-ray systems shall meet the following requirements:

A means for stepless adjustment of the size of the x-ray field shall be provided. Each dimension of the minimum field size at an SID of one hundred centimeters (100 cm) shall be equal to or less than five centimeters (5 cm);

(b) Means for visually defining the perimeter of the x-ray field shall be provided. The total misalignment of the edges of the visually defined field with the respective edges of the x-ray field along either the length or width of the visually defined field shall not exceed two percent (2%) of the distance from the source to the center of the visually defined field when the surface upon which it appears is perpendicular to the axis of the x-ray beam;

(c) When a light localizer is used to define the x-ray field, it shall provide an average illuminance of not less than one hundred sixty (160) lux (fifteen (15) foot-candles) at one hundred centimeters (100 cm) or at the maximum SID, whichever is less. The average illuminance shall be based on measurements made in the approximate center of each quadrant of the light field. Radiation therapy simulation systems are exempt from this requirement; and

(d) The edge of the light field at one hundred centimeters (100 cm) or at the maximum SID, whichever is less, shall have a contrast ratio, corrected for ambient lighting, of not less than four (4) in the case of beam-limiting devices designed for use on stationary equipment, and a contrast ratio of not less than three (3) in the case of beam-limiting devices designed for use on mobile and portable equipment. The contrast ratio is defined as I[1]/I[2], where I[1] is the illuminance three millimeters (3 mm) from the edge of the light field toward the center of the field; and I[2] is the illuminance three millimeters (3 mm) from the edge of the light field away from the center of the field. Compliance shall be determined with a measuring aperture of one millimeter (1 mm).

10854.16 Except when spot-film devices are in service, stationary general purpose x-ray systems shall meet the following requirements in addition to those prescribed in § 10854.16:

(a) Means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, to align the center of the x-ray field with respect to the center of the image receptor to within two percent (2%) of the SID, and to indicate the SID to within two percent (2%);

(b) The beam-limiting device shall numerically indicate the field size in the plane of the image receptor to which it is adjusted;

(c) Indication of field size dimensions and SIDs shall be specified in centimeters or inches and shall be such that aperture adjustments result in x-ray field dimensions in the plane of the image receptor which correspond to those indicated by the beam-limiting device to within two percent (2%) of the SID when the beam axis is indicated to be perpendicular to the plane of the image receptor; and

(d) Compliance measurements will be made at discrete SIDs and image receptor dimensions in common clinical use (such as SIDs of one hundred (100), one hundred fifty (150), and two hundred (200) centimeters or thirty-six (36), forty (40), fort-eight (48), and seventy-two (72) inches and nominal image receptor dimensions of thirteen (13), eighteen (18), twenty-four (24), thirty (30), thirty-five (35), forty (40), and forty-three (43) centimeters or five (5), seven (7), eight (8), nine (9), ten (10), eleven (11), twelve (12), fourteen (14), and seventeen (17) inches or at any other specific dimensions at which the beam-limiting device or its associated diagnostic x-ray system is uniquely designed to operate.

10854.17 Equipment for use with intraoral image receptors. Radiographic equipment designed for use with an intraoral image receptor shall be provided with means to limit the x-ray beam such that:

(a) If the minimum source-to-skin distance (SSD) is eighteen centimeters (18 cm) or more, the x-ray field at the minimum SSD shall be containable in a circle having a diameter of no more than seven centimeters (7 cm); and

(b) If the minimum SSD is less than eighteen centimeters (18 cm), the x-ray field at the minimum SSD shall be containable in a circle having a diameter of no more than six centimeters (6 cm).

10854.18 Radiographic equipment designed for only one image receptor size at a fixed SID shall be provided with means to limit the field at the plane of the image receptor to dimensions no greater than those of the image receptor, and to align the center of the x-ray field with the center of the image receptor to within two percent (2%) of the SID, or shall be provided with means to both size and align the x-ray field such that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor.

10854.19 Radiographic systems designed only for mammography and general purpose radiography systems, when special attachments for mammography are in service, manufactured on or after November 1, 1977, and before September 30, 1999, shall be provided with means to limit the useful beam such that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor at any designated SID except the edge of the image receptor designed to be adjacent to the chest wall where the x-ray field may not extend beyond this edge by more than two percent (2%) of the SID. This requirement can be met with a system that performs as prescribed in § 10854.23(a), (b), and (c). When the beam-limiting device and image receptor support device are designed to be used to immobilize the breast during a mammographic procedure and the SID may vary, the SID indication specified in § 10854.23(b) and (c) shall be the maximum SID for which the beam-limiting device or aperture is designed.

10854.20 Mammographic beam-limiting devices manufactured on or after September 30, 1999, shall be provided with a means to limit the useful beam such that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor by more than two percent (2%) of the SID. This requirement can be met with a system that performs as prescribed in § 10854.23(a), (b), and (c). For systems that allow changes in the SID, the SID indication specified in § 10854.23(b) and (c) shall be the maximum SID for which the beam-limiting device or aperture is designed.

10854.21 Each image receptor support device manufactured on or after November 1, 1977, intended for installation on a system designed for mammography shall have clear and permanent markings to indicate the maximum image receptor size for which it is designed.

10854.22 Radiographic systems not specifically covered in § 10854.16, 10854.17, 10854.23(b), 10854.23(c), and 10854.31, and systems covered in Paragraph (a), which are also designed for use with extraoral image receptors and when used with an extraoral image receptor, shall be provided with means to limit the x-ray field in the plane of the image receptor so that such field does not exceed each dimension of the image receptor by more than two percent (2%) of the SID, when the axis of the x-ray beam is perpendicular to the plane of the image receptor. In addition, means shall be provided to align the center of the x-ray field with the center of the image receptor to within two percent (2%) of the SID, or means shall be provided to both size and align the x-ray field such that the x-ray field at the plane of the image receptor does not extend beyond any edge of the image receptor. These requirements may be met with:

(a) A system which performs in accordance with §§ 10854.16 and 10854.17; or when alignment means are also provided, may be met with either;

(b) An assortment of removable, fixed-aperture, beam-limiting devices sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Each such device shall have clear and permanent markings to indicate the image receptor size and SID for which it is designed; or

(c) A beam-limiting device having multiple fixed apertures sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Permanent, clearly legible markings shall indicate the image receptor size and SID for which each aperture is designed and shall indicate which aperture is in position for use.

10854.23 The requirements of this section shall apply to radiographic systems which contain positive bean limitation (PBL).

10854.24 When a PBL system is provided, it shall prevent x-ray production when:

Either the length or width of the x-ray field in the plane of the image receptor differs from the corresponding image receptor dimension by more than three percent (3%) of the SID; or

The sum of the length and width differences as stated in § 10854.25(a) without regard to sign exceeds 4 percent of the SID; and

10854.25 When provided, the PBL system shall function as described in § 10854.25 whenever all the following conditions are met:

(a) The image receptor is inserted into a permanently mounted cassette holder;

(b) The image receptor length and width are less than fifty centimeters (50 cm);

(c) The x-ray beam axis is within plus or minus three degrees (+/-3º) of vertical and the SID is ninety centimeters (90 cm.) to one hundred thirty centimeters (130 cm.) inclusive; or the x-ray beam axis is within plus or minus three degrees (+/-3º) of horizontal and the SID is ninety centimeters (90 cm) to two hundred five centimeters (205 cm) inclusive;

(d) The x-ray beam axis is perpendicular to the plane of the image receptor to within plus or minus three degrees (3º); and

(e) Neither tomographic nor stereoscopic radiography is being performed.

10854.26 Compliance with the requirements of § 10854.25 shall be determined when the equipment indicates that the beam axis is perpendicular to the plane of the image receptor and the provisions of § 10854.26 are met. Compliance shall be determined no sooner than five (5) seconds after insertion of the image receptor.

10854.27 The PBL system shall be capable of operation such that, at the discretion of the operator, the size of the field may be made smaller than the size of the image receptor through stepless adjustment of the field size. Each dimension of the minimum field size at an SID of one hundred centimeters (100 cm) shall be equal to or less than five centimeters (5 cm). Return to PBL function as described in § 10854.25 shall occur automatically upon any change of image receptor size or SID.

10854.28 A capability may be provided for overriding PBL in case of system failure and for servicing the system. This override may be for all SIDs and image receptor sizes. A key shall be required for any override capability that is accessible to the operator. It shall not be possible to remove the key while PBL is overridden. Each such key switch or key shall be clearly and durably labeled as follows:

“For X-ray Field Limitation System Failure”.

10854.29 The override capability is considered accessible to the operator if it is referenced in the operator's manual or in other material intended for the operator or if its location is such that the operator would consider it part of the operational controls.

10854.30 The following requirements shall apply to spot-film devices, except when the spot-film device is provided for use with a radiation therapy simulation system:

(a) Means shall be provided between the source and the patient for adjustment of the x-ray field size in the plane of the image receptor to the size of that portion of the image receptor which has been selected on the spot-film selector. Such adjustment shall be accomplished automatically when the x-ray field size in the plane of the image receptor is greater than the selected portion of the image receptor. If the x-ray field size is less than the size of the selected portion of the image receptor, the field size shall not open automatically to the size of the selected portion of the image receptor unless the operator has selected that mode of operation;

(b) Neither the length nor the width of the x-ray field in the plane of the image receptor shall differ from the corresponding dimensions of the selected portion of the image receptor by more than three percent (3%) of the SID when adjusted for full coverage of the selected portion of the image receptor. The sum, without regard to sign, of the length and width differences shall not exceed four percent (4%) of the SID. On spot-film devices manufactured after February 25, 1978, if the angle between the plane of the image receptor and beam axis is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor, and compliance shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor;

The center of the x-ray field in the plane of the image receptor shall be aligned with the center of the selected portion of the image receptor to within two percent (2%) of the SID; and

(d) Means shall be provided to reduce the x-ray field size in the plane of the image receptor to a size smaller than the selected portion of the image receptor such that:

(1) For spot-film devices used on fixed-SID fluoroscopic systems which are not required to, and do not provide stepless adjustment of the x-ray field, the minimum field size, at the greatest SID, does not exceed one hundred square centimeters (125 cm2); or

(2) For spot-film devices used on fluoroscopic systems that have a variable SID or stepless adjustment of the field size, the minimum field size, at the greatest SID, shall be containable in a square of five centimeters by five centimeters (5 cm x 5 cm).

10854.31 A capability may be provided for overriding the automatic x-ray field size adjustment in case of system failure. If it is so provided, a signal visible at the fluoroscopist's position shall indicate whenever the automatic x-ray field size adjustment override is engaged. Each such system failure override switch shall be clearly labeled as follows:

“For X-ray Field Limitation System Failure”.

10854.32 X-ray systems designed for use with an intraoral image receptor shall be provided with means to limit the source-skin distance to not less than:

Eighteen centimeters (18 cm) if operable above fifty kilovolts peak (50 kVp); or

(b) Ten centimeters (10 cm) cm if not operable above fifty kilovolts peak (50 kVp).

10854.33 Mobile and portable x-ray systems other than dental shall be provided with means to limit the source-skin distance to not less than thirty centimeters (30 cm).

10854.34 The x-ray control shall provide visual indication whenever x-rays are produced. In addition, a signal audible to the operator shall indicate that the exposure has terminated.

10854.35 Where two or more radiographic tubes are controlled by one exposure switch, the tube or tubes which have been selected shall be clearly indicated before initiation of the exposure. This indication shall be both on the x-ray control and at or near the tube housing assembly which has been selected.

10854.36 Radiation emitted from the x-ray tube shall not exceed:

(a) An air kerma of twenty-six hundredths microgray (0.26 microGy) (vice three hundredths milliroentgens (0.03 mR) exposure) in one minute (1 min.) at five centimeters (5 cm) from any accessible surface of the diagnostic source assembly, with the beam-limiting device fully open, the system fully charged, and the exposure switch, timer, or any discharge mechanism not activated. Compliance shall be determined by measurements averaged over an area of one-hundred square centimeters (100 cm2) with no linear dimension greater than twenty centimeters (20 cm); and

An air kerma of eighty-eight hundredths microgray (0.88 mGy) (vice one hundred milliroentgens (100 mR) exposure) in one hour (1 hr.) at one hundred centimeters (100 cm) from the x-ray source, with the beam-limiting device fully open, when the system is discharged through the x-ray tube either manually or automatically by use of a discharge switch or deactivation of the input power. Compliance shall be determined by measurements of the maximum air kerma per discharge multiplied by the total number of discharges in one hour (1 hr.) (duty cycle). The measurements shall be averaged over an area of one hundred square centimeters (100 cm2) with no linear dimension greater than twenty centimeters (20 cm).

10854.37 For x-ray systems manufactured after September 5, 1978, and before September 30, 1999, which are designed only for mammography, the transmission of the primary beam through any image receptor support provided with the system shall be limited such that the air kerma five centimeters (5 cm) from any accessible surface beyond the plane of the image receptor supporting device does not exceed eighty-eight hundredths microgray (0.88 mGy) (vice 0.1 mR exposure) for each activation of the tube.

10854.38 For mammographic x-ray systems manufactured on or after September 30, 1999:

(a) At any SID where exposures can be made, the image receptor support device shall provide a primary protective barrier that intercepts the cross section of the useful beam along every direction except at the chest wall edge;

(b) The x-ray system shall not permit exposure unless the appropriate barrier is in place to intercept the useful beam as required in § 10854.38(a); and

(c) The transmission of the useful beam through the primary protective barrier shall be limited such that the air kerma five centimeters (5 cm) from any accessible surface beyond the plane of the primary protective barrier does not exceed eighty-eight hundredths microgray (0.88 mGy) (vice 0.1 mR exposure) for each activation of the tube.

10854.39 Compliance with the requirements of § 10854.37 and 10854.38(c) for transmission shall be determined with the x-ray system operated at the minimum SID for which it is designed, at the maximum rated peak tube potential, at the maximum rated product of x-ray tube current and exposure time (mAs) for the maximum rated peak tube potential, and by measurements averaged over an area of one hundred square centimeters (100 cm2) with no linear dimension greater than twenty centimeters (20 cm). The sensitive volume of the radiation measuring instrument shall not be positioned beyond the edge of the primary protective barrier along the chest wall side.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10854

22-B DCMR § 10855 FLUOROSCOPIC EQUIPMENT

10855.1 The provisions of this section apply to equipment for fluoroscopic imaging or for recording images from the fluoroscopic image receptor, except computed tomography x-ray systems manufactured on or after November 29, 1984.

10855.2 The fluoroscopic imaging assembly shall be provided with a primary protective barrier which intercepts the entire cross section of the useful beam at any SID. The x-ray tube used for fluoroscopy shall not produce x-rays unless the barrier is in position to intercept the entire useful beam. The AKR due to transmission through the barrier with the attenuation block in the useful beam combined with radiation from the fluoroscopic image receptor shall not exceed 3.34 x 10<-3> percent of the entrance AKR, at a distance of ten centimeters (10 cm.) from any accessible surface of the fluoroscopic imaging assembly beyond the plane of the image receptor. Radiation therapy simulation systems shall be exempt from this requirement provided the systems are intended only for remote control operation and the manufacturer sets forth instructions for assemblers with respect to control location as part of the information required in § 10853.14. Additionally, the manufacturer shall provide to users, under § 10853.15(a)(1), precautions concerning the importance of remote control operation.

10855.3 The AKR shall be measured in accordance with § 10855.12. The AKR due to transmission through the primary barrier combined with radiation from the fluoroscopic image receptor shall be determined by measurements averaged over an area of one hundred square centimeters (100 cm2) with no linear dimension greater than twenty centimeters (20 cm). If the source is below the tabletop, the measurement shall be made with the input surface of the fluoroscopic imaging assembly positioned thirty centimeters (30 cm) above the tabletop. If the source is above the tabletop and the SID is variable, the measurement shall be made with the end of the beam-limiting device or spacer as close to the tabletop as it can be placed, provided that it shall not be closer than thirty centimeters (30 cm). Movable grids and compression devices shall be removed from the useful beam during the measurement. For all measurements, the attenuation block shall be positioned in the useful beam ten centimeters (10 cm) from the point of measurement of entrance AKR and between this point and the input surface of the fluoroscopic imaging assembly.

10855.4 For fluoroscopic equipment manufactured after February 25, 1978, when the angle between the image receptor and the beam axis of the x-ray beam is variable, means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor. Compliance with § 10855.7 through 10855.9 shall be determined with the beam axis indicated to be perpendicular to the plane of the image receptor.

10855.5 Means shall be provided to permit further limitation of the x-ray field to sizes smaller than the limits of § 10855.7 through 10855.9. Beam-limiting devices manufactured after May 22, 1979, and incorporated in equipment with a variable SID or the capability of a visible area of greater than three hundred square centimeters (300 cm2), shall be provided with means for stepless adjustment of the x-ray field. Equipment with a fixed SID and the capability of a visible area of no greater than three hundred square centimeters (300 cm2) shall be provided with either stepless adjustment of the x-ray field or with a means to further limit the x-ray field size at the plane of the image receptor to one hundred twenty five square centimeters (125 cm2) or less. Stepless adjustment shall, at the greatest SID, provide continuous field sizes from the maximum obtainable to a field size containable in a square of five centimeters by five centimeters (5 cm x 5 cm). This paragraph does not apply to non-image-intensified fluoroscopy.

10855.6 The x-ray field produced by non-image-intensified fluoroscopic equipment shall not extend beyond the entire visible area of the image receptor. Means shall be provided for stepless adjustment of field size. The minimum field size, at the greatest SID, shall be containable in a square of five centimeters by five centimeters (5 cm x 5 cm).

10855.7 For fluoroscopic equipment manufactured before June 10, 2006, other than radiation therapy simulation systems, the following applies:

(a) Neither the length nor the width of the x-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than three percent (3%) of the SID. The sum of the excess length and the excess width shall be no greater than four percent (4%) of the SID; and

(b) For rectangular x-ray fields used with circular image receptors, the error in alignment shall be determined along the length and width dimensions of the x-ray field which pass through the center of the visible area of the image receptor.

10855.8 For fluoroscopic equipment manufactured on or after June 10, 2006, other than radiation therapy simulation systems, the maximum area of the x-ray field in the plane of the image receptor shall conform with one (1) of the following requirements:

When any linear dimension of the visible area of the image receptor measured through the center of the visible area is less than or equal to thirty four centimeters (34 cm) in any direction, at least eighty percent (80%) of the area of the x-ray field overlaps the visible area of the image receptor; or

(b) When any linear dimension of the visible area of the image receptor measured through the center of the visible area is greater than thirty four centimeters (34 cm) in any direction, the x-ray field measured along the direction of greatest misalignment with the visible area of the image receptor does not extend beyond the edge of the visible area of the image receptor by more than two centimeters (2 cm).

10855.9 For x-ray systems manufactured on or after June 10, 2006, the following applies:

(b) The error in alignment shall be determined along the length and width dimensions of the x-ray field which pass through the center of the visible area of the image receptor.

10855.10 If the fluoroscopic x-ray field size is adjusted automatically as the SID or image receptor size is changed, a capability may be provided for overriding the automatic adjustment in case of system failure. If it is so provided, a signal visible at the fluoroscopist's position shall indicate whenever the automatic field adjustment is overridden. Each such system failure override switch shall be clearly labeled as follows:

“For X-ray Field Limitation System Failure”.

10855.11 X-ray production in the fluoroscopic mode shall be controlled by a device which requires continuous pressure by the operator for the entire time of any exposure. When recording serial radiographic images from the fluoroscopic image receptor, the operator shall be able to terminate the x-ray exposure(s) at any time, but means may be provided to permit completion of any single exposure of the series in process.

10855.12 For fluoroscopic equipment, the following requirements apply:

(a) Equipment provided with automatic exposure rate control (AERC) shall not be operable at any combination of tube potential and current that will result in an AKR in excess of eighty-eight milligray (88 mGy) per minute (vice ten roentgen per minute (10 R/min.) exposure rate) at the measurement point specified in § 10855.15, except as specified in § 10855.12(e);

(b) Equipment provided without AERC shall not be operable at any combination of tube potential and current that will result in an AKR in excess of forty four milligray (44 mGy) per minute (vice five roentgen per minute (5 R/min.) exposure rate) at the measurement point specified in § 10855.15, except as specified in § 10855.12(e);

(c) Equipment provided with both an AERC mode and a manual mode shall not be operable at any combination of tube potential and current that will result in an AKR in excess of eighty-eight milligray (88 mGy) per minute (vice ten roentgen per minute (10 R/min.) exposure rate) in either mode at the measurement point specified in § 10855.15, except as specified in § 10855.12(e);

(d) Equipment may be modified in accordance with § 10853.31 to comply with § 10855.13. When the equipment is modified, it shall bear a label indicating the date of the modification and the statement:

“Modified to comply with 22 DCMR B § 10855.23”.

(e) Exceptions to the § 10855.12 requirements for fluoroscopic equipment are as follows:

During recording of fluoroscopic images; or

(2) When a mode of operation has an optional high-level control, in which case that mode shall not be operable at any combination of tube potential and current that will result in an AKR in excess of the rates specified in § 10855.12(a), (b), or (c) at the measurement point specified in § 10855.15, unless the high-level control is activated. Special means of activation of high-level controls shall be required. The high-level control shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high-level control is being employed.

10855.13 Fluoroscopic equipment manufactured on or after May 19, 1995:

(a) Shall be equipped with AERC if operable at any combination of tube potential and current that results in an AKR greater than forty-four milligray (44 mGy) per minute (vice five roentgen per minute (5 R/min.) exposure rate) at the measurement point specified in § 10855.15. Provision for manual selection of technique factors may be provided; and

(b) Shall not be operable at any combination of tube potential and current that will result in an AKR in excess of eighty-eight milligray (88 mGy) per minute (vice ten roentgen per minute (10 R/min.) exposure rate) at the measurement point specified in § 10855.15, except as specified in § 10855.14.

10855.14 Exceptions to the § 10855 requirements for fluoroscopic equipment are as follows:

For equipment manufactured prior to June 10, 2006, during the recording of images from a fluoroscopic image receptor using photographic film or a video camera when the x-ray source is operated in a pulsed mode;

For equipment manufactured on or after June 10, 2006, during the recording of images from the fluoroscopic image receptor for the purpose of providing the user with a recorded image(s) after termination of the exposure. Such recording does not include images resulting from a last-image-hold feature that are not recorded; and

(c) When a mode of operation has an optional high-level control and the control is activated, in which case the equipment shall not be operable at any combination of tube potential and current that will result in an AKR in excess of one hundred seventy-six milligray (176 mGy) per minute (vice twenty roentgen per minute (20 R/min.) exposure rate) at the measurement point specified in § 10855.15. Special means of activation of high-level controls shall be required. The high-level control shall be operable only when continuous manual activation is provided by the operator. A continuous signal audible to the fluoroscopist shall indicate that the high-level control is being employed.

10855.15 Compliance with § 10855.12 shall be determined as follows:

If the source is below the x-ray table, the AKR shall be measured at one centimeter (1 cm) above the tabletop or cradle;

(b) If the source is above the x-ray table, the AKR shall be measured at thirty centimeters (30 cm) above the tabletop with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement;

(c) In a C-arm type of fluoroscope, the AKR shall be measured at thirty centimeter (30 cm) from the input surface of the fluoroscopic imaging assembly, with the source positioned at any available SID, provided that the end of the beam-limiting device or spacer is no closer than thirty centimeters (30 cm) from the input surface of the fluoroscopic imaging assembly;

(d) In a C-arm type of fluoroscope having an SID less than forty-five centimeters (45 cm), the AKR shall be measured at the minimum SSD; and

(e) In a lateral type of fluoroscope, the air kerma rate shall be measured at a point fifteen centimeters (15 cm) from the centerline of the x-ray table and in the direction of the x-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. If the tabletop is movable, it shall be positioned as closely as possible to the lateral x-ray source, with the end of the beam-limiting device or spacer no closer than fifteen centimeters (15 cm) to the centerline of the x-ray table.

10855.16 Fluoroscopic radiation therapy simulation systems are exempt from the requirements set forth in § 10855.12.

10855.17 RESERVED

10855.18 During fluoroscopy and cinefluorography, x-ray tube potential and current shall be continuously indicated. Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in accordance with § 10853.17.

10855.19 Means shall be provided to limit the source-skin distance to not less than thirty-eight centimeters (38 cm) on stationary fluoroscopes and to not less than thirty centimeters (30 cm) on mobile and portable fluoroscopes. In addition, for fluoroscopes intended for specific surgical application that would be prohibited at the source-skin distances specified in this section, provisions may be made for operation at shorter source-skin distances but in no case less than twenty centimeters (20 cm). When provided, the manufacturer must set forth precautions with respect to the optional means of spacing, in addition to other information as required in § 10853.15.

10855.20 For stationary, mobile, or portable C-arm fluoroscopic systems manufactured on or after June 10, 2006, having a maximum source-image receptor distance of less than forty-five centimeters (45 cm), means shall be provided to limit the source-skin distance to not less than nineteen centimeters (19 cm). Such systems shall be labeled for extremity use only. In addition, for those systems intended for specific surgical application that would be prohibited at the source-skin distances specified in this subsection, provisions may be made for operation at shorter source-skin distances but in no case less than ten centimeters (10 cm). When provided, the manufacturer must set forth precautions with respect to the optional means of spacing, in addition to other information as required in § 10853.17.

10855.21 Fluoroscopic equipment manufactured before June 10, 2006, shall be provided with means to preset the cumulative irradiation time of the fluoroscopic tube. The maximum cumulative time of the timing device shall not exceed five (5) minutes without resetting. A signal audible to the fluoroscopist shall indicate the completion of any preset cumulative irradiation-time. Such signal shall continue to sound while x-rays are produced until the timing device is reset. Fluoroscopic equipment may be modified in accordance with § 10853.31 and 10853.32 to comply with the requirements of § 10853.23. When the equipment is modified, it shall bear a label indicating the statement:

“Modified to comply with 22 DCMR B § 10853.23”.

10855.22 As an alternative to the requirements of this section, radiation therapy simulation systems may be provided with a means to indicate the total cumulative exposure time during which x-rays were produced, and which is capable of being reset between x-ray examinations.

10855.23 For x-ray controls manufactured on or after June 10, 2006, there shall be provided for each fluoroscopic tube:

(a) A display of the fluoroscopic irradiation time at the fluoroscopist's working position. This display shall function independently of the audible signal described in § 10855.24. The following requirements apply:

(1) When the x-ray tube is activated, the fluoroscopic irradiation time in minutes and tenths of minutes shall be continuously displayed and updated at least once every six (6) seconds;

The fluoroscopic irradiation time shall also be displayed within six (6) seconds of termination of an exposure and remain displayed until reset; and

(3) Means shall be provided to reset the display to zero (0) prior to the beginning of a new examination or procedure.

10855.24 A signal audible to the fluoroscopist shall sound for each passage of five (5) minutes of fluoroscopic irradiation time during an examination or procedure. The signal shall sound until manually reset or, if automatically reset, for at least two (2) seconds.

10855.25 In addition to the other requirements of this section, mobile and portable fluoroscopes shall provide an image receptor incorporating more than a simple fluorescent screen.

10855.26 Fluoroscopic equipment manufactured on or after June 10, 2006, shall be equipped with means to display last-image-hold (LIH) following termination of the fluoroscopic exposure.

10855.27 For an LIH image obtained by retaining pre-termination fluoroscopic images, if the number of images and method of combining images are selectable by the user, the selection shall be indicated prior to initiation of the fluoroscopic exposure.

10855.28 For an LIH image obtained by initiating a separate radiographic-like exposure at the termination of fluoroscopic imaging, the techniques factors for the LIH image shall be selectable prior to the fluoroscopic exposure, and the combination selected shall be indicated prior to initiation of the fluoroscopic exposure.

10855.29 Means shall be provided to clearly indicate to the user whether a displayed image is the LIH radiograph or fluoroscopy. Display of the LIH radiograph shall be replaced by the fluoroscopic image concurrently with re-initiation of fluoroscopic exposure, unless separate displays are provided for the LIH radiograph and fluoroscopic images.

10855.30 The predetermined or selectable options for producing the LIH radiograph shall be described in the information required by § 10853.17. The information shall include a description of any technique factors applicable for the selected option and the impact of the selectable options on image characteristics and the magnitude of radiation emissions.

10855.31 Fluoroscopic equipment manufactured on or after June 10, 2006, shall display at the fluoroscopist's working position the AKR and cumulative air kerma. The following requirements apply for each x-ray tube used during an examination or procedure:

(a) When the x-ray tube is activated and the number of images produced per unit time is greater than six (6) images per second, the AKR in milligram per minute shall be continuously displayed and updated at least once every second;

(b) The cumulative air kerma in units of milligram shall be displayed either within five (5) seconds of termination of an exposure or displayed continuously and updated at least once every five (5) seconds;

(d) The AKR and cumulative air kerma shall represent the value for conditions of free-in-air irradiation at one (1) of the following reference locations specified according to the type of fluoroscope. The reference location shall be identified and described specifically in the information provided to users according to § 10853.20(c).

10855.32 For fluoroscopes with x-ray source below the x-ray table, x-ray source above the table, or of lateral type, the reference locations shall be the respective locations specified in § 10855.15(a), (b), or (e) for measuring compliance with air kerma rate limits.

10855.33 For C-arm fluoroscopes, the reference location shall be fifteen centimeters (15 cm.) from the isocenter toward the x-ray source along the beam axis. Alternatively, the reference location shall be at a point specified by the manufacturer to represent the location of the intersection of the x-ray beam with the patient's skin.

10855.34 Means shall be provided to reset to zero (0) the display of cumulative air kerma prior to the commencement of a new examination or procedure.

10855.35 The displayed AKR and cumulative air kerma shall not deviate from the actual values by more than plus or minus thirty-five percent (35%) over the range of six milligray per minute (6 mGy/min.) and one hundred milligray (100 mGy) to the maximum indication of AKR and cumulative air kerma, respectively. Compliance shall be determined with an irradiation time greater than three (3) seconds.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10855

22-B DCMR § 10856 HIGH INTENSITY MERCURY VAPOR DISCHARGE LAMPS

10856.1 The provisions of this section apply to any high-intensity mercury vapor discharge lamp that is designed, intended, or promoted for illumination purposes and is manufactured or assembled after March 7,1980, except as described in § 10856.6.

10856.2 As used in this section the following definitions apply:

High-intensity mercury vapor discharge lamp - any lamp including any "mercury vapor" and "metal halide" lamp, with the exception of the tungsten filament self-ballasted mercury vapor lamp, incorporating a high-pressure arc discharge tube that has a fill consisting primarily of mercury and that is contained within an outer envelope;

Advertisement - any catalog, specification sheet, price list, and any other descriptive or commercial brochure and literature, including videotape and film, pertaining to high-intensity mercury vapor discharge lamps;

Packaging - any lamp carton, outer wrapping, or other means of containment that is intended for the storage, shipment, or display of a high-intensity mercury vapor lamp and is intended to identify the contents or recommend its use;

Outer envelope - the lamp element, usually glass, surrounding a high-pressure arc discharge tube, that, when intact, attenuates the emission of shortwave ultraviolet radiation;

Shortwave ultraviolet radiation - ultraviolet radiation with wavelengths shorter than three hundred twenty nanometers (320 nm);

Cumulative operating time - means the sum of the times during which electric current passes through the high-pressure arc discharge;

Self-extinguishing lamp - means a high-intensity mercury vapor discharge lamp that is intended to comply with the requirements of § 10856.6 as applicable; and

Reference ballast - is an inductive reactor designed to have the operating characteristics as listed in Section 7 in the American National Standard Specifications for High-Intensity Discharge Lamp Reference Ballasts (ANSI C82.5-1977) or its equivalent.

10856.3 Each high-intensity mercury vapor discharge lamp shall:

Meet the requirements of either § 10856.5 or § 10856.9; and

(b) Be permanently labeled or marked in such a manner that the name of the manufacturer and the month and year of manufacture of the lamp can be determined on an intact lamp and after the outer envelope of the lamp is broken or removed. The name of the manufacturer and month and year of manufacture may be expressed in code or symbols, provided the manufacturer has previously supplied the Director, Center for Devices and Radiological Health, with the key to the code or symbols and the location of the coded information or symbols on the lamp.

10856.4 In lieu of permanently affixing or inscribing tags or labels on the product as required by §§ 10845.2 and 10846.1, the manufacturer of any high-intensity mercury vapor discharge lamp may permanently affix or inscribe such required tags or labels on the lamp packaging uniquely associated with the applicable lamp.

10856.5 Each self-extinguishing lamp manufactured after March 7, 1980 shall cease operation within a cumulative operating time not to exceed fifteen (15) minutes following complete breakage or removal of the outer envelope (with the exception of fragments extending fifty millimeters (50 mm) or less from the base shell).

10856.6 Each self-extinguishing lamp manufactured after September 7, 1981, shall cease operation within a cumulative operating time not to exceed fifteen (15) minutes following breakage or removal of at least three square centimeters (3 cm2) of contiguous surface of the outer envelope.

10856.7 Each self-extinguishing lamp shall be clearly marked with the letter "T" on the outer envelope and on another part of the lamp in such a manner that it is visible after the outer envelope of the lamp is broken or removed.

10856.8 Lamp packaging for each self-extinguishing lamp shall clearly and prominently display:

The letter "T"; and

(b) The wording: "This lamp should self-extinguish within fifteen (15) minutes after the outer envelope is broken or punctured. If such damage occurs, TURN OFF AND REMOVE LAMP to avoid possible injury from hazardous shortwave ultraviolet radiation.".

10856.9 Any high-intensity mercury vapor discharge lamp that does not comply with § 10856.5 shall be clearly and legibly marked with the letter "R" on the outer envelope and on another part of the lamp in such a manner that it is visible after the outer envelope of the lamp is broken or removed.

10856.10 Lamp packaging for each high-intensity mercury vapor discharge lamp that does not comply with § 10856.5 shall clearly and prominently display:

The letter "R"; and

(b) The wording "WARNING: This lamp can cause serious skin burn and eye inflammation from shortwave ultraviolet radiation if outer envelope of the lamp is broken or punctured. Do not use where people will remain for more than a few minutes unless adequate shielding or other safety precautions are used. Lamps that will automatically extinguish when the outer envelope is broken or punctured are commercially available.".

10856.11 Advertising for any high-intensity mercury vapor discharge lamp that does not comply with § 10856.5 shall prominently display the following wording: "WARNING: This lamp can cause serious skin burn and eye inflammation from shortwave ultraviolet radiation if outer envelope of the lamp is broken or punctured. Do not use where people will remain for more than a few minutes unless adequate shielding or other safety precautions are used. Lamps that will automatically extinguish when the outer envelope is broken or punctured are commercially available.".

10856.12 Any high-intensity mercury vapor discharge lamp under test for compliance with the requirements set forth in § 10856.5 shall be started and operated under the following conditions as applicable:

Lamp voltage, current, and orientation shall be those indicated or recommended by the manufacturer for operation of the intact lamp;

The lamp shall be operated on a reference ballast;

(c) The lamp shall be started in air that has a temperature of twenty five plus or minus five degrees Celsius (25+/-5º C). Heating and movement of the air surrounding the lamp shall be that produced by the lamp and ballast alone;

(d) If any test is performed in an enclosure, the enclosure shall be not less than two hundred twenty-seven thousandth cubic meters (0.227 m3 (eight cubic feet (8 cu. ft.)); and

(e) Any lamp designed to be operated only in a specific fixture or luminaire that the lamp manufacturer supplies or specifies shall be tested in that fixture or luminaire. Any other lamp shall be tested with no reflector or other surrounding material.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). Copies are available from American National Standards Institute, 1430 Broadway, New York, NY 10018. District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10856

22-B DCMR § 10857 ULTRASONIC THERAPY PRODUCTS

10857.1 The provisions of this section are applicable as specified herein to any ultrasonic therapy product for use in physical therapy manufactured on or after February 17, 1979.

10857.2 As used in this section the following definitions apply:

Amplitude modulated waveform - a waveform in which the ratio of the temporal-maximum pressure amplitude spatially averaged over the effective radiating surface to the root-mean-square pressure amplitude spatially averaged over the effective radiating surface is greater than one and five hundredths (1.05);

Applicator - that portion of a fully assembled ultrasonic therapy product that is designed to emit ultrasonic radiation and which includes one or more ultrasonic transducers and any associated housing;

Beam cross-section - the surface in any plane consisting of the points at which the intensity is greater than five percent (5%) of the spatial-maximum intensity in that plane;

Beam nonuniformity ratio - the ratio of the temporal-average spatial-maximum intensity to the temporal-average effective intensity;

Centroid of a surface - the point whose coordinates are the mean values of the coordinates of the points of the surface;

Collimating applicator - an applicator that does not meet the definition of a focusing applicator as specified in the paragraph “Focusing applicator” of this section and for which the ratio of the area of at least one beam cross-section, whose centroid is twelve centimeters (12 cm) from the centroid of the effective radiating surface, to the area of the effective radiating surface is less than two (2);

Continuous-wave waveform - a waveform in which the ratio of the temporal-maximum pressure amplitude spatially averaged over the effective radiating surface to the root-mean-square pressure amplitude spatially averaged over the effective radiating surface is less than or equal to one and five hundredths (1.05);

(h) Diverging applicator - means an applicator that does not meet the definition of a collimating applicator or a focusing applicator as specified in paragraphs “Collimating applicator” and ”Focusing applicator” of this section;

(i) Effective intensity - the ratio of the ultrasonic power to the focal area for a focusing applicator. For all other applicators, the effective intensity is the ratio of the ultrasonic power to the effective radiating area. Effective intensity is expressed in watts per square centimeter (W/cm2);

(j) Effective radiating area - the area consisting of all points of the effective radiating surface at which the intensity is five percent (5%) or more of the maximum intensity at the effective radiating surface, expressed in square centimeters (cm2);

(k) Effective radiating surface - the surface consisting of all points five millimeters (5 mm) from the applicator face;

(l) Focal area - the area of the focal surface, expressed in square centimeters (cm2);

(m) Focal length - the distance between the centroids of the effective radiating surface and the focal surface, for a focusing applicator, expressed in centimeters (cm);

(n) Focal surface - the beam cross-section with smallest area of a focusing applicator;

(o) Focusing applicator - an applicator in which the ratio of the area of the beam cross-section with the smallest area to the effective radiating area is less than one-half (1/2);

(p) Generator - that portion of a fully assembled ultrasonic therapy product that supplies electrical energy to the applicator. The generator may include, but is not limited to, a power supply, ultrasonic frequency oscillator, service controls, operation controls, and a cabinet to house these components;

(q) Maximum beam non-uniformity ratio - the maximum value of the beam non-uniformity ratio characteristic of a model of an ultrasonic therapy product;

(r) Operation control - any control used during operation of an ultrasonic therapy product that affects the ultrasonic radiation emitted by the applicator;

(s) Pressure amplitude - the instantaneous value of the modulating waveform, and is p1(t) in the expression for a pressure wave, p(t)=p1(t) p2(t), where p(t) is the instantaneous pressure, p1(t) is the modulating envelope, and p2(t) is the relative amplitude of the carrier wave normalized to a peak height of one (1). All are periodic functions of time (t0 at any point in space. The period of p1(t) is greater than the period of p2(t);

(t) Pulse duration - a time interval, expressed in seconds, beginning at the first time the pressure amplitude exceeds the minimum pressure amplitude plus ten percent (10%) of the difference between the maximum and minimum pressure amplitudes, and ending at the last time the pressure amplitude returns to this value;

(u) Pulse repetition rate - the repetition frequency of the waveform modulating the ultrasonic carrier wave expressed in pulses per second (pps);

(v) Service control - any control provided for the purpose of adjustment that is not used during operation and can affect the ultrasonic radiation emitted by the applicator, or can alter the calibration or accuracy of an indicator or operation control;

(w) Ultrasonic frequency - the frequency of the ultrasonic radiation carrier wave, expressed in Hertz (Hz), kilohertz (kHz), or megahertz (MHz);

(x) Ultrasonic power - the total power emitted in the form of ultrasonic radiation by the applicator averaged over each cycle of the ultrasonic radiation carrier wave, expressed in watts;

(y) Ultrasonic therapy product –

Any device intended to generate and emit ultrasonic radiation for therapeutic purposes at ultrasonic frequencies above sixteen kilohertz (16kHz.); or

(2) Any generator or applicator designed or specifically designated for use in a device as specified in Paragraph (a); and

(z) Ultrasonic transducer - a device used to convert electrical energy of ultrasonic frequency into ultrasonic radiation or vice versa.

10857.3 The requirements of this section are applicable to each ultrasonic therapy product as defined in Paragraphs (a) and (b) of § 10857.2 when the generator and applicator are designated or intended for use together, or to each generator when the applicator(s) intended for use with the generator does not contain controls that affect the functioning of the generator.

10857.4 A means shall be incorporated to indicate the magnitudes of the temporal-average ultrasonic power and the temporal-average effective intensity when emission is of continuous-wave waveform. The error in the indication of the temporal-average ultrasonic power shall not exceed plus or minus twenty percent (+/- 20%) for all emissions greater than ten percent (10%) of the maximum emission.

10857.5 A means shall be incorporated to indicate the magnitudes of the temporal-maximum ultrasonic power and the temporal-maximum effective intensity when the emission is of amplitude-modulated waveform. The sum of the errors in the indications of the temporal-maximum ultrasonic power and the ratio of the temporal-maximum effective intensity to the temporal-average effective intensity specified in § 10857.14 of this section shall not exceed plus or minus twenty percent (+/-20%) for all emissions greater than ten percent (10%) of the maximum emission.

10857.6 A means shall be incorporated to enable the duration of emission of ultrasonic radiation for treatment to be preset and such means shall terminate emission at the end of the preset time. Means shall also be incorporated to enable termination of emission at any time. Means shall be incorporated to indicate the magnitude of the duration of emission (expressed in minutes) to within one-half minute (0.5) minute of the preset duration of emission for setting less than five (5) minutes, to within ten percent (10%) of the preset duration of emission for settings of from five (5) minutes to ten (10) minutes, and to within one (1) minute of the preset duration of emission for settings greater than ten (10) minutes.

10857.7 A means shall be incorporated for indicating the magnitudes of pulse duration and pulse repetition rate of the emitted ultrasonic radiation, if there are operation controls for varying these quantities.

10857.8 A means shall be incorporated for indicating the magnitude of the ultrasonic frequency of the emitted ultrasonic radiation, if there is an operation control for varying this quantity.

10857.9 A means shall be incorporated to provide a clear, distinct, and readily understood visual indicator when and only when electrical energy of appropriate ultrasonic frequency is being applied to the ultrasonic transducer(s).

10857.10 In addition to the labeling requirements in Chapter 103 and the requirements of §§ 10845 and 10846, each ultrasonic therapy product shall be subject to the applicable labeling requirements of this section.

10857.11 Each operation control shall be clearly labeled identifying the function controlled and, where appropriate, the units of measure of that function. If a separate control and indicator are associated with the same function, then labeling the appropriate units of measure of that function is required for the indicator but not for the control.

10857.12 Each service control that is accessible without displacement or removal of any part of the ultrasonic therapy product shall be clearly labeled identifying the function controlled and shall include the phrase "for service adjustment only."

10857.13 Each generator shall bear a label that states:

The brand name;

Model designation, and unique serial number or other unique identification so that it is individually identifiable;

Ultrasonic frequency (unless there is an operation control for varying this quantity); and

Type of waveform (continuous wave or amplitude modulated).

10857.14 Generators employing amplitude-modulated waveforms shall also bear a label that provides the following information: Pulse duration and pulse repetition rate (unless there are operation controls for varying these quantities), an illustration of the amplitude-modulated waveform, and the ratio of the temporal-maximum effective intensity to the temporal-average effective intensity. (If this ratio is a function of any operation control setting, then the range of the ratio shall be specified, and the waveform illustration shall be provided for the maximum value of this ratio.).

10857.15 Each applicator shall bear a label that provides the following information:

(a) The brand name, model designation, and unique serial number or other unique identification so the applicator is individually identifiable;

(b) A designation of the generator(s) for which the applicator is intended; and

(c) The ultrasonic frequency, effective radiating area, maximum beam nonuniformity ratio, type of applicator (focusing, collimating, diverging), and for a focusing applicator the focal length and focal area.

10857.16 Labels required by this section shall be permanently affixed to or inscribed on the ultrasonic therapy product; they shall be legible and clearly visible. If the size, configuration, or design of the ultrasonic therapy product would preclude compliance with the requirements of this paragraph, the Director, Center for Devices and Radiological Health, may approve alternate means of providing such labels.

10857.17 Tests on which certification pursuant to § 10845 is based shall account for all measurement errors and uncertainties. Such tests shall also account for increases in emission and degradation in radiation safety that occur with age.

10857.18 Except as provided in § 10849, tests for compliance with each of the applicable requirements of this section shall be made:

For all possible combinations of adjustments of the controls listed in the operation instructions;

With the ultrasonic radiation emitted into the equivalent of an infinite medium of distilled, degassed water at thirty degrees Celsius (30 °C) for measurements concerning the ultrasonic radiation; and

(c) With line voltage variations in the range of plus or minus ten percent (+/-10%) of the rated value specified by the manufacturer.

10857.19 Measurements for determination of the spatial distribution of the ultrasonic radiation field shall be made with a detector having dimensions of less than one (1) wavelength in water or an equivalent measurement technique.

10857.20 The manufacturer of an ultrasonic therapy product shall provide or cause to be provided to servicing dealers and distributors, and to others upon request, at a cost not to exceed the cost of preparation and distribution adequate instructions for operations, service, and calibration, including a description of those controls and procedures that could be used to increase radiation emission levels, and a schedule of maintenance necessary to keep equipment in compliance with this section. The instructions shall include adequate safety precautions that may be necessary regarding ultrasonic radiation exposure.

10857.21 The manufacturer of an ultrasonic therapy product shall provide as an integral part of any user instruction or operation manual that is regularly supplied with the product, or, if not so supplied, shall cause to be provided with each ultrasonic therapy product, and to others upon request, at a cost not to exceed the cost of preparation and distribution the following:

Adequate instructions concerning assembly, operation, safe use, any safety procedures and precautions that may be necessary regarding the use of ultrasonic radiation, and a schedule of maintenance necessary to keep the equipment in compliance with this section. The operation instructions shall include a discussion of all operation controls, and shall describe the effect of each control;

(b) Adequate description of the spatial distribution of the ultrasonic radiation field and the orientation of the field with respect to the applicator. This will include a textual discussion with diagrams, plots, or photographs representative of the beam pattern. If there is more than one (1) ultrasonic transducer in an applicator and their positions are not fixed relative of each other, then the description must specify the spatial distribution of the ultrasonic radiation field emitted by each ultrasonic transducer and present adequate examples of the combination field of the ultrasonic transducers with regard to safe use. The description of the ultrasonic radiation field shall state that such description applies under conditions specified in § 10857.18(b);

(c) Adequate description, as appropriate to the product, of the uncertainties in magnitude expressed in terms of percentage error, of the ultrasonic frequency effective radiating area, and, where applicable, the ratio of the temporal-maximum effective intensity to the temporal-average effective intensity, pulse duration, pulse repetition rate, focal area, and focal length. The errors in indications specified in §§ 10857.4 and 10857.5 shall be stated in the instruction manual; and

(d) A listing of controls, adjustments, and procedures for operation and maintenance, including the warning "Caution--use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous exposure to ultrasonic energy.”.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10857

22-B DCMR § 10899 DEFINITIONS

10899.1 As used in this chapter, the following terms shall have the meanings ascribed:

Accidental radiation occurrence - a single event or series of events that has/have resulted in injurious or potentially injurious exposure of any person to electronic product radiation as a result of the manufacturing, testing, or use of an electronic product.

Act – the Federal Food, Drug, and Cosmetic Act, approved June 25, 1938, 21 U.S.C. § 301, et seq.

Ambulatory surgical facility (ASF) - a distinct entity that operates for the primary purpose of furnishing same day outpatient surgical services to patients. An ASF may be either an independent entity (for example, not a part of a provider of services or any other facility) or operated by another medical entity (such as, under the common ownership, licensure, or control of an entity). An ASF is subject to this regulation regardless of whether it is licensed by a federal, state, municipal, or local government or regardless of whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the ASF must report that event regardless of the nature or location of the medical service provided by the ASF.

Audiologist - any person qualified by training and experience to specialize in the evaluation and rehabilitation of individuals whose communication disorders center in whole or in part in the hearing function. In some states audiologists must satisfy specific requirements for licensure.

Beam blocking device - a movable or removable portion of any enclosure around a cold-cathode gas discharge tube, which may be opened or closed to permit or prevent the emergence of an exit beam.

Become aware - when an employee of the entity required to report has acquired information that reasonably suggests a reportable adverse event has occurred.

(a) If you are a device user facility, you are considered to have "become aware" when medical personnel, as defined in this subsection, who are employed by or otherwise formally affiliated with your facility, obtain information about a reportable event.

(b) If you are a manufacturer, you are considered to have become aware of an event when any of your employees becomes aware of a reportable event that is required to be reported within thirty (30) calendar days or that is required to be reported within five (5) work days because the Department requested reports in accordance with § 10422.1(b). You are also considered to have become aware of an event when any of your employees with management or supervisory responsibilities over persons with regulatory, scientific, or technical responsibilities, or whose duties relate to the collection and reporting of adverse events, becomes aware, from any information, including any trend analysis, that a reportable MDR event or events necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health.

(c) If you are an importer, you are considered to have become aware of an event when any of your employees becomes aware of a reportable event that is required to be reported by you within thirty (30) days.

Business day - Monday through Friday, except federal holidays.

Caused or contributed - when a death or serious injury was or may have been attributed to a medical device, or that a medical device was or may have been a factor in a death or serious injury, including events occurring as a result of:

(a) Failure;

(b) Malfunction;

(d) Manufacture;

(e) Labeling; or

(f) User error.

Chassis family - a group of one (1) or more models with all of the following common characteristics:

(a) The same circuitry in the high voltage, horizontal oscillator, and power supply sections;

(b) The same worst component failures;

(d) The same design and installation.

Classification name - the term used by the Department and its classification panels to describe a device or class of devices for purposes of classifying devices under Section 513 of the Federal Food, Drug, and Cosmetic Act.

Class III certification - a certification that the submitter pursuant to 21 U.S.C. § 360(k) has conducted a reasonable search of all known information about the class III device and other similar, legally marketed devices.

Class III summary - a summary of the types of safety and effectiveness problems associated with the type of device being compared and a citation to the information upon which the summary is based. The summary must be comprehensive and describe the problems to which the type of device is susceptible and the causes of such problems.

Cold-cathode gas discharge tube - an electronic device in which electron flow is produced and sustained by ionization of contained gas atoms and ion bombardment of the cathode.

Commerce -

(a) Commerce between any place in any State and any place outside thereof, and

(b) Commerce wholly within the District of Columbia.

Commercial distribution - any distribution of a device intended for human use which is held or offered for sale but does not include the following:

(a) Internal or interplant transfer of a device between establishments within the same parent, subsidiary, or affiliate company;

(b) Any distribution of a device intended for human use which has in effect an approved exemption for investigational use under 21 U.S.C. § 360j(g) and Chapter 109 of this subtitle;

(c) Any distribution of a device, before the effective date of Chapter 109 of this subtitle, that was not introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, and that is classified into class III under 21 U.S.C. § 360c(f); provided that the device is intended solely for investigational use, and under 21 U.S.C. § 360c(f)(2)(A) the device is not required to have an approved premarket approval application as provided in 21 U.S.C. § 360e; or

(d) For foreign establishments, the distribution of any device that is neither imported nor offered for import into the U.S.

Design input - the physical and performance requirements of a device that are used as a basis for device design.

Design output - the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record.

Design review - a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.

Design validation - establishing by objective evidence that device specifications conform to user needs and intended use(s).

Device history record (DHR) - a compilation of records containing the production history of a finished device.

Device master record (DMR) - a compilation of records containing the procedures and specifications for a finished device.

Device user facility - a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility as defined in this subsection, which is not a physician's office as defined in this subsection. School nurse offices and employee health units are not device user facilities.

Diagnostic radiology facility - any facility in which an x-ray system(s) is used in any procedure that involves irradiation of any part of the human body for the purpose of diagnosis or visualization. Offices of individual physicians, dentists, podiatrists, and chiropractors, as well as mobile laboratories, clinics, and hospitals are all examples of diagnostic radiology facilities.

Director –the Director of the Department of Health or his or her designee.

Dispenser - any person, partnership, corporation, or association engaged in the sale, lease, or rental of hearing aids to any member of the consuming public or any employee, agent, sales person, or representative of such a person, partnership, corporation, or association.

Department –the District of Columbia Department of Health.

Distributor - a person engaged in the business of offering electronic products for sale to dealers, without regard to whether such person is or has been primarily or customarily engaged in such business.

District standard - a performance standard.

Ear specialist - any licensed physician who specializes in diseases of the ear and is medically trained to identify the symptoms of deafness in the context of the total health of the patient, and is qualified by special training to diagnose and treat hearing loss. Such physicians are also known as otolaryngologists, otologists, and otorhinolaryngologists.

Electromagnetic radiation - includes the entire electromagnetic spectrum of radiation of any wavelength. The electromagnetic spectrum illustrated in Figure 1 includes, but is not limited to, gamma rays, x-rays, ultra-violet, visible, infrared, microwave, radiowave, and low frequency radiation.

Electronic product -

(a) Any manufactured or assembled product which, when in operation:

(1) Contains or acts as part of an electronic circuit; and

(2) Emits (or in the absence of effective shielding or other controls would emit) electronic product radiation; or

(b) Any manufactured or assembled article that is intended for use as a component, part, or accessory of a product described in Paragraph (a)(1) and which, when in operation, emits (or in the absence of effective shielding or other controls would emit) such radiation.

Establish - define, document (in writing or electronically), and implement.

Establishment - a place of business under one (1) management at one (1) general physical location at which a device is manufactured, assembled, or otherwise processed.

Exit beam - that portion of the radiation which passes through the aperture resulting from the opening of the beam blocking device.

Expected life of a device - the time that a device is expected to remain functional after it is placed into use. Certain implanted devices have specified "end of life" (EOL) dates. Other devices are not labeled as to their respective EOL, but are expected to remain operational through activities such as maintenance, repairs, or upgrades, for an estimated period of time.

Exposure -the sum of the electrical charges on all of the ions of one (1) sign produced in air when all electrons liberated by photons in a volume element of air are completely stopped in air divided by the mass of the air in the volume element. The special unit of exposure is the roentgen. One (1) roentgen equals 2.5810 - n4 coulombs/kilogram.

External surface - the cabinet or enclosure provided by the manufacturer as part of the receiver. If a cabinet or enclosure is not provided as part of the receiver, the external surface shall be considered to be a hypothetical cabinet, the plane surfaces of which are located at those minimum distances from the chassis sufficient to enclose all components of the receiver except that portion of the neck and socket of the cathode-ray tube which normally extends beyond the plane surfaces of the enclosure.

Five (5)-day report - a medical device report that must be submitted by a manufacturer to us under § 10422 on a form or an electronic equivalent approved under § 10406, within five (5) work days.

21 U.S.C. § 360(k) statement - a statement under 21 U.S.C. § 360c(i), asserting that all information in a premarket notification submission regarding safety and effectiveness will be made available within thirty (30) days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent. The information to be made available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret or confidential commercial information, as defined in § 10602.11.

21 U.S.C. § 360(k) summary (summary of any information respecting safety and effectiveness) - a summary, submitted under 21 U.S.C. § 360c(i), of the safety and effectiveness information contained in a premarket notification submission upon which a determination of substantial equivalence can be based. Safety and effectiveness information refers to safety and effectiveness data and information supporting a finding of substantial equivalence, including all adverse safety and effectiveness information.

Humanitarian device exemption (HDE) - a premarket approval application submitted pursuant to this section seeking a humanitarian device exemption from the effectiveness requirements of 21 U.S.C. §§ 360d and 360e.

Health authority –a physician designated to administer state and local laws relating to public health.

Hearing aid - any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing.

Hospital - a distinct entity that operates for the primary purpose of providing diagnostic, therapeutic (such as medical, occupational, speech, and physical), surgical, and other patient services for specific and general medical conditions. Hospitals include general, chronic disease, rehabilitative, psychiatric, and other special-purpose facilities. A hospital may be either independent (for example, not a part of a provider of services or any other facility) or may be operated by another medical entity (such as, under the common ownership, licensure, or control of another entity). A hospital is covered by this regulation regardless of whether it is licensed by a federal, state, municipal, or local government or whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the hospital must report that event regardless of the nature or location of the medical service provided by the hospital.

Humanitarian use device (HUD) - a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than four thousand (4,000) individuals in the United States per year.

Investigational device exemption (IDE) – an agreement through which the federal government permits the testing of a new medical device in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval or Premarket Notification (510(k) submission to the Food and Drug Administration.

Infrasonic, sonic (or audible) and ultrasonic waves - refers to energy transmitted as an alteration (pressure, particle displacement or density) in a property of an elastic medium (gas, liquid, or solid) that can be detected by an instrument or listener.

Initial importer - any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package. Any term defined in Section 201 of the Act shall have that meaning.

Lot or batch - one (1) or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.

Malfunction - the failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. The intended performance of a device refers to the intended use for which the device is labeled or marketed, as defined in § 9301.

Management with executive responsibility - those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system.

Master file - a reference source that a person submits to the Department of Health A master file may contain detailed information on a specific manufacturing facility, process, methodology, or component used in the manufacture, processing, or packaging of a medical device.

Manufacturer - any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure. The term includes any person who either:

Repackages or otherwise changes the container, wrapper, or labeling of a device in furtherance of the distribution of the device from the original place of manufacture;

Initiates specifications for devices that are manufactured by a second party for subsequent distribution by the person initiating the specifications;

Manufactures components or accessories that are devices that are ready to be used and are intended to be commercially distributed and intended to be used as is, or are processed by a licensed practitioner or other qualified person to meet the needs of a particular patient; or

Is the U.S. agent of a foreign manufacturer.

Manufacturer - any person engaged in the business of manufacturing, assembling, or importing electronic products. (21 C.F.R., Subchapter J, Radiological Health).

Manufacturer or importer report number - the number that uniquely identifies each individual adverse event report submitted by a manufacturer or importer. This number consists of the following three parts:

(a) The Department of Health registration number for the manufacturing site of the reported device, or the registration number for the importer. If the manufacturing site or the importer does not have an establishment registration number, the Department will assign a temporary MDR reporting number until the site is registered in accordance with Chapter 105 of this subtitle. The Department will inform the manufacturer or importer of the temporary MDR reporting number;

(b) The four (4)-digit calendar year in which the report is submitted; and

(c) The five (5) -digit sequence number of the reports submitted during the year, starting with 00001. (For example, the complete number will appear as follows: 1234567-1995-00001.).

Manufacturing material - any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent, or a byproduct constituent produced during the manufacturing process, which is present in or on the finished device as a residue or impurity not by design or intent of the manufacturer.

Material change - includes any change or modification in the labeling or advertisements that affects the identity or safety and effectiveness of the device. These changes may include, but are not limited to, changes in the common or usual or proprietary name, declared ingredients or components, intended use, contraindications, warnings, or instructions for use. Changes that are not material may include graphic layouts, grammar, or correction of typographical errors which do not change the content of the labeling, changes in lot number, and, for devices where the biological activity or known composition differs with each lot produced, the labeling containing the actual values for each lot.

Maximum test voltage – one hundred thirty root mean squared volts (130 VRMS) if the receiver is designed to operate from nominal one hundred ten to one hundred twenty root mean squared volt (120-130 VRMS) power sources. If the receiver is designed to operate from a power source having some voltage other than from nominal one hundred ten to one hundred twenty root mean squared volts (110-120 VRMS) maximum test voltage means one hundred ten percent (110%) of the nominal root mean squared voltage specified by the manufacturer for the power source.

MDR - means medical device report.

MDR reportable event (or reportable event) –

(a) An event that user facilities become aware of that reasonably suggests that a device has or may have caused or contributed to a death or serious injury; or

(b) An event that manufacturers or importers become aware of that reasonably suggests that one of their marketed devices:

(1) May have caused or contributed to a death or serious injury, or

(2) Has malfunctioned and that the device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Medical device –an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is:

Recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them;

Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals;

Intended to affect the structure or any function of the body of man or other animals; and

Does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

Medical personnel - an individual who:

(a) Is licensed, registered, or certified by a State, territory, or other governing body, to administer health care;

(b) Has received a diploma or a degree in a professional or scientific discipline;

(d) Is a supervisor of these persons.

Model - any identifiable, unique electronic product design, and refers to products having the same structural and electrical design characteristics and to which the manufacturer has assigned a specific designation to differentiate between it and other products produced by that manufacturer.

Model family - products having similar design and radiation characteristics but different manufacturer model numbers.

