cmr-105-145.00•105 CMR 145.00 — Licensing of out-of-hospital dialysis units in Massachusetts
105 CMR 145.00 — Licensing of out-of-hospital dialysis units in Massachusetts
cmr-105-145.00105 CMR 145.00Regulation
105 CMR: DEPARTMENT OF PUBLIC HEALTH 105 CMR 145.000: LICENSING OF OUT-OF-HOSPITAL DIALYSIS UNITS IN MASSACHUSETTS Section
105 CMR 145.00 Licensing of out-of-hospital dialysis units in Massachusetts
145.001 Purpose
145.001: Purpose
145.010 Scope
145.010: Scope
145.020 Definitions
145.020: Definitions
145.025 Special Projects
145.025: Special Projects
145.099 Waivers
145.099: Waivers Staffing
145.100 Governing Body
145.100: Governing Body
145.110 Administrator
145.110: Administrator
145.120 Medical Director
145.120: Medical Director
145.121 Qualifications of Medical Director
145.121: Qualifications of Medical Director
145.122 Hours Staffed by Medical Director
145.122: Hours Staffed by Medical Director
145.123 Medical Director and Administrator
145.123: Medical Director and Administrator
145.124 Medical Staff
145.124: Medical Staff
145.125 Medical Staff By-laws
145.125: Medical Staff By-laws
145.130 On-call Practitioner
145.130: On-call Practitioner
145.140 Nurse Manager
145.140: Nurse Manager
145.141 Qualifications of Nurse Manager
145.141: Qualifications of Nurse Manager
145.142 Hours Staffed by Nurse Manager
145.142: Hours Staffed by Nurse Manager
145.150 Nursing Personnel
145.150: Nursing Personnel
145.151 Nursing Staff on Duty
145.151: Nursing Staff on Duty
145.152 Qualifications of Nursing Personnel
145.152: Qualifications of Nursing Personnel
145.153 Clinical Hemodialysis Technicians
145.153: Clinical Hemodialysis Technicians
145.160 Counseling Services
145.160: Counseling Services Physical Environment
145.200 Location of Dialysis Unit
145.200: Location of Dialysis Unit
145.210 Space Requirements per Dialysis Station
145.210: Space Requirements per Dialysis Station
145.220 Isolation Room
145.220: Isolation Room
145.225 Home Training Room
145.225: Home Training Room
145.230 Dialysis Unit Support Spaces
145.230: Dialysis Unit Support Spaces
145.240 Sinks in Treatment Area
145.240: Sinks in Treatment Area
145.245 Mechanical Ventilation
145.245: Mechanical Ventilation
145.250 Condition of Premises
145.250: Condition of Premises
145.260 Linen
145.260: Linen
145.270 Water System
145.270: Water System
145.280 Waste Disposal
145.280: Waste Disposal
145.290 Infection Control
145.290: Infection Control
145.291 Emergency Electrical Service
145.291: Emergency Electrical Service Affiliation Agreements
145.300 Affiliation Agreements Required
145.300: Affiliation Agreements Required
145.330 Affiliation Agreement for Kidney Transplantation Service
145.330: Affiliation Agreement for Kidney Transplantation Service
145.340 Affiliation Agreement for Home Dialysis
145.340: Affiliation Agreement for Home Dialysis
145.360 Form of Affiliation Agreement
145.360: Form of Affiliation Agreement
145.370 Affiliation Agreements with Out-of-state Hospitals
145.370: Affiliation Agreements with Out-of-state Hospitals Patient Care
145.400 Admission Policies and Procedures
145.400: Admission Policies and Procedures
145.410 Patient's Designated Practitioner
145.410: Patient's Designated Practitioner
145.420 Annual Patient Evaluation
145.420: Annual Patient Evaluation
145.430 Availability of Alternative Modes of Treatment
145.430: Availability of Alternative Modes of Treatment (MA REG. # 1379, Dated 11-30-18)
105 CMR: DEPARTMENT OF PUBLIC HEALTH 145.000: continued
145.440 Healthcare-associated Infection Data Collection, Submission and Reporting
145.440: Healthcare-associated Infection Data Collection, Submission and Reporting
145.450 Serious Complaint Procedure
145.450: Serious Complaint Procedure
145.455 Serious Incident Reports
145.455: Serious Incident Reports
145.460 Evaluation of Quality
145.460: Evaluation of Quality
145.470 Pharmaceutical Services
145.470: Pharmaceutical Services Medical Records
145.500 Medical Records Required for Each Patient
145.500: Medical Records Required for Each Patient
145.505 Record-keeping Facilities and Equipment
145.505: Record-keeping Facilities and Equipment
145.510 Medical Record Identification Number
145.510: Medical Record Identification Number
145.515 Responsibility for Completing Medical Record
145.515: Responsibility for Completing Medical Record
145.520 Practitioner’s Orders
145.520: Practitioner’s Orders
145.525 Telephone Orders
145.525: Telephone Orders
145.530 Responsibility for Keeping Medical Records
145.530: Responsibility for Keeping Medical Records
145.535 Medical Record System
145.535: Medical Record System
145.540 Content of Medical Record
145.540: Content of Medical Record
145.545 Safeguards against Loss and Use of Medical Records by Unauthorized Persons
145.545: Safeguards against Loss and Use of Medical Records by Unauthorized Persons
145.550 Removal of Medical Record
145.550: Removal of Medical Record
145.555 Release of Medical Record
145.555: Release of Medical Record
145.560 Medical Record Policies
145.560: Medical Record Policies Other Requirements
145.600 Procurement, Use and Storage of Blood
145.600: Procurement, Use and Storage of Blood
145.700 Emergency Preparedness Plan
145.700: Emergency Preparedness Plan
145.710 Familiarity with Emergency Preparedness Plan
145.710: Familiarity with Emergency Preparedness Plan
145.720 Provisions of Emergency Preparedness Plan
145.720: Provisions of Emergency Preparedness Plan
145.730 Fire Drills
145.730: Fire Drills
145.740 Emergency Supplies and Equipment
145.740: Emergency Supplies and Equipment Home Dialysis
145.800 Access to Home Dialysis
145.800: Access to Home Dialysis
145.805 Written Plan for Training of Home Dialysis Patients
145.805: Written Plan for Training of Home Dialysis Patients
145.810 Training Personnel and Equipment
145.810: Training Personnel and Equipment
145.815 Inspection of Equipment at Home
145.815: Inspection of Equipment at Home
145.820 Procedures for Supervision of Home Dialysis
145.820: Procedures for Supervision of Home Dialysis