Modified model - a product that is redesigned so that actual or potential radiation emission, the manner of compliance with a standard, or the manner of radiation safety testing is affected.

Newly acquired information - data, analyses, or other information not previously submitted to the agency, which may include (but are not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (for example, meta-analyses) if the studies, events or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to the Department of Health.

Nonconformity - the non-fulfillment of a specified requirement.

Nursing home - means:

An independent entity (such as, not a part of a provider of services or any other facility) or one operated by another medical entity (for example, under the common ownership, licensure, or control of an entity) that operates for the primary purpose of providing:

Skilled nursing care and related services for persons who require medical or nursing care;

(2) Hospice care to the terminally ill; or

(3) Services for the rehabilitation of the injured, disabled, or sick.

A nursing home is subject to this regulation regardless of whether it is licensed by a federal, state, municipal, or local government or whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the nursing home must report that event regardless of the nature or location of the medical service provided by the nursing home.

Official correspondent - the person designated by the owner or operator of an establishment as responsible for the following:

(a) The annual registration of the establishment;

(b) Contact with the Department for device listing;

(c) Maintenance and submission of a current list of officers and directors to the Department of Health upon the request of the Department of Health;

(d) The receipt of pertinent correspondence from the Department directed to and involving the owner or operator or any of the firm's establishments; and

The annual certification of medical device reports required by 21 C.F.R. § 804.30 or forwarding the certification form to the person designated by the firm as responsible for the certification.

Outpatient diagnostic facility - a distinct entity that:

(a) Operates for the primary purpose of conducting medical diagnostic tests on patients;

(b) Does not assume ongoing responsibility for patient care; and

Outpatient diagnostic facilities include outpatient facilities providing radiography, mammography, ultrasonography, electrocardiography, magnetic resonance imaging, computerized axial tomography, and in vitro testing. An outpatient diagnostic facility may be either independent (for example, not a part of a provider of services or any other facility) or operated by another medical entity (such as, under the common ownership, licensure, or control of an entity). An outpatient diagnostic facility is covered by this regulation regardless of whether it is licensed by a federal, state, municipal, or local government or whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the outpatient diagnostic facility must report that event regardless of the nature or location of the medical service provided by the outpatient diagnostic facility.

Outpatient treatment facility - a distinct entity that operates for the primary purpose of providing nonsurgical therapeutic (medical, occupational, or physical) care on an outpatient basis or in a home health care setting. Outpatient treatment facilities include ambulance providers, rescue services, and home health care groups. Examples of services provided by outpatient treatment facilities include the following: Cardiac defibrillation, chemotherapy, radiotherapy, pain control, dialysis, speech or physical therapy, and treatment for substance abuse. An outpatient treatment facility may be either independent (for example, not a part of a provider of services or any other facility) or operated by another medical entity (such as, under the common ownership, licensure, or control of an entity). An outpatient treatment facility is covered by this regulation regardless of whether it is licensed by a federal, state, municipal, or local government or whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the outpatient treatment facility must report that event regardless of the nature or location of the medical service provided by the outpatient treatment facility.

Owner or operator - the corporation, subsidiary, affiliated company, partnership, or proprietor directly responsible for the activities of the registering establishment.

Owner or consignee - the person who has the rights of a consignee under the provisions of Sections 483, 484, and 485 of the Tariff Act of 1930, as amended (19 U.S.C. §§ 1483, 1484, 1485).

Particulate radiation –

(a) Charged particles, such as protons, electrons, alpha particles, or heavy particles, which have sufficient kinetic energy to produce ionization or atomic or electron excitation by collision, electrical attractions, or electrical repulsion; or

(b) Uncharged particles, such as neutrons, which can initiate a nuclear transformation or liberate charged particles having sufficient kinetic energy to produce ionization or atomic or electron excitation.

Patient of the facility - any individual who is being diagnosed or treated or receiving medical care at or under the control or authority of the facility. This includes employees of the facility or individuals affiliated with the facility who, in the course of their duties, suffer a device-related death or serious injury that has or may have been caused or contributed to by a device used at the facility.

Permanent - irreversible impairment or damage to a body structure or function, excluding trivial impairment or damage.

Phototherapy product - means any ultraviolet lamp, or product containing such lamp, that is intended for irradiation of any part of the living human body by light in the wavelength range of two hundred to four hundred nanometers (200-400 nm.), in order to perform a therapeutic function.

Physician's office - a facility that operates as the office of a physician or other health care professional for the primary purpose of examination, evaluation, and treatment or referral of patients. Examples of physician offices include dentist offices, chiropractor offices, optometrist offices, nurse practitioner offices, school nurse offices, school clinics, employee health clinics, or freestanding care units. A physician's office may be independent, a group practice, or part of a Health Maintenance Organization.

Premarket Approval Application (PMA) - any premarket approval application for a class III medical device, including all information submitted with or incorporated by reference therein. "PMA" includes a new drug application for a device under 21 U.S.C. § 360j(1).

PMA amendment - information an applicant submits to the Department of Health to modify a pending PMA or a pending PMA supplement.

PMA supplement - a supplemental application to an approved PMA for approval of a change or modification in a class III medical device, including all information submitted with or incorporated by reference therein.

Process validation - establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.

Product - components, manufacturing materials, in- process devices, finished devices, and returned devices.

Purchaser - the first person who, for value, or as an award or prize, acquires an electronic product for purposes other than resale, and includes a person who leases an electronic product for purposes other than subleasing.

Quality - the totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance.

Quality administration procedures - are those management actions intended to guarantee that monitoring techniques are properly performed and evaluated and that necessary corrective measures are taken in response to monitoring results. These procedures provide the organizational framework for the quality assurance program.

Quality assurance - the planned and systematic actions that provide adequate confidence that a diagnostic x-ray facility will produce consistently high quality images with minimum exposure of the patients and healing arts personnel. The determination of what constitutes high quality will be made by the facility producing the images. Quality assurance actions include both "quality control" techniques and "quality administration" procedures.

Quality assurance program - an organized entity designed to provide "quality assurance" for a diagnostic radiology facility. The nature and extent of this program will vary with the size and type of the facility, the type of examinations conducted, and other factors.

Quality audit - a systematic, independent examination of a manufacturer's quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives.

Quality control techniques - are those techniques used in the monitoring (or testing) and maintenance of the components of an x-ray system. The quality control techniques thus are concerned directly with the equipment.

Rework - action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution.

Sale or purchase - includes any lease or rental of a hearing aid to a member of the consuming public who is a user or prospective user of a hearing aid.

Serious, adverse health consequences - any significant adverse experience, including those which may be either life-threatening or involve permanent or long term injuries, but excluding injuries that are nonlife-threatening and that are temporary and reasonably reversible.

Serious injury - an injury or illness that:

(a) Is life-threatening;

(b) Results in permanent impairment of a body function or permanent damage to a body structure; or

(c) Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.

Service controls - all of those controls on a television receiver provided by the manufacturer for purposes of adjustment which, under normal usage, are not accessible to the user.

Specification - any requirement with which a product, process, service, or other activity must conform.

State - a state, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, and American Samoa.

Statement of material fact - a representation that tends to show that the safety or effectiveness of a device is more probable than it would be in the absence of such a representation. A false affirmation or silence or an omission that would lead a reasonable person to draw a particular conclusion as to the safety or effectiveness of a device also may be a false statement of material fact, even if the statement was not intended by the person making it to be misleading or to have any probative effect.

Television receiver - an electronic product designed to receive and display a television picture through broadcast, cable, or closed circuit television.

Thirty (30)-day PMA supplement - a supplemental application to an approved PMA in accordance with § 10608.6.

United States (designated) agent - a person residing or maintaining a place of business in the United States whom a foreign establishment designates as its agent. This definition excludes mailboxes, answering machines or services, or other places where an individual acting as the foreign establishment's agent is not physically present.

Usable picture - a picture in synchronization and transmitting viewable intelligence.

Used hearing aid - any hearing aid that has been worn for any period of time by a user. However, a hearing aid shall not be considered "used" merely because it has been worn by a prospective user as a part of a bona fide hearing aid evaluation conducted to determine whether to select that particular hearing aid for that prospective user, if such evaluation has been conducted in the presence of the dispenser or a hearing aid health professional selected by the dispenser to assist the buyer in making such a determination.

User controls - all of those controls on a television receiver, provided by the manufacturer for purposes of adjustment, which on a fully assembled receiver under normal usage, are accessible to the user.

User facility report number - the number that uniquely identifies each report submitted by a user facility to manufacturers and to us. This number consists of the following three parts:

The user facility's ten (10) digit Centers for Medicare and Medicaid Services (CMS) number (if the CMS number has fewer than 10 digits, fill the remaining spaces with zeros);

(b) The four (4) digit calendar year in which the report is submitted; and

(c) The four-digit sequence number of the reports submitted for the year, starting with 0001. (For example, a complete user facility report number will appear as follows: 1234560000-2004-0001. If a user facility has more than one CMS number, it must select one (1) that will be used for all of its MDR reports. If a user facility has no CMS number, it should use all zeros in the appropriate space in its initial report (such as, 0000000000-2004-0001). We will assign a number for future use and send that number to the user facility. This number is used in the Department’s record of the initial report, in subsequent reports, and in any correspondence with the user facility. If a facility has multiple sites, the primary site may submit reports for all sites and use one (1) reporting number for all sites if the primary site provides the name, address, and CMS number for each respective site.).

Validation - confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.

Verification - confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.

Wholesale distributor - any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user.

X-ray system - an assemblage of components for the controlled production of diagnostic images with x-rays. It includes minimally an x-ray high voltage generator, an x-ray control, a tube-housing assembly, a beam-limiting device, and the necessary supporting structures. Other components that function with the system, such as image receptors, image processors, view boxes, and darkrooms, are also parts of the system.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10899

22-B109 INVESTIGATIONAL DEVICE EXEMPTIONS

22-B DCMR § 10900 SCOPE

10900.1 The purpose of this chapter is to encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use, and to that end to maintain optimum freedom for scientific investigators in their pursuit of this purpose. This chapter provides procedures for the conducting clinical investigations of devices. An approved IDE permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device. An IDE approved under § 10910 or considered approved under § 10901 exempts a device from the requirements of the following sections of the Act and regulations issued thereunder:

(a) Misbranding under 21 U.S.C. § 352;

(b) Registration, listing, and premarket notification under 21 U.S.C. § 360;

(d) Premarket approval under 21 U.S.C. § 360e;

(e) A banned device regulation under 21 U.S.C. § 360f;

(f) Records and reports under 21 U.S.C. § 360i;

(g) Restricted device requirements under 21 U.S.C. § 360j(e);

(h) Good manufacturing practice requirements under 21 U.S.C. § 360j(f) except for the requirements found in § 10705 of this subtitle, if applicable (unless the sponsor states an intention to comply with these requirements under §§ 10907.2 (c) or 10927.2(d)(5) of this subtitle); and

(i) Color additive requirements.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10900

22-B DCMR § 10901 APPLICABILITY

10901.1 This chapter applies to all clinical investigations of devices to determine safety and effectiveness, except as provided in § 10901.3.

10901.2 The following categories of investigations are considered to have approved applications for IDE unless the Department has notified a sponsor under § 10907.1(a) that approval of an application is required:

(a) An investigation of a device other than a significant risk device, if the device is not a banned device and the sponsor:

(1) Labels the device in accordance with § 10902;

(2) Obtains investigational review board (IRB) approval of the investigation after presenting the reviewing IRB with a brief explanation of why the device is not a significant risk device, and maintains such approval;

(3) Ensures that each investigator participating in a § 10907.1(a) investigation of the device obtains from each subject under the investigator's care, informed consent and documents it, unless documentation is waived by an IRB under 21 CFR § 56.109(c).

(4) Complies with the requirements of § 10918 with respect to monitoring investigations;

(5) Maintains the records required under § 10927.2(d) and (e) makes the reports required under § 10929.2 (a)-(c) and (e)-(j);

(6) Ensures that participating investigators maintain the records required by § 10927.1(c)(1) and make the reports required under § 10929.1(a), (b), (e), and (g); and

(7) Complies with the prohibitions in § 10903 against promotion and other practices; and

(b) An investigation of a device other than one subject to § 10901.5, if the investigation was begun on or before July 16, 1980, and to be completed, and is completed, on or before January 19, 1981.

10901.3 This chapter, with the exception of § 10926, does not apply to investigations of the following categories of devices:

(a) A device, other than a transitional device, in commercial distribution immediately before May 28, 1976, when used or investigated in accordance with the indications in labeling in effect at that time;

(b) A device, other than a transitional device, introduced into commercial distribution on or after May 28, 1976, that the Department has determined to be substantially equivalent to a device in commercial distribution immediately before May 28, 1976, and that is used or investigated in accordance with the indications in the labeling the Department reviewed under §§ 10512 through 10521 in determining substantial equivalence;

(1) Is noninvasive,

(2) Does not require an invasive sampling procedure that presents significant risk,

(3) Does not, by design or intention, introduce energy into a subject, and

(4) Is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure;

(d) A device undergoing consumer preference testing, testing of a modification, or testing of a combination of two (2) or more devices in commercial distribution, if the testing is not for the purpose of determining safety or effectiveness and does not put subjects at risk;

(e) A device intended solely for veterinary use;

(f) A device shipped solely for research on or with laboratory animals and labeled in accordance with § 10902.3;

(g) A custom device as defined in § 10999, unless the device is being used to determine safety or effectiveness for commercial distribution; and

(h) A shipment or other delivery of an in vitro diagnostic product shall:

(1) For a product in the laboratory research phase of development, and not represented as an effective in vitro diagnostic product, all labeling bears the statement, prominently placed: “For Research Use Only. Not for use in diagnostic procedures.”; and

(2) For a product being shipped or delivered for product testing prior to full commercial marketing (for example, for use on specimens derived from humans to compare the usefulness of the product with other products or procedures which are in current use or recognized as useful), all labeling bears the statement, prominently placed: “For Investigational Use Only. The performance characteristics of this product have not been established.”.

10901.4 In the case of a class II or class III device described in § 10901.3(a) or (b), this section applies beginning on the date stipulated in a Department regulation or order that calls for the submission of premarket approval applications for an unapproved class III device, or establishes a performance standard for a class II device.

10901.5 A sponsor that, on July 16, 1980, has an effective investigational new drug application (IND) for an investigation of a device shall continue to comply with the requirements of 21 C.F.R., part 312 until ninety (90) days after that date. To continue the investigation after that date, a sponsor shall comply with § 10901.2(a), if the device is not a significant risk device, or shall have obtained Department approval under § 10910 of an IDE application for the investigation of the device.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10901

22-B DCMR § 10902 LABELING OF INVESTIGATIONAL DEVICES

10902.1 An investigational device or its immediate package shall bear a label with the following information: the name and place of business of the manufacturer, packer, or distributor (in accordance with § 10300), the quantity of contents, if appropriate, and the following statement:

“CAUTION--Investigational device. Limited by District of Columbia law to investigational use.”

The label or other labeling shall describe all relevant contraindications, hazards, adverse effects, interfering substances or devices, warnings, and precautions.

10902.2 The labeling of an investigational device shall not bear any statement that is false or misleading and shall not represent that the device is safe or effective for the purposes for which it is being investigated.

10902.3 An investigational device shipped solely for research on or with laboratory animals shall bear on its label the following statement:

“CAUTION--Device for investigational use in laboratory animals or other tests that do not involve human subjects.”.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10902

22-B DCMR § 10903 PROHIBITION OF PROMOTION AND OTHER PRACTICES

10903.1 A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not:

(a) Promote or test market an investigational device, until after the Department has approved the device for commercial distribution;

(b) Commercialize an investigational device by charging the subjects or investigators for a device a price larger than that necessary to recover costs of manufacture, research, development, and handling; or

10903.2 If data developed by the investigation indicate in the case of a class III device that premarket approval cannot be justified or in the case of a class II device that it will not comply with an applicable performance standard or an amendment to that standard, the sponsor shall promptly terminate the investigation.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10903

22-B DCMR § 10904 WAIVERS

10904.1 A sponsor may request the Department to waive any requirement of this section. A waiver request, with supporting documentation, may be submitted separately or as part of an application to the address in § 10906.

10904.2 The Department may, by letter, grant a waiver of any requirement that the Department finds is not required by the Act and is unnecessary to protect the rights, safety, or welfare of human subjects.

10904.3 Any requirement shall continue to apply unless and until the Department waives it.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10904

22-B DCMR § 10905 IMPORT AND EXPORT REQUIREMENTS

10905.1 In addition to complying with other requirements of this part, a person who imports or offers for importation an investigational device subject to this part shall be the agent of the foreign exporter with respect to investigations of the device and shall act as the sponsor of the clinical investigation, or ensure that another person act as the agent of the foreign exporter and the sponsor of the investigation.

10905.2 A person exporting an investigational device subject to this section shall obtain Department prior approval, as required by Chapter 103 of this title or comply with the Act.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10905

22-B DCMR § 10906 ADDRESS FOR INVESTIGATIONAL DEVICE EXEMPTION CORRESPONDENCE

10906.1 If you are sending an application, supplemental application, report, request for waiver, request for import or export approval, or other correspondence relating to matters covered by this part, you must address it to the Department of Health, 899 North Capitol St., N.E., 2nd Floor, Washington, DC 20002. You must state on the outside wrapper of each submission what the submission is, for example, an “IDE application,” a “supplemental IDE application,” or a “correspondence concerning an IDE (or an IDE application).”

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10906

22-B DCMR § 10907 APPLICATION

10907.1 A sponsor:

(a) Shall submit an application to the Department if the sponsor intends to use a significant risk device in an investigation, intends to conduct an investigation that involves an exception from informed consent under § 10602.6, or if DOH notifies the sponsor that an application is required for an investigation;

(b) Shall not begin an investigation for which the Department’s approval of an application is required until the Department has approved the application;

(c) Shall submit three (3) copies of a signed “Application for an Investigational Device Exemption'' (IDE application), together with accompanying materials, by registered mail or by hand to the address in § 10906. Subsequent correspondence concerning an application or a supplemental application shall be submitted by registered mail or by hand; or

(d) Shall submit a separate IDE for any clinical investigation involving an exception from informed consent under § 10602.6. Such a clinical investigation is not permitted to proceed without the prior written authorization of the Department. The Department shall provide a written determination thirty (30) days after the Department receives the IDE or earlier.

10907.2 If the investigation involves an exception to informed consent, the sponsor shall prominently identify on the cover sheet that the investigation is subject to the requirements of informed consent under § 10602.6.

10907.3 An IDE application shall include, in the following order:

(a) The name and address of the sponsor;

(b) A complete report of prior investigations of the device and an accurate summary of those sections of the investigational plan described in § 10908.1(a) through (e) or, in lieu of the summary, the complete plan. The sponsor shall submit to the Department a complete investigational plan and a complete report of prior investigations of the device if no IRB has reviewed them, if the Department has found an IRB's review inadequate, or if the Department requests them;

(c) A description of the methods, facilities, and controls used for the manufacture, processing, packing, storage, and, where appropriate, installation of the device, in sufficient detail so that a person generally familiar with good manufacturing practices can make a knowledgeable judgment about the quality control used in the manufacture of the device;

(d) An example of the agreements to be entered into by all investigators to comply with investigator obligations under this part, and a list of the names and addresses of all investigators who have signed the agreement;

(e) A certification that all investigators who will participate in the investigation have signed the agreement, that the list of investigators includes all the investigators participating in the investigation, and that no investigators will be added to the investigation until they have signed the agreement;

(f) A list of the name, address, and chairperson of each IRB that has been or will be asked to review the investigation and a certification of the action concerning the investigation taken by each such IRB;

(g) The name and address of any institution at which a part of the investigation may be conducted that has not been identified in accordance with § 10907.3(f);

(h) If the device is to be sold, the amount to be charged and an explanation of why sale does not constitute commercialization of the device;

(i) A claim for categorical exclusion or an environmental assessment under 21 C.F.R. § 25.30 or 21 C.F.R. § 25.34, or an environmental assessment under 21 C.F.R. § 25.40;

(j) Copies of all labeling for the device;

(k) Copies of all forms and informational materials to be provided to subjects to obtain informed consent; and

(l) Any other relevant information the Department requests for review of the application.

10907.4 The Department may request additional information concerning an investigation or revision in the investigational plan. The sponsor may treat such a request as a disapproval of the application for purposes of requesting a hearing.

10907.5 Information previously submitted to the Department in accordance with this chapter ordinarily need not be resubmitted, but may be incorporated by reference.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10907

22-B DCMR § 10908 INVESTIGATIONAL PLAN

10908.1 The investigational plan shall include, in the following order:

(a) The name and intended use of the device and the objectives and duration of the investigation;

(b) A written protocol describing the methodology to be used and an analysis of the protocol demonstrating that the investigation is scientifically sound;

(c) A description and analysis of all increased risks to which subjects will be exposed by the investigation; the manner in which these risks will be minimized; a justification for the investigation; and a description of the patient population, including the number, age, sex, and condition;

(d) A description of each important component, ingredient, property, and principle of operation of the device and of each anticipated change in the device during the course of the investigation;

(e) The sponsor's written procedures for monitoring the investigation and the name and address of any monitor;

(f) Copies of all labeling for the device;

(g) Copies of all forms and informational materials to be provided to subjects to obtain informed consent;

(h) A list of the names, locations, and chairpersons of all IRBs that have been or will be asked to review the investigation, and a certification of any action taken by any of those IRBs with respect to the investigation;

The name and address of each institution at which a part of the investigation may be conducted that has not been identified in § 10908.1(h); and

(j) A description of records and reports that will be maintained on the investigation in addition to those prescribed in §§ 10927, 10928, and 10929.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10908

22-B DCMR § 10909 REPORT OF PRIOR INVESTIGATIONS

10909.1 The report of prior investigations shall include reports of all prior clinical, animal, and laboratory testing of the device and shall be comprehensive and adequate to justify the proposed investigation.

10909.2 The report also shall include:

(a) A bibliography of all publications, whether adverse or supportive, that are relevant to an evaluation of the safety or effectiveness of the device, copies of all published and unpublished adverse information, and, if requested by an IRB or the Department, copies of other significant publications;

(b) A summary of all other unpublished information (whether adverse or supportive) in the possession of, or reasonably obtainable by, the sponsor that is relevant to an evaluation of the safety or effectiveness of the device; and

(c) If information on nonclinical laboratory studies is provided, a statement that all such studies have been conducted in compliance with applicable requirements in the good laboratory practice regulations in 21 C.F.R., part 58, or if any such study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance. Failure or inability to comply with this requirement does not justify failure to provide information on a relevant nonclinical test study.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10909

22-B DCMR § 10910 DEPARTMENT OF HEALTH ACTION ON APPLICATIONS

10910.1 The Department will notify the sponsor in writing of the date it receives an application. DOH may approve an investigation as proposed, approve it with modifications, or disapprove it. An investigation may not begin until:

(a) Thirty (30) days after the Department receives the application at the address in § 10906 for the investigation of a device other than a banned device, unless DOH notifies the sponsor that the investigation may not begin; or

(b) The Department approves, by order, an IDE for the investigation.

10910.2 The Department may disapprove or withdraw approval of an application if it finds that:

(a) There has been a failure to comply with any requirement of this part or the act, any other applicable regulation or statute, or any condition of approval imposed by an IRB or the Department;

(b) The application or a report contains an untrue statement of a material fact, or omits material information required by this section;

(c) The sponsor fails to respond to a request for additional information within the time prescribed by the Department; and

(d) There is reason to believe that the risks to the subjects are not outweighed by the anticipated benefits to the subjects and the importance of the knowledge to be gained, or informed consent is inadequate, or the investigation is scientifically unsound, or there is reason to believe that the device as used is ineffective;

(e) It is otherwise unreasonable to begin or to continue the investigation owing to the way in which the device is used or the inadequacy of:

(1) The report or prior investigations or the investigational plan;

(2) The methods, facilities, and controls used for the manufacturing, processing, packaging, storage, and, where appropriate, installation of the device; or

(3) Monitoring and reviewing the investigation.

10910.3 If the Department disapproves an application or proposes to withdraw approval of an application, the Department will notify the sponsor in writing.

(a) A disapproval order will contain a complete statement of the reasons for disapproval and a statement that the sponsor has an opportunity to request a hearing under 21 C.F.R., part 16.

(b) A notice of a proposed withdrawal of approval will contain a complete statement of the reasons for withdrawal and a statement that the sponsor has an opportunity to request a hearing. The Department will provide the opportunity for hearing before withdrawal of approval, unless the Department determines in the notice that continuation of testing under the exemption will result in an unreasonable risk to the public health and orders withdrawal of approval before any hearing.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10910

22-B DCMR § 10911 SUPPLEMENTAL APPLICATIONS

10911.1 The following are required for changes the in investigational plan:

(a) Except as described in Paragraphs (b) through (d), a sponsor must obtain approval of a supplemental application under § 10910.1, and IRB approval when appropriate (see 21 C.F.R. §§ 56.110 and 56.111), prior to implementing a change to an investigational plan. If a sponsor intends to conduct an investigation that involves an exception to informed consent of this chapter, the sponsor shall submit a separate IDE application in accordance with § 10907.1.

(b) The requirements of Subsection (a) regarding the Department approval of a supplement do not apply in the case of a deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency. Such deviation shall be reported to the Department within five (5) working days after the sponsor learns of it (see § 10929.1(d)).

(c) A sponsor may make certain changes without prior approval of a supplemental application under Paragraph (a) if the sponsor determines that these changes meet the criteria described in § 10911.2 and 10911.3, on the basis of credible information defined in § 10911.4, and the sponsor provides notice to the Department within five (5) working days of making these changes; and

10911.2 The requirements in § 10911.1(a) regarding the Department approval of a supplement do not apply to developmental changes in the device (including manufacturing changes) that do not constitute a significant change in design or basic principles of operation and that are made in response to information gathered during the course of an investigation.

10911.3 The requirements in § 10911.1(a) regarding the Department approval of a supplement do not apply to changes to clinical protocols that do not affect:

(a) The validity of the data or information resulting from the completion of the approved protocol, or the relationship of likely patient risk to benefit relied upon to approve the protocol;

(b) The scientific soundness of the investigational plan; or

10911.4 The definition of credible information shall be as follows:

(a) Credible information to support developmental changes in the device (including manufacturing changes) includes data generated under the design control procedures of § 10705, preclinical or animal testing, peer reviewed published literature, or other reliable information such as clinical information gathered during a trial or marketing; or

(b) Credible information to support changes to clinical protocols is defined as the sponsor’s documentation supporting the conclusion that a change does not have a significant impact on the study design or planned statistical analysis, and that the change does not affect the rights, safety, or welfare of the subjects. Documentation shall include information such as peer reviewed published literature, the recommendation of the clinical investigator(s), or the data gathered during the clinical trial or marketing.

10911.5 Changes meeting the criteria in § 10911.2 and 10911.3 that are supported by credible information as defined in Paragraph § 10911.4 may be made without prior Department approval if the sponsor submits a notice of the change to the IDE not later than five (5) working days after making the change. Changes to devices are deemed to occur on the date the device, manufactured incorporating the design or manufacturing change, is distributed to the investigator(s). Changes to a clinical protocol are deemed to occur when a clinical investigator is notified by the sponsor that the change should be implemented in the protocol or, for sponsor-investigator studies, when a sponsor-investigator incorporates the change in the protocol. Such notices shall be identified as a “notice of IDE change.”

10911.6 For a developmental or manufacturing change to the device, the notice shall include a summary of the relevant information gathered during the course of the investigation upon which the change was based; a description of the change to the device or manufacturing process (cross-referenced to the appropriate sections of the original device description or manufacturing process); and, if design controls were used to assess the change, a statement that no new risks were identified by appropriate risk analysis and that the verification and validation testing, as appropriate, demonstrated that the design outputs met the design input requirements. If another method of assessment was used, the notice shall include a summary of the information which served as the credible information supporting the change.

10911.7 For a protocol change, the notice shall include a description of the change (cross-referenced to the appropriate sections of the original protocol); an assessment supporting the conclusion that the change does not have a significant impact on the study design or planned statistical analysis; and a summary of the information that served as the credible information supporting the sponsor's determination that the change does not affect the rights, safety, or welfare of the subjects.

10911.8 The requirements of § 10911.1(a) do not apply to minor changes to the purpose of the study, risk analysis, monitoring procedures, labeling, informed consent materials, and IRB information that do not affect:

(1) The validity of the data or information resulting from the completion of the approved protocol, or the relationship of likely patient risk to benefit relied upon to approve the protocol;

(2) The scientific soundness of the investigational plan; or

(3) The rights, safety, or welfare of the human subjects involved in the investigation. Such changes shall be reported in the annual progress report for the IDE, under § 10929.2(e).

10911.9 A sponsor shall submit to the Department a certification of any IRB approval of an investigation or a part of an investigation not included in the IDE application. If the investigation is otherwise unchanged, the supplemental application shall consist of an updating of the information required by § 10907.2 and §10907.3 and a description of any modifications in the investigational plan required by the IRB as a condition of approval. A certification of IRB approval need not be included in the initial submission of the supplemental application, and such certification is not a re-condition for agency consideration of the application. Nevertheless, a sponsor may not begin a part of an investigation at a facility until the IRB has approved the investigation, the Department has received the certification of IRB approval, and the Department, under § 10910.1, has approved the supplemental application relating to that part of the investigation (see 21 C.F.R. § 56.103(a)).

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10911

22-B DCMR § 10912 TREATMENT USE OF AN INVESTIGATIONAL DEVICE

10912.1 A device that is not approved for marketing may be under clinical investigation for a serious or immediately life-threatening disease or condition in patients for whom no comparable or satisfactory alternative device or other therapy is available. During the clinical trial or prior to final action on the marketing application, it may be appropriate to use the device in the treatment of patients not in the trial under the provisions of a treatment IDE.

10912.2 The purpose of this section is to facilitate the availability of promising new devices to desperately ill patients as early in the device development process as possible, before general marketing begins, and to obtain additional data on the device's safety and effectiveness. In the case of a serious disease, a device ordinarily may be made available for treatment use under this section after all clinical trials have been completed. In the case of an immediately life-threatening disease, a device may be made available for treatment use under this section prior to the completion of all clinical trials.

10912.3 For the purpose of this section, an “immediately life-threatening” disease means a stage of a disease in which there is a reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment.

10912.4 For purposes of this section, “treatment use” of a device includes the use of a device for diagnostic purposes.

10912.5 The Department shall consider the use of an investigational device under a treatment IDE if:

(a) The device is intended to treat or diagnose a serious or immediately life-threatening disease or condition;

(b) There is no comparable or satisfactory alternative device or other therapy available to treat or diagnose that stage of the disease or condition in the intended patient population;

(c) The device is under investigation in a controlled clinical trial for the same use under an approved IDE, or such clinical trials have been completed; and

(d) The sponsor of the investigation is actively pursuing marketing approval or clearance of the investigational device with due diligence.

10912.6 Applicants for the treatment use of an IDE shall abide by the following:

(a) A treatment IDE application shall include, in the following order:

(1) The name, address, and telephone number of the sponsor of the treatment IDE;

(2) The intended use of the device, the criteria for patient selection, and a written protocol describing the treatment use;

(3) An explanation of the rationale for use of the device, including, as appropriate, either a list of the available regimens that ordinarily should be tried before using the investigational device, or an explanation of why the use of the investigational device is preferable to the use of available marketed treatments;

(4) A description of clinical procedures, laboratory tests, or other measures that will be used to evaluate the effects of the device and to minimize risk;

(5) Written procedures for monitoring the treatment use and the name and address of the monitor;

(6) Instructions for use for the device and all other labeling as required under § 10902;

(7) Information that is relevant to the safety and effectiveness of the device for the intended treatment use. Information from other IDE's may be incorporated by reference to support the treatment use;

(8) A statement of the sponsor’s commitment to meet all applicable responsibilities under this section and 21 C.F.R., part 56 and to ensure compliance of all participating investigators with the informed consent requirements of 21 C.F.R., part 50;

(9) An example of the agreement to be signed by all investigators participating in the treatment IDE and certification that no investigator will be added to the treatment IDE before the agreement is signed; and

(10) If the device is to be sold, the price to be charged and a statement indicating that the price is based on manufacturing and handling costs only; and

(b) A licensed practitioner who receives an investigational device for treatment use under a treatment IDE is an “investigator” under the IDE and is responsible for meeting all applicable investigator responsibilities under this part and 21 C.F.R., parts 50 and 56.

10912.7 The Department may act on treatment IDE applications in the following manner:

(a) Treatment use may begin thirty (30) days after the Department receives the treatment IDE submission at the address specified in § 10906, unless the Department notifies the sponsor in writing earlier than the thirty (30) days that the treatment use may or may not begin. The Department may approve the treatment use as proposed or approve it with modifications;

(b) DOH may disapprove or withdraw approval of a treatment IDE if:

(1) The criteria specified in § 10912.5 are not met or the treatment IDE does not contain the information required in § 10912.6;

(2) The Department determines that any of the grounds for disapproval or withdrawal of approval listed in § 10910.2(a) through (e) apply;

(3) The device is intended for a serious disease or condition and there is insufficient evidence of safety and effectiveness to support such use;

(4) The device is intended for an immediately life-threatening disease or condition and the available scientific evidence, taken as a whole, fails to provide a reasonable basis for concluding that the device:

(A) May be effective for its intended use in its intended population; or

(B) Would not expose the patients to whom the device is to be administered to an unreasonable and significant additional risk of illness or injury;

(5) There is reasonable evidence that the treatment use is impeding enrollment in, or otherwise interfering with the conduct or completion of, a controlled investigation of the same or another investigational device;

(6) The device has received marketing approval or clearance or a comparable device or therapy becomes available to treat or diagnose the same indication in the same patient population for which the investigational device is being used;

(7) The sponsor of the controlled clinical trial is not pursuing marketing approval or clearance with due diligence;

(8) Approval of the IDE for the controlled clinical investigation of the device has been withdrawn; or

(9) The clinical investigator(s) named in the treatment IDE are not qualified by reason of their scientific training or experience to use the investigational device for the intended treatment use; and

(c) If DOH disapproves or proposes to withdraw approval of a treatment IDE, DOH will follow the procedures set forth in § 10910.3.

10912.8 Treatment use of an investigational device is conditioned upon the sponsor and investigators complying with the safeguards of the IDE process and the regulations governing informed consent and institutional review boards.

10912.9 The sponsor of a treatment IDE shall submit progress reports on a semi-annual basis to all reviewing IRB's and the Department until the filing of a marketing application. These reports shall be based on the period of time since initial approval of the treatment IDE and shall include the number of patients treated with the device under the treatment IDE, the names of the investigators participating in the treatment IDE, and a brief description of the sponsor's efforts to pursue marketing approval or clearance of the device. Upon the filing of a marketing application, progress reports shall be submitted annually in accordance with § 10929.2(e).The sponsor of a treatment IDE is responsible for submitting all other reports required under § 10929.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10912

22-B DCMR § 10913 CONFIDENTIALITY OF DATA AND INFORMATION

10913.1 The Department will not disclose the existence of an IDE unless its existence has previously been publicly disclosed or acknowledged, until DOH approves an application for premarket approval of the device subject to the IDE; or a notice of completion of a product development protocol for the device has become effective.

10913.2 The Department shall make available summaries or data under the following conditions:

(a) DOH will make publicly available, upon request, a detailed summary of information concerning the safety and effectiveness of the device that was the basis for an order approving, disapproving, or withdrawing approval of an application for an IDE for a banned device. The summary shall include information on any adverse effect on health caused by the device.

(b) If a device is a banned device or if the existence of an IDE has been publicly disclosed or acknowledged, data or information contained in the file is not available for public disclosure before approval of an application for premarket approval or the effective date of a notice of completion of a product development protocol except as provided in this section. The Department may, in its discretion, disclose a summary of selected portions of the safety and effectiveness data, that is, clinical, animal, or laboratory studies and tests of the device, for public consideration of a specific pending issue.

(c) If the existence of an IDE file has not been publicly disclosed or acknowledged, no data or information in the file are available for public disclosure except as provided in this subsection.

(d) Notwithstanding Subsection (b), the Department will make available to the public, upon request, the information in the IDE that was required to be filed in Docket Number 95S-0158 in the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., Rm. 1-23, Rockville, MD 20857, for investigations involving an exception from informed consent. Persons wishing to request this information shall submit a request under the Freedom of Information Act.

10913.3 Upon request or on its own initiative, the Department shall disclose to an individual on whom an investigational device has been used a copy of a report of adverse device effects relating to that use.

10913.4 Except as otherwise provided in this section, the availability for public disclosure of data and information in an IDE file shall be handled in accordance with § 10602.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10913

22-B DCMR § 10914 GENERAL RESPONSIBILITIES OF SPONSORS

10914.1 Sponsors are responsible for selecting qualified investigators and providing them with the information they need to conduct the investigation properly, ensuring proper monitoring of the investigation, ensuring that IRB review and approval are obtained, submitting an IDE application to the Department, and ensuring that any reviewing IRB and the Department are promptly informed of significant new information about an investigation. Additional responsibilities of sponsors are described in §§ 10907 through 10913 and §§ 10927 through 10929.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10914

22-B DCMR § 10915 DEPARTMENT OF HEALTH AND INSTITUTIONAL REVIEW BOARD APPROVAL

10915.1 A sponsor shall not begin an investigation or part of an investigation until an IRB and the Department have both approved the application or supplemental application relating to the investigation or part of an investigation.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10915

22-B DCMR § 10916 SELECTING INVESTIGATORS AND MONITORS

10916.1 A sponsor shall select investigators qualified by training and experience to investigate the device.

10916.2 A sponsor shall ship investigational devices only to qualified investigators participating in the investigation.

10916.3 A sponsor shall obtain from each participating investigator a signed agreement that includes:

(a) The investigator’s curriculum vitae;

(b) Where applicable, a statement of the investigator's relevant experience, including the dates, location, extent, and type of experience;

(c) If the investigator was involved in an investigation or other research that was terminated, an explanation of the circumstances that led to termination;

(d) A statement of the investigator's commitment to:

(1) Conduct the investigation in accordance with the agreement, the investigational plan, this section and other applicable Department regulations, and conditions of approval imposed by the reviewing IRB or the Department;

(2) Supervise all testing of the device involving human subjects; and

(3) Ensure that the requirements for obtaining informed consent are met; and

(e) Sufficient accurate financial disclosure information to allow the sponsor to submit a complete and accurate certification or disclosure statement as required under 21 C.F.R., part 54. The sponsor shall obtain a commitment from the clinical investigator to promptly update this information if any relevant changes occur during the course of the investigation and for one (1) year following completion of the study. This information shall not be submitted in an IDE application, but shall be submitted in any marketing application involving the device.

10916.4 A sponsor shall select monitors qualified by training and experience to monitor the investigational study in accordance with this part and other applicable Department regulations.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10916

22-B DCMR § 10917 INFORMING INVESTIGATORS

10917.1 A sponsor shall supply all investigators participating in the investigation with copies of the investigational plan and the report of prior investigations of the device.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10917

22-B DCMR § 10918 MONITORING INVESTIGATIONS

10918.1 A sponsor who discovers that an investigator is not complying with the signed agreement, the investigational plan, the requirements of this part or other applicable Department regulations, or any conditions of approval imposed by the reviewing IRB or the Department shall promptly either secure compliance, or discontinue shipments of the device to the investigator and terminate the investigator's participation in the investigation. A sponsor shall also require such an investigator to dispose of or return the device, unless this action would jeopardize the rights, safety, or welfare of a subject.

10918.2 In the event of unanticipated adverse device effects:

(a) A sponsor shall immediately conduct an evaluation of any unanticipated adverse device effect; and

(b) A sponsor who determines that an unanticipated adverse device effect presents an unreasonable risk to subjects shall terminate all investigations or parts of investigations presenting that risk as soon as possible. Termination shall occur not later than five (5) working days after the sponsor makes this determination and not later than fifteen (15) working days after the sponsor first received notice of the effect.

10918.3 If the device is a significant risk device, a sponsor may not resume a terminated investigation without IRB and Department approval. If the device is not a significant risk device, a sponsor may not resume a terminated investigation without IRB approval and, if the investigation was terminated under § 10918.2(b), Department approval.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10918

22-B DCMR § 10919 EMERGENCY RESEARCH

10919.1 A sponsor shall monitor the progress of all investigations involving an exception from informed consent under 21 C.F.R., part 50. When the sponsor receives from the IRB information concerning the public disclosures under 21 C.F.R. § 50.24(a)(7)(ii) and (a)(7)(iii), the sponsor shall promptly submit to the IDE file and to Department, copies of the information that was disclosed, identified by the IDE number.

10919.2 The sponsor also shall monitor such investigations to determine when an IRB determines that it cannot approve the research because it does not meet the criteria in the exception in 21 C.F.R. § 50.24(a) or because of other relevant ethical concerns. The sponsor promptly shall provide this information in writing to the Department, investigators who are asked to participate in this or a substantially equivalent clinical investigation, and other IRB's that are asked to review this or a substantially equivalent investigation.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10919

22-B DCMR § 10920 INSTITUTIONAL REVIEW BOARD COMPOSITION, DUTIES, AND FUNCTIONS

10920.1 An IRB reviewing and approving investigations under 21 C.F.R., part 56 shall comply with the requirements in these regulations in all respects, including its composition, duties, and functions.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10920

22-B DCMR § 10921 INSTITUTIONAL REVIEW BOARD APPROVAL

10921.1 An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all investigations covered by this part.

10921.2 If no IRB exists or if the Department finds that an IRB's review is inadequate, a sponsor may submit an application to the Department.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10921

22-B DCMR § 10922 INSTITUTIONAL REVIEW BOARD’S CONTINUING REVIEW

10922.1 The IRB shall conduct its continuing review of an investigation in accordance with 21 C.F.R., part 56.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10922

22-B DCMR § 10923 SIGNIFICANT RISK DEVICE DETERMINATIONS

10923.1 If an IRB determines that an investigation, presented for approval under § 10901.2(a)(2), involves a significant risk device, it shall so notify the investigator and, where appropriate, the sponsor. A sponsor may not begin the investigation except as provided in § 10910.1.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10923

22-B DCMR § 10924 GENERAL RESPONSIBILITIES OF INVESTIGATORS

10924.1 An investigator is responsible for ensuring that an investigation is conducted according to the signed agreement, the investigational plan and applicable Department regulations, for protecting the rights, safety, and welfare of subjects under the investigator's care, and for the control of devices under investigation. An investigator also is responsible for ensuring that informed consent is obtained in accordance with 21 C.F.R., part 50. Additional responsibilities of investigators are described in §§ 10927 through 10929.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10924

22-B DCMR § 10925 SPECIFIC RESPONSIBILITIES OF INVESTIGATORS

10925.1 An investigator may determine whether potential subjects would be interested in participating in an investigation, but shall not request the written informed consent of any subject to participate, and shall not allow any subject to participate before obtaining IRB and Department approval.

10925.2 An investigator shall conduct an investigation in accordance with the signed agreement with the sponsor, the investigational plan, this part and other applicable Department regulations, and any conditions of approval imposed by an IRB or the Department.

10925.3 An investigator shall permit an investigational device to be used only with subjects under the investigator's supervision. An investigator shall not supply an investigational device to any person not authorized under this section to receive it.

10925.4 A clinical investigator shall disclose to the sponsor sufficient accurate financial information to allow the applicant to submit complete and accurate certification or disclosure statements required in 21 C.F.R., part 54. The investigator shall promptly update this information if any relevant changes occur during the course of the investigation and for one (1) year following completion of the study.

10925.5 Upon completion or termination of a clinical investigation or the investigator's part of an investigation, or at the sponsor's request, an investigator shall return to the sponsor any remaining supply of the device or otherwise dispose of the device as the sponsor directs.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10925

22-B DCMR § 10926 DISQUALIFICATION OF A CLINICAL INVESTIGATOR

10926.1 If the Department has information indicating that an investigator has repeatedly or deliberately failed to comply with the requirements of Chapter 109 or 21 C.F.R., parts 50 or 56, or has repeatedly or deliberately submitted false information either to the sponsor of the investigation or in any required report, the Department will furnish the investigator written notice of the matter under complaint and offer the investigator an opportunity to explain the matter in writing, or, at the option of the investigator, in an informal conference. If an explanation is offered and accepted by the Department, the disqualification process will be terminated. If an explanation is offered but not accepted by the Department, the investigator will be given an opportunity for a regulatory hearing before the Department on the question of whether the investigator is entitled to receive investigational devices.

10926.2 After evaluating all available information, including any explanation presented by the investigator, if the Department determines that the investigator has repeatedly or deliberately failed to comply with the requirements of Chapter 109 or 21 C.F.R., parts 50 or 56, or has deliberately or repeatedly submitted false information either to the sponsor of the investigation or in any required report, the Department will notify the investigator, the sponsor of any investigation in which the investigator has been named as a participant, and the reviewing IRB that the investigator is not entitled to receive investigational devices. The notification will provide a statement of basis for such determination.

10926.3 Each IDE and each cleared or approved application submitted under §§ 10512 through 10521 or Chapters 106 or 109 of this subtitle containing data reported by an investigator who has been determined to be ineligible to receive investigational devices will be examined to determine whether the investigator has submitted unreliable data that are essential to the continuation of the investigation or essential to the approval or clearance of any marketing application.

10926.4 If the Department determines, after the unreliable data submitted by the investigator are eliminated from consideration, that the data remaining are inadequate to support a conclusion that it is reasonably safe to continue the investigation, the Department will notify the sponsor who shall have an opportunity for a regulatory hearing. If a danger to the public health exists, however, the Department shall terminate the IDE immediately and notify the sponsor and the reviewing IRB of the determination. In such case, the sponsor shall have an opportunity for a regulatory hearing before the Department on the question of whether the IDE should be reinstated.

10926.5 If the Department determines, after the unreliable data submitted by the investigator are eliminated from consideration, that the continued clearance or approval of the marketing application for which the data were submitted cannot be justified, the Department will proceed to withdraw approval or rescind clearance of the medical device in accordance with the applicable provisions of the Act.

10926.6 An investigator who has been determined to be ineligible to receive investigational devices may be reinstated as eligible when the Department determines that the investigator has presented adequate assurances that the investigator will employ investigational devices solely in compliance with the provisions of Chapter 109 or 21 C.F.R., parts 50 or 56.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10926

22-B DCMR § 10927 RECORDS

10927.1 A participating investigator shall maintain the following accurate, complete, and current records relating to the investigator's participation in an investigation:

(a) All correspondence with another investigator, an IRB, the sponsor, a monitor, or the Department, including required reports;

(b) Records of receipt, use or disposition of a device that relate to:

(1) The type and quantity of the device, the dates of its receipt, and the batch number or code mark;

(2) The names of all persons who received, used, or disposed of each device; and

(3) Why and how many units of the device have been returned to the sponsor, repaired, or otherwise disposed of;

(c) Records of each subject's case history and exposure to the device. Case histories include the case report forms and supporting data including, for example, signed and dated consent forms and medical records including, for example, progress notes of the physician, the individual's hospital chart(s), and the nurses' notes. Such records shall include:

(1) Documents evidencing informed consent and, for any use of a device by the investigator without informed consent, any written concurrence of a licensed physician and a brief description of the circumstances justifying the failure to obtain informed consent. The case history for each individual shall document that informed consent was obtained prior to participation in the study;

(2) All relevant observations, including records concerning adverse device effects (whether anticipated or unanticipated), information and data on the condition of each subject upon entering, and during the course of, the investigation, including information about relevant previous medical history and the results of all diagnostic tests; and

(3) A record of the exposure of each subject to the investigational device, including the date and time of each use, and any other therapy;

(d) The protocol, with documents showing the dates of and reasons for each deviation from the protocol; and

(e) Any other records that the Department requires to be maintained by regulation or by specific requirement for a category of investigations or a particular investigation.

10927.2 A sponsor shall maintain the following accurate, complete, and current records relating to an investigation:

(a) All correspondence with another sponsor, a monitor, an investigator, an IRB, or the Department, including required reports;

(b) Records of shipment shall include the name and address of the consignee, type and quantity of device, date of shipment, and batch number or code mark. Records of disposition shall describe the batch number or code marks of any devices returned to the sponsor, repaired, or disposed of in other ways by the investigator or another person, and the reasons for and method of disposal;

(c) Signed investigator agreements including the financial disclosure information required to be collected under § 10916.3(e) in accordance with 21 C.F.R., part 54;

(d) For each investigation subject to § 10901.2(a) of a device other than a significant risk device, the records described in §10927.2(e) and the following records, consolidated in one location and available for the Department inspection and copying:

(1) The name and intended use of the device and the objectives of the investigation;

(2) A brief explanation of why the device is not a significant risk device;

(3) The name and address of each investigator;

(4) The name and address of each IRB that has reviewed the investigation;

(5) A statement of the extent to which the good manufacturing practice regulation in Chapter 107 will be followed in manufacturing the device; and

(6) Any other information required by the Department.

(e) Records concerning adverse device effects (whether anticipated or unanticipated) and complaints; and

(f) Any other records that the Department requires to be maintained by regulation or by specific requirement for a category of investigation or a particular investigation.

10927.3 An IRB shall maintain records in accordance with 21 C.F.R., part 56.

10927.4 An investigator or sponsor shall maintain the records required by this subpart during the investigation and for a period of two (2) years after the latter of the following two (2) dates:

The date on which the investigation is terminated or completed; or

The date that the records are no longer required for purposes of supporting a PMA or a notice of completion of a product development protocol.

10927.5 An investigator or sponsor may withdraw from the responsibility to maintain records for the period required in §10927.4 and transfer custody of the records to any other person who will accept responsibility for them under this section, including the requirements of § 10928. Notice of a transfer shall be given to the Department not later than ten (10) working days after transfer occurs.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10927

22-B DCMR § 10928 INSPECTIONS

10928.1 A sponsor or an investigator who has authority to grant access shall permit authorized Department employees, at reasonable times and in a reasonable manner, to enter and inspect any establishment where devices are held (including any establishment where devices are manufactured, processed, packed, installed, used, or implanted or where records of results from use of devices are kept).

10928.2 A sponsor, IRB, or investigator, or any other person acting on behalf of such a person with respect to an investigation, shall permit authorized Department employees, at reasonable times and in a reasonable manner, to inspect and copy all records relating to an investigation.

10928.3 An investigator shall permit authorized Department employees to inspect and copy records that identify subjects, upon notice that the Department has reason to suspect that adequate informed consent was not obtained, or that reports required to be submitted by the investigator to the sponsor or IRB have not been submitted or are incomplete, inaccurate, false, or misleading.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10928

22-B DCMR § 10929 REPORTS

10929.1 An investigator shall prepare and submit the following complete, accurate, and timely reports:

(a) An investigator shall submit to the sponsor and to the reviewing IRB a report of any unanticipated adverse device effect occurring during an investigation as soon as possible, but in no event later than ten (10) working days after the investigator first learns of the effect;

(b) An investigator shall report to the sponsor, within five (5) working days, a withdrawal of approval by the reviewing IRB of the investigator's part of an investigation;

(c) An investigator shall submit progress reports on the investigation to the sponsor, the monitor, and the reviewing IRB at regular intervals, but in no event less often than yearly;

(d) An investigator shall notify the sponsor and the reviewing IRB (see 21 C.F.R. § 56.108(a)(3) and (4)) of any deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency. Such notice shall be given as soon as possible, but in no event later than five (5) working days after the emergency occurred. Except in such an emergency, prior approval by the sponsor is required for changes in or deviations from a plan, and if these changes or deviations may affect the scientific soundness of the plan or the rights, safety, or welfare of human subjects, the Department and IRB in accordance with § 10911.1 also is required;

(e) If an investigator uses a device without obtaining informed consent, the investigator shall report such use to the sponsor and the reviewing IRB within five (5) working days after the use occurs;

(f) An investigator shall, within three (3) months after termination or completion of the investigation or the investigator's part of the investigation, submit a final report to the sponsor and the reviewing IRB; and

(g) An investigator shall, upon request by a reviewing IRB or the Department, provide accurate, complete, and current information about any aspect of the investigation.

10929.2 A sponsor shall prepare and submit the following complete, accurate, and timely reports:

A sponsor who conducts an evaluation of an unanticipated adverse device effect under § 10918.2 shall report the results of such evaluation to the Department and to all reviewing IRBs and participating investigators within ten (10) working days after the sponsor first receives notice of the effect. Thereafter the sponsor shall submit such additional reports concerning the effect as the Department requests;

(b) A sponsor shall notify the Department and all reviewing IRBs and participating investigators of any withdrawal of approval of an investigation or a part of an investigation by a reviewing IRB within five (5) working days after receipt of the withdrawal of approval;

(c) A sponsor shall notify all reviewing IRBs and participating investigators of any withdrawal of the Department approval of the investigation, and shall do so within five (5) working days after receipt of notice of the withdrawal of approval;

(d) A sponsor shall submit to the Department, at six (6) month intervals, a current list of the names and addresses of all investigators participating in the investigation. The sponsor shall submit the first of such lists six (6) months after the Department approval;

(e) At regular intervals, and at least yearly, a sponsor shall submit progress reports to all reviewing IRB's. In the case of a significant risk device, a sponsor shall also submit progress reports to the Department. A sponsor of a treatment IDE shall submit semi-annual progress reports to all reviewing IRBs and Department in accordance with § 10912.6 and annual reports in accordance with this section;

(f) A sponsor shall notify the Department and all reviewing IRBs of any request that an investigator return, repair, or otherwise dispose of any units of a device. Such notice shall occur within thirty (30) working days after the request is made and shall state why the request was made;

(g) In the case of a significant risk device, the sponsor shall notify the Department within thirty (30) working days of the completion or termination of the investigation and shall submit a final report to the Department and all reviewing the IRBs and participating investigators within six (6) months after completion or termination. In the case of a device that is not a significant risk device, the sponsor shall submit a final report to all reviewing IRBs within six (6) months after termination or completion;

(h) A sponsor shall submit to the Department a copy of any report by an investigator under § 10929.1(e) of use of a device without obtaining informed consent, within five (5) working days of receipt of notice of such use;

(i) If an IRB determines that a device is a significant risk device, and the sponsor had proposed that the IRB consider the device not to be a significant risk device, the sponsor shall submit to the Department a report of the IRB's determination within five (5) working days after the sponsor first learns of the IRB's determination; and

(j) A sponsor shall, upon request by a reviewing IRB or the Department, provide accurate, complete, and current information about any aspect of the investigation.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10929

22-B DCMR § 10999 DEFINITIONS

10999.1 As used in this chapter, the following terms shall have the meanings ascribed:

Act – the Federal Food, Drug, and Cosmetic Act. approved June 25, 1938, 21 U.S.C. § 301, et seq.

Custom device - a device that:

(a) Necessarily deviates from devices generally available or from an applicable performance standard or premarket approval requirement in order to comply with the order of an individual physician or dentist;

(b) Is not generally available to, or generally used by, other physicians or dentists;

(d) Is not offered for commercial distribution through labeling or advertising; and

(e) Is intended for use by an individual patient named in the order of a physician or dentist, and is to be made in a specific form for that patient, or is intended to meet the special needs of the physician or dentist in the course of professional practice.

Department – District of Columbia Department of Health.

DOH – District of Columbia Department of Health.

Implant – A device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of thirty (30) days or more. The Department may, in order to protect public health, determine that devices placed in subjects for shorter periods are also “implants” for purposes of this part.

Institution – a person, other than an individual, who engages in the conduct of research on subjects or in the delivery of medical services to individuals as a primary activity or as an adjunct to providing residential or custodial care to humans. The term includes, for example, a hospital, retirement home, confinement facility, academic establishment, and device manufacturer. The term has the same meaning as “facility” in 21 U.S.C. § 360j(g).

Institutional review board (IRB) – any board, committee, or other group formally designated by an institution to review biomedical research involving subjects and established, operated, and functioning in conformance with 21 C.F.R., part 56. The term has the same meaning as “institutional review committee” in 21 U.S.C. § 360j(g).

Investigational device – a device, including a transitional device, that is the object of an investigation.

Investigation – a clinical investigation or research involving one (1) or more subjects to determine the safety or effectiveness of a device.

Investigator – an individual who actually conducts a clinical investigation (for example, under whose immediate direction the test article is administered or dispensed to, or used involving a subject) or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.

Monitor (n) – an individual designated by a sponsor or contract research organization to oversee the progress of an investigation. The monitor may be an employee of a sponsor or a consultant to the sponsor, or an employee of or consultant to a contract research organization.

Monitor (v) – to oversee an investigation.

Noninvasive – when applied to a diagnostic device or procedure, means one that does not by design or intention:

(a) Penetrate or pierce the skin or mucous membranes of the body, the ocular cavity, or the urethra, or

(b) Enter the ear beyond the external auditory canal, the nose beyond the nares, the mouth beyond the pharynx, the anal canal beyond the rectum, or the vagina beyond the cervical os. For purposes of this part, blood sampling that involves simple venipuncture is considered noninvasive, and the use of surplus samples of body fluids or tissues that are left over from samples taken for non-investigational purposes is also considered noninvasive.

Person – includes any individual, partnership, corporation, association, scientific or academic establishment, Government agency or organizational unit of a Government agency, and any other legal entity.

Significant risk device – an investigational device that:

(a) Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;

(b) Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject;

(c) Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or

(d) Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.

Sponsor – a person who initiates, but who does not actually conduct, the investigation, that is, the investigational device is administered, dispensed, or used under the immediate direction of another individual. A person other than an individual that uses one (1) or more of its own employees to conduct an investigation that it has initiated is a sponsor, not a sponsor-investigator, and the employees are investigators.

Sponsor-investigator – an individual who both initiates and actually conducts, alone or with others, an investigation, that is, under whose immediate direction the investigational device is administered, dispensed, or used. The term does not include any person other than an individual. The obligations of a sponsor-investigator under this section include those of an investigator and those of a sponsor.

Subject – a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A subject may be in normal health or may have a medical condition or disease.

Termination – a discontinuance, by sponsor or by withdrawal of IRB or the Department approval, of an investigation before completion.

Transitional device – a device subject to 21 U.S.C. § 360(j)(l), that is, a device that the Department considered to be a new drug or an antibiotic drug before May 28, 1976.

Unanticipated adverse device effect – any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.

History

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10999

22-B111 NUTRITION STANDARDS FOR DISTRICT AGENCIES

22-B DCMR § 11100 AUTOMATED VENDING OPERATIONS NUTRITION STANDARDS

11100.1 Each Automated Vending Operation operator authorized to install an Automated Vending Operation in a District of Columbia Facility shall provide a sign in close proximity to each installed Automated Vending Operation that discloses nutritional information for all items or potential items for sale that complies with the standards for nutritional labeling set forth at 21 Code of Federal Regulations Part 101. Alternatively, the sign can provide a web link that provides the same information for each item.

11100.2 Each Automated Vending Operation operator authorized to install an Automated Vending Operation in a District of Columbia Facility shall provide DC Health- approved signage in close proximity to each installed Automated Vending Operation that educates and assists consumers in the selection of Healthy Food Items and Healthy Beverage Items.

11100.3 Healthy Food Items and Healthy Beverage Items shall be displayed in a way that they are distinguishable from non-healthy food and beverage items and shall be stocked in a manner that provides line of sight priority for Healthy Food Items and Healthy Beverage Items.

11100.4 At least fifty percent (50%) of all food and beverage items shall meet the following standards:

(a) Have less than 0.5 milligrams of trans fats per serving;

(b) Have less than 200 milligrams sodium per serving; and

(c) For refrigerated or non-refrigerated entrée-type vended food items, contain less than 480 milligrams sodium per serving.

11100.5 The Automated Vending Operation operator should ensure that at least fifty percent (50%) of all packaged food and beverage choices are Healthy Food Items or Healthy Beverage Items as guided by the General Services Administration document “Health and Sustainability Guidelines for Federal Concessions and Vending Operations”.

11100.6 The standards in this section shall not apply to District of Columbia boards and commissions, Advisory Neighborhood Commissions, the Council of the District of Columbia, or the District of Columbia Courts.

History

SOURCE: Final Rulemaking published at 67 DCR 9508 (August 7, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 11100

22-B DCMR § 11101 STANDARDS FOR FOOD AND BEVERAGES PROVIDED AT MEETINGS AND EVENTS

11101.1 All food and beverage items purchased for meetings and events held at a District of Columbia Facility must be labeled with calories per serving as sold (or calories per measure provided for salad bar-type service). The organizer of the meeting or event should ensure that at least fifty percent (50%) of all food and beverage choices are Healthy Food Items or Healthy Beverage Items as guided by the General Services Administration document “Health and Sustainability Guidelines for Federal Concessions and Vending Operations.” Calorie labeling must be displayed on each item or on signs adjacent to each food and beverage item.

11101.2 Fruits, other than fresh unprocessed fruits, must be packaged in one-hundred percent (100%) water or unsweetened juice, with no added sugars.

11101.3 Vegetables, other than raw unprocessed fresh vegetables or salad-type vegetables, shall be steamed, baked, or grilled, utilizing little or no added fats or oils and must contain no more than 230 milligrams sodium, as served.

11101.4 The following protein food items shall meet the following standards:

Fresh meat or seafood protein foods shall be lean and shall be steamed, baked, or grilled utilizing little or no added fats or oils;

Vegetarian entrée offerings shall be low fat and contain less than 480 milligrams sodium per serving; and

Canned or frozen tuna, seafood, and salmon must contain less than 290 milligrams sodium per serving and canned meat less than 480 milligrams sodium per serving.

11101.5 Cereals and Grains shall meet the following standard:

(a) When grains are offered (e.g., rice, bread, pasta), then a one-hundred percent (100%) whole grain option must be offered for that item as the standard choice. When there are more than two cereal grain options, at least one must contain no less than three (3) grams of dietary fiber;

(b) All cereal grains offered (e.g., rice, bread, pasta), must contain no more than 230 milligrams sodium per serving; and

(c) At least fifty percent (50%) of breakfast cereals offered must contain at least three (3) grams of dietary fiber and no more than ten (10) grams of total sugars per serving.

11101.6 Dairy (yogurt/cheese/fluid milk) shall meet the following standards:

Only two percent (2%), one percent (1%), and fat-free fluid milk shall be offered;

Only low fat (two percent (2%) or less) or fat-free cottage cheese items shall be offered;

(c) Only two percent (2%), one percent (1%) or fat-free yogurt with no added sugars or yogurts labeled as reduced or less sugar according to United States Food and Drug Administration labeling standards shall be offered; and

(d) Processed cheeses must contain no more than 230 mg sodium per serving.

11101.7 Beverages offerings shall meet the following standards:

At least fifty percent (50%) of available beverage choices (other than 100% juice and unsweetened milk) must contain no more than 40 kcal/serving;

Juices must be one-hundred percent (100%) juice with no added sugars;

(d) Drinking water must be offered at no charge at all meetings and events.

11101.8 A prominently displayed statement regarding the availability of additional nutritional information available upon request must be placed where the food is served.

11101.9 Vegetable oils, shortenings, or margarines used for frying, pan-frying (sautéing), grilling, baking, or as a spread (or for deep frying cake batter and yeast dough) shall not be used unless the label or other documentation for the oil indicates zero (0) grams trans fat per serving. Oils and fats used in food preparation and as spreads must also be low (1 gram or less) in saturated fats.

11101.10 All individual food items must contain no more than 480 milligrams sodium per serving, unless otherwise designated.

11101.11 All meals must contain no more than 900 milligrams sodium.

11101.12 Deep-fried food options should be limited to no more than one choice per day.

11101.13 These standards in this section shall not apply to District of Columbia boards and commissions, Advisory Neighborhood Commissions, the Council of the District of Columbia, or the District of Columbia Courts, or to food served by the Departments of Corrections and Behavioral Health to persons residing at their institutions or in their direct custody, or served to children in schools.

History

SOURCE: Final Rulemaking published at 67 DCR 9508 (August 7, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 11101

22-B DCMR § 11102 PHYSICAL ACTIVITY BREAKS

11102.1 In order to promote physical activity, physical activity breaks may be offered during meetings. Halfway through meetings lasting more than one (1) hour, meeting leaders can choose to hold a five (5)- to ten (10)-minute physical activity break, featuring dancing, stretching, walking, etc. Additionally, periodic physical activity breaks may be included in the agendas for all day events.

History

SOURCE: Final Rulemaking published at 67 DCR 9508 (August 7, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 11102

22-B DCMR § 11199 DEFINITIONS

11199.1 When used in this section, the following terms shall have the meanings ascribed:

Added Sugars - Sugars that are either added during the processing of foods, or are packaged as such, and include sugars (free, mono- and disaccharides), sugars from syrups and honey, and sugars from concentrated fruit or vegetable juices that are in excess of what would be expected from the same volume of one hundred percent (100%) fruit or vegetable juice of the same type.

Automated Vending Operation - A fully automated self-service vending operation offered for public use that displays pre-packaged food and/or beverages that may be purchased upon completion of an automated payment method. The operation may include one or more automated vending machines that dispense servings of food or beverages in bulk or in packages, or prepared by the machine, without the necessity of replenishing the device between each vended operation.

Baked - A food preparation method in which food is cooked in an oven, utilizing dry heat.

Cheese - A food consisting of the coagulated, compressed, and usually ripened curd of milk separated from the whey.

Cholesterol - A necessary nutrient from animal-based foods that is carried in the bloodstream.

Deep Fried - A food preparation method in which food is cooked by submerging it in hot oil.

Dietary Fiber - A type of carbohydrate that cannot be digested by the body’s digestive enzymes.

District of Columbia Facility – A building or any part thereof that is owned, leased or otherwise controlled by the District of Columbia or any subordinate or independent District agency.

Entrée-type Vended Food Item – A vended main course or meal up to 350 calories per package or item.

Grams - A metric unit of mass equivalent to one thousandth of a kilogram.

Grill - A food preparation method in which food is cooked on a rack directly over a heat source.

GSA Guidelines – United States General Services Administration Health and Sustainability Guidelines for Federal Concessions and Vending Operations, available at https://www.gsa.gov/real-estate/facilities-management/tenant-services/concessions-and-cafeterias-healthy-food-in-the-federal-workplace.

Healthy Beverage Item – In addition to bottled water, a beverage that contains fewer than forty (40) calories per serving or one of the following: (1) fat-free or 1% low fat dairy milk; (2) calcium or vitamin D fortified soy milk with less than 200 calories per container; or (3) a container with twelve (12) ounces or less of (i) 100% fruit juice; (ii) vegetable juice that contains less than 230 milligrams of sodium per serving; or (iii) fruit juice combined with water with no added sugars and no more than 200 milligrams of sodium.

Healthy Food Item - An item that contains: (1) no more than 200 calories per package; (2) less than thirty-five percent (35%) of total calories from fat, except for foods containing one hundred percent (100%) nuts or seeds with no added fats; (3) less than ten percent (10%) of calories from saturated fat; and (4) no more than thirty-five percent (35%) of calories from total sugars, except for 1%, 2%, or non-fat dairy products, non-dairy milk products, fruits, and vegetables.

Juice - The liquid obtained from or present in fruit or vegetables.

Lean - A term used to describe an individual food as packaged when it contains less than ten (10) grams of fat, four point five (4.5) grams or less of saturated fat, and less than 95 milligrams of cholesterol per reference amount and per 100 grams.

Low Fat – A serving that contains no more than three (3) grams of fat.

Margarine - A butter-like product made of refined vegetable oils, sometimes blended with animal fats, and emulsified, usually with water or milk.

Meal - The combination of foods eaten at regular occasions, such as breakfast, lunch, dinner, or supper; a meal usually includes two or more food items.

Milligram - A metric unit of mass equivalent to one thousandth of a gram.

Nutrition Facts Label - A statement placed on packaged food items listing nutrients by serving size.

Packaged - Bottled, canned, securely bagged, or securely wrapped, whether packaged in a food establishment or a food processing plant.

Partially Hydrogenated Vegetable Oils - Oils that contain trans fatty acids, or trans fats, through a chemical process where liquid vegetable oil is turned into solid fat.

Processed cheese - A food product made from cheese (and sometimes other, unfermented, dairy by-product ingredients), plus emulsifiers, saturated vegetable oils, extra salt, food colorings, whey or sugar. Also known as prepared cheese, cheese product, plastic cheese, or cheese singles.

Protein - A nutrient found in foods such as meat, dairy products, nuts, and certain grains and beans, used to build and maintain bones, muscles, and skin.

Saturated Fat - A fat that is saturated with hydrogen molecules and mainly found in animal sources such as meat and dairy. It is typically solid at room temperature.

Sauté - A food preparation method in which food is cooked quickly in a small amount of oil or liquid over direct heat.

Serving – A standardized amount of a food, such as a cup or an ounce, used in providing information about a food within a food group, such as in dietary guidance. Serving size on the Nutrition Facts label is determined based on the Reference Amounts Customarily Consumed (RACC) for foods that have similar dietary usage, product characteristics, and customarily consumed amounts for consumers to make “like product” comparisons. Recommended servings for different foods and beverages are found in the U.S. Department of Health and Human Services and U.S. Department of Agriculture. 2015–2020 Dietary Guidelines for Americans. 8th Edition. December 2015. Available at:

http://health.gov/dietaryguidelines/2015/guidelines.

Shortening - A fat made that is solid at room temperature. Butter, lard and vegetable oils which have been hydrogenated to create a solid are examples of shortening.

Spread - A food that is spread onto products such as bread and crackers to enhance the flavor or texture of food.

Total Calories - A measure of the amount of energy in a serving of food.

Total Calories from Fat - The number of total calories in a food that come from fat.

Total Sugar - The total number of grams of sugars in a serving.

Trans Fat - A type of fat that is created through a chemical process in which hydrogen is added to vegetable oil, converting it from a liquid into solid fat at room temperature. Trans fat has no nutritional value.

Vegetarian - food that does not include meat and animal tissue products but may contain eggs and dairy products such as milk and cheese.

History

SOURCE: Final Rulemaking published at 67 DCR 9508 (August 7, 2020). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 11199

22-B112 HEALTH CARE FACILITIES-REQUIRED VACCINATIONS

22-B DCMR § 11200 VACCINATION REQUIREMENT

11200.1 No health care facility may, after October 8, 2021, hire, employ, contract with, or grant privileges or credentials to, or continue to employ, contract with, or grant privileges or credentials to any person who is required to be vaccinated against COVID-19 in compliance with § 230 of Subtitle B (Public Health and Medicine) of Title 22 (Health) of the District of Columbia Municipal Regulations (“DCMR”), absent the grant of an exemption pursuant to § 231 of Subtitle B (Public Health and Medicine) of Title 22 (Health) of the DCMR, who has not either:

(a) Received the first dose of the Pfizer-BioNTech COVID-19 vaccine on or before September 30, 2021, and received the second dose of the Pfizer-BioNTech COVID-19 vaccine within the time period established in the dosing schedule for the vaccine; or

(b) Received the first dose of the Moderna COVID-19 vaccine on or before September 30, 2021, and received the second dose of the Moderna COVID-19 vaccine within the time period established in the dosing schedule for the vaccine; or

11200.2 No health care facility may, after November 8, 2021, hire, employ, contract with, or grant privileges or credentials to, or continue to employ, contract with, or grant privileges or credentials to any person who is required to be vaccinated against COVID-19 in compliance with § 230 of Subtitle B (Public Health and Medicine) of Title 22 (Health) of the DCMR, absent the grant of an exemption pursuant to § 231 of Subtitle B (Public Health and Medicine) of Title 22 (Health) of the DCMR, who has not received a second dose of the Pfizer-BioNTech COVID-19 vaccine, or a second dose of the Moderna COVID-19 vaccine, as required under § 11200.1.

11200.3 A health care facility shall maintain documentation confirming that each employee, contractor, volunteer, and privilege or credential recipient of a health care facility who is required to be vaccinated against COVID-19 in compliance with § 230 of Subtitle B (Public Health and Medicine) of Title 22 (Health) of the DCMR has received the required COVID-19 vaccination, or has been granted an exemption pursuant to § 231 of Subtitle B (Public Health and Medicine) of Title 22 (Health) of the DCMR.

11200.4 A health care facility may impose COVID-19 vaccination requirements on its employees, contractors, volunteers, and those to whom it grants credentials or privileges that are stricter than the requirements imposed by this section, such as requiring vaccination against COVID-19 by a date earlier than required by this section, or requiring that unvaccinated employees, contractors, volunteers, and privilege or credential recipient of a health care facility be tested regularly for COVID-19.

History

SOURCE: Final Rulemaking published at 69 DCR 002469 (March 25, 2022). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 11200

22-B DCMR § 11201 APPLICABLE FACILITIES

11201.1 For purposes of this chapter, the term “health care facility” shall include the following:

(a) An ambulatory surgical facility, assisted living residence, community residence facility, group home for persons with intellectual disabilities, home care agency, hospice, hospital, maternity center, nursing home, or renal dialysis facility, as defined in § 2 of the Health-Care and Community Residence Facility, Hospice and Home Care Licensure Act of 1983, effective February 24, 1984 (D.C. Law 5-48; D.C. Official Code § 44-501(a) (2012 Repl.));

(b) A nurse staffing agency, as defined in § 2 of the Nurse Staffing Agency Act of 2003, effective March 10, 2004 (D.C. Law 15-7; D.C. Official Code § 44-1051.02(7) (2012 Repl.));

(c) A clinical laboratory, as defined in § 2(3) of the Clinical Laboratory Act of 1988, effective March 16, 1989 (D.C. Law 7-182; D.C. Official Code § 44-201(3) (2015 Repl.));

(d) A tissue bank, as defined in § 3 of the District of Columbia Tissue Bank Act, effective September 10, 1962 (76 Stat. 534; Pub. L. 87-656; D.C. Official Code § 7-1541.02(4)); and

(e) A home support agency, as defined in § 9999.1 of Chapter 99 (Home Support Agencies) of Subtitle B (Public Health and Medicine) of Title 22 (Health) of the DCMR.

History

SOURCE: Final Rulemaking published at 69 DCR 002469 (March 25, 2022). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 11201

22-B DCMR § 11202 PROOF OF COVID-19 VACCINATION

11202.1 Each employee, contractor, volunteer, and privilege or credential recipient of a health care facility must provide written proof to the health care facility, by the dates set forth in §§ 11200.1 and 11200.2, that they have obtained the required COVID-19 vaccination, or have been granted an exemption under § 231 of Subtitle B (Public Health and Medicine) of Title 22 (Health) of the DCMR.

11202.2 A health care facility shall require each of its employees, contractors, volunteers, and privilege or credential recipients to provide written proof, by the dates set forth in §§ 11200.1 and 11200.2, that they have received the required COVID-19 vaccination, or been granted an exemption under § 231 of Subtitle B (Public Health and Medicine) of Title 22 (Health) of the DCMR.

11202.3 A health care facility shall be subject to enforcement, as described in § 11203, for its failure to obtain written proof of vaccination, or written proof of the grant of an exemption, for each employee, contractor, volunteer, and privilege or credential recipient who is required to be vaccinated in accordance with § 230 of Subtitle B (Public Health and Medicine) of Title 22 (Health) of the DCMR.

History

SOURCE: Final Rulemaking published at 69 DCR 002469 (March 25, 2022). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 11202

22-B DCMR § 11203 ENFORCEMENT

11203.1 A health care facility that fails to comply with the requirements of §§ 11200 or 11202 shall be subject to disciplinary and enforcement actions, which may result in the revocation, suspension, or denial of a facility’s license, registration, or certification, a civil fine, or other penalties in accordance with the Health-Care and Community Residence Facility, Hospice and Home Care Licensure Act of 1983, effective February 24, 1984 (D.C. Law 5-48; D.C. Official Code § 44-509 (2012 Repl.)), the Clinical Laboratory Act of 1988, effective March 16, 1989 (D.C. Law 7-182; D.C. Official Code § 44-212 (2015 Repl.)), or the Nurse Staffing Agency Act of 2003, effective March 10, 2004 (D.C. Law 15-74; D.C. Official Code §§ 44-1051.07 and 44-1051.18 (2012 Repl.)), whichever is applicable.

11203.2 The Department of Health may, by written or electronic correspondence, direct a health care facility that has not complied with the requirements of §§ 11200 or 11202 to either become fully compliant by a date set forth in the correspondence, or to surrender its license, registration, or certification by that date, and may impose a fine or other disciplinary action.

11203.3 If a health care facility has not complied with the requirements of §§ 11200 or 11202, the Department of Health may deny its application for the renewal of a license, certification, or registration, or may impose a fine or other disciplinary action for non-compliance, or both.

History

SOURCE: Final Rulemaking published at 69 DCR 002469 (March 25, 2022). District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 11203

22-C MEDICAL MARIJUANA

22-C1 GENERAL PROVISIONS

22-C DCMR § 100 APPLICABILITY

This chapter shall apply to applicants for and holders of a qualifying patient or caregiver registration card to possess, use, administer, or dispense medical cannabis in the District of Columbia, and to authorized practitioners who provide written recommendations for the use of medical cannabis under the Act.

No person shall possess, use, administer, or dispense cannabis in any form for the purpose of a medical use unless the person is registered with the Alcoholic Beverage and Cannabis Board under the Act.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10133 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 100

22-C DCMR § 101 SIGNATURE REQUIREMENTS

101.1 Where the Act or this subtitle requires a signature, the requirement shall be satisfied by a wet ink signature, e-signature, digital signature, clickwrap signature, or any other mark demonstrating an intent to sign unless a specific type of signature is specifically required by the Act or this subtitle.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 101

22-C2 CONDITIONS OF REGISTRATION

22-C DCMR § 200 GENERAL PROVISIONS

A registration identification card shall not be transferable to another person.

A registration identification card issued under this chapter is the property of the District of Columbia and shall be surrendered upon demand of the Board.

As part of the registration process, applicants shall sign a written statement certifying that the applicant assumes any and all risk or liability that may result under District of Columbia and federal laws from the possession, use, administration, or dispensing of medical cannabis. The applicant shall further acknowledge that he or she understands that the medical cannabis laws and enforcement thereof of the District of Columbia and the Federal government are subject to change at any time.

The applications for a patient or caregiver registration shall specifically recite, verbatim, each of the following notices:

(a) Limitation of Liability -- To the extent provided by Section 12 of the Act (D.C. Official Code § 7-1671.11), the District of Columbia shall not be liable to the registrant, its employees, agents, business invitees, licensees, customers, clients, family members or guests for any damage, injury, accident, loss, compensation or claim, based on, arising out of, or resulting from a person’s participation in the District of Columbia’s medical cannabis program, including: any fire, robbery, theft, mysterious disappearance or any other casualty; or injury arising from the use of medical cannabis obtained through the program. This Limitation of Liability provision shall survive expiration or the earlier termination of this registration if such registration is granted; and

(b) Federal Prosecution -- The United States Congress has determined that cannabis is a controlled substance and has placed cannabis in Schedule I of the Controlled Substance Act. Growing, distributing, and possessing cannabis in any capacity, other than as a part of a federally authorized research program, is a violation of federal laws. The District of Columbia’s law authorizing the District’s medical cannabis program will not excuse any person from any violation of the federal laws governing cannabis or authorize any person to violate federal laws.

As part of the registration process, every applicant for either a patient or caregiver registration shall sign a written statement attesting to the following:

The applicant acknowledges receipt and advisement of the notices set forth in § 200.4;

The applicant agrees to and accepts the limitation of liability against the District, as set forth in § 200.4;

The applicant assumes any and all risk or liability that may result under District of Columbia or federal laws arising from the possession, use, cultivation, administration, or dispensing of medical cannabis;

The applicant understands that the medical cannabis laws and enforcement thereof of the District of Columbia and the Federal government are subject to change at any time; and

The applicant chooses to sign this attestation willingly and without reservation and is fully aware of its meaning and effect.

Within fourteen (14) calendar days of any change in the qualifying patient's name, address, caregiver, or authorized practitioner, a qualifying patient who has been issued a registration identification card shall:

Submit a completed patient change of information form to the Board, and include as applicable:

Designation of a new caregiver; or

A recommendation form from the new authorized practitioner;

Surrender their current registration identification card to the Board;

Immediately notify their caregiver of the change;

Pay the required fee to receive a new registration identification card; and

Be issued a new registration card that reflects the change.

Within fourteen (14) calendar days of receiving notice of a qualifying patient's change of name, address, or authorized practitioner, the patient's registered caregiver shall:

Submit a written request for a new registration identification card to the Board on a form provided by the Board;

Surrender their registration identification card;

Pay the required fee to receive a new registration identification card; and

Be issued a new registration identification card that reflects the change.

Within fourteen (14) calendar days of the authorized practitioner declaring that a qualifying patient no longer suffers from a qualifying medical condition or treatment, the qualifying patient shall:

Surrender their registration card to the Board; and

Notify their registered caregiver of the change.

Within fourteen (14) calendar days of receiving notice that a qualifying patient has changed their caregiver, or that the patient no longer suffers from a qualifying medical condition or treatment, the Board shall send written notice via U.S. Postal Service certified mail to the caregiver's address on file with the Board. The caregiver's protections under the Act shall expire ten (10) days after delivery of the notice or the caregiver's failure to claim the notice.

Within fourteen (14) calendar days after receiving notice that a qualifying patient has designated a different individual to serve as their caregiver or that the qualifying patient no longer suffers from a qualifying medical condition or treatment, the caregiver shall surrender their registration card to the Board.

In the event that a qualifying patient or a caregiver experiences the theft, loss, or destruction of their registration card, he or she shall:

Within forty-eight (48) hours after discovery, provide verbal notification to the Board or the Board’s designee;

Submit the required written notification reporting forms to the Board within seventy-two (72) hours after the initial discovery;

Pay the required fee; and

Be issued a new registration identification card.

Within fourteen (14) calendar days after any change in a caregiver's name or

address, he or she shall:

Notify the Board in writing of the change; and

Pay the required fee, and be issued a new registration identification card, if applicable.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10134 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 200

22-C3 USE OF MEDICAL CANNABIS

22-C DCMR § 300 MEDICAL USE OF CANNABIS

300.1 A qualifying patient shall only purchase, possess, and administer medical cannabis, or use paraphernalia, for treatment of a qualifying medical or dental condition or the side effects of a qualifying medical treatment after:

Obtaining a signed, written recommendation from an authorized practitioner within the last two (2) years in accordance with the Act, except for individuals twenty-one (21) years of age and older, who shall be permitted to self-certify on a form provided by ABCA that they are utilizing cannabis for medical purposes as part of the registration process, and registering with ABCA; or

Enrolling in another jurisdiction’s medical cannabis program.

A qualifying patient or caregiver shall only purchase, possess, dispense, use, administer, or assist in the administration of medical cannabis, medical cannabis products, and paraphernalia obtained from an internet retailer or retailer licensed with the Board. A qualifying patient or caregiver may purchase medical cannabis, medical cannabis products, and paraphernalia at any internet retailer or retailer that is licensed with the Board.

A qualifying patient or caregiver shall only transport medical cannabis and medical cannabis products in a container or sealed package bearing the label received from the internet retailer or retailer.

A qualifying patient or caregiver shall not use or administer medical cannabis or medical cannabis products at a medical cannabis business, except that a qualifying patient or caregiver may use or administer medical cannabis at a Board-approved safe-use treatment facility, summer garden, or educational activity that occurs at a licensed retailer.

Medical cannabis shall only be administered by or to a qualifying patient at:

(a) The qualifying patient’s residence, if permitted by the property owner;

(b) If permitted by the landlord, the residence of an individual who has given permission to the qualifying patient to administer medical cannabis at their residence;

(c) A medical treatment facility when receiving medical care for a qualifying medical or dental condition or a qualifying medical or dental treatment, if permitted by the medical treatment facility;

(d) A Board-approved safe-use treatment facility, summer garden, or educational activity that occurs at a licensed retailer; or

(e) To the extent consistent with federal law, a school where the qualifying patient is enrolled, if the school has a policy in place for allowing the administration of medication at school and medical cannabis is administered in a non-smokeable form.

A qualifying patient who is a minor shall only purchase, possess, use, and administer medical cannabis, medical cannabis products, and paraphernalia after receiving: (1) a recommendation from an authorized practitioner and registering with ABCA and (2) a signed, written statement from the minor’s parent or legal guardian that is submitted with the minor’s ABCA registration. The signed, written statement shall affirm that the parent or legal guardian:

(a) Understands the qualifying medical or dental condition or qualifying medical or dental treatment of the minor;

(b) Understands the potential benefits and adverse effects of the use of medical cannabis in general, and specifically, in the case of the minor;

(c) Consents to the use of medical cannabis for the minor’s qualifying medical or dental condition or qualifying medical or dental treatment;

(d) Consents to, or designates another adult to, serve as the caregiver for the minor qualifying patient; and

(e) Consents that the caregiver shall control the acquisition, possession, dosage, and frequency of use of medical cannabis by the minor qualifying patient.

Nothing in the Act or this subtitle shall be construed as permitting a qualifying patient to:

(a) Undertake any task under the influence of medical cannabis when doing so would constitute negligence or professional malpractice; or

(b) Operate, navigate, or be in actual physical control of any motor vehicle, scooter, bicycle, e-bike, aircraft, or motorboat while under the influence of medical cannabis.

No qualifying patient or caregiver shall use butane or other explosive gases to extract or separate resin from cannabis, or tetrahydrocannabinol from cannabis, or in any other manner.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 5, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011) [EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10137 (December 2, 2011); as amended by Final Rulemaking published at 63 DCR 1627 (February 12, 2016); as amended by Final Rulemaking published at 64 DCR 2259 (February 24, 2017); as amended by Final Rulemaking published at 64 DCR 7485 (August 4, 2017); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 300

22-C DCMR § 301 MEDICAL CANNABIS POSSESSION AND PURCHASE LIMITS

301.1 The maximum amount of medical cannabis or medical cannabis products a qualifying patient or caregiver may possess at any time or purchase from a licensed internet retailer or retailer within a 30-day period, whether individually or in combination, is:

(a) Eight (8) ounces of dried medical cannabis; or

(b) Two hundred and forty (240) grams of medical cannabis concentrate for a patient twenty-one (21) years old of age or older, or sixty (60) grams of medical cannabis concentrate for a patient between eighteen (18) and twenty (20) years old; or

(c) Medical cannabis products in any form containing a combined total of six hundred thousand milligrams (600,000 mg) of THC.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 301

22-C DCMR § 302 BARRING NOTICES

BARRING NOTICES

302.1 A internet retailer or retailer shall have the right to refuse service to a qualifying patient or caregiver who:

Engages in abusive, intimidating, threatening, or disruptive conduct while on the premises of a internet retailer or retailer; or

Presents a registration identification card that appears to have been fraudulent, tampered, altered, or owned by another person.

A internet retailer or retailer shall have the right to seek a barring notice from MPD to keep a qualifying patient or caregiver who has engaged in abusive, intimidating, threatening, or disruptive conduct from unlawfully entering the registered premises as prohibited by D.C. Official Code § 22-3302.

History

SOURCE: Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 302

22-C4 DISPOSAL OF MEDICAL CANNABIS

22-C DCMR § 400 DISPOSAL OF MEDICAL CANNABIS BY QUALIFYING PATIENTS AND CAREGIVERS

A qualifying patient or caregiver who is no longer registered with the Board shall not transfer, share, give, or deliver any unused medical cannabis in their possession to another qualifying patient or caregiver for use or destruction, regardless of whether the person is registered with the District's Program.

A qualifying patient or caregiver shall not dispose of medical cannabis in any manner other than permitted under this chapter.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10140 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 400

22-C5 QUALIFYING PATIENTS

22-C DCMR § 500 QUALIFICATION FOR PATIENT REGISTRATION

500.1 To qualify for a patient registration identification card, an applicant shall:

(a) Except as otherwise provided by District law, be a bona fide resident of the District of Columbia at the time the application is filed with the Board and remain a bona fide resident during treatment with medical cannabis;

(b) Have a qualifying medical condition or be undergoing a qualifying medical treatment;

(c) Have a signed recommendation from an authorized practitioner, or if twenty-one (21) years of age or older, self-certify on a form provided by ABCA, for the use of medical cannabis meeting the requirements of this chapter; and

(d) If the qualifying patient is a minor, the signed written consent of their parent or legal guardian.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10140 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 500

22-C DCMR § 501 RESIDENCY

501.1 For purposes of this subtitle, a patient shall be a resident of the District of Columbia if the individual:

(a) Is physically present in the District of Columbia;

(b) Has taken verifiable actions to make the District their home indefinitely with no present intent to reside elsewhere; and

501.2 In proving bona fide District residency, an applicant shall submit:

A non-expired Real ID driver license issued by the District of Columbia Department of Motor Vehicles; or

(b) At least one (1) of the following items:

(1) A valid unexpired lease or rental agreement in the name of the applicant on a District of Columbia residential property;

(2) A pay stub issued less than forty-five (45) days prior to the application date which shows evidence of the applicant’s withholding of District income tax;

(3) Current official documentation of financial assistance received by the applicant from the District Government including, but not limited to Temporary Assistance for Needy Families (TANF), Medicaid, the State Child Health Insurance Program (SCHIP), Supplemental Security Income (SSI), housing assistance, or other governmental programs;

(4) A current motor vehicle registration in the name of the applicant evidencing District residency;

(5) A valid unexpired District motor vehicle operator’s permit or other official non-driver identification in the name of the applicant;

(6) Bank statements, utility bills, and telephone bills, including cell phone bills from a period within the two (2) months immediately preceding the application date in the name of the applicant on a District of Columbia residential address; or

(7) Any other document that, in the judgment of the Board, demonstrates that the applicant is a current resident.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10141 (December 2, 2011); as amended by Final Rulemaking published at 67 DCR 3572 (March 27, 2020); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 501

22-C DCMR § 502 QUALIFYING PATIENTS APPLICATION

502.1 To apply for a patient registration identification card, an applicant shall submit a completed application to the Board on the required forms, which shall include:

(a) The applicant’s full legal name and date of birth;

(b) One (1) clear photocopy of a U.S., state, or District government-issued photo ID, such as a driver license, as proof of identity;

(c) Proof of District residency, including the applicant’s District of Columbia residential address which shall not be a post office box number;

(d) Designation of the individual who will serve as the applicant’s caregiver, if applicable;

(e) Either a signed and dated authorized practitioner’s recommendation for the use of medical cannabis meeting the requirements of this chapter, that is dated not more than two (2) years prior to the application date, or a signed ABCA self-certification form; and

(f) Payment of the required application fee.

502.2 To apply for a registration identification card for a minor, the parent or legal guardian of the minor shall submit a completed application to the Board on the required forms, which shall include:

(a) The minor and parent or legal guardian’s social security numbers, or if the applicant does not have a social security number, the applicant shall:

(1) Submit with the application a sworn affidavit, under penalty of perjury, stating that he or she does not have a social security number; and

(2) Provide the Board with their social security information once a social security number has been obtained;

(b) Two (2) recent passport-type photographs of the minor’s face measuring two inches by two inches (2 in. x 2 in.), which clearly expose the area from the top of the forehead to the bottom of the chin;

(c) One (1) clear photocopy of U.S., state, or District government-issued photo ID issued to the parent or legal guardian, such as a driver’s license, as proof of identity;

(d) Proof of the minor and parent or legal guardian’s District residency, including their District of Columbia residential address which shall not be a post office box number;

(e) A signed and dated written physician’s recommendation for the use of medical cannabis meeting the requirements of this chapter, that is dated not more than ninety (90) days prior to the application date;

(f) Designation of the individual who will serve as the minor’s caregiver;

(g) [REPEALED].

(h) The signed, written statement of the minor’s parent or legal guardian affirming that he or she:

(1) Understands the qualifying medical condition or qualifying medical treatment of the minor;

(2) Understands the potential benefits and potential adverse effects of the use of medical cannabis, in general, and specifically, in the case of the minor;

(3) Consents to the use of medical cannabis for the treatment of the minor’s qualifying medical condition or treatment of the side effects of the minor’s qualifying medical treatment; and

(4) Consents to, or has designated another adult to, serve as the caregiver for the qualifying patient and that the caregiver will control the acquisition, possession, dosage, and frequency of use of medical cannabis by the qualifying patient; and

(i) Payment of the required application fee.

502.3 The minor’s designated caregiver shall also register with the Board and obtain a caregiver registration identification card.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10142 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026); as amended by Final Rulemaking published at 73 DCR 008495 (June 12, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 502

22-C DCMR § 503 NONRESIDENT QUALIFYING PATIENTS

503.1 Before dispensing medical cannabis to a nonresident qualifying patient, a registered internet retailer or retailer shall:

(a) Verify the nonresident qualifying patient’s identity through comparison of their unexpired government-issued identification card and either their temporary medical cannabis patient card issued by ABCA or a valid, unexpired nonresident patient card or state-issued or U.S. territory-issued document from the jurisdiction that the patient resides; and

(b) Confirm through the real-time electronic records system that the nonresident qualifying patient has not reached the allowable medical cannabis purchase limits for the thirty (30)-day period.

503.2 An internet retailer or retailer shall not dispense medical cannabis to a nonresident qualifying patient that does not hold either a temporary medical cannabis patient card issued by ABCA or a valid unexpired nonresident patient card or state-issued or U.S. territory-issued document from the jurisdiction that the patient resides.

503.3 [REPEALED].

503.4 A licensed internet retailer or retailer shall not dispense medical cannabis to a nonresident qualifying patient if ABCA determines that there is a shortage of medical cannabis, or the real-time electronic records system is inactive.

503.5 In the case of purchase by a nonresident qualifying patient that does not hold a temporary medical cannabis patient card issued by ABCA, the internet retailer or retailer shall retain a copy of both the nonresident patient card or state-issued or U.S. territory-issued document, and a copy of the government-issued identification card.

503.6 The internet retailer or retailer shall conspicuously post a sign which shall be not less than twelve (12) inches wide and twelve (12) inches long in an area that will be easily viewed and read by the public stating, “It is illegal to transport medical cannabis across state lines.”

503.7 Notwithstanding § 503.1(a) and § 503.2, an internet retailer or retailer may satisfy § 503.1(a) and § 503.2 and dispense medical cannabis and medical cannabis products to a nonresident patient by verifying the nonresident patient’s identity through a comparison of:

(a) An unexpired government-issued identification card of the patient;

(b) If required by the issuing jurisdiction, proof of residency in the other jurisdiction, along with any other document necessary to prove enrollment in the other jurisdiction’s program; and

(c) A written certification form issued by the patient’s state or jurisdiction of residence that has been completed by an authorized practitioner provided the state or jurisdiction’s written certification form contains:

(1) The name, address, and telephone number of the practitioner;

(2) The name of the qualifying patient presenting the written certification form;

(3) The date the certification form was issued by the practitioner;

(4) The signature or electronic signature of the practitioner; and

(5) Confirmation that the authorized practitioner has determined that medical cannabis is appropriate for the treatment of a qualifying medical or dental condition or a side effect of a qualifying medical or dental treatment, that is consistent with the standard of care in that jurisdiction.

503.8 In the case of purchase by a nonresident qualifying patient utilizing a written certification form issued by another state or jurisdiction that has been completed by an authorized practitioner, the internet retailer or retailer shall use the number on the unexpired government issued identification card as the non-resident’s patient number.

History

SOURCE: Final Rulemaking published at 65 DCR 3650 (April 6, 2018); as amended by Final Rulemaking published at 67 DCR 7479 (June 12, 2020); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR §503

22-C DCMR § 504 TEMPORARY NON-RESIDENT MEDICAL CANNABIS PATIENT CARD

504.1 A non-resident qualifying patient visiting the District of Columbia may apply to ABCA to receive a temporary non-resident medical cannabis patient card that is either 3 days, 30 days, 90 days, 180 days or 365 days in length.

504.2 To apply for a temporary non-resident medical cannabis patient card, an applicant shall submit a complete application to ABCA on the required forms, which shall include:

The applicant’s full legal name and date of birth;

One (1) recent passport-type photograph of the applicant’s face measuring two inches by two inches (2 in. x 2 in.), which clearly expose the area from the top of the forehead to the bottom of the chin;

One (1) clear photocopy of a photo ID issued by a U.S. state, U.S. territory, the District of Columbia, or a foreign government-, such as a driver’s license or passport, as proof of identity;

A signed and dated written authorized practitioner’s recommendation for the use of medical cannabis meeting the requirements of this chapter, that is dated not more than two (2) years prior to the application date, except for individuals twenty-one (21) years of age and older, who shall be permitted to self-certify on a form provided by ABCA that they are utilizing cannabis for medical purposes as part of their application;

Designation of the individual who will serve as the patient’s caregiver, if applicable; and

(f) Payment of the required application fee.

504.3 An applicant applying for a temporary non-resident medical cannabis patient card who is a minor shall further provide that the application is completed by the parent or legal guardian of the minor, and includes

(a) All of the information required by Section 504.2; and

(b) A signed written statement from the minor’s parent or legal guardian attesting to the information set forth in § 300.6.

504.4 A minor shall not be issued a temporary non-resident medical cannabis patient card until a registered caregiver is designated on the application and the caregiver has been issued a medical cannabis caregiver registration card from ABCA.

504.5 After the expiration of a temporary non-resident medical cannabis patient card, the nonresident cardholder may apply to ABCA to be issued another temporary non-resident identification card.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR §504

22-C DCMR § 505 SELF-CERTIFICATION FORM

505.1 The ABCA Self-Certification Form shall require the following information:

(a) Name;

(b) Address;

(d) Age; and

(e) Whether the applicant has any condition for which treatment with medical cannabis would be beneficial, as determined by an authorized practitioner, or is undertaking a qualifying medical or dental treatment.

505.2 The ABCA Self-Certification Form shall require the qualifying patient to make the certifications required by D.C. Official Code §§ 7–1671.02(c) and 7-1671.05(b)(3).

505.3 Any qualifying patient registration card containing a self-certification form that was issued to a person under the age of twenty-one (21) or who has otherwise falsified information contained in the self-certification form shall be revoked.

505.4 If the Board has cause to believe that a self-certification form is false or otherwise filed in violation of this title or this subtitle, the Board may require the qualifying patient to demonstrate through the submission of evidence that the self-certification is valid.

505.5 A qualifying patient required to submit proof of their self-certification shall have 15 calendar days unless extended by the Board to file appropriate documentation of their condition or treatment. If the qualifying patient fails to respond, then the Board may immediately revoke their registration.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR §505

22-C6 CAREGIVERS

22-C DCMR § 600 LIMITATIONS ON CAREGIVERS

600.1 A caregiver shall only possess and dispense medical cannabis to a qualifying patient, and possess and use paraphernalia, for the sole purpose of assisting in the administration of medical cannabis to a qualifying patient in accordance with the Act and this subtitle.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10144 (December 2, 2011); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR §600

22-C DCMR § 601 CAREGIVER QUALIFICATIONS

601.1 To qualify for a caregiver registration identification card, an applicant shall:

(a) Be designated by a qualifying patient to serve as the person authorized, on the qualifying patient’s behalf, to possess, obtain from a internet retailer or retailer, dispense, and assist in the administration of medical cannabis;

(b) Be registered with the Board as the qualifying patient's caregiver;

(d) Be at least eighteen (18) years of age.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10144 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR §601

22-C DCMR § 602 CAREGIVER APPLICATION

602.1 To apply for a caregiver registration identification card, an applicant shall submit a completed application to the Board on the required forms, which shall include:

(a) The applicant’s social security number, or if the applicant does not have a social security number, the applicant shall:

(1) Submit with the application a sworn affidavit, under penalty of perjury, stating that he or she does not have a social security number; and

(2) Provide the Board with their social security information once a social security number has been obtained;

(b) One (1) recent passport-type photograph of the applicant’s face measuring two inches by two inches (2 in. x 2 in.), which clearly expose the area from the top of the forehead to the bottom of the chin;

(c) One (1) clear photocopy of a photo ID issued by a U.S. state, U.S. territory, the District of Columbia, or a foreign government-, such as a driver’s license or passport, as proof of identity; and

(d) The caregiver’s residential address, which shall not be a post office box number.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10144 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR §602

22-C DCMR § 603 MEDICAL CANNABIS OBTAINED FROM INTERNET RETAILER OR RETAILER

A caregiver shall only obtain medical cannabis for the qualifying patient from a internet retailer or retailer registered by the Board and shall not:

Grow or cultivate medical cannabis for the qualifying patient;

Purchase medical cannabis from unlicensed sources; or

Obtain medical cannabis from other registered qualifying patients and caregivers.

If the qualifying patient makes a change to the information set forth on their registration card, both the qualifying patient and the caregiver must surrender their registration identification cards to the Board and obtain new registration identification cards reflecting the change.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10145 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR §603

22-C7 REGISTRATION CARDS

22-C DCMR § 700 ISSUANCE OF REGISTRATION CARDS

Upon receipt and approval of a valid and complete application, the Board shall issue a registration identification card to a qualifying patient or caregiver in accordance with the Act and this subtitle.

700.2 A registration identification card issued pursuant to this chapter shall expire two (2) years after the date of issuance and may be renewed in accordance with the renewal provisions under this chapter. Upon receipt of a complete application, ABCA shall issue the applicant a temporary patient registration card that shall be valid for ninety (90) days. Temporary patient registration cards issued on or after April 18, 2025, and prior to July 17, 2025, shall be valid for ninety (90) days after the date of issuance, regardless of the expiration date printed on the temporary patient registration card.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10146 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026); as amended by Final Rulemaking published at 73 DCR 008495 (June 12, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR §700

22-C DCMR § 701 CONTENTS OF REGISTRATION CARDS

701.1 A qualifying patient registration identification card shall contain:

(a) The date of issuance and expiration date;

(b) The qualifying patient’s full, legal name, and the full, legal name of the patient’s caregiver, if applicable;

(d) The photograph of the qualifying patient;

(e) [REPEALED].

(f) The District of Columbia medical license number of the recommending physician, if the qualifying patient is a minor.

(g) A Board internal authentication identifier.

701.2 A caregiver registration identification card shall contain:

(a) The date of issuance and expiration date;

(b) The caregiver’s full, legal name, and the qualifying patient’s full, legal name;

(d) The photograph of the caregiver;

(e) [REPEALED].

(f) The District of Columbia medical license number of the recommending physician, if the qualifying patient is a minor.

(g) A Board internal authentication identifier.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10146 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR §701

22-C DCMR § 702 RENEWAL OF REGISTRATION CARDS

Not later than sixty (60) days prior to the expiration of a registration identification card, the qualifying patient or caregiver may apply for renewal of their registration identification card as follows:

Submit a completed renewal application to the Board on the required forms and include:

One (1) clear photocopy of a U.S., state or District government-

issued photo ID, such as a driver's license, as proof of identity;

Proof of District residency by meeting the requirements set forth in

§ 501.2, if applicable;

(3) A signed and dated written recommendation from an authorized practitioner for the use of medical cannabis meeting the requirements of this chapter, that is dated not more than two (2) years prior to the application date or, for patients twenty-one (21) years of age and older, a signed ABCA self-certification form; and

Pay the required application fee.

To renew a registration identification card for a minor, the parent or legal guardian of the minor shall submit a completed application to the Board on the required forms, which shall include:

One (1) clear photocopy of U.S., state or District government-issued photo ID issued to the parent or legal guardian, such as a driver's license, as proof of identity;

Proof of the minor and parent or legal guardian's District residency by meeting the requirements set forth in § 501.2;

A signed and dated written recommendation from an authorized practitioner for the use of medical cannabis meeting the requirements of this chapter, that is dated not more than two (2) years prior to the application date or, for patients twenty-one (21) years of age and older, a signed ABCA self-certification form;

Designation of the individual who will serve as the minor's caregiver;

The signed, written statement of the minor's parent or legal guardian

affirming that he or she:

Understands the qualifying medical condition or qualifying medical treatment of the minor;

Understands the potential benefits and potential adverse effects of the use of medical cannabis, in general, and specifically, in the case of the minor;

Consents to the use of medical cannabis for the treatment of the

minor's qualifying medical condition or treatment of the side effects of the minor's qualifying medical treatment;

Consents to, or has designated another adult to, serve as the caregiver for the qualifying patient and that the caregiver will control the acquisition, possession, dosage, and frequency of use of medical cannabis by the qualifying patient; and

Payment for the required application fee.

The minor's designated caregiver shall also renew their registration with the Board and obtain a new caregiver registration identification card.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10147 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR §702

22-C8 AUTHORIZED PRACTITIONERS

22-C DCMR § 800 QUALIFICATIONS TO BE A RECOMMENDING AUTHORIZED PRACTITIONER

800.1 An authorized practitioner who is licensed and in good standing to practice medicine, osteopathy, advanced practice registered nursing, dentistry, naturopathic medicine, or as a physician assistant in the District of Columbia may recommend the use of medical cannabis to a qualifying patient if the authorized practitioner:

Is in a bona fide relationship with the qualifying patient, which for purposes of complying with this chapter and the Act shall mean that the authorized practitioner:

Has completed a full assessment of the patient’s medical or dental history and current medical or dental condition, including a personal physical examination, not more than ninety (90) days prior to making the recommendation; and

Has responsibility for the ongoing care and treatment of the patient either directly or in consultation with another licensed authorized practitioner;

(b) Makes the recommendation based upon the authorized practitioner’s assessment of the qualifying patient’s:

(1) Medical or dental history;

(2) Current medical or dental condition; and

(3) A review of other approved medications and treatments that might provide the qualifying patient with relief from a qualifying medical or dental condition or the side effects of a qualifying medical or dental treatment; and

800.2 An authorized practitioner who is licensed and in good standing to practice medicine, osteopathy, advanced practice registered nursing, dentistry, naturopathic medicine, or as a physician assistant in the District of Columbia may evaluate a patient for the sole or primary purpose of the recommendation of medical cannabis only if:

[REPEALED].

The recommending authorized practitioner complies with the requirements set forth in Subsection 800.1; and

There is no exchange of any form of remuneration, gift, donation, bartering, referral fees, or fee-splitting between the referring and recommending authorized practitioner either directly or indirectly.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10148 (December 2, 2011); as amended by Final Rulemaking published at 64 DCR 11922 (November 17, 2017); as amended by Final Rulemaking published at 65 DCR 3926 (April 13, 2018); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026) District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 800

22-C DCMR § 801 FORM OF RECOMMENDATION

801.1 An authorized practitioner’s recommendation that a qualifying patient may use medical cannabis shall be written on a form provided by the Board and include the following:

(a) The name, address, telephone number, and specialty or primary area of clinical practice of the authorized practitioner;

(b) The authorized practitioner's District of Columbia health occupation license number;

(d) [REPEALED].

(e) A statement certifying that the patient has a qualifying medical or dental condition or suffers from the side effects of a qualifying medical or dental treatment, and that in the authorized practitioner’s professional opinion the potential benefits of the medical use of cannabis would likely outweigh the health risks for this patient;

(f) The length of time that the qualifying patient has been under the care of the authorized practitioner;

(g) A statement that the authorized practitioner has explained the potential risks and benefits of the use of cannabis to the qualifying patient and the qualifying patient’s parent or legal guardian, if applicable;

(h) The authorized practitioner’s signature and date.

(i) The qualifying patient's signed consent for the release of medical or dental information related to the patient's qualifying medical or dental condition or treatment.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10148 (December 2, 2011); as amended by Final Rulemaking published at 65 DCR 3926 (April 13, 2018); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 801

22-C DCMR § 802 RECORDS MAINTAINED BY AUTHORIZED PRACTITIONERS AND BOARD

802.1 An authorized practitioner recommending the use of medical cannabis to a qualifying patient shall maintain a record for each qualifying patient which shall:

(a) Accurately reflect the evaluation and treatment of the patient and include the following as applicable:

(1) Patient’s name and the date(s) of treatment;

(2) Patient’s medical or dental history and updated health history;

(3) Documented results of a full assessment of the patient’s medical or dental history and current medical or dental condition;

(4) Documented results of the authorized practitioner’s physical examination of the patient;

(5) Treatment plan;

(6) Informed consent document(s);

(7) Diagnosis and treatment rendered;

(8) List of drugs prescribed, administered, dispensed and the quantity;

(9) Radiographs;

(10) Patient financial/billing records;

(11) Name of the authorized practitioner or assistive personnel providing service(s);

(12) Laboratory work orders; and

(b) Be kept for three (3) years after last seeing the patient or three (3) years after a minor patient reaches eighteen (18) years of age.

802.2 The Board shall maintain a confidential record identifying each authorized practitioner for the purpose of monitoring compliance with the Act.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10148 (December 2, 2011); as amended by Final Rulemaking published at 65 DCR 3926 (April 13, 2018); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026) District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 802

22-C DCMR § 803 PROHIBITED OFFICE LOCATIONS

803.1 An authorized practitioner recommending the use of medical cannabis to a qualifying patient shall not:

Have a professional office located at or adjacent to an internet retailer or retailer, cultivation center, or testing laboratory;

Have employees, agents, volunteers, or independent-contractors affiliated directly or indirectly with the authorized practitioner located at or adjacent to a medical cannabis business; or

Receive financial compensation directly or indirectly from a medical cannabis business, or a director, officer, member, incorporator, agent, or employee of a medical cannabis business.

803.2 An authorized practitioner recommending the use of medical cannabis to a qualifying patient shall not have employees, agents, volunteers, or independent-contractors affiliated directly or indirectly with an internet retailer or retailer, cultivation center, or testing laboratory on the premises of the authorized practitioner’s professional office, clinic, or an institutional facility where the authorized practitioner sees patients or has privileges to see patients.

803.3 An authorized practitioner recommending the use of medical cannabis to a qualifying patient shall not have expediters or employees, agents, volunteers or independent-contractors affiliated directly or indirectly with an expediter on the premises of the authorized practitioner professional office, clinic, or an institutional facility where the authorized practitioner sees patients or has privileges to see patients.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10148 (December 2, 2011); as amended by Final Rulemaking published at 64 DCR 11922 (November 17, 2017); as amended by Final Rulemaking published at 65 DCR 3926 (April 13, 2018); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 803

22-C DCMR § 804 NOTIFICATION OF END OF QUALIFYING MEDICAL OR DENTAL CONDITION OR TREATMENT

804.1 An authorized practitioner shall notify the Board in writing within fourteen (14) calendar days after advising a qualifying patient that he or she no longer suffers from a qualifying medical or dental condition or treatment.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10148 (December 2, 2011); as amended by Final Rulemaking published at 65 DCR 3926 (April 13, 2018); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024). District of Columbia Municipal Regulations Medical Marijuana 22-C DCMR § 804

22-C DCMR § 805 [REPEALED]

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10148 (December 2, 2011); as amended by Final Rulemaking published at 65 DCR 3926 (April 13, 2018); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024). District of Columbia Municipal Regulations Medical Marijuana 22-C DCMR § 805

22-C DCMR § 806 [REPEALED]

History

SOURCE: Final Rulemaking published at 65 DCR 3926 (April 13, 2018); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024). District of Columbia Municipal Regulations Medical Marijuana 22-C DCMR § 806

22-C DCMR § 807 TELEHEALTH MEDICINE

Authorized practitioners may provide telehealth medicine services to qualifying patients, including recommending the use of medical cannabis in accordance with this title, consistent with the laws and regulations governing their medical practice.

For purposes of this section, "telehealth medicine" means the use of electronic information and telecommunication technologies, including teleconference and videoconference, to provide care when the qualifying patient and the authorized practitioner are not in the same place at the same time.

History

SOURCE: Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026) District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 807

22-C9 DENIAL OF APPLICATIONS

22-C DCMR § 900 DENIAL OF APPLICATIONS FOR PATIENT AND CAREGIVER REGISTRATIONS

The Board may deny an application or renewal application for a qualifying patient or caregiver registration identification card only if:

The application is incomplete and the applicant fails to provide the missing information or documents within the time period allotted by the Board;

The Board determines after further inquiry or investigation that the information provided was false, misleading, forged, or altered;

The Board determines that the caregiver has a disqualifying conviction; or

The application otherwise fails to comply with the Act or this title.

Denial by the Board of an application or renewal application for a qualifying patient or caregiver registration identification card shall be deemed a final order in this matter.

An applicant or renewal applicant for a qualifying patient or caregiver registration identification card may request a hearing with the Board to review any decision by ABCA denying an application or renewal application. The hearing request shall be in writing and filed with the Board within thirty (30) days from service of the notice of denial.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10151 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024). District of Columbia Municipal Regulations Medical Marijuana 22-C DCMR § 900

22-C10 ENFORCEMENT

22-C DCMR § 1000 ENFORCEMENT AUTHORITY

1000.1 The Board and ABCA shall have the authority to enforce the provisions of the Act and this subtitle with respect to licensees, any premises where an application pursuant to the Act has been filed, and unlicensed establishments.

1000.2 ABCA investigators may issue citations for civil violations of the Act and this subtitle that are set forth in the schedule of civil penalties.

1000.3 A citation for any violation for which the penalty includes the suspension of a license shall be issued under the direct authority of the Board as a result of an investigation carried out by ABCA investigators.

1000.4 Violations committed by an unlicensed person selling cannabis in violation of the provisions of the Act and the regulations may be referred by the Board to the Office of the Attorney General for investigation and prosecution.

1000.5 ABCA investigators may request and check the identification of a patient or caregiver inside of or attempting to enter a licensed medical cannabis facility. ABCA investigators may seize evidence that substantiates a violation under the Act and the regulations, which may include seizing cannabis and cannabis products sold to unregistered minors and unauthorized persons and fake identification documents used by minors and other unauthorized persons to register or be licensed with ABCA.

1000.6 ABCA investigators may seize a medical cannabis license or registration from an establishment or individual if:

The license has been suspended, revoked, or cancelled by the Board;

The license has expired;

The license has been tampered with, altered, belongs to another person, or otherwise used in a fraudulent manner;

(d) The medical cannabis facility is no longer in existence; or

(e) The medical cannabis facility has been closed by another District government agency.

1000.7 ABCA investigators are authorized to conduct announced and unannounced, as well as undercover, inspections and investigations of all licensees and any premises where an application for licensure has been filed.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10148 (December 2, 2011); as amended by Final Rulemaking published at 65 DCR 3926 (April 13, 2018); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 1000

22-C DCMR § 1001 EXAMINATION OF PREMISES AND BOOKS AND RECORDS

1001.1 An applicant for a license, and each licensee, shall allow an ABCA investigator or any member of ABCA’s enforcement division a full opportunity to examine, at any time during business hours:

(a) The premises where medical cannabis or medical cannabis products are cultivated, manufactured, kept, sold, delivered, tested, or consumed for which an application for a license or endorsement has been made or for which a license or endorsement has been issued; and

(b) The books and records of the business for which an application for a license has been made or for which a license has been issued. This shall include the license holder’s confidential records, including those related to qualifying patients, nonresident qualifying patients, caregivers, and authorized practitioners.

1001.2 ABCA investigators shall examine the premises and books and records of each licensed medical cannabis facility in the District at least once each year. The investigators shall make reasonable efforts to ensure that the licensee will know in advance the date of the inspection.

1001.3 All books and records required to be maintained by a licensee shall be maintained at the licensed premises unless a separate location in the District is approved by the Board.

1001.4 Notwithstanding § 1001.3, a medical cannabis facility may store its books and records electronically; provided that they provide the ABCA investigator, or another employee of ABCA’s enforcement division with access to the electronic records during normal business hours and produce the physical books and records within forty-eight (48) hours of notice of an inspection.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10154 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 1001

22-C DCMR § 1002 NOTICE OF INVESTIGATIVE REPORTS

1002.1 ABCA shall provide a licensee with an ABCA investigative report that may result in a show-cause civil enforcement hearing by ABCA within 90 days of the date upon which the incident occurred.

1002.2 The requirement in subsection § 1002.1 of this section shall be stayed if the report is referred to another federal, state, or District agency for investigation and such investigation remains pending.

1002.3 A licensee that has not received an investigative report in compliance with § 1002.1 may petition the Board to obtain a copy of the document.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10155 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 1002

22-C DCMR § 1003 AUTHORIZATION TO ISSUE FINES, SUSPEND, AND REVOKE LICENSES

1003.1 The Board may fine, as set forth in the schedule of civil penalties, and suspend or revoke the license of, any licensee during the license period if the licensee violates any provision of the Act or this subtitle.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10155 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 1003

22-C DCMR § 1004 GENERAL VIOLATIONS

1004.1 It shall be a violation when:

The licensee violates any of the provisions of the Act or this subtitle;

The licensee fails to superintend in person, or through a manager approved by the Board, the facility for which the license was issued;

The licensee interferes or fails to cooperate with an ABCA investigation;

(d) The licensee fails to follow its settlement agreement;

(e) The licensee fails to follow its security plan or other plan submitted as part of its license application;

(f) The licensee fails to follow a Board order or condition;

(g) The licensee fails to follow the terms of its license approved by the Board;

(h) The licensee purposely or knowingly destroys evidence of a crime;

(i) The licensee directly or indirectly gives, offers, or promises anything of value to an ABCA investigator, or offers or promises any ABCA investigator to give anything of value to any other person or entity, with the intent to:

(1) Influence any official act or investigation;

(2) Influence an ABCA investigator to commit or aid in committing, collude in, or allow any fraud on the Board; or

(3) Induce an ABCA investigator to do or omit to do any act in violation of the lawful duty of the ABCA investigator; or

(j) The licensee knowingly tampers with evidence. For purposes of this paragraph, the term “tampers with evidence” means any action that destroys, alters, conceals, or falsifies any sort of evidence.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10158 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 1004

22-C DCMR § 1005 UNLAWFUL AND DISORDERLY PURPOSE VIOLATION

1005.1 It shall be a violation for the licensee to allow the licensed establishment to be used for any unlawful purpose contrary to District law.

1005.2 A single incident of criminal assault as defined in Chapter 4 of Title 22 of the D.C. Official Code, criminal sexual abuse as defined in Chapter 30 of Title 22 of the D.C. Official Code, or crime of violence as defined in D.C. Official Code § 23-1331(4) shall be sufficient to prove a violation of Subsection 1005.1 of this section; provided, that the licensee has engaged in a method of operation that is conducive to unlawful or disorderly conduct.

1005.3 A violation of 1005.1 shall not require the showing of a criminal conviction but only substantial evidence that the criminal conduct occurred.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 1005

22-C DCMR § 1006 [RESERVED]

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 1006

22-C DCMR § 1007 PROHIBITION ON UNAUTHORIZED SALES

1007.1 A licensee shall not deliver, dispense, give, sell, or serve medical cannabis, medical cannabis products, or paraphernalia to the following persons at the time of purchase:

(a) A person who is not a registered qualifying patient, caregiver, or otherwise authorized to purchase medical cannabis, medical cannabis products, or paraphernalia; or

(b) A minor unless the person holds a valid and unexpired medical cannabis patient card issued by ABCA or another jurisdiction and is accompanied by a parent or legal guardian.

1007.2 No licensee shall permit the possession or consumption of medical cannabis or medical cannabis products by a minor at the licensed facility unless the minor:

is a qualifying patient at a Board-approved safe-use treatment facility, summer garden, or educational activity;

Holds a valid and unexpired medical cannabis patient card issued by ABCA or another jurisdiction; and

Is accompanied by a parent or legal guardian.

1007.3 Any stayed suspension days imposed by the Board shall activate and be served by the licensee upon a finding by the Board that the licensee has committed another violation of this section within one year of the date that the violation that resulted in the stayed suspension was adjudicated.

1007.4 It shall be an affirmative defense to a charge under this section that the licensee or the licensee’s agent was shown and inspected a fake or fraudulent identification document from the patient of such quality, and that lacked any of the indicia of a fake or fraudulent identification document, that a reasonable person would believe that it was valid. For the purposes of this subsection, if at the time of inspection, any of the following were present, the presumption shall be that a reasonable person would not believe that the identification document shown by the patient or the patient’s caregiver was valid:

(a) The identification was visibly damaged;

(b) The identification lacked the physical materials or features of the valid identification being imitated;

(d) The identification is displayed past the printed expiration date; or

(e) The licensee or their agent knew or had reason to know the person who self-certified to obtain a patient registration card from ABCA was under the age of twenty-one (21).

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 1007

22-C DCMR § 1008 ILLEGAL CONSUMPTION

1008.1 A licensee that does not hold a safe-use treatment facility endorsement, summer garden, or an education tasting endorsement shall not allow any person to consume, inhale, or otherwise use medical cannabis or medical cannabis products on the premises or possess medical cannabis or medical cannabis products on the premises in an open or unsealed container.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 1008

22-C DCMR § 1009 OPEN CONTAINERS

1009.1 No licensee shall knowingly permit a person to leave the premises with an open or unsealed container of medical cannabis or medical cannabis products.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 1009

22-C DCMR § 1010 MANDATORY REVOCATION

1010.1 The Board shall revoke the license of a licensee as a result of any of the following events during the period for which the license was issued:

(a) The licensee has been convicted of multiple violations of the terms of the Act or this title in accordance with 22-C DCMR § 6301.1(e);

(b) The licensee has knowingly permitted, in the licensed establishment:

(1) The illegal sale, or negotiations for sale, or the use, of any controlled substance identified in the Controlled Substances Act; or

(2) The possession, other than for personal use, or sale, or negotiations for sale, of drug paraphernalia in violation of the Controlled Substances Act or the Drug Paraphernalia Act of 1982, effective September 17, 1982 (D.C. Law 4-149; D.C. Official Code § 48-1101 et seq.), except for medical cannabis, medical cannabis products, and medical cannabis paraphernalia;

(c) The licensee has been convicted of a felony after the issuance of the license if the felony constitutes a crime of violence, a gun offense, tax evasion, fraud, or credit card fraud; or

(d) The licensee has been convicted of assaulting an ABCA investigator or other District government official while the investigator or other official was conducting an investigation or performing other governmental functions.