145.825 Provision of Supplies to Home
145.825: Provision of Supplies to Home
145.830 Provision of Renal and Ancillary Services
145.830: Provision of Renal and Ancillary Services
145.835 Medical Records on Home Dialysis Patients
145.835: Medical Records on Home Dialysis Patients
145.845 Affiliation Agreements for Home Dialysis Patients
145.845: Affiliation Agreements for Home Dialysis Patients
145.850 Description of Home Dialysis Program
145.850: Description of Home Dialysis Program
145.900 Licensing and Related Administrative Procedures
145.900: Licensing and Related Administrative Procedures
145.910 Severability
145.910: Severability
145.001 Purpose
145.001: Purpose The purpose of 105 CMR 145.000 is to provide for the protection of the health and safety of individuals receiving dialysis in out-of-hospital dialysis units.
145.010 Scope
145.010: Scope (A) Procedures Permitted in an Out-of-Hospital Dialysis Unit. The unit shall provide dialysis and/or home training on the premises as set forth in 105 CMR 145.050 through 145.980 and, also if permitted under the terms of its license, a home dialysis program as set forth in 105 CMR 145.800 through 145.850. Each Out-of-hospital Dialysis Unit shall comply with all applicable state and federal statutes and regulations pertaining to health care facilities.
105 CMR: DEPARTMENT OF PUBLIC HEALTH
145.010 continued
145.010: continued (B) Procedures Not Permitted in an Out-of-hospital Dialysis Unit. No unit shall provide acute dialysis or any other service which under 105 CMR 130.000 may be provided only at a hospital, nor shall any unit engage in any activity that is permitted only at long-term care facilities or duties under 105 CMR 150.000.
145.020 Definitions
145.020: Definitions Back-up Dialysis means dialysis given to a patient in a situation other than the patient's usual dialysis environment. Chronic Maintenance Dialysis means the usual periodic dialysis treatments of a patient who has chronic renal disease. Commissioner means the Commissioner of Public Health or his or her designee. Department means the Department of Public Health. Direct Care Staff means registered nurses, licensed practical nurses, and trained dialysis technicians who provide direct care to patients undergoing dialysis in the unit. Direct care staff may include charge nurses, but shall not include the nurse manager, nurses assigned to dialysis training, or technicians assigned to dialyzer preparation or reuse, equipment maintenance, and water testing and purification. Governing Body means, in the case of a corporation, the board of directors, or an executive committee thereof empowered under the bylaws of the corporation to supervise the operation of the unit; or in every other case, the owner and such other individuals as are associated with the owner in the management of the unit. Healthcare-associated Infection (HAl) means a localized or systemic condition that results from an adverse reaction to the presence of an infectious agent or its toxins that: (1) occurs in a patient in an out-of-hospital dialysis unit; and (2) was not present or incubating at the time of the admission during which the reaction occurs; (3) meets the criteria for a specific infection as defined by the federal Centers for Disease Control and Prevention and its National Healthcare Safety Network; and (4) any additional elements as set forth in administrative guidelines of the Department based on the National Healthcare Safety Network. Home Hemodialysis means chronic maintenance dialysis performed at home by a trained patient with the assistance of a trained partner. Home Peritoneal Dialysis means chronic maintenance dialysis performed at home by a trained patient with or without the assistance of a trained partner. Licensed or Approved Hospital means any hospital licensed under M.G.L. c. 111, § 51. Licensed Practical Nurse means an individual who is currently licensed pursuant to M.G.L. c. 112, § 74A, to practice practical nursing in Massachusetts. National Healthcare Safety Network NHSN means the HAI tracking system by the federal Centers for Disease Control and Prevention. Nurse Practitioner means a nurse who is authorized to practice advanced practice registered nursing as a nurse practitioner by the Board of Registration in Nursing. Original License means the first license issued to a person to maintain the premises named therein, whether upon the initial establishment of the unit or subsequently upon the relocation or transfer of ownership of the unit. 11/30/18 105 CMR - 723
105 CMR: DEPARTMENT OF PUBLIC HEALTH
145.020 continued
145.020: continued Out-of-hospital Dialysis Unit or Unit means a unit, however named, maintained separate from a licensed or approved hospital or license issued thereto, whether conducted for charity or for profit, for the purpose of providing chronic maintenance dialysis to persons suffering from chronic renal disease and other dialysis as permitted by law. It shall not include a dialysis unit maintained as part of a licensed or approved hospital. Person means any individual or his estate upon his death; or a partnership, corporation, or trust or other unincorporated association; or any receiver, trustee, or other liquidating agent of any of the foregoing while acting in such capacity. Physician means an individual who is currently licensed pursuant to M.G.L. c. 112, § 2, to practice medicine or osteopathy in Massachusetts. Physician Assistant means a person who is licensed by the Board of Registration of Physician Assistants. Registered Nurse means an individual who is currently registered pursuant to M.G.L. c. 112, § 74, to practice professional nursing in Massachusetts. Renewal License means the first and each subsequent renewal of the original license to maintain premises named therein as an out-of-hospital dialysis unit. Transfer of Ownership includes, in the case of a partnership, any change in partners, and, in the case of a corporation, any transfer of 50% or more of the outstanding shares of stock in such corporation.