1010.2 For the purposes of this section:

(a) The term “personal use” means the possession of drug paraphernalia in circumstances where there is no evidence of an intent to distribute or manufacture a controlled substance; and

(b) Successive sales or negotiations for sale shall be deemed evidence of knowing permission.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 1010

22-C11 CONFIDENTIALITY OF RECORDS

22-C DCMR § 1100 MEDICAL CANNABIS PATIENT RECORDS

1100.1 The Board shall maintain a confidential list of qualifying patients and caregivers to whom it has issued registration identification cards.

1100.2 All information obtained by the Board relating to qualifying patients and caregivers shall be confidential and subject to the protections of the District's privacy laws and privileges, including specifically the following:

Applications and supporting information submitted by qualifying patients and caregivers;

Individual names and other identifying information about qualifying patients and caregivers;

Certifications issued by practitioners;

Information on identification cards; and

Information relating to the qualifying patient's medical condition(s).

1100.3 To the extent consistent with District and federal law, ABCA employees may access confidential records as necessary to perform their official duties.

1100.4 The Board shall verify to law enforcement personnel whether a registration identification card is valid.

1100.5 The Board may disclose confidential information in the course of any judicial or administrative proceeding in response to an order of the court, provided that the Board discloses only the information expressly authorized by such order.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10161 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 1100

22-C12 [RESERVED]

22-C DCMR § 1200 [RESERVED]

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10161 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 1200

22-C13 FEES

22-C DCMR § 1300 PATIENT AND CAREGIVER REGISTRATION FEES

1300.1 The registration, renewal, and replacement fees for a two (2) year patient or caregiver registration or other patient card are as follows:

(a) Initial registration fee for a qualifying patient - $0.00;

(b) Initial registration fee for a caregiver - $0.00;

Renewal fee for a caregiver - $0.00;

Replacement card fee - $10.00;

The fee for a physical patient or caregiver registration card beginning on August 11, 2023 - $10.00;

The fee for a 30-day temporary non-resident medical cannabis patient card shall be $30.00 until September 24, 2023;

Beginning on September 25, 2023, the fees for a temporary non-resident medical cannabis patient card fee are as follows:

Temporary non-resident medical cannabis patient card fee (3 days) - $10.00;

Temporary non-resident medical cannabis patient card fee (30 days) - $20.00;

Temporary non-resident medical cannabis patient card fee (90 days) - $50.00;

Temporary non-resident medical cannabis patient card fee (180 days) - $75.00; and

Temporary non-resident medical cannabis patient card fee (365 days) - $100.00.

1300.2 Notwithstanding the initial or renewal application fees for a qualifying patient set forth in § 1300.1(a)-(d), a qualifying patient who files an initial or renewal application by August 10, 2023, shall receive a two-year registration card at no cost.

1300.3 Beginning on August 11, 2023, ABCA shall only issue a qualifying patient or caregiver a digital registration card. On or after August 11, 2023, a qualifying patient or caregiver may request a physical card from ABCA for a fee of $10.00.

1300.4 A qualifying patient who establishes pursuant to § 1300.5 that their income level is equal to or less than two hundred percent (200%) of the federal poverty level, shall be entitled to purchase medical cannabis directly, or through a caregiver, on a sliding scale from a licensed internet retailer or retailer in the District of Columbia if the qualifying patient satisfies the Board of the following:

That the individual is a current Medicaid or DC Alliance recipient or eligible for Medicaid or to participate in the DC Alliance program; or

(b) Documentation verifying that the individual’s total gross income and other financial resources, including child support payments, alimony and rent payments received, and any other income received on a regular basis, is equal to or less than two hundred percent (200%) of the federal poverty level, as defined by the U.S. Department of Health and Human Services; and

income and existing financial resources to obtain a sufficient supply of medical cannabis.

1300.5 To verify income for the purposes of § 1300.4(b), an individual shall submit an affidavit providing the following, if applicable:

(a) Earning statements received within the previous thirty (30) days;

(b) District of Columbia or Federal tax filings for the most recent tax year;

(c) For newly employed applicants, a verifiable copy of an offer of employment that states the amount of salary to be paid;

(d) A copy of a social security or worker’s compensation benefit statement;

(e) Proof of child support or alimony received;

(f) Proof of any other unearned income or assets, including but not limited to, stocks, bonds, annuities, private pension and retirement accounts; and

(g) Any other item(s) of proof deemed by the Board, the Director or the Director’s agent reasonably calculated to demonstrate a person’s income.

1300.6 An individual shall submit the required verifying information set forth in § 1300.5 for each renewal or request for a replacement card in order to continue to purchase medical cannabis from a licensed internet retailer or retailer on a sliding scale.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10162 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 1300

22-C DCMR § 1301 PAYMENT OF MEDICAL CANNABIS FACILITY ANNUAL FEES

1301.1 Medical cannabis facility license fees shall be paid annually. The fee for the first year shall be paid within sixty (60) calendar days of Board approval but prior to license issuance. The renewal fee shall be paid on or before the anniversary date of issuance of the license.

1301.2 The applicant shall pay the annual license fee for the first year to the D.C. Treasurer. The applicant’s duplicate receipt shall accompany the annual license fee payment.

1301.3 A licensee’s failure to timely remit the annual license fee shall be cause for the Board to suspend a previously approved or issued license until the licensee pays the fee and any late fees imposed by the Board for late payment not to exceed the annual cost of the license. If a licensee is delinquent thirty (30) days or more on payment of the annual license fee, the Board shall give notice to the licensee of its intent to cancel the license. The licensee shall have fourteen (14) days to respond to the notice in writing. If the Board thereafter determines that the failure to pay the annual fee and late fee is not for good cause, the Board shall cancel the license.

1301.4 Nothing in this section shall preclude a medical cannabis business from paying in advance the second or third-year annual license fee.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 1301

22-C DCMR § 1302 APPLICATION FEES

1302.1 The application filing fees for standard medical cannabis business applicants are as follows:

Retailer, Internet Retailer, Cultivation Center - $8,000;

Manufacturer, Courier - $4,000;

Testing Laboratory - $0;

Transfer to New Location - $5,000;

Facility Capacity or Physical Plant Change - $2,000;

Transfer of Ownership Change - $2,000;

Change of Director, Officer, Member, Incorporator, or Agent - $100; and

Corporate or Trade Name Change - $100.

1302.2 The application filing fees for social equity medical cannabis business and substantial change applicants are as follows:

Retailer, Internet Retailer, Cultivation Center - $2,000;

Manufacturer, Courier - $1,000;

Testing Laboratory - $0;

Transfer to New Location - $5,000;

Facility Capacity or Physical Plant Change - $2,000;

Transfer of Ownership Change to Another Social Equity Applicant - $625;

Change of Director, Officer, Member, Incorporator, or Agent - $100; and

Corporate or Trade Name Change - $25.

The application filing fees for both standard and social equity applicants for a retailer endorsement or permit are as follows:

(a) Retailer Delivery Endorsement, Summer Garden Endorsement - $ 300;

(b) Safe-Use Treatment Facility Endorsement - $1,000;

(d) Certified Training Provider Permit - $100.

1302.4 The application fees for conditional licenses are as follows:

For a standard applicant for a cultivation center, manufacturer, retailer, internet retailer, or courier, the applicant shall pay an application fee of $800 and an additional $1,200 fee if approved;

For a social equity applicant for a cultivation center, manufacturer, retailer, internet retailer, or courier, the applicant shall pay an application fee of $200 and an additional $300 fee if approved;

For either a standard or social equity applicant for a testing laboratory, the applicant shall pay an application fee of $0;

For a standard applicant for a testing laboratory, the applicant shall pay a $0 fee if approved; and

For a social equity applicant for a testing laboratory, the applicant shall pay a $0 fee if approved.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 1302

22-C DCMR § 1303 LICENSE AND ENDORSEMENT FEES

1303.1 The annual license fees for standard cultivation center, manufacturer, internet retailer, retailer, courier, and testing laboratory licensees are as follows:

Cultivation Center Tier 1 -$11,000;

Cultivation Center Tier 2 -$16,000;

Cultivation Center Tier 3 -$21,000;

Cultivation Center Tier 4 -$26,000;

Cultivation Center Tier 5 -$31,000;

Cultivation Center Tier 6 -$36,000;

Manufacturer -$4,000;

Manufacturer and Extraction -$8,000;

Retailer -$16,000;

Internet Retailer License -$16,000;

Courier – $8,000; and

Testing Laboratory License -$7,500.

1303.2 The annual license fees for social equity cultivation center, manufacturer, internet retailer, retailer, courier, and testing laboratory licensees for the first three (3) years of operation shall be as follows:

Cultivation Center Tier 1 -$2,750;

Cultivation Center Tier 2 -$4,000;

Cultivation Center Tier 3 -$5,250;

Cultivation Center Tier 4 -$6,500;

Cultivation Center Tier 5 -$7,750;

Cultivation Center Tier 6 -$9,000;

Manufacturer -$1,000;

Manufacturer and Extraction -$2,000;

Retailer -$4,000;

Internet Retailer License -$4,000;

Courier – $2,000; and

Testing Laboratory License -$1,875.

1303.3 The annual endorsement and permit fees for both standard and social equity licensees are as follows:

Retailer Delivery -$300;

Summer Garden - $300;

Education Tasting - $130;

Safe-Use Treatment Facility - $2,000; and

Medical Cannabis Certification Training Permit - $300.

1303.4 The fee for a duplicate, replacement, or lost license, permit, or endorsement shall be $25.

1303.5 The fee for a returned or declined check shall be $100.

1303.6 Late fees for failing to timely renew a license shall be $50 per day, up to a maximum of the fee for the relevant license.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 1303

22-C DCMR § 1304 DETERMINING CULTIVATION CENTER TIER

1304.1 A cultivation center shall be deemed to qualify for a specific Tier for the purposes of assessing fees based upon the following criteria:

Tier 1 - Mature cannabis plant grow canopy area greater than 0 square feet but no more than 10,000 square feet;

Tier 2 - Mature cannabis plant grow canopy area greater than 10,000 square feet but no more than 25,000 square feet;

Tier 3 - Mature cannabis plant grow canopy area greater than 25,000 square feet but no more than 50,000 square feet;

Tier 4 - Mature cannabis plant grow canopy area greater than 50,000 square feet but no more than 75,000 square feet;

Tier 5 - Mature cannabis plant grow canopy area greater than 75,000 square feet but no more than 100,000 square feet; and

Tier 6 - Mature cannabis plant grow canopy area greater than 100,000 square feet.

1304.2 The size of the mature cannabis plant grow canopy area shall be assessed at the greatest size at any point or time during the licensing period for the entire license period.

1304.3 A cultivation center that permits the mature cannabis plant grow area to grow in size sufficient to qualify under a higher Tier shall pay the fee for the new Tier immediately upon reaching the new Tier or within thirty (30) days written notice provided by ABCA. A cultivation center that fails to pay the required fee shall be subject to the suspension of its license until the appropriate Tier fee is paid.

1304.4 A cultivation center shall not be able to obtain a refund should the mature cannabis plant growth area be reduced sufficiently to qualify for a lower Tier.

1304.5 The mature cannabis plant grow canopy area shall include all plant grow areas in the facility whether adjoined or in separate locations.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 1304

22-C DCMR § 1305 CANOPY MEASUREMENT

1305.1 In order to measure the cannabis grow canopy area to determine the appropriate Tier, the measurement shall be calculated in square feet and measured using clearly identifiable boundaries of all areas(s) that will contain flowering or vegetative plants larger than eight (8) inches tall and eight (8) inches wide at any point in time, including all of the space(s) within the boundaries.

1305.2 A canopy may be noncontiguous, but each separate area included in the total canopy calculations shall be separated by an identifiable boundary which includes: interior walls, shelves, greenhouse walls, hoop house walls, garden benches, hedge rows, fencing, garden beds, or garden plots. If flowering or vegetative plants larger than eight (8) inches tall and eight (8) inches wide are being cultivated using a shelving system, the surface area of each level shall be included in the total canopy calculation.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 1305

22-C DCMR § 1306 DETERMINING MANUFACTURER CATEGORY

1306.1 There shall be two types of manufacturing license categories:

(a) A Type 1 manufacturing license shall authorize the production of all medical cannabis products except for those authorized by a Type 2 manufacturing license; and

(b) A Type 2 manufacturing and extraction license shall be required if the medical cannabis facility intends to manufacture medical cannabis products utilizing hazardous materials, flammable and combustible liquids, compressed gases, cryogenic fluids, or extraction equipment that requires an operational permit from the Office of the Fire Marshal, Fire Prevention Division, DC Fire and Emergency Medical Services Department (Office of the Fire Marshal). A listing of when an operational permit is required from the Office of the Fire Marshal is set forth in Sections F-107.10.1 through F-107.10.43 of the D.C. Fire Prevention Code (2008).

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 1306

22-C14 MEDICAL CANNABIS ADVISORY COMMITTEE

22-C DCMR § 1400 COMPOSITION OF ADVISORY COMMITTEE

1400.1 The Advisory Committee (Committee) shall consist of seven (7) members, which shall be appointed as follows:

The Director of the Department of Behavioral Health or their designee;

The Director of the Department of Health or their designee;

The Director of ABCA or their designee;

Two (2) members appointed by the City Administrator, one (1) of which shall be a member of a internet retailer or retailer; cultivation center, or testing laboratory; and

Two (2) members appointed by ABCA's Director who shall be District residents and possess either a medical or science background that is relevant to the medical cannabis industry.

1400.2 The Director of ABCA or their designee, shall act as the chair of the Committee.

All actions of the Committee shall be taken pursuant to a vote of a majority of the members of the Committee. For purposes of determining the existence of a quorum, a quorum shall be deemed to mean a majority of the appointed members.

1400.4 The chairperson shall only vote in cases of a tie among Committee members.

1400.5 Each member of the Committee shall serve at the pleasure of the Mayor, the appointing agency director, or City Administrator. Public members of the Committee shall serve a maximum term of three (3) years from the date of appointment and may be reappointed.

1400.6 Members of the Committee shall not be compensated for time expended in the performance of their Committee duties.

History

SOURCE: Final Rulemaking published at 60 DCR 10061 (July 12, 2013); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 1400

22-C DCMR § 1401 DUTIES AND RESPONSIBILITIES OF THE ADVISORY COMMITTEE

1401.1 The Advisory Committee shall convene as needed to monitor best practices in other states, monitor scientific research on the use of medical cannabis, monitor the effectiveness of the District’s medical cannabis program, the adequacy of the medical cannabis supply in the District of Columbia, and make recommendations to the Mayor, the Council, the Board, or consult with other agencies.

The Committee shall conduct a fair and impartial proceeding, assure that the facts are fully elicited, and avoid delay. The chairperson shall have authority to take all measures necessary for the maintenance of order and for the efficient, fair and impartial resolution of issues that arise during public hearing proceedings or any public meeting in which a quorum of the Committee are present.

History

SOURCE: Final Rulemaking published at 60 DCR 10061 (July 12, 2013); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 1401

22-C DCMR § 1402 [REPEALED]

History

SOURCE: Final Rulemaking published at 60 DCR 10061 (July 12, 2013); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024). District of Columbia Municipal Regulations Medical Marijuana 22-C DCMR § 1402

22-C DCMR § 1403 [REPEALED]

History

SOURCE: Final Rulemaking published at 60 DCR 10061 (July 12, 2013); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024). District of Columbia Municipal Regulations Medical Marijuana 22-C DCMR § 1403

22-C19 INQUIRIES TO THE BOARD

22-C DCMR § 1900 COMPLAINTS

1900.1 The Board shall receive, at any time during the license period, complaints from any person, or an affected ANC, alleging a violation by a licensee of the terms of its license or an unlicensed person.

1900.2 Complaints shall be in writing and set forth enough information to allow the Board or its staff to investigate the matter.

1900.3 In addition to written complaints identifying the complainant, any person may make an anonymous complaint in writing to the Board or orally to any ABCA investigator.

1900.4 Anonymous complaints shall be investigated to the best of the Board’s ability but may result in no action being taken if an anonymous complainant fails to provide the Board or the ABCA investigator with sufficient information.

1900.5 All written complaints under this section that identify the complainant by name and address shall be responded to by the Board or its staff within ninety (90) days of receipt of the complaint. The response shall advise the complainant of the action that the Board or its staff has taken on the matter or provide a copy of the establishment’s investigative history.

1900.6 The Board shall maintain records documenting complaints received and the action taken in response to the complaint.

1900.7 In the case where a complainant has not received a timely response, the complainant may petition the Board to release a copy of the target licensee’s investigative history for review.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 1900

22-C DCMR § 1901 LETTERS OF INFORMATION

1901.1 Any person, group, licensee, or business organization may make a written request to the Board for general information concerning staff procedures, Board procedures, the Act, this title, or any other matter of a general nature affecting the licensing of medical cannabis in the District of Columbia.

1901.2 The Board shall respond to all such letters in writing and may refer the writer directly to a member of the ABCA Staff, to a specific section of the Act or this title, or to other District of Columbia government officials. The response may also suggest that the writer retain the services of an attorney to properly advise the individual as to how to proceed in a particular matter. If the writer’s inquiry is so broad, inexact, or vague that the Board is unable to respond, the Board shall so advise the writer and may request that the writer provide additional information.

1901.3 Any statement contained in the Board’s letters of information provides only general guidance to the writer and shall not be binding on the writer or binding on the Board if the Board is later presented with a more particularized factual situation. Further, the Board’s responses shall not provide any basis for appeal to any court in the District of Columbia.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 1901

22-C DCMR § 1902 ADVISORY OPINIONS

1902.1 Any ANC, person, group, licensee, or business organization may make a written request to the Board for an advisory opinion when:

(a) The requestor is confronted with a situation involving the Act or this title which requires, or may require, the individual to take action; and

(b) The legality or propriety of the action to be taken is not clear from the plain text of the Act or this title.

1902.2 Any request for an advisory opinion shall set forth sufficient information to allow the Board to understand the issues involved and to frame a response. The requestor shall also state which section of the Act or section of this title the requestor wishes the Board to interpret or clarify, with respect to the stated set of facts.

1902.3 If the requestor presents insufficient facts in any request for an advisory opinion, the Board may, in its discretion, issue a letter of information; engage in fact-finding through investigation or a discretionary hearing; request the requestor to provide by letter more facts or details in support of their request; or decline to issue an advisory opinion.

1902.4 The decision to issue or not issue an advisory opinion shall be solely in the discretion of the Board.

1902.5 If issued, an advisory opinion is not binding upon the requestor but shall constitute guidance to the requestor as to how the Board may interpret the Act or this title on a particular matter, the facts of which are consistent with those raised by the requestor. Where the requestor is also a licensee, the Board may issue a show-cause notice pursuant to § 6204 of this title in the instance where the facts raised by the requestor provide the Board with reasonable cause to believe that the licensee should be fined, suspended, or revoked.

1902.6 If the requestor disagrees with the Board’s advisory opinion in any respect, the individual may, within twenty (20) calendar days after issuance of the opinion, petition the Board in writing to reconsider its opinion, setting forth in detail the reasons and legal argument which support the requestor’s points of disagreement, or may request the Board to issue a declaratory order, pursuant to § 1903. Advisory opinions shall not be deemed a final order of the Board.

1902.7 All advisory opinions of the Board shall be made available to the public on the agency’s website.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 1902

22-C DCMR § 1903 DECLARATORY ORDERS

1903.1 Any ANC, person, group, licensee, or business organization may make a written request to the Board to issue a declaratory order in accordance with the DC APA regarding the applicability of the Act, this subtitle or any other statute or regulation enforceable by the Board, to terminate a controversy other than a contested case or to remove uncertainty regarding a specific factual situation. If the request for a declaratory order involves an existing settlement agreement, the Board, in its discretion, may decline to issue an order or require a party to provide notice of the request to the other signatories to an existing settlement agreement and permit the other parties to intervene in the matter.

1903.2 Any request for a declaratory order shall:

(a) Set forth a particular and specific set of facts; and

(b) State in detail the reasons for uncertainty as to the applicability of the Act, this title or other statutes enforceable by the Board or state in detail why a controversy exists.

1903.3 Any declaratory order issued by the Board shall state the Board’s Findings of Fact and Conclusions of Law. If the circumstances so warrant, the declaratory order may include an order by the Board to the requestor to cease and desist any practice or activity which is violative of applicable statutes or this title.

1903.4 All facts asserted in a request for a declaratory order shall be supported by sworn affidavit of the requestor. If the Board determines that further facts are necessary, it shall request the requestor to provide those facts by written affidavit or may receive those facts by stipulation at a non-contested case fact-finding hearing.

1903.5 Any requestor may appeal the order by petitioning the Board, in writing, within twenty (20) calendar days after issuance of the declaratory order, to reconsider its order by setting forth, in detail, either newly discovered facts or legal arguments that show one (1) or more errors of law in the Board’s order.

1903.6 All declaratory orders of the Board determined to be in the public interest in accordance with Section 9 of the DC APA (D.C. Official Code § 2-508), shall be published in the District of Columbia Register and shall be available for public inspection and copying at a reasonable charge at the offices of the Board.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 1903

22-C50 LICENSED MEDICAL CANNABIS BUSINESSES

22-C DCMR § 5000 MEASURING DISTANCES

5000.1 In establishing the distance between one (1) or more places, (such as the actual distance of a medical cannabis business from a school or recreation center, as defined in the Act), the distance shall be measured linearly by the Board and shall be the shortest distance between the property lines of the places.

5000.2 If a boundary line measured by the Board touches upon any portion of a parcel or lot, the parcel or lot shall be within the area being identified by the Board.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10164 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5000

22-C DCMR § 5001 COMPUTATION OF TIME

5001.1 In computing any period of time specified in this title, the day of the act, event, or default shall not be counted, and the last day of the period shall be counted unless it is a Saturday, Sunday, legal holiday, or day on which ABCA is officially closed, in which event the time period shall continue until the next day that is not a Saturday, Sunday, legal holiday, or day on which ABCA is not closed.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10164 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024). District of Columbia Municipal Regulations Medical Marijuana 22-C DCMR § 5001

22-C DCMR § 5002 Locations and Ownership

5002.1 An application for a medical cannabis business registration shall identify the proposed location of the medical cannabis business by street mailing address, including suite or unit number if applicable. No post office box numbers shall be permitted. An applicant shall not be permitted to alter, change, or substitute the proposed location of the medical cannabis business after the application has been submitted.

5002.2 A registration for a medical cannabis business shall be issued for the specific location identified on the application, and is valid only for the owner, premises, and name designated on the registration and the location for which it is issued.

5002.3 An application for a medical cannabis business registration shall clearly identify the individual applicant, partnership or limited liability company applicant, or corporate applicant as required under this subtitle. An applicant shall not be permitted to change the proposed ownership or controlling interest of the entity after the application has been submitted.

5002.4 A registration for a medical cannabis business and the authorization to apply for the registration upon approval by the Board, shall be issued for the specific individual applicant, partnership or limited liability company applicant, or corporate applicant as identified in the application.

5002.5 A medical cannabis business registration shall not be assigned, leased, or subcontracted, in whole or in part.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10164 (December 2, 2011); as amended by Final Rulemaking published at 60 DCR 10061 (July 12, 2013); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5002

22-C DCMR § 5003 [RESERVED]

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5003

22-C51 REGISTRATION AND PERMIT CATEGORIES

22-C DCMR § 5100 REGISTRATION PERIODS

5100.1 Each license issued by the Board shall be valid for three (3) years unless otherwise stated in this title, except in the following circumstances:

(a) When suspended or revoked; and

(b) When the registration takes effect on a date in between the dates established by the Board for the regular renewal registration period, in which case the registration shall be valid only until the end of the registration period.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10165 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5100

22-C DCMR § 5101 RENEWAL PERIODS

5101.1 The three (3) year renewal period for each medical cannabis facility license listed below shall occur sequentially every three (3) years starting with the following dates:

License Classification Licensure Period Ending Year

Courier Jan. 1 to Dec. 31 2024

Cultivation Center Jan. 1 to Dec. 31 2025

Internet Retailer Jan. 1 to Dec. 31 2023

Manufacturer Jan. 1 to Dec. 31 2025

Retailer Jan. 1 to Dec. 31 2023

Testing Laboratory Jan. 1 to Dec. 31 2024

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10166 (December 2, 2011); as amended by Final Rulemaking published at 65 DCR 7565 (July 20, 2018); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5101

22-C DCMR § 5102 EXTENSION OF EXPIRATION DATES OF PROTESTED REGISTRATIONS

5102.1 Unless a registration is otherwise summarily suspended under this subtitle, the registration of a medical cannabis business that has received written notice of the Board's intent not to renew the registration shall continue in effect until such time as the Board has taken final action on the registration.

5102.2 In the case of applications for the renewal of a registration or for transfer to a new owner, the registration shall continue in effect until the Board has taken final action on the registration.

5102.3 A registration that is continued under this chapter shall be continued in effect only for purposes of the original location. No operations shall take place at a new location until a new registration has been issued for that location.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10166 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5102

22-C DCMR § 5103 REGISTRATION AND PERMIT FEES

5103.1 All application, registration, and permit fees shall be paid by credit card, certified check, money order, business check, attorney's check, or personal check payable to the D.C. Treasurer. Applicants shall pay the fees specified by the Board at the time an application is filed. All fees are nonrefundable.

5103.2 The annual fee for each director, officer, member, incorporator, or agent registration shall be two hundred dollars ($200).

5103.3 The annual fee for an employee registration shall be seventy-five dollars ($75).

5103.4 The annual fee for a Manager's registration shall be one hundred fifty dollars ($150).

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10166 (December 2, 2011).as amended by Final Rulemaking published at 65 DCR 7565 (July 20, 2018); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5103

22-C DCMR § 5104 [REPEALED]

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10167 (December 2, 2011); as amended by Final Rulemaking published at 60 DCR 10061 (July 12, 2013); as amended by Final Rulemaking published at 65 DCR 7565 (July 20, 2018). District of Columbia Municipal Regulations Medical Marijuana 22-C DCMR § 5104

22-C DCMR § 5105 MEDICAL CANNABIS CERTIFICATION PROVIDER PERMIT

5105.1 A person or entity wishing to become a medical cannabis certification provider shall obtain a medical cannabis certification provider permit which shall allow the holder to provide a medical cannabis training and education certification program in the District of Columbia. For purposes of this section, a "medical cannabis certification provider" shall mean any person or entity approved by the Board to conduct a medical cannabis and education training program as set forth in § 5105.2.

5105.2 A medical cannabis certification provider shall include the following subjects in its education training program; which shall be submitted to the Board for approval:

(a) The effect medical cannabis use has on the body and behavior, especially as to driving ability, and that driving under the influence of cannabis is prohibited under the Act;

(b) Procedures for the proper handling and dispensing of medical cannabis to qualifying patients and caregivers;

(d) Prevention techniques involving effective identification and carding procedures;

(e) Explanation of the Legalization of Cannabis for Medical Treatment Amendment Act of 2010 and Federal law relating to cannabis and ensuring compliance with this title and District law;

(f) Advertising, promotion, and marketing of medical cannabis; and

(g) Security and theft prevention.

5105.3 An application for a medical cannabis certification provider permit shall:

(a) Be completed on a form provided by the Board;

(b) Include a copy of the proposed training materials, curriculum, and examinations; and

5105.4 The Board shall make the final determination as to the qualifications of the applicant and compliance of the applicant's program with § 5105.2, and may require a fact-finding hearing with the applicant prior to issuing its decision.

5105.5 Approval of a medical cannabis training and education program shall expire after three (3) years from the date of the course obtaining approval. The applicant shall resubmit a program to the Board for approval as part of its application to renew its medical cannabis certification provider permit.

5105.6 A medical cannabis certification provider permit shall be valid for three (3) years.

5105.7 When a person completes the approved education training program provided by a medical cannabis certification provider, the provider shall issue the person a medical cannabis training certificate. The certificate shall be valid for three (3) years and may be reissued to the holder upon completion of the training necessary to qualify for the initial certificate.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10168 (December 2, 2011); as amended by Final Rulemaking published at 65 DCR 7565 (July 20, 2018); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5105

22-C DCMR § 5106 MANAGER LICENSE

5106.1 A manager’s license shall authorize the licensee to manage a licensed medical cannabis business.

5106.2 The holder of a manager’s license may be employed by one or more licensed medical cannabis facilities without further investigation, subject to compliance by the licensed business. A manager’s license issued to a manager may be utilized by the manager at any licensed medical cannabis facility.

5106.3 A manager shall complete a medical cannabis training and education program conducted by a Board approved provider. The manager shall be recertified every 3 years from the date of the initial certification.

5106.4 A manager required to complete a medical cannabis training and education Program under this section shall submit proof of certification to the Board on a form supplied by a Board-approved training provider.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10169 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5106

22-C DCMR § 5107 [RESERVED]

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10166 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5107

22-C DCMR § 5108 [RESERVED]

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10166 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5108

22-C DCMR § 5109 [RESERVED]

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10166 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5109

22-C DCMR § 5110 NON-TRANSFERABLE REGISTRATION CARDS

5110.1 All persons required to register with the Board shall receive and wear on their person, while working in a restricted access area at a medical cannabis business, a non-transferable uniform registration identification card from the Board.

5110.2 The non-transferable registration card shall be presented by a manager, director, officer, member, incorporator, agent and employee of a medical cannabis business to a Board investigator to confirm that the person is authorized to cultivate, dispense, distribute, possess, test, or transport medical cannabis, or to manufacture, possess, or distribute paraphernalia.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10171 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5110

22-C52 REGISTRATION LIMITATIONS

22-C DCMR § 5200 DISTANCE REQUIREMENTS

5200.1 A medical cannabis business, except for a courier license, shall not locate within three hundred feet (300 ft.) of a preschool, primary or secondary school, or recreation center unless the main entrance to the preschool, primary, or secondary school, or recreation center, or the nearest property line of the school or recreation center, is actually on or occupies ground zoned commercial or industrial according to the official atlases of the Zoning Commission of the District of Columbia.

5200.2 No new retailer license shall be issued for a location that is within four hundred feet (400 ft.) of another retailer.

5200.3 An academy or other facility providing educational services operated by the Department of Youth Rehabilitation Services or the D.C. Department of Corrections at a residential facility subject to mandatory detention at the facility shall not be deemed to be a school.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10172 (December 2, 2011); as amended by Final Rulemaking published at 64 DCR 12676 (December 15, 2017); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5200

22-C DCMR § 5201 REGISTRATION APPLICATIONS NEAR SCHOOLS AND RECREATION CENTERS

5201.1 A dispensary, cultivation center, or testing laboratory shall not locate within three hundred feet (300 ft.) of a preschool, primary or secondary school, or recreation center.

The three hundred foot (300 ft.) distance shall be measured in accordance with the provisions of § 5000 of this subtitle.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10172 (December 2, 2011); as amended by Final Rulemaking published at 64 DCR 12676 (December 15, 2017); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019). District of Columbia Municipal Regulations Medical Marijuana 22-C DCMR § 5201

22-C53 GENERAL REGISTRATION REQUIREMENTS

22-C DCMR § 5300 DENIAL OF REGISTRATION FOR VIOLATIONS OF LAW

5300.1 The Board may deny registration to an applicant if evidence shows that the applicant has permitted conduct at the medical cannabis business which is in violation of this subtitle.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10172 (December 2, 2011); as amended by Final Rulemaking published at 64 DCR 12676 (December 15, 2017); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5300

22-C DCMR § 5301 CERTIFICATE OF OCCUPANCY AND PERMITS

5301.1 A registration may not be issued for a medical cannabis business unless the applicant obtains a valid certificate of occupancy for the premises in which the business for which the registration is sought is located, and is also the holder of all other licenses and permits required by law or regulation for that business. A registration for a medical cannabis business shall not be issued for any premises located within a residentially zoned district.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10172 (December 2, 2011); as amended by Final Rulemaking published at 64 DCR 12676 (December 15, 2017); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5301

22-C DCMR § 5302 REGISTRATION APPROVAL BEFORE ISSUANCE OF CERTIFICATE OF OCCUPANCY

5302.1 The Board is authorized, in its discretion, to approve the granting of a registration for a medical cannabis business, subject to all other requirements of the Act or this subtitle, to an applicant prior to the issuance of a certificate of occupancy for the building in which the registered premises shall be located, if the Board finds to its satisfaction the following:

(a) That an applicant for registration has entered into a bona fide agreement with the owner of the building proposed to be constructed or remodeled;

(b) That, under the bona fide agreement, the applicant has agreed to lease, purchase, or otherwise occupy all or a portion of the building for the applicant's use in carrying on the business which would be authorized by the registration;

(c) That the agreement provides that all or the portion of the proposed building to be occupied for business purposes registered under this chapter is to be constructed or remodeled in accordance with specifications set forth in the agreement;

(d) That the agreement describes the quarters as reasonably adequate and appropriate for the business to be carried on under the authority of the registration;

(e) A zoning determination letter issued by DCRA, which reflects that the zoning of the premises to be registered will allow the issuance of the registration; and

(f) That the applicant shall not engage in the purchase, sale, possession, or testing of medical cannabis unless and until a certificate of occupancy and all other business licenses have been issued for the business.

5302.2 An application for a registration under § 5302.1 shall be made on forms prescribed by the Board and shall include the following information:

(a) The street address of the establishment to be registered or, in the case of new construction, the lot and square numbers of the ground upon which the establishment will be located; and

(b) The date on which the applicant plans to open the establishment.

5302.3 A registration approved by the Board under § 5302.1 shall not be issued until the premises has been finally inspected by the Board, and until the applicant provides to the Board the following:

(a) A certificate of occupancy for the registered premises;

(b) Copies of all necessary business licenses for the premises;

(d) Copies of an executed lease or deed for the registered premises, provided, however, that the business terms of the lease including the rent may be redacted by the applicant; and

(e) All necessary approvals required under this title from the Metropolitan Police Department (MPD), DCRA, and the Board.

Applicants for registration under § 5302.1 shall pay the appropriate registration fee, as set forth in this subtitle, and approval by the Board shall remain effective for one hundred twenty (120) days from the date of the approval, except that the Board may grant an extension at its discretion for good cause shown.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10172 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5302

22-C DCMR § 5303 FAILURE TO OPEN OR OPERATE

5303.1 A registration for a medical cannabis business shall be returned to the Board if the medical cannabis business fails to open for business within one hundred twenty (120) days after the registration has been issued, except that the Board may grant an extension at its discretion for good cause shown.

5303.2 A registration for a medical cannabis business shall be returned to the Board if the medical cannabis business fails to operate for any reason for more than sixty (60) consecutive days after it has opened for business.

5303.3 An applicant that has been deemed eligible for a internet retailer or retailer registration shall complete the steps to obtain a registration and open for business within one hundred twenty (120) days from the date of receipt of the notice of selection.

5303.4 Except as provided in § 5303.6, if an applicant that has been deemed eligible for a internet retailer or retailer registration, or a registrant that has received a internet retailer or retailer registration, fails to open for business within one hundred twenty (120) days, the Board shall withdraw the applicant’s selection, and consider the next highest-ranking applicant. If a registration has been issued, the registrant shall surrender and return the registration to the Board.

5303.5 If there are no applications pending, the Board may open the application process to select a replacement medical cannabis business applicant.

5303.6 The Board may grant an applicant that has been deemed eligible for a internet retailer or retailer registration an extension at its discretion for good cause shown.

5303.7 The Board may hold a safekeeping hearing pursuant to § 6209 to determine whether to extend or cancel a registration for a medical cannabis business under this section.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10174 (December 2, 2011); as amended by Final Rulemaking published at 65 DCR 5172 (May 11, 2018); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5303

22-C54 REGISTRATION APPLICATIONS

22-C DCMR § 5400 QUALIFICATIONS FOR LICENSURE

5400.1 Before issuing, or renewing a registration or permit for either a business applicant or an individual applicant, the Board shall determine that the applicant meets all of the following criteria:

The applicant is of good character and generally fit for the responsibilities of registration;

The applicant is at least twenty-one (21) years of age;

(c) The applicant has not had a felony conviction for a crime of violence as defined in D.C. Official Code § 23-1331(4), a gun offense, tax evasion, fraud, or credit card fraud within the three (3) years preceding the date the application is filed with ABCA unless the applicant demonstrates rehabilitation and fitness for licensure in accordance with section 7 of the Act (D.C. Official Code § 7-1671.06);

(d) The applicant has paid the annual fee;

(e) The applicant is not a licensed authorized practitioner making patient recommendations;

(f) The applicant is not a person whose authority to be a caregiver or qualifying patient has been revoked by the Board; and

(g) The applicant has complied with all the requirements of the Act and this chapter.

5400.2 The Board shall not register either a business applicant or an individual applicant that has failed to file required District tax returns or owes more than one hundred dollars ($100) in outstanding debt to the District as a result of the items specified in D.C. Official Code: § 47-2862(a)(1) through (6) subject to the exceptions specified in D.C. Official Code § 47-2862(b).

5400.3 In addition to the requirements of § 5400.1, an applicant for a licensed medical cannabis facility shall demonstrate to the satisfaction of the Board that the applicant is the true and actual owner of the facility for which the license is sought and the individual intends to carry on the business for himself or herself and not as the agent of any other individual, partnership, association, limited liability company, or corporation not identified in the application.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10174 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5400

22-C DCMR § 5401 OPEN APPLICATION PERIOD

5401.1 Applications for a new medical cannabis business license shall only be accepted by the Board during an open application period as specified by the Board by publishing a Notice in the District of Columbia Register. The period selected by the Board shall not be extended.

5401.2 An application for a new testing laboratory may be filed with the Board at any time.

5401.3 At the start of each open application period for a new cultivation center, manufacturer, internet retailer, retailer, or courier license the Board shall publish a notice in the District of Columbia Register setting forth the process for submission of the applications, which shall include:

The opening and ending dates for the submission of applications for a new cultivation center, manufacturer, internet retailer, retailer, or courier license;

The address and email address to submit an application to the Board; and

The process for obtaining application materials from the Board.

5401.4 The Notice required in § 5401.3 of this chapter shall appear, at a minimum, in the District of Columbia Register and on ABCA’s website.

5401.5 At the start of each open application period for new medical cannabis business registrations, the Board shall publish a notice in the District of Columbia Register setting forth the process for submission of the applications, which shall include:

Until June 1, 2022, the opening and ending dates for the submission of Letters of Intent to the Board by all individuals and entities who intend to apply for medical cannabis business registrations;

Until June 1, 2022, the opening and ending dates for the submission of applications for a medical cannabis business registration by those individuals and entities that have timely submitted Letters of Intent to the Board, meeting the requirements set forth in § 5401.4 of this chapter. After June 1, 2022, an applicant shall no longer be required to submit a Letter of Intent to the Board to file an application.

Until June 1, 2022, a statement that only the individuals and entities that timely submit Letters of Intent to the Board, meeting the requirements set forth in § 5401.4 of this chapter, shall be permitted to submit an application for a medical cannabis business registration;

The address for submission to the Board; and

The process for obtaining application materials from the Board.

5401.6 The Notice required in § 5401.5 of this chapter shall appear, at a minimum, in the

District of Columbia Register and on ABCA's website.

5401.7 Applicants shall file a separate Letter of Intent and a separate application for each registration sought.

5401.8 An applicant may apply for or hold more than one (1) cultivation center registration, but may apply for or hold only one (1) internet retailer or retailer registration or testing laboratory registration.

5401.9 An applicant for a testing laboratory shall not apply for or have a medical cannabis business registration.

5401.10 Until June 1, 2022, only the individuals and entities that timely submitted Letters of Intent to the Board, and received a letter of acceptance from the Board, shall be permitted to submit an application for a medical cannabis business registration.

5401.11 A motion for reconsideration may be filed by the applicant within ten (10) calendar days of receipt of the denial of the Letter of Intent.

5401.12 The motion for reconsideration filed in accordance with § 5401.11 shall be in writing.

5401.13 The Board shall grant a motion for reconsideration for good cause shown.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10175 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5401

22-C DCMR § 5402 APPLICATION REQUIREMENTS

5402.1 A person applying for issuance, transfer to a new owner, or renewal of a license, endorsement, or permit, or for approval of substantial changes in operation, including a transfer to a new location related to a licensed medical cannabis facility, shall file with the Board an application in the form prescribed by the Board.

5402.2 The application shall contain the information set forth in this chapter and any additional information that the Board may require.

5402.3 A separate application shall be filed for each medical cannabis facility for which a license is sought.

5402.4 The Board may require an applicant to submit additional documents and information needed to properly process an application.

5402.5 The Board shall not accept as filed, and shall take no action upon, any application that is not complete.

5402.6 An applicant for a medical cannabis business may amend or correct its license application at any time prior to Board approval.

5402.7 Any changes to an applicant’s listed contact information, including mailing address, e-mail address, and telephone number, and other information as required by this chapter and provided on its license application that has been submitted to or approved by the Board shall be reported to ABCA within thirty (30) calendar days of the change. The failure to comply with this subsection after a written warning has been issued concerning the licensee’s timely compliance shall be deemed a violation if not corrected within fifteen (15) days of receipt of the warning.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10172 (December 2, 2011); as amended by Final Rulemaking published at 64 DCR 13490 (December 29, 2017); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5402

22-C DCMR § 5403 APPLICATION CONTENTS

5403.1 The application of a person or entity applying for a medical cannabis business license shall include:

In the case of a partnership or limited liability company applicant, the names and addresses of each member of the partnership or limited liability company and their ownership shares;

In the case of a corporation, the legal name of the corporation, the proposed trade name of the business, place of incorporation, principal place of business, and the names and addresses of each of the corporation’s principal officers, directors, and shareholders holding, directly or beneficially, one percent (1%) or more of its common stock;

Whether the corporation is for-profit or non-profit;

The name, address, telephone number, and e-mail address of the owners of the medical cannabis facility for which the license is sought;

The address of the premises where the license is sought;

The name and e-mail address of either an owner of the medical cannabis facility or the owner’s designee, for purposes of receiving communications from ABCA, including correspondence, hearing notices and other types of service of process, and Board orders;

The type of license, endorsements, and other permits sought through submission of the application;

The proximity of the facility to the nearest public or private, elementary, middle, charter, junior high, or high school and recreation center, and the name of the school and recreation center;

Proposed hours of operation of the facility; hours of sale of medical cannabis and medical cannabis products; summer garden hours; and safe-use treatment facility hours if applicable;

The size and design of the facility, which shall include the number of occupants permitted both inside and on any safe-use treatment facility or summer garden;

The location of all restricted access areas closed to the public;

An affidavit that complies with § 47-2863;

Documents or other written statements or evidence establishing to the satisfaction of the Board that the person applying for the license, endorsement, or permit meets all of the qualifications set forth in the Act and this subtitle;

The size and design of the facility;

A lease or deed for the proposed location;

A zoning certificate authorizing the proposed business activity or a certificate of occupancy for the proposed location;

A food manufacturing permit and other permits from the Department of Health, if required;

An operational permit from the Office of the Fire Marshal, if required.

A certificate of good standing for the corporation;

A site plan showing the entire structure of the medical cannabis facility, including the street(s), parking lot(s), other tenants within the facility, any other entities in facilities that physically border the applicant; and the area designated for trash disposal; and

The medical cannabis facility applicant acknowledgment attestation form.

5403.2 An applicant for a medical cannabis business license shall file a security plan with their application.

5403.3 If protested by an affected Advisory Neighborhood Commission, the applicant for a cultivation center, manufacturer, internet retailer, or retailer license shall also provide information at the Board protest hearing related to the appropriateness of the facility regarding:

The facility’s impact on peace, order, and quiet, including measures to prevent noise disturbances and litter, and measures to foster public safety;

The facility’s impact on residential parking and vehicular and pedestrian safety, including the availability of parking at or near the establishment and the proximity of the business to public transportation and shared transportation services (e.g., Metro, bus, bike share station); and

The facility’s impact on real property values, including measures to prevent blight and maintain its building and efforts to prevent odor nuisances from impacting neighboring properties, and whether the property was subject to any building code violations while under the ownership or control of the applicant, and whether the violations indicated have been resolved.

5403.4 An applicant for any license shall advise the Board, in the application, as to the source of funds used to acquire or develop the business for which the license is sought.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10172 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5403

22-C DCMR § 5404 APPLICATION FOR A SUBSTANTIAL CHANGE

5404.1 A licensee shall obtain the approval of the Board by filing an application for a substantial change, if not initially approved as part of the licensee’s initial application, prior to:

(1) Changing or expanding its location;

(2) Increasing the facility’s plant capacity or physical plant count to another tier, if a cultivation center;

(3) Adding a safe-use treatment facility or summer garden;

(4) Extracting medical cannabis if not previously permitted or authorized;

(5) Increasing the hours of operation, delivery, or the hours of sale, service, or consumption of cannabis at the premises, the safe-use treatment facility, or the summer garden; or

(6) Increasing the physical occupancy or capacity of the premises, the safe-use treatment facility, or the summer garden or allowing or permitting more persons than permitted by the Board.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10185 (December 2, 2011); as amended by Final Rulemaking published at 60 DCR 10061 (July 12, 2013); as amended by Final Rulemaking published at 64 DCR 13490 (December 29, 2017); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5404

22-C DCMR § 5405 ABANDONMENT OF APPLICATION

5405.1 The Board may deem an application abandoned or withdrawn if an applicant fails to provide any additional documents within thirty (30) days of a request from ABCA or the Board for additional or required information.

5405.2 An applicant may seek an extension of time to submit documents needed to process the application upon a showing of good cause. An extension granted by the Board shall not exceed thirty (30) days.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10189 (December 2, 2011).; as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5405

22-C DCMR § 5406 APPLICATION CERTIFICATION AND SIGNATURE

5406.1 An individual applicant, all of the general partners of an applicant partnership, all of the members of a limited liability company, or the president or vice-president of an applicant corporation shall sign a statement with an original signature, which may be a signature by wet ink, an electronic signature, or a copy thereof, certifying that the application is complete and accurate, and agreeing to all certifications required by the Board.

5406.2 The medical cannabis facility application of a person or entity applying for a medical cannabis business license shall state each of the following notices:

Limitation of Liability -- To the extent provided by Section 12 of the Act (D.C. Official Code § 7-1671.11), the District of Columbia shall not be liable to the registrant, its employees, agents, business invitees, licensees, customers, clients, family members or guests for any damage, injury, accident, loss, compensation, or claim, based on, arising out of, or resulting from a person’s participation in the District of Columbia’s medical cannabis program, including but not limited to the following: any fire, robbery, theft, mysterious disappearance, or any other casualty; or injury arising from the use of medical cannabis obtained through the program. This Limitation of Liability provision shall survive expiration or the earlier termination of this registration if such registration is granted; and

Federal Prosecution - The United States Congress has determined that cannabis is a controlled substance and has placed cannabis in Schedule I of the Controlled Substance Act. Growing, distributing, and possessing cannabis in any capacity, other than as a part of a federally authorized research program, is a violation of federal laws. The District of Columbia’s law authorizing the District’s medical cannabis program will not excuse any licensee from any violation of the federal laws governing cannabis or authorize any licensee to violate federal laws.

Knowledge of Law – The applicant swears or affirms that the ownership is sufficiently familiar with the District of Columbia’s medical cannabis laws to superintend a medical cannabis business and has the ability to ensure the business complies with the law.

True and Actual Owner- The applicant is the true and actual owner of the business for which the license is sought and that he or she intends to carry on the business for himself or herself and not as the agent of any other individual, partnership, association, or corporation not identified in the application; and that the licensed establishment will be managed by the applicant in person or by a manager approved by the Board.

5406.3 As part of the application process, every applicant for a licensed medical cannabis business shall sign a written statement attesting to the following:

The applicant acknowledges receipt and advisement of the notices set forth in § 5406.2 of this subtitle;

The applicant agrees to and accepts the limitation of liability against the District, and the requirement to indemnify, hold harmless, and defend the District, as set forth in § 5406.2 of this subtitle;

The applicant assumes any and all risk or liability that may result under District of Columbia or federal laws arising from the possession, use, cultivation, administration, dispensing, or testing of medical cannabis;

The applicant understands that the medical cannabis laws and enforcement thereof by the District of Columbia and the Federal government are subject to change at any time; and

The applicant chooses to sign this attestation willingly and without reservation and is fully aware of its meaning and effect.

5406.4 The making of a false statement, whether made with or without the knowledge or consent of the applicant, shall, in the reasonable discretion of the Board based on the materiality and willfulness of the false statement, constitute sufficient cause for denial of the application or revocation of the license.

5406.5 A person shall not knowingly submit an altered document or application to the Board for the purpose of deceiving the Board. The submission of an altered document intended to deceive the Board, may, at the reasonable discretion of the Board, constitute sufficient cause for denial of the application or revocation of the license.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10191 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5406

22-C DCMR § 5407 BOARD AUTHORITY TO ISSUE LICENSES

5407.1 The Board may issue medical cannabis facility licenses to persons who meet the requirements set forth in the Act and the regulations.

5407.2 All medical cannabis facility licenses issued under this title, unless otherwise stated, shall be valid for a term of three (3) years and may be renewed upon completion of the procedures set forth in the Act and this title and payment of the required fees.

5407.3 A license to sell medical cannabis, medical cannabis products, and paraphernalia in the District can be granted only by the Board upon completion of the application and review process as contained in the Act and this title.

5407.4 Unless otherwise stated in the Act or this title, each license or permit shall particularly describe the place where the rights of the license are to be exercised.

5407.5 The Board, in issuing licenses, may require that certain conditions be met if it determines that the inclusion of the conditions will be in the best interest of the locality, section, or portion of the District where the licensed facility is to be located. The Board, in setting the conditions, shall state, in writing, the rationale for the determination.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10185 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5407

22-C DCMR § 5408 DIRECTOR, OFFICER, MEMBER, INCORPORATOR, AND AGENT REGISTRATION REQUIREMENTS

5408.1 The application for a director, officer, member, incorporator, or agent registration shall include:

(a) Written statements or evidence establishing to the satisfaction of the Board that the applicant meets all of the registration qualifications; and

(b) An individual who has been approved by the Board as a director, officer, member, incorporator, or agent shall not be required to register as an employee or manager. However, nothing in this subsection shall obviate the requirement in Subsection 5604.1 that in the absence of an owner, a licensed medical cannabis business is required to have a Board-approved manager present at the licensed establishment during the hours that the licensed medical cannabis business is open.

5408.2 An applicant for a non-profit or for-profit corporation, partnership, or limited liability company shall identify all of its directors, officers, members, or incorporators on its registration application. An applicant for a medical cannabis business may submit simultaneously registration applications for individual directors, officers, members, incorporators and agents at the time its medical cannabis business registration application is filed.

5408.3 During the pendency of the public emergency issued by the Mayor in response to the COVID-19 pandemic, an owner of a licensed medical cannabis business may request that the Board issue a temporary registration card to an agent valid for forty-five (45) days provided, that the following information is provided:

A completed facility employment application for the prospective agent;

A written statement from the medical cannabis business attesting that the agent has been selected to work at their facility; and

A signed attestation from the prospective agent confirming that he or she:

Has not been convicted of a crime of violence, a gun offense, tax evasion, fraud, or credit card fraud within the three (3) years prior to filing the application; and

Has not previously had their authority to participate in the Medical Cannabis Program revoked by Department of Health or the Board.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10194 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5408

22-C DCMR § 5409 EMPLOYEE REGISTRATION REQUIREMENTS

5409.1 The application for an employee registration shall include:

(a) Written statements or evidence establishing to the satisfaction of the Board that the applicant meets all of the registration qualifications.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10194 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5409

22-C DCMR § 5410 MANAGER LICENSE REQUIREMENTS

5410.1 The application for a manager registration shall include:

(a) A notarized written statement from the applicant that they have read the Act and this title and have knowledge of District and federal law relating to cannabis;

(b) Written statements or evidence establishing to the satisfaction of the Board that the applicant meets all of the registration qualifications; and

5410.2 The medical cannabis and education certificate requirement shall not take effect until sixty (60) days after the effective date of these regulations. An individual who has been approved by the Board as a manager shall not also be required to register as an employee.

5410.3 An owner of a medical cannabis business may request that the Board issue a temporary license card to a manager valid for forty-five (45) days.

5410.4 The temporary registration card issued pursuant to § 5410.3 shall expire after forty-five (45) days or upon approval or denial of the manager's registration application.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10195 (December 2, 2011).; as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5410

22-C DCMR § 5411 CRIMINAL BACKGROUND CHECKS

5411.1 Each applicant for a medical cannabis business license, except for an applicant for an agent, employee, or manager registration, shall be required to undergo a criminal background check prior to being registered or licensed. In the case of an applicant for a non-profit or for-profit corporation, a criminal background check shall be conducted on all of its directors, officers, members, and incorporators.

5411.2 Except for social equity applicants, ABCA shall not require the submission of a criminal background check for a director, officer, member, or incorporator until the agency deems the applicant otherwise qualified for licensure and its license application accepted by the agency.

5411.3 Consistent with D.C. Official Code § 7-1671.06(u)(2)(A), ABCA’s determination that an applicant is qualified, or its license or registration application should be accepted does not overrule the Board’s authority to deem the applicant qualified or unqualified, hold a qualifications hearing, or to otherwise deem the applicant unfit for licensure.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10194 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5411

22-C DCMR § 5412 LICENSE PROHIBITED IN RESIDENTIAL USE DISTRICT

5412.1 No license shall be issued to a medical cannabis business located in a residential-use district as defined in the Zoning Regulations and shown in the official atlases of the Zoning Commission for the District.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10195 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5412

22-C DCMR § 5413 RESTRICTIONS ON OWNERSHIP AND HOLDING A CONFLICTING INTEREST

1 The holder of a testing laboratory license shall not hold, own, control or have any beneficial or other financial interest in a cultivation center, manufacturer, internet retailer, retailer, or courier license.

5413.2 The holder of a courier license shall not hold, own, control or have any beneficial or other financial interest in a cultivation center, manufacturer, internet retailer, retailer, or testing laboratory license.

5413.3 The holder of a cultivation center license shall not hold, own, control, or have any beneficial or other financial interest in more than two (2) cultivation center licenses.

5413.4 The holder of a retailer or internet retailer license shall not hold, own, control, or have any beneficial or other financial interest in a combined number of more than three (3) internet retailer and retailer licenses.

5413.5 The holder of a cultivation center license shall not hold, own, control or have any beneficial or other financial interest in more than one retailer license.

5413.6 The holder of an internet retailer license shall not hold, own, control or have any beneficial or financial interest in a cultivation center license.

5413.7 The Board may fine as set forth in the schedule of civil penalties, suspend, and revoke the license of a person that obtains ownership or control of a license, whether in whole or in part, in violation of this section or permit the person to place the license in safekeeping for a period not to exceed one hundred and eighty (180) days to facilitate the sale, transfer, divestment or other action necessary to comply with this section.

5413.8 It shall be a violation for a licensee to obtain an interest prohibited by this section.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10196 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5413

22-C DCMR § 5414 RENEWAL APPLICATION

5414.1 An applicant for license renewal shall self-certify the accuracy of its application, including any changes in ownership or other documents and submissions constituting a part of the application for its initial license or, if appropriate, at the time of application by the medical cannabis facility for a substantial change in operation.

5414.2 Each license for a medical cannabis business issued by the Board shall be valid for three (3) years, except in the following circumstances:

(a) When suspended or revoked; or

(b) When the license takes effect on a date in between the dates established by the Board for the regular renewal licensing period, in which case the license shall be valid only until the end of the license period.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10196 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5414

22-C DCMR § 5415 SECURITY PLAN

5415.1 All medical cannabis businesses shall be required to file with their initial application and maintain a written and compliant security plan with the Board.

5415.2 A compliant security plan shall fully provide or describe the following:

(a) A statement on the type of security training provided for, and completed by, establishment personnel, which shall include conflict resolution, handling robberies and violent incidents, and medical emergencies;

(b) Procedures for handling violent incidents, other emergencies, and calling the Metropolitan Police Department;

(d) A site and floor plan detailing:

(1) All entrances and exits to the facility;

(2) The location of any windows, skylights, roof hatches, and outdoor lighting;

(3) The number and location of security cameras used by the business and their field of view;

(4) The location of all alarm inputs (door contacts, motion detectors, duress/hold up devices) and alarm sirens;

(5) The location of the digital video recorder and alarm control panel;

(6) Restricted and public areas; and

(7) The structure the facility is housed in, including nearby street(s), parking lots and other tenants that are within or border the facility;

(e) Security measures taken by the applicant to prevent individuals from entering the limited access area portion of the premises;

(f) Procedures for using and maintaining an incident log;

(g) Procedures for preserving a crime scene;

(h) The closing procedures after the cessation of business each day, including steps to properly store cannabis in a secure area and to prevent theft; and

(i) Procedures to prevent theft, robbery, or the diversion of medical cannabis in compliance with District law.

5415.3 A licensee shall provide either in-person or virtual training regarding its security plan to all employees and security within thirty (30) days of hire and at least once per year thereafter.

5415.4 A licensee may amend or replace an existing security plan on file with the Board by filing a new security plan that is compliant with this section.

5415.5 A licensee provided written notice that its submitted plan is deficient under this regulation shall file a corrected security plan within fifteen (15) days of receiving notice.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10196 (December 2, 2011); as amended by Final Rulemaking published at 60 DCR 10061 (July 12, 2013); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5415

22-C DCMR § 5416 CONDITIONAL LICENSE

5416.1 A conditional license application may be filed by both standard and social equity applicants for a cultivation center, manufacturer, internet retailer, retailer, or courier license that do not currently have a proposed location. A conditional license application may only be filed with the Board during an open application period noticed in the District of Columbia Register and on the ABCA website.

5416.2 An applicant for a conditional license shall indicate the type of license facility applied for in the application and request conditional status.

5416.3 If approved, the holder of a conditional license has one (1) year from the date of Board approval to submit to ABCA:

(1) A lease or similar documentation;

(2) A security plan;

(3) A certificate of occupancy for the proposed location;

(4) A permanent medical cannabis facility license application;

(5) Any remaining or additional licensing or endorsement fees owed to ABCA; and

(6) Any other documentation requested by the Board.

5416.4 The Board shall deem the conditional license expired and cancel the license if all the documents listed in §§ 5403 and 5416.3 are not provided within one (1) year from the date of Board approval.

5416.5 A conditional license application is not required to undergo a forty-five (45)-calendar day public comment period. Approved conditional license applicants are required to undergo a forty-five (45)-calendar day public comment period after their permanent medical cannabis facility application is filed with ABCA.

5416.6 A conditional license does not permit the holder to distribute, purchase, possess, cultivate, manufacture, or sell medical cannabis or medical cannabis products.

5416.7 A one (1)-year conditional license cannot be sold or transferred to a new owner.

5416.8 The holder of a conditional license is required to have their facility operational within one (1)-year of Board approval.

5416.9 The one (1)-year conditional license period shall not be extended.

5416.10 A conditional license approved by the Board shall count toward the requirement that at least fifty percent (50%) of all new cultivation center, manufacturer, internet retailer, retailer, and courier licenses be set aside for social equity applicants.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10197 (December 2, 2011); as amended by Final Rulemaking published at 60 DCR 10061 (July 12, 2013); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5416

22-C DCMR § 5417 SOCIAL EQUITY APPLICANT STATUS

5417.1 At least fifty percent (50%) of all new cultivation center, manufacturer, internet retailer, retailer, and courier licenses shall be set aside for social equity applicants. Only social equity applicants and medical cannabis certified business enterprises are eligible to receive equity, grants, and loans from the medical cannabis social equity fund.

5417.2 A social equity applicant is entitled to a seventy-five percent (75%) fee reduction on application and licensing fees associated with receiving a medical cannabis facility license for the first three years. The seventy-five (75%) fee reduction for social equity applicants does not apply to endorsement fees, including the application fees.

5417.3 To qualify as a social equity applicant, an applicant must satisfy two (2) or more of the following criteria:

(a) Has at least one (1) owner who is a District resident, individually or collectively owns at least fifty percent (50%) of the business, and is a returning citizen;

(b) Has at least one (1) owner who is a District resident, individually or collectively owns at least fifty percent (50%) of the business, and is married to or in a civil union, has a child, or is the child of a person or has a non-parent legal guardian, or a grandparent or a sibling who is or has been arrested, convicted, or incarcerated in the District or any other jurisdiction for a cannabis or drug-related offense; or

(c) Has at least one (1) owner who is a District resident, individually or collectively owns at least fifty percent (50%) of the business and has an income that does not exceed one hundred and fifty percent (150%) of the median family income as set forth by the United States Department of Housing and Urban Development, adjusted for household size, at the time the applicant submits the application.

5417.4 In order to qualify for a social equity applicant status, an applicant shall file with its application a Social Equity Declaration Form.

5417.5 A complete application from a social equity applicant shall also provide or describe the following for each owner:

The two (2) or more criteria that qualify the applicant for social equity status in accordance with § 5417.3;

An affidavit, which shall be referred to as the Social Equity Applicant Attestation Form, attesting to:

(1) The number of owners who meet the criteria for a social equity applicant;

(2) The ownership interests, incomes, and net worth of any owners;

(3) The location of all managerial employees in the principal office;

(4) The residency of owners, employees, and contractors; and

(5) The locations of the assets and the percentages of the assets in each location.

Proof of District residency for each owner claiming social equity applicant status, which shall include two (2) of the following:

(1) Proof of payment of D.C. personal income tax during the last tax period;

(2) A current tax withholding statement which contains the applicant’s name;

(3) Current official documentation of financial assistance from the District (such as Temporary Assistance for Needy Families or housing assistance);

(4) Valid, unexpired D.C. driver’s license or non-driver’s identification;

(5) Valid, unexpired vehicle registration;

(6) Valid, unexpired lease and rent receipts for a period within two (2) months immediately preceding consideration of residency; or

(7) Utility bills with paid receipts or cancelled checks from a period within the two (2) months immediately preceding the filing of the application.

If claiming social equity applicant status based upon returning citizen status, each owner claiming this status shall provide with their application law enforcement or court documents demonstrating proof of arrest, conviction, or incarceration for a drug-related offense;

If claiming social equity applicant status based upon the incarceration of an immediate family member due to cannabis or drug-related offense, each owner claiming this status, shall:

(1) Identify the immediate family member that qualifies the applicant;

(2) Identify the nature of the qualifying relationship, including whether the relation is based on a marriage or civil union, and whether the applicant is the parent of a qualifying child or the child of a qualifying parent or non-parent legal guardian, or has a qualifying grandparent or sibling;

(3) Provide documents proving the relationship (e.g., birth certificate, marriage certificate, proof of legal guardianship);

(4) Provide law enforcement or court documents demonstrating arrest, incarceration, or conviction; and

(5) Provide law enforcement or court documents demonstrating that the arrest, conviction, or incarceration of the qualifying relative was due to a cannabis or drug-related offense.

If claiming social equity applicant status based on income, for each owner claiming this status, the applicant shall provide proof of income and household size, which shall include:

(1) Documentation establishing proof of income tax filing or withholding in the District of Columbia from the tax year prior to the date of the application; or

(2) If the documentation described in subparagraph (1) is not possible to obtain, a notarized statement of net income anticipated to be received with the next twelve (12) months, based on the previous twelve (12) months and explanation of the reason for failing to obtain one of the documents listed in subparagraph (1) of this paragraph.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10198 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5417

22-C DCMR § 5418 LIMITATION ON SUCCESSIVE APPLICATIONS AFTER DENIAL

5418.1 The Board shall not consider an application for the same class of license, permit, endorsement, or substantial change by the same applicant if the Board has denied a previously filed application within five (5) years.

5418.2 Notwithstanding Subsection 5418.1, if an application is withdrawn for good cause, as determined by the Board, and prior to the protest status hearing, or if a previously filed application for the same license class, permit, endorsement, or substantial change was denied by the Board on purely technical or procedural grounds, a successive application by such applicant may be considered.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10198 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5418

22-C DCMR § 5419 CONTINUANCES

5419.1 The Board may, on the request of both an affected ANC and the applicant, extend an affected ANC’s comment period deadline for the sole purpose of allowing the ANC to vote on and provide comment on a dispensary, cultivation center, or testing laboratory registration application.

History

SOURCE: Final Rulemaking published at 71 DCR 002388 (March 8, 2024). District of Columbia Municipal Regulations Medical Marijuana 22-C DCMR § 5419

22-C DCMR § 5420 MEDICAL CANNABIS CERTIFIED BUSINESS ENTERPRISE AFFIDAVIT

5420.1 The applicant shall attest by completing the Annual Personal Net Income Attestation Form that the annual personal net income of each owner of the enterprise applying for a medical cannabis business license does not exceed $349,999.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5420

22-C DCMR § 5421 APPROPRIATENESS REQUIREMENT

5421.1 To qualify for issuance, renewal of a license, transfer of a license to a new

location, or an application for the approval of a substantial change in operation as determined by the Board, an applicant shall demonstrate to the satisfaction of the Board that the medical cannabis establishment is appropriate for the locality, section, or portion of the District where it is to be located.

5421.2 In determining the appropriateness of a medical cannabis establishment, the Board shall consider all relevant evidence of record, including:

(a) The effect of the establishment on real property values;

(b) The effect of the establishment on peace, order, and quiet; and

5421.3 In determining the appropriateness of a medical cannabis establishment for initial issuance of a license or a transfer of a license to a new location, the Board shall also consider the following as they relate to the appropriateness factors described in § 5421.2:

(a) The proximity of the establishment to schools, recreation centers, day care centers, public libraries, or other similar facilities;

(b) The effect of the establishment on the operation and clientele of schools, recreation centers, day care centers, public libraries, or other similar facilities; and

(c) Whether issuance of the license would create or contribute to an overconcentration of licensed medical cannabis establishments of the same type.

5421.4 The requirements of this section shall only apply to applicants for a cultivation center, manufacturer, internet retailer, or retailer license.

5421.5 For purposes of establishing the appropriateness of the medical cannabis establishment, the applicant shall present to the Board such evidence and argument as would lead a reasonable person to conclude the following:

(a) The establishment will not interfere with the peace, order, and quiet of the relevant area, considering such elements as noise, rowdiness, loitering, litter, and criminal activity;

(b) The establishment will not have an adverse impact on residential parking needs, considering available public and private parking and any arrangements made to secure such parking for the clientele of the establishment;

(c) The flow of traffic to be generated by the establishment will be of such pattern and volume as to neither increase the likelihood of vehicular accidents nor put pedestrians at an unreasonable risk of harm from vehicles; and

(d) The establishment will not have an adverse impact on real property values in the locality, section, or portion of the District of Columbia where it is to be located, considering such elements as blight, the presence of graffiti, the history of building violations and vacancy status under the applicant, and the physical impact of the property on neighboring properties, including odors and noise.

5421.6 Whenever an applicant has initially presented evidence to show that the establishment is appropriate, any protestant opposing the license shall present to the Board such evidence and argument as would establish the inappropriateness of the establishment, and as would overcome, to the satisfaction of a reasonable person, the evidence and argument presented by the applicant.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5421

22-C DCMR § 5422 PRESUMPTION OF APPROPRIATENESS

5422.1 If notice in accordance with the Act and this chapter is provided and no valid objection regarding appropriateness is filed by a protestant, the application shall be presumed to be appropriate for the locality, section, or portion of the District where it is located.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5422

22-C DCMR § 5423 DENIAL FOR VIOLATIONS OF THE LAW

5423.1 The Board may deny a license to an applicant if the preponderance of the evidence shows that the applicant has permitted conduct at the medical cannabis establishment that is in violation of the Act or this chapter.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5423

22-C DCMR § 5424 SPOUSAL INTEREST IN LICENSE

5424.1 The spouse of a license holder may apply for a separate medical cannabis business license if the individual can establish that the conflict-of-interest provisions found at 22-C DCMR § 5413 will not be violated. Specifically, in applying for a license the spouse not holding a medical cannabis business license must submit a signed and notarized affidavit which states that:

(a) The applicant has no present or future ownership, except for an executory interest or property distributed in accordance with Title 16 of the D.C. Official Code or similar marriage or domestic partnership separation, annulment, or divorce law in another jurisdiction, in any other licensed medical cannabis business that the applicant is prohibited from owning under the Act;

(b) The applicant’s spouse will have no ownership interest in the license being sought by the applicant;

(c) The applicant or another corporation (in which the spouse is not an officer, shareholder or member) is solely liable for the business rather than the spouse or spouse’s business;

(d) The applicant’s spouse will not have any operational control over the establishment and will not serve in a management capacity for the establishment or apply for a manager’s license for that establishment; and

(e) The applicant will not transfer any medical cannabis inventory to, or receive any medical cannabis inventory from, their spouse’s licensed establishment.

5424.2 The applicant shall provide documentation, upon request of the Board, necessary to validate the applicant’s sworn affidavit. Failure to submit the necessary documentation within ten (10) business days of the Board’s request may result in the suspension or revocation of the applicant’s license unless an extension is granted by the Board.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5424

22-C DCMR § 5425 NOTICE BY BOARD

5425.1 Upon the receipt of an application filed by a cultivation center, manufacturer, internet retailer, or retailer, excluding conditional license applications, for the issuance or renewal of a license, for a substantial change in operation as determined by the Board, for the transfer of a license to a new location, or for a unilateral petition to amend or terminate a settlement agreement, the Board shall give notice of the application to the following parties:

The Councilmember of the ward where the establishment is or will be located; and

(b) All ANCs in the ward where the establishment is or will be located.

5425.2 The notice shall contain the legal name and trade name of the applicant, the street address of the establishment for which the license is sought, the type of license sought, and a description of the nature of the operation the applicant has proposed or the proposed change in operation.

5425.3 The notice shall state that ANCs objecting to approval of the application are entitled to be heard before the granting of the application and shall inform the recipient of the final day of the protest period and the date, time, and place of the roll call hearing in accordance with this chapter.

5425.4 The Board shall give notice by electronic mail on or before the first day of the forty-five (45)-day comment period to:

(a) The ANC office established pursuant to D.C. Official Code § 1-1309.13(e), with a copy to each ANC member in the affected ward;

(b) The ANC chairperson in the affected ward; and

5425.5 The Board shall publish the notices required under this section in the District of Columbia Register.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5425

22-C DCMR § 5426 LICENSEE NOTICE REQUIREMENT

5426.1 A cultivation center, manufacturer, or retailer applicant that is required to undergo a forty-five (45)-day public comment period under the Act or this chapter shall post two (2) notices, furnished by ABCA, of the application in conspicuous places on the outside of the establishment for the duration of the protest period.

5426.2 The notices shall state:

(a) The information required by § 5425;

(b) The final day of the protest period;

(d) The telephone number and mailing address of ABCA; and

(e) That any person willfully removing, obliterating, or defacing the notices shall be guilty of a violation of this chapter.

5426.3 An applicant who fails to maintain the posted notices continuously during the protest period shall be guilty of a violation of this chapter.

5426.4 If the Board determines that the notices posted at an applicant’s establishment have not remained visible to the public for the duration of the forty-five (45)-day protest period, the Board shall require the reposting of the notices and shall reschedule the roll call hearing for a date at least forty-five (45) days after the originally scheduled hearing, unless the applicant has fully performed all other notice requirements and the Board determines that it is in the best interest of the parties to proceed at an earlier date.

5426.5 An applicant for an internet retailer license shall not be required to post the two (2) notices required by this section; provided, that the notice shall be posted on the applicant’s website for the entire forty-five (45)-day public comment period.

5426.6 An applicant for a new or renewal license or for the transfer of a license to a new location shall take a picture of the posted placards within two (2) calendar days of the date the placards were posted, and upon request of the Board provide a copy of the picture, or pictures, of the posted notices that includes the date and time that the pictures were taken.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5426

22-C DCMR § 5427 STANDING TO FILE PROTEST

5427.1 An ANC located within 600 feet of the applicant’s proposed location may protest the issuance or renewal of a license, or the transfer of a license to a new location involving a cultivation center, manufacturer, retailer, or internet retailer.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5427

22-C DCMR § 5428 FILING A PROTEST

5428.1 Any affected ANC objecting to the approval of an application shall notify the Board in writing of its intention to object and the grounds for the objection within the protest period. The initial protest letter filed by the ANC shall state all appropriateness grounds that the ANC intends to raise, and any other legal issue related to the application.

5428.2 Protests submitted by the ANC shall be signed by the Chairperson, the Vice-Chairperson or any other person authorized to sign a protest by the ANC’s bylaws, or a resolution adopted by the ANC.

5428.3 The protest shall state the name and position of the designated representative who shall receive correspondence from the Board on behalf of the ANC.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5428

22-C DCMR § 5429 ANC COMMENTS

5429.1 An affected ANC shall notify the Board in writing of its recommendations, if any, and serve a copy upon the applicant or licensee, not less than seven (7) calendar days before the date of the protest hearing. The Board shall give great weight to the ANC recommendations as required by Section 13 of the Advisory Neighborhood Commissions Act of 1975, effective March 26, 1976 (D.C. Law 1-58; D.C. Official Code § 1-309.10). The applicant or licensee may file a written objection or respond to the comments at the protest hearing.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5429

22-C DCMR § 5430 EXTENDING THE LICENSURE PERIOD

5430.1 Licenses that have been made the subject of protest hearings shall be extended as provided by this section.

5430.2 If the Board has not issued a decision on the matter, and the license has expired, the license shall continue in effect until such time as the Board has rendered a final decision.

5430.3 In the case of protested applications for a transfer to a new location, the license shall continue in effect only for purposes of the original location, and operations at the new location shall be prohibited until the Board has rendered a final decision.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5430

22-C DCMR § 5431 APPLICATION REVIEW

5431.1 Upon receipt of a complete new, renewal, or transfer to new location application filed by a cultivation center, manufacturer, internet retailer, or internet retailer, excluding conditional license applications, the Board shall schedule a roll call hearing on the application. The roll call hearing shall not take place until after the close of the forty-five (45)-day protest period.

5431.2 Before any license is issued or renewed, the Board shall ensure that proper notice has been provided to the public and that an ANC located in the same ward as the applicant has been given at least forty-five (45) days in which to protest the license and that a roll call hearing has been conducted.

5431.3 If no protest has been received by the Board from an affected ANC during the protest period, the Board shall consider the application within ten (10) days after the end of the protest period.

5431.4 If a protest has been received by the Board during the protest period, the Board shall take the following actions:

(a) The Board shall schedule a protest hearing, to be held within one hundred and twenty (120) days of the end of the protest period, for new license applications to receive testimony and other evidence regarding the application.

(b) The parties shall be informed of their obligation to attend a mediation for the purpose of discussing and resolving, if possible, the objections raised by the protestants.

5431.5 The Board shall issue a decision in accordance with the Act and this chapter.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5431

22-C DCMR § 5432 ROLL CALL HEARING

5432.1 The roll call hearing shall be a non-adversarial proceeding conducted by the Board or the Board’s agent, in which a list of applications for a new or renewed license, transfer to new location, or a substantial change in operation, and the protestants thereto, shall be read to the public.

5432.2 For the purposes of this subsection, the term “Board’s agent” means an employee at or above the Grade 12 level in the Office of the General Counsel within ABCA, excluding the ABCA General Counsel, who shall have the authority to:

(a) Regulate the course of the hearing;

(b) Request the persons appearing at the hearing to identify themselves, and to provide contact information, including e-mail addresses;

(d) Identify the parties with standing and the filed protest issues;

(e) Schedule mediation;

(f) Adjourn a hearing and establish the date when the hearing will be continued; and

(g) Take any other action considered necessary by the Board.

5432.3 Each applicant and each protestant shall attend the roll call hearing in person or appear through a designated representative.

5432.4 The ANC may designate any member or every member of its Commission, or a non-member of the Commission, to participate in the protest process, hearings, and negotiating settlement agreements.

5432.5 Failure to appear in person or through a designated representative at the roll call hearing may result in denial of the license application or dismissal of a protest, unless, in the discretion of the Board, good cause is shown for the failure to appear. Examples of good cause for failure to appear may include:

(a) Sudden, severe illness or accident;

(b) Death or sudden illness in the immediate family, such as spouse, partner children, parents, siblings;

(d) Severe inclement weather.

5432.6 A recommendation by the Board’s agent to dismiss a license application or dismiss a protest for failure to attend the roll call hearing shall be forwarded to the Board for issuance of a written order.

5432.7 At the roll call hearing, the Board’s agent shall have the authority to:

(a) Regulate the course of the hearing;

(b) Request the persons appearing at the hearing to identify themselves, and provide contact information including email addresses;

(d) Identify the parties with standing and the filed protest issues, if undisputed;

(e) Approve a joint request from the parties to schedule mediation;

(f) Adjourn a hearing and establish the date when the hearing will be continued; and

(g) Take any other action authorized by, or necessary under, this section.

5432.8 At the roll call hearing the parties shall be required, on a form prescribed by the Board, to provide their name, address, email address, and telephone numbers, as well as the same information for any attorney or non-attorney representative representing the parties. The parties shall also indicate on the form their consent to service by electronic means to their email address or to the email address of their attorney or representative.

5432.9 Upon the scheduling of the roll call hearing, all parties shall be prohibited from participating in any ex parte communication with the Board’s agent relevant to the merits of the proceeding. This shall include any oral or written communication not in the public hearing record with respect to which reasonable prior notice is not given to all parties to the proceeding.

5432.10 The roll call hearing shall be open to the public and transcribed by a certified court reporter.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5432

22-C DCMR § 5433 PROTEST STATUS HEARING

5433.1 The protest status hearing is a proceeding held by the Board at which the parties may address any unresolved legal issues from the roll call hearing, including whether a protestant granted conditional standing has subsequently met the standard for full standing, or address motions or pleadings previously filed with the Board.

5433.2 At the protest status hearing, the parties also inform the Board of their progress in reaching a settlement agreement. The Board in its discretion may set another status hearing if the Board determines that the parties are close to reaching a settlement agreement or that mediation might be helpful.

5433.3 Failure to appear at the protest status hearing either in person or through a designated representative may result in denial of the license application or dismissal of a protest, unless, in the discretion of the Board, good cause is shown for the failure to appear. Examples of good cause for failure to appear include, but are not limited to:

(a) Sudden, severe illness or accident;

(b) Death or sudden illness in the immediate family, such as spouse, partner, children, parents, or siblings;

(d) Severe inclement weather.

5433.4 The protest status hearing shall be open to the public and transcribed by a certified court reporter.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5433

22-C DCMR § 5434 PARTY DISMISSAL

5434.1 If an applicant or a protestant is dismissed and not reinstated by the Board for good cause after failing to appear at a roll call hearing, status hearing, or protest hearing, the Board may deny the license application, dismiss the protest, or take both actions if appropriate.

5434.2 If an applicant’s request to renew its license is dismissed and not reinstated by the Board for good cause, the applicant shall be permitted to submit a second renewal application upon the filing of an application fee of one thousand dollars ($1,000).

5434.3 The re-filed second renewal application shall be submitted to ABCA within ten (10) calendar days of receipt of the Board’s order dismissing the license application or not reinstating the license application in the event that a request for reinstatement was filed by the applicant. In the event that the applicant fails to resubmit its second renewal application within ten (10) calendar days, the Board shall issue a cease-and-desist order to the applicant notifying the business to immediately cease the sale, distribution, manufacturing, or delivery of medical cannabis, medical cannabis products, and paraphernalia upon expiration of the non-renewed license for the prior licensing period.

5434.4 If a second renewal application is re-filed by an applicant within ten (10) calendar days, any protestant that appeared at the roll call hearing or status hearing where the applicant was dismissed for failure to appear shall not be required to refile a previously submitted valid protest letter.

5434.5 If an applicant’s re-filed second renewal application is dismissed for failure to appear at a hearing and not reinstated by the Board for good cause, the license renewal application shall be denied. The applicant shall be required to file a new license application, and the Board shall not accept a third license renewal application from the applicant.

5434.6 If an applicant’s request to terminate or amend its settlement agreement is dismissed and not reinstated by the Board for good cause, the applicant shall not be permitted to file a subsequent request to terminate or amend its settlement agreement until the next three-year renewal period.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5434

22-C DCMR § 5435 ESTABLISHMENT OF GEOGRAPHIC BOUNDARIES IN A PROTEST

5435.1 Upon recognition by the Board of a properly filed protest at a roll call hearing, the geographic boundary of the protest shall be deemed the “section.” The applicant may select another geographic area permitted by this section. The applicant shall submit the alternative proposed boundaries to the Board and the protestants no later than ten (10) calendar days after the roll call hearing.

5435.2 Any protestant may object to the area and boundaries proposed by an applicant by filing a written objection with the Board no later than thirty (30) calendar days after receipt of the applicant’s proposed boundaries. The objection shall also be served on the applicant in accordance with the Act and this title. The objection shall state in detail the following:

(a) The reasons for objecting to the boundaries proposed by the applicant;

(b) The boundaries proposed by the protestant; and

5435.3 The applicant may file a reply to the protestant’s objection within seven (7) days of receipt of the objection.

5435.4 Any protestant or applicant who makes a submission to the Board may forward written argument or documentary evidence to the Board in support of the boundaries he or she proposes.

5435.5 The Board shall determine, on a case-by-case basis, the size of the area relevant for the appropriateness review. In making this determination, the Board shall consider the overall characteristics of the area, including population, density, and general commercial and residential activities.

5435.6 For the purpose of determining the appropriateness of a license, the geographic areas to be considered by the Board shall be measured pursuant to § 101.1 and shall be as follows:

(a) A “locality,” which shall be the immediate neighborhood of the establishment and whose boundary shall be at a distance of six hundred feet (600 ft.) from the establishment;

(b) A “section,” whose boundary shall be at an area larger than the immediate neighborhood and whose boundary shall be at a distance of twelve hundred feet (1,200 ft.) from the establishment; and

(c) A “portion,” whose boundary shall be at an area larger than a “section” and whose boundary shall be at a distance of eighteen hundred feet (1,800

ft.) from the establishment.

5435.7 In determining the area to be considered, the Board shall consider the overall characteristics of the alternative areas, including the following:

(a) The population and density of the areas surrounding the establishment;

(b) The general commercial and residential activities in the areas surrounding the establishment;

(c) Geographical factors, such as parks, rail lines, major thoroughfares, bodies of water, cemeteries, and unimproved or unused property, which may tend to define physically an area to be considered; and

(d) Historical patterns of commercial or residential activity leading to an identification of a given area as a distinct, generally recognized neighborhood, or larger area.

5435.8 The Board shall make a final decision on the boundaries without a hearing and based on the submissions received from the applicant and the protestant.

5435.9 The Board’s final decision shall be made and announced at the first status hearing for the application at issue unless no geographic boundary selection is made by the parties.

5435.10 In establishing a geographic boundary, including the designations of locality, section, or portion set forth in the Act or this chapter, the Board shall measure the specified distance in an arc from each corner of the building on which the licensed establishment is located, connecting the arcs by tangent lines.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5435

22-C DCMR § 5436 DECISIONS OF THE BOARD

5436.1 No application shall be approved until the Board has determined that the applicant has complied with the Act and this title or, in the case of a renewal, has fulfilled the license requirements. The Board shall make findings of fact with respect to each requirement, including the appropriateness standards set forth in the Act and the regulations.

5436.2 For the purposes of this section, the record shall close thirty (30) days after a hearing is concluded to allow the parties to submit proposed findings of fact and conclusions of law and any other document submissions requested by the Board.

5436.3 Within ninety (90) days after the close of the record, the Board shall issue its written decision accompanied by findings of fact and conclusions of law.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5436

22-C DCMR § 5437 PROTEST PARTIES

5437.1 The parties to the protest hearing shall be the applicant and the protestants as identified at the roll call hearing.

5437.2 If there is more than one protestant, the Board, in its discretion, may request that multiple protestants confer among themselves and designate one person to conduct the protestants’ case. In the case where the protestants fail to agree, the Board may select the protestant presentation order and limit the presentation time of one or more parties to ensure that the applicant and protestants have similar presentation times.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5437

22-C DCMR § 5438 MEDIATION

5438.1 A mediation among the parties shall be held to discuss and resolve, if possible, the objections raised by the protestants. If the parties fail to reach a settlement agreement on one or more of the protest issues, they shall so inform the Board at the scheduled protest status hearing or the protest hearing and the Board shall proceed with a protest hearing as to all unresolved issues.

5438.2 Mediation, which may be arranged at a roll call hearing or any other time, shall be set on a mutually convenient date before the scheduled protest status hearing or the protest hearing.

5438.3 At the request of all parties, and if a mediation would be unlikely to succeed, the Board may waive the parties’ obligation to attend a mediation.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5438

22-C DCMR § 5439 PROTEST HEARINGS

5439.1 The parties to a protest hearing shall be the applicant or licensee and the protestants.

5439.2 At the protest hearing, an applicant or licensee may give a brief opening statement summarizing the evidence and testimony they intend to present regarding the appropriateness of the application or license at issue. Thereafter, the protestant may give a brief opening statement summarizing the evidence they intend to present to rebut or overcome the evidence and argument presented by the applicant or licensee.

5439.3 At the conclusion of the opening statements, the Board shall call its own witnesses, if any, who shall testify to the results of their investigation into the appropriateness of the establishment.

5439.4 At the conclusion of testimony by the Board’s witnesses, if any, the applicant shall call its witnesses to give testimony and present evidence regarding the appropriateness of the establishment.

5439.5 At the conclusion of testimony by the applicant’s witnesses, the protestant shall call witnesses to give testimony and present evidence.

5439.6 All witnesses shall testify under oath and shall be subject to questioning by the Board and to cross-examination by the opposing party.

5439.7 In any case where there is more than one (1) protestant, the Board, in its discretion, may request that the protestants designate one (1) person to conduct the protestant’s case, to give opening and closing statements, and to examine and cross-examine witnesses.

5439.8 The Board may, on a motion from either party or on its own motion, limit the number of persons who may testify on behalf of the applicant, licensee, or protestant if the Board determines the testimony would be redundant.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5439

22-C DCMR § 5440 SETTLEMENT AGREEMENTS

5440.1 The applicant and one or more ANCs that have protested, or would have standing to protest, an application pursuant to the Act or this title may, at any time, negotiate a settlement and enter into a written settlement agreement setting forth the terms of the settlement.

5440.2 The signatories to the agreement shall submit the agreement to the Board for approval. A settlement agreement, amendment to a settlement agreement, or cancellation of a settlement agreement shall not be effective until the Board issues a written Order approving the proposed settlement.

5440.3 All provisions of a settlement agreement approved by the Board shall be enforceable by ABCA or the Board unless prohibited by the Act or this chapter.

5440.4 A settlement agreement not approved by the Board shall not be enforced by ABCA or the Board.

5440.5 Unless a shorter term is agreed upon by the parties, a settlement agreement shall run for the term of a license, including renewal periods, unless it is terminated or amended in writing by the parties and the termination or amendment is approved by the Board.

5440.6 The terms of a settlement agreement submitted by the parties shall be consistent with District of Columbia law, typed, and in compliance with the Act and this title.

5440.7 A settlement agreement submitted to the Board shall include the form provided by the Board that shall be deemed part of the agreement and at a minimum:

(a) Identify all parties to the agreement;

(b) Contain the contact information for all parties; and

5440.8 When the parties file an additional settlement agreement or amendment to an existing settlement agreement, the Board may, before considering the agreement or amendment, require the parties to cancel all prior agreements and consolidate all intended settlement terms into one comprehensive document before approval.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5440

22-C DCMR § 5441 SUCCESSOR ANC

5441.1 After the approval of a settlement agreement between the licensee and an ANC or the filing of a protest, if the District legally changes the boundaries of ANCs and the licensed location is located in a new ANC’s jurisdiction, the new ANC shall, to the extent consistent with governing law, be deemed the successor-in-interest and replace the original ANC as a party to the agreement and the protest.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5441

22-C DCMR § 5442 AUTOMATIC TERMINATION

5442.1 A settlement agreement shall be terminated by the Board upon petition of the applicant if the applicant shows that the Board has approved a transfer of the license to a new location at least twelve hundred feet (1,200 ft.) away from the prior location after the initial approval of the agreement. The licensee may request a declaratory order terminating the settlement agreement if its settlement agreement qualifies for termination under this section.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5442

22-C DCMR § 5443 BOARD REVIEW OF SETTLEMENT AGREEMENTS

5443.1 If the Board determines that the settlement agreement complies with all applicable laws and regulations and the applicant otherwise qualifies for licensure, it may, in its discretion, approve the license application, conditioned upon the licensee’s compliance with the terms of the settlement agreement. The Board shall incorporate the text of the settlement agreement in its order and the settlement agreement shall be enforceable by the Board.

5443.2 The Board may reject any settlement agreement that is not in accordance with the law, not in the public interest, or otherwise not in the interest of ABCA to enforce.

5443.3 The Board may reject a settlement agreement that does not represent the entire agreement of the parties or when any or all of the terms of the settlement agreement:

Violate the Act or this title, the Constitution, the D.C. Human Rights Act, or any other law or regulation;

Are not in the public interest;

Are not in the agency’s interest to enforce because it is overly burdensome, unenforceable, or overrides the prosecutorial or other discretion provided to the Board or the District;

Are incomplete, not final, or vague; or

Require the licensee or the District to exercise control over third parties outside the premises.

5443.4 The parties may submit a settlement agreement at any time, except that, on the date of the protest hearing or after the close of the record, the parties may only file a settlement agreement with the permission of the Board.

5443.5 If the Board determines that a settlement agreement submitted by the parties does not comply with all applicable laws and regulations, the Board may condition approval of the settlement agreement on the parties’ acceptance of modifications of the agreement proposed by the Board. If the parties reject the modifications proposed by the Board, they may submit a new settlement agreement for Board review that complies with applicable laws and regulations, or the Board may order the parties to proceed to a Protest Hearing.

5443.6 The Board shall issue an Order rejecting the settlement agreement if the parties to a settlement agreement reject the modifications proposed by the Board and fail to submit a new settlement agreement, or fail to respond to the Board’s modifications, within thirty (30) days of receiving notice of the modifications.

5443.7 If the Board issues an Order denying the settlement agreement and a protest has been filed against the application, the matter will be scheduled for a Protest Hearing.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5443

22-C DCMR § 5444 UNILATERAL AMENDMENT OR TERMINATION

5444.1 The Board may accept an application to amend or terminate a settlement agreement by fewer than all parties in the following circumstances:

(A) During the license’s renewal period; and

(B) After four (4) years from the date of the Board’s decision initially approving the settlement agreement.

5444.2 Notice of an application under § 5444.1 to amend or terminate a settlement agreement shall be given both to the parties of the agreement and to the public at the time of the applicant’s renewal application according to the renewal procedures required under the Act and this chapter.

5444.3 The Board may approve a request by fewer than all parties to amend or terminate a settlement agreement for good cause shown if it makes each of the following findings based upon sworn evidence:

The applicant seeking the amendment or termination has made a diligent effort to locate all other parties to the settlement agreement; or if non-applicant parties are located, the applicant has made a good faith attempt to negotiate a mutually acceptable amendment or termination of the settlement agreement;

The need for an amendment or termination is either caused by circumstances beyond the control of the applicant or is due to a change in the neighborhood where the applicant’s establishment is located; and

The amendment or termination will not have an adverse impact on the neighborhood where the establishment is located.

5444.4 To fulfill the good-faith attempt criteria of this section, the applicant shall file a sworn affidavit with the Board at the time that an application to amend or terminate a settlement agreement by fewer than all parties is filed stating that either:

(a) A meeting occurred between the parties which did not result in agreement; or

(b) The non-applicant parties refused to meet with the applicant.

5444.5 For the purposes of this section, the term “license’s renewal period” means the sixty (60)-day period before the expiration date of a license.

5444.6 Upon the filing of a valid petition for termination or amendment, any signatory party that has not filed a valid protest against the petition shall automatically be removed from the agreement.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5444

22-C DCMR § 5445 ENFORCEABLE SETTLEMENT AGREEMENT PROVISIONS

5445.1 A settlement agreement enforceable by the Board under this chapter may, to the extent consistent with the Act, include:

(a) Provisions allowing or prohibiting background or recorded music or other amplified sounds, restricting the location of music and sound equipment, and the hours that recorded or background music may be provided;

(b) Provisions requiring specific methods to mitigate sound or noise disturbances, including, but not limited to, specific architectural features; requiring doors and windows to remain closed except in the case of ingress and egress; sound barriers and other sound proofing elements; the use of sound limiters and other equipment; and the placement of sound equipment;

(c) Provisions requiring cleanliness, odor, smoke, litter, and trash control on the premises and in the immediate area surrounding the premises, including, but not limited to, the frequency the immediate area is cleaned; trash removal times; efforts to limit rat and vermin infestation, the use of odor control technology, the establishment of non-smoking areas, and trash and recycling management;

(d) Provisions requiring specific parking arrangements;

(e) Provisions requiring the use of validated or valet parking so long as the required valet service is properly approved and has all licenses, permits, and other approvals required by law;

(f) Requirements that the applicant or existing licensee use and maintain an incident log and that the incident log be made available to ABCA and the Board, upon request;

(g) Provisions requiring the filing and compliance with a security plan in accordance with the Act and this title;

(h) Notice to cure provisions;

(i) Provisions restricting the indoor and outdoor hours of operation, and hours of medical cannabis sales and delivery;

(j) Provisions prohibiting or restricting the utilization of floors and outdoor areas, or the occupancy of all or a portion of the premises;

(k) Provisions requiring the use security cameras, minimum identification checking procedures, minimum security personnel staffing, the use of various doors as exits and entrances except in the case of an emergency, restricting the consumption of cannabis and cannabis products, and other safety and security policies and procedures unless otherwise required by law or the Board;

(l) Provisions requiring minimum training for managers and staff;

Provisions requiring the posting of signage or information on the establishment’s website; and

(n) Provisions that mandate that the establishment comply with existing District law and all licenses, permits, and other privileges granted by the District.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5445

22-C DCMR § 5446 UNENFORCEABLE SETTLEMENT AGREEMENT PROVISIONS

5446.1 The Board shall not enforce the following if included in a settlement agreement covered by this chapter:

Provisions that require approval from a signatory or third party to file an application or request with the Board;

Provisions that require additional or specific notice to a signatory or third party outside of the notice required by law;

Provisions that restrict the sale or transfer of the business to new or different owners or require or restrict a change in the type of license;

Provisions that prohibit the act of filing of an application or request with the District. This section does not prevent the settlement agreement from allowing, restricting, or prohibiting various activities of the business;

Provisions that mandate the purchase, service, or sale of specific types of food, non-alcoholic beverages, and medical cannabis; mandate the type of cuisine; mandate the use of brands or types of medical cannabis and other products; or mandate any or all prices set by the business;

Provisions restricting customers based on age, gender, national origin, status as a student, or other criteria prohibited by the D.C. Human Rights Act (D.C. Official Code § 2-1401.01 et seq.);

Provisions requiring the use of specific businesses; require the joining of any group; or requiring the hiring of any specific person or local individuals;

Provisions that create additional administrative procedures in addition to those required by ABCA or the District, alter the penalties of existing laws, or otherwise restrict prosecutorial or Board discretion;

Provisions that require the licensee or their agents to attend ANC or community meetings, events, or otherwise require them to appear or communicate with the signatories or third parties;

Provisions that require the establishment to provide money, buy specific goods or services, or provide financial or other benefits to the community or its agents; provide discounts, free goods and service; or offer specific promotions;

Provisions requiring the provision of contracts, incident logs, and other documents to the signatories or third parties except to ABCA or the Board;

Provisions that require a minimum or maximum level of food, non-alcoholic beverage, or cannabis sales to the public, individuals, qualified patients, or other persons authorized to purchase goods and services from the establishment or require the purchase of specific products by qualified patients, caregivers, or other customers.

Provisions that require future negotiation or create probationary periods that may alter the terms of the license, the settlement agreement, or the operation of the business after approval of the agreement; and

Provisions that create a plant limit or restrict the products that may manufactured, dispensed, or sold by the licensee.

5446.2 A settlement agreement provision that requires a violation of District law shall not be enforced, even if the law did not exist at the time the agreement was approved.

5446.3 If a settlement agreement provision is deemed unenforceable after approval of the agreement, it shall be presumed that the parties intended for the remainder of the agreement to remain enforceable.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5446

22-C DCMR § 5447 DISCOVERY OF LICENSEE DOCUMENTS

5447.1 An ANC granted standing as a protestant during the pendency of the protest may request from ABCA a copy of a contract to which a licensee is a party, an incident log kept by a licensee, or similar document, if obtained by ABCA, except for patient and caregiver records, financial information, or any other document that in the determination of the Board merits privacy protection.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5447

22-C DCMR § 5448 QUALIFICATIONS HEARING

5448.1 The Board may hold a qualifications hearing before issuing, transferring, or renewing a license, registration, or permit to determine whether the applicant, licensee, registrant, or permittee meets the criteria set forth in the Act and this subtitle even if not raised as part of a protest.

5448.2 A qualifications hearing shall be conducted as a contested case pursuant to the DC APA.

5448.3 The Board shall give notice to the applicant, licensee, or permittee, by personal service or certified mail, requiring the person to appear before the Board within 15 calendar days after receipt of the notice to provide evidence establishing that the person meets the criterion set forth in the Act and this title.

5448.4 The hearing notice required by § 5448.3 of this section shall include:

(a) The criterion about which the Board is requesting information;

(b) The evidence to be considered by the Board at the hearing, including documentation, exhibits, investigative reports, or electronic or digitally stored information; and

5448.5 If after notice has been provided, as required by § 5448.3 of the section, the applicant refuses or otherwise fails to appear at the hearing, the Board may hold the hearing ex parte.

5448.6 The Board shall deny the issuance, transfer, or renewal of a license, registration, or permit application if it determines that the applicant does not meet the criteria set forth in the Act or this title.

5448.7 In issuing or renewing a license, registration, or permit, or approving a transfer, the Board may require that certain conditions be met, consistent with the requirements set forth in the Act or this title.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5448

22-C DCMR § 5449 UNLICENSED ESTABLISHMENT APPLICATION

5449.1 An unlicensed establishment described in Section 7a of the Act (D.C. Official Code § 7-1671.06a) applying for a cultivation center, internet retailer, or retailer license shall provide the information required by Section 7a of the Act (D.C. Official Code § 7-1671.06a) in order to be eligible to file a license application for a cultivation center, internet retailer, or retailer license.

5449.2 In order to satisfy Section 7a(a)(2)(B) of the Act (D.C. Official Code § 7-1671.06a(a)(2)(B)), an applicant for an unlicensed establishment applying for a cultivation center shall provide an architectural map of the facility indicating where medical cannabis will be grown, processed, and packaged and attest that the proposed facility will have sufficient power and heating and ventilation systems to support medical cannabis growing activity.

5449.3 Once an unlicensed establishment files an application, no amendment to the selected location for the license may be accepted until the license is issued.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5449

22-C DCMR § 5450 [RESERVED]

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5450

22-C55 REGISTRATION CHANGES

22-C DCMR § 5500 TRADE NAMES AND CORPORATE NAMES

5500.1 No medical cannabis business registered under the Act shall utilize any name other than that of an individual, including a corporate or trade name, without first obtaining approval from the Board for use of the corporate or trade name.

5500.2 A medical cannabis business registered under the Act may file a written request with the Board to add an additional trade name at a location currently authorized for the sale or testing of medical cannabis. The Board, in its discretion, may approve the use of an additional trade name. Any additional trade name approved by the Board shall appear on the establishment's written registration.

5500.3 A medical cannabis business registered under the Act shall not use or display a trade name, corporate name, or sign bearing the words “pharmacy”, “apothecary”, “drug store”, or other phrase that implies that the practice of any health profession occurs on the premises.

5500.4 Any trade name requested by an applicant shall not be identical or confusingly similar to one currently used under a previously issued or existing registration.

5500.5 [REPEALED].

5500.6 [REPEALED].

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10198 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5500

22-C DCMR § 5501 INDIVIDUAL OWNERSHIP, PARTNERSHIP, LIMITED LIABILITY COMPANY OR PARTNERSHIP, AND CORPORATE CHANGES

5501.1 For a corporation that holds a medical cannabis business license, if there is a change in corporate officers or directors, or other persons, owning or controlling one percent (1%) or more, but less than fifty percent (50%), of that corporation’s common stock, the corporation shall submit to the Board, within fifteen (15) calendar days of the change, the minutes or other instrument giving the names and addresses of any new officer, director, or person owning or controlling any percentage of the stock.

5501.2 For a partnership or limited liability company that holds a medical cannabis business license, if there is a change in the ownership of the partnership or limited liability company of one percent (1%) or more, but less than fifty percent (50%), of the total ownership interest of the business, the partnership or limited liability company shall submit to the Board in a timely manner, but no later than fifteen (15) calendar days after the change has occurred, the instruments reflecting the change in ownership interests.

5501.3 Within fifteen (15) calendar days of the changes set forth in § 5501.1 and § 5501.2, the individual owner, partnership, limited liability company or partnership, or corporation shall submit to the Board any relevant data pertaining to the personal and business history of any new officer, director, stockholder, member, general or limited partner, or other person that the Board may require, and each new person shall apply for a license as required under this subtitle.

5501.4 Each individual seeking to own or control interest of at least one percent (1%) in a partnership, limited liability company, or corporation shall pass a criminal background check and pay the applicable registration fee as required by the Act and this subtitle.

5501.5 The proposed transferee(s) shall not operate the licensed medical cannabis business until they have received a license issued by the Board.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10199 (December 2, 2011); as amended by Final Rulemaking published at 60 DCR 10061 (July 12, 2013); as amended by Final Rulemaking published at 67 DCR 5383 (May 22, 2020); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5501

22-C DCMR § 5502 TRANSFER OF EQUAL OR MAJORITY OWNERSHIP OR CONTROL

5502.1 At least thirty (30) days before executing an agreement that will result in the transfer of ownership or control of fifty percent (50%) or more of the ownership interest or common stock of an entity that holds a licensed medical cannabis business, the current licensee shall submit to the Board an application for a transfer of equal or majority ownership or control.

5502.2 A licensee shall not complete the sale or transfer of fifty percent (50%) or more of its ownership or control of an entity that holds a licensed medical cannabis business until the licensee has received written approval from the Board of the sale or transfer.

5502.3 If a licensee transfers ownership or control of fifty percent (50%) or more of its ownership or control of an entity that holds a licensed medical cannabis business without Board approval, the license shall automatically be deemed void and shall be surrendered to the Board upon demand.

5502.4 The Board shall not approve an application for a transfer of fifty percent (50%) or more of its ownership or control of a licensed medical cannabis business until a complete application providing the following information is filed:

(a) The legal name or trade name of the business and a copy of the trade name registration, if applicable;

(b) The name, address, date of birth, and social security number of the individual owner, partners, limited liability company or partnership member, principal officers, directors, or shareholders (no P.O. Boxes will be accepted);

(c) The Certificate of Good Standing for the partnership, limited liability company or partnership, or corporation, issued within thirty (30) days of the date of submission of the application;

(d) A Basic Business Registration with a General Business registration endorsement;

(e) A certificate of occupancy for the premises issued in the name of the new owner, if applicable;

(f) Evidence that the transferee has entered into a bona fide agreement with the owner of the building to lease, purchase, or occupy the premises;

(g) A signed and notarized Acknowledgment and Attestation form;

(h) Information on the source of funds used to acquire the ownership or control interests of the business;

(i) A copy of both the Bill of Sale and the Purchase and Sale Agreement between the licensee and the transferee, if such documents exist; and

(j) A notarized and signed copy of the Transfer of License Affidavit Form.

5502.5 The proposed transferee(s) shall pass a criminal background check as required by the Act and the regulations.

5502.6 The proposed transferee(s) shall not operate the licensed medical cannabis business until they have received a license issued by the Board.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10199 (December 2, 2011); as amended by Final Rulemaking published at 60 DCR 10061 (July 12, 2013); as amended by Final Rulemaking published at 67 DCR 5383 (May 22, 2020); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5502

22-C DCMR § 5503 CHANGE OF LOCATION OR EXPANSION

5503.1 At least thirty (30) days before executing an agreement that will result in the change of location or expansion of a medical cannabis business, the registrant shall submit to the Board an application for a change of location or expansion.

5503.2 An application for change of location or expansion of a medical cannabis business into an adjacent property shall be subject to ANC review, and shall not be approved if the relocation would result in more than two (2) dispensaries or six (6) cultivation centers being registered to operate within a single election ward.

5503.3 A registrant shall not relocate or expand until the registrant has received written approval from the Board to relocate or expand.

5503.4 If a registrant relocates or expands without Board approval, the registrant’s registration, or authorization to apply for a registration, shall automatically be deemed void and shall be surrendered to the Board upon demand.

5503.5 To apply for a change of location or to expand into adjacent property, a registrant shall complete a Board application form and provide the following:

The legal business name, including trade name, if applicable, and current address of the medical cannabis business;

(b) The contact person’s name, address, email address, telephone number, and facsimile number;

(d) The proposed date for closing the current location, if relocating;

(e) The proposed date of relocation or expansion;

(f) The proposed date of opening the new location or expanded location;

(g) All required ownership information including the name, title, address, and telephone number of the individual owner, partner(s), corporate officer(s), or members;

(h) A valid zoning determination letter for the proposed location;

A certified surveyor’s report detailing the proximity of the proposed location to the nearest public or private preschool, primary or secondary school or recreation center;

(j) Evidence that the registrant has entered into a bona fide agreement with the owner of the building to lease, purchase, or occupy the new location or expanded premises;

(k) The site plan for the proposed location or expanded location;

(l) A detailed security plan for the proposed location or expanded location;

(m) A detailed description of the proposed operations plan and closure plan for the proposed location;

(n) A detailed description of the proposed business plan and services to be offered for the proposed location or expanded location;

(o) A detailed description of the suitability of the proposed location or expanded location;

(p) A proposed staffing plan;

(q) The proposed product safety, quality control, and labeling plan;

(r) The proposed recordkeeping and inventory tracking plan;

(s) The environmental plan for the proposed location or expanded location, if

applicable;

(t) A signed and notarized Physician Affidavit Form, if applicable; and

(u) A signed and notarized Acknowledgment and Attestation form.

5503.6 As part of the review of an application for a change of location, the Board shall give written notice through the mail of the application to all ANCs in the affected ward, pursuant to the requirements set forth in § 5107 of this subtitle.

5503.7 Pursuant to § 5109 of this subtitle, the comments timely submitted by an ANC located in the affected ward for consideration shall relate to the ANC's concerns or support regarding the proposed location including but not limited to:

The potential adverse impact of the proposed location to the neighborhood; and

An overconcentration or lack of medical cannabis businesses in the affected ward.

5503.8 The timely comments submitted by an ANC located in the affected ward, shall be reviewed by the Board in accordance with D.C. Official Code § 1-309.10(d).

History

SOURCE: Final Rulemaking published at 67 DCR 5383 (May 22, 2020); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5503

22-C56 GENERAL OPERATING REQUIREMENTS

22-C DCMR § 5600 INSTRUCTIONS TO REGISTRANTS

5600.1 The Board shall develop and furnish to registrants, at the time of issuance of registration, written information describing the laws and regulations applicable to the medical cannabis business's day-to-day operations.

5600.2 Applications shall also be made available on ABCA's website. To the extent possible, applications shall be posted on ABCA's website in various languages for informational purposes. Applications submitted to the Board shall be completed in English.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10199 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5600

22-C DCMR § 5601 POSTING OF IDENTIFICATION REQUIREMENT BY RETAILER AND INTERNET RETAILER

5601.1 The notice required to be posted by the retailer shall state that no person shall be sold medical cannabis who does not produce both:

(a) A valid registration card issued by the Board or valid out of state documentation demonstrating enrollment in another jurisdiction’s medical cannabis program; and

(b) A valid government issued photo identification document displaying proof of age that matches the name on the registration card.

5601.2 An internet retailer shall be required to post the information required by § 5601.1 on its website.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10200 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5601

22-C DCMR § 5602 HOURS OF OPERATION, SALE, SERVICE, AND DELIVERY

5602.1 A retailer may operate and sell medical cannabis, and a retailer with a retail delivery endorsement may deliver medical cannabis, on any day and at any time except between the hours of 11:00 p.m. and 7:00 a.m.

5602.2 A licensed courier, cultivation center, internet retailer, manufacturer, and testing laboratory shall not be open to the public.

5602.3 A manufacturer may operate its business twenty-four (24) hours a day.

5602.4 A cultivation center may operate its business twenty-four (24) hours a day.

5602.5 A testing laboratory may operate on any day and at any time except between the hours of 9:00 p.m. and 5:00 a.m.

5602.6 A registered cultivation center or its contracted agent may deliver to medical cannabis dispensaries on any day and at any time except between the hours of 9:00 p.m. and 7:00 a.m.

5602.7 A registered testing laboratory or its contracted agent may collect medical cannabis samples from a cultivation center on any day and at any time except between the hours of 9:00 p.m. and 5:00 a.m.

5602.8 A courier and internet retailer may operate, sell, and deliver medical cannabis on any day and at any time except between the hours of 11:00 p.m. and 7:00 a.m.

5602.9 A registered cultivation center or testing laboratory shall permit only a registered director, officer, member, incorporator, agent, manager, employee, or government or law enforcement official on the registered premises.

5602.10 The Board may further limit the hours of operation for a medical cannabis business on a case-by-case basis as a condition of registration in response to written comments received from an ANC in the affected ward, or as the result of the dispensary, cultivation center, or testing laboratory's failure to comply with the Act, or this subtitle.

5602.11 A medical cannabis business may maintain its websites, mobile applications, and third-party listings active after its Board-approved hours and receive internet orders for medical cannabis so long as no medical cannabis is dispensed or delivered to a qualifying patient, caregiver, or courier until its Board-approved hours permit the business to open.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10199 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5602

22-C DCMR § 5603 LOCKING AND SECURING OF MEDICAL MARIJUANA DURING NON-OPERATING HOURS

5603.1 A registered medical cannabis business shall keep all medical cannabis located on the premises in a separate storage area which is securely closed and locked during all hours when the establishment is prohibited from operating or is closed. The storage area shall have a volumetric intrusion detection device(s) installed and connected to the facility intrusion detection system.

5603.2 A medical cannabis business shall be required to install and use a safe for overnight storage of any processed cannabis, transaction records, and cash on the registered premises. The safe shall be a UL listed burglar-proof safe with a minimum rating of TL-30. Safes weighing less than seven hundred fifty pounds (750 lb.) shall be installed in a steel clad concrete block or otherwise securely anchored to a fixed part of the facility structure.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10200 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5603

22-C DCMR § 5604 MANAGER’S APPLICATION

5604.1 In the absence of an owner, a licensed medical cannabis business shall have a Board-approved manager present at the licensed premises during the hours that the licensed medical cannabis business is open.

5604.2 An applicant for a manager’s license shall submit:

An application to the Board on the prescribed form;

A copy of their certificate showing completion of a medical cannabis training and education program from a Board-approved medical cannabis certification provider; and

The required fee.

5604.3 If a licensed medical cannabis business has designated one or more persons to manage the licensed business, each manager shall be the holder of a valid manager’s license which shall be renewable each year.

5604.4 A manager’s license shall remain valid until surrendered, expired, suspended, or revoked.

5604.5 An applicant for a manager’s license shall be subject to the requirements of the Act and this title.

5604.6 A licensed medical cannabis business may file a written request with the Board that an applicant for a manager’s license who has not completed a medical cannabis training and education certification program be issued a temporary manager’s license and shall attest that the applicant for the manager’s license will complete the medical cannabis and cannabis training within thirty (30) calendar days of receipt of the temporary manager’s license.

5604.7 The written request for a temporary manager’s license shall set forth the name of the licensed establishment, the trade name, the address of the establishment, the name of the applicant for the manager’s license, and the reason why the issuance of the temporary manager’s license is necessary.

5604.8 The temporary manager’s license issued pursuant to § 5604.8 shall cease after thirty (30) days or upon the approval or denial of the manager’s license application.

5604.9 A manager’s license shall expire one (1) year from issuance.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10201 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5604

22-C DCMR § 5605 DESTRUCTION AND DISPOSAL OF UNUSED OR SURPLUS MEDICAL CANNABIS AND REPORTING THEFT

5605.1 A medical cannabis business shall destroy or dispose of unused or surplus medical cannabis and its by-products by providing it to MPD for destruction.

5605.2 All unused or surplus medical cannabis and its by-products shall be weighed and documented and submitted to MPD on a form provided by MPD prior to being delivered to MPD by the medical cannabis business for destruction.

5605.3 A medical cannabis business that has had its registration renewal denied, or revoked, or is going out of business may obtain approval from the Board by submitting a written request to sell and transport medical cannabis to another medical cannabis business. The Board shall notify MPD of such approval prior to any medical cannabis being transported to another medical cannabis business.

5605.4 A medical cannabis business shall report any stolen or lost medical cannabis by filing a police report, by calling 911, or in person with the Police District where the registered business resides either in person or in writing within twenty-four (24) hours of becoming aware of the theft or loss.

5605.5 For purposes of this section, “unused or surplus medical cannabis” shall be defined as any harvested or unharvested cannabis, both processed and unprocessed, which is possessed by a cultivation center, dispensary, or testing laboratory and includes:

(a) Any cannabis plants possessed by a cultivation center in excess of the authorized plant limitation;

(b) Any cannabis that has spoiled or is unusable for medical purposes;

(d) Any cannabis that has or appears to have been tampered with; and

(e) Any cannabis that has completed testing at a testing laboratory, or unused sample materials.

5605.6 [REPEALED].

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10201 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5605

22-C DCMR § 5606 NOTICE OF CRIMINAL CONVICTION OF DIRECTOR, OFFICER, MEMBER, INCORPORATOR, AGENT OR EMPLOYEE

5606.1 If a licensed medical cannabis business discovers that any director, officer, member, incorporator, agent, or employee has at any time during their employment been convicted of a felony, it shall notify the Board within seven (7) days of that discovery.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10202 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5606

22-C DCMR § 5607 LABELING AND PACKAGING OF MEDICAL CANNABIS

5607.1 No medical cannabis shall be dispensed or distributed to a qualifying patient or caregiver unless the container in which it is distributed bears a legible label, firmly affixed, stating:

(a) The name of the cultivation center where the medical cannabis was produced and the manufacture date;

(b) The name of the internet retailer or retailer where the medical cannabis was dispensed;

The quantity of medical cannabis contained within;

The cannabinoid profile of the medical cannabis contained within, including the THC level;

(e) Any other ingredient or ingredients besides medical cannabis contained within;

(f) [REPEALED];

(g) The dispensing date that the medical cannabis was transferred to the qualifying patient or caregiver;

(h) The qualifying patient’s name and registration card number; and

(i) A statement that the product is for medical use, not for resale or transfer to another person, containing the following language: “Contains Cannabis. Keep out of the reach of children.”

5607.2 All medical cannabis a sold or otherwise distributed by a cultivation center shall be packaged and labeled in a manner that advises the purchaser that it contains cannabis, specifies the amount of cannabis in the product, and that the cannabis is intended for medical use solely by the patient to whom it is sold, and that any re-sale or re-distribution of the medical cannabis to a third person is prohibited.

5607.3 The label shall include all ingredients contained in the product, in order from most abundant to least abundant. The label for ingestible items shall identify potential food allergy ingredients, including milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soybeans. The product shall be packaged in a sealed container that cannot be opened without obvious damage to the packaging.

5607.4 The label shall contain the following warning: “There may be health risks associated with the ingestion or use of this product.” Please consult your physician if you have any questions or concerns.

5607.5 All medical cannabis shall be labeled with a list of all chemical additives, including but not limited to non-organic and organic pesticides, herbicides and fertilizers that were used in the cultivation and production of the medical cannabis.

5607.6 A cultivation center may place a trade or product name on the medical cannabis container prior to transporting it to a internet retailer or retailer.

5607.7 The label shall not contain any of the following information:

(a) Any false or misleading statement or design; or

(b) Any seal, flag, crest, coat of arms, or other insignia likely to mislead the qualifying patient to believe that the product has been endorsed, made, or used by the District government.

5607.8 A medical cannabis business shall not alter, obliterate, or destroy any label attached to a medical cannabis container.

5607.9 A internet retailer or retailer shall place for transport purposes packaged and labeled medical cannabis in a separate sealed container prior to dispensing medical cannabis to a qualifying patient or caregiver. This separate sealed container shall comply with these regulations and include a label containing the following required information contained in § 5607.1:

(a) The dispensing date the medical cannabis was transferred to the qualifying patient or caregiver; and

(b) The qualifying patient’s name and registration card number.

5607.10 A medical cannabis business shall not use the word(s) “candy” or “candies” on the product, packaging, or labeling of any medical cannabis product.

5607.11 A medical cannabis business shall not place any content, image, or labeling that specifically targets individuals under the age of twenty-one (21), including but not limited to, cartoon characters or similar images, on the product, packaging, or a container holding medical cannabis.

5607.12 A cultivation center that produces edible cannabis products or cannabis-infused products shall ensure that all edible cannabis products or cannabis-infused products offered for sale:

Are labeled clearly and unambiguously as medical cannabis;

Are not presented in packaging or with labeling that is appealing to children; and

Have packaging designed or constructed to be significantly difficult for children under five (5) years of age to open, but not normally difficult for adults to use properly.

5607.13 The cultivation center or manufacturer shall place medical cannabis or medical cannabis products in either tamper-evident or tamper-proof packaging so long as such packaging is difficult for children under five (5) years of age to open prior to transporting the products to the internet retailer or retailer.

5607.14 The internet retailer or retailer shall not open the medical cannabis package prior to being sold to the qualifying patient or his or her caregiver, except for purposes of adding the barcode and patient labels.

5607.15 The Director may prohibit a medical cannabis business from selling any medical cannabis product upon a finding by the Director that the product is deceptively labeled or branded in a manner which is misleading about its content or that contains injurious or adulterated ingredients.

5607.16 In addition to the other labeling requirements of this section, all edible cannabis products, and cannabis-infused products shall be labeled in accordance with 16 C.F.R. Part 1700 (2016), Poison prevention packaging; 21 C.F.R. Part 101 (2016), Food Labeling, as specified in Section 1102 of the District Food Code Regulations (Title 25-A DCMR).

5607.17 An internet retailer, retailer, cultivation center, and manufacturer shall submit its labeling to the Board for approval and record

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10210 (December 2, 2011); as amended by Final Rulemaking published at 64 DCR 7487 (August 4, 2017); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5607

22-C DCMR § 5608 INGESTIBLE ITEMS

5608.1 No medical cannabis business shall produce any cannabis product in an edible form, or other form which is intended to be eaten, drunk, or otherwise consumed orally, unless it has:

(a) Prepared the product at a cultivation center facility that meets all requirements of a retail food establishment, including any Department of Health licensing and certification requirements;

(b) Complied with all District of Columbia health regulations relating to the production, preparation, and sale of prepared food items in accordance with Title 25 DCMR, Subtitle A (Food and Food Operations); and

(c) Obtained all licenses, permits, endorsements, or other permissions required by law, including any Hazard Analysis and Critical Control Points (HACCP) plan required by law, before producing any ingestible products.

5608.2 A medical cannabis business shall not create, process, sell or transfer a cannabis item that:

(a) That by its shape, design or flavor is likely to appeal to minors, including:

(1) Products that are modeled after non-cannabis products primarily consumed by and marketed to children; or

(2) Products in the shape of an animal, vehicle, person, fruit, or character;

(b) That is made by applying cannabinoid concentrates or extracts to commercially available candy or snack food items;

(d) That contains more than 200 mg of THC per package;

(e) That contains more than 20mg of THC per serving size or piece; or

(f) That requires cooking or baking by the consumer.

5608.3 In addition to the requirements of § 5608.2, chocolate cannabis-infused products shall comply with the following requirements:

(a) Each serving size piece shall be individually wrapped; and

(b) Each serving size piece shall be affixed with a stamp or the imprinted letters “THC.”

5608.4 The sale of an ingestible item containing either a serving size piece of more than 20 mg of THC or more than 200 mg of THC per package shall be permitted as follows:

(a) Notwithstanding the THC limits set forth in subsections 5608.2, a medical cannabis business may apply to the Board to manufacture, sell, and transfer to other medical cannabis businesses as permitted by law ingestible items that may be sold only to qualifying patients with a written recommendation from an authorized practitioner, and that contain:

(1) Serving size pieces with a maximum of 50 mg of THC; and

(2) No more than 500 mg of THC per package.

(b) It shall be a violation of this title for a medical cannabis business to sell ingestible items containing more than 20 mg of THC per serving size piece or 200 mg of THC per package to a qualifying patient that does not possess a valid written recommendation from an authorized practitioner.

(c) The serving size and per package THC limits set forth in paragraph (a) of this subsection shall not apply to the sale of:

Ingestible capsules;

Tinctures; and

Non-injectable syringes no larger than 5,000 mg.

(d) A qualifying patient with a valid non-resident patient card issued by another state or jurisdiction that does not permit patient self-certification shall be deemed as possessing a written recommendation from an authorized practitioner and shall be eligible to purchase ingestible items consistent with the limits set forth in paragraphs (a)(1) and (a)(2).

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10210 (December 2, 2011); as amended by Final Rulemaking published at 64 DCR 7487 (August 4, 2017); as amended by Final Rulemaking published at 66 DCR 4244 (April 5, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5608

22-C DCMR § 5609 PERMITTED FORMS OF MEDICAL CANNABIS

5609.1 Dispensaries and cultivation centers may dispense or distribute medical cannabis in any form deemed safe which allows patients to eat, inhale, or otherwise use medical cannabis for medical purposes. Medical cannabis shall be subject to testing for quality assurance and safety purposes.