145.025 Special Projects
145.025: Special Projects The Department will consider proposals for special projects for the innovative delivery of dialysis services. No such proposal shall be implemented without prior written approval of the Department. The Department may impose conditions on special projects as necessary.
145.099 Waivers
145.099: Waivers The Department may waive the applicability to a particular unit of one or more of the requirements set forth in 105 CMR 145.000 if: (A) the Department finds that: (1) compliance would cause undue hardship to the unit; (2) the unit is in substantial compliance with the spirit of the requirement; and (3) the unit's non-compliance does not jeopardize the health or safety of its patients and does not limit the unit's capacity to give adequate care; and (B) the unit provides to the Department written documentation supporting its request for a waiver.
145.100 Governing Body
145.100: Governing Body The unit shall have an effective governing body or designated person or persons with full legal authority and responsibility for the governance and operation of the unit; establishing and implementing policies regarding management and operations; oversight and accountability for the quality assessment and performance improvement program; and the appointment of a qualified administrator reporting to the governing body who shall be responsible for the day-to- day operations.
145.110 Administrator
145.110: Administrator There shall be an administrator responsible for the administration of the unit. The administrator must be physically present in the unit as necessary to perform the duties of his or her position.
105 CMR: DEPARTMENT OF PUBLIC HEALTH
145.120 Medical Director
145.120: Medical Director There shall be a medical director who shall be responsible for planning, organizing, coordinating and directing the unit's professional services and for liaison with the affiliated institutions. The medical director shall be physically present in the unit as necessary to carry out these responsibilities.
145.121 Qualifications of Medical Director
145.121: Qualifications of Medical Director The medical director shall be a physician who is certified, or is an active candidate for certification, by the American Board of Internal Medicine, and who has had at least one year of formal training in chronic renal disease patient care or at least two years of experience in such care. In either case, a significant portion of the required time shall have been spent working in a dialysis unit that provides maintenance dialysis to patients with chronic renal disease.
145.122 Hours Staffed by Medical Director
145.122: Hours Staffed by Medical Director The medical director is not required to be a full time employee; provided that he or she devotes sufficient time to ensure the proper provision of professional services in accordance with the unit's by-laws and 105 CMR 145.000.
145.123 Medical Director and Administrator
145.123: Medical Director and Administrator The position of administrator and medical director may be held by the same person; provided, that such a person is able to carry out both responsibilities.
145.124 Medical Staff
145.124: Medical Staff The medical director, with the governing body, shall establish criteria for granting privileges to licensed physicians or other providers. The medical director shall review credentials of candidates for medical staff membership and make recommendations to the governing body on the initial appointment of candidates. The medical director must periodically conduct appraisals of the members and make recommendations to the governing body for reappointment of medical staff.
145.125 Medical Staff By-laws
145.125: Medical Staff By-laws The medical staff must operate pursuant to by-laws and rules approved by the governing body. The by-laws must describe the organization of the medical staff and set forth rules for its operation. The by-laws must describe the procedure for applying for medical staff privileges, and the qualifications to be met by a candidate in order for the candidate to be appointed and/or reappointed to the medical staff by the governing body.
145.130 On-call Practitioner
145.130: On-call Practitioner Whenever patients are undergoing treatment in the unit, a physician, physician assistant or nurse practitioner shall be available on-call to provide medical consultation and treatment of patients as needed. This practitioner must be on the staff of the unit and must meet such requirements for practice at the unit as the governing body may set forth in the unit by-laws. The medical director may serve in this capacity when on the premises.
145.140 Nurse Manager
145.140: Nurse Manager Each unit shall have a nurse manager, who shall direct the nursing staff in the provision of nursing services to patients.
145.141 Qualifications of Nurse Manager
145.141: Qualifications of Nurse Manager The nurse manager shall be a registered nurse with at least 12 months experience as a registered nurse and at least six months of experience in dialysis treatment and chronic renal disease patient care.