History

Source: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10204 (December 2, 2011); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5609

22-C DCMR § 5610 ELECTRONIC RECORDING SECURITY AND ALARM SYSTEM

5610.1 A medical cannabis business shall be required to operate and maintain in good working order a twenty-four (24) hour, seven (7) days a week, a closed circuit television (CCTV) surveillance system on the premises that complies with the following minimum standards:

(a) Visually records and monitors all building entrances and exits, all parking lot areas, rear alley areas immediately adjacent to the building, and covers the entire inside of the facility, including all limited access areas, and including all areas where medical cannabis is cultivated, stored, dispensed, tested, or destroyed. Fixed cameras shall be installed to provide a consistent recorded image of these areas. The medical cannabis business shall instruct the company or individuals installing the surveillance cameras to maximize the quality of facial and body images and to avoid backlighting and physical obstructions;

(b) Cameras installed outdoors and in low-light interior areas shall be day/night cameras with a minimum resolution of six hundred (600) lines per inch (analog) or D1 (IP) and a minimum light factor requirement of seven tenths (0.7) LUX. The installation of additional lighting may be required to increase picture clarity and brightness. Cameras shall be calibrated and focused to maximize the quality of the recorded image;

(d) A display monitor with a minimum screen size of twelve inches (12 in.) shall be connected to the electronic recording security system at all times;

(e) Electronic recording security systems are required to be maintained in good working order at all times. The owner of a medical cannabis business shall instruct each manager, employee, or agent overseeing the functioning of the video recording security system to immediately report any malfunctioning or technical problems with the system;

(f) Security recordings shall meet the following minimum requirements:

(1) The recorded image resolution shall be at least D1; and

(2) The recorded image frame rate shall be at least three (3) frames per second during alarm or motion based recording.

(g) Security recordings shall be retained by the medical cannabis business for a minimum of thirty (30) days. The recording system for the security cameras must be located in a locked, tamper-proof compartment. A medical cannabis business shall be prohibited from taping over existing security video from the last thirty (30) days; and

(h) Upon request, the security recording shall be made available within forty- eight (48) hours to MPD, the Board, or an ABCA investigator.

5610.2 A medical cannabis business shall install, maintain, and use a professionally monitored robbery and burglary alarm system; which meets the following requirements:

(a) The control panel shall be a UL listed burglar alarm control panel;

(b) The system shall report to a UL listed central monitoring station;

(d) At a minimum, the system shall provide coverage of all facility entrances and exits, rooms with exterior windows, rooms with exterior walls or walls shared with other facility tenants, roof hatches, skylights, and storage room(s) that contain safe(s);

(e) The system shall include at least one (1) holdup alarm for staff use; and

(f) The system shall be inspected, and all devices tested annually by a qualified alarm vendor.

5610.3 A medical cannabis business shall maintain for a period of three (3) years reports of incidents that triggered an alarm. Such reports shall be made available to ABCA during any inspection of the facility. A medical cannabis business shall notify the Board by electronic means within twenty-four (24) hours of any incident in which a theft, burglary, robbery, or break in occurred, whether or not items were actually removed from the facility. The facility manager shall follow up the initial notice with a written report describing in detail the factual circumstances surrounding the incident and include an inventory of all stolen items, if applicable.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10204 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5610

22-C DCMR § 5611 EDUCATIONAL CLASSES AND DEMONSTRATIONS

5611.1 A retailer may offer educational classes and demonstrations to qualifying patients, caregivers, and non-resident qualifying patients upon issuance of an education tasting endorsement.

5611.2 Educational classes and demonstrations permitted to be offered on-site shall include cooking and how-to classes and demonstrations, including how to utilize cannabis paraphernalia, how to cook foods with medical cannabis, and other medical cannabis preparation techniques.

5611.3 A retailer shall only offer educational classes and demonstrations on the retailer’s registered premises.

5611.4 A retailer may permit a qualifying patient, caregiver, or non-resident qualifying patient to smell or touch medical cannabis products provided medical cannabis is not administered or consumed on the registered premises and the medical cannabis has not been sold or otherwise given away.

5611.5 An educational activity that includes the smoking, administering, or consumption of medical cannabis shall be prohibited.

5611.6 A retailer shall ensure that containers of medical cannabis to be utilized for educational activities are labeled as such and may not be sold.

5611.7 A retailer shall ensure that medical cannabis containers to be utilized for educational purposes remain in its secure storage area during non-operating hours.

5611.8 A retailer shall not allow a qualifying patient, caregiver, or non-resident qualifying patient to leave the premises with medical cannabis that was made available or offered as part of the educational activity.

5611.9 A retailer shall destroy and dispose of medical cannabis utilized during the educational activity consistent with the requirements of this subtitle. This subsection shall include all medical cannabis that is physically touched or handled by patients, caregivers, or staff as part of the educational activity.

5611.10 A retailer with an educational tasting endorsement may offer educational activities on the registered premises between the hours of 7:00 a.m. and 11:00 p.m., daily.

5611.11 A retailer shall be permitted to charge a qualifying patient, caregiver, or non- resident qualifying patient an additional fee to attend or participate in the educational class or demonstration.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10207 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5611

22-C DCMR § 5612 PRODUCTION OF VALID IDENTIFICATION REQUIRED

5612.1 An internet retailer or retailer shall refuse to sell or deliver medical cannabis to any person who fails to produce a valid medical cannabis patient card issued by ABCA or a nonresident patient card or state-issued document and a valid government issued photo identification document displaying proof of age that matches the name on the patient card.

5612.2 A licensee shall take steps reasonably necessary to ascertain whether any person to whom the licensee sells, delivers, or serves medical cannabis is a qualifying patient registered or authorized to purchase or possess medical cannabis, and that the sale otherwise complies with the medical cannabis quantity and sale limits provided by the Act and this title.

5612.3 Any person who supplies a valid and unexpired medical cannabis patient card or medical cannabis caregiver card showing their legal age to be the legal age and authorization to obtain medical cannabis and all other documents required by the Act and this title, if required, shall be deemed authorized to obtain medical cannabis.

5612.4 The provisions of this section notwithstanding, no licensee shall discriminate on any basis prohibited by the Human Rights Act of 1977, effective December 13, 1977 (D.C. Law 2-38; D.C. Official Code § 2-1401.01 et seq.).

5612.5 It shall be an affirmative defense to a violation of § 5612.1 that the licensee or their agent was shown and inspected a fake or fraudulent identification document of such quality that a reasonable person would believe that it was valid unless:

(a) The identification was visibly damaged;

(b) The identification lacked the physical materials or features of the valid identification being imitated;

(d) The identification is displayed past the printed expiration date; or

(e) The licensee or their agent knew the person was not authorized or ineligible to obtain medical cannabis.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10207 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5612

22-C DCMR § 5613 TEMPORARY SURRENDER OF REGISTRATION -- SAFEKEEPING

5613.1 A registered medical cannabis business that discontinues its operations for any reason shall surrender its registration to the Board for safekeeping within three (3) calendar days of discontinuing its operations. The Board shall hold the registration for one hundred twenty (120) days or until the establishment resumes business whichever occurs first. If the registrant has not initiated proceedings to resume operations within one hundred twenty (120) days, the Board shall deem the registration abandoned and cancel the registration.

5613.2 The Board may extend the period of safekeeping beyond one hundred twenty (120) days only for good cause, such as fire, flood, other natural disaster; rebuilding or reconstruction; or to complete the sale of the establishment, and only if the extension is not likely to adversely affect the District’s ability to serve the needs of all registered qualifying patients.

5613.3 This section shall not relieve a registered medical cannabis business from the responsibility for renewing the registration upon its expiration.

5613.4 If a medical cannabis business notifies the Board that the establishment has ceased to do business under the registration or if the Board cancels the registration under this section, the registration shall be marked as "cancelled."

5613.5 A registration suspended by the Board under this title shall be stored with the Board.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10207 (December 2, 2011); as amended by Final Rulemaking published at 60 DCR 10061 (July 12, 2013); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5613

22-C DCMR § 5614 CO-LOCATION AND INTEGRATION

5614.1 Nothing in this title shall preclude two (2) or more cultivation centers from locating in the same building, provided that they maintain:

(a) Separate books and records; and

(b) Their own secure and distinct registered premises that is separated at a minimum by a fixed boundary.

5614.2 Separately licensed medical cannabis businesses may be located in the same building or space but shall maintain separate books and records and a separate secure space. A medical cannabis business may share space or the same address if the licensed medical cannabis businesses demonstrate to the satisfaction of the Board that the medical cannabis businesses will have their own separate secure space, maintain separate inventory, records, and financial accounts, and otherwise operate in accordance with the Act and this title.

5614.3 Nothing in this title shall preclude two (2) or more testing laboratories from locating in the same building, provided that they maintain:

(a) Separate books, equipment, staff, and records; and

(b) Their own secure and distinct registered premises that is separated, at minimum, by a fixed boundary.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10208 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5614

22-C DCMR § 5615 SEED-TO-SALE TRACKING

5615.1 A medical cannabis business shall purchase access to the METRC real-time electronic records system.

5615.2 All information required by this section shall be entered into the real-time electronic records system designated in § 5615.1.

5615.3 All information entered into the METRC real-time electronic records system shall be true, complete, and a real-time electronic record of the event, information, or occurrence recorded in the system.

5615.4 All information required to be entered into the real-time electronic records system shall be entered immediately at the time of the transaction, event, or occurrence, or the information becomes available to the licensee or its agents.

5615.5 A courier, internet retailer, or retailer shall enter the following information into the real-time electronic records system:

All transactions where the licensee distributed or sold medical cannabis to a qualifying patient, nonresident qualifying patient, or caregiver, including,

(1) The quantity of medical cannabis distributed, delivered, or dispensed;

(2) Whether the transaction was fulfilled at the store, by curbside delivery, or delivery at another location;

(3) The amount of money or other consideration provided by the purchaser; and

The name and address of the purchaser;

The quantity of medical cannabis or medical cannabis products at the facility; and

The destruction or disposal of cultivated, processed, or acquired medical cannabis, the method used, the reason for its destruction or disposal, and proof of disposal.

5615.6 A cultivation center and manufacturer shall enter the following information into the real-time electronic records system:

The date of each distribution, transportation, or sale of medical cannabis to an internet retailer, manufacturer, retailer, or testing laboratory;

The name, address, and license number of the internet retailer, manufacturer, or retailer;

The quantity of medical cannabis and paraphernalia distributed, transported, or sold to the internet retailer, manufacturer, or retailer;

The price charged and the amount received for the medical cannabis or medical cannabis products distributed, transported, or sold to the internet retailer, manufacturer, or retailer;

The type, brand, and quantity of medical cannabis or medical cannabis products maintained at the cultivation center on a daily basis;

The number of plants being grown at the cultivation center on a daily basis;

The type, brand name, and quantity of medical cannabis or medical cannabis products produced on a daily basis;

The results of the testing laboratory analysis for five (5) years from the date of the test; and

The destruction or disposal of cultivated, processed, or acquired medical cannabis or medical cannabis products, the method used, the reason for its destruction or disposal, and proof of disposal.

5615.7 It is an affirmative defense to a violation of § 5615.6(h) that the medical cannabis or medical cannabis product was not subject to a testing requirement due to the absence of testing laboratory licenses in the District of Columbia or that all testing laboratories were in safekeeping, not in operation, or out of business for a period of more than fourteen (14) days.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10208 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5615

22-C DCMR § 5616 SIGN REQUIREMENTS

5616.1 A retailer shall post at its building entrance in a conspicuous place, a sign from the Board that states the following:

Minors are precluded from entering the premises unless they are a qualifying patient and are in the presence of a parent or guardian; and

Smoking, ingesting, or consuming cannabis on the premises is prohibited.

5616.2 A retailer with a Board-approved safe-use treatment facility, summer garden, or education tasting endorsement shall not be required to post the language contained in § 5616.1(b).

5616.3 A medical cannabis business shall post a sign provided by the Board at all areas of ingress and egress to limited access areas, which reads: "Access to this area is restricted to persons registered with the Board visibly displaying a registration identification card."

5616.4 An internet retailer or retailer shall conspicuously post a sign on the premises accessible to the public; make a booklet or other document readily available to the public; or on its website post information or a document containing the current retail prices of all items available for sale.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10208 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5616

22-C DCMR § 5617 OUTDOOR LIGHTING REQUIREMENTS

5617.1 A medical cannabis business shall be required for security purposes to have sufficient lighting outside of the registered business each day between sunset and sunrise that adequately illuminates the medical cannabis business and its immediate surrounding area, including storage areas, parking lots, entry areas such as the front facade, and any adjoining public sidewalk.

5617.2 Outdoor lighting shall be hooded or oriented so as to deflect light away from adjacent properties.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10209 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5617

22-C DCMR § 5618 MINIMUM STAFFING LEVELS

5618.1 An internet retailer or retailer shall be staffed with at least two (2) persons during its hours of operation.

5618.2 A cultivation center shall be staffed with at least two (2) persons when employees are present inside of the cultivation center.

5618.3 A testing laboratory shall be staffed with at least two (2) persons when employees are present inside of the testing laboratory.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10209 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5618

22-C DCMR § 5619 LIMITED ACCESS AREAS

5619.1 Medical cannabis shall only be grown, cultivated, stored, weighed, displayed, packaged, sold, possessed for sale, or tested only in a limited access area under the control of the medical cannabis business. A medical cannabis business shall permit only those persons registered with the Board to enter the limited access area.

5619.2 A limited access area, including all areas of ingress and egress, shall be designated by the medical cannabis business on its application. The limited access area shall be either a building, room, or other contiguous area upon the registered premises.

5619.3 A medical cannabis business shall post a sign provided by the Board at all areas of ingress and egress identifying the limited access area.

5619.4 Persons registered by the Board shall wear their registration identification issued by the Board at all times while working or entering the limited access area.

5619.5 It shall be a violation of this title for a registered or non-registered person to be located within a limited access area unless the person’s registration identification is visibly displayed.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10210 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5619

22-C DCMR § 5620 MANUFACTURING STANDARDS

5620.1 In the course of producing and growing medical cannabis, a cultivation center or manufacturer is forbidden from using any of the following substances or techniques:

(a) Synthetic pesticides (for example defoliants and desiccants, fungicides, insecticides and rodenticides), or wood preservatives (such as arsenate);

(b) Fertilizer or composted plant and animal material that contains a substance prohibited by this section;

(d) Synthetic growth regulators;

(e) Synthetic allopathic veterinary drugs, including antibiotics and parasiticides;

(f) Synthetic processing substances, aids and ingredients, and food additives and processing aids including sulphates, nitrates and nitrites;

(g) Equipment, packaging materials and storage containers, or bins that contain synthetic fungicide, preservative or fumigant; or

(h) Any pesticide, fungicide, fertilizer, rodenticide, or drug banned by the Department of Agriculture or Food and Drug Administration.

5620.2 The prohibition on “synthetic growth regulators” shall not preclude the use of artificial lighting or lighting equipment.

5620.3 A cultivation center or manufacturer shall obtain written approval from the Board before engaging in the use of butane or other explosive gases to extract or separate resin or tetrahydrocannabinol from cannabis or to produce or process any form of cannabis concentrates or cannabis-infused product.

5620.4 In reviewing a request for the use of butane or other explosive gases, the Board may consult with subject matter experts in the field, the Fire and Emergency Medical Services Department, and the Department of Energy and Environment as to the safety and sufficiency of the cultivation center’s proposal.

5620.5 Pesticides may be legally used on medical cannabis by cultivation centers under the following criteria:

(a) Any pesticide used in the cultivation of medical cannabis must be registered with the Department of Energy and Environment (DOEE);

(b) The use of any pesticide used in the cultivation of medical cannabis must comply with the regulations promulgated by the DOEE; and

(c) Any pesticide registered with the DOEE may be used in accordance with its label or labeling directions for the cultivation of medical cannabis in the District of Columbia provided, that for products registered by the Environmental Protection Agency under Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act:

All active ingredients of the pesticide product are exempt from the requirements of a tolerance, as established under 40 CFR Part 180, Subparts D and E;

The pesticide product label allows use on the intended site of application;

The pesticide product label expressly allows use on crops or plants intended for human consumption; and

The active ingredients of the pesticide product are allowed for use on tobacco by the Environmental Protection Agency.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10210 (December 2, 2011); as amended by Final Rulemaking published at 64 DCR 6637 (July 14, 2017); as amended by Final Rulemaking published at 64 DCR 7485 (August 4, 2017); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5620

22-C DCMR § 5621 TRANSPORT OF MEDICAL CANNABIS

5621.1 A licensed medical cannabis business shall obtain from the Board a transporter license to transport medical cannabis within the District of Columbia to another licensed medical cannabis business if permitted by law. An original transporter license shall be required for each vehicle being designated by the licensed medical cannabis business or its contracted agent to be authorized to deliver medical cannabis to another licensed medical cannabis business.

5621.2 A licensed medical cannabis business, or its contracted agent, shall not transport medical cannabis within the District of Columbia without an original transporter license. A licensed medical cannabis business shall permit only an employee, director, officer, member, incorporator, or agent registered with the Board or its contracted agent to transport medical cannabis to another licensed medical cannabis business.

5621.3 Upon demand by an ABCA investigator, the registered person in charge of the transportation or its contracted agent shall exhibit to the ABCA investigator an original transporter license.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10211 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5621

22-C DCMR § 5622 INVENTORY

5622.1 Each licensed medical cannabis business shall be required to develop, implement, and maintain, on its registered premises, a written real-time inventory control plan, which shall:

(a) Establish inventory controls and procedures it will use to conduct inventory reviews and verify the business’s cultivated, stored, useable and unusable cannabis and cannabis products that are in its possession; and

(b) Include its procedures for storing cannabis and cannabis products and preventing theft and diversion.

5622.2 Each licensed medical cannabis business shall be responsible for inputting and maintaining in METRC an accurate inventory in real time of all cannabis and cannabis products in the possession of the licensed medical cannabis business. This inventory shall include all cannabis and cannabis products available for cultivation, finished usable cannabis and cannabis products available for sale, immature and mature plants, and unusable cannabis and cannabis products at the registered premises.

5622.3 In entering inventory into METRC, pursuant to § 5615, a licensed medical cannabis business shall include damaged, defective, expired, or adulterated cannabis or cannabis products awaiting disposal, including the name, the quantity, and the reasons for which the licensed medical cannabis business is maintaining the cannabis or cannabis products.

5622.4 In tracking its cannabis and cannabis products inventory, a licensed medical cannabis business shall:

(a) Update cannabis and cannabis product inventories on at least a daily basis;

(b) Conduct a monthly inventory audit of cultivated, stored, useable and unusable cannabis and cannabis products; and

5622.5 The record of an inventory audit conducted pursuant to § 5622.4(b) or (c) shall include, at a minimum, the date of the audit, a summary of the audit findings, and the name, signature, and title of the person(s) who conducted the audit.

5622.6 A licensed medical cannabis business that becomes aware of a reportable loss, discrepancies identified during an audit, diversion, or theft whether or not the cannabis or cannabis products are subsequently recovered, or the responsible parties are identified, shall notify the Board within twenty-four (24) hours.

5622.7 For the purpose of this section, the phrase “unusable cannabis and cannabis products” means the seeds and roots of the cannabis plant, as well as any products derived therefrom.

History

SOURCE: Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5622

22-C DCMR § 5623 MANUFACTURING RESTRICTIONS AT CULTIVATION CENTERS

5623.1 A cultivation center that does not hold a manufacturer’s license may distribute and produce medical cannabis in the form of pre-rolls and bulk fresh or dried cannabis flower and other cannabis plant material.

5623.2 A cultivation center that does not possess a manufacturer’s license shall not produce concentrates, edibles, infused edibles, lozenges, vaping products, tinctures, topicals, or any other product except those listed in 5623.1.

5623.3 A cultivation center that does not possess a manufacturer’s license shall not extract THC, CBD, or other chemicals from cannabis plants.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5623

22-C DCMR § 5624 RETAILER DELIVERY ENDORSEMENT

5624.1 A retailer may apply for a retailer delivery endorsement, which shall authorize curbside pickup and off-site delivery of medical cannabis, medical cannabis products, and paraphernalia to qualifying patients and their caregivers.

5624.2 An internet retailer shall not be required to obtain a delivery endorsement to deliver medical cannabis, medical cannabis products, and paraphernalia off-site to qualifying patients and their caregivers.

5624.3 Medical cannabis that cannot be delivered shall be returned to the internet retailer or retailer. A retailer or internet retailer that uses the services of a licensed courier must accept returns during their hours of operation from the licensed courier if the courier determines that the patient’s or caregiver’s order is undeliverable.

5624.4 The internet retailer’s or retailer’s delivery driver(s) shall wear an employee badge when making deliveries.

5624.5 The internet retailer or retailer shall implement a mechanism or process for patients and caregivers to submit copies of their registration cards and identification cards to the internet retailer or retailer for verification prior to delivery, and the internet retailer or retailer shall maintain a copy of both as part of the internet retailer’s or retailer’s recordkeeping requirements;

5624.6 The qualifying patient or caregiver ordering the medical cannabis and medical cannabis products shall be physically present at the residence or the commercial building in the District where medical cannabis and medical cannabis products can be lawfully delivered. For purposes of this paragraph, “physically present at the residence” includes the residence’s porch, driveway, or yard. The phrase does not include any place that is not included within the residence’s property line, including the sidewalk or the curb.

5624.7 An internet retailer or retailer may make deliveries up to seven (7) days a week, but shall only make deliveries between the hours of 7:00 a.m. and 11:00 p.m.

5624.8 The internet retailer or retailer shall implement a mechanism or recordkeeping process for patients and caregivers to document receipt of medical cannabis deliveries and shall maintain the records as part of the internet retailer and retailer’s recordkeeping requirements.

5624.9 An internet retailer or retailer delivery driver shall only travel from the internet retailer and retailer to the driver’s assigned delivery address(es) and return to the internet retailer and retailer.

5624.10 The internet retailer or retailer shall record each delivery in the METRC delivery manifest system in real-time and maintain a copy of the record as part of the internet retailer and retailer’s recordkeeping requirements.

5624.11 The internet retailer or retailer shall provide a copy of its delivery manifest to the Board or ABCA investigators immediately upon request.

5624.12 An internet retailer or retailer may use the services of a courier.

5624.13 An internet retailer or retailer shall only store medical cannabis at its licensed location unless stored at a courier’s licensed premise in accordance with the time restrictions provided by the Act and this title.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5624

22-C DCMR § 5625 SAFE-USE TREATMENT FACILITY

5625.1 The holder of a retailer’ license shall be eligible to apply for a Safe-Use Treatment Facility endorsement.

5625.2 An application for a Safe-Use Treatment Facility endorsement shall be filed as a substantial change.

5625.3 An applicant for a Safe-Use Treatment Facility shall provide an architectural map of the premises that identifies:

The area to be covered by the endorsement;

The location of all security cameras;

All access doors and walls of the Safe-Use Treatment Facility;

The location of the ventilation system and pollution or odor control unit;

The smoke-free area for employees to monitor the facility; and

All of the information required by section 7c(e)(2) of the Act (D.C. Official Code § 7-1671.06c(e)(2)).

5625.4 The holder of a Safe-Use Treatment Facility endorsement shall not permit odor, smoke, or by-products from the combustion of cannabis to be detectable by sense of smell in a separate residence or commercial property, whether located on the same lot or a separate lot, if emanating from the interior of the licensed premises.

5625.5 A Safe-Use Treatment Facility shall not offer disc jockeys, live bands and any other form of entertainment as provided by D.C. Official Code § 25-101(19A) and (21A). A Safe-Use Treatment Facility may offer prerecorded and background music, movies, television, radio, and other media that does not qualify as entertainment in accordance with D.C. Official Code § 25-101(19A) and (21A).

5625.6 Security cameras installed in the Safe-Use Treatment Facility shall record all areas where patients are permitted, except for the interior of bathrooms, and shall be operated in accordance with the rules governing security cameras as described in the Act and this title.

5625.7 No qualifying patient shall possess more medical cannabis than permitted by the medical cannabis quantity limit provided by the Act or this chapter.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5625

22-C DCMR § 5626 SUMMER GARDEN ENDORSEMENT

5626.1 An applicant for or the holder of a retailer’s license shall be eligible to apply for a Summer Garden if also issued Safe-Use Treatment Facility endorsement.

5626.2 An application for a Summer Garden endorsement shall be filed with the initial application for licensure or as a substantial change.

5626.3 An applicant for a Summer Garden shall provide an architectural map of the premises that identifies:

The area to be covered by the endorsement;

The location of all security cameras;

All access doors and walls of the Summer Garden; and

All of the information required by section 7c of the Act (D.C. Official Code § 7-1671.06c(e)(2)).

5626.4 The holder of a Summer Garden endorsement shall not permit odor, smoke, or by-products from the combustion of cannabis to be detectable by sense of smell in the interior of a separate premise with its windows or doors closed.

5626.5 A Summer Garden may offer recorded and background music but shall not offer disc jockeys, live bands or any other form of entertainment or live performance as provided by D.C. Official Code §§ 25-101(19A) and 25-101(21A).

5626.6 Security cameras installed in the Summer Garden area shall record all areas where patients are permitted, except for the interior of bathrooms, and shall be operated in accordance with the rules governing security cameras as described in the Act and this title.

5626.7 No qualifying patient shall possess more medical cannabis than permitted by the medical cannabis quantity limit provided by the Act or this chapter.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5626

22-C DCMR § 5627 MANDATORY TRAINING

5627.1 All directors, officers, members, incorporators, agents, employees, and managers shall receive training on the topics required by § 5105 at least once every three (3) years. The licensee shall maintain a written log or record on the licensed premises that must be made available to ABCA or the Board upon request for a period of at least four (4) years showing:

The trainer or presenter;

The date(s) and time(s) of the training;

A list of the directors, officers, members, incorporators, agents, employees, and managers that attended the training; and

The manner in which the training was provided (in-person class, online, etc.).

5627.2 No director, officer, member, incorporator, agent, or employee shall be required to obtain a medical cannabis training certificate from a Board-approved certified medical cannabis training provider in order to comply with § 5627.1. This subsection shall not apply to managers.

5627.3 A director, officer, member, incorporator, agent, or employee shall be initially trained on the topics required by § 5105 within thirty (30) calendar days of being registered with ABCA as either a director, officer, member, incorporator, agent or employee. This subsection shall not apply to managers.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5627

22-C DCMR § 5628 MANAGEMENT AGREEMENT

5628.1 A licensee or applicant who enters into a management agreement with a third-party for the management of a medical cannabis business shall provide the Board with a copy of the agreement within thirty (30) calendar days of execution.

5628.2 Notice of cancellation or termination of a management agreement shall be provided in writing to the Board within thirty (30) calendar days of the cancellation or termination.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5628

22-C57 PROHIBITED AND RESTRICTED ACTIVITIES

22-C DCMR § 5700 SALE, PURCHASE, AND POSSESSION OF MEDICAL CANNABIS

5700.1 A licensed internet retailer or retailer shall not receive or purchase medical cannabis from a source other than a cultivation center or manufacturer licensed in the District of Columbia.

5700.2 It is a violation for the retailer to allow a person to possess, use, or consume any cannabis or cannabis products not sold or distributed by a licensed internet retailer or retailer.

History

Source: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10211 (December 2, 2011); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5700

22-C DCMR § 5701 SALE OF MEDICAL CANNABIS BY CULTIVATION CENTERS

5701.1 A cultivation center shall not be permitted to sell medical cannabis to qualified patients or caregivers. It shall be a violation of this subtitle for a cultivation center to sell medical cannabis to qualifying patients or caregivers.

5701.2 It shall be unlawful for a cultivation center to sell or distribute medical cannabis to a person or entity other than an internet retailer or retailer registered in the District of Columbia.

5701.3 It shall be unlawful for a cultivation center to sell medical cannabis from plants not grown at a registered location in the District of Columbia.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10212 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5701

22-C DCMR § 5702 UNSEALED PACKAGES IN COMMERCIAL OR PUBLIC VEHICLES

5702.1 No driver of a commercial or public vehicle in the District of Columbia shall have in their possession, while in or on the vehicle, any opened or unsealed package containing medical cannabis.

History

Source: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10212 (December 2, 2011); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5702

22-C DCMR § 5703 DELIVERY OF MEDICAL CANNABIS

5703.1 Except as provided in §§ 5703.2 and 5703.3, a internet retailer or retailer shall not be permitted to transport or deliver medical cannabis to a qualifying patient or caregiver or non- resident qualifying patient or from a cultivation center or testing laboratory. It shall be a violation of this subtitle for a internet retailer or retailer to transport or deliver medical cannabis to a qualifying patient or caregiver or non-resident qualifying patient, cultivation center, or testing laboratory other than as provided in §§ 5703.2 and 5703.3.

5703.2 An internet retailer or retailer, meeting the requirements of § 5703.3, shall only be permitted to deliver medical cannabis to a qualifying patient or caregiver registered in the District of Columbia Medical Cannabis Program and that has been issued a District of Columbia Government medical cannabis card. An internet retailer or retailer shall also be permitted to deliver in the District of Columbia to a non-resident qualifying patient unless ABCA determines that there is a shortage of medical cannabis or the real- time electronic records system is inactive. An internet retailer or retailer shall not deliver or transport medical cannabis to a non-resident patient who does not possess a valid medical cannabis card issued by the state or U.S. territory in which they reside or to a District resident who possesses a medical cannabis card that was not issued by Department of Health or, after December 9, 2020, by ABCA. An internet retailer or retailer that delivers medical cannabis to non-qualifying non-resident patients or individuals who possess cards issued by unauthorized entities shall be subject to disciplinary action, up to and including revocation of registration.

5703.3 A licensed internet retailer, retailer, or courier shall only be permitted to deliver medical cannabis, medical cannabis products, and paraphernalia to a qualifying patient or caregiver registered in the Program or to a non-resident qualifying patient if the internet retailer, retailer, or courier complies with the following requirements:

The internet retailer, retailer, or courier shall register its delivery vehicles with the Board by completing a Board-issued application form and providing all required information, which shall include each vehicle’s license plate number, vehicle identification number (VIN), and its make, model and color;

There shall be no limit on the number of delivery vehicles that an internet retailer, retailer, or courier may register with the Board;

A delivery vehicle shall not be marked with any signage, symbols, images, or advertisement identifying the vehicle as associated with medical cannabis;

A delivery vehicle shall have a functioning global positioning system (GPS) to ensure that the most direct delivery route is followed;

A delivery driver shall be an employee of the internet retailer or retailer or an employee or independent contractor of the courier;

The internet retailer, retailer, or courier shall register the name and medical cannabis employee registration number of each delivery driver with the Board;

Each delivery driver of an internet retailer, retailer, or courier shall have an active District of Columbia medical cannabis employee registration;

Each delivery driver of an internet retailer, retailer, or courier shall have their ABCA issued registration card on their person when making deliveries;

The internet retailer, retailer, or courier shall implement a mechanism or process for patients and caregivers to submit copies of their registration cards and identification cards, or relevant information contained therein, to the internet retailer, retailer, or courier for verification prior to delivery, and the internet retailer, retailer, or courier shall maintain a copy of both as part of the internet retailer, retailer’s or courier’s recordkeeping requirements;

Prior to delivery, the internet retailer, retailer, or courier shall:

Verify that the patient, or the patient and caregiver, is actively enrolled in the District’s medical cannabis program or is a non-resident qualifying patient, by checking their medical cannabis registration card and comparing it to their records in order to ensure that the information matches;

Verify that the delivery address is a residence or a commercial building address in the District that is not on federal or District government property or public or private school grounds;

Maintain a copy of the Program or out-of-state or U.S. territory registration card and a copy of the valid government-issued identification card;

Verify that the patient’s requested amount does not exceed the legal medical cannabis possession and sale limits, as set by section 7(o)(1) of the Act (D.C. Official Code § 7-1671.06(o)(1)), 22-C DCMR § 301, and 22-C DCMR § 5709; and

Receive and only accept an order by electronic or other means from a qualifying patient or the qualifying patient’s caregiver or a non- resident qualifying patient.

The internet retailer, retailer, or courier shall only make deliveries to residential or commercial building addresses located within the District that are not on federal or District government property or public or private school grounds, except as provided in Section 6a(c) of the Act (D.C. Official Code § 7-1671.05a(c)), to qualifying patients and caregivers registered in the District medical cannabis program or to non-resident qualifying patients as set forth in § 5703.2 when the patient or caregiver is physically present;

The patient or caregiver ordering the medical cannabis shall be physically present at the residence or the commercial building in the District where medical cannabis can be lawfully delivered. For purposes of this paragraph, "physically present at the residence" includes the residence’s porch, driveway, or yard. The phrase does not include any place that is not included within the residence’s property line, including the sidewalk or the curb;

The internet retailer, retailer, or courier may make deliveries up to seven (7) days a week, but shall only make deliveries between the hours of 7:00 a.m. and 11:00 p.m.;

The internet retailer, retailer, or courier shall implement a mechanism or recordkeeping process for patients and caregivers to document receipt of medical cannabis deliveries and shall maintain the records as part of the internet retailer or retailer’s recordkeeping requirements. If, in an enforcement action pursuant to Chapter 10 or Chapter 62 of this subtitle, a patient or caregiver disputes receiving the medical cannabis and the internet retailer or retailer does not have documentation proving the delivery occurred, the Board shall apply a rebuttable presumption that the delivery did not occur;

An internet retailer, retailer, or courier delivery driver shall only travel from the internet retailer, retailer or courier to the driver’s assigned delivery address(es) and return to the internet retailer, retailer, or courier;

The internet retailer, retailer, or courier shall record each delivery in the METRC delivery manifest system in real-time and maintain a copy of the record as part of the internet retailer or retailer’s recordkeeping requirements; and

The internet retailer, retailer, or courier shall provide a copy of its delivery manifest to the Board or ABCA investigators immediately upon request.

5703.4 A retailer may dispense medical cannabis through curbside pickup or at-the-door pickup to a qualifying patient or caregiver or non-resident qualifying patient only if the retailer holds a retailer delivery endorsement and complies with the following requirements:

The retailer shall only be permitted to dispense medical cannabis through curbside pickup or at-the-door pickup to a qualifying patient or caregiver registered in the Program, or to a patient enrolled in another state’s medical cannabis program who is recognized by the Board, as evidenced by a state-issued medical cannabis patient card and with a government-issued identification card. A retailer that dispenses medical cannabis to individuals who possess cards issued by unauthorized entities on the Internet or states that are not yet recognized by the Board shall be subject to disciplinary action up to and including revocation of registration;

The retailer shall implement a mechanism or process for a patient or a District registered caregiver to submit a copy of the patient or registered caregiver’s, medical cannabis registration card and the patient or registered caregiver’s, government-issued identification card to the retailer for verification prior to dispensing. The retailer shall maintain a copy of both as part of the retailer’s recordkeeping requirements;

Prior to dispensing, the retailer shall:

Verify that the patient, or patient and registered caregiver, is actively registered in the District’s medical cannabis program, or that the non-resident patient is actively enrolled in another state’s medical cannabis program;

(2) Maintain a copy of the medical cannabis program or out of state or U.S. territory registration card and a copy of the government-issued identification card; and

(3) Verify that the patient’s requested amount does not exceed the legal medical cannabis possession and sale limits, as set by section 7(o)(1) of the Act (D.C. Official Code § 7-1671.06(o)(1)), 22-C DCMR § 301, and 22-C DCMR § 5709.

The retailer shall implement procedures to ensure that curbside pickup or at-the-door pickup is completed quickly and efficiently; and

The retailer shall implement a mechanism or recordkeeping process for patients to document receipt of curbside pickup or at-the-door pickup and shall maintain the records as part of the retailer’s recordkeeping requirements.

5703.5 At the retailer’s discretion, the retailer may require electronic payment before scheduling a delivery, curbside pickup, or at-the-door pickup; may limit deliveries, curbside pickup, and or at-the-door pickup to electronic payment only.

5703.6 A cultivation center shall not be permitted to deliver medical cannabis to any premises other than the specific licensed premises of the internet retailer or retailer where the medical cannabis is to be sold for resale to qualifying patients and caregivers.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10212 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5703

22-C DCMR § 5704 PLANT LIMITATIONS

5704.1 An internet retailer or retailer shall not be permitted to possess or sell cannabis plants. It shall be a violation of this subtitle for an internet retailer or retailer to possess or sell cannabis plants or for a cultivation center to sell cannabis plants to an internet retailer or retailer.

5704.2 An internet retailer or retailer shall not be permitted to possess or sell cannabis plants or clones. It shall be a violation of this subtitle for an internet retailer or retailer to possess or sell cannabis plants or clones, or for a cultivation center to sell cannabis plants or clones to an internet retailer or retailer.

5704.3 For purposes of this subtitle, a “clone” shall be considered a cannabis plant when:

(a) There is readily observable evidence of root formation that is either at least three (3) inches in length or that has sprouted hair-like fibers that are visible to the naked eye; or

(b) The clone has reached eight (8) inches in height.

5704.4 Cultivation centers shall tag and track all cannabis plants, in any stage of growth, from seed to sale in the Marijuana Enforcement Tracking Reporting Compliance (METRC) system.

5704.5 All clones shall be tagged and tracked in the METRC system upon being placed in the water or propagation solution, regardless of whether they have reached plant status.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10212 (December 2, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 67 DCR 8837 (July 17, 2020); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5704

22-C DCMR § 5705 PROHIBITION REGARDING ON-PREMISE CONSUMPTION

5705.1 A medical cannabis business shall not permit the consumption of medical cannabis at the registered premises in any form. The medical cannabis business shall dispense or distribute medical cannabis in a closed container that shall not be opened after sale, or the contents consumed, on the premises where sold. An internet retailer or retailer may exhibit for display purposes only clear jars of medical cannabis to assist qualifying patients in making informed purchase making decisions.

5705.2 It shall be a violation of this subtitle for a medical cannabis business to have on the registered premises any medical cannabis or cannabis paraphernalia that shows evidence of the medical cannabis having been consumed or partially consumed.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10213 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5705

22-C DCMR § 5706 TIE-IN PURCHASES PROHIBITED

5706.1 A cultivation center or manufacturer shall not require, directly or indirectly, a licensee to purchase any type of medical cannabis, medical cannabis product, paraphernalia, or other commodity in order to purchase any other medical cannabis product.

5706.2 An internet retailer or retailer shall not require, directly or indirectly, a qualifying patient or caregiver to purchase any type of medical cannabis, medical cannabis product, paraphernalia, or other commodity in order to purchase any other medical cannabis product.

History

Source: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10213 (December 2, 2011); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5706

22-C DCMR § 5707 MINIMUM AGE AND ENTRY REQUIREMENTS

5707.1 A person under twenty-one (21) years of age shall not be employed by an internet retailer or retailer to sell or dispense medical cannabis.

5707.2 A person under twenty-one (21) years of age shall not be employed by a cultivation center to grow or cultivate medical cannabis.

5707.3 A person under twenty-one (21) years of age shall not be employed by a testing

laboratory to test medical cannabis.

5707.4 A person under the age of eighteen (18) shall be precluded from purchasing medical cannabis from an internet retailer or retailer unless he or she is a qualifying patient and is in the presence of a parent or guardian.

5707.5 An internet retailer or retailer may prohibit an individual who is not a qualifying patient, caregiver, or on official government business from entering or remaining on the registered premises.

5707.6 An internet retailer or retailer, cultivation center and testing laboratory shall maintain a visitor log on-site. An internet retailer or retailer's visitor log shall include the visitor's name, title, company, date, time, and purpose of the visit.

5707.7 An internet retailer or retailer, cultivation center and testing laboratory shall provide visitor identification badges and register any visitors that are not qualifying patients or caregivers or non-resident qualifying patients, including but not limited to vendors, potential vendors, managers, agents, or employees, elected officials, and medical consultants.

5707.8 In the event of an emergency, a licensed medical cannabis business shall be permitted to provide an outside contractor with access to a limited or restricted access area for the sole purpose of making repairs when not open to the public. The licensed medical cannabis business shall be required to log in and out the outside contractor and retain with the log a photocopy of the outside contractor’s government issued identification.

5707.9 A medical cannabis business shall provide any utilized outside contractor with a visitor identification badge prior to entering a limited or restricted access area and shall be escorted at all times by a registered medical cannabis business owner, manager, employee or agent. The outside contractor shall have their visitor identification badge displayed at all times while he or she is working in the limited or restricted access area. The medical cannabis business shall ensure that the outside contractor does not touch any plant or medical cannabis. All visitor badges shall be returned to the medical cannabis business upon exit.

5707.10 A medical cannabis business shall allow access to limited or restricted access areas to emergency services personnel, such as firefighters, MPD, ABCA investigators, or other government officials in the performance of their duties without an escort in order to perform their job.

5707.11 For non-emergency repairs, an internet retailer or retailer that is not open to the public, a cultivation center, or a testing laboratory shall provide notice to ABCA before allowing an outside contractor, such as an electrician or repair person, to work in a limited or restricted access area between the hours of 7:00 a.m. and 9:00 p.m.

5707.12 For the purposes of this section, an emergency repair is one that needs to be performed in order to prevent a risk of injury, a risk to the health of any person,

property damage, or other conditions that would necessitate the closing of the facility.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10213 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5707

22-C DCMR § 5708 COMPENSATION OR GIFTS

5708.1 It shall be a violation of this subtitle for a medical cannabis business, or a director, officer, member, incorporator, agent, or employee of a medical cannabis business to provide financial compensation, an office, or anything of value to an authorized practitioner who recommends the use of medical cannabis.

5708.2 A medical cannabis business shall not be permitted to hold educational seminars, classes, or discussions regarding medical cannabis for authorized practitioners.

5708.3 It shall be a violation of this subtitle for a medical cannabis business, or a director, officer, member, incorporator, agent, or employee of a medical cannabis business to provide financial compensation, an office, or anything of value to a testing laboratory or the testing laboratory's director, officer, member, incorporator, agent, or employee.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10213 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5708

22-C DCMR § 5709 MEDICAL CANNABIS SALE, DISTRIBUTION, AND DISPENSING RESTRICTIONS

5709.1 A courier, internet retailer, or retailer shall not provide a qualifying patient or caregiver more than the legal medical cannabis possession limit, as set by Section 7(o)(1) of the Act (D.C. Official Code § 7-1671.06(o)(1)) and 22-C DCMR § 301.

5709.2 The maximum amount of medical cannabis an internet retailer or retailer, whether individually or in combination, may distribute, dispense, or sell to a qualifying patient directly or through their caregiver, in a 30-day period, is:

Eight (8) ounces of dried medical cannabis; or

Two hundred and forty (240) grams of medical cannabis concentrate for a patient 21 years old of age or older, or sixty (60) grams of medical cannabis concentrate for a patient between 18 and 20 years old; or

Medical cannabis products in any form containing a combined total of 600,000 mg of THC.

5709.3 The maximum amount limits set forth in paragraphs (b) and (c) of this subsection

shall take effect on October 2, 2023.

5709.4 It shall be an affirmative defense to a violation of 5709.2 that the District’s electronic inventory tracking system did not indicate at the time of sale that the patient had reached their 30-day quantity limit at the time the transaction occurred.

5709.5 An internet retailer or retailer shall dispense medical cannabis and distribute paraphernalia only to a qualifying patient or caregiver.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 5, 2011) [EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10137 (December 2, 2011); as amended by Final Rulemaking published at 64 DCR 2259 (February 24, 2017); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5709

22-C DCMR § 5710 VISIBILITY

5710.1 A medical cannabis business shall not permit medical cannabis or paraphernalia to be visible from any public or other property not owned by the medical cannabis business.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10214 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5710

22-C58 ADVERTISING

22-C DCMR § 5800 SIGN ADVERTISING

5800.1 Signs located on the exterior of a licensed establishment that advertise medical cannabis shall not, in the aggregate, exceed ten (10) square feet; provided, that the square footage of any signs located on the exterior of the licensed establishment that contain only a licensed establishment’s trade name shall not count toward the ten (10) square foot limit.

5800.2 (a) An exterior-facing sign placed on a window of a licensed establishment that indicates that there is medical cannabis on the property shall only be placed on the interior side of such window.

(b) Signs placed on the windows of a licensed establishment shall not, in aggregate, occupy more than twenty-five percent (25%) of the window space.

5800.3 No sign related to medical cannabis or that indicates the presence of medical cannabis at the licensed establishment shall be posted on any side of an exterior entrance or exit door of the licensed establishment.

5800.4 The owner of a licensed establishment shall remove from the establishment any sign that does not conform to this section.

History

Source: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10214 (December 2, 2011); as amended by Notice of Final Rulemaking published at 73 DCR 003195 (March 6, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5800

22-C DCMR § 5801 PROHIBITED STATEMENTS

5801.1 A registered cultivation center or dispensary shall not use any picture or illustration that depicts a child or immature person, or objects (such as toys), suggestive of the presence of a child, and any statement, design, device, picture, or illustration designed to be especially appealing to children or immature persons.

5801.2 A statement that is known by the dispensary, cultivation center, or testing laboratory to be false or misleading with respect to advertised price charged to the qualifying patient, ingredients of medical marijuana, source of manufacturer, or statements as to health benefits, shall be prohibited.

5801.3 A statement that encourages the use or purchase of medical marijuana without a registration card shall be prohibited.

5801.4 No licensed or unlicensed cannabis business shall represent that goods or services provided by the business or that the business itself is compliant with the Legalization of Possession of Minimal Amounts of Marijuana for Personal Use Initiative of 2014, effective February 26, 2015 (D.C. Law 20-153; D.C. Official Code passim).

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10214 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 003195 (March 6, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5801

22-C59 RECORDS AND REPORTS

22-C DCMR § 5900 CULTIVATION CENTER AND MANUFACTURER BOOKS AND RECORDS

5900.1 Each licensed cultivation center or manufacturer shall keep and maintain upon the licensed premises true, complete, legible, and current books and records, including the following:

(a) The date of each sale to a licensee;

(b) The name, address, and license number of the licensee;

(d) The price charged, and the amount received for the medical cannabis from the licensee;

(e) The quantity and form of medical cannabis maintained by the business;

(f) The number of plants being grown at the cultivation center on a daily basis; and

(g) The results of the testing laboratory analysis for five (5) years from the date of the test.

5900.2 These books and records, excluding the requirement in paragraph (g) of this subsection, shall be maintained by the cultivation center or manufacturer for a period of four (4) years.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10215 (December 2, 2011); ); as corrected by Errata Notice published at 58 DCR 10604 (December 16, 2011); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5900

22-C DCMR § 5901 CULTIVATION CENTER AND MANUFACTURER INVOICES

5901.1 With each sale of medical cannabis, the cultivation center and manufacturer shall cause to be made in duplicate an invoice of the sale showing the following information:

(a) The date of each sale to a licensee;

(b) The name, address, and license number of the licensee;

(d) The price of each item in each sale with the total price; and

(e) A true, accurate, legible, and complete statement of the terms and conditions on which the sale is made.

5901.2 With each sale, the invoice shall be prepared in duplicate, and shall be consecutively numbered.

5901.3 All invoices and delivery slips shall be systematically filed and maintained for a period of four (4) years from date of delivery.

History

Source: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10215 (December 2, 2011); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5901

22-C DCMR § 5902 COURIER AND RETAILER BOOKS AND RECORDS

5902.1 Each courier, internet retailer, and retailer shall keep and maintain upon the licensed premises, true, complete, and current books and records which include invoices that adequately and fully reflect all purchases and sales of medical cannabis made to and by the licensee.

5902.2 Records shall include and distinctly show the following information:

(a) The quantity, form, and price of medical cannabis and paraphernalia purchased from a licensee;

(b) The date and time of delivery of each purchase from a licensee;

(d) The quantity, form, and price of medical cannabis distributed or dispensed to the qualifying patient or caregiver;

(e) The consideration given by the qualifying patient or caregiver for the medical cannabis;

(f) The name, address, and card number of the qualifying patient or caregiver of the medical cannabis;

(g) The name, initials, or employee identification number of the person who dispensed or sold the medical cannabis; and

(h) The quantity of medical cannabis still available for sale at the licensed establishment.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10216 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5902

22-C DCMR § 5903 CULTIVATION CENTER AND MANUFACTURER REPORTS

5903.1 Cultivation center and manufacturer licensees shall, on or before the thirtieth (30th) day of July and January, furnish to the Board on a form to be prescribed by the Board a statement under oath showing the following information:

(a) The quantity of medical cannabis or medical cannabis product manufactured during the preceding six (6) months;

(b) The quantity of each medical cannabis or medical cannabis product sold during the preceding six (6) months;

(d) The quantity and price of paraphernalia sold during the preceding six (6) months;

(e) The amount of medical cannabis or medical cannabis products destroyed or disposed of during the preceding six (6) months;

(f) Certification from MPD that medical cannabis that was cultivated or the medical cannabis products were relinquished for destruction or disposal;

(g) The total expenditures for manufacturing medical cannabis or medical cannabis products during the preceding six (6) months;

(h) The total amount of sales of medical cannabis or medical cannabis products during the preceding six (6) months;

(i) The licensee’s gross revenue based upon its medical cannabis or medical cannabis product sales during the preceding six (6) months;

(j) The amount of sales tax reported to OTR during the preceding six (6) months;

(k) The quantity of medical cannabis or medical cannabis products still available for sale at the establishment on the date the report is filed with the Board;

(l) The name, address, home telephone number, and date of birth of each current employee; and

(m) An affidavit executed by an individual licensee, partner of an applicant partnership, or the appropriate officer of an applicant corporation, attesting to the truth of the submitted report.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10216 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5903

22-C DCMR § 5904 COURIER AND RETAILER REPORTS

5904.1 On or before the thirtieth (30th) day of July and January, a courier, internet retailer or retailer licensee shall furnish to the Board on a form to be prescribed by the Board a statement under oath showing the following information:

(a) The quantity and price of medical cannabis or medical cannabis products distributed or dispensed to qualifying patients and caregivers during the preceding six (6) months;

(b) The licensee’s total expenditures for distributing or dispensing medical cannabis or medical cannabis products during the preceding six (6) months;

(d) The quantity of paraphernalia sold by the licensee during the preceding six (6) months;

(e) The licensee’s gross revenue based upon its medical cannabis, medical cannabis products, and paraphernalia sales during the preceding six (6) months;

(f) The amount of sales tax reported by the licensee to OTR during the preceding six (6) months;

(g) The amount of medical cannabis or medical cannabis products that were destroyed or disposed of during the preceding six (6) months;

(h) Certification from MPD that the medical cannabis or medical cannabis products described in paragraph (g) were relinquished for destruction or disposal;

(i) The quantity of medical cannabis or medical cannabis products still available for sale at the licensee on the date the report is filed with the Board;

(j) The name, address, home telephone number, and date of birth of each current employee; and

(k) An affidavit executed by an individual registrant, partner of an applicant partnership, or the appropriate officer of an applicant corporation, attesting to the truth of the submitted report.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10216 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5904

22-C DCMR § 5905 [RESERVED]

History

Source: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10219 (December 2, 2011).

22-C DCMR § 5906 RETENTION AND INSPECTION OF BOOKS AND RECORDS

5906.1 The books and records referred to in this chapter, including the original and duplicate invoices, shall be open to inspection by the Board, ABCA’s Enforcement Division, or any other District agency that may have jurisdiction over the establishment, including OTR, Department of Licensing and Consumer Protection, the Department of Buildings, and D.C. Fire and Emergency Medical Services Department, during the establishment’s approved hours of operation.

5906.2 A licensed medical cannabis business shall keep and maintain all books and records referred to in this chapter on the licensed premises for a period of four (4) years after the latest transaction recorded in those books and records.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10216 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5906

22-C DCMR § 5907 REPORTING CORPORATE OFFICER, MANAGER, AND OTHER LICENSED STAFF CHANGES

5907.1 A licensed medical cannabis business shall notify the Board within ten (10) days after a registered director, officer, member, incorporator, agent, employee, or manager ceases to work at, volunteer at, manage, or own the operation. The director, officer, member, incorporator, agent, employee, or manager shall surrender their identification card to the Board within ten (10) days of ceasing to work at, manage, own, or otherwise be associated with the operation.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10216 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 5907

22-C60 [REPEALED]

22-C DCMR § 6000 [REPEALED]

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10216 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6000

22-C DCMR § 6001 [REPEALED]

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10185 (December 2, 2011); as amended by Final Rulemaking published at 64 DCR 13490 (December 29, 2017); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6001

22-C DCMR § 6002 [REPEALED]

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10185 (December 2, 2011); as amended by Final Rulemaking published at 64 DCR 13490 (December 29, 2017); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6002

22-C61 MANDATORY REVOCATION AND MANDATORY SUSPENSION

22-C DCMR § 6100 [RESERVED]

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10224 (December 2, 2011).; as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6100

22-C62 ENFORCEMENT PROCEEDINGS AND HEARINGS

22-C DCMR § 6200 [RESERVED]

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10224 (December 2, 2011).; as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6200

22-C DCMR § 6201 REVOCATION AND SUSPENSION – GENERAL PROVISIONS

6201.1 Except in the case of a summary suspension or revocation action, the Board shall not revoke or suspend a registration until the holder of the registration has been given an opportunity to be heard in their defense.

6201.2 If a registration is revoked or suspended, no part of the registration fee shall be returned.

6201.3 If the Board revokes a registration for a medical cannabis business, no registration shall be issued to the same person or persons whose registration is so revoked for the same or any other location for five (5) years following the revocation, except as provided below.

6201.4 If the Board revokes a manager's registration or a registration for a person other than a medical cannabis business, a manager's registration or individual registration shall not be issued to the same person for two (2) years.

6201.5 This section shall not apply to registrations revoked by the Board for the convenience of the District.

6201.6 Upon revocation, the remaining medical cannabis stock of the license whose license has been revoked shall be disposed of only with the approval of the Board.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10224 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6201

22-C DCMR § 6202 [RESERVED]

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10224 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6202

22-C DCMR § 6203 SUMMARY SUSPENSION OR REVOCATION

6203.1 If the Board determines, after investigation, that the operations of a licensee present an imminent danger to the health and safety of the public, the Board may summarily revoke, suspend, or restrict, without a prior hearing, the license to sell, manufacture, distribute, or deliver medical cannabis, medical cannabis products or paraphernalia in the District.

6203.2 The Board, after investigation, may also summarily revoke, suspend, or restrict the license of a licensee when the preponderance of the evidence shows that the establishment has been:

The scene of a criminal assault as defined in Chapter 4 of Title 22 of the D.C. Official Code, or a crime of violence, as defined in D.C. Official Code § 23-1331(4), against a police officer, government inspector or investigator, or other governmental official, who was acting in their official capacity, when such assault occurred by patrons who were within 1,000 feet of the establishment;

In violation of the District of Columbia Controlled Substances Act or the Drug Paraphernalia Act of 1982, effective September 17, 1982 (D.C. Law 4-149; D.C. Official Code § 48-1101 et seq.); or

The scene of an assault or crime of violence, as defined in D.C. Official Code § 23-1331(4), against a patient or caregiver by the ownership, management, employees, or agents of a licensed medical cannabis business.

6203.3 The notice of summary suspension or revocation shall contain the following:

A statement setting forth the reasons for the action and any proposed action, including a specification of any specific violation complained of;

Reference to any particular section of the Act or this subtitle allegedly violated;

A date of both a show cause status and evidentiary show cause hearing as well as the contact information for the assigned Office of Attorney General attorney, if known;

A statement that the Board may proceed ex parte if the registrant does not appear for the show cause hearing.

A statement that operations must cease immediately, with the exception of necessary tending requirements by cultivation centers;

A statement that the licensed medical cannabis business must submit to an immediate inventory of all medical cannabis items on the premises by ABCA investigators;

A statement that the licensed medical cannabis business must surrender all registration cards and permits associated with the licensed medical cannabis business to the Board within twenty-four (24) hours of receiving the summary suspension notice;

A statement setting forth the reasons for the summary action, including a specification of any specific violation complained of;

A statement that the registrant may request an immediate hearing before the Board for the purpose of determining whether the suspension shall continue in accordance with § 6203.5; and that

A statement that a person aggrieved by a final summary action may file an appeal with the District of Columbia Court of Appeals in accordance with the District of Columbia Administrative Procedure Act, effective October 21, 1968 (82 Stat.1204; D.C. Official Code § 2-501 et seq.).

6203.4 If the Board orders the suspension or revocation of a license, the Board shall post two (2) notices in conspicuous places at or near the main street entrance of the outside of the establishment. The posted notice shall state that the license has been suspended, the period of the suspension, and that the suspension is ordered because of an alleged violation of the Act or of the regulations promulgated under the Act. Any licensee willfully removing, obliterating, or defacing the notice shall be guilty of a violation of this chapter.

6203.5 A licensee may request a hearing within three (3) business days after service of notice of a summary revocation, suspension, fine, or restriction of license. The Board shall hold a hearing within two (2) business days of receipt of a timely request and shall issue a decision within three (3) business days after the hearing.

6203.6 In rendering a decision on a summary suspension hearing, the Board may suspend or restrict the license of the licensee. Additionally, after issuing a decision, the Board may hold additional proceedings to review, amend, or vacate the Board’s Order, to ensure compliance with any conditions and to monitor the licensee's operations.

6203.7 A request for a hearing under this chapter shall include the following:

A statement of the facts relevant to the review of the action;

A statement of the arguments that the respondent considers relevant to the review of the action; and

Any other evidence considered relevant.

6203.8 If the registrant fails to request a hearing within the time and in the manner specified in the notice, the summary suspension shall become final and shall continue unless duly reversed by the Board.

6203.9 A person aggrieved by a final summary action may file an appeal in accordance with the procedures set forth in the DC APA.

6203.10 The decision rendered by the Board following a hearing conducted pursuant to this section shall be the final order in the matter. Either party may seek review of the Board’s decision with the District of Columbia Court of Appeals in accordance with the DC APA.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10224 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6203

22-C DCMR § 6204 SHOW CAUSE HEARINGS

6204.1 Whenever the Board has reasonable cause to believe that any registration or permit should be suspended or revoked pursuant to Section 6 of the Act, it shall notify the person to whom the registration or permit was issued by personal service or certified mail at the last address recorded by that person with the Board, citing that person to appear before the Board not less than thirty (30) days thereafter. The notice shall state the time and place set by the Board for the hearing.

6204.2 Notwithstanding § 6204.1, the Board may serve the registrant by electronic mail if they agree to accept service by email. Service shall be sent to the email address on file or the registrant or their resident agent or counsel and shall be deemed served on the date and time stated on the email.

6204.3 The holder of the registration of permit shall appear in their defense in person or virtually and may have representation by counsel or other designated representative and shall be entitled to offer evidence before the Board with respect to the charges.

6204.4 If the person whose registration or permit is sought to be suspended or revoked waives the hearing or fails to appear at the time and place set for the hearing, the Board may proceed ex parte, unless the Board extends the time for the hearing.

6204.5 The Board shall make its findings of fact based upon the evidence which has been presented to it.

6204.6 The Board may, in its discretion, accept from both (1) the holder of the registration or permittee and (2) the Office of the Attorney General or the prosecuting entity an offer in compromise and settlement to resolve the charges brought at the show cause hearing by the District of Columbia against the holder of the registration or permit. An offer in compromise and settlement may be tendered to the Board at any time prior to the issuance of a decision by the Board on the contested matter.

6204.7 An offer submitted by the parties and accepted by the Board shall constitute a waiver of appeal and judicial review.

6204.8 A show cause hearing shall be conducted pursuant to the procedures set forth in Chapter 17 of Title 23 of the DCMR.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10224 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6204

22-C DCMR § 6205 NOTICE TO DISTRICT AGENCIES

6205.1 The Board shall provide written notice to MPD of any decision that results in the suspension or revocation of a license held by licensed medical cannabis business.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10236 (December 2, 2011); as amended by Final Rulemaking published at 60 DCR 10061 (July 12, 2013); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6205

22-C DCMR § 6206 NOTICE OF SUSPENSION OR REVOCATION TO PUBLIC

6206.1 If a license held by a licensed medical cannabis business is revoked or suspended, the Board shall post two (2) notices in conspicuous places at or near the main street entrance of the outside of the establishment.

6206.2 The posted notice shall state that the registration has been suspended, the period of the suspension, and that the suspension is ordered because of a violation of the Act or this title.

6206.3 Any person willfully removing, obliterating, or defacing the notice shall be guilty of a violation of this chapter.