105 CMR: DEPARTMENT OF PUBLIC HEALTH
145.142 Hours Staffed by Nurse Manager
145.142: Hours Staffed by Nurse Manager The nurse manager shall be a full-time employee of the unit.
145.150 Nursing Personnel
145.150: Nursing Personnel The unit shall have on duty sufficient direct care nursing personnel to ensure that all patients undergoing dialysis have nursing care, provided by registered nurses or licensed practical nurses trained in chronic dialysis, available at all times at a ratio of at least one direct care staff member to every three patients. If dialysis is performed in more than one room of the unit, at least one nursing staff member shall be present at all times in each room in which a patient is undergoing dialysis.
145.151 Nursing Staff on Duty
145.151: Nursing Staff on Duty There shall be at least one registered nurse other than the nurse manager on duty whenever patients are undergoing dialysis in the unit and appropriately trained licensed nursing staff sufficient to meet the needs of the patients. A registered nurse may give direct patient care provided that he or she is also available to all patients for provision of any nursing care that must by law be provided by a registered nurse.
145.152 Qualifications of Nursing Personnel
145.152: Qualifications of Nursing Personnel Nursing staff shall have training or experience in chronic maintenance dialysis appropriate to their duties.
145.153 Clinical Hemodialysis Technicians
145.153: Clinical Hemodialysis Technicians Clinical hemodialysis technicians trained in chronic dialysis may assist the licensed nursing staff and be given responsibilities appropriate to their training and experience. Such responsibilities may include starting and ending dialysis, maintenance and use of dialysis equipment, surveillance of the patient's condition during dialysis, and administration of agents prescribed for regulation of blood clotting mechanisms as part of the dialysis process.
145.160 Counseling Services
145.160: Counseling Services The unit shall make available to each patient, when needed, either through its own resources or through affiliations under 105 CMR 145.300, or through another institution or agency under written agreement, the following professional services: social services, dietary counseling, mental health services and vocational counseling.
145.200 Location of Dialysis Unit
145.200: Location of Dialysis Unit The dialysis area shall be separate from other patient care and administrative activities and shall not be located in an area that provides access to such other areas.
145.210 Space Requirements per Dialysis Station
145.210: Space Requirements per Dialysis Station There shall be space between beds, in addition to that necessary for associated equipment, sufficient to allow access to provide needed care and services, prevent cross contamination, and to accommodate medical emergency equipment and staff access to the patient by at least two persons.
145.220 Isolation Room
145.220: Isolation Room A room shall be provided for isolation of potentially infectious patients which shall be physically separated from any other dialysis area, and shall be used in accordance with written policies approved by the medical director and nurse manger that provide for infection control procedures. The isolation room must be at least 110 square feet and must be equipped with a handwashing sink.
105 CMR: DEPARTMENT OF PUBLIC HEALTH
145.225 Home Training Room
145.225: Home Training Room If home training is provided in the dialysis unit, a private treatment area of at least 120 square feet shall be provided for patients who are being trained to use dialysis equipment at home. The home training room must contain a work counter, handwashing facilities and a separate drain for fluid disposal.
145.230 Dialysis Unit Support Spaces
145.230: Dialysis Unit Support Spaces There shall be adequate provision for the following support spaces in conveniently accessible locations: (A) Space for patients’ belongings; (B) Toilet and handwashing facilities for patients; (C) Toilet and handwashing facilities for staff; (D) Examination room with handwashing facilities; (E) Medication station with work counter and handwashing facilities; (F) Clean supply storage room; (G) Soiled workroom equipped with flushing rim sink, handwashing facilities, work counter, storage cabinets, waste receptacles, and soiled linen receptacle; (H) Housekeeping room with floor receptor sink; and (I) Reprocessing room. If dialyzers are reused, the unit must contain a reprocessing room sized to perform the required functions. The reprocessing room must provide for one-way flow of materials from soiled to clean. The reprocessing room must have provisions for refrigeration for temporary storage of dialyzers, decontamination/cleaning areas, sinks, a packaging area, and dialyzer storage cabinets.
145.240 Sinks in Treatment Area
145.240: Sinks in Treatment Area The unit shall provide sufficient sinks with warm water and soap available in the treatment area to facilitate handwashing.
145.245 Mechanical Ventilation
145.245: Mechanical Ventilation The unit shall provide all rooms that do not have direct access to the outside with satisfactory mechanical ventilation. The unit shall provide mechanical exhaust ventilation in the isolation room, toilet rooms, soiled workroom, housekeeping room and reprocessing room.
145.250 Condition of Premises
145.250: Condition of Premises The premises shall be maintained in good repair and in compliance with 105 CMR 410.000: Minimum Standards of Fitness for Human Habitation (State Sanitary Code: Chapter II) at all times.
145.260 Linen
145.260: Linen The unit shall make arrangements for the cleaning of linen unless only disposable linen is used. Space and equipment shall be provided for the handling and separate storage of soiled and clean linen.
145.270 Water System
145.270: Water System Water and equipment used for dialysis must meet the water and dialysate quality standards and equipment requirements as issued by the Department in guidelines, based on standards issued by the Association for the Advancement of Medical Instrumentation (AAMI).
105 CMR: DEPARTMENT OF PUBLIC HEALTH
145.270 continued
145.270: continued (A) Non-municipal Water System. Where the water supply is not the municipal water system, the unit must obtain written approval of the source of the water supply from the local Board of Health. (B) Connections to Other Piping. The water system shall have no connection to another piping system or to any fixture that presents a foreseeable risk of contamination of the water supply.
145.280 Waste Disposal
145.280: Waste Disposal The unit shall provide appropriate equipment and employ sanitary procedures for the collection, storage, and disposal of all solid wastes, including garbage, rubbish and other refuse, biological wastes and infectious materials. (A) Disposal of Infectious and Contaminated Waste. The unit shall dispose of infectious or physically dangerous medical or biological waste in accordance with 105 CMR 480.000: Minimum Requirements for the Management of Medical or Biological Waste (State Sanitary Code Chapter VIII). The unit is responsible for the disposal of medical or biological waste generated on its licensed premises and for any such waste generated at any home dialysis program for which the unit provides supplies and services pursuant to 105 CMR 145.825 and 105 CMR 145.830. (B) Disposal of Non-contaminated Solid Wastes. Non-contaminated solid wastes shall be collected, stored, and disposed of in a manner that will prevent the transmission of disease, not to create a nuisance or fire hazard and not to provide a breeding place for insects or rodents. Such solid wastes shall be stored, either indoors or out-doors, in a sanitary rodent-proof, fire-proof, non-absorbent, water-tight container. (C) Containers for Waste Disposal. Containers used to collect or store solid wastes shall be emptied and cleaned as necessary to maintain a sanitary environment.
145.290 Infection Control
145.290: Infection Control (A) The unit shall have and must follow written policies and procedures approved by the medical director and nurse manager for infection control within the unit. (B) Such policies and procedures shall include, but need not be limited to the following: (1) Standards and procedures for housekeeping and sanitation; (2) Standards and procedures for aseptic techniques to be used; (3) Procedures for surveillance, reporting, evaluating, and keeping records of infections among patients and personnel, with particular emphasis on sub-clinical hepatitis; (4) A definition of hepatitis infection for the purpose of such surveillance, and specific indications of the need for and procedures to be used in isolation; and (5) A policy pertaining to eating and drinking in the dialysis area or areas.
145.291 Emergency Electrical Service
145.291: Emergency Electrical Service (A) An emergency source of electrical power shall be provided on the premises of the dialysis facility. (B) The source of the emergency electrical service shall be as follows: an emergency electrical generating set, including prime mover and generator, equipped with an automatic transfer switch, which will transfer within ten seconds, and shall be reserved exclusively for supplying the emergency electrical system. The generator set(s) shall have sufficient capacity and proper rating to meet the maximum expected demand of the Essential Electrical System at any one time. (C) The emergency electrical services shall be provided to circuits as follows: (1) Lighting. (a) All task lighting, exitways, exit signs, exit directional signs, exit doorways, stairways, corridors, and lobby.
105 CMR: DEPARTMENT OF PUBLIC HEALTH
145.291 continued
145.291: continued (b) Patient treatment rooms/cubicles, nursing station, medication preparation area, clean workroom, soiled workroom, equipment storage room, mechanical rooms and patient lounge area. (c) Generator set location and switch gear location. (2) Equipment. (a) Dialysis distribution systems and related equipment, and, if provided, the water treatment system. (b) A minimum of one duplex receptacle on each side of patient bed or chair. (c) One duplex receptacle in the equipment breakdown room. (d) Corridor receptacles in the patient treatment area. (e) Essential refrigerators. (f) Telephone equipment, nurses call and intercom systems that depend on electrical power supplied by the facility. (g) Central batch delivery equipment and related systems, if provided. (h) HVAC systems. (i) Fire alarm and extinguishing systems. (D) The generator must be checked at least quarterly under the operating load to ensure its proper operation. (E) Records of routine tests as well as periodic maintenance checks must be maintained in the facility's files and be available for review.
145.300 Affiliation Agreements Required
145.300: Affiliation Agreements Required The unit shall affiliate with licensed or approved hospitals, other institutions, and agencies in such a manner as to ensure that its patients, whether dialyzed at the unit or at home, can receive inpatient care, routine and emergency dialysis and other hospital services, and emergency medical care 24 hours a day, seven days a week. The agreement must ensure that hospital services are available promptly to the unit’s patients when needed and include reasonable assurances that patients from the unit are accepted and treated in emergencies.
145.330 Affiliation Agreement for Kidney Transplantation Service
145.330: Affiliation Agreement for Kidney Transplantation Service The unit shall have an affiliation agreement with at least one hospital for kidney transplantation services, including: (A) Tissue typing and matching, surgical transplant capability, kidney perfusion or other storage devices, immunology services directly or by affiliation; (B) Availability of surgeons qualified by skill or training in the transplantation of kidneys; (C) Availability of physicians qualified by skill or training in the management of post transplant patients.