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10236 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6206

22-C DCMR § 6207 [REPEALED]

History

SOURCE: Notice of Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Notice of Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Notice of Final Rulemaking published at 58 DCR 10128, 10236 (December 2, 2011); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6207

22-C DCMR § 6208 FACT-FINDING HEARINGS

6208.1 Prior to rendering a final decision on a licensing or registration request or an ABCA Investigative Report, the Board may hold a non-evidentiary fact-finding hearing to obtain further information from an applicant, licensee, registrant, witness, government official, or any other member of the public with the permission of the Board.

6208.2 A dispensary, cultivation center, testing laboratory, or a registered patient or caregiver shall not be fined or have its registration suspended or revoked at a fact- finding hearing. However, information provided at a fact-finding hearing may result in an enforcement action being taken under the Act or this subtitle. The fact- finding hearing may also result in the Board initiating an action to deny, modify, place conditions, or approve an application, as well as any other action authorized by the Act or this subtitle.

6208.3 An applicant or registration holder that fails to appear at a fact-finding hearing without good cause or refuses to respond to questions asked by the Board may have their application deemed abandoned, which shall result in the denial of their application.

6208.4 At any time, in its discretion, the Board may limit or exclude the submission of evidence, statements, and testimony at the hearing.

6208.5 All fact-finding hearings shall be open to the public unless closed to the public in accordance with section 405 of the Open Meetings Act, effective March 31, 2011, (D.C. Law 18-350; D.C. Official Code § 2-575), as amended.

History

SOURCE: Final Rulemaking published at 71 DCR 002388 (March 8, 2024). District of Columbia Municipal Regulations Medical Marijuana 22-C DCMR § 6208

22-C DCMR § 6209 SAFEKEEPING HEARINGS

6209.1 The Board may hold a contested case safekeeping hearing to determine whether to extend or cancel a registration for a medical cannabis business that is currently not open or operating as required by §§ 5303 and 5613.

6209.2 In determining whether to extend or cancel a registration, the Board shall consider whether the holder of the registration has made reasonable progress toward opening or reopening.

6209.3 The term "reasonable progress" for purposes of this section shall mean taking deliberate steps to start or resume business operations, including acquiring necessary permits or approvals from DCRA, the Office of Zoning, the Historic Preservation Board, or any District agency, executing contractual agreements or lease agreements, retaining contractors, or transferring the license to a new owner or new location, if permitted. The Board may also take into account any prior commitments made by the holder of the registration to the Board.

History

SOURCE: Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6209

22-C DCMR § 6210 CEASE AND DESIST

6210.1 The Board, in its discretion, may issue a cease-and-desist order immediately suspending a license, following the process described in § 6210.2, when one (1) of the following has occurred:

(a) The licensee has been issued a notice of summary suspension by the Department of Health;

(b) The licensee’s basic business license has expired;

(d) The licensee’s sales tax certificate has been suspended or revoked by the OTR;

(e) The corporation, limited liability company, partnership, or other entity owning the license is no longer in good standing to operate in the District;

(f) The licensee has failed to pay a Board-ordered fine or a citation by the payment deadline; or

(g) Payment has been made to ABCA with a check returned unpaid.

6210.2 The Board shall give written notice to the licensee of its intent to issue a cease-and-desist order. The licensee shall have fourteen (14) calendar days to respond to the notice. If the Board thereafter determines that one of the circumstances described in § 6210.1 has occurred, and that the licensee’s failure to address the issues set forth in § 6210.1 is not for good cause, the Board shall issue the cease-and-desist order.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6210

22-C DCMR § 6211 CANCELLATION DUE TO EVICTION

6211.1 If the Board, after an investigation, but before a hearing, has cause to believe that a licensee has been evicted from the premises or has otherwise vacated the premises and an application for safekeeping or transfer to a new location or person has not been submitted, the Board shall issue an order cancelling the license after providing the licensee with written notice of the basis for the cancellation and 30 days to submit:

(a) A written request to the Board to hold a hearing or decision on the papers; and

(b) Evidence disputing the basis for the cancellation.

6211.2 The Board, in its reasonable discretion, may adjudicate the cancellation appeal on the papers without holding a hearing if there is no dispute regarding any material facts.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6211

22-C DCMR § 6212 REQUEST FOR HEARING ON CITATION

6212.1 A licensee may challenge the issuance of a citation issued by an ABCA Investigator by requesting a show cause hearing before the Board either in writing or on a form provided by ABCA. The written request for a show cause hearing must be received by ABCA within thirty (30) days from the date that the citation was issued to the establishment.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6212

22-C DCMR § 6213 OFFER-IN-COMPROMISE

6213.1 The Board may, in its discretion, accept from the licensee and the Office of the Attorney General for the District of Columbia an offer-in-compromise to resolve the charges brought by the District of Columbia against the licensee.

6213.2 An offer-in-compromise may be presented to the Board at the show cause status hearing or show cause hearing.

6213.3 The offer-in-compromise shall be consistent with the range of fines set forth in this title.

6213.4 An offer-in-compromise and settlement may be tendered to the Board at any time prior to the issuance of a decision by the Board on the contested matter.

6213.5 An offer submitted by the parties and accepted by the Board shall constitute a waiver of appeal and judicial review and other hearing rights granted by this title, the regulations, and the D.C. Administrative Procedure Act.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6213

22-C63 PENALTIES

22-C DCMR § 6300 ABCA CIVIL PENALTY SCHEDULE

6300.1 [Reserved for Civil Penalty Chart]

6300.2 The penalties contained under this section shall become effective after the completion of the Council review described in D.C. Official Code § 7-1671.08(e), and then five (5) days after publication in the District of Columbia Register.

6300.3 None of the descriptions contained in the civil penalty schedule shall be construed to expand, limit, or define any specific violation.

6300.4 Whether violations are classified as primary tier or secondary tier shall be determined with reference to the ABCA civil penalty schedule in effect when the violation was committed.

History

SOURCE: Final Rulemaking published at 61 DCR 5262 (May 23, 2014); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6300

22-C DCMR § 6301 PRIMARY TIER VIOLATIONS

6301.1 The Board may fine a licensee for a primary tier violation after a show cause hearing as follows:

(a) For the first primary tier violation, the fine shall be $ 1,000-$ 2,000;

(b) For the second primary tier violation within two (2) years, the fine shall be $ 2,000-$ 4,000;

(d) For the fourth primary tier violation in four (4) years, the license shall be revoked or fined no less than $30,000 and suspended for thirty (30) consecutive days; and

(e) For the fifth primary tier violation in four (4) years, the license shall be revoked.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6301

22-C DCMR § 6302 SECONDARY TIER VIOLATIONS

6302.1 The Board may fine a licensee for a secondary tier violation at a show cause hearing as follows:

(a) For the first secondary tier violation, $250-$500;

(b) For the second secondary tier violation within two (2) years, $500-$750;

(d) A licensee found in violation of a secondary tier violation for the fourth time within four (4) years shall be penalized according to a first primary tier violation ($1,000-2,000). Every subsequent secondary tier offense within five (5) years of the first violation shall be fined according to the schedule for primary tier violations.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6302

22-C DCMR § 6303 CITATIONS

6303.1 ABCA investigators may issue citations for primary tier, secondary tier, and other violations of the Act and this title.

6303.2 If the licensee admits guilt for a violation listed in a citation, the licensee shall only pay the minimum fine for the offense based on the type and level of the offense, as indicated in §§ 6301 and 6302.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6303

22-C DCMR § 6304 WARNINGS

6304.1 An ABCA investigator may issue an administrative written warning before the issuance of a citation for a violation.

6304.2 In not less than ten (10) business days following the issuance of an administrative written warning, an ABCA investigator shall conduct a subsequent inspection of the licensed premises to ensure that the licensee has taken corrective action for the violation found for which the administrative written warning was issued. If corrections to violations that resulted in the issuance of the administrative written warning are not completed at the time of the subsequent inspection, the ABCA investigator shall issue the licensee a citation or refer the matter to the ABC Board if:

(a) Other violations that are not entitled to a warning are observed; or

(b) The licensee already has three or more secondary tier violations.

6304.3 A licensee entitled to a mandatory administrative written warning for a first violation shall not be entitled to a mandatory administrative written warning for a second or subsequent violation of the same offense committed within four (4) years of issuance of the first mandatory administrative written warning.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6304

22-C DCMR § 6305 VIOLATION HISTORY COMPUTATION

6305.1 This section applies to all instances that require a computation of a person’s or licensee’s violation history.

6305.2 The review period for computing the number of a licensee’s prior primary and secondary tier violations commences on the date of violation in the instant case and runs backward for the number of years specified in this section.

6305.3 The computation of violation history shall only include prior adjudicated cases whose dates of adjudication fall within the applicable review period for the instant case.

6305.4 The date of adjudication for computation purposes shall be the date:

(a) The citation was paid;

(b) A final written order finding liability has been issued by the Board;

(d) The date an offer-in compromise was accepted by the Board.

6305.5 The computation shall not include:

(a) Any violation that has not been adjudicated as of the date of the violation in the instant case; or

(b) Any adjudicated case whose date of adjudication falls outside of the review period.

6305.6 A licensee shall be found liable for a second, third, or additional level primary or secondary tier violation, whichever is applicable, if one (1) of the prior violations of the same tier was adjudicated within look back period from the date of violation in the instant case.

6305.7 Each date upon which a violation is committed shall constitute a separate violation.

6305.8 When a violation requires multiple instances, a continuous course of conduct, or other ongoing acts to sustain a charge, the date of the violation shall be the last date on which any act related to the violation occurred.

6305.9 If multiple secondary tier violations are committed on the same date, they will be counted as one (1) violation for purposes of computing a licensee’s violation history.

6305.10 If the Board suspends a respondent’s license but stays the suspension:

(a) The stay shall commence on the date of adjudication and conclude on the one (1)-year anniversary of that date; and

(b) The stay shall be revoked and the suspension imposed upon adjudication of any subsequent violation within the stay period.

6305.11 Written warnings, either issued by the Board or by citation, are not counted as violations for computation purposes.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6305

22-C DCMR § 6306 COLLECTION OF FINES

6306.1 Any fines collected by the Board shall be paid immediately, unless otherwise ordered by the Board, to the D.C. Treasurer.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6306

22-C64 TESTING LABORATORIES

22-C DCMR § 6400 APPLICABILITY

6400.1 The provisions of this chapter shall apply to an individual or entity that is registered by the Board, or applying for a registration, to test medical cannabis and medical cannabis products.

6400.2 The provisions of this chapter do not apply to the in-house testing by a cultivation center of its own cultivated crop or products. However, a cultivation center shall not sell any of its cultivated crop or products until the crop or products have been tested and certified by an independent testing laboratory registered by the Board to test medical cannabis and medical cannabis products.

History

SOURCE: Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6400

22-C DCMR § 6401 GENERAL PROVISIONS

6401.1 A testing laboratory shall not be owned or operated, in whole or in part, by a director, officer, member, incorporator, agent, or employee of a cultivation center, manufacturer, internet retailer, retailer, or testing laboratory.

6401.2 No owner, member, manager, employee, or agent of a testing laboratory shall have an ownership interest in, or a direct or indirect financial interest in any other licensed medical cannabis business except for one (1) or more testing laboratories.

6401.3 A testing laboratory shall not handle, test, or analyze medical cannabis or medical cannabis products in the District of Columbia unless the laboratory has been issued a medical cannabis license.

6401.4 Medical cannabis or medical cannabis products shall be sold only after a representative sample has been tested by a registered testing laboratory and the test results have been uploaded to the District of Columbia’s electronic tracking system, which verify the medical cannabis sample has received passing results.

6401.5 A testing laboratory shall not cultivate, process, manufacture, distribute, provide, or sell medical cannabis or medical cannabis products in any form.

6401.6 A testing laboratory shall not permit the consumption of medical cannabis or medical cannabis products in any form on the premises.

6401.7 A testing laboratory shall not share a facility with a licensed medical cannabis business but may operate in the same building so long as it has its own separate space.

6401.8 A testing laboratory shall not falsify, change, modify, or otherwise alter in any way the results of quantitative or other analyses performed on samples or the corresponding certificates of analysis.

6401.9 A testing laboratory shall not employ any sampling methods that do not ensure that a random sample is collected for analysis, or that could provide results that are not representative of a batch or lot from which a sample is taken.

6401.10 A testing laboratory shall not prepare samples in such a manner as to provide results that are not representative of a batch or lot from which a sample is taken.

6401.11 A testing laboratory shall not store medical cannabis or medical cannabis products in quantities greater than that which is necessary to perform required analysis.

6401.12 A testing laboratory shall not transport medical cannabis or medical cannabis products in quantities greater than that which is necessary to perform required analysis.

6401.13 A testing laboratory shall not perform analysis on any medical cannabis or medical cannabis products that has not been obtained from a licensed medical cannabis business.

6401.14 A testing laboratory shall not perform analysis on any medical cannabis or medical cannabis product that has not been identified in the real-time electronic records system.

6401.15 A testing laboratory shall not endorse, advertise, or make claims on behalf of any cultivation center, dispensary, brand or strain of medical cannabis, or brand or type of medical cannabis product.

History

SOURCE: Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6401

22-C DCMR § 6402 TESTING LABORATORY LICENSE APPLICATION

6402.1 In addition to the requirements contained in the Act and other provisions of this title, an application for a testing laboratory license shall also contain the following:

(a) A laboratory testing plan that demonstrates the applicant’s knowledge, experience, training, and applicable certifications in laboratory testing techniques, and ability to provide and ensure quality assurance, quality control, proficiency testing, analytical processes, chain of custody, sample retention, space, recordkeeping, results reporting, and corrective action protocols and a timeline for obtaining accreditation, if applicable;

(b) A notarized written statement from the applicant that he or she has read the Act and this subtitle and has knowledge of the District and federal laws and regulations relating to medical cannabis; and

(c) Information regarding whether the applicant has qualified as a medical cannabis certified business enterprise or social equity applicant or is eligible to qualify as a medical cannabis certified business enterprise or social equity applicant.

History

SOURCE: Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6402

22-C DCMR § 6404 ACCREDITATION, CERTIFICATION AND INSPECTION

6404.1 A testing laboratory registrant shall be accredited pursuant to standard ISO/IEC 17025 of the International Organization for Standardization by a nonprofit, impartial organization that operates in conformance with standard ISO/IEC 17011 of the International Organization for Standardization and is a signatory to the Mutual Recognition Arrangement of the International Laboratory Accreditation Cooperation.

6404.2 A testing laboratory registrant shall obtain the accreditation required by § 6404.1 of this subtitle within six (6) months after being issued a registration by the Board.

6404.3 The Board may suspend or revoke the registration of a testing laboratory that fails to obtain the accreditation required by § 6404.1 of this subtitle within six (6) months after being issued a registration by the Board.

6404.4 A registered testing laboratory shall remain in good standing with a Board approved proficiency testing program.

6404.5 The Board shall conduct unannounced compliance inspections of registered testing laboratories on at least an annual basis.

6404.6 The Board shall conduct investigations within seventy-two (72) hours of receiving a complaint against a registered testing laboratory.

History

SOURCE: Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024). District of Columbia Municipal Regulations Medical Marijuana 22-C DCMR § 6404

22-C DCMR § 6405 RECORDS RETENTION

6405.1 A testing laboratory shall create, and maintain for not less than five (5) years, and make them immediately available to the Board upon request, records of the testing it conducted on medical cannabis and medical cannabis products, which shall include:

(a) The time, date, and location the sample was obtained;

(b) A description of the sample, including the amount;

(d) The results of the tests; and

(e) The time, date, and method of disposal or destruction of the sample after testing was completed, and the amount of sample disposed of or destroyed.

6405.2 A testing laboratory shall maintain the following records for not less than five (5) years, and make the records immediately available to the Board or ABCA upon request:

(a) Test results;

(b) Quality control and quality assurance records;

(d) Chain-of-custody records;

(e) Proficiency testing records;

(f) Analytical data to include printouts generated by the instrumentations;

(g) Accession numbers;

(h) Specimen type;

(i) Raw data of calibration standards and curves, controls and subject results;

(j) Final and amended reports;

(k) Acceptable reference range parameters;

(l) The identity of the analyst; and

(m) The date of the analysis.

History

SOURCE: Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6405

22-C DCMR § 6406 LABORATORY PERSONNEL QUALIFICATIONS AND DUTIES

6406.1 All testing laboratory personnel shall be registered with the Board.

6406.2 All testing laboratory personnel shall:

(a) Pass a criminal background check pursuant to § 5411 of this subtitle; and

(b) Sign an attestation stating that they do not have any conflicts of interest with any other registered medical cannabis facility or personnel.

6406.3 A testing laboratory shall be staffed with at least the following personnel who shall meet the following requirements and perform the following duties:

(a) Laboratory Director:

(1) Shall have earned a Doctor of Medicine degree (M.D.), Doctor of Osteopathic Medicine degree (D.O.), or doctorate degree in chemical, physical, biological or clinical laboratory sciences from a college or university that at the time of the awarding of the degree was accredited by an accrediting body recognized by the United States Department of Education, and have at least two (2) years of post-degree laboratory experience;

(2) Shall be responsible for the overall operation of the testing laboratory, including but not limited to:

(A) Ensuring that the testing laboratory achieves and maintains quality standards;

(B) Analytical operation;

(D) Supervising all laboratory personnel;

(E) Recordkeeping;

(F) Reporting results and data; and

(G) Ensuring compliance with all regulatory requirements; and

(3) May also serve in any other personnel role;

(b) Technical Supervisor:

(1) Shall have earned at least:

(A) A master’s degree in medical technology, clinical laboratory science, or chemical, physical or biological science from a college or university that at the time of the awarding of the degree was accredited by an accrediting body recognized by the United States Department of Education, and have at least two (2) years of post-degree training and experience in high-complexity testing; or

(B) A bachelor’s degree in medical technology, clinical laboratory science, or chemical, physical or biological science from a college or university that at the time of the awarding of the degree was accredited by an accrediting body recognized by the United States Department of Education, and have at least four (4) years of post-degree training and experience in high-complexity testing;

(2) Shall be responsible for, including but not limited to:

(A) Supervising laboratory personnel (with the exception of The Laboratory Director);

(B) Ensuring appropriate testing methods are performed;

(D) Verifying and ensuring the accuracy of test results; and

(E) Training and competency assessments of laboratory personnel; and

(3) May also serve in the roles of Quality Assurance Manager, Testing Personnel and Collection Specialist;

(1) Shall have earned at least:

(A) A master’s degree or bachelor’s degree in clinical laboratory science, medical technology, or chemical, physical or biological science from a college or university that at the time of the awarding of the degree was accredited by an accrediting body recognized by the United States Department of Education, and have at least one (1) year of post-degree training and experience in high-complexity testing; or

(B) An associate’s degree in medical laboratory technology from a college or university that at the time of the awarding of the degree was accredited by an accrediting body recognized by the United States Department of Education, and have at least two (2) years of post-degree training and experience in high-complexity testing;

(2) Shall be responsible for, but not limited to:

(A) Implementing standard operating procedures (SOPs) for the testing laboratory;

(B) Ensuring that SOPs are followed; and

(3) May also serve in the roles of Testing Personnel and Collection Specialist, if he or she meets the qualifications;

(d) Testing Personnel:

(1) Shall have earned at least a master’s degree or bachelor’s degree in clinical laboratory science, medical technology, or chemical, physical or biological science from a college or university that at the time of the awarding of the degree was accredited by an accrediting body recognized by the United States Department of Education;

(2) Shall be responsible for testing medical cannabis samples as set forth in § 6409 of this subtitle, and providing accurate results; and

(3) May also serve in the role of the Collection Specialist.

(e) Collection Specialist:

Shall have earned at least:

(2) Shall be responsible for:

(A) The selection and collection of representative samples from cultivation centers;

(B) Maintaining chain of custody; and

(3) Shall not serve in any other personnel role unless he or she meets the educational and training requirements for that role as set forth in this subtitle.

History

SOURCE: Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6406

22-C DCMR § 6407 [REPEALED]

History

SOURCE: Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6407

22-C DCMR § 6409 [REPEALED]

History

SOURCE: Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6409

22-C DCMR § 6410 [REPEALED]

History

SOURCE: Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6410

22-C65 CANNABIS TESTING

22-C DCMR § 6500 MEDICAL CANNABIS TESTING REQUIREMENT

6500.1 Upon the issuance of a testing laboratory license, ABCA shall provide notice in the District of Columbia Register that a testing lab has become operational and that the testing requirement is in effect.

6500.2 Once notice of the issuance of a testing lab is issued in the District of Columbia Register, no medical cannabis or medical cannabis product shall be sold or distributed to an internet retailer, manufacturer, retailer, qualifying patient or caregiver until it has been tested and determined to be unadulterated as provided by this title.

6500.3 No licensee shall distribute, sell, or transfer adulterated medical cannabis to another licensee or person unless the product is being sent to a testing laboratory for the purposes of testing in compliance with the Act and this subtitle, for the purposes of disposal or destruction, complying with a court order, law enforcement investigation, or order of the Board.

6500.4 Section 6503 through 6600 shall not apply to the testing of medical cannabis samples provided by qualifying patients in accordance with the Act.

6500.5 Section 6503 through 6600 shall not apply to the testing of medical cannabis samples from cultivation centers and manufacturers for the purposes of quality assurance, research, and development in accordance with the Act so long as such samples are not dispensed, distributed, or sold to internet retailers, retailers, or the public.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6500

22-C DCMR § 6501 STANDARD OPERATING PROCEDURE REQUIREMENTS

6501.1 A testing laboratory shall have a written manual of standard operating procedures, with detailed instructions for performing each testing method the testing laboratory uses and the minimum standards for each test. The written manual of standard operating procedures must be available to each employee at the testing laboratory at all times.

6501.2 A testing laboratory shall establish, maintain, implement, and comply with the policies and procedures contained in its manual of standard operating procedures. At a minimum, a facility's standard operating procedures shall include policies and procedures that:

(a) Designate areas in the facility that are compartmentalized based on function, including any areas to which access is restricted, and including areas that segregate samples awaiting analysis from those samples being analyzed or prepared for analysis, to prevent cross-contamination;

(b) Provide best practices for safe, secure, and proper testing of medical cannabis;

(c) Establish training and safety policies and procedures to ensure that any person involved in analytical testing of medical cannabis:

(1) Has been fully trained in the safe operation and maintenance of any and all instrumentation that will be used in the testing of medical cannabis, with supporting documentation of the training;

(2) Has been fully trained in the safe use, handling, and storage of any and all chemicals that will be used in the testing of medical cannabis, in accordance with OSHA protocols, with supporting documentation of the training;

(3) Has direct access to applicable safety data sheets and labels; and

(4) Has been fully trained regarding compliance with the District’s laws and regulations;

(d) Ensure the chain of custody for all medical cannabis will be documented in the inventory tracking system;

(e) Ensure the facility will be maintained with adequate lighting, ventilation, temperature, sanitation, equipment, and security for the testing of medical cannabis, including requiring that the testing laboratory shall:

(1) Keep the facility free of debris, dust, rodents, insects, birds, and animals of any kind, and any other potential contaminants;

(2) Use chemicals, cleaning solutions, and other sanitizing agents generally accepted for laboratory use, and store them in a manner that protects against contamination;

(3) Maintain a cleaning and equipment maintenance log at the facility, including any preventive and routine maintenance plans and corresponding records, and whether the maintenance is performed by laboratory staff or by service contract with third-parties or the original equipment manufacturer;

(4) Routinely calibrate its scales, balances, or other weight and/or mass measuring devices using “National Institute of Standards and Technology” (NIST)-traceable reference weights, at least once each calendar year; and

(5) Standardize all analytical test instrumentation using reference materials traceable to reference material producers accredited to ISO/IEC 17034 “General Requirements for the Competence of Reference Material Producers” or the national metrology institute (NMI), where available;

(f) Address the analysis, storage, sample inventory tracking, and transportation of plant material, medical cannabis extract, and medical cannabis products; and

(g) Address the following:

(1) Sample Collection;

(2) Sample preparation for each matrix that will be tested;

(3) Reagent, solution, and reference standard preparation;

(4) Instrument setup, if applicable;

(5) Standardization of volumetric reagent solutions, if applicable;

(6) Data acquisition;

(7) Calculation of results;

(8) Identification criteria;

(9) Quality control frequency;

(10) Quality control acceptance criteria; and

(11) Corrective action protocol.

6501.3 The Laboratory Director shall approve, sign, and date each standard operating procedure and each revision to any standard operating procedure.

6501.4 A testing laboratory shall establish and maintain procedures to document a clear and unbroken chain of custody at all stages from sampling to destruction, which shall include:

(a) Documenting each person handling the original samples, aliquots, and extracts;

(b) Documenting any transfer of samples, aliquots, and extracts to another testing facility for additional testing or transfer at the request of the cannabis cultivation facility that provided the testing sample;

(c) Maintaining a current list of authorized persons and restricting entry to the cannabis testing facility to those authorized persons;

(d) Securing the cannabis testing facility during non-working hours;

(e) Using a secured area to log in and aliquot samples; and

(f) Documenting the disposal of samples, aliquots, and extracts.

6501.5 A testing laboratory shall establish and maintain sample requirement procedures that include:

(a) Issuing instructions for the minimum sample requirements and storage requirements;

(b) Documenting the condition of the external package and integrity seals utilized to prevent contamination of or tampering with the sample;

(c) Documenting the condition and amount of sample provided at the time the sample is received at the cannabis testing facility;

(d) Securing short-term and long-term storage areas when not in use; and

(e) Ensuring samples are stored appropriately.

6501.6 A testing laboratory shall document the chain of custody of each sample in the Board’s medical cannabis inventory tracking system.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6501

22-C DCMR § 6502 TESTING REQUIREMENTS AND METHODOLOGIES

6502.1 Each testing laboratory shall:

Follow the most current version of the “Cannabis Inflorescence: Standards of Identity, Analysis, and Quality Control” monograph published by the American Herbal Pharmacopoeia;

(b) Follow the most current version of “Recommendations for Regulators -- Cannabis Operations” published by the American Herbal Products Association;

(c) Follow most current version of the “Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals – An Aid to the Interpretation of ISO/IEC 17025:2005 (2015”) published by AOAC International;

(d) Adopt and follow most current version of the minimum good laboratory practices which must, at a minimum, satisfy the “OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring” published by the Organization for Economic Co-operation and Development;

(e) Maintain internal standard operating procedures; and

(f) Maintain a quality control and quality assurance program.

6502.2 A testing laboratory shall use, when available, testing methods that have undergone validation by the “Official Methods of Analysis of AOAC International,” the Performance Tested Methods Program of the Research Institute of AOAC International, the “Bacteriological Analytical Manual” of the Food and Drug Administration, the International Organization for Standardization, the United States Pharmacopeia, the “Microbiology Laboratory Guidebook” of the Food Safety and Inspection Service of the United States Department of Agriculture or an equivalent third-party validation study approved by the Board.

6502.3 A testing laboratory shall test and analyze a statistically representative sample from each batch of medical cannabis or medical cannabis products for, at minimum:

(a) Moisture content;

(b) Water activity;

(1) Delta-9-tetrahydrocannabinolic acid (THCA);

(2) Delta-9-tetrahydrocannabinol (THC);

(3) Cannabidiolic acid (CBDA);

(4) Cannabidiol (CBD); and

(5) Cannabinol (CBN);

(d) Foreign matter contamination;

(e) Microbial contamination;

(f) Mycotoxin contamination;

(g) Heavy metal contamination, including, at minimum, arsenic, cadmium, lead, and mercury;

(h) Pesticide and fertilizer residue,

(i) Residual solvents;

(j) Cannabinoid and Terpene Profile;

(k) Product Assessment (for edible products);

(l) Homogeneity (for edible products); and

(m) Any other items requested by or approved by the Board.

6502.4 All samples shall be personally selected and collected by the testing laboratory personnel on site at the cultivation center.

6502.5 The samples personally selected and collected by the testing laboratory shall include, at a minimum:

One (1) testable sample of the final product of flower, from each harvest for every strain of medical cannabis grown by the cultivation center;

One (1) testable sample of the final product of flower stored and packaged at the internet retailer or retailer; and

One (1) testable sample of each type of product produced from each batch of medical cannabis, such as but not limited to, the following:

Tincture;

Topical;

Shatter;

Oils;

Edibles;

Wax;

Kief; and

Hash.

6502.6 A testing laboratory shall timely upload into the tracking system the test results for each batch of medical cannabis or medical cannabis product tested.

6502.7 The testing laboratory may retest or reanalyze the sample or a different sample from the same batch by following its standard operating procedures to confirm or refute the original result, upon request by the cultivation center or upon request by the Board at the cultivation center's expense.

6502.8 A testing laboratory shall implement an acceptable method of testing, such as, but not limited to:

(a) Gas Chromatography;

(b) Gas Chromatography Mass Spectrometry;

(d) Thin Layer Chromatography;

(e) High Performance Liquid Chromatography; and

(f) Liquid Chromatography Mass Spectroscopy.

6502.9 A testing laboratory using Gas Chromatography shall perform and maintain records of the following, which shall be readily available to the staff operating the equipment:

(a) Document the conditions of the gas chromatograph, including the detector response;

(b) Perform and document preventive maintenance as required by the manufacturer;

(d) Use an internal standard for each qualitative and quantitative analysis that has similar chemical and physical properties to that of the compound identified;

(e) Establish criteria of acceptability for variances between different aliquots and different columns; and

(f) Document the monitoring of the response (area or peak height) of the internal standard to ensure consistency overtime of the analytical system.

6502.10 A testing laboratory using Gas Chromatography Mass Spectrometry shall perform and maintain records of the following, which shall be readily available to the staff operating the equipment:

(a) Perform and document preventive maintenance as required by the manufacturer;

(b) Document the changes of septa as specified in the standard operating procedure;

(d) Maintain records of mass spectrometer tuning;

(e) Establish written criteria for an acceptable mass spectrometer tune;

(f) Document corrective actions if a mass spectrometer tune is unacceptable;

(g) Monitor analytic analyses to check for contamination and carry-over;

(h) Use selected ion monitoring within each run to assure that the laboratory compares ion ratios and retention times between calibrators, controls and samples for identification of an analyte;

(i) Use an internal standard for qualitative and quantitative analysis that has similar chemical and physical properties to that of the compound identified and is isotopically labeled when available or appropriate for the assay;

(j) Document the monitoring of the response (area or peak height) for the internal standard to ensure consistency overtime of the analytical system;

(k) Define the criteria for designating qualitative results as positive;

(l) Ensure that when a library is used to qualitatively match an analyte, the relative retention time and mass spectra from a known standard or control shall be run on the same system before reporting the results; and

(m) Evaluate the performance of the instrument after routine and preventive maintenance (such as clipping or replacing the column or cleaning the source) prior to analyzing subject samples.

6502.11 A testing laboratory using Immunoassays shall perform and maintain records of the following, which shall be readily available to the staff operating the equipment:

(a) Perform and document preventive maintenance as required by the manufacturer;

(b) Validate any changes or modifications to a manufacturer's approved assays or testing methods when the sample being tested is not included in the list of samples approved for assaying or testing by the manufacturer; and

(c) Define acceptable separation or measurement units (absorbance intensity or counts per minute) for each assay, which shall be consistent with the manufacturer's instructions.

6502.12 A testing laboratory using Thin Layer Chromatography shall perform and maintain records of the following, which shall be readily available to the staff operating the equipment:

(a) Apply unextracted standards to each thin layer chromatographic plate;

(b) Include in its standard operating procedures the preparation of mixed solvent systems, spray reagents and designation of their lifetimes;

(d) Evaluate, establish, and document acceptable performance for new thin layer chromatographic plates before placing them into service;

(e) Verify that the spotting technique used precludes the possibility of contamination and carry-over;

(f) Measure all appropriate Rf values for qualitative identification purposes;

(g) Use and record sequential color reactions, when applicable;

(h) Maintain a copy of the developer TLC plates for each bath of samples analyzed; and

(i) Analyze an appropriate matrix blank with each batch of samples analyzed.

6502.13 A testing laboratory using High Performance Liquid Chromatography shall perform and maintain records of the following, which shall be readily available to the staff operating the equipment:

(a) Perform and document preventive maintenance as required by the manufacturer;

(b) Monitor and document the performance of the HPLC instrument each day of testing;

(d) Create standard operating procedures for acceptability when eluting solvents are recycled;

(e) Use an internal standard for each qualitative and quantitative analysis that has similar chemical and physical properties to that of the compound identified when available or appropriate for the assay; and

(f) Document the monitoring of the response (area or peak height) of the internal standard to ensure consistency overtime of the analytical system.

6502.14 A testing laboratory using Liquid Chromatography Mass Spectroscopy shall perform and maintain records of the following, which shall be readily available to the staff operating the equipment:

(a) Perform and document preventive maintenance as required by the manufacturer;

(b) Maintain records of mass spectrometer tuning;

(d) Use an internal standard with each qualitative and quantitative analysis that has similar chemical and physical properties to that of the compound identified and is isotopically labeled when available or appropriate for the assay;

(e) Document the monitoring of the response (area or peak height) of the internal standard to ensure consistency overtime of the analytical system;

(f) Compare two transitions and retention times between calibrators, controls and samples within each run;

(g) Document and maintain records when changes in source, source conditions, eluent, or column are made to the instrument; and

(h) Evaluate the performance of the instrument when changes in source, source conditions, eluent, or to a column are made prior to reporting test results.

6502.15 A testing laboratory shall determine if the following pesticides are within the acceptable limit using the following chart:

Table A. Insecticide Critical Limits in Parts Per Million (PPM)

Insectide

Critical Limit

Acetamiprid

0.2

Abamectin

0.5

Aldicarb

0.4

Bifenazate

0.2

Carbofuran

0.2

Chlorantraniliprole

0.2

Chlorpyrifos

0.2

Cyfluthrin

1.0

DDVP (Dichlorvos)

0.1

Diazinon

0.2

Dimethoate

0.2

Fenpyroximate

0.5

Fipronil

0.4

Flonicamid

1.0

Imidacloprid

0.4

Malathion

0.2

Methiocarb

0.2

Methomyl

0.4

Naled

0.5

Oxamyl

1.0

Permethrin

0.5

Phosmet

0.2

Piperonyl butoxide

1.0

Pyrethrins

1.0

Spinosad

0.2

Spiromesifen

0.2

Spirotetramat

0.2

Thiacloprid

0.2

Thiamethoxam

0.2

6502.16 A testing laboratory shall determine if the following plant growth regulators are within the acceptable limit using the following chart:

Table B. Plant Growth Regulator Critical Limits in Parts Per Million (PPM)

Plant Growth Regulator

Critical Limit

Ancymidol

0.2

Carbaryl

0.2

Daminozide (Alar)

0.1

Ethephon

1.0

Flurprimidol

0.2

Paclobutrazol

0.4

6502.17 A testing laboratory shall determine if the following fungicides are within the acceptable limit using the following chart:

Table C. Fungicide Critical Limits in Parts Per Million (PPM)

Fungicide

Critical Limit

Azoxystrobin

0.2

Bifenthrin

0.2

Boscalid

0.4

Fludioxonil

0.4

Imazalil

0.2

Kresoxim-methyl

0.4

Metalaxyl

0.2

Myclobutanil

0.2

Propiconazole

0.4

Trifloxystrobin

0.2

6502.18 A testing laboratory shall determine if the following acaricides are within the acceptable limit using the following chart:

Table D. Acaricide Critical Limits in Parts Per Million (PPM)

Acaricide

Critical Limit

Clofentezine

0.2

Etoxazole

0.2

6502.19 A testing laboratory shall determine if the following ovicide is within the acceptable limit using the following chart:

Table E. Ovicide Critical Limits in Parts Per Million (PPM)

Ovicide

Critical Limit

Hexythiazox

1.0

6502.20 [REPEALED].

6502.21 A testing laboratory shall determine if the following microbial impurities are within the acceptable limit using the following chart:

Table G. Microbiological Impurity Critical Limits in Colony Forming Units (CFU/g)

Microbiological Impurity

Critical Limit

E. coli

< 100

Salmonella spp.

Total Aerobic Microbial Count

100,000

Total Yeast and Mold Count

100,000

6502.22 A testing laboratory shall determine if the following heavy metals are within the acceptable limit using the following chart:

Table H. Heavy Metal Critical Limits in Parts Per Million (PPM)

Heavy Metal

Critical Limit

Arsenic

0.4

Barium

60.0

Cadmium

0.4

Chromium

0.6

Lead

< 1.0

Mercury

0.2

Selenium

26.0

Silver

1.4

6502.23 A testing laboratory shall determine if the Water Activity (Aw) of a sample is within an acceptable limit. For purposes of this section, the Aw of a sample shall be acceptable if it is below 0.65Aw.

6502.24 A testing laboratory shall determine if an edible is a potentially hazardous food by using the following charts:

Table I. Interaction of pH and Aw for control of spores in food heat-treated to destroy Vegetative cells and subsequently packaged

Aw values

pH values

4.6 or less

4.6 – 5.6

5.6

≤0.92

Non-PHF*/non-

TCS food**

Non-PHF/non-

TCS food

Non-PHF/non-

TCS food

0.92 - .95

Non-PHF/non-

TCS food

Non-PHF/non-

TCS food

PA***

0.95

Non-PHF/non-

TCS food

PHF means Potentially Hazardous Food

** TCS Food means Time/Temperature Control for Safety Food

*** PA means Product Assessment required

Table J. Interaction of pH and Aw for control of vegetative cells and spores in food not heat-treated but not packaged

Aw values

pH values

< 4.2

4.2 – 4.6

4.6 – 5.0

5.0

< 0.88

non-PHF*/non-

TCS food**

non-PHF/

non-TCS food

non-PHF/

non- TCS food

non-PHF/

non –TCS food

0.88 – 0.90

non-PHF/

non-TCS food

non-PHF/

non-TCS food

non-PHF/

non-TCS food

PA***

0.90 – 0.92

non-PHF/non-

TCS food

non-PHF/

non-TCS food

0.92

non-PHF/non-

TCS food

PHF means Potentially Hazardous Food

** TCS Food means Time/Temperature Control for Safety Food

*** PA means Product Assessment required

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6502

22-C DCMR § 6503 CREATION OF BATCHES

6503.1 A cultivation center or manufacturer shall divide medical cannabis or medical cannabis products into homogenous batches not to exceed 50 pounds, and as directed by a testing laboratory.

6503.2 A cultivation center or manufacturer shall divide medical cannabis and medical cannabis products into homogenous batches as directed by a testing laboratory, and in accordance with the following size limitations:

Medical cannabis or medical cannabis product batches containing concentrated medical cannabis may not exceed 50 pounds (22.7 kilograms); and

Medical cannabis product batches containing medical cannabis extract or products that are infused with medical cannabis or medical cannabis extract may not exceed 70,000 unpackaged retail servings.

6503.3 A cultivation center or manufacturer shall assign a unique batch identifier to the cannabis or cannabis products, and when cannabis is harvested or trimmed,

(a) Medical cannabis flower shall be assigned to a batch containing a single strain from a single harvest date; and

Medical cannabis trim may be assigned to a batch containing multiple strains and from multiple trimming dates.

6503.4 A batch may be divided into multiple containers.

6503.5 If medical cannabis or medical cannabis product yield is in excess of the batch size limitations, the yield must be divided into separate batches in accordance with this section in order to be sampled.

6503.6 All medical cannabis and medical cannabis products in each batch must be uniform throughout except for cannabis leaf trim.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6503

22-C DCMR § 6504 SAMPLE REQUIREMENTS FOR MEDICAL CANNABIS

6504.1 With the exception of pre-rolled medical cannabis, all cannabis and cannabis products must be in final form ready to be packaged upon receipt of passing results for all required tests to be sampled.

6504.2 A cultivation center or manufacturer may not alter the medical cannabis or medical cannabis product batch after sampling has occurred.

6504.3 The testing laboratory or their agent shall sample the amount of cannabis and cannabis products in increments in accordance with the tables below:

Cannabis Flower and Trim

Batch Size Range (lbs)

Batch Size Range (kg)

Minimum Sample Amount (g)

Sample Increments Representing Total Minimum Sample Amount

0-1.00

0 - 0.453592

2.50

1.01-10.00

0.4581283 - 4.53592

4.00

10.01-20.00

4.5404596 - 9.07185

7.50

20.01-40.00

9.0763833 - 18.1437

11.0

40.01-50.00

18.148231 - 22.6796

16.50

6504.4 If a testing laboratory or their agent requires a sample amount that exceeds the minimum sample amount for medical cannabis batch size range as specified in the table above, the testing laboratory or their agent must use sample increments of 0.5 grams.

Cannabis Products - Concentrated Cannabis

Batch Size Range (lbs)

Batch Size Range (kg)

Minimum Sample Amount (g)

Sample Increments Representing Total Minimum Sample Amount

0-1.00

0 - 0.453592

1.25

1.01-2.00

0.4581283 - 0.907185

2.00

2.01-5.00

0.9117207 - 2.26796

3.75

5.01-15.00

2.272498 - 6.80389

5.50

15.01-50.00

6.8084215 - 22.6796

8.25

6504.5 If a testing laboratory or their agent requires a sample amount that exceeds the minimum sample amount for the batch size range of medical cannabis or medical cannabis product containing concentrated medical cannabis, as specified in the table above, the testing laboratory or their agent must use sample increments of 0.25 grams.

Cannabis Products - Cannabis Infused Products

Batch Size Range (Unpackaged Servings)

Minimum Sample Amount (Unpackaged Servings)

Minimum Number of units for Sampling a 5-Serving Unit

Minimum Number of units for Sampling a 10-Serving Unit

Minimum Number of units for Sampling a 20-Serving Unit

Minimum Number of units for Sampling a 100-Serving Unit

0-100

100-1,000

1,000-5,000

5,000-10,000

10,000-50,000

50,000-70,000

6504.6 A serving unit is a single quantity of all pre-packaged total servings for one product package of medical cannabis infused product intended for sale.

6504.7 The cultivation center or manufacturer must determine the size of a serving for each medical cannabis infused product, and the number of servings in the medical cannabis or medical cannabis product batch. If the minimum required number of sample servings does not align with the anticipated final form of the product, the testing laboratory or their agent must increase sample increments to ensure products are sampled in final form.

6504.8 If a testing laboratory or their agent requires a sample amount that exceeds the minimum sample amount for the batch size range of medical cannabis or medical cannabis product containing infused medical cannabis, as specified in the table above, the testing laboratory or their agent must use sample increments of one serving.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6504

22-C DCMR § 6505 PACKAGING OF SAMPLES FOR TESTING

6505.1 All samples of cannabis or cannabis products must be transferred to a testing facility in sealed, child-resistant, and tamper-evident containers that are supplied by a testing facility or that meet criteria specified by a testing facility.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6505

22-C DCMR § 6506 TESTING FOR RESIDUAL SOLVENTS

6506.1 Cultivation centers and manufacturers shall test all products for residual solvents and processing chemicals in accordance with this section before distributing, selling, or otherwise transferring the product to an internet retailer, manufacturer, or retailer.

6506.2 The testing laboratory shall analyze at minimum 0.25 grams of the representative sample of cannabis product or pre-rolls to determine whether residual solvents or processing chemicals are present.

6506.3 The testing laboratory shall report the result of the residual solvents and processing chemicals testing in unit micrograms per gram (μg/g) in the testing results and indicate “pass” or “fail” in the result report.

6506.4 The sample shall be deemed to have passed the residual solvents and processing chemicals testing if the presence of any residual solvent or processing chemical listed in the following tables in Category I and Category II does not exceed the indicated critical limit, except that:

The critical limit for ethanol does not apply to cannabis products that are tinctures; and

The critical limit for ethanol or isopropyl alcohol does not apply to cannabis products that are topical cannabis products.

Category I Residual Solvent or Processing Chemical

CAS No.

Cannabis Product or Pre-Roll Critical Limit (μg/g)

1,2-Dichloroethane

107-06-2

1.0

Benzene

71-43-2

1.0

Chloroform

67-66-3

1.0

Ethylene oxide

75-21-8

1.0

Methylene chloride

75-09-2

1.0

Trichloroethylene

79-01-6

1.0

Category II Residual Solvent or Processing Chemical

CAS No.

Cannabis Product or Pre-roll Action Level (μg/g)

Acetone

67-64-1

5000

Acetonitrile

75-05-8

410

Butane

106-97-8

5000

Ethanol

64-17-5

5000

Ethyl acetate

141-78-6

5000

Ethyl ether

60-29-7

5000

Heptane

142-82-5

5000

Hexane

110-54-3

290

Isopropyl alcohol

67-63-0

5000

Methanol

67-56-1

3000

Pentane

109-66-0

5000

Propane

74-98-6

5000

Toluene

108-88-3

890

Total xylenes (ortho-, meta-, para-)

1330-20-7

2170

6506.5 If the sample fails residual solvents and processing chemicals testing, the batch from which the sample was collected fails residual solvents and processing chemicals testing and shall be deemed adulterated.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6506

22-C DCMR § 6507 TESTING FOR MYCOTOXIN

6507.1 Cultivation centers and manufacturers shall test all products for mycotoxin in accordance with this section before distributing, selling, or otherwise transferring the product to an internet retailer, manufacturer, or retailer.

6507.2 The testing laboratory shall analyze at minimum 0.5 grams of the representative sample of medical cannabis and medical cannabis products to determine whether mycotoxins are present.

6507.3 The testing laboratory shall report the result of the mycotoxins in unit micrograms per gram (μg/g) in the testing results and indicate “pass” or “fail” in the result report.

6507.4 The sample shall be deemed to have passed mycotoxin testing if both the following

conditions are met:

(a) Total of aflatoxin B1, B2, G1, and G2 does not exceed 20 μg/kg of substance; and

(b) Ochratoxin A does not exceed 20 μg/kg of substance.

6507.5 If the sample fails mycotoxin testing, the batch from which the sample was collected fails mycotoxin testing and shall be deemed adulterated.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6507

22-C DCMR § 6508 TESTING FOR FOREIGN MATERIAL

6508.1 Cultivation centers and manufacturers shall test all products for mold, mildew, pests, and other foreign materials in accordance with this section before distributing, selling, or otherwise transferring the product to an internet retailer, manufacturer, or retailer.

6508.2 The testing laboratory shall analyze the representative sample of medical cannabis and medical cannabis products to determine whether mold, mildew, pests and other foreign material is present.

6508.3 The licensed laboratory shall report the result of the foreign material test by indicating “pass” or “fail” in the result report.

6508.4 The testing laboratory shall perform foreign material testing required by this section on the total representative sample prior to sample homogenization.

6508.5 When the testing laboratory performs foreign material testing, the laboratory shall, at minimum, do all of the following:

(a) Examine both the exterior and interior of the dried flower sample, and

(b) Examine the exterior of the cannabis product sample.

6508.6 The sample shall be deemed to have passed the foreign material testing if the presence of foreign material does not exceed:

1/4 of the total sample area covered by sand, soil, cinders, or dirt;

1/4 of the total sample area covered by mold or mildew;

(d) 1/4 of the total sample area covered by an imbedded foreign material.

6508.7 If the sample fails foreign material testing, the batch from which the sample was collected fails foreign material testing and shall be deemed adulterated.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6508

22-C DCMR § 6509 TESTING FOR FERTILIZER AND NUTRIENTS

6509.1 Cultivation centers and manufacturers shall test all products for the presence and concentration of fertilizer and nutrients in accordance with this section before distributing, selling, or otherwise transferring the product to an internet retailer, manufacturer, or retailer.

6509.2 A leaf tissue sample or other test designed to elicit the presence and concentration of the following nutrients in the sampled medical cannabis or medical cannabis product:

(a) Nitrogen (N);

(b) Phosphorus (P);

(d) Calcium (Ca);

(e) Magnesium (Mg);

(f) Sulfur (S);

(g) Boron (B);

(h) Copper (Cu);

(i) Iron (Fe);

(j) Manganese (Mn);

(k) Zinc (Zn);

(l) Molybdenum (Mo);

(m) Sodium (Na); and

(n) Chloride (Cl).

6509.3 The cultivation center and manufacturer shall be required to disclose to the testing

laboratory all fertilizers and nutrients used during the growing or production of the medical cannabis or medical cannabis product being tested.

6509.4 The testing laboratory shall further test for the presence of all fertilizers and nutrients disclosed by the cultivation center and manufacturer in accordance with the testing labs standard operating procedures.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6509

22-C DCMR § 6511 RESULT REPORTING

6511.1 A testing laboratory shall issue results for each sample tested which shall address the following:

(a) Whether the chemical profile of the medical cannabis sample conforms to the accepted variety for the following compounds:

(1) Delta-9-tetrahydrocannabinol (THC);

(2) Delta-9-tetrahydrocannabinolic acid (THCA);

(3) Cannabidiol (CBD);

(4) Cannabidiolic acid (CBDA);

(5) The terpenes described in the most current version of the cannabis inflorescence monograph published by the American Herbal Pharmacopeia (AHP);

(6) Cannabigerol (CBG); and

(7) Cannabinol (CBN);

(b) That the presence of the following contaminants do not exceed the levels as provided in § 6409 of this subtitle;

(1) Heavy metals; and

(2) Pesticide residue;

(1) The total aerobic microbial count (TAMC);

(2) The total combined yeast and molds count (TYMC);

(3) Pseudomonas aeruginosa (P. aeruginosa);

(4) Aspergillus spp;

(5) Staphylococcus aureus (S. aureus);

(6) Aflatoxin B1, B2, G1 and G2; and

(7) Ochratoxin A;

(d) Whether the batch is within specification for the characteristics of:

(1) Odor;

(2) Appearance;

(3) Fineness; and

(4) Moisture content.

6511.2 The testing laboratory shall enter results into the Board’s electronic tracking system within twenty-four (24) hours from the date of the test.

6511.3 The level of contaminants in medical cannabis and medical cannabis products shall not exceed the standards provided in this subtitle, and if any of the standards are exceeded, the cultivation center shall not sell or otherwise transfer any portion of the batch of medical cannabis or medical cannabis products to an internet retailer or retailer.

6511.4 In the event the testing laboratory results determine that the sample does not meet the standards required in this subtitle, the cultivation center may seek approval from the Board to reprocess the batch and/or harvest. If written approval is granted by the Board, the cultivation center may:

(a) Reprocess the batch and/or harvest according to their SOPs; and

(b) Have the reprocessed product tested by the same testing laboratory.

6511.5 Upon receiving notification in the tracking system that the batch failed to pass testing, a cultivation center shall immediately quarantine the non-conforming batch until any reprocessing and testing is performed; or until the batch is destroyed by MPD.

6511.6 For purposes of this section, quarantine means that the batch shall be separated from all other inventory and the quarantine status shall be indicated in the tracking system. The quarantine shall be lifted only by the Board in writing, and only upon receipt of test results in the inventory tracking system documenting that the batch conforms to the required testing standards.

6511.7 The testing laboratory shall notify the Board of results that do not meet the standards and specifications set forth in this subtitle within twenty-four (24) hours of completion of analysis.

6511.8 A cultivation center shall release a batch and/or harvest for sale only if the results from the laboratory testing facility have determined that the sample has met the standards and specifications set forth in this subtitle.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6511

22-C66 ADULTERATED CANNABIS

22-C DCMR § 6600 PROHIBITION ON DISTRIBUTING ADULTERATED PRODUCTS

6600.1 Medical cannabis and medical cannabis products that exceed, fail, or violate any of the testing standards, testing limits, or testing levels provided by the Act or this chapter shall be deemed adulterated and unfit for use or consumption.

6600.2 If a sample taken from a batch exceeds, fails, or violates any of the testing standards, testing limits, or testing levels set by this chapter, the batch from which the sample was collected shall also be deemed adulterated.

6600.3 A cultivation center or manufacturer shall not sell, distribute, or otherwise transfer any portion of the batch of medical cannabis or medical cannabis products that qualify as adulterated and unfit for use or consumption in accordance with this section to an internet retailer, manufacturer, or retailer.

6600.4 A internet retailer or retailer shall not sell, distribute, or otherwise transfer any portion of the batch of medical cannabis or medical cannabis products deemed adulterated and unfit for consumption in accordance with this section to any person.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6600

22-C67 COURIERS

22-C DCMR § 6700 COURIERS

6700.1 A courier shall not obtain medical cannabis or medical cannabis product except when:

(a) Fulfilling an order submitted by a qualifying patient or caregiver, on behalf of a licensed internet retailer or retailer; or

(b) Obtaining medical cannabis in their personal capacity, in a manner consistent with the Act and this subtitle, for their own personal use and consumption.

6700.2 A courier may store and prepare medical cannabis or medical cannabis product obtained from a licensed internet retailer or retailer for delivery at its licensed location but shall not hold the product for more than 24 hours.

6700.3 Medical cannabis and medical cannabis products that cannot be delivered shall be returned to the internet retailer or retailer. An internet retailer or retailer that uses the services of a courier must accept returns by the courier when in operation.

6700.4 A courier may make deliveries up to seven (7) days a week, but shall only make deliveries between the hours of 9:00 a.m. and 9:00 p.m.

6700.5 A courier delivery driver shall only travel from the internet retailer and retailer to the driver’s assigned delivery address(es) and return to the internet retailer, retailer, or courier.

6700.6 The courier shall record each delivery in the METRC delivery manifest system in real-time and maintain a copy of the record as part of the internet retailer and retailer’s recordkeeping requirements.

6700.7 The courier shall provide a copy of its delivery manifest to the Board or ABCA investigators immediately upon request.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 6700

22-C96 MORATORIUMS

22-C DCMR § 9600 ESTABLISHMENT OF MORATORIUM

9600.1 If the Board reasonably determines that it is in the public interest to do so based on the standards set forth in the Act, the Board may, by rule:

(a) Limit the number of medical cannabis business licenses of any class to be issued; or

(b) Declare a moratorium on the issuance of licenses of any class in any ward, single-member district, or ANC.

9600.2 An ANC may request the Board to issue regulations establishing a moratorium.

9600.3 A moratorium issued by the Board in accordance with this section shall have a prospective effect and shall not apply to existing licenses.

9600.4 A moratorium shall be effective for five (5) years from the date of final rulemaking, or for a lesser period as determined by the Board.

9600.5 If the Board acts on a moratorium request, a moratorium request for the same area, or an area covering substantially the same area, shall not be considered for two (2) years from the date of the Board’s action.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9600

22-C DCMR § 9601 MORATORIUM PROCEDURES

9601.1 The moratorium request shall be made to the Board in writing, providing:

(a) The identity of the ANC;

(b) The resolution containing the official ANC vote and statement approving of the moratorium request filed with the Board;

(d) The class or classes of licenses to be covered by the moratorium;

(e) A detailed statement of the reasons that the moratorium is appropriate under at least two (2) of the appropriateness standards set forth in the Act and this chapter; and

(f) A statement identifying whether the moratorium shall be either a ward, ANC, or single-member district.

9601.2 A moratorium may be sought for a single class of license or for any combination of the classes of licenses except for those licenses exempted by § 9600.6.

9601.3 No moratorium request to limit the number of licenses to be issued, the number of licenses issued for any single class, or the issuance of amended licenses for any single class that constitute a substantial change shall be considered by the Board unless all the requirements of subsection § 9601.1 have been met and the following conditions are satisfied:

(a) If the requested moratorium area is a single-member district, there shall exist in the area at least three (3) licensed establishments of the same class or six (6) licensed establishments of any class or combination of classes;

(b) If the requested moratorium area is an ANC, there shall exist in the area at least six (6) establishments of the same class or twelve (12) establishments of any class or combination of classes; or

(c) If the requested moratorium area is the Ward, there shall exist in the area at least nine (9) establishments of the same class or eighteen (18) establishments of any class or combination of classes.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9601

22-C DCMR § 9602 MORATORIUM NOTICE

9602.1 If a moratorium request meets all the requirements set forth in this chapter, the Board shall provide notice to the public according to the same procedures as required by § 5425.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9602

22-C DCMR § 9603 MORATORIUM HEARING

9603.1 The Board shall hold a public hearing to review a proposed moratorium. The public hearing shall be a rulemaking hearing under section 6 of the DC APA and not in the nature of a contested case under section 10 of the DC APA.

9603.2 At the public hearing, any interested person may appear to give oral or written testimony in support of, or in opposition to, the moratorium request.

9603.3 In addition to receiving testimony from the public, the Board shall request formal comments from the following persons or agencies:

(1) The Councilmembers within whose wards the requested moratorium area is located;

(2) The ANCs within whose boundaries the requested moratorium area is located and any other ANC abutting the proposed moratorium area;

(3) The Assistant City Administrator for Economic Development, or their designee;

(4) The Office of Planning, or its successor agency; and

(5) The District Commander of the Metropolitan Police Department in which the requested moratorium zone is located.

9603.4 In deciding on a moratorium request, the Board shall consider the extent to which the testimony and comments show that the requested moratorium is appropriate under at least two (2) of the appropriateness standards set forth in the Act and this title.

9603.5 The Board may grant the moratorium request:

(1) In whole or in part;

(2) By enlarging or decreasing the moratorium area; or

(3) By limiting the moratorium to no more than one class of license.

9603.6 The Board may deny the moratorium request in its entirety.

9603.7 The decision of the Board shall be final and shall be issued in writing, including each member’s vote.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9603

22-C97 HEARING PROCEDURES

22-C DCMR § 9700 HEARING PROCEDURES - APPLICABILITY

9700.1 This chapter shall apply to all hearings held before the Board, including:

(a) Roll call hearings or status hearings regarding the issuance, transfer, or renewal of a license, or the making of substantial changes to a licensee’s business operations under authority of the Act;

(b) Protest hearings regarding the issuance, transfer or renewal of a license, or the making of substantial changes to a licensee’s business operations under authority of the Act;

(d) Show cause hearings, summary suspension hearings, or summary revocation hearings regarding the revocation or suspension of a license issued under the Act.

9700.2 The Board may, for good cause shown and in the interest of justice or to prevent hardship, waive any provision of this chapter which is not required by the Act in any proceeding after duly advising the parties of its intention to do so.

9700.3 The following hearings held before the Board shall be conducted in the same manner as hearings conducted pursuant to D.C. Official Code § 2-509:

(a) Protest hearings;

(b) Show cause hearings;

(d) Cease and desist hearings;

(e) Contested fact finding hearings in which the Board may suspend or revoke one’s license or issue an order or interpretation that may impact the rights of a licensee or applicant; and

(f) Qualifications hearings.

9700.4 The following hearings held before the Board shall be deemed discretionary hearings:

(a) Uncontested fact-finding hearings, including the request to extend a license safekeeping; and

(b) Rulemaking hearings.

9700.5 The provisions of this chapter are intended to be consistent with the DC APA (D.C. Official Code § 2-501 et seq.). If there is any conflict between this chapter and the DC APA, the DC APA shall govern.

9700.6 To the extent that there is any conflict within this chapter, provisions of specific application shall supersede those of general application.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9700

22-C DCMR § 9701 CONTINUANCES

9701.1 A hearing may be continued for good cause.

9701.2 A written motion for a continuance shall be filed with the Board at least six (6) calendar days before the scheduled hearing date and served upon all parties at least six (6) calendar days before the hearing. To be granted, the motion shall, in the opinion of the Board, set forth good and sufficient cause for continuance or demonstrate that an emergency exists.

9701.3 A continuance shall not waive the requirements governing the time in which to file objections, petitions, or other pleadings.

9701.4 The Board may, on motion of any party or on its own motion, continue a hearing to permit an ANC to vote on a material issue in the hearing, upon a determination that the interests of justice will be served by the granting of the continuance to any party, or for administrative convenience.

9701.5 The Board may waive the provisions of this section if all parties agree to a continuance, to prevent hardship, in the interest of justice, or for administrative convenience.

9701.6 An attorney who knows or should know of a scheduling conflict shall immediately, but no later than two (2) days before the scheduled hearing, file a motion for continuance with the Board, with copies submitted to the opposing party or parties. A scheduling conflict with another tribunal may be considered good cause for continuing the proceeding.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9701

22-C DCMR § 9702 WITNESSES

9702.1 A party shall have the right to call and examine witnesses.

9702.2 Except as provided in § 9702.3, at any proceeding before the Board in a contested case, the Board may hear as witnesses all persons residing within and outside the neighborhood who desire to be heard.

9702.3 The Board may exclude any irrelevant or unduly repetitious evidence or testimony.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9702

22-C DCMR § 9703 RULE ON WITNESSES

9703.1 At the request of a party, or on its own motion, the Board shall order witnesses excluded so that they will not hear the testimony of other witnesses.

9703.2 The following persons shall not be excluded from hearings before the Board:

(a) The applicant or the licensee;

(b) The designated representative for a party to a proceeding; or

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9703

22-C DCMR § 9704 EXAMINATION OF WITNESSES

9704.1 In any proceeding before the Board, each party shall have the right to present in person or by counsel or designated representative, the party’s case or defense, including oral and documentary evidence, to submit rebuttal evidence, and to cross-examine witnesses, unless the matter at issue has been dismissed by the Board.