145.340 Affiliation Agreement for Home Dialysis
145.340: Affiliation Agreement for Home Dialysis The unit shall have an affiliation agreement with at least one hospital or out-of-hospital dialysis unit for provision of home dialysis training program conforming to 105 CMR 145.800 through 145.850 if such a program is not provided by the unit.
145.360 Form of Affiliation Agreement
145.360: Form of Affiliation Agreement Every affiliation agreement shall be in writing and shall set forth the policies and procedures that will govern the referral and transfer of patients between the unit and the licensed or approved hospital affiliated institution or agency, including patient care referral information.
105 CMR: DEPARTMENT OF PUBLIC HEALTH
145.370 Affiliation Agreements with Out-of-state Hospitals
145.370: Affiliation Agreements with Out-of-state Hospitals Units near to or accessible to hospitals in other states may maintain affiliation with those hospitals for purposes of 105 CMR 145.310, 145.320, and 145.330 provided, that those hospitals have been approved to provide chronic maintenance dialysis or transplantation services by the respective state's designated authority or the federal government.
145.400 Admission Policies and Procedures
145.400: Admission Policies and Procedures A patient beginning dialysis or transferring from another dialysis unit shall be admitted to the unit only after completion of a written evaluation by a physician on staff at the out-of- hospital dialysis unit. Written admission criteria must be developed to identify patients who require initiation of dialysis in a hospital, prior to transfer to an out-of-hospital dialysis unit.
145.410 Patient's Designated Practitioner
145.410: Patient's Designated Practitioner The care of each patient at the unit shall be under the supervision of a qualified physician, physician assistant, or nurse practitioner of the patient's choice or acceptable to the patient. This practitioner must be on the staff of the unit and must meet such requirements for practice at the unit as the governing body may set forth in the unit by-laws.
145.420 Annual Patient Evaluation
145.420: Annual Patient Evaluation Each patient shall be evaluated at least annually by an interdisciplinary team composed of a physician, nurse, social worker, dietician or others involved in the care of the patient as to the appropriateness and effectiveness of the treatment received and the need for continuation of or change in treatment. Such consideration shall include evaluation of the appropriateness of at least home dialysis, self-dialysis and transplantation. A record of each evaluation is to be made part of the patient’s clinical record.
145.430 Availability of Alternative Modes of Treatment
145.430: Availability of Alternative Modes of Treatment All patients shall have access to alternative methods of treatment of chronic renal disease such as home dialysis or transplantation. Evidence of such access shall be available in the contents of the written agreements with hospitals and the unit's own policies, including written criteria for selection of patients for home dialysis.
145.440 Healthcare-associated Infection Data Collection, Submission and Reporting
145.440: Healthcare-associated Infection Data Collection, Submission and Reporting (A) Each free-standing dialysis unit shall: (1) register with the NHSN; and (2) grant access to the Department, in accordance with guidelines of the Department, to healthcare associated infection data elements reportable to the NHSN. (B) Each free-standing dialysis unit shall collect and submit to the NHSN, and then grant access, as provided under 105 CMR 145.440(A), to the Department, to healthcare-associated infection data elements. (C) Each free-standing dialysis unit shall collect and submit to the Department other data related to infection control, including process measures, in accordance with guidelines of the Department.
145.450 Serious Complaint Procedure
145.450: Serious Complaint Procedure Each unit shall develop a written procedure that ensures prompt and complete investigations of all serious complaints that are filed against the unit, employees of the unit or members of its professional staff. The procedure shall include, at a minimum, the following provisions:
105 CMR: DEPARTMENT OF PUBLIC HEALTH
145.450 continued
145.450: continued (A) Designation of a senior member of the unit administration as the person responsible for overseeing the investigation of serious complaints lodged against the unit, an employee, or a member of the professional staff; (B) Establishment of a reporting procedure that ensures that the designated administrator will receive reports of serious complaints within one day from unit staff, in writing; (C) Development by the designated administrator of a written process for investigation, which must include the following: (1) A process of fact-gathering that he or she will utilize, including provision for interviewing of the complainant, patient, and relevant witnesses; (2) Creation of a complaint file that includes the original report of complaint, progress reports as investigation is carried out and outcome of investigation including action taken, if any; and (3) Notification of the complainant of the outcome of the investigation. (D) The complaint files shall be available for inspection by agents of the Department.
145.455 Serious Incident Reports
145.455: Serious Incident Reports (A) A unit shall immediately report to the Department, pursuant to Department guidelines, any of the following that occurs on premises covered by its license: (1) death that is unanticipated, not related to the natural course of the patient’s illness or underlying condition, or that is the result of an error or other incident as specified in guidelines of the Department; (2) full or partial evacuation of the facility for any reason; (3) fire; (4) suicide; (5) serious criminal acts; (6) pending or actual strike action by its employees, and contingency plans for operation of the unit; or (7) any other serious incident or accident as specified in guidelines of the Department. (B) A unit shall immediately report to the Department, for any patient treated at the unit, any suspected instance(s) of abuse, neglect, mistreatment of that patient, or misappropriation of that patient’s property, at or by a nursing home, rest home, home health, home maker or hospice facility.