9704.2 In a protest hearing in which there is more than one (1) protest, and the Board has required the protestants to designate one (1) person to conduct the protestant’s case, the designated individual shall present the protestant’s case, give the opening and closing statements, and examine and cross-examine witnesses on behalf of the protestants.

9704.3 Any member of the Board may question any witness at any time during or after examination or cross-examination, subject to objection by a party.

9704.4 Any oral or documentary evidence may be received, but the Board shall exclude irrelevant, immaterial, or unduly repetitious evidence.

9704.5 The Board may impose a time limitation on oral arguments and witness testimony as it deems appropriate.

9704.6 The Board shall afford all parties the opportunity to present oral argument unless limited in accordance with § 9704.2.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9704

22-C DCMR § 9705 PARTIES, INTERVENTION, AND RIGHT TO BE HEARD

9705.1 The parties to a show cause hearing shall be the following:

(a) The respondent, licensee, permittee, or applicant; and

(b) The District of Columbia.

9705.2 The parties to a protest hearing shall be the applicant and the protestants and their

designated representatives, if any.

9705.3 The parties to a fact-finding hearing shall be the licensee, permittee, or applicant for a license, and such other persons whose appearance the Board deems necessary and who are designated by the Board as parties.

9705.4 The Board may, in its discretion, permit interested persons other than parties, as defined in this chapter, to intervene in a proceeding for such general or limited purpose as the Board may specify.

9705.5 A person permitted to intervene under this section shall comply with all conditions fixed by the Board and shall not be considered a party to the proceedings.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9705

22-C DCMR § 9706 COMPUTATION OF TIME FOR FILINGS

9706.1 Whenever a party to a proceeding under this chapter has the right or is required to perform some act within a specified time period after the service of notice upon the party, and the notice is served upon that party by mail, three (3) days shall be added to the prescribed period.

9706.2 Except as otherwise provided by law, any time period prescribed by this chapter may, for good cause shown, be extended by the Board with notice to all parties.

9706.3 For purposes of computing time that is stated in days or a longer unit of time, exclude the day of the event that triggers the computation of time.

9706.4 For purposes of computing time that is stated in days or a longer unit of time, every day, including intermediate Saturdays, Sundays and legal holidays is counted. Count the last day of the period, but if the last day is a Saturday, Sunday or legal holiday, the period continues to run until the end of the next day that is not a Saturday, Sunday or legal holiday.

9706.5 For purposes of computing time that is stated in hours, begin counting every hour immediately at the conclusion of the event that triggers the period, including hours during intermediate Saturdays, Sundays and legal holidays. If the time period would end on a Saturday, Sunday, or legal holiday, the time period continues to run until the same time on the next day that is not a Saturday, Sunday, or legal holiday.

9706.6 Unless a different time is set by a statute, regulation or Board order, the last day of a specified time period is at midnight for electronic filing, and at the close of business on the last day for filing by any other means.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9706

22-C DCMR § 9707 SERVICE OF PAPERS

9707.1 Any papers filed with the Board or on opposing parties in a contested case shall be served by personal delivery, first class U.S. mail, registered or certified mail, or by electronic mail. Proof of service shall be shown as required by the regulations.

9707.2 Any papers required to be served upon a party may be served upon the party or

the party’s designated representative.

9707.3 When a party has appeared through a representative, who has filed a written notice of appearance service shall be made upon the representative of record.

9707.4 Service upon a party or the party’s designated representative may be made in the following manner:

(a) By personal delivery;

(b) By use of a process server;

(d) By electronic mail; or

(e) As otherwise authorized by law.

9707.5 Service upon a party shall be completed upon any of the following acts:

(a) Handing the paper to the person to be served;

(b) Leaving the paper at the licensed premises with the owner, manager, or other employee of the establishment;

(c) Leaving the paper at the party’s usual place of residence with some individual of suitable age and discretion residing therein;

(d) Deposit of the paper in the U.S. Mail, by registered or certified mail, properly stamped and addressed;

(e) By electronic mail at the e-mail address on file with ABCA;

(f) Deposit of the paper in the U.S. Mail, by first class mail, properly stamped and addressed, by an attorney of record; or

(g) By an action in conformity with an order of the Board in any proceeding.

9707.6 Proof of service shall state the name and address of the person served, the manner of service, and the date of service.

9707.7 Proof of service shall be shown by one of the following:

(a) Written acknowledgement of the person served or that person’s representative;

(b) The certificate of the person making the service;

9707.8 Service shall also be deemed proper upon a showing that the party actually received delivery of the notice or paper, irrespective of the delivery method.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9707

22-C DCMR § 9708 APPEARANCE AND REPRESENTATION

9708.1 An individual may represent himself or herself in any proceeding before the Board.

9708.2 An attorney may represent any party before the Board by submitting a Notice of Appearance or completing ABCA’s Attorney/Representative Designation Form to the Board.

9708.3 In addition to this chapter, the District of Columbia Rules of Professional Conduct shall govern the conduct of all attorneys appearing before the Board.

9708.4 An authorized officer, director, partner, or employee may represent a corporation, partnership, limited partnership, or other legal entity before the Board. Parties appearing before the Board pursuant to this section may be required to demonstrate that authority.

9708.5 Any party appearing before the Board in any proceeding may bring an interpreter of their choice.

9708.6 If it appears to the Board that the facts or issues in a matter before it are so intricate or involved that, in the interests of justice, of conserving time, or of facilitating preparation of an adequate record, a party ought to be represented by an attorney, the Board may urge the party to obtain counsel and shall allow the party a reasonable time, not to exceed fourteen (14) calendar days, to do so, as long as the rights of the other parties to the hearing are not substantially and adversely affected.

9708.7 Any person authorized to appear pursuant to this section may sign any paper required or permitted by the Act, this chapter, or any other statute or regulation to be filed with the Board.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9708

22-C DCMR § 9709 NOTICE OF APPEARANCE

9709.1 A non-lawyer representative shall submit a signed statement containing that person’s name, address, e-mail address, telephone number, and the nature of the representation, or ABCA’s Attorney/Representative Designation Form prior to appearing before the Board.

9709.2 The written statement or the Attorney/Representative Designation Form required by this chapter shall be made a part of the Board’s record of the proceeding and shall be served on all parties to the proceeding.

9709.3 Any attorney appearing as counsel in any proceeding shall submit a Notice of Appearance containing their name, e-mail address, office address, office telephone number, D.C. Bar number, and nature of the representation or ABCA’s Attorney/Representative Designation Form to the Board.

9709.4 In the case of law students who appear before the Board under the direction of an accredited law school clinical program, the supervising attorney shall register with the Board.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9709

22-C DCMR § 9710 SCHEDULING AND CONDUCT OF HEARINGS: GENERAL PROVISIONS

9710.1 The Board shall not schedule any hearing until the applicant has submitted, in writing to the Board, all information and documents required by the Act and the regulations.

9710.2 Before a person may be heard to object to approval of an application, the person shall have notified the Board and the applicant or licensee, by any of the means listed in § 5433, of their intent to object, and of the grounds for the objection, prior to the end of the protest period.

9710.3 Decorum and good order shall be maintained at all times during hearings, and the Board may exclude or order the removal from the hearing room of any person who refuses to comply with a reasonable order of the Board.

9710.4 The Chairperson of the Board shall preside over all proceedings conducted by the Board under the authority of the Act and this chapter.

9710.5 The Chairperson of the Board shall conduct all proceedings in accordance with the provisions of this chapter, the Act, and the District of Columbia Administrative Procedures Act.

9710.6 The Chairperson of the Board shall have the authority to:

(a) Open and close a meeting or hearing;

(b) Administer oaths and affirmations;

(d) Take any other action in accordance with the above provisions in furtherance of a fair and orderly hearing.

9710.7 In the event the Chairperson is unable or unavailable to preside over a hearing or meeting, the Chairperson may designate a member of the Board to act as the presiding officer in the Chairperson’s absence.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9710

22-C DCMR § 9711 EVIDENCE: GENERAL RULES

9711.1 Any party objecting to the admission of evidence shall state the grounds relied upon for the objection.

9711.2 Formal exceptions to the rulings of the Board made during the course of a hearing shall not be required.

9711.3 The parties may, by stipulation in writing filed with the Board, or in the record at a hearing, agree upon any facts relevant to a proceeding, or upon the substance of the testimony which would be given by a witness.

9711.4 The Board, in its discretion, may require additional evidence on any matter covered by stipulation.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9711

22-C DCMR § 9712 BURDEN OF PROOF

9712.1 In all protest hearings before the Board, the applicant shall have the burden of proof to show by substantial evidence in the record that the licensing action meets the appropriate standards in accordance with this title.

9712.2 In all show cause proceedings before the Board, the District of Columbia shall have the burden of proof to show by substantial evidence in the record that the respondent has committed a violation of the Act or this chapter.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9712

22-C DCMR § 9713 OPENING AND CLOSING STATEMENTS

9713.1 In all protest hearings before the Board, the applicant shall open and close the case insofar as presentation of evidence and argument are concerned.

9713.2 In all show cause proceedings before the Board, the District of Columbia shall open and close the case insofar as presentation of evidence and argument are concerned.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9713

22-C DCMR § 9714 OFFERS OF PROOF

9714.1 Any offer of proof made in connection with an objection to any ruling of the Board which rejects or excludes proffered oral testimony shall consist of a statement for the record of the substance of the evidence which the party contends would be established by the testimony.

9714.2 If the excluded evidence is documentary, a copy of the written evidence shall be marked for identification and shall constitute the offer of proof.

9714.3 The document shall be retained by the Board as part of the record for purposes of an appeal.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9714

22-C DCMR § 9715 DOCUMENTARY EVIDENCE

9715.1 Documentary evidence offered at any hearing before the Board shall, if received by the Board, be retained by the Board.

9715.2 Any party who intends to offer documentary evidence at a hearing shall, seven (7) calendar days prior to the hearing, disclose the evidence to the opposing party. Absent good cause, failure to disclose documentary evidence seven (7) calendar days prior to the hearing may result in the Board excluding the evidence.

9715.3 The Board may, in its discretion, permit the withdrawal of original documents received into evidence and the substitution of certified copies in lieu of the originals.

9715.4 When relevant and material matters offered into evidence are contained in a book or other document which also contains other matters not material or relevant, the person offering the evidence shall plainly designate the matters offered, and the immaterial and irrelevant parts shall be excluded and segregated insofar as practicable.

9715.5 All exhibits that a party intends to introduce at a hearing must be identified on and attached to an exhibit form. Parties shall include the exhibit form, including copies of the exhibits, with the Protest Information Form.

9715.6 Exhibits reasonably anticipated to be used for impeachment need not be included on or attached to the exhibit form.

9715.7 If a document is readily available to the general public, a party need only provide a complete citation to the source of the document and how the document may be accessed.

9715.8 The Board may exclude at the hearing any exhibit(s) not disclosed on the exhibit form if the Board finds that the opposing party has been prejudiced by the failure to disclose or if there has been a knowing failure to disclose.

9715.9 The Board shall have the discretion to receive documentary evidence from the parties not already listed or attached to the exhibit form upon a finding of good cause.

9715.10 The investigative report and attachments shall be part of the Board’s record, and it shall not be necessary for the parties to formally move for admission of the investigative report or portions of it into the evidentiary record.

9715.11 The exhibit form and any attachments shall be served on all parties and the Board’s Office of General Counsel seven (7) days prior to the hearing.

9715.12 If a PowerPoint presentation or similar presentation is used by the parties, a paper copy of the exhibit shall be filed with the Board.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9715

22-C DCMR § 9716 RECORDS IN PROCEEDINGS

9716.1 When any part of the record in any other proceeding before the Board, a criminal or civil action, or a proceeding before any administrative agency is offered in evidence, a certified true copy of that part of that record shall be presented to the Board as an exhibit, except in the following instances:

(a) It is described in a manner which makes it readily identifiable, and the offeror agrees to supply copies at a later time as required by the Board;

(b) There is a stipulation on the record that it may be incorporated by reference and the Board directs the incorporation; or

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9716

22-C DCMR § 9717 MOTIONS

9717.1 Any party to a protest may seek relief from the Board against an opposing party by filing a motion with the Board. Unless otherwise specified, motions shall conform to the following requirements:

(a) Be in writing;

(b) Served upon the other parties to the protest by electronic mail or the first-class U.S. Postal Service; and

9717.2 Any party may file a response in opposition to a motion within seven (7) calendar days after service of the motion. In the case of motions for continuances which have been filed by a party on the sixth (6th) calendar day before a scheduled hearing, responses shall either be made in writing and served by personal delivery on all parties prior to the hearing or shall be made orally on the date of the hearing.

9717.3 A response to a motion shall not include a motion for other affirmative relief against the moving party.

9717.4 If a party filing an opposition submits a motion for other affirmative relief, it shall be done by separate pleading.

9717.5 A reply may be filed within three (3) calendar days after service of a response in opposition to a motion, but the reply shall not re-argue propositions presented in the motion, nor present matters which are not strictly in reply to the opposition.

9717.6 A request for reinstatement of the license application or the protest must be filed with the Board within ten (10) days after receipt of the order after dismissal for failure to appear. In reviewing the request for reinstatement of the license application or the protest, the Board shall consider whether, in the discretion of the Board, the party has shown good cause for their failure to appear in accordance with § 5432.5.

9717.7 No further pleading shall be filed except by leave of the Board.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9717

22-C DCMR § 9718 POST-HEARING SUBMISSIONS

9718.1 No document or other information shall be accepted for the record after the close of a hearing except as follows:

(a) Unless accompanied by a Motion to Re-open the Record demonstrating good cause and the lack of prejudice to any party;

(b) Until all parties are afforded due notice and an opportunity to rebut the information; or

(c) Upon official notice of a material fact not appearing in the evidence in the record in accordance with section 10(b) of the District of Columbia Administrative Procedure Act, approved October 21, 1968 (82 Stat. 1207; D.C. Official Code § 2-509(b)).

9718.2 The Board shall afford parties an opportunity to file Proposed Findings of Fact and Conclusions of Law within thirty (30) calendar days after receipt of the transcript from the hearing. The Board may, in its discretion, grant an extension to file Proposed Findings of Fact and Conclusions of Law for good cause. An extension granted by the Board shall not exceed twenty (20) calendar days after the initial deadline.

9718.3 A copy of the Proposed Findings of Fact and Conclusions of Law shall be served on each party.

9718.4 Proposed Findings of Fact and Conclusions of Law shall be limited to the record and shall not include new legal issues that were not raised during the hearing.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9718

22-C DCMR § 9719 DECISIONS OF THE BOARD

9719.1 Unless otherwise required, within ninety (90) calendar days after the close of the record, the Board shall render its written decision accompanied by Findings of Fact and Conclusions of Law.

9719.2 Findings of Fact and Conclusions of Law shall consist of a concise statement of the Board’s conclusions on each contested issue of fact and shall be based solely upon evidence contained in the record and facts of which the Board properly took judicial notice.

9719.3 Findings of Fact and Conclusions of Law shall be supported by and in accordance with reliable, probative, and substantial evidence.

9719.4 All written decisions of the Board shall be available for public inspection and copying at a reasonable cost.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9719

22-C DCMR § 9720 RECONSIDERATION, REHEARING, REARGUMENT, AND STAY

9720.1 A motion for reconsideration, rehearing, reargument, or stay of a decision or order of the Board shall be filed with the Board, and a copy shall be served on each party and intervenor.

9720.2 A motion for reconsideration shall state briefly the matters of record alleged to have been erroneously decided, the grounds relied upon, and the relief sought.

9720.3 If a motion is based in whole or in part on a new matter, that new matter shall be set forth in the motion stating that the petition could not by due diligence have known or discovered the new matter prior to the date the case was presented to the Board for a decision.

9720.4 The Board may, in its discretion, permit or require oral argument upon a motion filed under this section.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9720

22-C DCMR § 9721 EX PARTE COMMUNICATIONS

9721.1 If a proceeding is a contested case within the meaning of the DC APA (D.C. Official Code § 2-502(8)), the following restrictions shall apply:

(a) A person shall not make or knowingly cause to be made to a member of the Board an ex parte communication relevant to the merits of the proceeding; and

(b) No member of the Board shall make or cause to be made to any interested persons outside the Board an ex parte communication relevant to the merits of the proceeding.

9721.2 The prohibitions set forth in this section shall apply upon the filing of a protest against an application for an original, transfer, substantial change or renewal license, or upon the issuance of notice to appear for a show cause hearing.

9721.3 For purpose of this section, “ex parte communication” does not include an inquiry regarding the Board’s procedure or practice, or a request for a status report on a matter, proceeding, or notice of a meeting or hearing.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9721

22-C DCMR § 9722 TRANSCRIPTS OF HEARINGS

9722.1 Hearings shall be recorded and transcribed under the direction of the Board.

9722.2 Changes in the official transcript may be made only in cases of material error.

9722.3 A motion to correct the transcript shall be filed with the Board within ten (10) calendar days of the date the transcript is available to the movant. Copies of the motion shall be served on all parties.

9722.4 If no objections to the motion are filed within five (5) days after service of the motion, the Board may correct the transcript.

9722.5 The Board shall have final authority to dispose of all motions for correction of the record.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9722

22-C DCMR § 9723 POST HEARING MOTIONS

9723.1 A petition for reconsideration, rehearing, reargument, or stay of a decision or order of the Board may be filed by a party within ten (10) days after the date of receipt of the Board’s final order.

9723.2 The filing of a post hearing motion shall not stay the final order unless the stay is specifically ordered by the Board.

9723.3 A stay of a decision shall be granted only upon good cause, which shall consist of unusual or exceptional circumstances.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9723

22-C DCMR § 9724 WAIVER

9724.1 The Board may, for good cause shown and in the interests of justice or to prevent hardship, waive any of the provisions contained in this chapter in any proceeding after duly advising the parties of its intention to do so.

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9724

22-C98 SLIDING SCALE PROGRAM

22-C DCMR § 9800 SLIDING SCALE PROGRAM

9800.1 An internet retailer or retailer shall make available discounted cannabis on a sliding scale to qualifying patients determined eligible pursuant to § 1300.4 of this title. The term “make available” in this section means that a licensee violates this section if a qualified patient eligible for discounted medical cannabis requests the discount and is denied by the licensee.

9800.2 A qualifying patient who establishes their qualifications under § 1300.4 of this subtitle, shall be entitled to purchase medical cannabis directly, or through a caregiver, on a sliding scale from an internet retailer or retailer in the District of Columbia.

9800.3 An internet retailer or retailer shall sell medical cannabis to a qualifying patient, who is registered to purchase medical cannabis on a sliding scale, and possesses a registration card denoting such, at a discount of not less than twenty (20%) of its regular retail price.

9800.4 It shall be an affirmative defense to a violation of § 9800.1 that the sale or dispensing of medical cannabis or medical cannabis products to the qualified patient denied a sliding scale discount would be in violation of the law (e.g., intoxicated, failed to present adequate identification).

History

SOURCE: Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9800

22-C99 DEFINITIONS

22-C DCMR § 9900 DEFINITIONS

9900.1 When used in this subtitle, the following terms and phrases shall have the meanings ascribed:

ABCA – Alcoholic Beverage and Cannabis Administration

Acaricide – A substance poisonous to ticks or mites.

Act – means the Legalization of Marijuana for Medical Treatment Initiative of 1999 (Act), effective, effective July 27, 2010 (D.C. Law 18-210; D.C. Official Code §§ 7-1671.01, et seq.(2011 Supp.)).

Active Medical Cannabis Program - a program established by a state or U.S.

territory that allows the use of cannabis for one's medical needs.

Administer or Administration – means the direct introduction of medical cannabis, whether by inhalation, ingestion, or any other means, into the body of a person.

Adulterated – Describes medical cannabis or a medical cannabis product that exceeds, fails, or violates any of the testing standards, testing limits, or testing levels of various substances set by the Act or this title.

ANC – means Advisory Neighborhood Commission.

Applicant – means, as the context requires, the individual applicant, each member of an applicant partnership or limited liability company, or each of the principal officers, directors, and shareholders of an applicant corporation, or, if other than an individual, the applicant entity.

Authorized practitioner- a physician, advanced practice registered nurse, physician assistant, dentist, or naturopathic physician who is licensed and in good standing to practice under District law.

Batch –

(a) A quantity of usable medical cannabis from a harvest lot; or

(b) A quantity of cannabinoid concentrate or extract or cannabinoid product from a process lot.

Board – Alcoholic Beverage and Cannabis Board

Bona fide relationship with a qualifying patient- a relationship between an authorized practitioner and qualifying patient for which the authorized practitioner:

(a) Has completed a full assessment of the patient’s medical or dental history and current medical or dental condition, including a personal physical or dental examination; and

(b) Has responsibility for the ongoing care and treatment of the patient.

Business applicant – a person who has made an application to register a medical cannabis business or medical cannabis certification provider permit and who has an application pending before the Board.

Cannabis Plant - means a plant of the genus Cannabis in any stage of growth except for clones.

Caregiver- a person who:

(a) Is designated by a qualifying patient as the person authorized, on the qualifying patient's behalf, to possess, obtain from a internet retailer or retailer, dispense, administer, and assist in the administration of medical cannabis;

(b) Is registered with the Board as the qualifying patient's caregiver;

(c) Is not currently, with the exception of caregivers providing services on behalf of nursing homes and hospices, serving as the caregiver for another qualifying patient; and

(d) Is at least eighteen (18) years of age.

Chain of custody – Procedures employed by a testing laboratory to record the possession of samples from the time of sampling through destruction.

Civil Infractions Act- means Department of Consumer and Regulatory Affairs Civil Infractions Act of 1985, effective October 5, 1985 (D.C. Law 6-42; D.C. Official Code §§ 2-1801.01, et seq. (2007 Repl. & 2011 Supp.))

Clone – means a plant clipping from a female cannabis plant that is less than eight (8) inches in height, is not yet root-bound, is growing in a propagation solution or water, and that is capable of developing into a new cannabis plant.

Commercially manufactured food- means food prepared and/or processed in a licensed food facility.

Concentrate- means products consisting wholly or in part of the resin extracted from any part of the plant Cannabis and having a THC concentration greater than ten percent, or a substance obtained by separating cannabinoids from cannabis by:

A mechanical extraction process;

(B) A chemical extraction process using a nonhydrocarbon-based solvent, such as vegetable glycerin, vegetable oils, animal fats, isopropyl alcohol or ethanol; or

(C) A chemical extraction process using the hydrocarbon-based solvent carbon dioxide, provided that the process does not involve the use of high heat or pressure.

Controlled Substances Act – means the District of Columbia Uniform Controlled Substances Act of 1981, effective August 5, 1981 (D.C. Law 4-29; D.C. Official Code §§ 48-901.02, et seq. (2009 Repl. & 2011 Supp.)).

Cultivation Center - means a facility operated by an organization or business registered with the Board pursuant to Section 6 of the Act from or at which medical cannabis is cultivated, possessed, manufactured, and distributed in the form of medical cannabis, and paraphernalia is possessed and distributed to dispensaries.

Day – means calendar day unless specifically stated otherwise.

DC APA – means the District of Columbia Administrative Procedure Act, approved October 21, 1968 (82 Stat. 1207; D.C. Official Code § 2-501 et seq.).

DCRA – means the Department of Consumer and Regulatory Affairs

Dentist – an individual who is licensed and in good standing to practice dentistry under District law, but does not include an individual who only holds a dental teaching license.

Director – means the Director of the Alcoholic Beverage and Cannabis Administration or their designee or designees.

Dispense – means to distribute medical cannabis to a qualifying patient or caregiver pursuant to the Act and the rules issued pursuant to section 14 of the Act.

Distribute – means the actual, constructive, or attempted transfer from one person to another.

Drug-related offense – means any offense that involves the possession, distribution, manufacture, cultivation, sale, transfer, or the attempt or conspiracy to possess, distribute, manufacture, cultivate, sell or transfer cannabis or any substance the possession of which is prohibited by the Controlled Substances Act, Title 21 of the United States Code (Controlled Substance Act), or any equivalent state or foreign government law creating criminal penalties for the sale, distribution, possession, or use of illegal drugs or narcotics.

Edible medical cannabis products- means a food or potable liquid into which a cannabinoid concentrate, cannabinoid extract or dried cannabis leaves or flowers have been incorporated, but does not include a tincture or a cannabinoid product intended to be placed under the tongue or in the mouth using a dropper or spray delivery method, such as but not limited, to a sublingual spray.

Expediter - other than a registered caregiver, any person or entity employed, contracted, volunteering, or compensated by any form of remuneration, gift, donation, or bartering, to register individuals as patients in the medical cannabis program, to connect individuals with recommending authorized practitioners, to solicit individuals to become qualifying patients, to complete application forms or to assist individuals in completing application forms to become qualifying patients, or to transport or deliver to the Board application forms for individuals seeking to become qualifying patients.

Fact-finding hearing - a hearing held by the Board to obtain further information from an applicant in response to either (1) a licensing or registration request or (2) an investigation conducted by ABCA.

Federal Poverty Level - means the income level, which varies by household size, under which families in the continental United States are formally considered to be in poverty. The Secretary for the U.S. Department of Health and Human Services publishes a revised poverty level each year in the Federal Register.

Fraud – means a conviction for violation of sections 121 through 127h of the District of Columbia Theft and White Collar Crimes Act of 1982, effective December 1, 1982 (D.C. Official Code § 22-3221 – 22-3227.08) or any conviction in another jurisdiction with an element that involves these violations.

Fungicide – A chemical that destroys fungus.

Gun offense – means

(a) A conviction for the sale, purchase, transfer, receipt, acquisition, possession, use, manufacture, carrying, transportation, registration, or licensing of a firearm under Chapter 45 of Title 22, or an attempt or conspiracy to commit any of the foregoing offenses;

(b) A conviction for violating D.C. Official Code § 7-2502.01, § 7-2504.01, § 7-2505.01, § 7-2506.01, or § 7-2509.06, or an attempt or conspiracy to commit any of those offenses;

(c) A conviction for a firearms-related violation of the provisions in D.C. Official Code § 22-402 (assault with a dangerous weapon), § 22-2603.02 (unlawful possession of contraband), or § 22-2803(b) (carjacking); or

(d) Violations in other jurisdictions of any offense with an element that involves the violations listed in subparagraphs (a) – (c) of this paragraph.

Human consumption - means the consumption of medical cannabis by a person through oral ingestion, absorption through the skin, inhalation through smoking, vaporization or other means.

Individual Applicant - an individual who has made an application for a manager's registration or for registration as a director, officer, member, incorporator, agent, or employee and who has an application pending before the Board.

Letter of information - a written request from the Board for further factual information in response to a request for an advisory opinion.

Locality - means the area within 600 feet of an establishment.

Location - means a particular parcel of land that is defined by an address or other descriptive means.

Management agreement - means an operational agreement between the licensee and a third-party allowing the third party to manage the establishment on behalf of the licensee for a fee.

Manager - an individual who has obtained a manager's registration from the Board and who is designated by the medical cannabis business to manage the registered premises in the absence of a registered owner.

Manufacture - means the production, preparation, propagation, compounding, conversion, or processing of cannabis, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis, and includes any packaging or repackaging of the substance or labeling or re-labeling of its container.

Marijuana - shall have the same meaning as provided in section 102(3)(A) of the Controlled Substances Act.

Medical Cannabis - means cannabis cultivated, manufactured, possessed, distributed, dispensed, obtained, or administered in accordance with the Act and this title and all types of products containing medical cannabis such as infused beverages, concentrates, dried leaf, edibles, kief, oils, tinctures, and pre-rolls.

Medical Cannabis Business – a licensed courier, cultivation center, internet retailer, manufacturer, retailer, testing laboratory, or any other business operating pursuant to a license authorized by the Act and this title. This term does not refer to personal licenses such as those for qualified patients, caregivers, authorized practitioners, managers, employees, and agents.

Medical cannabis-infused products - means products that contain cannabis or cannabis extracts, are intended for human use, are derived from cannabis, and have a THC concentration no greater than ten percent. The term “cannabis-infused products” does not include either useable medical cannabis or cannabis concentrates. The term “cannabis-infused products” does include tinctures and topicals.

METRC – means the electronic track and trace platform provided by the Marijuana Enforcement Tracking Reporting Compliance (METRC) company.

Minor - means any person under eighteen (18) years of age, but does not include an emancipated minor.

MPD - means the Metropolitan Police Department.

Nonresident Card - a medical cannabis patient card issued by a state or U.S. territory that has a medical cannabis program and issues either a card or state- issued document evidencing the patient's participation in the program.

Non-Resident Cardholder – a non-resident of the District of Columbia that is deemed a qualified patient once issued a medical cannabis patient card from ABCA so long as the card is valid and unexpired. This term does not include a nonresident qualifying patient who is registered in another jurisdiction’s medical cannabis program.

Nonresident Qualifying Patient - a person that is not a resident of the District of Columbia who is enrolled in another jurisdiction's medical cannabis program and issued an official card by a local, state, federal government entity recognizing their participation in the jurisdiction's medical cannabis program; provided, that a patient from another jurisdiction shall not be a qualifying patient if ABCA determines that there is a shortage of medical cannabis or the real-time electronic records system referenced in Section 6(4)(A) of the Act (D.C. Official Codes § 7- 1671.05(4)(A)) is inactive.

OAG - means the Office of the Attorney General.

OAH - means the Office of Administrative Hearings.

Offer in Compromise - a negotiation between the Government and the Respondent to settle the charges brought by the Government for those violations committed by the Respondent in the instant case.

OTR - means the Office of Tax and Revenue.

Overconcentration - means the existence of multiple licensed establishments in a single locality, section, or portion of the District of Columbia that adversely impacts that locality, section, or portion of the District of Columbia, taking into account the appropriateness standards.

Ovicide - A substance that kills eggs.

Paraphernalia - means:

(a) Objects used, intended for use, or designated for use in preparing, storing, ingesting, inhaling, or otherwise introducing medical cannabis into the human body; and

(b) Kits, objects, devices, or equipment used, intended for use, or designated for use in planting, propagating, manufacturing, cultivation, growing, harvesting, processing, or preparing medical cannabis.

Person - means a natural person, partnership, association, company, corporation, limited liability company, or organization, or a manager, agent, owner, director, officer, or employee thereof.

Physician - means an individual who is licensed and in good standing to practice medicine or osteopathy under District law.

Placard - means a written notice posted at an establishment for the purpose of notifying the public of action involving a new or transfer to new location registration application for either a medical cannabis business.

Plant Growth Regulator – A substance used to alter the plants’ characteristics.

Portion - means the area within 1,800 feet of an establishment.

Potentially Hazardous Food- food that contains moisture or protein that is capable of supporting the rapid and accelerating growth of infectious or toxigenic microorganisms.

Premises – means a distinct and definite location, which may include a building, a part of a building, a room, or any other definite contiguous area.

Product Assessment – Test to determine if an edible is a Potentially Hazardous Food.

Program- means the medical cannabis program established by section 6 of the Act.

Qualifying medical condition-means:

(a) Human immunodeficiency virus;

(b) Acquired immune deficiency syndrome;

(d) Conditions characterized by severe and persistent muscle spasm, such as multiple sclerosis;

(e) Cancer; or

(f) Any other condition, as determined by rulemaking, that is:

(1) Chronic or long lasting;

(2) Debilitating or interferes with the basic functions of life; and

(3) A serious medical condition for which the use of medical cannabis is beneficial:

(A) That cannot be effectively treated by any ordinary medical or surgical measure; or

For which there is scientific evidence that the use of medical cannabis is likely to be significantly less addictive than the ordinary medical treatment for that condition.

Qualifying medical or dental condition - any condition for which treatment with medical cannabis would be beneficial, as determined by the patient’s authorized practitioner.

Qualifying medical or dental treatment- means:

(a) Chemotherapy;

(b) The use of azidothymidine or protease inhibitors;

(d) Any other treatment, as determined by rulemaking, whose side effects require treatment through the administration of medical cannabis in the same manner as a qualifying medical or dental condition.

Qualifying patient - a resident of the District who has a qualifying medical or dental condition or is undergoing a qualifying medical or dental treatment, a non-resident cardholder, or a patient enrolled in another jurisdiction’s medical cannabis program; provided, that a patient from another jurisdiction shall not be a qualifying patient if the Board determines that there is a shortage of medical cannabis or the real-time electronic records system referenced in the Act is inactive.

Quorum - a majority of the appointment members of the Committee being present.

Real-time electronic records system – means the electronic database designated by ABCA for use by the medical cannabis industry to track in real-time the planting, harvesting, processing, distribution, and sale of cannabis. The electronic database designated by ABCA is METRC.

Registration period – means the period of time between the authorized beginning and expiration dates for each registration.

Residence- means a dwelling or dwelling unit in which a person lives in a particular locality with the intent to make it a fixed and permanent home.

Safekeeping hearing - means a proceeding held by the Board to determine whether reasonable cause exists to extend the period that a registration is in safekeeping with the Board or whether the registration should be cancelled by the Board.

Section - means the area within 1,200 feet of an establishment unless the context indicates that the term “section” was not used to refer to a physical area.

Seedling- means a cannabis plant that has no flowers, is at least eight (8) inches in height but less than twelve (12) inches in height, and that is less than twelve (12) inches in diameter.

Site - means any location or medical cannabis to which pesticide is applied.

State-issued document - a document issued by the State or U.S. territory agency responsible for administering the medical cannabis program in that state or U.S. territory which bears on its face the nonresident patient's name and program identification number, and an official seal or imprint.

Tamper Evident – means a container or packaging having an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred. If a breached or missing indicator or barrier would not, in and of itself, provide consumers with such evidence, the packaging may still qualify as tamper-evident if, in conjunction with such device, a printed statement is prominently displayed on the product label to alert the consumer of the original presence of the indicator or barrier.

Tamper Proof – means a container or packaging that, once sealed, clearly shows whether it has been opened.

TCS Food – A food that requires time and temperature control in order to ensure food safety.

Testable Sample – A representative sample that is large enough in quantity to perform all of the required tests.

Testing Laboratory - An entity that is not owned or operated by a director, officer, member, incorporator, agent, or employee of a medical cannabis business, and is registered by the Board to test medical cannabis and medical cannabis products that are to be sold.

Tincture- means a solution of alcohol, cannabinoid concentrate, or extract, which may or may not include other ingredients intended for human consumption or ingestion.

Tolerance - means a level of pesticide residue in or on food that the Environmental Protection Agency has determined with reasonable certainty will not pose a hazard to public health when used in accordance with label directions.

Topical- means a cannabinoid product intended to be applied to skin or hair.

Useable medical cannabis – means the dried leaves and flowers of the cannabis plant, and any mixture of preparation thereof, and does not include seeds, stems, stalks or roots of the plant.

Water Activity – The available water ratio for microorganisms or bacteria to grow, expressed on a scale of 0 to 1, where 1 is pure water.

History

SOURCE: Emergency and Third Proposed Rulemaking published at 58 DCR 3299 (April 15, 2011)[EXPIRED]; as amended by Emergency and Fourth Proposed Rulemaking published at 58 DCR 7207 (August 12, 2011)[EXPIRED]; as amended by Final Rulemaking published at 58 DCR 10128, 10237 (December 2, 2011); as amended by Final Rulemaking published at 60 DCR 10061 (July 12, 2013); as amended by Final Rulemaking published at 64 DCR 6639 (July 14, 2017); as amended by Final Rulemaking published at 64 DCR 7487 (August 4, 2017); as amended by Final Rulemaking published at 64 DCR 11922 (November 17, 2017); as amended by Final Rulemaking published at 65 DCR 3650 (April 6, 2018); as amended by Final Rulemaking published at 65 DCR 3926 (April 13, 2018); as amended by Final Rulemaking published at 66 DCR 10217 (August 9, 2019); as amended by Final Rulemaking published at 67 DCR 7479 (June 12, 2020); as amended by Final Rulemaking published at 67 DCR 8837 (July 17, 2020); as amended by Final Rulemaking published at 71 DCR 002388 (March 8, 2024); as amended by Final Rulemaking published at 73 DCR 002136 (February 20, 2026). District of Columbia Municipal Regulations Medical Cannabis 22-C DCMR § 9900

22-D BIRTH AND DEATH

22-D3 DEATH WITH DIGNITY

22-D DCMR § 300 GENERAL PROVISIONS

300.1 This chapter shall apply to the following:

(a) District residents diagnosed with a terminal disease;

(b) Physicians licensed in the District;

(d) Pharmacies registered in the District; and

(e) Funeral directors and funeral services providers licensed in the District

300.2 Information collected pursuant to this chapter shall not be a public record and shall not be available for inspection by the public under the Freedom of Information Act of 1976, pursuant to Section 17 of the Act.

300.3 This chapter shall not be construed to authorize any person to end a person’s life by lethal injection, mercy killing, active euthanasia, or any other method of medication not authorized under the Act or this chapter.

300.4 Actions taken in accordance with the Act or pursuant to this chapter shall not constitute suicide, assisted suicide, mercy killing, active euthanasia, or homicide for the purposes of any provision of District law.

300.5 This chapter shall not be construed to authorize a qualified patient to ingest a covered medication in a public place or in such a way that death will result in a public place.

300.6 For the purpose of this chapter a patient may establish residency by providing any two (2) of the following original documents that include a valid address in the District:

(a) A utility bill or computer printout (water, gas, electric, oil, or cable), with name and address, issued within the last sixty (60) days (disconnect notices not accepted);

(b) A telephone bill or computer printout (cell phone, wireless, or pager bills acceptable), reflecting patient’s name and current address, issued within the last sixty (60) days (disconnect notices not accepted);

(d) An unexpired lease or rental agreement with the name of the patient listed as the lessee, permitted resident, or renter (may be a photocopy). The unexpired lease or rental agreement shall be signed by all parties;

(e) A District property tax bill or tax assessment issued within the last twelve (12) months reflecting the applicant's name and property address;

(f) An unexpired homeowner's or renter’s insurance policy reflecting the patient’s name and address;

(g) A letter with picture from the Court Services and Offender Supervision Agency or the Department of Corrections certifying the patient’s name and District residency issued within the last sixty (60) days;

(h) A Department of Motor Vehicles proof of residency form signed by the certifier residing at the residence and a copy of the certifier's unexpired District driver’s license or District identification card;

(i) A bank, credit union, credit card, or investment account statement issued within the last sixty (60) days reflecting the patient’s name and address;

(j) A piece of official mail—received from any government agency (with the patient’s full name and address) to include contents and envelope received within the last sixty (60) days;

(k) A form from a social service provider that includes the patient’s name and address issued within the last sixty (60) days;

(l) A medical bill issued within the last sixty (60) days reflecting the patient’s name and address;

(m) A student loan statement issued within the last sixty (60) days reflecting the patient’s name and address;

(n) A home line of equity statement issued within the last sixty (60) days reflecting the patient’s name and address;

(o) A car or personal loan statement (no coupon books/vouchers accepted) issued within the last sixty (60) days reflecting the patient’s name and address; or

(p) A home security system bill issued within the last sixty (60) days reflecting the patient’s name and address.

300.7 If at any time a patient participating in the Program or the patient’s agent disposes of covered medication, the patient shall be considered to have withdrawn from the Program and shall re-initiate the three step process (two oral requests and a written request) if the patient wishes to acquire covered medication again.

History

SOURCE: Final Rulemaking published at 64 DCR 12076 (November 24, 2017). District of Columbia Municipal Regulations Birth and Death 22-D DCMR § 300

22-D DCMR § 301 PATIENT PARTICIPATION

301.1 A patient may participate in the Program if the patient is:

(a) At least eighteen (18) years of age;

(b) A resident of the District;

(d) Diagnosed with a terminal disease.

301.2 To participate in the Program a patient shall first complete the training module provided by the Director regarding the Program.

(a) The training module shall include:

(1) Advice on the selection of witnesses;

(2) A link to the appropriate form for requesting covered medication;

(3) Information on who may prescribe and dispense a covered medication;

(4) Information on executing a Do Not Resuscitate Order or similar document;

(5) Information on the responsible use of a covered medication; and

(6) Information on the responsible disposal of unused covered medications.

(b) The patient shall attest to having completed the training module on the application form provided by the Director.

301.3 After completing the training module, a patient may request covered medication from an attending physician by making two (2) oral requests to the physician that are separated by at least fifteen (15) days. In addition, the patient shall submit a written request to the physician, on a form provided by the Director, before making the second oral request and at least forty-eight (48) hours before covered medication is prescribed or dispensed. The patient may, on the written request form, designate any person the patient chooses to serve as the patient’s agent for the purpose of safely disposing of unused covered medication. Any person so designated shall acknowledge acceptance of responsibility to safely dispose of unused covered medication by signing the form.

301.4 The written request required by § 301.3 shall be witnessed by two (2) individuals, neither of which may be the patient’s attending physician at the time of the request, and one of which shall not be:

(a) A relative of the patient by blood, marriage, or adoption;

(b) Entitled to any portion of the patient’s estate under a will or by operation of law at the time the patient or any witness signs the request; or

301.5 If a patient is a resident of a long-term care facility at the time of the written request, one of the witnesses required by § 301.4 shall be an individual the facility designates, provided that the facility shall not designate an owner, operator, or employee of the facility.

301.6 The patient may:

(a) Execute, at any time, a “Do Not Resuscitate Order”, “Comfort Care Order”, or other document that provides instructions to emergency responders not to prolong the life of a person who has a terminal disease and is experiencing cardiac or pulmonary arrest.

(b) Notify the Director, after completing the three step process (two oral requests and a written request), that the patient is participating in the Program; or

301.7 If a patient notifies the Director that the patient is participating in the Program, the Director shall notify the Office of Unified Communications and the Office of the Chief Medical Examiner.

301.8 If the patient chooses to withdraw from the Program, the patient shall notify the Director of the withdrawal. The Director shall provide notice of the patient’s withdrawal from the Program to the Office of Unified Communications and the Office of the Chief Medical Examiner (OCME).

History

SOURCE: Final Rulemaking published at 64 DCR 12076 (November 24, 2017). District of Columbia Municipal Regulations Birth and Death 22-D DCMR § 301

22-D DCMR § 302 HEALTH CARE PROVIDER PARTICIPATION

302.1 A health care provider, including a health care professional, shall not be required, by contract or otherwise, to dispense or prescribe covered medication.

302.2 If a health care provider, including a health care professional, is unable or unwilling to participate in the Program, and the patient transfers his or her care to a new health care provider, the prior health care provider shall, upon the patient’s request, transfer a copy of the patient’s medical record to the new health care provider.

302.3 A health care provider may prohibit any health care provider it employs or contracts with from participating in the Program on the prohibiting health care provider’s premises or within the scope of the health care provider’s duties for the prohibiting health care provider, provided that the prohibiting health care provider has notified the employee or contractor of this policy before the employee or contractor has provided the covered medication.

302.4 An attending physician who is licensed in the District, and who is not prohibited from participation under this section, may participate in the Program after completing the training module approved by the Director.

302.5 After completing the training module and receiving a written request for covered medication, an attending physician shall:

(a) Determine that the patient:

(1) Has a terminal disease;

(2) Is capable;

(3) Has made the request voluntarily; and

(4) Is a resident of the District;

(b) Inform the patient of:

(1) The patient’s medical diagnosis;

(2) The patient’s prognosis;

(3) The potential risks associated with taking a covered medication;

(4) The probable result of taking a covered medication;

(5) The feasible alternatives to taking a covered medication, including comfort care, hospice care, and pain control; and

(6) The availability of supportive counseling to address the range of possible psychological and emotional stress involved with the end stages of life;

(d) Refer the patient for counseling if the attending physician believes the patient may have a psychiatric or psychological disorder or depression that impairs the patient’s judgment;

(e) Recommend that the patient notify next of kin, friends, and a spiritual advisor, if applicable, of the decision to request covered medication;

(f) Counsel the patient about the importance of having another person present when the patient ingests covered medication, and of not taking covered medication in a public place;

(g) Inform the patient that the patient may rescind a request for covered medication at any time and in any manner; and

(h) Verify, immediately before dispensing a covered medication or delivering a prescription for a covered medication, that the patient is making an informed decision.

302.6 The attending physician shall document, file in the patient’s medical record, and make available to the Department for compliance review:

(a) The date of each patient oral request for covered medication;

(b) The date of receipt of the written request for covered medication;

(1) Diagnosis and prognosis of the patient;

(2) Determination that the patient is a District resident and the documentation the patient supplied to support the determination;

(3) Determination that the patient is capable, is acting voluntarily, and has made an informed decision to request covered medication;

(4) Offer to the patient to rescind the request for covered medication before the second oral request;

(5) Notation on the form provided by the Director that all requirements of the Act have been met;

(6) Notation on the form provided by the Director of all steps taken to carry out the patient’s request for covered medication, including the medication dispensed or prescribed;

(d) The consulting physician’s:

(1) Diagnosis and prognosis of the patient;

(2) Verification that the patient is capable, acting voluntarily, and has made an informed decision to request covered medication;

(e) The report by the psychiatrist or psychologist of the outcome and determinations of counseling, if applicable; and

(f) For a patient who died after using a covered medication;

(1) The patient’s age at death;

(2) The patient’s education level, if known;

(3) The patient’s race or ethnicity;

(4) The patient’s sex;

(5) The patient’s type of insurance, if known;

(6) The patient’s terminal disease; and

(7) Whether the patient died due to using a covered medication.

302.7 When a patient has been referred to a consulting physician, as required by § 302.5(c), the consulting physician shall:

(a) Examine the patient and the patient’s medical records to confirm, in writing, the attending physician’s diagnosis and prognosis that the patient has a terminal disease;

(b) Verify, in writing, to the attending physician that the patient:

(1) Is capable, including that patient does not suffer from a psychiatric or psychological disorder or depression that impairs the patient’s judgment;

(2) Is acting voluntarily; and

(3) Has made an informed decision;

(c) Complete the consult form provided by the Director and immediately submit the completed form to the attending physician; and

(d) Refer the patient for counseling if the consulting physician believes the patient may have a psychiatric or psychological disorder or depression that impairs the patient’s judgment.

302.8 The attending physician shall not dispense or prescribe covered medication to a patient who has been referred for counseling until the patient receives counseling and the psychologist or psychiatrist who counseled the patient determines and reports to the attending physician that the patient does not have a psychiatric or psychological disorder or depression that causes impaired judgment. The attending physician shall document the results of the psychological or psychiatric evaluation on the form to be submitted to the Department.

302.9 After the attending physician has completed all the requirements of §§ 302.5 and 302.6, and after the attending physician offers the patient another opportunity to rescind the patient’s request, the attending physician may dispense directly to the patient, or prescribe, covered medication, including ancillary medication intended to minimize patient discomfort.

302.10 If the attending physician prescribes covered medication rather than dispensing it directly to the patient, the attending physician first shall offer the patient another opportunity to rescind the patient’s request and then shall:

(a) Contact a pharmacist who is licensed in the District and authorized to participate in the Program, and inform the pharmacist of the prescription;

(b) Deliver the written prescription to the pharmacist personally, by telephone, by facsimile, or electronically; and

302.11 If the attending physician dispenses the medication, the attending physician shall immediately notify the Department on a form provided by the Director that covered medication has been dispensed. The Department shall provide the notification form, or information contained therein, to the OCME.

302.12 Within thirty (30) days after a patient dies from ingesting a covered medication, or as soon as practicable after the health care provider is made aware of a patient’s death resulting from ingesting the covered medication, the health care provider shall notify the Department of the patient’s death.

History

SOURCE: Final Rulemaking published at 64 DCR 12076 (November 24, 2017). District of Columbia Municipal Regulations Birth and Death 22-D DCMR § 302

22-D DCMR § 303 PHARMACIST PARTICIPATION

303.1 A pharmacist licensed in the District may participate in the Program after completing the training module approved by the Director.

303.2 A pharmacist shall only provide covered medication to a qualified patient when the pharmacist has received the prescription for covered medication from the attending physician.

303.3 After a pharmacist has prepared a prescription for covered medication, the pharmacist shall dispense the covered medication only to the following:

(a) The qualified patient;

(b) The attending physician; or

303.4 If the qualified patient has verbally designated an agent to receive covered medication, the pharmacist shall, as soon as practicable, document the name of the person the qualified patient has verbally designated as an agent.

303.5 Immediately upon dispensing covered medication, the pharmacist shall notify the attending physician by facsimile or electronically, and shall notify the Department by emailing the Pharmacy Dispensing Form to the address provided on the Form. The Department shall provide the Pharmacy Dispensing Form, or information contained therein, to the OCME.

History

SOURCE: Final Rulemaking published at 64 DCR 12076 (November 24, 2017). District of Columbia Municipal Regulations Birth and Death 22-D DCMR § 303

22-D DCMR § 304 FUNERAL SERVICES AND DEATH RECORDS REQUIREMENTS

304.1 Neither a funeral director nor any funeral services personnel shall disclose to anyone any information they may have that the decedent has participated in the Program.

304.2 Death record clearances by the OCME shall be required for all deaths occurring in the District of Columbia for which covered medications have been dispensed regardless of disposition type or place. Death record clearance includes review of the death certificate to ensure that the:

(a) Cause of death is etiologically specific; and

(b) Manner of death is appropriate for a non-OCME physician (natural) or as determined by the Chief Medical Examiner.

304.3 Within forty-eight (48) hours after death, the physician in charge of a patient’s care for the condition that resulted in death shall complete, sign, and return the medical certification portion of the death certificate to the funeral director.

304.4 An attending physician completing the death certificate for a decedent who participated in the Program shall identify the cause of death as the underlying medical condition consistent with the International Classification of Diseases without reference to the fact that the decedent ingested a covered medication.

304.5 An attending physician completing the death certification for a decedent who participated in the Program shall not include any of the following terms in the cause of death or manner of death sections:

(a) PAS (physician assisted suicide);

(b) MAID (medical assistance in dying or medically assisted dying);

(d) DWD (death with dignity);

(e) Legally prescribed or legal prescription;

(f) Physician-assisted dying;

(g) The term for any covered medication; and

(h) Any reference to the Act or this chapter.

304.6 A death record related to a participant in the Program shall only list “natural” as the manner of death, or as otherwise determined by the Chief Medical Examiner.

304.7 The Registrar may require an attending physician for a patient who participated in the Program to furnish related information to the Registrar sooner than the thirty (30)-day notification deadline provided for in the Act if necessary to complete the certificate of death.

History

SOURCE: Final Rulemaking published at 64 DCR 12076 (November 24, 2017). District of Columbia Municipal Regulations Birth and Death 22-D DCMR § 304

22-D DCMR § 305 SAFE DISPOSAL OF COVERED MEDICATION

305.1 If a patient participating in the Program chooses not to use covered medication, the patient, or an agent the patient has designated to dispose of unused covered medication, shall not:

(a) Dispose of covered medication by flushing it down a toilet, sink, sewer, or any other source that may result in the covered medication being conducted to the waters of the District; or

(b) Return the covered medication to a pharmacy or the physician that dispensed the covered medication.

305.2 A person in possession of unused covered medication, regardless of whether the person is the patient or an agent of the patient, shall safely dispose of the covered medication. Safe disposal may consist of the following:

(a) Take the covered medication out of the original container;

(b) Mix the covered medication with an undesirable substance such as cat litter or used coffee grounds;

(c) Place the mixture of covered medication and undesirable substance into a disposable container, such as a used plastic food container or sealable bag;

(d) Conceal or remove personal information, including the prescription number, from the prescription container by scratching off the information or covering it with permanent black marker; and

(e) Place the sealed container and the empty covered medication containers into the household trash.

History

SOURCE: Final Rulemaking published at 64 DCR 12076 (November 24, 2017). District of Columbia Municipal Regulations Birth and Death 22-D DCMR § 305

22-D DCMR § 306 CONFIDENTIALITY

306.1 No person may permit inspection of, disclose information contained in, or copy or issue a copy of any part of a record or related death record except as authorized by the Act and this chapter.

306.2 The Registrar may authorize the disclosure of information contained in death records, including Death with Dignity supporting documentation, for research purposes.

History

SOURCE: Final Rulemaking published at 64 DCR 12076 (November 24, 2017). District of Columbia Municipal Regulations Birth and Death 22-D DCMR § 306

22-D DCMR § 399 DEFINITIONS

399.1 When used in this chapter, the following words and phrases shall have the meanings ascribed:

Act—the Death with Dignity Act of 2016, effective February 18, 2017 (D.C. Law 21-182; D.C. Official Code §§ 7-661.01 et seq.), applicable as of June 6, 2017.

Agent—a person chosen by a qualified patient to receive covered medication on the patient’s behalf, to safely dispose of unused covered medication on the patient’s behalf, or both.

Attending physician—the physician selected by, or assigned to, the patient who has primary responsibility for the treatment and care of the patient.

Capable—having the mental capacity to make and communicate health care decisions to a health care provider.

Consulting physician—a physician who is qualified by specialty or experience to make a professional diagnosis and prognosis regarding the patient’s disease and who is willing to participate in the provision of covered medication to a qualified patient in accordance with the Act.

Covered medication—a drug, which when prescribed for a person with a terminal illness, is intended to result in humane and peaceful death. This term includes: Secobarbital, Pentobarbital, Phenobarbital, chloral hydrate, and morphine sulfate.

Day—Calendar day.

Department—Department of Health.

Director—Director of the Department of Health.

Health care professional—a physician who is a doctor of osteopathic medicine (DO), a doctor of allopathic medicine (MD), or a pharmacist (PharmD).

Health care provider—a person, partnership, corporation, facility, or institution that is licensed, certified, or authorized under District law to administer health care or dispense medication in the ordinary course of business or practice of a profession.

Oral request—means:

(a) Spoken in-person communication or sign language interpretation;

(b) Communication over the telephone;

(d) A request, by a patient who is not capable of using the means of communication described in (a) and (b), that is written or typed by the patient in the attending physician’s presence and is immediately given directly to the attending physician by the patient.

Program—the process authorized by the Act by which a qualified patient may request covered medication from a physician and self-administer covered medication to achieve humane and peaceful death.

Record—a certificate, report, or form submitted to the Director for the Program.

Registrar—the person appointed by the Director to administer the system of vital records for the District.

Terminal disease—an incurable and irreversible disease that has been medically confirmed and is expected, within reasonable medical judgment, to result in death within six (6) months.

History

SOURCE: Final Rulemaking published at 64 DCR 12076 (November 24, 2017). District of Columbia Municipal Regulations Birth and Death 22-D DCMR § 399

Title 22 DCMR — HEALTH

22-A MENTAL HEALTH

22-A1 CONSENT TO TREATMENT

22-A DCMR § 100 PURPOSE AND APPLICATION

22-A DCMR § 101 INFORMED CONSENT TO TREATMENT

22-A DCMR § 102 INFORMED CONSENT FROM SUBSTITUTE DECISION-MAKER

22-A DCMR § 103 INFORMED CONSENT NOT REQUIRED IN EMERGENCY

22-A DCMR § 104 ADMINISTRATION OF MEDICATION

22-A DCMR § 105 ADVANCE DIRECTIVES AND INSTRUCTIONS

22-A DCMR § 199 DEFINITIONS

22-A3 CONSUMER GRIEVANCE PROCEDURES

22-A DCMR § 300 PURPOSE AND APPLICATION

22-A DCMR § 301 CONSUMER RIGHTS AND PROTECTIONS PROCEDURE

22-A DCMR § 302 INDEPENDENT PEER ADVOCACY PROGRAMS

22-A DCMR § 303 CORE SERVICES AGENCY TRANSITIONAL PEER ADVOCACY PROGRAM

22-A DCMR § 304 GRIEVANCE PROCEDURE - GENERAL PROVISIONS

22-A DCMR § 305 FILING A GRIEVANCE

22-A DCMR § 306 MH PROVIDER GRIEVANCE PROCEDURE

22-A DCMR § 307 DMH REVIEW OF GRIEVANCES

22-A DCMR § 308 EXTERNAL REVIEW OF GRIEVANCES

22-A DCMR § 309 DMH MONITORING AND REPORTING

22-A DCMR § 399 DEFINITIONS

22-A5 USE OF RESTRAINTS AND SECLUSION

22-A DCMR § 500 PURPOSES AND APPLICATION

22-A DCMR § 501 GENERAL PROVISIONS REGARDING THE USE OF RESTRAINT AND SECLUSION

22-A DCMR § 502 CONSUMER RIGHTS REGARDING THE USE OF RESTRAINTS AND SECLUSION

22-A DCMR § 503 RESTRAINTS GENERALLY

22-A DCMR § 504 SECLUSION GENERALLY

22-A DCMR § 505 PROHIBITIONS ON THE USE OF RESTRAINTS AND SECLUSION

22-A DCMR § 506 INITIATING THE USE OF FOUR-POINT AND FIVE-POINT RESTRAINTS OR SECLUSION

22-A DCMR § 507 SPECIFIC PROCEDURES FOR THE USE OF SECLUSION

22-A DCMR § 508 MONITORING THE USE OF FOUR-POINT AND FIVE-POINT RESTRAINT OR SECLUSION

22-A DCMR § 509 POST EVENT ANALYSIS OF THE USE OF FOUR-POINT AND FIVE-POINT RESTRAINT OR SECLUSION

22-A DCMR § 510 TREATMENT TEAM DEBRIEFING MEETING REGARDING THE USE OF FOUR-POINT AND FIVE POINT RESTRAINTS OR SECLUSION

22-A DCMR § 511 PHYSICAL HOLDS

22-A DCMR § 512 MEDICAL RESTRAINTS

22-A DCMR § 513 LEGALLY MANDATED RESTRAINTS

22-A DCMR § 514 DRUG(S) USED AS A RESTRAINT

22-A DCMR § 515 USE OF RESTRAINTS OR SECLUSION WITH SPECIAL POPULATIONS

22-A DCMR § 516 INJURY OR DEATH AS A RESULT OF RESTRAINT OR SECLUSION

22-A DCMR § 517 PROTECTIVE MEASURES

22-A DCMR § 518 NOTIFICATION OF PARENT(S) OR LEGAL GUARDIAN(S) OF USE OR CONTINUATION OF RESTRAINTS OR SECLUSION

22-A DCMR § 519 MH PROVIDER POLICIES AND PROCEDURES

22-A DCMR § 520 MH PROVIDER REPORTING REQUIREMENTS

22-A DCMR § 521 STAFF EDUCATION AND TRAINING

22-A DCMR § 522 VIOLATIONS OF THIS CHAPTER

22-A DCMR § 599 DEFINITIONS

22-A10 FEES AND TRAINER EXPENSES FOR THE DEPARTMENT OF BEHAVIORAL HEALTH TRAINING EVENTS

22-A DCMR § 1000 PURPOSE

22-A DCMR § 1001 FEES

22-A DCMR § 1002 TRAINER FEES

22-A DCMR § 1099 DEFINITIONS

22-A12 DEPARTMENT OF MENTAL HEALTH PRIORITY POPULATIONS RULE

22-A DCMR § 1200 PRIORITY POPULATIONS - GENERAL REQUIREMENTS

22-A DCMR § 1201 CHILDREN OR YOUTH WITH SERIOUS EMOTIONAL DISTURBANCE

22-A DCMR § 1202 PERSONS WITH SERIOUS MENTAL ILLNESS

22-A DCMR § 1299 DEFINITIONS

22-A22 SUPPORTED HOUSING SERVICES FOR MENTAL HEALTH CONSUMERS

22-A DCMR § 2200 GENERAL PROVISIONS

22-A DCMR § 2201 CORE SERVICES AGENCIES RESPONSIBILITIES FOR SUPPORTED HOUSING SERVICES

22-A DCMR § 2202 HOME FIRST SUBSIDY PROGRAM FOR MENTAL HEALTH CONSUMERS

22-A DCMR § 2203 WAIVER OF RULES

22-A DCMR § 2204 ELIGIBILITY CRITERIA

22-A DCMR § 2205 APPLICATION PROCESS

22-A DCMR § 2206 WAITING LIST

22-A DCMR § 2207 PRIORITY POPULATIONS FOR SUPPORTED HOUSING SUBSIDIES

22-A DCMR § 2208 HOME FIRST SUBSIDY PROGRAM

22-A DCMR § 2209 LANDLORD PARTICIPATION

22-A DCMR § 2210 RECERTIFICATION

22-A DCMR § 2211 CONSUMER PARTICIPATION

22-A DCMR § 2212 ELIGIBLE UNITS

22-A DCMR § 2213 VOLUNTARY RELOCATION IF RECEIVING A HOME FIRST SUBSIDY

22-A DCMR § 2214 TEMPORARY ABSENCES

22-A DCMR § 2215 EVICTIONS AND LEASE TERMINATIONS BY LANDLORDS

22-A DCMR § 2216 TERMINATION OF ASSISTANCE

22-A DCMR § 2217 RIGHT TO REVIEW

22-A DCMR § 2218 RIGHT TO A HEARING IF RECEIVING A HOME FIRST SUBSIDY

22-A DCMR § 2299 DEFINITIONS

22-A25 HEALTH HOME CERTIFICATION STANDARDS

22-A DCMR § 2500 HEALTH HOME PROGRAM