145.460 Evaluation of Quality
145.460: Evaluation of Quality (A) Each unit shall establish an organized, comprehensive program that is adequate to regularly review and evaluate the quality of care provided. The program shall: (1) be defined in writing and approved by the governing body; (2) identify an individual to be responsible for the implementation and continuity of the program; (3) be reevaluated at least monthly; and (4) describe the mechanisms in effect to identify and resolve problems. (B) The findings of the program shall, as appropriate, be utilized in the revision of facility policies and procedures.
145.470 Pharmaceutical Services
145.470: Pharmaceutical Services If controlled substances are stored and administered at the facility directly to patients, the facility shall register with the Department pursuant to M.G.L. c. 94C, § 7 and must comply with the provisions for storage and administration of controlled substances pursuant to the Federal Food, Drug and Cosmetics Act, M.G.L. c. 94C, and 105 CMR 700.000: Implementation of M.G.L. c. 94C.
105 CMR: DEPARTMENT OF PUBLIC HEALTH
145.500 Medical Records Required for Each Patient
145.500: Medical Records Required for Each Patient The unit must maintain a medical record for every patient admitted to the out-of-hospital dialysis unit from the time of admission to the time of discharge. The unit must maintain a current medical record for every patient whose home dialysis is under the supervision of the unit.
145.505 Record-keeping Facilities and Equipment
145.505: Record-keeping Facilities and Equipment The unit shall maintain facilities and equipment, appropriately located and adequate to ensure the accurate processing, checking, indexing, filing and prompt retrieval of all medical records and their safe storage.
145.510 Medical Record Identification Number
145.510: Medical Record Identification Number Each medical record shall carry a unique identifying number from the time of the patient's initial admission.
145.515 Responsibility for Completing Medical Record
145.515: Responsibility for Completing Medical Record The unit must ensure the completion of a medical record. The record shall be completed by a physician, physician assistant, or nurse practitioner.
145.520 Practitioner’s Orders
145.520: Practitioner’s Orders Physician, physician assistant, or nurse practitioner orders shall be legibly entered into the medical record and shall be dated and signed by the physician, physician assistant, or nurse practitioner making the order.
145.525 Telephone Orders
145.525: Telephone Orders Telephone orders shall be signed and dated by the physician, physician assistant, or nurse practitioner within 72 hours.
145.530 Responsibility for Keeping Medical Records
145.530: Responsibility for Keeping Medical Records The unit shall designate a person to be in charge of keeping medical records in the manner prescribed in 105 CMR 145.000.
145.535 Medical Record System
145.535: Medical Record System Each unit shall develop a workable system for identifying, filing, indexing, and retrieving medical records.
145.540 Content of Medical Record
145.540: Content of Medical Record (A) General Requirement. Medical records shall be retained for six years after the unit’s last treatment of a patient. The medical record shall be sufficiently detailed to enable effective continuing care to the patient, and to enable communication among the medical professionals contributing to the patient’s care. (B) Specific Provisions. Each medical record shall include at least the following: (1) Identification data including the patient's name, address, age and next of kin, and guardian, if any; (2) The name, address, and telephone number of the patient's designated practitioner; (3) History of present illness, past medical history, and family medical history;
105 CMR: DEPARTMENT OF PUBLIC HEALTH
145.540 continued
145.540: continued (4) Records of initial and periodic physical examinations at intervals to be stated in written policies, approved by the medical director including all findings resulting from an assessment of all systems of the body; (5) Reports of all diagnostic procedures, tests, evaluations and examinations; (6) Records of treatment including order sheets, transfusion records, and record and date of each dialysis treatment; (7) Records of complications of treatment, accidents or untoward incidents regarding patients; (8) Progress notes, which shall be recorded in sufficient detail to delineate the course and results of treatment; (9) Information pertaining to hospital admissions during the patient's course of treatment, including a discharge summary from the hospital whenever possible; (10) A record of the patient's evaluations by an interdisciplinary team as set forth in 105 CMR 145.420. Records of annual evaluations shall list other methods of treatment considered and the indications for continued chronic maintenance dialysis, home dialysis, self-dialysis, transplantation or other methods of treatment; (11) Discharge summary or clinical resume, which shall briefly recapitulate the significant findings and events of the patient's dialysis treatments and arrangements made for future care; and (12) Date of admission and discharge.
145.545 Safeguards against Loss and Use of Medical Records by Unauthorized Persons
145.545: Safeguards against Loss and Use of Medical Records by Unauthorized Persons The unit shall develop policies to safeguard its medical records and the information therein against loss and use by unauthorized persons.
145.550 Removal of Medical Record
145.550: Removal of Medical Record No medical records shall be removed from the unit except as required by legal action. In the event removal is required by legal action, a duplicate shall be made and kept at the unit until such time as the original is returned from the court.
145.555 Release of Medical Record
145.555: Release of Medical Record Prior to release of any information from a medical record to any person not authorized by law to receive such information, the unit shall have, and place in the record, the written consent of the patient, or the patient’s appropriate legal representative.
145.560 Medical Record Policies
145.560: Medical Record Policies The unit shall have written policies, either in the unit's by-laws or established by the administrator pursuant to such by-laws, with respect to at least the following: (A) Use of Records by Authorized Personnel. Use of records by authorized personnel; (B) Transmittal Outside the Unit of Information from Medical Record. Transmittal outside the unit of information from a record, to an authorized person as defined in the by-laws as approved by the governing body; (C) Designation of Persons Authorized to Receive Medical Record. Designation of persons authorized under 105 CMR 145.560(A) and (B) to receive information from a record by either name of person or class of personnel or duty assignment, or any combination of such means; and (D) Release of Information from Medical Records Outside the Unit. Release of information from a record outside the unit to any other person, including a list, supported by advice of counsel to the unit, of such classes of persons who, by law, are entitled to access to such information without the consent provided for under 105 CMR 145.555.
105 CMR: DEPARTMENT OF PUBLIC HEALTH
145.600 Procurement, Use and Storage of Blood
145.600: Procurement, Use and Storage of Blood The unit shall obtain blood from a blood bank immediately prior to its administration. All blood so obtained shall be identified, stored, handled and administered in accordance with 105 CMR 135.000: Use of Blood, Blood Components and Derivatives for the Purpose of Transfusion.
145.700 Emergency Preparedness Plan
145.700: Emergency Preparedness Plan Each unit shall have and maintain a comprehensive written emergency preparedness plan for staff and patients.
145.710 Familiarity with Emergency Preparedness Plan
145.710: Familiarity with Emergency Preparedness Plan Every staff member shall be familiar with the plan and be able to execute his or her responsibility under the plan. A copy of the plan shall be available to members of the staff, and to any other person on request. Staff shall ensure that patients have a copy of the plan and are trained in emergency preparedness. Emergency preparedness training shall be documented.
145.720 Provision of Emergency Preparedness Plan
145.720: Provision of Emergency Preparedness Plan The emergency preparedness plan shall specify persons to be notified, location of alarms and fire extinguishers, evacuation routes, procedures for evacuation of persons with disabilities, and assignment of specific responsibilities by name or title of employee. The plan shall include provisions for direction and control, communication, alerts and warnings, and evacuation and/or closure of the unit.
145.730 Fire Drills
145.730: Fire Drills Fire drills shall be conducted for all staff at least twice a year at varied times, including two drills per work shift per year. The unit shall maintain records that identify the dates and attendance at such drills.
145.740 Emergency Supplies and Equipment
145.740: Emergency Supplies and Equipment The unit shall maintain on the premises and immediately available at all times emergency drugs, including, at a minimum, drugs to treat allergic and hypoglycemic reactions, and medical supplies and equipment including, but not limited to, oxygen, airways, suction, artificial resuscitator, and an automated external defibrillator or, if appropriately trained staff are available, a defibrillator.
145.800 Access to Home Dialysis
145.800: Access to Home Dialysis Every unit shall have a home dialysis program or provide its patients access to such a program through affiliation under 105 CMR 145.340.
145.805 Written Plan for Training of Home Dialysis Patients
145.805: Written Plan for Training of Home Dialysis Patients There shall be a written plan for the training of patients and partners in home dialysis.
145.810 Training Personnel and Equipment
145.810: Training Personnel and Equipment There shall be training personnel and equipment for instructing patients and partners in home dialysis.
145.815 Inspection of Equipment at Home
145.815: Inspection of Equipment at Home There shall be policies and procedures for supervision of installation and inspection of equipment in the home. These policies and procedures shall be approved by the medical director and director of nursing.
105 CMR: DEPARTMENT OF PUBLIC HEALTH
145.820 Procedures for Supervision of Home Dialysis
145.820: Procedures for Supervision of Home Dialysis There shall be procedures approved by the medical director and director of nursing for supervision of initial dialysis at home.
145.825 Provision of Supplies to Home
145.825: Provision of Supplies to Home There shall be a continuing program for arranging for the provision of supplies to patients at home.
145.830 Provision of Renal and Ancillary Services
145.830: Provision of Renal and Ancillary Services Each patient on home dialysis shall have available any renal and ancillary services necessary for his/her care on the same basis as patients being dialyzed in the unit.
145.835 Medical Records on Home Dialysis Patients
145.835: Medical Records on Home Dialysis Patients Clinical records shall be maintained for patients in a home dialysis program and maintained by the unit in the same manner as set forth in 105 CMR 145.500 through 145.560.
145.845 Affiliation Agreements for Home Dialysis Patients
145.845: Affiliation Agreements for Home Dialysis Patients Each patient on home dialysis shall, under the affiliation agreement of the unit, have access to the services of affiliate hospitals on the same basis as patients being dialyzed in the unit.
145.850 Description of Home Dialysis Program
145.850: Description of Home Dialysis Program The unit shall have and maintain a written description of the nature and the scope of the program which shall be available upon request to any patient or other person. The responsibilities of each participating institution or agency shall be set forth in this description.
145.900 Licensing and Related Administrative Procedures
145.900: Licensing and Related Administrative Procedures Licensing and related administrative procedures for out-of-hospital dialysis units shall be the same as those set forth in 105 CMR 140.101 through 140.150.
145.910 Severability
145.910: Severability The provisions of 105 CMR 145.000 are severable. If any provision herein is declared unconstitutional or invalid by a court of competent jurisdiction, the validity of the remaining portions shall not be so affected. REGULATORY AUTHORITY 105 CMR 145.000: M.G.L. c. 111, §§ 3, 51A and 53.
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